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VA-Based Peritoneal Dialysis Program Feasibility Considerations and Process Outline

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Wed, 04/12/2023 - 11:26

Compared with hemodialysis (HD), peritoneal dialysis (PD) offers comparable survival and superior patient-centered and health services outcomes.1,2 This has prompted repeated calls over the past 2 decades for policies to increase the use of home dialysis and, more specifically, for PD in the United States.3,4

Veterans comprise nearly 10% of the population with end-stage kidney disease (ESKD) burden; > 50,000 US veterans are currently on dialysis.5,6 A majority of these veterans receive their chronic kidney disease (CKD) care through their affiliated US Department of Veterans Affairs (VA) medical centers (VAMCs).

figure 1
However, there are only 71 hospital-affiliated or free-standing HD and 28 outpatient PD units within the Veterans Health Administration (VHA) (Figure 1). Together, these units serve only about 3500 veterans on HD and about 300 veterans with PD. More than 90% of veterans receive their dialysis care from non-VA facilities. Thus, veterans progressing from CKD to ESKD commonly need to transition their VA-based nephrology care to non-VA facilities, causing fragmentation of care during a medically fragile period. Such transitions adversely impact the quality of ESKD care and reduce the probability of PD use. PD use among veterans is lower (~7%) compared with the general ESKD population (~12%).7

To address these needs, the VHA National Kidney Disease Program (NKDP) formed a 4-member PD workgroup in 2019. Considering the breadth of challenges involved, the PD workgroup broadly designed its approach based on the I CARE (Integrity, Commitment, Advocacy, Respect, and Excellence) VA Core Values.
figure 2
The workgroup devised a conceptual model with 3 focus areas, each comprising a subgroup led by a workgroup member: respecting the veteran’s choice for PD, advocating for universal access to PD, and providing excellence in PD care within the VHA (Figure 2). While the passage of the Choice Act (2014) and the Mission Act (2018) was recognized to have increased access to PD for veterans through non-VA purchased care, lack of availability within the VA infrastructure was considered a significant residual limitation to greater PD use.8

This review focuses on the initial deliberations of the PD access subgroup and provides a guide to establishing a new local VA PD program.
figure 3
We describe the process by dividing it into 3 operational phases: examining the prerequisites, analyzing clinical and financial feasibility, and outlining the process of administrative approval (Figure 3).

 

 

Step 1: Prerequisites

A functional nephrology service is a bedrock prerequisite for establishing a new PD program. A clinician champion capable of leading the effort is equally necessary. Occasionally, the prevalent ESKD economic and health care burden prompts local VAMC leadership to consider a new PD program to improve the quality or availability of services. More commonly, though, the nephrology section and the clinician champion are the first to recognize the need. In either scenario, the champion will require support and advocacy at multiple levels of local leadership, ie, the section or department chief, facility chief of staff, VAMC director, and the Veterans Integrated Service Network (VISN) director. The foremost task for the champion is to assess local clinical and infrastructure needs.

Goal Alignment

Any new VA nephrology program needs to be evaluated for its overall congruence with the local and national VA missions to improve the accessibility, integration, quality, and innovation of care for veterans. The following considerations are likely to apply to many VA systems.

Accessibility. A VHA directive recommends that all veterans be provided with the opportunity to choose and use any form of dialysis, especially home dialysis.9 Transitioning a veteran seamlessly from advanced CKD to PD requires the execution of multiple sequential processes in the pre-ESKD period, beginning with early identification of advanced CKD, timely referral to nephrology, education for shared dialysis decision making, coordination of care, and PD training and therapy.10 Splitting this sequence between VA and community-based care creates obstacles, including multiple approvals through VA Community Care Services that may substantially increase wait time and effort. This onerous process may be a significant deterrent against pursuing PD and increases the odds of emergency or inpatient initiation. Furthermore, the lack of PD availability limits the knowledge and experience among staff designated to assist veterans, which may result in inappropriate advocacy for HD or delay the transition to PD. Together, these processes can increase morbidity and health care use, and significantly delay or eliminate PD. Finally, many veterans reside in rural or remote areas where the expertise and the availability of PD may be unreliable. Establishing PD services within the local VAMC can improve access to PD, reduce the lead time needed to coordinate the transition to ESKD, and assist individual veterans in making an informed choice about dialysis. The program champion will need to identify and highlight all accessibility barriers within their business plan.

Integration. Many veterans receiving dialysis care at community-based facilities continue to receive nonnephrology care in the VA. This creates a parallel health care system with concerns for duplication of efforts and processes, suboptimal quality of care, and increased risk of medical errors. Establishing VA PD services increases access and integration of nephrology with other VA care.

Excellence. Studies of many chronic diseases have shown superior patient satisfaction and equal or superior quality of care delivered by the VA compared with that of non-VA facilities.11-14 Similarly, mortality rates for veterans receiving CKD and ESKD care in VA are lower compared with those at non-VA facilities.15-17 While these outcomes have not been examined for PD, integration of PD with VA care may lead to an improved overall quality of care and greater loyalty to the VA.

Innovation. Due to its integrated health care infrastructure, the VA is uniquely positioned to implement patient-centered and evidence-based pre-ESKD interventions that may improve outcomes. Prior studies have shown that pre-ESKD kidney disease education (KDE) improves pre- and post-ESKD outcomes, reduces health care costs, and leads to higher selection and use of home dialysis therapies.18-20 The VA recommends that all veterans with advanced CKD be provided access to pre-ESKD care and KDE. Unfortunately, KDE is uncommon among non-VA clinicians. A recent USRDS analysis reported that < 1% of patients with ESKD received pre-ESKD KDE.21 The ongoing Evaluate and Assess the effects of Comprehensive Pre-ESKD kidney disease Education on home dialysis in Veterans Trial (NCT04064086) should provide further evidence.

 

 

Step 2: Feasibility

A business plan requires the realistic projections of the costs and accounting for gains of the new clinical program. While there is limited guidance on personnel requirements when planning a PD program, we provide estimated resources needed to successfully establish and run a PD program (eAppendix 1, available online at doi:10.12788/fp.0356).

Clinical Considerations

Secondary or tertiary care VAMCs with multiple medical and surgical specialties routinely provide complex inpatient care. For these facilities, the lack of inpatient PD poses an obstacle to the provision of specialized nonnephrology care to veterans with ESKD, who are frequent users of such complex care. These considerations argue for the need for at least inpatient PD services at VAMCs that provide complex medical care for many veterans receiving PD in the community.

Deliberations for outpatient PD programs should be based on the clinical demands of ESKD care, the number of veterans likely to use PD, and growth projections. While there is no established minimum number that guarantees cost-effectiveness, most existing VA outpatient PD programs provide services for about 5 to 25 veterans. A local census can provide estimations of future PD needs. Travel considerations (ie, distance, terrain, traffic) may affect eligibility for purchased care and the decision where to receive PD. Many veterans may prefer PD from the local VAMC if it is convenient and allows them to maintain centralized VA care. Potential patients can be surveyed to gauge interest in receiving VA-based PD. Facilities providing structured pre-ESKD KDE may hold greater potential for PD growth, and it is important to highlight KDE infrastructure in the business plan.

Infrastructure

Spatial needs including clinic space and storage space for consumables, supplies, and equipment should be part of infrastructure requirements. The program champion may need to examine the available space for suitability and adequacy of the PD program early in the process. Ventilation renovations in the PD rooms should be incorporated into budget calculations. Water access for handwashing and PD effluent drainage should be confirmed, and if the program intends to establish home HD, additional considerations for the storage and water supply may be required. The VHA Handbook outlines the infrastructure requirements for a dialysis program.22 The VA has established national vendor contracts for dialysis equipment and consumables. However, a new PD program may need further guidance regarding the local agencies that provide administrative support and assist patients.

Telehealth technology has enabled many VAMCs to overcome geographical barriers for rural veterans.23 Ongoing expansion of community-based outpatient clinics (CBOCs) to include more rural locations is improving access to specialty care, while the launch of VA Video Connect (VVC) has further improved outreach. Investigators from Minneapolis have demonstrated the feasibility of multidisciplinary home-based telehealth management of veterans with CKD.24 Several existing nephrology sections across the VHA use a combination of VVC and CBOC-facilitated clinic visits to provide some pre-ESKD and ESKD care, including KDE, PD home visits and training, and comprehensive ESKD care visits. Recent changes in the clinical care pattern during the COVID-19 pandemic have further eased ESKD telehealth protocols. Integrating the projected use of telehealth in collaboration with existing resources available through the VHA NKDP can allow the local champion to improve the financial feasibility and long-term success of a new PD program.

 

 

Clinicians

Experience and expertise in managing PD vary among nephrologists. A recent survey found that only 11% of second-year nephrology trainees felt fully prepared to manage PD patients and 27% felt that they were minimally prepared.25 Thus, it is important to ensure that adequately trained nephrologists are available locally before initiating a new program, and if needed, coverage across VHS or VISN can be explored. One potential method to enhance practitioner comfort in PD is the use of existing peer-to-peer education through the VA Kidney Specialty Care Access Network-Extension for Community Health care Outcomes program that links health care professionals in rural areas with specialists at a tertiary care center.23 Nurses are a primary pillar for the success of home dialysis programs and the lack of a trained nursing workforce can be a significant limitation. Similarly, while the placement and management of complications related to PD catheters are not technically challenging, the availability of interventionists (either a surgeon or trained interventional radiologist) should be part of the business plan.

Financial Considerations

The financial considerations involving a new PD program within the VHA are complex (eAppendix 2, available online at doi:10.12788/fp.0356). ESKD is one of the most complex and costly comorbidities. It is a major determinant of the expenditure and revenue generation for facilities. The Veterans Equitable Resource Allocation system classifies ESKD on repeated dialysis as price category 10, indicating high complexity and cost. The VAMC workload and facility budget allocation is assessed annually and increases as the population of price group 10 veterans increases. VHA also provides additional Veterans Equitable Resource Allocation funds to VAMCs, which can improve the bottom line for VA-based dialysis units. Providing PD facilitates outpatient and inpatient management of comorbidities, allowing for substantial cost savings while improving the quality of nonrenal care. Outsourcing dialysis care can reduce the administrative burden, although, it deprives the VAMC of all dialysis-associated revenues while bearing the cost of all nonrenal and some renal care. The net effect is reduced facility productivity. In aggregate, establishing a local dialysis program requires greater financial resources for the capital and personnel costs; however, if captured appropriately these funds can be a major source of revenue and savings for the local VAMC.

Indirect costs are important for financial projections. Most community dialysis units operate as outpatient units, whereas all but a handful of the VA dialysis units operate within or near a VAMC. As a result, the VA units providing maintenance dialysis are regularly classified as inpatient centers while providing largely outpatient services, which negatively impacts overhead cost calculations. The predominant use of in-center HD as the default modality further sets an erroneously high baseline for the indirect cost of the VA-based PD services, especially considering that the principal savings of the home dialysis are through the reduction in the labor and capital costs. A rudimentary make-buy model for the in-center HD is available through the NKDP, and establishing a similar model for PD programs may be useful.

Cost considerations also may vary based on the model of ESKD care used locally. Of the 71 hospital-based and free-standing VA HD facilities, only 33 provide PD services, with 5 units providing only inpatient PD. The financial burden of establishing a fully operational outpatient PD program will be based on whether it is targeting a new unit or is expanding. The costs for equipment rental, disposables, and supplies vary based on the VA contract negotiations but are standardized across the nation with approved cost-of-living geographic adjustments. Caution needs to be exercised in employing a phased-hiring approach, as newer programs may require proportionally larger nursing resources due to greater needs for KDE, transitioning services, and training for PD. A target census-based hiring schedule should be negotiated with leadership before launch. If existing labor mapping does not allow for cross-coverage, part-time positions for physicians may be considered. Travel nurses, especially for PD training, can be considered to meet labor needs when long-term projections prohibit permanent full-time hires.

Finally, the balance sheet of a new program needs to account for different scenarios. In addition to nephrology costs, outsourcing veterans for PD services incurs multiple costs (eg, administrative, social work). Facilities with inpatient PD services alone are likely already bearing a component of the medications (including antibiotics) and/or surgical costs for their outsourced patients. These hidden costs are infrequently counted in projections. Facilities without inpatient PD cannot provide complex nonrenal care to ESKD patients on PD, even when the center is well equipped to provide it. These facilities also bear the cost of outsourcing even for complications related to PD. While a full estimation of these services varies, the hidden cost savings of many procedures or inpatient admissions, such as cardiovascular or musculoskeletal surgeries, can exceed those of dialysis in this complex population.

 

 

Step 3: proposal

There are no standardized formats for presenting a VHA business proposal; however, this outline provides a template. The business proposal should be designed to effectively communicate the collective data that describe the needs and requirements of a PD program to the local, regional, and national leadership. Not every rationale presented here will apply to an individual proposal and the local champion will need to tailor their rationale for their locale. A sample business plan is shown in eAppendix 3 (available online at doi:10.12788/fp.0356). VHA Handbook of dialysis requires that a PD nurse has a minimum of 12 months of nursing experience with at least 3 months of PD experience.25 Nursing training, education, and support should be discussed with nursing leadership and included in the business plan. Similarly, arrangements for laboratory, pharmacy, and prosthetics services and/or logistics to facilitate procurement of the needed devices, disposables, and supplies are essential and should be highlighted in the business plan.

Approval Process

figure 4
Though the initial explorations are conventionally undertaken with the support of the local leadership, starting a PD program is considered an augmentation of clinical services and thus requires multistage VHA approvals (Figure 4). The business proposal progresses through the local medicine service leadership and chief of staff to the facility director. The rationale presented in this review is general and has been drawn from the collective experience of authors and under the guidance of the VHA NKDP. However, it still requires deliberation by the local leadership, comprised of nonnephrology clinicians and administrative professionals to ensure its soundness and sustainability. Once approved locally, the VISN chief medical officer aided by the opinions from the NKDP office conducts a thorough evaluation of infrastructure allocations, supplies and support services, skills, competencies, and the privileges of all clinical and ancillary staff, and may conduct a site visit by an expert panel through the responsible clinical program office. The VISN director may also request changes to match any local mandates before approvals. Once approved, the VISN office simultaneously forwards the proposal to several services, including the Office of Nursing Services and the Office of Patient Care Services, which reviews the proposal for the appropriateness and determines the need for an on-site review before approval. These composite reviews and recommendations guide the highest offices in finalizing the decision, with the final approvals from the Under Secretary for Health.

Postapproval Process

Once approved, the champion will need to work closely with various services and managers to oversee infrastructural renovations and execute the hiring plans, establish standard operating procedures (SOPs), standardize staff proficiencies and functional statements, and finalize quality assessment parameters. Home dialysis standards have been addressed by NKDP and The Joint Commission. While PD requires home visits to assess the appropriateness of the environment, the PD program is accredited under hospital-based therapy. Standards and performance metrics should be incorporated into all the VA PD programs for standardization and assessment. Based on guidance from the VHA Handbook, quality metrics, such as dialysis adequacy, and rates of infection should be monitored and reviewed. The dialysis director may need to consider more frequent program evaluations in the first year to ensure appropriate troubleshooting. The VA infrastructure has developed the resources for a central repository for the PD SOPs and quality metrics, which can be obtained and adapted for the local program. Similarly, veteran satisfaction can be assessed through existing resources. Finally, the dialysis director can join the National VHA Dialysis Director listserv for regular updates on the existing and new VHA policies and NKDP updates.

Conclusions

Establishing a new PD program within a local federal infrastructure can appear daunting, both in terms of planning as well as approvals. However, the provision of home-based dialysis therapies may be beneficial to those in rural settings with limited access to in-center dialysis modalities as well as to those who seek autonomy and lifestyle independence in their medical care. Collaborations with the VHA NKDP or PD workgroup can help overcome many of the procedural hurdles, provide guidance about infrastructure and resource allocation and utilization, and provide easy access to established SOPs and quality parameters.

Acknowledgments

We acknowledge the late Dr. Catherine Do for her significant contribution to this manuscript. We also extend our sincere thanks to Dr. Holly Mattix-Kramer (Edward Hines Jr. Veterans Affairs Hospital and Loyola University Medical Center) for her prompt and valuable feedback on this manuscript.

References

1. Jung HY, Jeon Y, Park Y, et al. Better quality of life of peritoneal dialysis compared to hemodialysis over a two-year period after dialysis initiation. Sci Rep. 2019;9(1):10266. Published 2019 Jul 16. doi:10.1038/s41598-019-46744-1

2. Wong B, Ravani P, Oliver MJ, et al. Comparison of patient survival between hemodialysis and peritoneal dialysis among patients eligible for both modalities. Am J Kidney Dis. 2018;71(3):344-351. doi:10.1053/j.ajkd.2017.08.028

3. Chan CT, Collins K, Ditschman EP, et al. Overcoming barriers for uptake and continued use of home dialysis: an NKF-KDOQI Conference report. Am J Kidney Dis. 2020;75(6):926-934. doi:10.1053/j.ajkd.2019.11.007

4. Executive Order 13879: Advancing American kidney health. Fed Regist. 2019; 84(135):33817-33819. https://www.govinfo.gov/content/pkg/FR-2019-07-15/pdf/2019-15159.pdf

5. Patel TG, Pogach LM, Barth RH. CKD screening and management in the Veterans Health Administration: the impact of system organization and an innovative electronic record. Am J Kidney Dis. 2009;53(suppl 3):S78-S85. doi:10.1053/j.ajkd.2008.07.051

6. Saran R, Pearson A, Tilea A, et al. Burden and cost of caring for US veterans with CKD: initial findings from the VA Renal Information System (VA-REINS). Am J Kidney Dis. 2021;77(3):397-405. doi:10.1053/j.ajkd.2020.07.013

7. Sloan CE, Coffman CJ, Sanders LL, et al. Trends in peritoneal dialysis use in the United States after Medicare payment reform. Clin J Am Soc Nephrol. 2019;14(12):1763-1772. doi:10.2215/CJN.05910519

8. VA Maintaining Internal Systems and Strengthening Integrated Outside Networks Act of 2018. HR 5674. 115th Congress; Report No. 115-671, Part 1. May 3, 2018. Accessed February 9, 2023. https://www.congress.gov/115/bills/hr5674/BILLS-115hr5674rh.pdf

9. US Department of Veterans Affairs, Veterans Health Administration. Chronic kidney disease prevention, early recognition, and management. VHA Directive 1053. March 17, 2020. Accessed February 9, 2023. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8737

10. Blake PG, Quinn RR, Oliver MJ. Peritoneal dialysis and the process of modality selection. Perit Dial Int. 2013;33(3):233-241. doi:10.3747/pdi.2012.00119

11. Stroupe KT, Hynes DM, Giobbie-Hurder A, et al. Patient satisfaction and use of Veterans Affairs versus non-Veterans Affairs healthcare services by veterans. Med Care. 2005;43(5):453-460. doi:10.1097/01.mlr.0000160377.82164.d3

12. Anhang Price R, Sloss EM, Cefalu M, Farmer CM, Hussey PS. Comparing quality of care in Veterans Affairs and non-Veterans Affairs settings. J Gen Intern Med. 2018;33(10):1631-1638. doi:10.1007/s11606-018-4433-7

13. Blay E Jr, DeLancey JO, Hewitt DB, Chung JW, Bilimoria KY. Initial public reporting of quality at Veterans Affairs vs non-Veterans Affairs hospitals. JAMA Intern Med. 2017;177(6):882-885. doi:10.1001/jamainternmed.2017.0605

14. Nuti SV, Qin L, Krumholz HM. Outcome after admission at Veterans Affairs vs non-Veterans Affairs hospitals--reply. JAMA. 2016;316(3):346. doi:10.1001/jama.2016.5394

15. Streja E, Kovesdy CP, Soohoo M, et al. Dialysis provider and outcomes among United States veterans who transition to dialysis. Clin J Am Soc Nephrol. 2018;13(7):1055-1062. doi:10.2215/CJN.12951117

16. Wang V, Coffman CJ, Stechuchak KM, et al. Survival among veterans obtaining dialysis in VA and non-VA settings. J Am Soc Nephrol. 2019;30(1):159-168. doi:10.1681/ASN.2018050521

17. Kurella Tamura M, Thomas IC, Montez-Rath ME, et al. Dialysis initiation and mortality among older veterans with kidney failure treated in Medicare vs the Department of Veterans Affairs. JAMA Intern Med. 2018;178(5):657-664. doi:10.1001/jamainternmed.2018.0411

18. Devins GM, Mendelssohn DC, Barré PE, Taub K, Binik YM. Predialysis psychoeducational intervention extends survival in CKD: a 20-year follow-up. Am J Kidney Dis. 2005;46(6):1088-1098. doi:10.1053/j.ajkd.2005.08.017

19. Devoe DJ, Wong B, James MT, et al. Patient education and peritoneal dialysis modality selection: a systematic review and meta-analysis. Am J Kidney Dis. 2016;68(3):422-433. doi:10.1053/j.ajkd.2016.02.053

20. Lin E, Chertow GM, Yan B, Malcolm E, Goldhaber-Fiebert JD. Cost-effectiveness of multidisciplinary care in mild to moderate chronic kidney disease in the United States: A modeling study. PLoS Med. 2018;15(3):e1002532. Published 2018 Mar 27. doi:10.1371/journal.pmed.1002532

21. Shukla AM, Bozorgmehri S, Ruchi R, et al. Utilization of CMS pre-ESRD Kidney Disease Education services and its associations with the home dialysis therapies. Perit Dial Int. 2021;41(5):453-462. doi:10.1177/0896860820975586

22. US Dept of Veterans Affairs, Veterans Health Administration. Criteria and standards for VA dialysis programs. VHA Directive 1601. 2016. May 23, 2016. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3205

23. Crowley ST, Belcher J, Choudhury D, et al. Targeting access to kidney care via telehealth: the VA experience. Adv Chronic Kidney Dis. 2017;24(1):22-30. doi:10.1053/j.ackd.2016.11.005

24. Ishani A, Christopher J, Palmer D, et al. Telehealth by an interprofessional team in patients with CKD: a randomized controlled trial. Am J Kidney Dis. 2016;68(1):41-49. doi:10.1053/j.ajkd.2016.01.018

25. Gupta N, Taber-Hight EB, Miller BW. Perceptions of home dialysis training and experience among US nephrology fellows. Am J Kidney Dis. 2021;77(5):713-718.e1. doi:10.1053/j.ajkd.2020.09.014

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Anuradha Wadhwa, MDa,b; Linda F. Fried, MDc,d; Kerri Cavanaugh, MDe,f; Karen MacKichan, MDg,h; Arjun D. Sinha, MD, MSi,j; Sarah Adam, MSWa; Laurie Hippensteel, RNk; Scott Ruele, MDl,m; Susan T. Crowley, MDn,o; Ashutosh M. Shukla, MBBS, MDp,q

Correspondence: Ashutosh Shukla ([email protected])

aEdward Hines Jr. Veterans Affairs Hospital, Hines, Illinois

bLoyola University Medical Center, Chicago, Illinois

cPittsburgh Veterans Healthcare System, Pennsylvania

dUniversity of Pittsburgh Medical Center, Pennsylvania

eTennessee Valley Health System, Nashville

fVanderbilt University Medical Center, Nashville, Tennessee

gPhoenix Veterans Affairs Healthcare System, Arizona

hVISN 22 Desert Pacific Network

iRichard L. Roudebush Veterans Affairs Medical Center, Indianapolis, Indiana

jIndiana University School of Medicine, Indianapolis

kKansas City Veterans Affairs Medical Center, Missouri

lUniversity of Minnesota Medical Center, Minneapolis

mMinneapolis Veterans Affairs Health Care System, Minnesota

nVeterans Affairs Connecticut Healthcare System, New Haven

oYale University, New Haven, Connecticut

pNorth Florida/South Georgia Veterans Health System, Gainesville

qUniversity of Florida, Gainesville

Author disclosures

The authors report no outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

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No research activities were conducted; hence, ethics approval was not required.


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Anuradha Wadhwa, MDa,b; Linda F. Fried, MDc,d; Kerri Cavanaugh, MDe,f; Karen MacKichan, MDg,h; Arjun D. Sinha, MD, MSi,j; Sarah Adam, MSWa; Laurie Hippensteel, RNk; Scott Ruele, MDl,m; Susan T. Crowley, MDn,o; Ashutosh M. Shukla, MBBS, MDp,q

Correspondence: Ashutosh Shukla ([email protected])

aEdward Hines Jr. Veterans Affairs Hospital, Hines, Illinois

bLoyola University Medical Center, Chicago, Illinois

cPittsburgh Veterans Healthcare System, Pennsylvania

dUniversity of Pittsburgh Medical Center, Pennsylvania

eTennessee Valley Health System, Nashville

fVanderbilt University Medical Center, Nashville, Tennessee

gPhoenix Veterans Affairs Healthcare System, Arizona

hVISN 22 Desert Pacific Network

iRichard L. Roudebush Veterans Affairs Medical Center, Indianapolis, Indiana

jIndiana University School of Medicine, Indianapolis

kKansas City Veterans Affairs Medical Center, Missouri

lUniversity of Minnesota Medical Center, Minneapolis

mMinneapolis Veterans Affairs Health Care System, Minnesota

nVeterans Affairs Connecticut Healthcare System, New Haven

oYale University, New Haven, Connecticut

pNorth Florida/South Georgia Veterans Health System, Gainesville

qUniversity of Florida, Gainesville

Author disclosures

The authors report no outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Ethics and consent

No research activities were conducted; hence, ethics approval was not required.


Author and Disclosure Information

Anuradha Wadhwa, MDa,b; Linda F. Fried, MDc,d; Kerri Cavanaugh, MDe,f; Karen MacKichan, MDg,h; Arjun D. Sinha, MD, MSi,j; Sarah Adam, MSWa; Laurie Hippensteel, RNk; Scott Ruele, MDl,m; Susan T. Crowley, MDn,o; Ashutosh M. Shukla, MBBS, MDp,q

Correspondence: Ashutosh Shukla ([email protected])

aEdward Hines Jr. Veterans Affairs Hospital, Hines, Illinois

bLoyola University Medical Center, Chicago, Illinois

cPittsburgh Veterans Healthcare System, Pennsylvania

dUniversity of Pittsburgh Medical Center, Pennsylvania

eTennessee Valley Health System, Nashville

fVanderbilt University Medical Center, Nashville, Tennessee

gPhoenix Veterans Affairs Healthcare System, Arizona

hVISN 22 Desert Pacific Network

iRichard L. Roudebush Veterans Affairs Medical Center, Indianapolis, Indiana

jIndiana University School of Medicine, Indianapolis

kKansas City Veterans Affairs Medical Center, Missouri

lUniversity of Minnesota Medical Center, Minneapolis

mMinneapolis Veterans Affairs Health Care System, Minnesota

nVeterans Affairs Connecticut Healthcare System, New Haven

oYale University, New Haven, Connecticut

pNorth Florida/South Georgia Veterans Health System, Gainesville

qUniversity of Florida, Gainesville

Author disclosures

The authors report no outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Ethics and consent

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Compared with hemodialysis (HD), peritoneal dialysis (PD) offers comparable survival and superior patient-centered and health services outcomes.1,2 This has prompted repeated calls over the past 2 decades for policies to increase the use of home dialysis and, more specifically, for PD in the United States.3,4

Veterans comprise nearly 10% of the population with end-stage kidney disease (ESKD) burden; > 50,000 US veterans are currently on dialysis.5,6 A majority of these veterans receive their chronic kidney disease (CKD) care through their affiliated US Department of Veterans Affairs (VA) medical centers (VAMCs).

figure 1
However, there are only 71 hospital-affiliated or free-standing HD and 28 outpatient PD units within the Veterans Health Administration (VHA) (Figure 1). Together, these units serve only about 3500 veterans on HD and about 300 veterans with PD. More than 90% of veterans receive their dialysis care from non-VA facilities. Thus, veterans progressing from CKD to ESKD commonly need to transition their VA-based nephrology care to non-VA facilities, causing fragmentation of care during a medically fragile period. Such transitions adversely impact the quality of ESKD care and reduce the probability of PD use. PD use among veterans is lower (~7%) compared with the general ESKD population (~12%).7

To address these needs, the VHA National Kidney Disease Program (NKDP) formed a 4-member PD workgroup in 2019. Considering the breadth of challenges involved, the PD workgroup broadly designed its approach based on the I CARE (Integrity, Commitment, Advocacy, Respect, and Excellence) VA Core Values.
figure 2
The workgroup devised a conceptual model with 3 focus areas, each comprising a subgroup led by a workgroup member: respecting the veteran’s choice for PD, advocating for universal access to PD, and providing excellence in PD care within the VHA (Figure 2). While the passage of the Choice Act (2014) and the Mission Act (2018) was recognized to have increased access to PD for veterans through non-VA purchased care, lack of availability within the VA infrastructure was considered a significant residual limitation to greater PD use.8

This review focuses on the initial deliberations of the PD access subgroup and provides a guide to establishing a new local VA PD program.
figure 3
We describe the process by dividing it into 3 operational phases: examining the prerequisites, analyzing clinical and financial feasibility, and outlining the process of administrative approval (Figure 3).

 

 

Step 1: Prerequisites

A functional nephrology service is a bedrock prerequisite for establishing a new PD program. A clinician champion capable of leading the effort is equally necessary. Occasionally, the prevalent ESKD economic and health care burden prompts local VAMC leadership to consider a new PD program to improve the quality or availability of services. More commonly, though, the nephrology section and the clinician champion are the first to recognize the need. In either scenario, the champion will require support and advocacy at multiple levels of local leadership, ie, the section or department chief, facility chief of staff, VAMC director, and the Veterans Integrated Service Network (VISN) director. The foremost task for the champion is to assess local clinical and infrastructure needs.

Goal Alignment

Any new VA nephrology program needs to be evaluated for its overall congruence with the local and national VA missions to improve the accessibility, integration, quality, and innovation of care for veterans. The following considerations are likely to apply to many VA systems.

Accessibility. A VHA directive recommends that all veterans be provided with the opportunity to choose and use any form of dialysis, especially home dialysis.9 Transitioning a veteran seamlessly from advanced CKD to PD requires the execution of multiple sequential processes in the pre-ESKD period, beginning with early identification of advanced CKD, timely referral to nephrology, education for shared dialysis decision making, coordination of care, and PD training and therapy.10 Splitting this sequence between VA and community-based care creates obstacles, including multiple approvals through VA Community Care Services that may substantially increase wait time and effort. This onerous process may be a significant deterrent against pursuing PD and increases the odds of emergency or inpatient initiation. Furthermore, the lack of PD availability limits the knowledge and experience among staff designated to assist veterans, which may result in inappropriate advocacy for HD or delay the transition to PD. Together, these processes can increase morbidity and health care use, and significantly delay or eliminate PD. Finally, many veterans reside in rural or remote areas where the expertise and the availability of PD may be unreliable. Establishing PD services within the local VAMC can improve access to PD, reduce the lead time needed to coordinate the transition to ESKD, and assist individual veterans in making an informed choice about dialysis. The program champion will need to identify and highlight all accessibility barriers within their business plan.

Integration. Many veterans receiving dialysis care at community-based facilities continue to receive nonnephrology care in the VA. This creates a parallel health care system with concerns for duplication of efforts and processes, suboptimal quality of care, and increased risk of medical errors. Establishing VA PD services increases access and integration of nephrology with other VA care.

Excellence. Studies of many chronic diseases have shown superior patient satisfaction and equal or superior quality of care delivered by the VA compared with that of non-VA facilities.11-14 Similarly, mortality rates for veterans receiving CKD and ESKD care in VA are lower compared with those at non-VA facilities.15-17 While these outcomes have not been examined for PD, integration of PD with VA care may lead to an improved overall quality of care and greater loyalty to the VA.

Innovation. Due to its integrated health care infrastructure, the VA is uniquely positioned to implement patient-centered and evidence-based pre-ESKD interventions that may improve outcomes. Prior studies have shown that pre-ESKD kidney disease education (KDE) improves pre- and post-ESKD outcomes, reduces health care costs, and leads to higher selection and use of home dialysis therapies.18-20 The VA recommends that all veterans with advanced CKD be provided access to pre-ESKD care and KDE. Unfortunately, KDE is uncommon among non-VA clinicians. A recent USRDS analysis reported that < 1% of patients with ESKD received pre-ESKD KDE.21 The ongoing Evaluate and Assess the effects of Comprehensive Pre-ESKD kidney disease Education on home dialysis in Veterans Trial (NCT04064086) should provide further evidence.

 

 

Step 2: Feasibility

A business plan requires the realistic projections of the costs and accounting for gains of the new clinical program. While there is limited guidance on personnel requirements when planning a PD program, we provide estimated resources needed to successfully establish and run a PD program (eAppendix 1, available online at doi:10.12788/fp.0356).

Clinical Considerations

Secondary or tertiary care VAMCs with multiple medical and surgical specialties routinely provide complex inpatient care. For these facilities, the lack of inpatient PD poses an obstacle to the provision of specialized nonnephrology care to veterans with ESKD, who are frequent users of such complex care. These considerations argue for the need for at least inpatient PD services at VAMCs that provide complex medical care for many veterans receiving PD in the community.

Deliberations for outpatient PD programs should be based on the clinical demands of ESKD care, the number of veterans likely to use PD, and growth projections. While there is no established minimum number that guarantees cost-effectiveness, most existing VA outpatient PD programs provide services for about 5 to 25 veterans. A local census can provide estimations of future PD needs. Travel considerations (ie, distance, terrain, traffic) may affect eligibility for purchased care and the decision where to receive PD. Many veterans may prefer PD from the local VAMC if it is convenient and allows them to maintain centralized VA care. Potential patients can be surveyed to gauge interest in receiving VA-based PD. Facilities providing structured pre-ESKD KDE may hold greater potential for PD growth, and it is important to highlight KDE infrastructure in the business plan.

Infrastructure

Spatial needs including clinic space and storage space for consumables, supplies, and equipment should be part of infrastructure requirements. The program champion may need to examine the available space for suitability and adequacy of the PD program early in the process. Ventilation renovations in the PD rooms should be incorporated into budget calculations. Water access for handwashing and PD effluent drainage should be confirmed, and if the program intends to establish home HD, additional considerations for the storage and water supply may be required. The VHA Handbook outlines the infrastructure requirements for a dialysis program.22 The VA has established national vendor contracts for dialysis equipment and consumables. However, a new PD program may need further guidance regarding the local agencies that provide administrative support and assist patients.

Telehealth technology has enabled many VAMCs to overcome geographical barriers for rural veterans.23 Ongoing expansion of community-based outpatient clinics (CBOCs) to include more rural locations is improving access to specialty care, while the launch of VA Video Connect (VVC) has further improved outreach. Investigators from Minneapolis have demonstrated the feasibility of multidisciplinary home-based telehealth management of veterans with CKD.24 Several existing nephrology sections across the VHA use a combination of VVC and CBOC-facilitated clinic visits to provide some pre-ESKD and ESKD care, including KDE, PD home visits and training, and comprehensive ESKD care visits. Recent changes in the clinical care pattern during the COVID-19 pandemic have further eased ESKD telehealth protocols. Integrating the projected use of telehealth in collaboration with existing resources available through the VHA NKDP can allow the local champion to improve the financial feasibility and long-term success of a new PD program.

 

 

Clinicians

Experience and expertise in managing PD vary among nephrologists. A recent survey found that only 11% of second-year nephrology trainees felt fully prepared to manage PD patients and 27% felt that they were minimally prepared.25 Thus, it is important to ensure that adequately trained nephrologists are available locally before initiating a new program, and if needed, coverage across VHS or VISN can be explored. One potential method to enhance practitioner comfort in PD is the use of existing peer-to-peer education through the VA Kidney Specialty Care Access Network-Extension for Community Health care Outcomes program that links health care professionals in rural areas with specialists at a tertiary care center.23 Nurses are a primary pillar for the success of home dialysis programs and the lack of a trained nursing workforce can be a significant limitation. Similarly, while the placement and management of complications related to PD catheters are not technically challenging, the availability of interventionists (either a surgeon or trained interventional radiologist) should be part of the business plan.

Financial Considerations

The financial considerations involving a new PD program within the VHA are complex (eAppendix 2, available online at doi:10.12788/fp.0356). ESKD is one of the most complex and costly comorbidities. It is a major determinant of the expenditure and revenue generation for facilities. The Veterans Equitable Resource Allocation system classifies ESKD on repeated dialysis as price category 10, indicating high complexity and cost. The VAMC workload and facility budget allocation is assessed annually and increases as the population of price group 10 veterans increases. VHA also provides additional Veterans Equitable Resource Allocation funds to VAMCs, which can improve the bottom line for VA-based dialysis units. Providing PD facilitates outpatient and inpatient management of comorbidities, allowing for substantial cost savings while improving the quality of nonrenal care. Outsourcing dialysis care can reduce the administrative burden, although, it deprives the VAMC of all dialysis-associated revenues while bearing the cost of all nonrenal and some renal care. The net effect is reduced facility productivity. In aggregate, establishing a local dialysis program requires greater financial resources for the capital and personnel costs; however, if captured appropriately these funds can be a major source of revenue and savings for the local VAMC.

Indirect costs are important for financial projections. Most community dialysis units operate as outpatient units, whereas all but a handful of the VA dialysis units operate within or near a VAMC. As a result, the VA units providing maintenance dialysis are regularly classified as inpatient centers while providing largely outpatient services, which negatively impacts overhead cost calculations. The predominant use of in-center HD as the default modality further sets an erroneously high baseline for the indirect cost of the VA-based PD services, especially considering that the principal savings of the home dialysis are through the reduction in the labor and capital costs. A rudimentary make-buy model for the in-center HD is available through the NKDP, and establishing a similar model for PD programs may be useful.

Cost considerations also may vary based on the model of ESKD care used locally. Of the 71 hospital-based and free-standing VA HD facilities, only 33 provide PD services, with 5 units providing only inpatient PD. The financial burden of establishing a fully operational outpatient PD program will be based on whether it is targeting a new unit or is expanding. The costs for equipment rental, disposables, and supplies vary based on the VA contract negotiations but are standardized across the nation with approved cost-of-living geographic adjustments. Caution needs to be exercised in employing a phased-hiring approach, as newer programs may require proportionally larger nursing resources due to greater needs for KDE, transitioning services, and training for PD. A target census-based hiring schedule should be negotiated with leadership before launch. If existing labor mapping does not allow for cross-coverage, part-time positions for physicians may be considered. Travel nurses, especially for PD training, can be considered to meet labor needs when long-term projections prohibit permanent full-time hires.

Finally, the balance sheet of a new program needs to account for different scenarios. In addition to nephrology costs, outsourcing veterans for PD services incurs multiple costs (eg, administrative, social work). Facilities with inpatient PD services alone are likely already bearing a component of the medications (including antibiotics) and/or surgical costs for their outsourced patients. These hidden costs are infrequently counted in projections. Facilities without inpatient PD cannot provide complex nonrenal care to ESKD patients on PD, even when the center is well equipped to provide it. These facilities also bear the cost of outsourcing even for complications related to PD. While a full estimation of these services varies, the hidden cost savings of many procedures or inpatient admissions, such as cardiovascular or musculoskeletal surgeries, can exceed those of dialysis in this complex population.

 

 

Step 3: proposal

There are no standardized formats for presenting a VHA business proposal; however, this outline provides a template. The business proposal should be designed to effectively communicate the collective data that describe the needs and requirements of a PD program to the local, regional, and national leadership. Not every rationale presented here will apply to an individual proposal and the local champion will need to tailor their rationale for their locale. A sample business plan is shown in eAppendix 3 (available online at doi:10.12788/fp.0356). VHA Handbook of dialysis requires that a PD nurse has a minimum of 12 months of nursing experience with at least 3 months of PD experience.25 Nursing training, education, and support should be discussed with nursing leadership and included in the business plan. Similarly, arrangements for laboratory, pharmacy, and prosthetics services and/or logistics to facilitate procurement of the needed devices, disposables, and supplies are essential and should be highlighted in the business plan.

Approval Process

figure 4
Though the initial explorations are conventionally undertaken with the support of the local leadership, starting a PD program is considered an augmentation of clinical services and thus requires multistage VHA approvals (Figure 4). The business proposal progresses through the local medicine service leadership and chief of staff to the facility director. The rationale presented in this review is general and has been drawn from the collective experience of authors and under the guidance of the VHA NKDP. However, it still requires deliberation by the local leadership, comprised of nonnephrology clinicians and administrative professionals to ensure its soundness and sustainability. Once approved locally, the VISN chief medical officer aided by the opinions from the NKDP office conducts a thorough evaluation of infrastructure allocations, supplies and support services, skills, competencies, and the privileges of all clinical and ancillary staff, and may conduct a site visit by an expert panel through the responsible clinical program office. The VISN director may also request changes to match any local mandates before approvals. Once approved, the VISN office simultaneously forwards the proposal to several services, including the Office of Nursing Services and the Office of Patient Care Services, which reviews the proposal for the appropriateness and determines the need for an on-site review before approval. These composite reviews and recommendations guide the highest offices in finalizing the decision, with the final approvals from the Under Secretary for Health.

Postapproval Process

Once approved, the champion will need to work closely with various services and managers to oversee infrastructural renovations and execute the hiring plans, establish standard operating procedures (SOPs), standardize staff proficiencies and functional statements, and finalize quality assessment parameters. Home dialysis standards have been addressed by NKDP and The Joint Commission. While PD requires home visits to assess the appropriateness of the environment, the PD program is accredited under hospital-based therapy. Standards and performance metrics should be incorporated into all the VA PD programs for standardization and assessment. Based on guidance from the VHA Handbook, quality metrics, such as dialysis adequacy, and rates of infection should be monitored and reviewed. The dialysis director may need to consider more frequent program evaluations in the first year to ensure appropriate troubleshooting. The VA infrastructure has developed the resources for a central repository for the PD SOPs and quality metrics, which can be obtained and adapted for the local program. Similarly, veteran satisfaction can be assessed through existing resources. Finally, the dialysis director can join the National VHA Dialysis Director listserv for regular updates on the existing and new VHA policies and NKDP updates.

Conclusions

Establishing a new PD program within a local federal infrastructure can appear daunting, both in terms of planning as well as approvals. However, the provision of home-based dialysis therapies may be beneficial to those in rural settings with limited access to in-center dialysis modalities as well as to those who seek autonomy and lifestyle independence in their medical care. Collaborations with the VHA NKDP or PD workgroup can help overcome many of the procedural hurdles, provide guidance about infrastructure and resource allocation and utilization, and provide easy access to established SOPs and quality parameters.

Acknowledgments

We acknowledge the late Dr. Catherine Do for her significant contribution to this manuscript. We also extend our sincere thanks to Dr. Holly Mattix-Kramer (Edward Hines Jr. Veterans Affairs Hospital and Loyola University Medical Center) for her prompt and valuable feedback on this manuscript.

Compared with hemodialysis (HD), peritoneal dialysis (PD) offers comparable survival and superior patient-centered and health services outcomes.1,2 This has prompted repeated calls over the past 2 decades for policies to increase the use of home dialysis and, more specifically, for PD in the United States.3,4

Veterans comprise nearly 10% of the population with end-stage kidney disease (ESKD) burden; > 50,000 US veterans are currently on dialysis.5,6 A majority of these veterans receive their chronic kidney disease (CKD) care through their affiliated US Department of Veterans Affairs (VA) medical centers (VAMCs).

figure 1
However, there are only 71 hospital-affiliated or free-standing HD and 28 outpatient PD units within the Veterans Health Administration (VHA) (Figure 1). Together, these units serve only about 3500 veterans on HD and about 300 veterans with PD. More than 90% of veterans receive their dialysis care from non-VA facilities. Thus, veterans progressing from CKD to ESKD commonly need to transition their VA-based nephrology care to non-VA facilities, causing fragmentation of care during a medically fragile period. Such transitions adversely impact the quality of ESKD care and reduce the probability of PD use. PD use among veterans is lower (~7%) compared with the general ESKD population (~12%).7

To address these needs, the VHA National Kidney Disease Program (NKDP) formed a 4-member PD workgroup in 2019. Considering the breadth of challenges involved, the PD workgroup broadly designed its approach based on the I CARE (Integrity, Commitment, Advocacy, Respect, and Excellence) VA Core Values.
figure 2
The workgroup devised a conceptual model with 3 focus areas, each comprising a subgroup led by a workgroup member: respecting the veteran’s choice for PD, advocating for universal access to PD, and providing excellence in PD care within the VHA (Figure 2). While the passage of the Choice Act (2014) and the Mission Act (2018) was recognized to have increased access to PD for veterans through non-VA purchased care, lack of availability within the VA infrastructure was considered a significant residual limitation to greater PD use.8

This review focuses on the initial deliberations of the PD access subgroup and provides a guide to establishing a new local VA PD program.
figure 3
We describe the process by dividing it into 3 operational phases: examining the prerequisites, analyzing clinical and financial feasibility, and outlining the process of administrative approval (Figure 3).

 

 

Step 1: Prerequisites

A functional nephrology service is a bedrock prerequisite for establishing a new PD program. A clinician champion capable of leading the effort is equally necessary. Occasionally, the prevalent ESKD economic and health care burden prompts local VAMC leadership to consider a new PD program to improve the quality or availability of services. More commonly, though, the nephrology section and the clinician champion are the first to recognize the need. In either scenario, the champion will require support and advocacy at multiple levels of local leadership, ie, the section or department chief, facility chief of staff, VAMC director, and the Veterans Integrated Service Network (VISN) director. The foremost task for the champion is to assess local clinical and infrastructure needs.

Goal Alignment

Any new VA nephrology program needs to be evaluated for its overall congruence with the local and national VA missions to improve the accessibility, integration, quality, and innovation of care for veterans. The following considerations are likely to apply to many VA systems.

Accessibility. A VHA directive recommends that all veterans be provided with the opportunity to choose and use any form of dialysis, especially home dialysis.9 Transitioning a veteran seamlessly from advanced CKD to PD requires the execution of multiple sequential processes in the pre-ESKD period, beginning with early identification of advanced CKD, timely referral to nephrology, education for shared dialysis decision making, coordination of care, and PD training and therapy.10 Splitting this sequence between VA and community-based care creates obstacles, including multiple approvals through VA Community Care Services that may substantially increase wait time and effort. This onerous process may be a significant deterrent against pursuing PD and increases the odds of emergency or inpatient initiation. Furthermore, the lack of PD availability limits the knowledge and experience among staff designated to assist veterans, which may result in inappropriate advocacy for HD or delay the transition to PD. Together, these processes can increase morbidity and health care use, and significantly delay or eliminate PD. Finally, many veterans reside in rural or remote areas where the expertise and the availability of PD may be unreliable. Establishing PD services within the local VAMC can improve access to PD, reduce the lead time needed to coordinate the transition to ESKD, and assist individual veterans in making an informed choice about dialysis. The program champion will need to identify and highlight all accessibility barriers within their business plan.

Integration. Many veterans receiving dialysis care at community-based facilities continue to receive nonnephrology care in the VA. This creates a parallel health care system with concerns for duplication of efforts and processes, suboptimal quality of care, and increased risk of medical errors. Establishing VA PD services increases access and integration of nephrology with other VA care.

Excellence. Studies of many chronic diseases have shown superior patient satisfaction and equal or superior quality of care delivered by the VA compared with that of non-VA facilities.11-14 Similarly, mortality rates for veterans receiving CKD and ESKD care in VA are lower compared with those at non-VA facilities.15-17 While these outcomes have not been examined for PD, integration of PD with VA care may lead to an improved overall quality of care and greater loyalty to the VA.

Innovation. Due to its integrated health care infrastructure, the VA is uniquely positioned to implement patient-centered and evidence-based pre-ESKD interventions that may improve outcomes. Prior studies have shown that pre-ESKD kidney disease education (KDE) improves pre- and post-ESKD outcomes, reduces health care costs, and leads to higher selection and use of home dialysis therapies.18-20 The VA recommends that all veterans with advanced CKD be provided access to pre-ESKD care and KDE. Unfortunately, KDE is uncommon among non-VA clinicians. A recent USRDS analysis reported that < 1% of patients with ESKD received pre-ESKD KDE.21 The ongoing Evaluate and Assess the effects of Comprehensive Pre-ESKD kidney disease Education on home dialysis in Veterans Trial (NCT04064086) should provide further evidence.

 

 

Step 2: Feasibility

A business plan requires the realistic projections of the costs and accounting for gains of the new clinical program. While there is limited guidance on personnel requirements when planning a PD program, we provide estimated resources needed to successfully establish and run a PD program (eAppendix 1, available online at doi:10.12788/fp.0356).

Clinical Considerations

Secondary or tertiary care VAMCs with multiple medical and surgical specialties routinely provide complex inpatient care. For these facilities, the lack of inpatient PD poses an obstacle to the provision of specialized nonnephrology care to veterans with ESKD, who are frequent users of such complex care. These considerations argue for the need for at least inpatient PD services at VAMCs that provide complex medical care for many veterans receiving PD in the community.

Deliberations for outpatient PD programs should be based on the clinical demands of ESKD care, the number of veterans likely to use PD, and growth projections. While there is no established minimum number that guarantees cost-effectiveness, most existing VA outpatient PD programs provide services for about 5 to 25 veterans. A local census can provide estimations of future PD needs. Travel considerations (ie, distance, terrain, traffic) may affect eligibility for purchased care and the decision where to receive PD. Many veterans may prefer PD from the local VAMC if it is convenient and allows them to maintain centralized VA care. Potential patients can be surveyed to gauge interest in receiving VA-based PD. Facilities providing structured pre-ESKD KDE may hold greater potential for PD growth, and it is important to highlight KDE infrastructure in the business plan.

Infrastructure

Spatial needs including clinic space and storage space for consumables, supplies, and equipment should be part of infrastructure requirements. The program champion may need to examine the available space for suitability and adequacy of the PD program early in the process. Ventilation renovations in the PD rooms should be incorporated into budget calculations. Water access for handwashing and PD effluent drainage should be confirmed, and if the program intends to establish home HD, additional considerations for the storage and water supply may be required. The VHA Handbook outlines the infrastructure requirements for a dialysis program.22 The VA has established national vendor contracts for dialysis equipment and consumables. However, a new PD program may need further guidance regarding the local agencies that provide administrative support and assist patients.

Telehealth technology has enabled many VAMCs to overcome geographical barriers for rural veterans.23 Ongoing expansion of community-based outpatient clinics (CBOCs) to include more rural locations is improving access to specialty care, while the launch of VA Video Connect (VVC) has further improved outreach. Investigators from Minneapolis have demonstrated the feasibility of multidisciplinary home-based telehealth management of veterans with CKD.24 Several existing nephrology sections across the VHA use a combination of VVC and CBOC-facilitated clinic visits to provide some pre-ESKD and ESKD care, including KDE, PD home visits and training, and comprehensive ESKD care visits. Recent changes in the clinical care pattern during the COVID-19 pandemic have further eased ESKD telehealth protocols. Integrating the projected use of telehealth in collaboration with existing resources available through the VHA NKDP can allow the local champion to improve the financial feasibility and long-term success of a new PD program.

 

 

Clinicians

Experience and expertise in managing PD vary among nephrologists. A recent survey found that only 11% of second-year nephrology trainees felt fully prepared to manage PD patients and 27% felt that they were minimally prepared.25 Thus, it is important to ensure that adequately trained nephrologists are available locally before initiating a new program, and if needed, coverage across VHS or VISN can be explored. One potential method to enhance practitioner comfort in PD is the use of existing peer-to-peer education through the VA Kidney Specialty Care Access Network-Extension for Community Health care Outcomes program that links health care professionals in rural areas with specialists at a tertiary care center.23 Nurses are a primary pillar for the success of home dialysis programs and the lack of a trained nursing workforce can be a significant limitation. Similarly, while the placement and management of complications related to PD catheters are not technically challenging, the availability of interventionists (either a surgeon or trained interventional radiologist) should be part of the business plan.

Financial Considerations

The financial considerations involving a new PD program within the VHA are complex (eAppendix 2, available online at doi:10.12788/fp.0356). ESKD is one of the most complex and costly comorbidities. It is a major determinant of the expenditure and revenue generation for facilities. The Veterans Equitable Resource Allocation system classifies ESKD on repeated dialysis as price category 10, indicating high complexity and cost. The VAMC workload and facility budget allocation is assessed annually and increases as the population of price group 10 veterans increases. VHA also provides additional Veterans Equitable Resource Allocation funds to VAMCs, which can improve the bottom line for VA-based dialysis units. Providing PD facilitates outpatient and inpatient management of comorbidities, allowing for substantial cost savings while improving the quality of nonrenal care. Outsourcing dialysis care can reduce the administrative burden, although, it deprives the VAMC of all dialysis-associated revenues while bearing the cost of all nonrenal and some renal care. The net effect is reduced facility productivity. In aggregate, establishing a local dialysis program requires greater financial resources for the capital and personnel costs; however, if captured appropriately these funds can be a major source of revenue and savings for the local VAMC.

Indirect costs are important for financial projections. Most community dialysis units operate as outpatient units, whereas all but a handful of the VA dialysis units operate within or near a VAMC. As a result, the VA units providing maintenance dialysis are regularly classified as inpatient centers while providing largely outpatient services, which negatively impacts overhead cost calculations. The predominant use of in-center HD as the default modality further sets an erroneously high baseline for the indirect cost of the VA-based PD services, especially considering that the principal savings of the home dialysis are through the reduction in the labor and capital costs. A rudimentary make-buy model for the in-center HD is available through the NKDP, and establishing a similar model for PD programs may be useful.

Cost considerations also may vary based on the model of ESKD care used locally. Of the 71 hospital-based and free-standing VA HD facilities, only 33 provide PD services, with 5 units providing only inpatient PD. The financial burden of establishing a fully operational outpatient PD program will be based on whether it is targeting a new unit or is expanding. The costs for equipment rental, disposables, and supplies vary based on the VA contract negotiations but are standardized across the nation with approved cost-of-living geographic adjustments. Caution needs to be exercised in employing a phased-hiring approach, as newer programs may require proportionally larger nursing resources due to greater needs for KDE, transitioning services, and training for PD. A target census-based hiring schedule should be negotiated with leadership before launch. If existing labor mapping does not allow for cross-coverage, part-time positions for physicians may be considered. Travel nurses, especially for PD training, can be considered to meet labor needs when long-term projections prohibit permanent full-time hires.

Finally, the balance sheet of a new program needs to account for different scenarios. In addition to nephrology costs, outsourcing veterans for PD services incurs multiple costs (eg, administrative, social work). Facilities with inpatient PD services alone are likely already bearing a component of the medications (including antibiotics) and/or surgical costs for their outsourced patients. These hidden costs are infrequently counted in projections. Facilities without inpatient PD cannot provide complex nonrenal care to ESKD patients on PD, even when the center is well equipped to provide it. These facilities also bear the cost of outsourcing even for complications related to PD. While a full estimation of these services varies, the hidden cost savings of many procedures or inpatient admissions, such as cardiovascular or musculoskeletal surgeries, can exceed those of dialysis in this complex population.

 

 

Step 3: proposal

There are no standardized formats for presenting a VHA business proposal; however, this outline provides a template. The business proposal should be designed to effectively communicate the collective data that describe the needs and requirements of a PD program to the local, regional, and national leadership. Not every rationale presented here will apply to an individual proposal and the local champion will need to tailor their rationale for their locale. A sample business plan is shown in eAppendix 3 (available online at doi:10.12788/fp.0356). VHA Handbook of dialysis requires that a PD nurse has a minimum of 12 months of nursing experience with at least 3 months of PD experience.25 Nursing training, education, and support should be discussed with nursing leadership and included in the business plan. Similarly, arrangements for laboratory, pharmacy, and prosthetics services and/or logistics to facilitate procurement of the needed devices, disposables, and supplies are essential and should be highlighted in the business plan.

Approval Process

figure 4
Though the initial explorations are conventionally undertaken with the support of the local leadership, starting a PD program is considered an augmentation of clinical services and thus requires multistage VHA approvals (Figure 4). The business proposal progresses through the local medicine service leadership and chief of staff to the facility director. The rationale presented in this review is general and has been drawn from the collective experience of authors and under the guidance of the VHA NKDP. However, it still requires deliberation by the local leadership, comprised of nonnephrology clinicians and administrative professionals to ensure its soundness and sustainability. Once approved locally, the VISN chief medical officer aided by the opinions from the NKDP office conducts a thorough evaluation of infrastructure allocations, supplies and support services, skills, competencies, and the privileges of all clinical and ancillary staff, and may conduct a site visit by an expert panel through the responsible clinical program office. The VISN director may also request changes to match any local mandates before approvals. Once approved, the VISN office simultaneously forwards the proposal to several services, including the Office of Nursing Services and the Office of Patient Care Services, which reviews the proposal for the appropriateness and determines the need for an on-site review before approval. These composite reviews and recommendations guide the highest offices in finalizing the decision, with the final approvals from the Under Secretary for Health.

Postapproval Process

Once approved, the champion will need to work closely with various services and managers to oversee infrastructural renovations and execute the hiring plans, establish standard operating procedures (SOPs), standardize staff proficiencies and functional statements, and finalize quality assessment parameters. Home dialysis standards have been addressed by NKDP and The Joint Commission. While PD requires home visits to assess the appropriateness of the environment, the PD program is accredited under hospital-based therapy. Standards and performance metrics should be incorporated into all the VA PD programs for standardization and assessment. Based on guidance from the VHA Handbook, quality metrics, such as dialysis adequacy, and rates of infection should be monitored and reviewed. The dialysis director may need to consider more frequent program evaluations in the first year to ensure appropriate troubleshooting. The VA infrastructure has developed the resources for a central repository for the PD SOPs and quality metrics, which can be obtained and adapted for the local program. Similarly, veteran satisfaction can be assessed through existing resources. Finally, the dialysis director can join the National VHA Dialysis Director listserv for regular updates on the existing and new VHA policies and NKDP updates.

Conclusions

Establishing a new PD program within a local federal infrastructure can appear daunting, both in terms of planning as well as approvals. However, the provision of home-based dialysis therapies may be beneficial to those in rural settings with limited access to in-center dialysis modalities as well as to those who seek autonomy and lifestyle independence in their medical care. Collaborations with the VHA NKDP or PD workgroup can help overcome many of the procedural hurdles, provide guidance about infrastructure and resource allocation and utilization, and provide easy access to established SOPs and quality parameters.

Acknowledgments

We acknowledge the late Dr. Catherine Do for her significant contribution to this manuscript. We also extend our sincere thanks to Dr. Holly Mattix-Kramer (Edward Hines Jr. Veterans Affairs Hospital and Loyola University Medical Center) for her prompt and valuable feedback on this manuscript.

References

1. Jung HY, Jeon Y, Park Y, et al. Better quality of life of peritoneal dialysis compared to hemodialysis over a two-year period after dialysis initiation. Sci Rep. 2019;9(1):10266. Published 2019 Jul 16. doi:10.1038/s41598-019-46744-1

2. Wong B, Ravani P, Oliver MJ, et al. Comparison of patient survival between hemodialysis and peritoneal dialysis among patients eligible for both modalities. Am J Kidney Dis. 2018;71(3):344-351. doi:10.1053/j.ajkd.2017.08.028

3. Chan CT, Collins K, Ditschman EP, et al. Overcoming barriers for uptake and continued use of home dialysis: an NKF-KDOQI Conference report. Am J Kidney Dis. 2020;75(6):926-934. doi:10.1053/j.ajkd.2019.11.007

4. Executive Order 13879: Advancing American kidney health. Fed Regist. 2019; 84(135):33817-33819. https://www.govinfo.gov/content/pkg/FR-2019-07-15/pdf/2019-15159.pdf

5. Patel TG, Pogach LM, Barth RH. CKD screening and management in the Veterans Health Administration: the impact of system organization and an innovative electronic record. Am J Kidney Dis. 2009;53(suppl 3):S78-S85. doi:10.1053/j.ajkd.2008.07.051

6. Saran R, Pearson A, Tilea A, et al. Burden and cost of caring for US veterans with CKD: initial findings from the VA Renal Information System (VA-REINS). Am J Kidney Dis. 2021;77(3):397-405. doi:10.1053/j.ajkd.2020.07.013

7. Sloan CE, Coffman CJ, Sanders LL, et al. Trends in peritoneal dialysis use in the United States after Medicare payment reform. Clin J Am Soc Nephrol. 2019;14(12):1763-1772. doi:10.2215/CJN.05910519

8. VA Maintaining Internal Systems and Strengthening Integrated Outside Networks Act of 2018. HR 5674. 115th Congress; Report No. 115-671, Part 1. May 3, 2018. Accessed February 9, 2023. https://www.congress.gov/115/bills/hr5674/BILLS-115hr5674rh.pdf

9. US Department of Veterans Affairs, Veterans Health Administration. Chronic kidney disease prevention, early recognition, and management. VHA Directive 1053. March 17, 2020. Accessed February 9, 2023. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8737

10. Blake PG, Quinn RR, Oliver MJ. Peritoneal dialysis and the process of modality selection. Perit Dial Int. 2013;33(3):233-241. doi:10.3747/pdi.2012.00119

11. Stroupe KT, Hynes DM, Giobbie-Hurder A, et al. Patient satisfaction and use of Veterans Affairs versus non-Veterans Affairs healthcare services by veterans. Med Care. 2005;43(5):453-460. doi:10.1097/01.mlr.0000160377.82164.d3

12. Anhang Price R, Sloss EM, Cefalu M, Farmer CM, Hussey PS. Comparing quality of care in Veterans Affairs and non-Veterans Affairs settings. J Gen Intern Med. 2018;33(10):1631-1638. doi:10.1007/s11606-018-4433-7

13. Blay E Jr, DeLancey JO, Hewitt DB, Chung JW, Bilimoria KY. Initial public reporting of quality at Veterans Affairs vs non-Veterans Affairs hospitals. JAMA Intern Med. 2017;177(6):882-885. doi:10.1001/jamainternmed.2017.0605

14. Nuti SV, Qin L, Krumholz HM. Outcome after admission at Veterans Affairs vs non-Veterans Affairs hospitals--reply. JAMA. 2016;316(3):346. doi:10.1001/jama.2016.5394

15. Streja E, Kovesdy CP, Soohoo M, et al. Dialysis provider and outcomes among United States veterans who transition to dialysis. Clin J Am Soc Nephrol. 2018;13(7):1055-1062. doi:10.2215/CJN.12951117

16. Wang V, Coffman CJ, Stechuchak KM, et al. Survival among veterans obtaining dialysis in VA and non-VA settings. J Am Soc Nephrol. 2019;30(1):159-168. doi:10.1681/ASN.2018050521

17. Kurella Tamura M, Thomas IC, Montez-Rath ME, et al. Dialysis initiation and mortality among older veterans with kidney failure treated in Medicare vs the Department of Veterans Affairs. JAMA Intern Med. 2018;178(5):657-664. doi:10.1001/jamainternmed.2018.0411

18. Devins GM, Mendelssohn DC, Barré PE, Taub K, Binik YM. Predialysis psychoeducational intervention extends survival in CKD: a 20-year follow-up. Am J Kidney Dis. 2005;46(6):1088-1098. doi:10.1053/j.ajkd.2005.08.017

19. Devoe DJ, Wong B, James MT, et al. Patient education and peritoneal dialysis modality selection: a systematic review and meta-analysis. Am J Kidney Dis. 2016;68(3):422-433. doi:10.1053/j.ajkd.2016.02.053

20. Lin E, Chertow GM, Yan B, Malcolm E, Goldhaber-Fiebert JD. Cost-effectiveness of multidisciplinary care in mild to moderate chronic kidney disease in the United States: A modeling study. PLoS Med. 2018;15(3):e1002532. Published 2018 Mar 27. doi:10.1371/journal.pmed.1002532

21. Shukla AM, Bozorgmehri S, Ruchi R, et al. Utilization of CMS pre-ESRD Kidney Disease Education services and its associations with the home dialysis therapies. Perit Dial Int. 2021;41(5):453-462. doi:10.1177/0896860820975586

22. US Dept of Veterans Affairs, Veterans Health Administration. Criteria and standards for VA dialysis programs. VHA Directive 1601. 2016. May 23, 2016. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3205

23. Crowley ST, Belcher J, Choudhury D, et al. Targeting access to kidney care via telehealth: the VA experience. Adv Chronic Kidney Dis. 2017;24(1):22-30. doi:10.1053/j.ackd.2016.11.005

24. Ishani A, Christopher J, Palmer D, et al. Telehealth by an interprofessional team in patients with CKD: a randomized controlled trial. Am J Kidney Dis. 2016;68(1):41-49. doi:10.1053/j.ajkd.2016.01.018

25. Gupta N, Taber-Hight EB, Miller BW. Perceptions of home dialysis training and experience among US nephrology fellows. Am J Kidney Dis. 2021;77(5):713-718.e1. doi:10.1053/j.ajkd.2020.09.014

References

1. Jung HY, Jeon Y, Park Y, et al. Better quality of life of peritoneal dialysis compared to hemodialysis over a two-year period after dialysis initiation. Sci Rep. 2019;9(1):10266. Published 2019 Jul 16. doi:10.1038/s41598-019-46744-1

2. Wong B, Ravani P, Oliver MJ, et al. Comparison of patient survival between hemodialysis and peritoneal dialysis among patients eligible for both modalities. Am J Kidney Dis. 2018;71(3):344-351. doi:10.1053/j.ajkd.2017.08.028

3. Chan CT, Collins K, Ditschman EP, et al. Overcoming barriers for uptake and continued use of home dialysis: an NKF-KDOQI Conference report. Am J Kidney Dis. 2020;75(6):926-934. doi:10.1053/j.ajkd.2019.11.007

4. Executive Order 13879: Advancing American kidney health. Fed Regist. 2019; 84(135):33817-33819. https://www.govinfo.gov/content/pkg/FR-2019-07-15/pdf/2019-15159.pdf

5. Patel TG, Pogach LM, Barth RH. CKD screening and management in the Veterans Health Administration: the impact of system organization and an innovative electronic record. Am J Kidney Dis. 2009;53(suppl 3):S78-S85. doi:10.1053/j.ajkd.2008.07.051

6. Saran R, Pearson A, Tilea A, et al. Burden and cost of caring for US veterans with CKD: initial findings from the VA Renal Information System (VA-REINS). Am J Kidney Dis. 2021;77(3):397-405. doi:10.1053/j.ajkd.2020.07.013

7. Sloan CE, Coffman CJ, Sanders LL, et al. Trends in peritoneal dialysis use in the United States after Medicare payment reform. Clin J Am Soc Nephrol. 2019;14(12):1763-1772. doi:10.2215/CJN.05910519

8. VA Maintaining Internal Systems and Strengthening Integrated Outside Networks Act of 2018. HR 5674. 115th Congress; Report No. 115-671, Part 1. May 3, 2018. Accessed February 9, 2023. https://www.congress.gov/115/bills/hr5674/BILLS-115hr5674rh.pdf

9. US Department of Veterans Affairs, Veterans Health Administration. Chronic kidney disease prevention, early recognition, and management. VHA Directive 1053. March 17, 2020. Accessed February 9, 2023. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8737

10. Blake PG, Quinn RR, Oliver MJ. Peritoneal dialysis and the process of modality selection. Perit Dial Int. 2013;33(3):233-241. doi:10.3747/pdi.2012.00119

11. Stroupe KT, Hynes DM, Giobbie-Hurder A, et al. Patient satisfaction and use of Veterans Affairs versus non-Veterans Affairs healthcare services by veterans. Med Care. 2005;43(5):453-460. doi:10.1097/01.mlr.0000160377.82164.d3

12. Anhang Price R, Sloss EM, Cefalu M, Farmer CM, Hussey PS. Comparing quality of care in Veterans Affairs and non-Veterans Affairs settings. J Gen Intern Med. 2018;33(10):1631-1638. doi:10.1007/s11606-018-4433-7

13. Blay E Jr, DeLancey JO, Hewitt DB, Chung JW, Bilimoria KY. Initial public reporting of quality at Veterans Affairs vs non-Veterans Affairs hospitals. JAMA Intern Med. 2017;177(6):882-885. doi:10.1001/jamainternmed.2017.0605

14. Nuti SV, Qin L, Krumholz HM. Outcome after admission at Veterans Affairs vs non-Veterans Affairs hospitals--reply. JAMA. 2016;316(3):346. doi:10.1001/jama.2016.5394

15. Streja E, Kovesdy CP, Soohoo M, et al. Dialysis provider and outcomes among United States veterans who transition to dialysis. Clin J Am Soc Nephrol. 2018;13(7):1055-1062. doi:10.2215/CJN.12951117

16. Wang V, Coffman CJ, Stechuchak KM, et al. Survival among veterans obtaining dialysis in VA and non-VA settings. J Am Soc Nephrol. 2019;30(1):159-168. doi:10.1681/ASN.2018050521

17. Kurella Tamura M, Thomas IC, Montez-Rath ME, et al. Dialysis initiation and mortality among older veterans with kidney failure treated in Medicare vs the Department of Veterans Affairs. JAMA Intern Med. 2018;178(5):657-664. doi:10.1001/jamainternmed.2018.0411

18. Devins GM, Mendelssohn DC, Barré PE, Taub K, Binik YM. Predialysis psychoeducational intervention extends survival in CKD: a 20-year follow-up. Am J Kidney Dis. 2005;46(6):1088-1098. doi:10.1053/j.ajkd.2005.08.017

19. Devoe DJ, Wong B, James MT, et al. Patient education and peritoneal dialysis modality selection: a systematic review and meta-analysis. Am J Kidney Dis. 2016;68(3):422-433. doi:10.1053/j.ajkd.2016.02.053

20. Lin E, Chertow GM, Yan B, Malcolm E, Goldhaber-Fiebert JD. Cost-effectiveness of multidisciplinary care in mild to moderate chronic kidney disease in the United States: A modeling study. PLoS Med. 2018;15(3):e1002532. Published 2018 Mar 27. doi:10.1371/journal.pmed.1002532

21. Shukla AM, Bozorgmehri S, Ruchi R, et al. Utilization of CMS pre-ESRD Kidney Disease Education services and its associations with the home dialysis therapies. Perit Dial Int. 2021;41(5):453-462. doi:10.1177/0896860820975586

22. US Dept of Veterans Affairs, Veterans Health Administration. Criteria and standards for VA dialysis programs. VHA Directive 1601. 2016. May 23, 2016. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3205

23. Crowley ST, Belcher J, Choudhury D, et al. Targeting access to kidney care via telehealth: the VA experience. Adv Chronic Kidney Dis. 2017;24(1):22-30. doi:10.1053/j.ackd.2016.11.005

24. Ishani A, Christopher J, Palmer D, et al. Telehealth by an interprofessional team in patients with CKD: a randomized controlled trial. Am J Kidney Dis. 2016;68(1):41-49. doi:10.1053/j.ajkd.2016.01.018

25. Gupta N, Taber-Hight EB, Miller BW. Perceptions of home dialysis training and experience among US nephrology fellows. Am J Kidney Dis. 2021;77(5):713-718.e1. doi:10.1053/j.ajkd.2020.09.014

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Teaching the Teacher: Novel Faculty Development for VA Hospitalists

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Educating the next generation of health professionals is 1 of 4 congressionally mandated statutory missions of the US Department of Veterans Affairs (VA).1 Even before the COVID-19 pandemic, the number of veterans accessing VA health care was increasing, and those veterans are older and more medically complex than those who seek care outside the VA.2 Almost half of medical residents reported a decline in the quality of their clinical education since the institution of the 2011 duty hours regulations, and in the past decade, more attention has been paid to the need for structured faculty development programs that focus on clinicians’ roles as medical educators.3-6 Hospitalists in particular shoulder a large portion of inpatient medicine education.7 As a result, hospitalists have adapted known frameworks for medical education to their unique clinical setting and developed novel frameworks to meet the needs of their learners.8,9

Access to technology and social media have shaped the educational experience of young learners who are accustomed to quick answers and the rapidity of change.10 The clinical teaching landscape changed again with COVID-19, requiring at least temporary abandonment of traditional in-person teaching methods, which upended well-established educational norms.11,12 In this evolving field, even seasoned preceptors may feel ill-equipped to manage the nuances of modern clinical education and may struggle to recognize which teaching skills are most critical.13,14 Baseline core teaching competencies for medical educators have been previously described and are separate from clinical competencies; however, to our knowledge, no needs assessment has previously been performed specifically for VA hospitalist clinician educators.15

Between May and June of 2020, we distributed an online needs assessment to academic VA hospitalists to identify perceived barriers to effective clinical education and preferred strategies to overcome them. We received 71 responses from 140 hospitalists (50% response rate) on the Veterans Health Administration (VHA) academic hospitalist listserv. Of respondents, 59 (83%) reported teaching health professions trainees every year. VA hospitalists reported educating a diverse group of interprofessional learners, including medical residents and students, physician assistant students, nursing students, pharmacy residents and students, and podiatry students.

Only 14 respondents (20%) were aware of faculty development training available to them through their VA facility, while 53 (75%) were aware of similar resources through academic affiliates or other outside sources. More than 95% of respondents (n = 68) reported interest in receiving VA-specific faculty development to improve skills as clinician educators. The most preferred forms of delivery were in-person or virtual real-time workshops. VA hospitalists reported the least confidence in their ability to support struggling learners, balance supervision and autonomy, and develop individualized learning plans (Table 1).

Conversely, they reported the most confidence in their ability to teach about VA’s unique patient population, instruct different skill levels, and produce on-the-fly teaching topics.

With a better understanding of the needs of academic VA hospitalists, we sought to develop, implement, and measure the impact of a faculty development program that meets the specific needs of inpatient clinicians in the VA. Here we introduce the program, its content, and the experiences of initial participants.

 

 

Teaching the Teacher

Teaching the Teacher began at a single VA institution as a series of in-person, discussion-based faculty development workshops. The series met a local need for collaborative professional development in clinical education for hospitalists and specialists who round with health professions learners on the inpatient wards. Both novice and experienced clinicians participated in the series with positive feedback. Based on the results of the national needs assessment, the program has since expanded to other sites with support from the VHA Hospital Medicine Program Office. The project’s overarching goal was to facilitate sharing of best practices across VA sites and create a network of local and national VA educators that participants could continue to access even after course completion.

Teaching the Teacher is structured into 5 facilitated hour-long sessions that can be completed either daily for 1 week or weekly for 1 month at the discretion of each institution. Each session is dedicated to a subject identified on the needs assessment as being highest yield. The hospitalist needs assessment also identified the preference for targeted faculty development that is relevant specifically to VA clinicians. To meet this need, Teaching the Teacher delivers its content through the unique lens of VA medicine. The educational mission of the VA is threaded throughout all presentations, and tips to maximize teaching in the VA’s unique clinical environments are embedded into each hour. Examples include discussions on how to incorporate veteran patients into bedside teaching, handling challenging patient-practitioner interactions as they pertain to patients, and the use of VA resources to find and teach evidence-based medicine.Each session includes a set of learning objectives; within that framework, facilitators allow participants to guide the nuances of content based on their individual and institutional priorities. The pandemic continues to shape much of the course content, as both hospitalists and their trainees grapple with mental health challenges, decreased bedside teaching, and wide variations in baseline trainee competence due to different institutional responses to teaching during a pandemic.12,16 Content is regularly updated to incorporate new literature and feedback from participants and prioritize active participation. Continuing medical education/continuing educational units credit is available through the VA for course completion.

In the first session on modern learners, participants discuss the current generation of health professions trainees, including how personality characteristics and COVID-19 have impacted their learning experiences, and strategies to improve our ability to teach them successfully (Table 2).

The second session discusses technology use in their clinical teaching, including social media platforms and VA-specific evidence-based medicine resources. Other classes discuss supervision and autonomy; the relationship between modern learners and preceptors, cultivating a learning mindset; and teaching at the bedside.

The course was originally designed to be in person, but the COVID-19 pandemic forced a shift to online format. To achieve a high-quality learning environment, the course implemented best practices in virtual synchronous instruction, including setting expectations for participation and screen use at the beginning of the series and optimizing audiovisual technology.17 During each seminar, the use of breakout rooms, polling, and the chat function fostered and sustained engagement.17 After each seminar, participants received a recording of the session, a copy of the materials reviewed, and links to referenced readings.17 The course preserved the interactive aspect of the curriculum through both these previously described techniques and our novel approaches, such as facilitated live interactions with online VA resources.

The pandemic also had an impact on curriculum content, as facilitation of online learning was a new and necessary skill set for instructors and participants. To meet this evolving need, additions in content addressed best practices in synchronous and asynchronous online learning, and augmented discussions on navigating asynchronous learning modalities such as social media. A virtual format allowed for dissemination of this course across the country and for recruitment of new course facilitators from remote sites. The team of instructors included academic hospitalist faculty from 3 VA institutions.

 

 

Program Impact

Ten academically affiliated VA hospital medicine sections across 6 states have participated in Teaching the Teacher and several more are scheduled at other sites. Of the 10, 5 completed the course in collaboration with another VA site. Ninety-seven clinicians completed < 1 session synchronously but given the asynchronous option, this number likely underestimates the total audience. Participants included physicians, nurse practitioners, and physician assistants.

Surveys were conducted before and after the program, with 58 participants completing the presurvey, 32 the postsurvey, and 27 completing both. Of the 32 postsurvey respondents, 31 (97%) would recommend the seminar to colleagues. The live, discussion-based format was the most valued aspect of the course structure, with engaging facilitators and course content also ranking highly. Just over half (n = 17) indicated specific behavioral changes they plan to enact after completing the series, such as connecting with and better understanding learners, prioritizing high-quality feedback more deliberately, and bringing medicine to the bedside. The most common critiques of the course were requests for more time for feedback skills.

Discussion

Teaching the Teacher is a VA-specific faculty development seminar for hospitalists. Participants who responded to a survey reported that it met their needs as VA clinician educators. This is the first published needs assessment of academic VA hospitalists in their roles as clinician educators and the first faculty development initiative to address those specific needs using a collaborative, multisite approach. Although this program is a pilot, the positive response it has received has set a precedent for increased development and growth.

Teaching the Teacher presents a novel approach with a condensed curriculum that is more convenient and accessible to VA clinicians than previous programs with similar goals. Hospitalists have busy and variable work schedules, and it can be difficult to find time to participate in a traditional faculty development program. While these programs are becoming more commonplace, they are often longitudinal and require a significant time and/or financial commitment from participants.18 In contrast, Teaching the Teacher is only 5 hours long, can be viewed either synchronously or asynchronously, and is no cost to participants. In the future, other specialties may similarly value an efficient faculty development curriculum, and participation from clinicians outside of hospital medicine could augment the richness of content.

Teaching the Teacher’s curriculum is not meant to be exhaustive, but rather to spark conversation among colleagues. According to survey respondents, the most lauded aspect of this program was the facilitated, discussion-based structure, wherein participants are presented with common challenges and encouraged to share their experiences and solutions with colleagues. Of particular interest to the program’s mission of greater community building are the VA facilities that chose to complete the seminar with another hospitalist section from a different institution. Within this structure lies an opportunity for seasoned educators to informally mentor junior colleagues both within and across institutions, and foster connections among educators that continue beyond the completion of the series. We envision this program growing into an enduring professional development course that begins at onboarding and is revisited at regular intervals thereafter.

Another compelling aspect of this project is the interprofessional design, bringing physicians, nurse practitioners, and physician assistants together. Health education, like clinical care, is shifting to a team approach.19 The curriculum addresses topics previously described as high priority for interprofessional faculty development, such as fostering healthy team leadership, motivating learners, and appraising evidence and online resources.20 A pilot project in VA primary care facilities found that deliberate interprofessional education improved collaboration among health care professionals.21 Prior to Teaching the Teacher, no similar faculty development program provided interprofessional learning and collaboration for VA hospitalists.

 

 

Limitations and Future Directions

There are several limitations to this preliminary study. Participation at each site was voluntary and did not always reach the full potential audience of hospitalist clinician educators. As one participant stated, future directions include doing “more to involve teachers who need to learn [these skills]. The ones who attended [from our institution] were already the best teachers.” In addition, despite the asynchronous option, lack of protected time for faculty development may be a limiting factor in participation. Support from institutional and national leadership would likely improve participation.

Measured endpoints to date consist primarily of participant satisfaction and do not yet capture objective changes in teaching. Data collection is ongoing to assess immediate and longitudinal changes in confidence and behaviors of attendees and how this might affect their health professions learners.

Last, our initial needs assessment only targeted academic hospitalists, and the needs of VA hospitalists in rural areas or at facilities without academic affiliation may be different. More research is needed to understand the diverse faculty that comprises both urban and rural VA sites, what their professional development needs are, and how those needs can be met.

Conclusions

Teaching the Teacher is a faculty development pilot, tailored to meet the needs of VA hospitalist clinician educators, that has been voluntarily adopted at multiple VA sites. The facilitated discussion format allows participants to guide the conversation and personalize content, thereby promoting a culture of discussing challenges and best practices among colleagues that we hope endures beyond the bounds of the curriculum. The program focuses on elevating the specific teaching mission of the VA and could be incorporated into onboarding and regular VA-sponsored faculty development updates. While Teaching the Teacher was originally developed for VA hospitalists, most of the content is applicable to clinicians outside hospital medicine. This project serves as a model for training clinical educators and has opportunities to expand across VA as a customizable didactic platform.

Acknowledgments

We thank Brian Schneider, MD, for his tireless support of this program, as well as all the VA clinicians who have shared their time, talents, and wisdom with us since this program’s inception.

References

1. US Department of Veterans Affairs, Office of Academic Affiliations. Mission of the Office of Academic Affiliations. Updated September 24, 2019. Accessed November 29, 2022. https://www.va.gov/oaa/oaa_mission.asp

2. Eibner C, Krull H, Brown KM, et al. Current and projected characteristics and unique health care needs of the patient population served by the Department of Veterans Affairs. Rand Health Q. 2016;5(4):13. Published 2016 May 9.

3. Drolet BC, Christopher DA, Fischer SA. Residents’ response to duty-hour regulations--a follow-up national survey. N Engl J Med. 2012;366(24):e35. doi:10.1056/NEJMp1202848

4. Hatem CJ, Lown BA, Newman LR. The academic health center coming of age: helping faculty become better teachers and agents of educational change. Acad Med. 2006;81(11):941-944. doi:10.1097/01.ACM.0000242490.56586.64

5. Harvey MM, Berkley HH, O’Malley PG, Durning SJ. Preparing future medical educators: development and pilot evaluation of a student-led medical education elective. Mil Med. 2020;185(1-2):e131-e137. doi:10.1093/milmed/usz175

6. Jason H. Future medical education: Preparing, priorities, possibilities. Med Teach. 2018;40(10):996-1003. doi:10.1080/0142159X.2018.1503412

7. Natarajan P, Ranji SR, Auerbach AD, Hauer KE. Effect of hospitalist attending physicians on trainee educational experiences: a systematic review. J Hosp Med. 2009;4(8):490-498. doi:10.1002/jhm.537

8. Pascoe JM, Nixon J, Lang VJ. Maximizing teaching on the wards: review and application of the One-Minute Preceptor and SNAPPS models. J Hosp Med. 2015;10(2):125-130. doi:10.1002/jhm.2302

9. Martin SK, Farnan JM, Arora VM. Future: new strategies for hospitalists to overcome challenges in teaching on today’s wards. J Hosp Med. 2013;8(7):409-413. doi:10.1002/jhm.2057

10. Waljee JF, Chopra V, Saint S. Mentoring Millennials. JAMA. 2020;323(17):1716-1717. doi:10.1001/jama.2020.3085

11. Papapanou M, Routsi E, Tsamakis K, et al. Medical education challenges and innovations during COVID-19 pandemic. Postgrad Med J. 2022;98(1159):321-327. doi:10.1136/postgradmedj-2021-140032

12. Hilburg R, Patel N, Ambruso S, Biewald MA, Farouk SS. Medical education during the Coronavirus Disease-2019 pandemic: learning from a distance. Adv Chronic Kidney Dis. 2020;27(5):412-417. doi:10.1053/j.ackd.2020.05.017

13. Simpson D, Marcdante K, Souza KH, Anderson A, Holmboe E. Job roles of the 2025 medical educator. J Grad Med Educ. 2018;10(3):243-246. doi:10.4300/JGME-D-18-00253.1

14. Armstrong EG, Mackey M, Spear SJ. Medical education as a process management problem. Acad Med. 2004;79(8):721-728. doi:10.1097/00001888-200408000-00002

15. Srinivasan M, Li ST, Meyers FJ, et al. “Teaching as a Competency”: competencies for medical educators. Acad Med. 2011;86(10):1211-1220. doi:10.1097/ACM.0b013e31822c5b9a

16. Clark E, Freytag J, Hysong SJ, Dang B, Giordano TP, Kulkarni PA. 964. Impact of the COVID-19 pandemic on bedside medical education: a mixed-methods study. Open Forum Infect Dis. 2021;8(Suppl 1):S574. Published 2021 Dec 4. doi:10.1093/ofid/ofab466.1159

17. Ohnigian S, Richards JB, Monette DL, Roberts DH. optimizing remote learning: leveraging zoom to develop and implement successful education sessions. J Med Educ Curric Dev. 2021;8:23821205211020760. Published 2021 Jun 28. doi:10.1177/23821205211020760

18. Burgess A, Matar E, Neuen B, Fox GJ. A longitudinal faculty development program: supporting a culture of teaching. BMC Med Educ. 2019;19(1):400. Published 2019 Nov 1. doi:10.1186/s12909-019-1832-3

19. Stoddard HA, Brownfield ED. Clinician-educators as dual professionals: a contemporary reappraisal. Acad Med. 2016;91(7):921-924. doi:10.1097/ACM.0000000000001210

20. Schönwetter DJ, Hamilton J, Sawatzky JA. Exploring professional development needs of educators in the health sciences professions. J Dent Educ. 2015;79(2):113-123.

21. Meyer EM, Zapatka S, Brienza RS. The development of professional identity and the formation of teams in the Veterans Affairs Connecticut Healthcare System’s Center of Excellence in Primary Care Education Program (CoEPCE). Acad Med. 2015;90(6):802-809. doi:10.1097/ACM.0000000000000594

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Author and Disclosure Information

aDurham Veterans Affairs Medical Center, North Carolina

bDuke University School of Medicine, Durham, North Carolina

cPalo Alto Veterans Affairs Health System, California

dStanford School of Medicine, Palo Alto, California

eSacramento Veterans Affairs Medical Center, California

fRocky Mountain Regional Veterans Affairs Medical Center, Aurora, Colorado

gUniversity of Colorado School of Medicine, Aurora

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Ethics and consent

This project was deemed a nonresearch education assessment by the chief of medicine at the Durham Veterans Affairs Medical Center. Institutional review board requirements were waived.

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bDuke University School of Medicine, Durham, North Carolina

cPalo Alto Veterans Affairs Health System, California

dStanford School of Medicine, Palo Alto, California

eSacramento Veterans Affairs Medical Center, California

fRocky Mountain Regional Veterans Affairs Medical Center, Aurora, Colorado

gUniversity of Colorado School of Medicine, Aurora

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Ethics and consent

This project was deemed a nonresearch education assessment by the chief of medicine at the Durham Veterans Affairs Medical Center. Institutional review board requirements were waived.

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aDurham Veterans Affairs Medical Center, North Carolina

bDuke University School of Medicine, Durham, North Carolina

cPalo Alto Veterans Affairs Health System, California

dStanford School of Medicine, Palo Alto, California

eSacramento Veterans Affairs Medical Center, California

fRocky Mountain Regional Veterans Affairs Medical Center, Aurora, Colorado

gUniversity of Colorado School of Medicine, Aurora

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Ethics and consent

This project was deemed a nonresearch education assessment by the chief of medicine at the Durham Veterans Affairs Medical Center. Institutional review board requirements were waived.

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Educating the next generation of health professionals is 1 of 4 congressionally mandated statutory missions of the US Department of Veterans Affairs (VA).1 Even before the COVID-19 pandemic, the number of veterans accessing VA health care was increasing, and those veterans are older and more medically complex than those who seek care outside the VA.2 Almost half of medical residents reported a decline in the quality of their clinical education since the institution of the 2011 duty hours regulations, and in the past decade, more attention has been paid to the need for structured faculty development programs that focus on clinicians’ roles as medical educators.3-6 Hospitalists in particular shoulder a large portion of inpatient medicine education.7 As a result, hospitalists have adapted known frameworks for medical education to their unique clinical setting and developed novel frameworks to meet the needs of their learners.8,9

Access to technology and social media have shaped the educational experience of young learners who are accustomed to quick answers and the rapidity of change.10 The clinical teaching landscape changed again with COVID-19, requiring at least temporary abandonment of traditional in-person teaching methods, which upended well-established educational norms.11,12 In this evolving field, even seasoned preceptors may feel ill-equipped to manage the nuances of modern clinical education and may struggle to recognize which teaching skills are most critical.13,14 Baseline core teaching competencies for medical educators have been previously described and are separate from clinical competencies; however, to our knowledge, no needs assessment has previously been performed specifically for VA hospitalist clinician educators.15

Between May and June of 2020, we distributed an online needs assessment to academic VA hospitalists to identify perceived barriers to effective clinical education and preferred strategies to overcome them. We received 71 responses from 140 hospitalists (50% response rate) on the Veterans Health Administration (VHA) academic hospitalist listserv. Of respondents, 59 (83%) reported teaching health professions trainees every year. VA hospitalists reported educating a diverse group of interprofessional learners, including medical residents and students, physician assistant students, nursing students, pharmacy residents and students, and podiatry students.

Only 14 respondents (20%) were aware of faculty development training available to them through their VA facility, while 53 (75%) were aware of similar resources through academic affiliates or other outside sources. More than 95% of respondents (n = 68) reported interest in receiving VA-specific faculty development to improve skills as clinician educators. The most preferred forms of delivery were in-person or virtual real-time workshops. VA hospitalists reported the least confidence in their ability to support struggling learners, balance supervision and autonomy, and develop individualized learning plans (Table 1).

Conversely, they reported the most confidence in their ability to teach about VA’s unique patient population, instruct different skill levels, and produce on-the-fly teaching topics.

With a better understanding of the needs of academic VA hospitalists, we sought to develop, implement, and measure the impact of a faculty development program that meets the specific needs of inpatient clinicians in the VA. Here we introduce the program, its content, and the experiences of initial participants.

 

 

Teaching the Teacher

Teaching the Teacher began at a single VA institution as a series of in-person, discussion-based faculty development workshops. The series met a local need for collaborative professional development in clinical education for hospitalists and specialists who round with health professions learners on the inpatient wards. Both novice and experienced clinicians participated in the series with positive feedback. Based on the results of the national needs assessment, the program has since expanded to other sites with support from the VHA Hospital Medicine Program Office. The project’s overarching goal was to facilitate sharing of best practices across VA sites and create a network of local and national VA educators that participants could continue to access even after course completion.

Teaching the Teacher is structured into 5 facilitated hour-long sessions that can be completed either daily for 1 week or weekly for 1 month at the discretion of each institution. Each session is dedicated to a subject identified on the needs assessment as being highest yield. The hospitalist needs assessment also identified the preference for targeted faculty development that is relevant specifically to VA clinicians. To meet this need, Teaching the Teacher delivers its content through the unique lens of VA medicine. The educational mission of the VA is threaded throughout all presentations, and tips to maximize teaching in the VA’s unique clinical environments are embedded into each hour. Examples include discussions on how to incorporate veteran patients into bedside teaching, handling challenging patient-practitioner interactions as they pertain to patients, and the use of VA resources to find and teach evidence-based medicine.Each session includes a set of learning objectives; within that framework, facilitators allow participants to guide the nuances of content based on their individual and institutional priorities. The pandemic continues to shape much of the course content, as both hospitalists and their trainees grapple with mental health challenges, decreased bedside teaching, and wide variations in baseline trainee competence due to different institutional responses to teaching during a pandemic.12,16 Content is regularly updated to incorporate new literature and feedback from participants and prioritize active participation. Continuing medical education/continuing educational units credit is available through the VA for course completion.

In the first session on modern learners, participants discuss the current generation of health professions trainees, including how personality characteristics and COVID-19 have impacted their learning experiences, and strategies to improve our ability to teach them successfully (Table 2).

The second session discusses technology use in their clinical teaching, including social media platforms and VA-specific evidence-based medicine resources. Other classes discuss supervision and autonomy; the relationship between modern learners and preceptors, cultivating a learning mindset; and teaching at the bedside.

The course was originally designed to be in person, but the COVID-19 pandemic forced a shift to online format. To achieve a high-quality learning environment, the course implemented best practices in virtual synchronous instruction, including setting expectations for participation and screen use at the beginning of the series and optimizing audiovisual technology.17 During each seminar, the use of breakout rooms, polling, and the chat function fostered and sustained engagement.17 After each seminar, participants received a recording of the session, a copy of the materials reviewed, and links to referenced readings.17 The course preserved the interactive aspect of the curriculum through both these previously described techniques and our novel approaches, such as facilitated live interactions with online VA resources.

The pandemic also had an impact on curriculum content, as facilitation of online learning was a new and necessary skill set for instructors and participants. To meet this evolving need, additions in content addressed best practices in synchronous and asynchronous online learning, and augmented discussions on navigating asynchronous learning modalities such as social media. A virtual format allowed for dissemination of this course across the country and for recruitment of new course facilitators from remote sites. The team of instructors included academic hospitalist faculty from 3 VA institutions.

 

 

Program Impact

Ten academically affiliated VA hospital medicine sections across 6 states have participated in Teaching the Teacher and several more are scheduled at other sites. Of the 10, 5 completed the course in collaboration with another VA site. Ninety-seven clinicians completed < 1 session synchronously but given the asynchronous option, this number likely underestimates the total audience. Participants included physicians, nurse practitioners, and physician assistants.

Surveys were conducted before and after the program, with 58 participants completing the presurvey, 32 the postsurvey, and 27 completing both. Of the 32 postsurvey respondents, 31 (97%) would recommend the seminar to colleagues. The live, discussion-based format was the most valued aspect of the course structure, with engaging facilitators and course content also ranking highly. Just over half (n = 17) indicated specific behavioral changes they plan to enact after completing the series, such as connecting with and better understanding learners, prioritizing high-quality feedback more deliberately, and bringing medicine to the bedside. The most common critiques of the course were requests for more time for feedback skills.

Discussion

Teaching the Teacher is a VA-specific faculty development seminar for hospitalists. Participants who responded to a survey reported that it met their needs as VA clinician educators. This is the first published needs assessment of academic VA hospitalists in their roles as clinician educators and the first faculty development initiative to address those specific needs using a collaborative, multisite approach. Although this program is a pilot, the positive response it has received has set a precedent for increased development and growth.

Teaching the Teacher presents a novel approach with a condensed curriculum that is more convenient and accessible to VA clinicians than previous programs with similar goals. Hospitalists have busy and variable work schedules, and it can be difficult to find time to participate in a traditional faculty development program. While these programs are becoming more commonplace, they are often longitudinal and require a significant time and/or financial commitment from participants.18 In contrast, Teaching the Teacher is only 5 hours long, can be viewed either synchronously or asynchronously, and is no cost to participants. In the future, other specialties may similarly value an efficient faculty development curriculum, and participation from clinicians outside of hospital medicine could augment the richness of content.

Teaching the Teacher’s curriculum is not meant to be exhaustive, but rather to spark conversation among colleagues. According to survey respondents, the most lauded aspect of this program was the facilitated, discussion-based structure, wherein participants are presented with common challenges and encouraged to share their experiences and solutions with colleagues. Of particular interest to the program’s mission of greater community building are the VA facilities that chose to complete the seminar with another hospitalist section from a different institution. Within this structure lies an opportunity for seasoned educators to informally mentor junior colleagues both within and across institutions, and foster connections among educators that continue beyond the completion of the series. We envision this program growing into an enduring professional development course that begins at onboarding and is revisited at regular intervals thereafter.

Another compelling aspect of this project is the interprofessional design, bringing physicians, nurse practitioners, and physician assistants together. Health education, like clinical care, is shifting to a team approach.19 The curriculum addresses topics previously described as high priority for interprofessional faculty development, such as fostering healthy team leadership, motivating learners, and appraising evidence and online resources.20 A pilot project in VA primary care facilities found that deliberate interprofessional education improved collaboration among health care professionals.21 Prior to Teaching the Teacher, no similar faculty development program provided interprofessional learning and collaboration for VA hospitalists.

 

 

Limitations and Future Directions

There are several limitations to this preliminary study. Participation at each site was voluntary and did not always reach the full potential audience of hospitalist clinician educators. As one participant stated, future directions include doing “more to involve teachers who need to learn [these skills]. The ones who attended [from our institution] were already the best teachers.” In addition, despite the asynchronous option, lack of protected time for faculty development may be a limiting factor in participation. Support from institutional and national leadership would likely improve participation.

Measured endpoints to date consist primarily of participant satisfaction and do not yet capture objective changes in teaching. Data collection is ongoing to assess immediate and longitudinal changes in confidence and behaviors of attendees and how this might affect their health professions learners.

Last, our initial needs assessment only targeted academic hospitalists, and the needs of VA hospitalists in rural areas or at facilities without academic affiliation may be different. More research is needed to understand the diverse faculty that comprises both urban and rural VA sites, what their professional development needs are, and how those needs can be met.

Conclusions

Teaching the Teacher is a faculty development pilot, tailored to meet the needs of VA hospitalist clinician educators, that has been voluntarily adopted at multiple VA sites. The facilitated discussion format allows participants to guide the conversation and personalize content, thereby promoting a culture of discussing challenges and best practices among colleagues that we hope endures beyond the bounds of the curriculum. The program focuses on elevating the specific teaching mission of the VA and could be incorporated into onboarding and regular VA-sponsored faculty development updates. While Teaching the Teacher was originally developed for VA hospitalists, most of the content is applicable to clinicians outside hospital medicine. This project serves as a model for training clinical educators and has opportunities to expand across VA as a customizable didactic platform.

Acknowledgments

We thank Brian Schneider, MD, for his tireless support of this program, as well as all the VA clinicians who have shared their time, talents, and wisdom with us since this program’s inception.

Educating the next generation of health professionals is 1 of 4 congressionally mandated statutory missions of the US Department of Veterans Affairs (VA).1 Even before the COVID-19 pandemic, the number of veterans accessing VA health care was increasing, and those veterans are older and more medically complex than those who seek care outside the VA.2 Almost half of medical residents reported a decline in the quality of their clinical education since the institution of the 2011 duty hours regulations, and in the past decade, more attention has been paid to the need for structured faculty development programs that focus on clinicians’ roles as medical educators.3-6 Hospitalists in particular shoulder a large portion of inpatient medicine education.7 As a result, hospitalists have adapted known frameworks for medical education to their unique clinical setting and developed novel frameworks to meet the needs of their learners.8,9

Access to technology and social media have shaped the educational experience of young learners who are accustomed to quick answers and the rapidity of change.10 The clinical teaching landscape changed again with COVID-19, requiring at least temporary abandonment of traditional in-person teaching methods, which upended well-established educational norms.11,12 In this evolving field, even seasoned preceptors may feel ill-equipped to manage the nuances of modern clinical education and may struggle to recognize which teaching skills are most critical.13,14 Baseline core teaching competencies for medical educators have been previously described and are separate from clinical competencies; however, to our knowledge, no needs assessment has previously been performed specifically for VA hospitalist clinician educators.15

Between May and June of 2020, we distributed an online needs assessment to academic VA hospitalists to identify perceived barriers to effective clinical education and preferred strategies to overcome them. We received 71 responses from 140 hospitalists (50% response rate) on the Veterans Health Administration (VHA) academic hospitalist listserv. Of respondents, 59 (83%) reported teaching health professions trainees every year. VA hospitalists reported educating a diverse group of interprofessional learners, including medical residents and students, physician assistant students, nursing students, pharmacy residents and students, and podiatry students.

Only 14 respondents (20%) were aware of faculty development training available to them through their VA facility, while 53 (75%) were aware of similar resources through academic affiliates or other outside sources. More than 95% of respondents (n = 68) reported interest in receiving VA-specific faculty development to improve skills as clinician educators. The most preferred forms of delivery were in-person or virtual real-time workshops. VA hospitalists reported the least confidence in their ability to support struggling learners, balance supervision and autonomy, and develop individualized learning plans (Table 1).

Conversely, they reported the most confidence in their ability to teach about VA’s unique patient population, instruct different skill levels, and produce on-the-fly teaching topics.

With a better understanding of the needs of academic VA hospitalists, we sought to develop, implement, and measure the impact of a faculty development program that meets the specific needs of inpatient clinicians in the VA. Here we introduce the program, its content, and the experiences of initial participants.

 

 

Teaching the Teacher

Teaching the Teacher began at a single VA institution as a series of in-person, discussion-based faculty development workshops. The series met a local need for collaborative professional development in clinical education for hospitalists and specialists who round with health professions learners on the inpatient wards. Both novice and experienced clinicians participated in the series with positive feedback. Based on the results of the national needs assessment, the program has since expanded to other sites with support from the VHA Hospital Medicine Program Office. The project’s overarching goal was to facilitate sharing of best practices across VA sites and create a network of local and national VA educators that participants could continue to access even after course completion.

Teaching the Teacher is structured into 5 facilitated hour-long sessions that can be completed either daily for 1 week or weekly for 1 month at the discretion of each institution. Each session is dedicated to a subject identified on the needs assessment as being highest yield. The hospitalist needs assessment also identified the preference for targeted faculty development that is relevant specifically to VA clinicians. To meet this need, Teaching the Teacher delivers its content through the unique lens of VA medicine. The educational mission of the VA is threaded throughout all presentations, and tips to maximize teaching in the VA’s unique clinical environments are embedded into each hour. Examples include discussions on how to incorporate veteran patients into bedside teaching, handling challenging patient-practitioner interactions as they pertain to patients, and the use of VA resources to find and teach evidence-based medicine.Each session includes a set of learning objectives; within that framework, facilitators allow participants to guide the nuances of content based on their individual and institutional priorities. The pandemic continues to shape much of the course content, as both hospitalists and their trainees grapple with mental health challenges, decreased bedside teaching, and wide variations in baseline trainee competence due to different institutional responses to teaching during a pandemic.12,16 Content is regularly updated to incorporate new literature and feedback from participants and prioritize active participation. Continuing medical education/continuing educational units credit is available through the VA for course completion.

In the first session on modern learners, participants discuss the current generation of health professions trainees, including how personality characteristics and COVID-19 have impacted their learning experiences, and strategies to improve our ability to teach them successfully (Table 2).

The second session discusses technology use in their clinical teaching, including social media platforms and VA-specific evidence-based medicine resources. Other classes discuss supervision and autonomy; the relationship between modern learners and preceptors, cultivating a learning mindset; and teaching at the bedside.

The course was originally designed to be in person, but the COVID-19 pandemic forced a shift to online format. To achieve a high-quality learning environment, the course implemented best practices in virtual synchronous instruction, including setting expectations for participation and screen use at the beginning of the series and optimizing audiovisual technology.17 During each seminar, the use of breakout rooms, polling, and the chat function fostered and sustained engagement.17 After each seminar, participants received a recording of the session, a copy of the materials reviewed, and links to referenced readings.17 The course preserved the interactive aspect of the curriculum through both these previously described techniques and our novel approaches, such as facilitated live interactions with online VA resources.

The pandemic also had an impact on curriculum content, as facilitation of online learning was a new and necessary skill set for instructors and participants. To meet this evolving need, additions in content addressed best practices in synchronous and asynchronous online learning, and augmented discussions on navigating asynchronous learning modalities such as social media. A virtual format allowed for dissemination of this course across the country and for recruitment of new course facilitators from remote sites. The team of instructors included academic hospitalist faculty from 3 VA institutions.

 

 

Program Impact

Ten academically affiliated VA hospital medicine sections across 6 states have participated in Teaching the Teacher and several more are scheduled at other sites. Of the 10, 5 completed the course in collaboration with another VA site. Ninety-seven clinicians completed < 1 session synchronously but given the asynchronous option, this number likely underestimates the total audience. Participants included physicians, nurse practitioners, and physician assistants.

Surveys were conducted before and after the program, with 58 participants completing the presurvey, 32 the postsurvey, and 27 completing both. Of the 32 postsurvey respondents, 31 (97%) would recommend the seminar to colleagues. The live, discussion-based format was the most valued aspect of the course structure, with engaging facilitators and course content also ranking highly. Just over half (n = 17) indicated specific behavioral changes they plan to enact after completing the series, such as connecting with and better understanding learners, prioritizing high-quality feedback more deliberately, and bringing medicine to the bedside. The most common critiques of the course were requests for more time for feedback skills.

Discussion

Teaching the Teacher is a VA-specific faculty development seminar for hospitalists. Participants who responded to a survey reported that it met their needs as VA clinician educators. This is the first published needs assessment of academic VA hospitalists in their roles as clinician educators and the first faculty development initiative to address those specific needs using a collaborative, multisite approach. Although this program is a pilot, the positive response it has received has set a precedent for increased development and growth.

Teaching the Teacher presents a novel approach with a condensed curriculum that is more convenient and accessible to VA clinicians than previous programs with similar goals. Hospitalists have busy and variable work schedules, and it can be difficult to find time to participate in a traditional faculty development program. While these programs are becoming more commonplace, they are often longitudinal and require a significant time and/or financial commitment from participants.18 In contrast, Teaching the Teacher is only 5 hours long, can be viewed either synchronously or asynchronously, and is no cost to participants. In the future, other specialties may similarly value an efficient faculty development curriculum, and participation from clinicians outside of hospital medicine could augment the richness of content.

Teaching the Teacher’s curriculum is not meant to be exhaustive, but rather to spark conversation among colleagues. According to survey respondents, the most lauded aspect of this program was the facilitated, discussion-based structure, wherein participants are presented with common challenges and encouraged to share their experiences and solutions with colleagues. Of particular interest to the program’s mission of greater community building are the VA facilities that chose to complete the seminar with another hospitalist section from a different institution. Within this structure lies an opportunity for seasoned educators to informally mentor junior colleagues both within and across institutions, and foster connections among educators that continue beyond the completion of the series. We envision this program growing into an enduring professional development course that begins at onboarding and is revisited at regular intervals thereafter.

Another compelling aspect of this project is the interprofessional design, bringing physicians, nurse practitioners, and physician assistants together. Health education, like clinical care, is shifting to a team approach.19 The curriculum addresses topics previously described as high priority for interprofessional faculty development, such as fostering healthy team leadership, motivating learners, and appraising evidence and online resources.20 A pilot project in VA primary care facilities found that deliberate interprofessional education improved collaboration among health care professionals.21 Prior to Teaching the Teacher, no similar faculty development program provided interprofessional learning and collaboration for VA hospitalists.

 

 

Limitations and Future Directions

There are several limitations to this preliminary study. Participation at each site was voluntary and did not always reach the full potential audience of hospitalist clinician educators. As one participant stated, future directions include doing “more to involve teachers who need to learn [these skills]. The ones who attended [from our institution] were already the best teachers.” In addition, despite the asynchronous option, lack of protected time for faculty development may be a limiting factor in participation. Support from institutional and national leadership would likely improve participation.

Measured endpoints to date consist primarily of participant satisfaction and do not yet capture objective changes in teaching. Data collection is ongoing to assess immediate and longitudinal changes in confidence and behaviors of attendees and how this might affect their health professions learners.

Last, our initial needs assessment only targeted academic hospitalists, and the needs of VA hospitalists in rural areas or at facilities without academic affiliation may be different. More research is needed to understand the diverse faculty that comprises both urban and rural VA sites, what their professional development needs are, and how those needs can be met.

Conclusions

Teaching the Teacher is a faculty development pilot, tailored to meet the needs of VA hospitalist clinician educators, that has been voluntarily adopted at multiple VA sites. The facilitated discussion format allows participants to guide the conversation and personalize content, thereby promoting a culture of discussing challenges and best practices among colleagues that we hope endures beyond the bounds of the curriculum. The program focuses on elevating the specific teaching mission of the VA and could be incorporated into onboarding and regular VA-sponsored faculty development updates. While Teaching the Teacher was originally developed for VA hospitalists, most of the content is applicable to clinicians outside hospital medicine. This project serves as a model for training clinical educators and has opportunities to expand across VA as a customizable didactic platform.

Acknowledgments

We thank Brian Schneider, MD, for his tireless support of this program, as well as all the VA clinicians who have shared their time, talents, and wisdom with us since this program’s inception.

References

1. US Department of Veterans Affairs, Office of Academic Affiliations. Mission of the Office of Academic Affiliations. Updated September 24, 2019. Accessed November 29, 2022. https://www.va.gov/oaa/oaa_mission.asp

2. Eibner C, Krull H, Brown KM, et al. Current and projected characteristics and unique health care needs of the patient population served by the Department of Veterans Affairs. Rand Health Q. 2016;5(4):13. Published 2016 May 9.

3. Drolet BC, Christopher DA, Fischer SA. Residents’ response to duty-hour regulations--a follow-up national survey. N Engl J Med. 2012;366(24):e35. doi:10.1056/NEJMp1202848

4. Hatem CJ, Lown BA, Newman LR. The academic health center coming of age: helping faculty become better teachers and agents of educational change. Acad Med. 2006;81(11):941-944. doi:10.1097/01.ACM.0000242490.56586.64

5. Harvey MM, Berkley HH, O’Malley PG, Durning SJ. Preparing future medical educators: development and pilot evaluation of a student-led medical education elective. Mil Med. 2020;185(1-2):e131-e137. doi:10.1093/milmed/usz175

6. Jason H. Future medical education: Preparing, priorities, possibilities. Med Teach. 2018;40(10):996-1003. doi:10.1080/0142159X.2018.1503412

7. Natarajan P, Ranji SR, Auerbach AD, Hauer KE. Effect of hospitalist attending physicians on trainee educational experiences: a systematic review. J Hosp Med. 2009;4(8):490-498. doi:10.1002/jhm.537

8. Pascoe JM, Nixon J, Lang VJ. Maximizing teaching on the wards: review and application of the One-Minute Preceptor and SNAPPS models. J Hosp Med. 2015;10(2):125-130. doi:10.1002/jhm.2302

9. Martin SK, Farnan JM, Arora VM. Future: new strategies for hospitalists to overcome challenges in teaching on today’s wards. J Hosp Med. 2013;8(7):409-413. doi:10.1002/jhm.2057

10. Waljee JF, Chopra V, Saint S. Mentoring Millennials. JAMA. 2020;323(17):1716-1717. doi:10.1001/jama.2020.3085

11. Papapanou M, Routsi E, Tsamakis K, et al. Medical education challenges and innovations during COVID-19 pandemic. Postgrad Med J. 2022;98(1159):321-327. doi:10.1136/postgradmedj-2021-140032

12. Hilburg R, Patel N, Ambruso S, Biewald MA, Farouk SS. Medical education during the Coronavirus Disease-2019 pandemic: learning from a distance. Adv Chronic Kidney Dis. 2020;27(5):412-417. doi:10.1053/j.ackd.2020.05.017

13. Simpson D, Marcdante K, Souza KH, Anderson A, Holmboe E. Job roles of the 2025 medical educator. J Grad Med Educ. 2018;10(3):243-246. doi:10.4300/JGME-D-18-00253.1

14. Armstrong EG, Mackey M, Spear SJ. Medical education as a process management problem. Acad Med. 2004;79(8):721-728. doi:10.1097/00001888-200408000-00002

15. Srinivasan M, Li ST, Meyers FJ, et al. “Teaching as a Competency”: competencies for medical educators. Acad Med. 2011;86(10):1211-1220. doi:10.1097/ACM.0b013e31822c5b9a

16. Clark E, Freytag J, Hysong SJ, Dang B, Giordano TP, Kulkarni PA. 964. Impact of the COVID-19 pandemic on bedside medical education: a mixed-methods study. Open Forum Infect Dis. 2021;8(Suppl 1):S574. Published 2021 Dec 4. doi:10.1093/ofid/ofab466.1159

17. Ohnigian S, Richards JB, Monette DL, Roberts DH. optimizing remote learning: leveraging zoom to develop and implement successful education sessions. J Med Educ Curric Dev. 2021;8:23821205211020760. Published 2021 Jun 28. doi:10.1177/23821205211020760

18. Burgess A, Matar E, Neuen B, Fox GJ. A longitudinal faculty development program: supporting a culture of teaching. BMC Med Educ. 2019;19(1):400. Published 2019 Nov 1. doi:10.1186/s12909-019-1832-3

19. Stoddard HA, Brownfield ED. Clinician-educators as dual professionals: a contemporary reappraisal. Acad Med. 2016;91(7):921-924. doi:10.1097/ACM.0000000000001210

20. Schönwetter DJ, Hamilton J, Sawatzky JA. Exploring professional development needs of educators in the health sciences professions. J Dent Educ. 2015;79(2):113-123.

21. Meyer EM, Zapatka S, Brienza RS. The development of professional identity and the formation of teams in the Veterans Affairs Connecticut Healthcare System’s Center of Excellence in Primary Care Education Program (CoEPCE). Acad Med. 2015;90(6):802-809. doi:10.1097/ACM.0000000000000594

References

1. US Department of Veterans Affairs, Office of Academic Affiliations. Mission of the Office of Academic Affiliations. Updated September 24, 2019. Accessed November 29, 2022. https://www.va.gov/oaa/oaa_mission.asp

2. Eibner C, Krull H, Brown KM, et al. Current and projected characteristics and unique health care needs of the patient population served by the Department of Veterans Affairs. Rand Health Q. 2016;5(4):13. Published 2016 May 9.

3. Drolet BC, Christopher DA, Fischer SA. Residents’ response to duty-hour regulations--a follow-up national survey. N Engl J Med. 2012;366(24):e35. doi:10.1056/NEJMp1202848

4. Hatem CJ, Lown BA, Newman LR. The academic health center coming of age: helping faculty become better teachers and agents of educational change. Acad Med. 2006;81(11):941-944. doi:10.1097/01.ACM.0000242490.56586.64

5. Harvey MM, Berkley HH, O’Malley PG, Durning SJ. Preparing future medical educators: development and pilot evaluation of a student-led medical education elective. Mil Med. 2020;185(1-2):e131-e137. doi:10.1093/milmed/usz175

6. Jason H. Future medical education: Preparing, priorities, possibilities. Med Teach. 2018;40(10):996-1003. doi:10.1080/0142159X.2018.1503412

7. Natarajan P, Ranji SR, Auerbach AD, Hauer KE. Effect of hospitalist attending physicians on trainee educational experiences: a systematic review. J Hosp Med. 2009;4(8):490-498. doi:10.1002/jhm.537

8. Pascoe JM, Nixon J, Lang VJ. Maximizing teaching on the wards: review and application of the One-Minute Preceptor and SNAPPS models. J Hosp Med. 2015;10(2):125-130. doi:10.1002/jhm.2302

9. Martin SK, Farnan JM, Arora VM. Future: new strategies for hospitalists to overcome challenges in teaching on today’s wards. J Hosp Med. 2013;8(7):409-413. doi:10.1002/jhm.2057

10. Waljee JF, Chopra V, Saint S. Mentoring Millennials. JAMA. 2020;323(17):1716-1717. doi:10.1001/jama.2020.3085

11. Papapanou M, Routsi E, Tsamakis K, et al. Medical education challenges and innovations during COVID-19 pandemic. Postgrad Med J. 2022;98(1159):321-327. doi:10.1136/postgradmedj-2021-140032

12. Hilburg R, Patel N, Ambruso S, Biewald MA, Farouk SS. Medical education during the Coronavirus Disease-2019 pandemic: learning from a distance. Adv Chronic Kidney Dis. 2020;27(5):412-417. doi:10.1053/j.ackd.2020.05.017

13. Simpson D, Marcdante K, Souza KH, Anderson A, Holmboe E. Job roles of the 2025 medical educator. J Grad Med Educ. 2018;10(3):243-246. doi:10.4300/JGME-D-18-00253.1

14. Armstrong EG, Mackey M, Spear SJ. Medical education as a process management problem. Acad Med. 2004;79(8):721-728. doi:10.1097/00001888-200408000-00002

15. Srinivasan M, Li ST, Meyers FJ, et al. “Teaching as a Competency”: competencies for medical educators. Acad Med. 2011;86(10):1211-1220. doi:10.1097/ACM.0b013e31822c5b9a

16. Clark E, Freytag J, Hysong SJ, Dang B, Giordano TP, Kulkarni PA. 964. Impact of the COVID-19 pandemic on bedside medical education: a mixed-methods study. Open Forum Infect Dis. 2021;8(Suppl 1):S574. Published 2021 Dec 4. doi:10.1093/ofid/ofab466.1159

17. Ohnigian S, Richards JB, Monette DL, Roberts DH. optimizing remote learning: leveraging zoom to develop and implement successful education sessions. J Med Educ Curric Dev. 2021;8:23821205211020760. Published 2021 Jun 28. doi:10.1177/23821205211020760

18. Burgess A, Matar E, Neuen B, Fox GJ. A longitudinal faculty development program: supporting a culture of teaching. BMC Med Educ. 2019;19(1):400. Published 2019 Nov 1. doi:10.1186/s12909-019-1832-3

19. Stoddard HA, Brownfield ED. Clinician-educators as dual professionals: a contemporary reappraisal. Acad Med. 2016;91(7):921-924. doi:10.1097/ACM.0000000000001210

20. Schönwetter DJ, Hamilton J, Sawatzky JA. Exploring professional development needs of educators in the health sciences professions. J Dent Educ. 2015;79(2):113-123.

21. Meyer EM, Zapatka S, Brienza RS. The development of professional identity and the formation of teams in the Veterans Affairs Connecticut Healthcare System’s Center of Excellence in Primary Care Education Program (CoEPCE). Acad Med. 2015;90(6):802-809. doi:10.1097/ACM.0000000000000594

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Trauma-Informed Training for Veterans Treatment Court Professionals: Program Development and Initial Feedback

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Veterans who interact with the criminal justice system (ie, justice-involved veterans) have heightened rates of mental health and psychosocial needs, including posttraumatic stress disorder (PTSD), substance use disorder, depression, suicidal ideation and attempt, and homelessness.1,2 Alongside these criminogenic risk factors, recidivism is common among justice-involved veterans: About 70% of incarcerated veterans disclosed at least one prior incarceration.3

To address the complex interplay of psychosocial factors, mental health concerns, and justice involvement among veterans, veterans treatment courts (VTCs) emerged as an alternative to incarceration.4 VTC participation often consists of integrated treatment and rehabilitative services (eg, vocational training, health care), ongoing monitoring for substance use, graduated responses to address treatment adherence, and ongoing communication with the judge and legal counsel.4

A primary aim of these courts is to address psychosocial needs believed to underlie criminal behavior, thus reducing risk of recidivism and promoting successful recovery and community integration for eligible veterans. To do so, VTCs collaborate with community-based and/or US Department of Veterans Affairs services, such as the Veterans Justice Outreach program (VJO). VJO specialists identify and refer justice-involved veterans to Veterans Health Administration (VHA) and community care and serve as a liaison between VTC staff and VHA health care professionals (HCPs).5

VTC outcome studies highlight the importance of not only diverting veterans to problem-solving courts, but also ensuring their optimal participation. Successful graduates of VTC programs demonstrate significant improvements in mental health symptoms, life satisfaction, and social support, as well as lower rates of law enforcement interactions.6,7 However, less is known about supporting those veterans who have difficulty engaging in VTCs and either discontinue participation or require lengthier periods of participation to meet court graduation requirements.8 One possibility to improve engagement among these veterans is to enhance court practices to best meet their needs.

In addition to delivering treatment, VHA mental health professionals may serve a critical interdisciplinary role by lending expertise to support VTC practices. For example, equipping court professionals with clinical knowledge and skills related to motivation may strengthen the staff’s interactions with participants, enabling them to address barriers as they arise and to facilitate veterans’ treatment adherence. Additionally, responsiveness to the impact of trauma exposure, which is common among this population, may prove important as related symptoms can affect veterans’ engagement, receptivity, and behavior in court settings. Indeed, prior examinations of justice-involved veterans have found trauma exposure rates ranging from 60% to 90% and PTSD rates ranging from 27% to 40%.1,2 Notably, involvement with the justice system (eg, incarceration) may itself further increase risk of trauma exposure (eg, experiencing a physical or sexual assault in prison) or exacerbate existing PTSD.9 Nonetheless, whereas many drug courts and domestic violence courts have been established, problem-solving courts with a specialized focus on trauma exposure remain rare, suggesting a potential gap in court training.

VHA HCPs have the potential to facilitate justice-involved veterans’ successful court and treatment participation by coordinating with VJO specialists to provide training and consultation to the courts. Supporting efforts to effectively and responsively address criminogenic risk (eg, mental health) in VTC settings may in turn reduce the likelihood of recidivism.10 Given the elevated rates of trauma exposure among justice-involved veterans and the relative lack of trauma-focused VTCs, we developed a trauma-informed training for VTC professionals that centered on related clinical presentations of justice-involved veterans and frequently occurring challenges in the context of court participation.

 

 

Program Development

This educational program aimed to (1) provide psychoeducation on trauma exposure, PTSD, and existing evidence-based treatments; (2) present clinical considerations for justice-involved veterans related to trauma exposure and/or PTSD; and (3) introduce skills to facilitate effective communication and trauma-informed care practices among professionals working with veterans in a treatment court.

Prior to piloting the program, we conducted a needs assessment with VTC professionals and identified relevant theoretical constructs and brief interventions for inclusion in the training. Additionally, given the dearth of prior research on mental health education for VTCs, the team consulted with the developers of PTSD 101, a VHA workshop for veterans’ families that promotes psychoeducation, support, and effective communication.11 Doing so informed approaches to delivering education to nonclinical audiences that interact with veterans with histories of trauma exposure. As this was a program development project, it was determined to be exempt from institutional review board review.

Needs Assessment

In the initial stages of development, local VJO specialists identified regional VTCs and facilitated introductions to these courts. Two of the 3 Rocky Mountain region VTCs that were contacted expressed interest in receiving trauma-informed training. Based on preliminary interest, the facilitators conducted a needs assessment with VJO and VTC staff from these 2 courts to capture requests for specific content and past experiences with other mental health trainings.

Guided by the focus group model, the needs assessments took place during three 1-hour meetings with VJO specialists and a 1-hour meeting with VJO specialists, VTC professionals, and community-based clinical partners.12 Additionally, attending a VTC graduation and court session allowed for observations of court practices and interactions with veterans. A total of 13 professionals (judges, court coordinators, case managers, peer mentors, VJO specialists, and clinicians who specialize in substance use disorder and intimate partner violence) participated in the needs assessments.

The most critical need identified by court professionals was a focus on how to apply knowledge about trauma and PTSD to interactions with justice-involved veterans. This was reportedly absent from prior training sessions the courts had received. Both Rocky Mountain region VTCs expressed a strong interest in and openness to adapting practices based on research and practice recommendations. Additional requests that emerged included a refresher on psychoeducation related to trauma and how to address the personal impact of working with this population (eg, compassion fatigue).

Training Components

Based on the needs identified by VTC professionals and informed by consultation with the developers of PTSD 101,

 the training consisted of 3 components: psychoeducation, skills training, and consultation (Table 1).

Psychoeducation. The initial portion of the training consisted of psychoeducation to increase VTC staff familiarity with the distinctions between trauma exposure and a formal diagnosis of PTSD, mechanisms underlying PTSD, and evidence-based treatment. To deepen conceptual understanding of trauma and PTSD beyond an overview of criteria set forth in The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), psychoeducation centered on the drivers of avoidance (eg, short-term benefit vs long-term consequences), behaviors that often facilitate avoidance (eg, substance use), functions underlying these behaviors (eg, distress reduction), and structure and mechanisms of change in evidence-based treatments for PTSD, including cognitive processing therapy and prolonged exposure.13,14

 

 

Fostering court familiarity with cognitive processing therapy and prolonged exposure may bolster veteran engagement in treatment through regular reinforcement of skills and concepts introduced in therapy. This may prove particularly salient given the limited engagement with mental health treatment and elevated dropout rates from PTSD treatment among the general veteran population.15,16

Exercises and metaphors were used to illustrate concepts in multiple ways. For example, training attendees engaged in a “stop, drop, and roll” thought exercise in which they were asked to brainstorm behavioral reactions to catching on fire. This exercise illustrated the tendency for individuals to revert to common yet unhelpful attempts at problem solving (eg, running due to panic, which would exacerbate the fire), particularly in crisis and without prior education regarding adaptive ways to respond. Attendee-generated examples, such as running, were used to demonstrate the importance of practicing and reinforcing skill development prior to a crisis, to ensure proficiency and optimal response. Additionally, in prompting consideration of one’s response tendencies, this exercise may engender empathy and understanding for veterans.

Skills training. Efforts to promote veteran engagement in court, facilitate motivation and readiness for change, and address barriers that arise (eg, distress associated with court appearances) may support successful and timely graduation. As such, skills training constituted the largest component of the training and drew from observations of court practices and the VTCs’ identified challenges. Consistent with the project’s aims and reported needs of the court, skills that target common presentations following trauma exposure (eg, avoidance, hypervigilance) were prioritized for this pilot training. Strategies included brief interventions from dialectical behavior therapy, acceptance and commitment therapy, and motivational interviewing to strengthen the support provided by staff to veterans and address their needs (Table 2).

17-19 Additionally, we presented strategies for implementing sanctions and rewards that were influenced by trauma-informed care practices, such as highlighting veteran strengths and promoting agency in decision making.

Training attendees also participated in exercises to reiterate skills. For example, attendees completed an ambivalence matrix using an audience-identified common behavior that is difficult to change (eg, heavy alcohol use as a coping mechanism for distress).

Attendees engaged in an exercise that involved identifying unhelpful thoughts and behaviors, targets for validation, and veteran strengths from a hypothetical case vignette. This vignette involved a VTC participant who initially engaged effectively but began to demonstrate difficulty appropriately engaging in court and mental health treatment as well as challenging interactions with VTC staff (eg, raised voice during court sessions, not respecting communication boundaries).

Pilot Test

Based on scheduling parameters communicated by court coordinators, the pilot training was designed as a presentation during times reserved for court staffing meetings. To accommodate court preferences due to the COVID-19 pandemic, one 90-minute training was conducted virtually in March 2022, and the other training was conducted in person in April 2022 for 2 hours. The trainings were facilitated by 2 VHA clinical psychologists and included the judge, court coordinator, VJO specialist, peer mentors, case managers, probation/parole officers, and community-based HCPs who partner with the court (eg, social workers, psychologists). About 12 to 15 professionals attended each training session.

 

 

Feedback

Feedback was solicited from attendees via an anonymous online survey. Seven participants completed the survey; the response rate of about 20% was consistent with those observed for other surveys of court professionals.20 Many attendees also provided feedback directly to the facilitators. Feedback highlighted that the skills-based components not only were perceived as most helpful but also notably distinguished this training. “What set this training apart from other training events was the practical applications,” one attendee noted. “It was not just information or education, both instructors did an incredible job of explaining exactly how we could apply the knowledge they were sharing. They did this in such a way that it was easy to understand and apply.”

Specific skills were consistently identified as helpful, including managing intense emotions, addressing ambivalence, and approaching sanctions and rewards. Additionally, employing a less formal approach to the training, with relatable overviews of concepts and immediate responsiveness to requests for expansion on a topic, was perceived as a unique benefit: Another attendee appreciated that “It was beneficial to sit around a table with a less formal presentation and be able to ask questions.” This approach seemed particularly well suited for the program’s cross-disciplinary audience. Attendees reported that they valued the relatively limited focus on DSM-5 criteria. Attendees emphasized that education specific to veterans on evidence-based PTSD treatments, psychoeducation, and avoidance was very helpful. Respondents also recommended that the training be lengthened to a daylong workshop to accommodate greater opportunity to practice skills and consultation.

The consultation portion of the training provided insight into additional areas of importance to incorporate into future iterations. Identified needs included appropriate and realistic boundary setting (eg, addressing disruptions in the courtroom), suggestions for improving and expanding homework assigned by the court, and ways to address concerns about PTSD treatment shared by veterans in court (eg, attributing substance use relapses to the intensiveness of trauma-focused treatment vs lack of familiarity with alternate coping skills). Additionally, the VTC professionals’ desire to support mental health professionals’ work with veterans was clearly evident, highlighting the bidirectional value of interdisciplinary collaboration between VHA mental health professionals and VTC professionals.

Discussion

A trauma-informed training was developed and delivered to 2 VTCs in the Rocky Mountain region with the goal of providing relevant psychoeducation and introducing skills to bolster court practices that address veteran needs. Psychoeducational components of the training that were particularly well received and prompted significant participant engagement included discussions and examples of avoidance, levels of validation, language to facilitate motivation and address barriers, mechanisms underlying treatment, and potential functions underlying limited veteran treatment engagement. Distress tolerance, approaches to sanctions and rewards, and use of ambivalence matrices to guide motivation were identified as particularly helpful skills.

The pilot phase of this trauma-informed training provided valuable insights into developing mental health trainings for VTCs. Specifically, VTCs may benefit from the expertise of VHA HCPs and are particularly interested in learning brief skills to improve their practices. The usefulness of such trainings may be bolstered by efforts to form relationships with the court to identify their perceived needs and employing an iterative process that is responsive to feedback both during and after the training. Last, each stage of this project was strengthened by collaboration with VJO specialists, highlighting the importance of future collaboration between VJO and VHA mental health clinics to further support justice-involved veterans. For example, VJO specialists were instrumental in identifying training needs related to veterans’ clinical presentations in court, facilitating introductions to local VTCs, and helping to address barriers to piloting, like scheduling.

 

 

Modifications and Future Directions

The insights gained through the process of training design, delivery, and feedback inform future development of this training. Based on the feedback received, subsequent versions of the training may be expanded into a half- or full-day workshop to allow for adequate time for skills training and feedback, as well as consultation. Doing so will enable facilitators to further foster attendees’ familiarity with and confidence in their ability to use these skills. Furthermore, the consultation portion of this training revealed areas that may benefit from greater attention, including how to address challenging interactions in court (eg, addressing gender dynamics between court professionals and participants) and better support veterans who are having difficulty engaging in mental health treatment (eg, courts’ observation of high rates of dropout around the third or fourth session of evidence-based treatment for PTSD). Last, all attendees who responded to the survey expressed interest in a brief resource guide based on the training, emphasizing the need for ready access to key skills and concepts to support the use of strategies learned.

An additional future aim of this project is to conduct a more thorough evaluation of the needs and outcomes related to this trauma-informed training for VTC professionals. With the rapid growth of VTCs nationwide, relatively little examination of court processes and practices has occurred, and there is a lack of research on the development or effectiveness of mental health trainings provided to VTCs.21 Therefore, we intend to conduct larger scale qualitative interviews with court personnel and VJO specialists to obtain a clearer understanding of the needs related to skills-based training and gaps in psychoeducation. These comprehensive needs assessments may also capture common comorbidities that were not incorporated into the pilot training (eg, substance use disorders) but may be important training targets for court professionals. This information will be used to inform subsequent expansion and adaptation of the training into a longer workshop. Program evaluation will be conducted via survey-based feedback on perceived usefulness of the workshop and self-report of confidence in and use of strategies to improve court practices. Furthermore, efforts to obtain veteran outcome data, such as treatment engagement and successful participation in VTC, may be pursued.

Limitations

This training development and pilot project provided valuable foundational information regarding a largely unexamined component of treatment courts—the benefit of skills-based trainings to facilitate court practices related to justice-involved veterans. However, it is worth noting that survey responses were limited; thus, the feedback received may not reflect all attendees’ perceptions. Additionally, because both training sessions were conducted solely with 2 courts in the Rocky Mountain area, feedback may be limited to the needs of this geographic region.

Conclusions

A trauma-informed training was developed for VTCs to facilitate relevant understanding of justice-involved veterans’ needs and presentations in court, introduce skills to address challenges that arise (eg, motivation, emotional dysregulation), and provide interdisciplinary support to court professionals. This training was an important step toward fostering strong collaborations between VHA HCPs and community-based veterans courts, and feedback received during development and following implementation highlighted the perceived need for a skills-based approach to such trainings. Further program development and evaluation can strengthen this training and provide a foundation for dissemination to a broader scope of VTCs, with the goal of reducing recidivism risk among justice-involved veterans by promoting effective engagement in problem-solving court.

References

1. Blodgett JC, Avoundjian T, Finlay AK, et al. Prevalence of mental health disorders among justice-involved veterans. Epidemiol Rev.  2015;37(1):163-176. doi:10.1093/epirev/mxu003

2. Saxon AJ, Davis TM, Sloan KL, McKnight KM, McFall ME, Kivlahan DR. Trauma, symptoms of posttraumatic stress disorder, and associated problems among incarcerated veterans. Psychiatr Serv. 2001;52(7):959-964. doi:10.1176/appi.ps.52.7.959

3. Bronson J, Carson AC, Noonan M. Veterans in prison and jail, 2011-12. December 2015. Accessed January 11, 2023. https://bjs.ojp.gov/content/pub/pdf/vpj1112.pdf

4. Cartwright T. “To care for him who shall have borne the battle”: the recent development of veterans treatment courts in America. Stanford Law Rev. 2011;22(1):295-316.

5. Finlay AK, Smelson D, Sawh L, et al. U.S. Department of Veterans Affairs Veterans Justice Outreach Program: connecting justice-involved veterans with mental health and substance use disorder Treatment. Crim Justice Policy Rev. 2016;27(2):10.1177/0887403414562601. doi:10.1177/0887403414562601

6. Knudsen KJ, Wingenfeld S. A specialized treatment court for veterans with trauma exposure: implications for the field. Community Ment Health J. 2016;52(2):127-135. doi:10.1007/s10597-015-9845-9

7. Montgomery LM, Olson JN. Veterans treatment court impact on veteran mental health and life satisfaction. J Psychol Behav Sci. 2018;6(1):1-4. doi:10.15640/jpbs.v6n1a1

8. Tsai J, Finlay A, Flatley B, Kasprow WJ, Clark S. A national study of veterans treatment court participants: who benefits and who recidivates. Adm Policy Ment Health. 2018;45(2):236-244. doi:10.1007/s10488-017-0816-z

9. Wolff NL, Shi J. Trauma and incarcerated persons. In: Scott CL, ed. Handbook of Correctional Mental Health. American Psychiatric Publishing, Inc.; 2010:277-320.

10. Bonta J, Andrews DA. Risk-need-responsivity model for offender assessment and rehabilitation. Rehabilitation. 2007;6:1-22. https://www.publicsafety.gc.ca/cnt/rsrcs/pblctns/rsk-nd-rspnsvty/index-en.aspx

11. US Department of Veterans Affairs, Office of Mental Health and Suicide Prevention, Family Services Section; Caska-Wallace CM, Campbell SB, Glynn SM. PTSD 101 for family and friends: a support and education workshop. 2020.

12. Tipping J. Focus groups: a method of needs assessment. J Contin Educ Health Prof. 1998;18(3):150-154. doi:10.1002/chp.1340180304

13. Resick PA, Monson CM, Chard KM. Cognitive Processing Therapy for PTSD: A Comprehensive Manual. The Guilford Press; 2017.

14. Foa EB, Hembree EA, Rothbaum BO. Prolonged Exposure Therapy for PTSD: Emotional Processing of Traumatic Experiences: Therapist Guide. Oxford University Press; 2007. doi:10.1093/med:psych/9780195308501.001.0001

15. Seal KH, Maguen S, Cohen B, et al. VA mental health services utilization in Iraq and Afghanistan veterans in the first year of receiving new mental health diagnoses. J Trauma Stress. 2010;23(1):5-16. doi:10.1002/jts.20493

16. Edwards-Stewart A, Smolenski DJ, Bush NE, et al. Posttraumatic stress disorder treatment dropout among military and veteran populations: a systematic review and meta-analysis. J Trauma Stress. 2021;34(4):808-818. doi:10.1002/jts.22653

17. Linehan MM. Dialectical Behavior Therapy Skills Training Manual. 2nd ed. Guildford Press; 2015.

18. Hayes SC, Strosahl KD, Wilson KG. Acceptance and Commitment Therapy: The Process and Practice of Mindful Change. 2nd ed. Guildford Press; 2016.

19. Miller WR, Rollnick S. Motivational Interviewing: Preparing People for Change. 2nd ed. The Guildford Press; 2002.

20. National Center for State Courts. A survey of members of major national court organizations. October 2010. Accessed January 11, 2023. https://www.ncsc.org/__data/assets/pdf_file/0015/16350/survey-summary-10-26.pdf

21. Baldwin JM, Brooke EJ. Pausing in the wake of rapid adoption: a call to critically examine the veterans treatment court concept. J Offender Rehabil. 2019;58(1):1-29. doi:10.1080/10509674.2018.1549181

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aRocky Mountain Mental Illness Research, Education and Clinical Center for Suicide Prevention, Rocky Mountain Regional Veterans Affairs Medical Center, Aurora, Colorado

bUniversity of Colorado Anschutz Medical Campus, AuroracUS Department of Veterans Affairs Veterans Justice Programs, Washington DC

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aRocky Mountain Mental Illness Research, Education and Clinical Center for Suicide Prevention, Rocky Mountain Regional Veterans Affairs Medical Center, Aurora, Colorado

bUniversity of Colorado Anschutz Medical Campus, AuroracUS Department of Veterans Affairs Veterans Justice Programs, Washington DC

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Ethics

This qualitative improvement program was exempt from institutional review board approval.

Author and Disclosure Information

Alisha Desai, PhDa; Ryan Holliday, PhDa,b; Matthew Stimmel, PhDc; Lauren M. Borges, PhDa,b
Correspondence:
Alisha Desai ([email protected])

aRocky Mountain Mental Illness Research, Education and Clinical Center for Suicide Prevention, Rocky Mountain Regional Veterans Affairs Medical Center, Aurora, Colorado

bUniversity of Colorado Anschutz Medical Campus, AuroracUS Department of Veterans Affairs Veterans Justice Programs, Washington DC

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Ethics

This qualitative improvement program was exempt from institutional review board approval.

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Related Articles

Veterans who interact with the criminal justice system (ie, justice-involved veterans) have heightened rates of mental health and psychosocial needs, including posttraumatic stress disorder (PTSD), substance use disorder, depression, suicidal ideation and attempt, and homelessness.1,2 Alongside these criminogenic risk factors, recidivism is common among justice-involved veterans: About 70% of incarcerated veterans disclosed at least one prior incarceration.3

To address the complex interplay of psychosocial factors, mental health concerns, and justice involvement among veterans, veterans treatment courts (VTCs) emerged as an alternative to incarceration.4 VTC participation often consists of integrated treatment and rehabilitative services (eg, vocational training, health care), ongoing monitoring for substance use, graduated responses to address treatment adherence, and ongoing communication with the judge and legal counsel.4

A primary aim of these courts is to address psychosocial needs believed to underlie criminal behavior, thus reducing risk of recidivism and promoting successful recovery and community integration for eligible veterans. To do so, VTCs collaborate with community-based and/or US Department of Veterans Affairs services, such as the Veterans Justice Outreach program (VJO). VJO specialists identify and refer justice-involved veterans to Veterans Health Administration (VHA) and community care and serve as a liaison between VTC staff and VHA health care professionals (HCPs).5

VTC outcome studies highlight the importance of not only diverting veterans to problem-solving courts, but also ensuring their optimal participation. Successful graduates of VTC programs demonstrate significant improvements in mental health symptoms, life satisfaction, and social support, as well as lower rates of law enforcement interactions.6,7 However, less is known about supporting those veterans who have difficulty engaging in VTCs and either discontinue participation or require lengthier periods of participation to meet court graduation requirements.8 One possibility to improve engagement among these veterans is to enhance court practices to best meet their needs.

In addition to delivering treatment, VHA mental health professionals may serve a critical interdisciplinary role by lending expertise to support VTC practices. For example, equipping court professionals with clinical knowledge and skills related to motivation may strengthen the staff’s interactions with participants, enabling them to address barriers as they arise and to facilitate veterans’ treatment adherence. Additionally, responsiveness to the impact of trauma exposure, which is common among this population, may prove important as related symptoms can affect veterans’ engagement, receptivity, and behavior in court settings. Indeed, prior examinations of justice-involved veterans have found trauma exposure rates ranging from 60% to 90% and PTSD rates ranging from 27% to 40%.1,2 Notably, involvement with the justice system (eg, incarceration) may itself further increase risk of trauma exposure (eg, experiencing a physical or sexual assault in prison) or exacerbate existing PTSD.9 Nonetheless, whereas many drug courts and domestic violence courts have been established, problem-solving courts with a specialized focus on trauma exposure remain rare, suggesting a potential gap in court training.

VHA HCPs have the potential to facilitate justice-involved veterans’ successful court and treatment participation by coordinating with VJO specialists to provide training and consultation to the courts. Supporting efforts to effectively and responsively address criminogenic risk (eg, mental health) in VTC settings may in turn reduce the likelihood of recidivism.10 Given the elevated rates of trauma exposure among justice-involved veterans and the relative lack of trauma-focused VTCs, we developed a trauma-informed training for VTC professionals that centered on related clinical presentations of justice-involved veterans and frequently occurring challenges in the context of court participation.

 

 

Program Development

This educational program aimed to (1) provide psychoeducation on trauma exposure, PTSD, and existing evidence-based treatments; (2) present clinical considerations for justice-involved veterans related to trauma exposure and/or PTSD; and (3) introduce skills to facilitate effective communication and trauma-informed care practices among professionals working with veterans in a treatment court.

Prior to piloting the program, we conducted a needs assessment with VTC professionals and identified relevant theoretical constructs and brief interventions for inclusion in the training. Additionally, given the dearth of prior research on mental health education for VTCs, the team consulted with the developers of PTSD 101, a VHA workshop for veterans’ families that promotes psychoeducation, support, and effective communication.11 Doing so informed approaches to delivering education to nonclinical audiences that interact with veterans with histories of trauma exposure. As this was a program development project, it was determined to be exempt from institutional review board review.

Needs Assessment

In the initial stages of development, local VJO specialists identified regional VTCs and facilitated introductions to these courts. Two of the 3 Rocky Mountain region VTCs that were contacted expressed interest in receiving trauma-informed training. Based on preliminary interest, the facilitators conducted a needs assessment with VJO and VTC staff from these 2 courts to capture requests for specific content and past experiences with other mental health trainings.

Guided by the focus group model, the needs assessments took place during three 1-hour meetings with VJO specialists and a 1-hour meeting with VJO specialists, VTC professionals, and community-based clinical partners.12 Additionally, attending a VTC graduation and court session allowed for observations of court practices and interactions with veterans. A total of 13 professionals (judges, court coordinators, case managers, peer mentors, VJO specialists, and clinicians who specialize in substance use disorder and intimate partner violence) participated in the needs assessments.

The most critical need identified by court professionals was a focus on how to apply knowledge about trauma and PTSD to interactions with justice-involved veterans. This was reportedly absent from prior training sessions the courts had received. Both Rocky Mountain region VTCs expressed a strong interest in and openness to adapting practices based on research and practice recommendations. Additional requests that emerged included a refresher on psychoeducation related to trauma and how to address the personal impact of working with this population (eg, compassion fatigue).

Training Components

Based on the needs identified by VTC professionals and informed by consultation with the developers of PTSD 101,

 the training consisted of 3 components: psychoeducation, skills training, and consultation (Table 1).

Psychoeducation. The initial portion of the training consisted of psychoeducation to increase VTC staff familiarity with the distinctions between trauma exposure and a formal diagnosis of PTSD, mechanisms underlying PTSD, and evidence-based treatment. To deepen conceptual understanding of trauma and PTSD beyond an overview of criteria set forth in The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), psychoeducation centered on the drivers of avoidance (eg, short-term benefit vs long-term consequences), behaviors that often facilitate avoidance (eg, substance use), functions underlying these behaviors (eg, distress reduction), and structure and mechanisms of change in evidence-based treatments for PTSD, including cognitive processing therapy and prolonged exposure.13,14

 

 

Fostering court familiarity with cognitive processing therapy and prolonged exposure may bolster veteran engagement in treatment through regular reinforcement of skills and concepts introduced in therapy. This may prove particularly salient given the limited engagement with mental health treatment and elevated dropout rates from PTSD treatment among the general veteran population.15,16

Exercises and metaphors were used to illustrate concepts in multiple ways. For example, training attendees engaged in a “stop, drop, and roll” thought exercise in which they were asked to brainstorm behavioral reactions to catching on fire. This exercise illustrated the tendency for individuals to revert to common yet unhelpful attempts at problem solving (eg, running due to panic, which would exacerbate the fire), particularly in crisis and without prior education regarding adaptive ways to respond. Attendee-generated examples, such as running, were used to demonstrate the importance of practicing and reinforcing skill development prior to a crisis, to ensure proficiency and optimal response. Additionally, in prompting consideration of one’s response tendencies, this exercise may engender empathy and understanding for veterans.

Skills training. Efforts to promote veteran engagement in court, facilitate motivation and readiness for change, and address barriers that arise (eg, distress associated with court appearances) may support successful and timely graduation. As such, skills training constituted the largest component of the training and drew from observations of court practices and the VTCs’ identified challenges. Consistent with the project’s aims and reported needs of the court, skills that target common presentations following trauma exposure (eg, avoidance, hypervigilance) were prioritized for this pilot training. Strategies included brief interventions from dialectical behavior therapy, acceptance and commitment therapy, and motivational interviewing to strengthen the support provided by staff to veterans and address their needs (Table 2).

17-19 Additionally, we presented strategies for implementing sanctions and rewards that were influenced by trauma-informed care practices, such as highlighting veteran strengths and promoting agency in decision making.

Training attendees also participated in exercises to reiterate skills. For example, attendees completed an ambivalence matrix using an audience-identified common behavior that is difficult to change (eg, heavy alcohol use as a coping mechanism for distress).

Attendees engaged in an exercise that involved identifying unhelpful thoughts and behaviors, targets for validation, and veteran strengths from a hypothetical case vignette. This vignette involved a VTC participant who initially engaged effectively but began to demonstrate difficulty appropriately engaging in court and mental health treatment as well as challenging interactions with VTC staff (eg, raised voice during court sessions, not respecting communication boundaries).

Pilot Test

Based on scheduling parameters communicated by court coordinators, the pilot training was designed as a presentation during times reserved for court staffing meetings. To accommodate court preferences due to the COVID-19 pandemic, one 90-minute training was conducted virtually in March 2022, and the other training was conducted in person in April 2022 for 2 hours. The trainings were facilitated by 2 VHA clinical psychologists and included the judge, court coordinator, VJO specialist, peer mentors, case managers, probation/parole officers, and community-based HCPs who partner with the court (eg, social workers, psychologists). About 12 to 15 professionals attended each training session.

 

 

Feedback

Feedback was solicited from attendees via an anonymous online survey. Seven participants completed the survey; the response rate of about 20% was consistent with those observed for other surveys of court professionals.20 Many attendees also provided feedback directly to the facilitators. Feedback highlighted that the skills-based components not only were perceived as most helpful but also notably distinguished this training. “What set this training apart from other training events was the practical applications,” one attendee noted. “It was not just information or education, both instructors did an incredible job of explaining exactly how we could apply the knowledge they were sharing. They did this in such a way that it was easy to understand and apply.”

Specific skills were consistently identified as helpful, including managing intense emotions, addressing ambivalence, and approaching sanctions and rewards. Additionally, employing a less formal approach to the training, with relatable overviews of concepts and immediate responsiveness to requests for expansion on a topic, was perceived as a unique benefit: Another attendee appreciated that “It was beneficial to sit around a table with a less formal presentation and be able to ask questions.” This approach seemed particularly well suited for the program’s cross-disciplinary audience. Attendees reported that they valued the relatively limited focus on DSM-5 criteria. Attendees emphasized that education specific to veterans on evidence-based PTSD treatments, psychoeducation, and avoidance was very helpful. Respondents also recommended that the training be lengthened to a daylong workshop to accommodate greater opportunity to practice skills and consultation.

The consultation portion of the training provided insight into additional areas of importance to incorporate into future iterations. Identified needs included appropriate and realistic boundary setting (eg, addressing disruptions in the courtroom), suggestions for improving and expanding homework assigned by the court, and ways to address concerns about PTSD treatment shared by veterans in court (eg, attributing substance use relapses to the intensiveness of trauma-focused treatment vs lack of familiarity with alternate coping skills). Additionally, the VTC professionals’ desire to support mental health professionals’ work with veterans was clearly evident, highlighting the bidirectional value of interdisciplinary collaboration between VHA mental health professionals and VTC professionals.

Discussion

A trauma-informed training was developed and delivered to 2 VTCs in the Rocky Mountain region with the goal of providing relevant psychoeducation and introducing skills to bolster court practices that address veteran needs. Psychoeducational components of the training that were particularly well received and prompted significant participant engagement included discussions and examples of avoidance, levels of validation, language to facilitate motivation and address barriers, mechanisms underlying treatment, and potential functions underlying limited veteran treatment engagement. Distress tolerance, approaches to sanctions and rewards, and use of ambivalence matrices to guide motivation were identified as particularly helpful skills.

The pilot phase of this trauma-informed training provided valuable insights into developing mental health trainings for VTCs. Specifically, VTCs may benefit from the expertise of VHA HCPs and are particularly interested in learning brief skills to improve their practices. The usefulness of such trainings may be bolstered by efforts to form relationships with the court to identify their perceived needs and employing an iterative process that is responsive to feedback both during and after the training. Last, each stage of this project was strengthened by collaboration with VJO specialists, highlighting the importance of future collaboration between VJO and VHA mental health clinics to further support justice-involved veterans. For example, VJO specialists were instrumental in identifying training needs related to veterans’ clinical presentations in court, facilitating introductions to local VTCs, and helping to address barriers to piloting, like scheduling.

 

 

Modifications and Future Directions

The insights gained through the process of training design, delivery, and feedback inform future development of this training. Based on the feedback received, subsequent versions of the training may be expanded into a half- or full-day workshop to allow for adequate time for skills training and feedback, as well as consultation. Doing so will enable facilitators to further foster attendees’ familiarity with and confidence in their ability to use these skills. Furthermore, the consultation portion of this training revealed areas that may benefit from greater attention, including how to address challenging interactions in court (eg, addressing gender dynamics between court professionals and participants) and better support veterans who are having difficulty engaging in mental health treatment (eg, courts’ observation of high rates of dropout around the third or fourth session of evidence-based treatment for PTSD). Last, all attendees who responded to the survey expressed interest in a brief resource guide based on the training, emphasizing the need for ready access to key skills and concepts to support the use of strategies learned.

An additional future aim of this project is to conduct a more thorough evaluation of the needs and outcomes related to this trauma-informed training for VTC professionals. With the rapid growth of VTCs nationwide, relatively little examination of court processes and practices has occurred, and there is a lack of research on the development or effectiveness of mental health trainings provided to VTCs.21 Therefore, we intend to conduct larger scale qualitative interviews with court personnel and VJO specialists to obtain a clearer understanding of the needs related to skills-based training and gaps in psychoeducation. These comprehensive needs assessments may also capture common comorbidities that were not incorporated into the pilot training (eg, substance use disorders) but may be important training targets for court professionals. This information will be used to inform subsequent expansion and adaptation of the training into a longer workshop. Program evaluation will be conducted via survey-based feedback on perceived usefulness of the workshop and self-report of confidence in and use of strategies to improve court practices. Furthermore, efforts to obtain veteran outcome data, such as treatment engagement and successful participation in VTC, may be pursued.

Limitations

This training development and pilot project provided valuable foundational information regarding a largely unexamined component of treatment courts—the benefit of skills-based trainings to facilitate court practices related to justice-involved veterans. However, it is worth noting that survey responses were limited; thus, the feedback received may not reflect all attendees’ perceptions. Additionally, because both training sessions were conducted solely with 2 courts in the Rocky Mountain area, feedback may be limited to the needs of this geographic region.

Conclusions

A trauma-informed training was developed for VTCs to facilitate relevant understanding of justice-involved veterans’ needs and presentations in court, introduce skills to address challenges that arise (eg, motivation, emotional dysregulation), and provide interdisciplinary support to court professionals. This training was an important step toward fostering strong collaborations between VHA HCPs and community-based veterans courts, and feedback received during development and following implementation highlighted the perceived need for a skills-based approach to such trainings. Further program development and evaluation can strengthen this training and provide a foundation for dissemination to a broader scope of VTCs, with the goal of reducing recidivism risk among justice-involved veterans by promoting effective engagement in problem-solving court.

Veterans who interact with the criminal justice system (ie, justice-involved veterans) have heightened rates of mental health and psychosocial needs, including posttraumatic stress disorder (PTSD), substance use disorder, depression, suicidal ideation and attempt, and homelessness.1,2 Alongside these criminogenic risk factors, recidivism is common among justice-involved veterans: About 70% of incarcerated veterans disclosed at least one prior incarceration.3

To address the complex interplay of psychosocial factors, mental health concerns, and justice involvement among veterans, veterans treatment courts (VTCs) emerged as an alternative to incarceration.4 VTC participation often consists of integrated treatment and rehabilitative services (eg, vocational training, health care), ongoing monitoring for substance use, graduated responses to address treatment adherence, and ongoing communication with the judge and legal counsel.4

A primary aim of these courts is to address psychosocial needs believed to underlie criminal behavior, thus reducing risk of recidivism and promoting successful recovery and community integration for eligible veterans. To do so, VTCs collaborate with community-based and/or US Department of Veterans Affairs services, such as the Veterans Justice Outreach program (VJO). VJO specialists identify and refer justice-involved veterans to Veterans Health Administration (VHA) and community care and serve as a liaison between VTC staff and VHA health care professionals (HCPs).5

VTC outcome studies highlight the importance of not only diverting veterans to problem-solving courts, but also ensuring their optimal participation. Successful graduates of VTC programs demonstrate significant improvements in mental health symptoms, life satisfaction, and social support, as well as lower rates of law enforcement interactions.6,7 However, less is known about supporting those veterans who have difficulty engaging in VTCs and either discontinue participation or require lengthier periods of participation to meet court graduation requirements.8 One possibility to improve engagement among these veterans is to enhance court practices to best meet their needs.

In addition to delivering treatment, VHA mental health professionals may serve a critical interdisciplinary role by lending expertise to support VTC practices. For example, equipping court professionals with clinical knowledge and skills related to motivation may strengthen the staff’s interactions with participants, enabling them to address barriers as they arise and to facilitate veterans’ treatment adherence. Additionally, responsiveness to the impact of trauma exposure, which is common among this population, may prove important as related symptoms can affect veterans’ engagement, receptivity, and behavior in court settings. Indeed, prior examinations of justice-involved veterans have found trauma exposure rates ranging from 60% to 90% and PTSD rates ranging from 27% to 40%.1,2 Notably, involvement with the justice system (eg, incarceration) may itself further increase risk of trauma exposure (eg, experiencing a physical or sexual assault in prison) or exacerbate existing PTSD.9 Nonetheless, whereas many drug courts and domestic violence courts have been established, problem-solving courts with a specialized focus on trauma exposure remain rare, suggesting a potential gap in court training.

VHA HCPs have the potential to facilitate justice-involved veterans’ successful court and treatment participation by coordinating with VJO specialists to provide training and consultation to the courts. Supporting efforts to effectively and responsively address criminogenic risk (eg, mental health) in VTC settings may in turn reduce the likelihood of recidivism.10 Given the elevated rates of trauma exposure among justice-involved veterans and the relative lack of trauma-focused VTCs, we developed a trauma-informed training for VTC professionals that centered on related clinical presentations of justice-involved veterans and frequently occurring challenges in the context of court participation.

 

 

Program Development

This educational program aimed to (1) provide psychoeducation on trauma exposure, PTSD, and existing evidence-based treatments; (2) present clinical considerations for justice-involved veterans related to trauma exposure and/or PTSD; and (3) introduce skills to facilitate effective communication and trauma-informed care practices among professionals working with veterans in a treatment court.

Prior to piloting the program, we conducted a needs assessment with VTC professionals and identified relevant theoretical constructs and brief interventions for inclusion in the training. Additionally, given the dearth of prior research on mental health education for VTCs, the team consulted with the developers of PTSD 101, a VHA workshop for veterans’ families that promotes psychoeducation, support, and effective communication.11 Doing so informed approaches to delivering education to nonclinical audiences that interact with veterans with histories of trauma exposure. As this was a program development project, it was determined to be exempt from institutional review board review.

Needs Assessment

In the initial stages of development, local VJO specialists identified regional VTCs and facilitated introductions to these courts. Two of the 3 Rocky Mountain region VTCs that were contacted expressed interest in receiving trauma-informed training. Based on preliminary interest, the facilitators conducted a needs assessment with VJO and VTC staff from these 2 courts to capture requests for specific content and past experiences with other mental health trainings.

Guided by the focus group model, the needs assessments took place during three 1-hour meetings with VJO specialists and a 1-hour meeting with VJO specialists, VTC professionals, and community-based clinical partners.12 Additionally, attending a VTC graduation and court session allowed for observations of court practices and interactions with veterans. A total of 13 professionals (judges, court coordinators, case managers, peer mentors, VJO specialists, and clinicians who specialize in substance use disorder and intimate partner violence) participated in the needs assessments.

The most critical need identified by court professionals was a focus on how to apply knowledge about trauma and PTSD to interactions with justice-involved veterans. This was reportedly absent from prior training sessions the courts had received. Both Rocky Mountain region VTCs expressed a strong interest in and openness to adapting practices based on research and practice recommendations. Additional requests that emerged included a refresher on psychoeducation related to trauma and how to address the personal impact of working with this population (eg, compassion fatigue).

Training Components

Based on the needs identified by VTC professionals and informed by consultation with the developers of PTSD 101,

 the training consisted of 3 components: psychoeducation, skills training, and consultation (Table 1).

Psychoeducation. The initial portion of the training consisted of psychoeducation to increase VTC staff familiarity with the distinctions between trauma exposure and a formal diagnosis of PTSD, mechanisms underlying PTSD, and evidence-based treatment. To deepen conceptual understanding of trauma and PTSD beyond an overview of criteria set forth in The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), psychoeducation centered on the drivers of avoidance (eg, short-term benefit vs long-term consequences), behaviors that often facilitate avoidance (eg, substance use), functions underlying these behaviors (eg, distress reduction), and structure and mechanisms of change in evidence-based treatments for PTSD, including cognitive processing therapy and prolonged exposure.13,14

 

 

Fostering court familiarity with cognitive processing therapy and prolonged exposure may bolster veteran engagement in treatment through regular reinforcement of skills and concepts introduced in therapy. This may prove particularly salient given the limited engagement with mental health treatment and elevated dropout rates from PTSD treatment among the general veteran population.15,16

Exercises and metaphors were used to illustrate concepts in multiple ways. For example, training attendees engaged in a “stop, drop, and roll” thought exercise in which they were asked to brainstorm behavioral reactions to catching on fire. This exercise illustrated the tendency for individuals to revert to common yet unhelpful attempts at problem solving (eg, running due to panic, which would exacerbate the fire), particularly in crisis and without prior education regarding adaptive ways to respond. Attendee-generated examples, such as running, were used to demonstrate the importance of practicing and reinforcing skill development prior to a crisis, to ensure proficiency and optimal response. Additionally, in prompting consideration of one’s response tendencies, this exercise may engender empathy and understanding for veterans.

Skills training. Efforts to promote veteran engagement in court, facilitate motivation and readiness for change, and address barriers that arise (eg, distress associated with court appearances) may support successful and timely graduation. As such, skills training constituted the largest component of the training and drew from observations of court practices and the VTCs’ identified challenges. Consistent with the project’s aims and reported needs of the court, skills that target common presentations following trauma exposure (eg, avoidance, hypervigilance) were prioritized for this pilot training. Strategies included brief interventions from dialectical behavior therapy, acceptance and commitment therapy, and motivational interviewing to strengthen the support provided by staff to veterans and address their needs (Table 2).

17-19 Additionally, we presented strategies for implementing sanctions and rewards that were influenced by trauma-informed care practices, such as highlighting veteran strengths and promoting agency in decision making.

Training attendees also participated in exercises to reiterate skills. For example, attendees completed an ambivalence matrix using an audience-identified common behavior that is difficult to change (eg, heavy alcohol use as a coping mechanism for distress).

Attendees engaged in an exercise that involved identifying unhelpful thoughts and behaviors, targets for validation, and veteran strengths from a hypothetical case vignette. This vignette involved a VTC participant who initially engaged effectively but began to demonstrate difficulty appropriately engaging in court and mental health treatment as well as challenging interactions with VTC staff (eg, raised voice during court sessions, not respecting communication boundaries).

Pilot Test

Based on scheduling parameters communicated by court coordinators, the pilot training was designed as a presentation during times reserved for court staffing meetings. To accommodate court preferences due to the COVID-19 pandemic, one 90-minute training was conducted virtually in March 2022, and the other training was conducted in person in April 2022 for 2 hours. The trainings were facilitated by 2 VHA clinical psychologists and included the judge, court coordinator, VJO specialist, peer mentors, case managers, probation/parole officers, and community-based HCPs who partner with the court (eg, social workers, psychologists). About 12 to 15 professionals attended each training session.

 

 

Feedback

Feedback was solicited from attendees via an anonymous online survey. Seven participants completed the survey; the response rate of about 20% was consistent with those observed for other surveys of court professionals.20 Many attendees also provided feedback directly to the facilitators. Feedback highlighted that the skills-based components not only were perceived as most helpful but also notably distinguished this training. “What set this training apart from other training events was the practical applications,” one attendee noted. “It was not just information or education, both instructors did an incredible job of explaining exactly how we could apply the knowledge they were sharing. They did this in such a way that it was easy to understand and apply.”

Specific skills were consistently identified as helpful, including managing intense emotions, addressing ambivalence, and approaching sanctions and rewards. Additionally, employing a less formal approach to the training, with relatable overviews of concepts and immediate responsiveness to requests for expansion on a topic, was perceived as a unique benefit: Another attendee appreciated that “It was beneficial to sit around a table with a less formal presentation and be able to ask questions.” This approach seemed particularly well suited for the program’s cross-disciplinary audience. Attendees reported that they valued the relatively limited focus on DSM-5 criteria. Attendees emphasized that education specific to veterans on evidence-based PTSD treatments, psychoeducation, and avoidance was very helpful. Respondents also recommended that the training be lengthened to a daylong workshop to accommodate greater opportunity to practice skills and consultation.

The consultation portion of the training provided insight into additional areas of importance to incorporate into future iterations. Identified needs included appropriate and realistic boundary setting (eg, addressing disruptions in the courtroom), suggestions for improving and expanding homework assigned by the court, and ways to address concerns about PTSD treatment shared by veterans in court (eg, attributing substance use relapses to the intensiveness of trauma-focused treatment vs lack of familiarity with alternate coping skills). Additionally, the VTC professionals’ desire to support mental health professionals’ work with veterans was clearly evident, highlighting the bidirectional value of interdisciplinary collaboration between VHA mental health professionals and VTC professionals.

Discussion

A trauma-informed training was developed and delivered to 2 VTCs in the Rocky Mountain region with the goal of providing relevant psychoeducation and introducing skills to bolster court practices that address veteran needs. Psychoeducational components of the training that were particularly well received and prompted significant participant engagement included discussions and examples of avoidance, levels of validation, language to facilitate motivation and address barriers, mechanisms underlying treatment, and potential functions underlying limited veteran treatment engagement. Distress tolerance, approaches to sanctions and rewards, and use of ambivalence matrices to guide motivation were identified as particularly helpful skills.

The pilot phase of this trauma-informed training provided valuable insights into developing mental health trainings for VTCs. Specifically, VTCs may benefit from the expertise of VHA HCPs and are particularly interested in learning brief skills to improve their practices. The usefulness of such trainings may be bolstered by efforts to form relationships with the court to identify their perceived needs and employing an iterative process that is responsive to feedback both during and after the training. Last, each stage of this project was strengthened by collaboration with VJO specialists, highlighting the importance of future collaboration between VJO and VHA mental health clinics to further support justice-involved veterans. For example, VJO specialists were instrumental in identifying training needs related to veterans’ clinical presentations in court, facilitating introductions to local VTCs, and helping to address barriers to piloting, like scheduling.

 

 

Modifications and Future Directions

The insights gained through the process of training design, delivery, and feedback inform future development of this training. Based on the feedback received, subsequent versions of the training may be expanded into a half- or full-day workshop to allow for adequate time for skills training and feedback, as well as consultation. Doing so will enable facilitators to further foster attendees’ familiarity with and confidence in their ability to use these skills. Furthermore, the consultation portion of this training revealed areas that may benefit from greater attention, including how to address challenging interactions in court (eg, addressing gender dynamics between court professionals and participants) and better support veterans who are having difficulty engaging in mental health treatment (eg, courts’ observation of high rates of dropout around the third or fourth session of evidence-based treatment for PTSD). Last, all attendees who responded to the survey expressed interest in a brief resource guide based on the training, emphasizing the need for ready access to key skills and concepts to support the use of strategies learned.

An additional future aim of this project is to conduct a more thorough evaluation of the needs and outcomes related to this trauma-informed training for VTC professionals. With the rapid growth of VTCs nationwide, relatively little examination of court processes and practices has occurred, and there is a lack of research on the development or effectiveness of mental health trainings provided to VTCs.21 Therefore, we intend to conduct larger scale qualitative interviews with court personnel and VJO specialists to obtain a clearer understanding of the needs related to skills-based training and gaps in psychoeducation. These comprehensive needs assessments may also capture common comorbidities that were not incorporated into the pilot training (eg, substance use disorders) but may be important training targets for court professionals. This information will be used to inform subsequent expansion and adaptation of the training into a longer workshop. Program evaluation will be conducted via survey-based feedback on perceived usefulness of the workshop and self-report of confidence in and use of strategies to improve court practices. Furthermore, efforts to obtain veteran outcome data, such as treatment engagement and successful participation in VTC, may be pursued.

Limitations

This training development and pilot project provided valuable foundational information regarding a largely unexamined component of treatment courts—the benefit of skills-based trainings to facilitate court practices related to justice-involved veterans. However, it is worth noting that survey responses were limited; thus, the feedback received may not reflect all attendees’ perceptions. Additionally, because both training sessions were conducted solely with 2 courts in the Rocky Mountain area, feedback may be limited to the needs of this geographic region.

Conclusions

A trauma-informed training was developed for VTCs to facilitate relevant understanding of justice-involved veterans’ needs and presentations in court, introduce skills to address challenges that arise (eg, motivation, emotional dysregulation), and provide interdisciplinary support to court professionals. This training was an important step toward fostering strong collaborations between VHA HCPs and community-based veterans courts, and feedback received during development and following implementation highlighted the perceived need for a skills-based approach to such trainings. Further program development and evaluation can strengthen this training and provide a foundation for dissemination to a broader scope of VTCs, with the goal of reducing recidivism risk among justice-involved veterans by promoting effective engagement in problem-solving court.

References

1. Blodgett JC, Avoundjian T, Finlay AK, et al. Prevalence of mental health disorders among justice-involved veterans. Epidemiol Rev.  2015;37(1):163-176. doi:10.1093/epirev/mxu003

2. Saxon AJ, Davis TM, Sloan KL, McKnight KM, McFall ME, Kivlahan DR. Trauma, symptoms of posttraumatic stress disorder, and associated problems among incarcerated veterans. Psychiatr Serv. 2001;52(7):959-964. doi:10.1176/appi.ps.52.7.959

3. Bronson J, Carson AC, Noonan M. Veterans in prison and jail, 2011-12. December 2015. Accessed January 11, 2023. https://bjs.ojp.gov/content/pub/pdf/vpj1112.pdf

4. Cartwright T. “To care for him who shall have borne the battle”: the recent development of veterans treatment courts in America. Stanford Law Rev. 2011;22(1):295-316.

5. Finlay AK, Smelson D, Sawh L, et al. U.S. Department of Veterans Affairs Veterans Justice Outreach Program: connecting justice-involved veterans with mental health and substance use disorder Treatment. Crim Justice Policy Rev. 2016;27(2):10.1177/0887403414562601. doi:10.1177/0887403414562601

6. Knudsen KJ, Wingenfeld S. A specialized treatment court for veterans with trauma exposure: implications for the field. Community Ment Health J. 2016;52(2):127-135. doi:10.1007/s10597-015-9845-9

7. Montgomery LM, Olson JN. Veterans treatment court impact on veteran mental health and life satisfaction. J Psychol Behav Sci. 2018;6(1):1-4. doi:10.15640/jpbs.v6n1a1

8. Tsai J, Finlay A, Flatley B, Kasprow WJ, Clark S. A national study of veterans treatment court participants: who benefits and who recidivates. Adm Policy Ment Health. 2018;45(2):236-244. doi:10.1007/s10488-017-0816-z

9. Wolff NL, Shi J. Trauma and incarcerated persons. In: Scott CL, ed. Handbook of Correctional Mental Health. American Psychiatric Publishing, Inc.; 2010:277-320.

10. Bonta J, Andrews DA. Risk-need-responsivity model for offender assessment and rehabilitation. Rehabilitation. 2007;6:1-22. https://www.publicsafety.gc.ca/cnt/rsrcs/pblctns/rsk-nd-rspnsvty/index-en.aspx

11. US Department of Veterans Affairs, Office of Mental Health and Suicide Prevention, Family Services Section; Caska-Wallace CM, Campbell SB, Glynn SM. PTSD 101 for family and friends: a support and education workshop. 2020.

12. Tipping J. Focus groups: a method of needs assessment. J Contin Educ Health Prof. 1998;18(3):150-154. doi:10.1002/chp.1340180304

13. Resick PA, Monson CM, Chard KM. Cognitive Processing Therapy for PTSD: A Comprehensive Manual. The Guilford Press; 2017.

14. Foa EB, Hembree EA, Rothbaum BO. Prolonged Exposure Therapy for PTSD: Emotional Processing of Traumatic Experiences: Therapist Guide. Oxford University Press; 2007. doi:10.1093/med:psych/9780195308501.001.0001

15. Seal KH, Maguen S, Cohen B, et al. VA mental health services utilization in Iraq and Afghanistan veterans in the first year of receiving new mental health diagnoses. J Trauma Stress. 2010;23(1):5-16. doi:10.1002/jts.20493

16. Edwards-Stewart A, Smolenski DJ, Bush NE, et al. Posttraumatic stress disorder treatment dropout among military and veteran populations: a systematic review and meta-analysis. J Trauma Stress. 2021;34(4):808-818. doi:10.1002/jts.22653

17. Linehan MM. Dialectical Behavior Therapy Skills Training Manual. 2nd ed. Guildford Press; 2015.

18. Hayes SC, Strosahl KD, Wilson KG. Acceptance and Commitment Therapy: The Process and Practice of Mindful Change. 2nd ed. Guildford Press; 2016.

19. Miller WR, Rollnick S. Motivational Interviewing: Preparing People for Change. 2nd ed. The Guildford Press; 2002.

20. National Center for State Courts. A survey of members of major national court organizations. October 2010. Accessed January 11, 2023. https://www.ncsc.org/__data/assets/pdf_file/0015/16350/survey-summary-10-26.pdf

21. Baldwin JM, Brooke EJ. Pausing in the wake of rapid adoption: a call to critically examine the veterans treatment court concept. J Offender Rehabil. 2019;58(1):1-29. doi:10.1080/10509674.2018.1549181

References

1. Blodgett JC, Avoundjian T, Finlay AK, et al. Prevalence of mental health disorders among justice-involved veterans. Epidemiol Rev.  2015;37(1):163-176. doi:10.1093/epirev/mxu003

2. Saxon AJ, Davis TM, Sloan KL, McKnight KM, McFall ME, Kivlahan DR. Trauma, symptoms of posttraumatic stress disorder, and associated problems among incarcerated veterans. Psychiatr Serv. 2001;52(7):959-964. doi:10.1176/appi.ps.52.7.959

3. Bronson J, Carson AC, Noonan M. Veterans in prison and jail, 2011-12. December 2015. Accessed January 11, 2023. https://bjs.ojp.gov/content/pub/pdf/vpj1112.pdf

4. Cartwright T. “To care for him who shall have borne the battle”: the recent development of veterans treatment courts in America. Stanford Law Rev. 2011;22(1):295-316.

5. Finlay AK, Smelson D, Sawh L, et al. U.S. Department of Veterans Affairs Veterans Justice Outreach Program: connecting justice-involved veterans with mental health and substance use disorder Treatment. Crim Justice Policy Rev. 2016;27(2):10.1177/0887403414562601. doi:10.1177/0887403414562601

6. Knudsen KJ, Wingenfeld S. A specialized treatment court for veterans with trauma exposure: implications for the field. Community Ment Health J. 2016;52(2):127-135. doi:10.1007/s10597-015-9845-9

7. Montgomery LM, Olson JN. Veterans treatment court impact on veteran mental health and life satisfaction. J Psychol Behav Sci. 2018;6(1):1-4. doi:10.15640/jpbs.v6n1a1

8. Tsai J, Finlay A, Flatley B, Kasprow WJ, Clark S. A national study of veterans treatment court participants: who benefits and who recidivates. Adm Policy Ment Health. 2018;45(2):236-244. doi:10.1007/s10488-017-0816-z

9. Wolff NL, Shi J. Trauma and incarcerated persons. In: Scott CL, ed. Handbook of Correctional Mental Health. American Psychiatric Publishing, Inc.; 2010:277-320.

10. Bonta J, Andrews DA. Risk-need-responsivity model for offender assessment and rehabilitation. Rehabilitation. 2007;6:1-22. https://www.publicsafety.gc.ca/cnt/rsrcs/pblctns/rsk-nd-rspnsvty/index-en.aspx

11. US Department of Veterans Affairs, Office of Mental Health and Suicide Prevention, Family Services Section; Caska-Wallace CM, Campbell SB, Glynn SM. PTSD 101 for family and friends: a support and education workshop. 2020.

12. Tipping J. Focus groups: a method of needs assessment. J Contin Educ Health Prof. 1998;18(3):150-154. doi:10.1002/chp.1340180304

13. Resick PA, Monson CM, Chard KM. Cognitive Processing Therapy for PTSD: A Comprehensive Manual. The Guilford Press; 2017.

14. Foa EB, Hembree EA, Rothbaum BO. Prolonged Exposure Therapy for PTSD: Emotional Processing of Traumatic Experiences: Therapist Guide. Oxford University Press; 2007. doi:10.1093/med:psych/9780195308501.001.0001

15. Seal KH, Maguen S, Cohen B, et al. VA mental health services utilization in Iraq and Afghanistan veterans in the first year of receiving new mental health diagnoses. J Trauma Stress. 2010;23(1):5-16. doi:10.1002/jts.20493

16. Edwards-Stewart A, Smolenski DJ, Bush NE, et al. Posttraumatic stress disorder treatment dropout among military and veteran populations: a systematic review and meta-analysis. J Trauma Stress. 2021;34(4):808-818. doi:10.1002/jts.22653

17. Linehan MM. Dialectical Behavior Therapy Skills Training Manual. 2nd ed. Guildford Press; 2015.

18. Hayes SC, Strosahl KD, Wilson KG. Acceptance and Commitment Therapy: The Process and Practice of Mindful Change. 2nd ed. Guildford Press; 2016.

19. Miller WR, Rollnick S. Motivational Interviewing: Preparing People for Change. 2nd ed. The Guildford Press; 2002.

20. National Center for State Courts. A survey of members of major national court organizations. October 2010. Accessed January 11, 2023. https://www.ncsc.org/__data/assets/pdf_file/0015/16350/survey-summary-10-26.pdf

21. Baldwin JM, Brooke EJ. Pausing in the wake of rapid adoption: a call to critically examine the veterans treatment court concept. J Offender Rehabil. 2019;58(1):1-29. doi:10.1080/10509674.2018.1549181

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A Better Way to Breathe: Combining Allergy and Pulmonary Care Into One Clinic

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Asthma affects more than 300 million people worldwide.1 While many of these cases can achieve control with standard therapy, 5% to 10% of these cases are classified as severe asthma, remaining poorly controlled despite treatment with inhaled corticosteroids (ICS) and long-acting β agonists (LABA).2 These patients also account for the majority of morbidity and mortality associated with the disease, with increased hospitalizations, intensive care unit (ICU) stays, detrimental adverse effects of oral corticosteroids (OCS), and lower quality of life.3-6 Additionally, the financial repercussions of severe asthma are notable; in the United States, the estimated cost of asthma management is $82 billion annually, with $3 billion accounting for asthma-related work/school absences.7

In the past several years, the use of anti-immunoglobulin E (IgE), anti-interleukin-4 (IL-4), and anti-IL-5 biologic agents for severe asthma has been shown to decrease asthma exacerbations, improve lung function, reduce corticosteroid use, and decrease hospitalizations, especially for type 2 helper T cell (TH2-high) asthma.8-10 However, clinicians have observed significant barriers to the implementation and widespread use of biologics, including insurance coverage, long wait times, follow-up, and limited access for lower income groups.11,12

This article describes a unique model for a severe asthma clinic located at the Washington DC Veterans Affairs Medical Center (WDCVAMC) that is dually staffed by an allergist and pulmonologist. This clinic uses biologic agents for patients with difficult-to-treat asthma, many of whom require repeated or prolonged steroid use, in addition to prolonged and recurrent hospitalizations for exacerbations. The objective of this clinic is to provide a standardized approach to the management of severe asthma with the perspective of both an allergist and pulmonologist, thereby reducing the need to schedule appointments with multiple specialties and reducing delays in initiating biologics. This article presents the preliminary findings of 30 months of severe asthma management with various biologic agents, examining the impact of these therapies on hospitalizations, asthma exacerbations, ICU stays, and OCS use. The findings of this study support the benefits of biologics and suggest that the use of these agents within a dually staffed clinic may be a particularly effective model through which to manage severe asthma.

Background

Asthma affects approximately 20 million adults in the United States.13 Veterans are a population particularly impacted by asthma. Between 2015 and 2018, 10.9% of all veterans reported being diagnosed with asthma and 5.1% stated that they currently have asthma, compared with 13.4% and 8.0% of nonveterans, respectively.14 Veterans are susceptible to many of the factors that can trigger exacerbations while engaging in military service, such as chemical and environmental exposures both abroad and domestically.15,16 Additionally, medication adherence is often challenging among the veteran population, particularly with more involved therapy, such as inhaler use.17 Such factors contribute to asthma exacerbations, with 2.9% of veterans reporting at least 1 asthma exacerbation in the past 12 months.14

Over the past several years, the development and use of biologic agents have transformed the management of severe asthma.8 Before the development of biologic agents for severe asthma, treatment options for patients were limited. While OCS are frequently used for asthma exacerbations, they are associated with a multiplicity of undesirable adverse effects, including weight gain, mood lability, gastrointestinal upset, hyperglycemia, risk of bone fractures, and hypertension.18-20 The regular use of OCS are particularly problematic among other medical comorbidities commonly affecting the veteran population, such as diabetes and hypertension.21-22

The WDCVAMC severe allergy clinic used 3 biologic agents: omalizumab (anti-IgE), benralizumab (anti-IL-5), and agent dupilumab (anti-IL-4). These medications have shown significant improvements in quality of life, reduction in asthma exacerbations and hospitalizations, and decreased use of OCS.8,9 While research has firmly established the medical benefits of the use of biologic agents in severe asthma, several barriers exist in implementing widespread use.11,12

 

 



In Gelhorn and colleagues’ study examining both physician and patient challenges in the use of biologics for severe asthma, scheduling, administrative time, and insurance costs were found to be major barriers to the use of these medications.12 Patients expressed a preference for the administration of these medications in a specialist’s office but cited long wait times and scheduling difficulties as barriers. One of the most notable challenges from the physician perspective was the difficulty in obtaining reimbursement from insurance companies, requiring them to devote significant portions of time to prior authorizations and documentation.12

This article examines a dual specialty clinic that focuses on the treatment of severe asthma with biologic agents. This model is unique for several reasons. First, given the US Department of Veterans Affairs (VA) health care model, the health care practitioners (HCPs) in this clinic can avoid much of the administrative burden of obtaining reimbursement or working with insurance companies. Additionally, by dedicating specific days to the severe asthma clinic, patients do not experience long wait times to see both an allergist and pulmonologist. By seeing both clinicians, concurrent allergic and pulmonary issues can be addressed in the same visit, rather than delaying treatment by waiting on 2 specialist appointments.

Severe Asthma Clinic

The severe asthma clinic was started in September 2017 by a pulmonologist and an allergist at WDCVAMC. After experiencing substantial delays with the initiation of biologics for their patients and multiple referrals between their clinics, these physicians wanted to start a dually staffed asthma clinic to specifically focus on evaluating and treating severe asthma. A dedicated severe asthma clinic allowed the allergist and pulmonologist to streamline resources and collaborate to advocate for patients with the pharmacy section. Additionally, patients can benefit from the perspective of both specialists, as both the pulmonologist and allergist evaluate each patient and discuss the next steps of management.

This clinic is composed of 4 registered nurses, an allergist, and a pulmonologist. Clinic is held twice monthly through both telemedicine and in-office visits. The VA has strict guidelines for the use of certain biologics, including blood eosinophil count > 150 cells/µL, failure of traditional therapy, and frequent use of OCS. Additionally, to ensure these biologic agents are prescribed to patients that will benefit from them, the patients enrolled in this clinic are already on maximum therapy for their asthma, meaning all other therapeutic options (inhalers and oral medications) are being used. The clinic services all patients with severe asthma, not just patients who are on biologic therapy. Often, patients are referred to the severe allergy clinic late in their disease course given a lack of familiarity with biologic agents from prescribers and both institutional and insurance barriers.

Before the COVID-19 pandemic, spirometry and fractional exhaled nitric oxide (FENO) tests were recorded at each visit. Initially during the pandemic, the clinic transitioned to primarily telemedicine visits due to patients’ hesitance to seek in-person care. More recently, the clinic has transitioned back to primarily office visits; patients are seen in clinic on average every 3 months. At each visit, the patient is seen by both the pulmonologist and allergist. Additionally, the nursing staff reviews inhaler adherence with patients, spacer use, documents, Asthma Control Test (ACT) scores, and schedules follow-up visits.

Every 4 to 8 weeks, patients receive biologics agent at the WDCVAMC infusion center depending on the agent. The infusion center also instructs patients how to handle self-administered medications, like benralizumab, if the patient expresses a preference for taking it at home. Omalizumab has a boxed warning for anaphylaxis, although the other biologics in this study have a low risk of anaphylaxis. All patients receiving omalizumab, benralizumab, and dupilumab were provided with epinephrine injection devices in case of an allergic reaction and were taught how to use them in the clinic.23,24

 

 



If patients continued to experience asthma exacerbations after the initiation of a biologic, a change in agent was considered after 4 to 6 months. Additionally, a complete blood count, respiratory allergy panel, and pulmonary function tests (PFTs) were completed.

If a patient experienced an allergic reaction, the biologic agent was stopped. All patients had access to secure messaging to both the allergist and pulmonologist at this clinic. Figure 1 illustrates the general flow of our severe asthma clinic.

Clinic Patients

Preliminary data were obtained from a retrospective chart review of 15 patients enrolled in the severe asthma clinic over 30 months. The inclusion criteria for chart review consisted of patients aged > 18 years receiving a biologic agent for > 3 months for the treatment of severe asthma. The outcomes examined included steroid use, emergency department (ED) visits, hospitalizations, FEV1, and ICU stays.

Seven patients used benralizumab, 6 used dupilumab, and 2 used omalizumab (Table).

Of the patients examined, 8 had been on a biologic agent for 1 to 2 years while a smaller number of patients had been taking a biologic agent for less than a year (n = 2) or > 2 years (n = 5). Seven patients were referred to the specialty asthma clinic by a VA pulmonologist, 4 were referred by a hospitalist, 3 by an otolaryngologist, and 3 by their primary care physician.

 

 


There was a notable clinical improvement in these patients. Before starting a biologic agent, all the patients in this study were prescribed steroids at least once a year for an asthma exacerbation, with a mean of 4.2 steroid tapers per year.

After starting a biologic, only 3 of 15 patients required steroids for an exacerbation, with an average of 0.6 steroid tapers per year (Figure 2). Additionally, there was notable improvement observed in patients’ FEV1, with a mean of 10% after the initiation of a biologic (Figure 3).

The initiation of a biologic agent also resulted in fewer ED visits and hospitalizations. Two patients had an ED visit for an asthma exacerbation since starting a biologic agent and 1 patient had a hospital admission for an asthma exacerbation. No patients were hospitalized in the ICU after starting a biologic agent.

Discussion

The 15 patients in this initial data were referred to the severe asthma clinic by pulmonology, ear, nose, and throat (ENT), primary care, and a hospitalist during an in-patient stay. As the enrollment in our clinic grows, an increasing number of patients are referred from the allergy clinic as well. Patients in the severe asthma clinic also are referred by regional centers as news of the clinic is spread by word of mouth to surrounding VA facilities. As our clinic gains the capacity to serve more patients, we hope to contact WDCVAMC primary care, pulmonology, allergy, and ENT departments to raise awareness of the clinic.

Benralizumab and dupilumab were the most used agents in this preliminary data. This finding was largely due to the ability of patients to self-administer benralizumab, which was particularly beneficial during the COVID-19 pandemic. Of note, 5 patients in this study switched from another biologic agent to benralizumab due to the ability to self-administer. Three of 5 patients that required steroids after initiating benralizumab used fewer steroids than they had previously. This finding suggests benralizumab may be the preferred agent when travel time to health care is a challenge, reducing the need for frequent clinic visits and transportation.

This preliminary data supports previous studies that have demonstrated that biologic agents improve clinical outcomes by reducing asthma exacerbations, OCS use, hospitalizations, and ICU stays for patients on all 4 biologic agents. In addition to improving patient health through avoiding complications of prolonged OCS use and hospital stays, the decrease in ED visits and hospitalizations provides a substantial cost reduction to the health care system.  

 

 



These findings highlight the strength of a unique model of a combined allergy/pulmonary clinic. Before this combined clinic model, both pulmonology and allergy clinics noted delays in the initiation of biologics for patients who were potential candidates. Impediments include referrals between each specialty for evaluation of concurrent pulmonary conditions or allergy testing, overlap in asthma management, and a delay in coordination with the pharmacy department to start biologic agents. A dedicated severe asthma clinic staffed by both an allergist and pulmonologist provides a convenient option for patients to be seen by both specialists, reducing the need for separate appointments with each specialty, transportation to those appointments, and clinical time. This is particularly beneficial in a clinic such as this model, as this clinic serves patients from 4 states and Washington, DC. An additional benefit of this model is trained staff who directly communicate with the pharmacy in the initiation of these agents, allocate time to educating patients in biologic use, and coordinate follow-up.

Limitations

There were several limitations to this report. First, the number of patients examined in this preliminary data set is small. Due to the COVID-19 pandemic, there was a limited ability to see patients in person, and patients were seen exclusively over telemedicine for several months. For this reason, collecting data such as patient surveys and laboratory work following the initiation of a biologic was a challenge. Additionally, during the height of COVID-19, WDCVAMC did not perform aerosolizing procedures, such as PFTs and FENOs; thus, peak flows were obtained instead. Examining metrics, such as FENOs and IgE levels, and expanding PFT data would provide additional insight into the impact of biologic agents on clinical outcomes. Patient survey data in the form of ACTs or satisfaction surveys would also yield important data examining the impact of this clinic design and biologic use on patient experience. As of December 2022, 114 patients are enrolled in the clinic. We are working to collect the above laboratory results and spirometry for these patients so that these results can be published with a more robust data set. Another limitation of the information presented is that it is a retrospective data analysis; the data collected was contingent upon documentation and the assumption that these patients were exclusively receiving care through the VA. For example, steroid use before and after initiation of biologic was taken from asthma clinic notes and the patient’s medication list. Therefore, there is a possibility that not all instances were accounted for if that patient sought care outside the VA or whether it was not documented in a follow-up note.

Conclusions

The model of a combined allergy/pulmonology clinic can be particularly efficacious in the treatment of severe asthma, as it reduces the need for multiple appointments with different specialties, reduces wait time before starting a biologic agent, and offers the perspective of 2 specialists. This kind of model could be an example to many clinics in the VA. With a rapid increase in telemedicine due to the COVID-19 pandemic, multiple physicians consulting simultaneously is becoming a more feasible possibility across multiple specialties. As the use of biologics becomes more widespread, a combined clinic design is an efficient and promising method to improve severe asthma management.

This preliminary data continue to support previous research that shows biologic agents have led to better clinical outcomes through the reduction of asthma exacerbations, hospitalizations, and improved PFTs. While this initial data set highlights the results for 15 patients, there are 86 patients currently enrolled in this clinic. We are collecting additional data to publish more comprehensive results.

References

1. Lambrecht BN, Hammad H. The immunology of asthma. Nat Immunol. 2015;16(1):45-56. doi:10.1038/ni.3049

2. Moore WC, Bleecker ER, Curran-Everett D, et al. Characterization of the severe asthma phenotype by the National Heart, Lung, and Blood Institute’s Severe Asthma Research Program. J Allergy Clin Immunol. 2007;119(2):405-413. doi:10.1016/j.jaci.2006.11.639

3. Barnes PJ, Jonsson B, Klim JB. The costs of asthma. Eur Respir J. 1996;9(4):636-642. doi:10.1183/09031936.96.09040636

4. Bourdin A, Charriot J, Boissin C, et al. Will the asthma revolution fostered by biologics also benefit adult ICU patients?. Allergy. 2021;76(8):2395-2406. doi:10.1111/all.14688

5. Lloyd A, Price D, Brown R. The impact of asthma exacerbations on health-related quality of life in moderate to severe asthma patients in the UK. Prim Care Respir J. 2007;16(1):22-27. doi:10.3132/pcrj.2007.00002

6. Eisner MD, Yelin EH, Katz PP, Lactao G, Iribarren C, Blanc PD. Risk factors for work disability in severe adult asthma. Am J Med. 2006;119(10):884-891. doi:10.1016/j.amjmed.2006.01.016

7. Nurmagambetov T, Kuwahara R, Garbe P. The Economic Burden of Asthma in the United States, 2008-2013. Ann Am Thorac Soc. 2018;15(3):348-356. doi:10.1513/AnnalsATS.201703-259OC

8. McGregor MC, Krings JG, Nair P, Castro M. Role of biologics in asthma. Am J Respir Crit Care Med. 2019;199(4):433-445. doi:10.1164/rccm.201810-1944CI

9. Bice JB, Leechawengwongs E, Montanaro A. Biologic targeted therapy in allergic asthma. Ann Allergy Asthma Immunol. 2014;112(2):108-115. doi:10.1016/j.anai.2013.12.013

10. Darveaux J, Busse WW. Biologics in asthma--the next step toward personalized treatment. J Allergy Clin Immunol Pract. 2015;3(2):152-161. doi:10.1016/j.jaip.2014.09.014

11. Inselman JW, Jeffery MM, Maddux JT, Shah ND, Rank MA. Trends and disparities in asthma biologic use in the United States. J Allergy Clin Immunol Pract. 2020;8(2):549-554.e1. doi:10.1016/j.jaip.2019.08.024

12. Gelhorn HL, Balantac Z, Ambrose CS, Chung YN, Stone B. Patient and physician preferences for attributes of biologic medications for severe asthma. Patient Prefer Adherence. 2019;13:1253-1268. Published 2019 Jul 25. doi:10.2147/PPA.S198953

13. Centers for Disease Control and Prevention, National Center for Environmental Health. 2019 National Health Interview Survey (NHIS) data. Accessed December 6, 2022. https://www.cdc.gov/asthma/nhis/2019/data.htm

14. Zelaya CE BP, Moy E. Crude and age-adjusted percent distribution of respondent-assessed health status among adults aged 20 and over, by veteran status and other selected characteristics: United States, 2015-2018. National Center for Health Statistic. Updated June 19, 2020. Accessed December 12, 2022. https://www.cdc.gov/nchs/nhis/veterans_health_statistics/tables.htm

15. Szema AM, Peters MC, Weissinger KM, Gagliano CA, Chen JJ. New-onset asthma among soldiers serving in Iraq and Afghanistan. Allergy Asthma Proc. 2010;31(5):67-71. doi:10.2500/aap.2010.31.3383

16. Yi SW, Hong JS, Ohrr H, Yi JJ. Agent Orange exposure and disease prevalence in Korean Vietnam veterans: the Korean veterans health study. Environ Res. 2014;133:56-65. doi:10.1016/j.envres.2014.04.027

17. Huetsch JC, Uman JE, Udris EM, Au DH. Predictors of adherence to inhaled medications among veterans with COPD. J Gen Intern Med. 2012;27(11):1506-1512. doi:10.1007/s11606-012-2130-5

18. Mundell L, Lindemann R, Douglas J. Monitoring long-term oral corticosteroids. BMJ Open Qual. 2017;6(2):e000209. Published 2017 Nov 8. doi:10.1136/bmjoq-2017-000209

19. Van Staa TP, Leufkens HG, Abenhaim L, Zhang B, Cooper C. Use of oral corticosteroids and risk of fractures. J Bone Miner Res. 2005;20(8):1487-1486. doi:10.1359/jbmr.2005.20.8.1486

20. Warrington TP, Bostwick JM. Psychiatric adverse effects of corticosteroids. Mayo Clin Proc. 2006;81(10):1361-1367. doi:10.4065/81.10.1361

21. Miller DR, Safford MM, Pogach LM. Who has diabetes? Best estimates of diabetes prevalence in the Department of Veterans Affairs based on computerized patient data. Diabetes Care. 2004;27(suppl 2):B10-B21. doi:10.2337/diacare.27.suppl_2.b10

22. Acharya T, Tringali S, Singh M, Huang J. Resistant hypertension and associated comorbidities in a Veterans Affairs population. J Clin Hypertens (Greenwich). 2014;16(10):741-745. doi:10.1111/jch.12410

23. Dupixent (dupilumab). Prescribing information. Sanofi and Regeneron Pharmaceuticals; 2022. Accessed December 6, 2022. https://www.dupixenthcp.com/asthma/efficacy/safety-data

24. Li L, Wang Z, Cui L, Xu Y, Guan K, Zhao B. Anaphylactic risk related to omalizumab, benralizumab, reslizumab, mepolizumab, and dupilumab. Clin Transl Allergy. 2021;11(4):e12038. Published 2021 Jun 3. doi:10.1002/clt2.12038

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Kelly Colas, DO, PhDa; Kavita Vyas, MDb,c; Dipa K. Sheth, MDa,c,d
Correspondence:
Kelly Colas ([email protected])

aDepartment of Allergy and Immunology, University of Washington, Seattle
bDepartment of Pulmonary and Critical Care, Washington DC Veterans Affairs Medical Center
cGeorge Washington University, Washington, DC
dUniformed Services University of the Health Sciences, Bethesda, Maryland

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Ethics and consent

The intention of this project was to examine the implementation of a program for the improvement of patient care. As this project is qualitative improvement, it did not qualify for institutional review board approval.

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Kelly Colas, DO, PhDa; Kavita Vyas, MDb,c; Dipa K. Sheth, MDa,c,d
Correspondence:
Kelly Colas ([email protected])

aDepartment of Allergy and Immunology, University of Washington, Seattle
bDepartment of Pulmonary and Critical Care, Washington DC Veterans Affairs Medical Center
cGeorge Washington University, Washington, DC
dUniformed Services University of the Health Sciences, Bethesda, Maryland

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Ethics and consent

The intention of this project was to examine the implementation of a program for the improvement of patient care. As this project is qualitative improvement, it did not qualify for institutional review board approval.

Author and Disclosure Information

Kelly Colas, DO, PhDa; Kavita Vyas, MDb,c; Dipa K. Sheth, MDa,c,d
Correspondence:
Kelly Colas ([email protected])

aDepartment of Allergy and Immunology, University of Washington, Seattle
bDepartment of Pulmonary and Critical Care, Washington DC Veterans Affairs Medical Center
cGeorge Washington University, Washington, DC
dUniformed Services University of the Health Sciences, Bethesda, Maryland

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Ethics and consent

The intention of this project was to examine the implementation of a program for the improvement of patient care. As this project is qualitative improvement, it did not qualify for institutional review board approval.

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Article PDF

Asthma affects more than 300 million people worldwide.1 While many of these cases can achieve control with standard therapy, 5% to 10% of these cases are classified as severe asthma, remaining poorly controlled despite treatment with inhaled corticosteroids (ICS) and long-acting β agonists (LABA).2 These patients also account for the majority of morbidity and mortality associated with the disease, with increased hospitalizations, intensive care unit (ICU) stays, detrimental adverse effects of oral corticosteroids (OCS), and lower quality of life.3-6 Additionally, the financial repercussions of severe asthma are notable; in the United States, the estimated cost of asthma management is $82 billion annually, with $3 billion accounting for asthma-related work/school absences.7

In the past several years, the use of anti-immunoglobulin E (IgE), anti-interleukin-4 (IL-4), and anti-IL-5 biologic agents for severe asthma has been shown to decrease asthma exacerbations, improve lung function, reduce corticosteroid use, and decrease hospitalizations, especially for type 2 helper T cell (TH2-high) asthma.8-10 However, clinicians have observed significant barriers to the implementation and widespread use of biologics, including insurance coverage, long wait times, follow-up, and limited access for lower income groups.11,12

This article describes a unique model for a severe asthma clinic located at the Washington DC Veterans Affairs Medical Center (WDCVAMC) that is dually staffed by an allergist and pulmonologist. This clinic uses biologic agents for patients with difficult-to-treat asthma, many of whom require repeated or prolonged steroid use, in addition to prolonged and recurrent hospitalizations for exacerbations. The objective of this clinic is to provide a standardized approach to the management of severe asthma with the perspective of both an allergist and pulmonologist, thereby reducing the need to schedule appointments with multiple specialties and reducing delays in initiating biologics. This article presents the preliminary findings of 30 months of severe asthma management with various biologic agents, examining the impact of these therapies on hospitalizations, asthma exacerbations, ICU stays, and OCS use. The findings of this study support the benefits of biologics and suggest that the use of these agents within a dually staffed clinic may be a particularly effective model through which to manage severe asthma.

Background

Asthma affects approximately 20 million adults in the United States.13 Veterans are a population particularly impacted by asthma. Between 2015 and 2018, 10.9% of all veterans reported being diagnosed with asthma and 5.1% stated that they currently have asthma, compared with 13.4% and 8.0% of nonveterans, respectively.14 Veterans are susceptible to many of the factors that can trigger exacerbations while engaging in military service, such as chemical and environmental exposures both abroad and domestically.15,16 Additionally, medication adherence is often challenging among the veteran population, particularly with more involved therapy, such as inhaler use.17 Such factors contribute to asthma exacerbations, with 2.9% of veterans reporting at least 1 asthma exacerbation in the past 12 months.14

Over the past several years, the development and use of biologic agents have transformed the management of severe asthma.8 Before the development of biologic agents for severe asthma, treatment options for patients were limited. While OCS are frequently used for asthma exacerbations, they are associated with a multiplicity of undesirable adverse effects, including weight gain, mood lability, gastrointestinal upset, hyperglycemia, risk of bone fractures, and hypertension.18-20 The regular use of OCS are particularly problematic among other medical comorbidities commonly affecting the veteran population, such as diabetes and hypertension.21-22

The WDCVAMC severe allergy clinic used 3 biologic agents: omalizumab (anti-IgE), benralizumab (anti-IL-5), and agent dupilumab (anti-IL-4). These medications have shown significant improvements in quality of life, reduction in asthma exacerbations and hospitalizations, and decreased use of OCS.8,9 While research has firmly established the medical benefits of the use of biologic agents in severe asthma, several barriers exist in implementing widespread use.11,12

 

 



In Gelhorn and colleagues’ study examining both physician and patient challenges in the use of biologics for severe asthma, scheduling, administrative time, and insurance costs were found to be major barriers to the use of these medications.12 Patients expressed a preference for the administration of these medications in a specialist’s office but cited long wait times and scheduling difficulties as barriers. One of the most notable challenges from the physician perspective was the difficulty in obtaining reimbursement from insurance companies, requiring them to devote significant portions of time to prior authorizations and documentation.12

This article examines a dual specialty clinic that focuses on the treatment of severe asthma with biologic agents. This model is unique for several reasons. First, given the US Department of Veterans Affairs (VA) health care model, the health care practitioners (HCPs) in this clinic can avoid much of the administrative burden of obtaining reimbursement or working with insurance companies. Additionally, by dedicating specific days to the severe asthma clinic, patients do not experience long wait times to see both an allergist and pulmonologist. By seeing both clinicians, concurrent allergic and pulmonary issues can be addressed in the same visit, rather than delaying treatment by waiting on 2 specialist appointments.

Severe Asthma Clinic

The severe asthma clinic was started in September 2017 by a pulmonologist and an allergist at WDCVAMC. After experiencing substantial delays with the initiation of biologics for their patients and multiple referrals between their clinics, these physicians wanted to start a dually staffed asthma clinic to specifically focus on evaluating and treating severe asthma. A dedicated severe asthma clinic allowed the allergist and pulmonologist to streamline resources and collaborate to advocate for patients with the pharmacy section. Additionally, patients can benefit from the perspective of both specialists, as both the pulmonologist and allergist evaluate each patient and discuss the next steps of management.

This clinic is composed of 4 registered nurses, an allergist, and a pulmonologist. Clinic is held twice monthly through both telemedicine and in-office visits. The VA has strict guidelines for the use of certain biologics, including blood eosinophil count > 150 cells/µL, failure of traditional therapy, and frequent use of OCS. Additionally, to ensure these biologic agents are prescribed to patients that will benefit from them, the patients enrolled in this clinic are already on maximum therapy for their asthma, meaning all other therapeutic options (inhalers and oral medications) are being used. The clinic services all patients with severe asthma, not just patients who are on biologic therapy. Often, patients are referred to the severe allergy clinic late in their disease course given a lack of familiarity with biologic agents from prescribers and both institutional and insurance barriers.

Before the COVID-19 pandemic, spirometry and fractional exhaled nitric oxide (FENO) tests were recorded at each visit. Initially during the pandemic, the clinic transitioned to primarily telemedicine visits due to patients’ hesitance to seek in-person care. More recently, the clinic has transitioned back to primarily office visits; patients are seen in clinic on average every 3 months. At each visit, the patient is seen by both the pulmonologist and allergist. Additionally, the nursing staff reviews inhaler adherence with patients, spacer use, documents, Asthma Control Test (ACT) scores, and schedules follow-up visits.

Every 4 to 8 weeks, patients receive biologics agent at the WDCVAMC infusion center depending on the agent. The infusion center also instructs patients how to handle self-administered medications, like benralizumab, if the patient expresses a preference for taking it at home. Omalizumab has a boxed warning for anaphylaxis, although the other biologics in this study have a low risk of anaphylaxis. All patients receiving omalizumab, benralizumab, and dupilumab were provided with epinephrine injection devices in case of an allergic reaction and were taught how to use them in the clinic.23,24

 

 



If patients continued to experience asthma exacerbations after the initiation of a biologic, a change in agent was considered after 4 to 6 months. Additionally, a complete blood count, respiratory allergy panel, and pulmonary function tests (PFTs) were completed.

If a patient experienced an allergic reaction, the biologic agent was stopped. All patients had access to secure messaging to both the allergist and pulmonologist at this clinic. Figure 1 illustrates the general flow of our severe asthma clinic.

Clinic Patients

Preliminary data were obtained from a retrospective chart review of 15 patients enrolled in the severe asthma clinic over 30 months. The inclusion criteria for chart review consisted of patients aged > 18 years receiving a biologic agent for > 3 months for the treatment of severe asthma. The outcomes examined included steroid use, emergency department (ED) visits, hospitalizations, FEV1, and ICU stays.

Seven patients used benralizumab, 6 used dupilumab, and 2 used omalizumab (Table).

Of the patients examined, 8 had been on a biologic agent for 1 to 2 years while a smaller number of patients had been taking a biologic agent for less than a year (n = 2) or > 2 years (n = 5). Seven patients were referred to the specialty asthma clinic by a VA pulmonologist, 4 were referred by a hospitalist, 3 by an otolaryngologist, and 3 by their primary care physician.

 

 


There was a notable clinical improvement in these patients. Before starting a biologic agent, all the patients in this study were prescribed steroids at least once a year for an asthma exacerbation, with a mean of 4.2 steroid tapers per year.

After starting a biologic, only 3 of 15 patients required steroids for an exacerbation, with an average of 0.6 steroid tapers per year (Figure 2). Additionally, there was notable improvement observed in patients’ FEV1, with a mean of 10% after the initiation of a biologic (Figure 3).

The initiation of a biologic agent also resulted in fewer ED visits and hospitalizations. Two patients had an ED visit for an asthma exacerbation since starting a biologic agent and 1 patient had a hospital admission for an asthma exacerbation. No patients were hospitalized in the ICU after starting a biologic agent.

Discussion

The 15 patients in this initial data were referred to the severe asthma clinic by pulmonology, ear, nose, and throat (ENT), primary care, and a hospitalist during an in-patient stay. As the enrollment in our clinic grows, an increasing number of patients are referred from the allergy clinic as well. Patients in the severe asthma clinic also are referred by regional centers as news of the clinic is spread by word of mouth to surrounding VA facilities. As our clinic gains the capacity to serve more patients, we hope to contact WDCVAMC primary care, pulmonology, allergy, and ENT departments to raise awareness of the clinic.

Benralizumab and dupilumab were the most used agents in this preliminary data. This finding was largely due to the ability of patients to self-administer benralizumab, which was particularly beneficial during the COVID-19 pandemic. Of note, 5 patients in this study switched from another biologic agent to benralizumab due to the ability to self-administer. Three of 5 patients that required steroids after initiating benralizumab used fewer steroids than they had previously. This finding suggests benralizumab may be the preferred agent when travel time to health care is a challenge, reducing the need for frequent clinic visits and transportation.

This preliminary data supports previous studies that have demonstrated that biologic agents improve clinical outcomes by reducing asthma exacerbations, OCS use, hospitalizations, and ICU stays for patients on all 4 biologic agents. In addition to improving patient health through avoiding complications of prolonged OCS use and hospital stays, the decrease in ED visits and hospitalizations provides a substantial cost reduction to the health care system.  

 

 



These findings highlight the strength of a unique model of a combined allergy/pulmonary clinic. Before this combined clinic model, both pulmonology and allergy clinics noted delays in the initiation of biologics for patients who were potential candidates. Impediments include referrals between each specialty for evaluation of concurrent pulmonary conditions or allergy testing, overlap in asthma management, and a delay in coordination with the pharmacy department to start biologic agents. A dedicated severe asthma clinic staffed by both an allergist and pulmonologist provides a convenient option for patients to be seen by both specialists, reducing the need for separate appointments with each specialty, transportation to those appointments, and clinical time. This is particularly beneficial in a clinic such as this model, as this clinic serves patients from 4 states and Washington, DC. An additional benefit of this model is trained staff who directly communicate with the pharmacy in the initiation of these agents, allocate time to educating patients in biologic use, and coordinate follow-up.

Limitations

There were several limitations to this report. First, the number of patients examined in this preliminary data set is small. Due to the COVID-19 pandemic, there was a limited ability to see patients in person, and patients were seen exclusively over telemedicine for several months. For this reason, collecting data such as patient surveys and laboratory work following the initiation of a biologic was a challenge. Additionally, during the height of COVID-19, WDCVAMC did not perform aerosolizing procedures, such as PFTs and FENOs; thus, peak flows were obtained instead. Examining metrics, such as FENOs and IgE levels, and expanding PFT data would provide additional insight into the impact of biologic agents on clinical outcomes. Patient survey data in the form of ACTs or satisfaction surveys would also yield important data examining the impact of this clinic design and biologic use on patient experience. As of December 2022, 114 patients are enrolled in the clinic. We are working to collect the above laboratory results and spirometry for these patients so that these results can be published with a more robust data set. Another limitation of the information presented is that it is a retrospective data analysis; the data collected was contingent upon documentation and the assumption that these patients were exclusively receiving care through the VA. For example, steroid use before and after initiation of biologic was taken from asthma clinic notes and the patient’s medication list. Therefore, there is a possibility that not all instances were accounted for if that patient sought care outside the VA or whether it was not documented in a follow-up note.

Conclusions

The model of a combined allergy/pulmonology clinic can be particularly efficacious in the treatment of severe asthma, as it reduces the need for multiple appointments with different specialties, reduces wait time before starting a biologic agent, and offers the perspective of 2 specialists. This kind of model could be an example to many clinics in the VA. With a rapid increase in telemedicine due to the COVID-19 pandemic, multiple physicians consulting simultaneously is becoming a more feasible possibility across multiple specialties. As the use of biologics becomes more widespread, a combined clinic design is an efficient and promising method to improve severe asthma management.

This preliminary data continue to support previous research that shows biologic agents have led to better clinical outcomes through the reduction of asthma exacerbations, hospitalizations, and improved PFTs. While this initial data set highlights the results for 15 patients, there are 86 patients currently enrolled in this clinic. We are collecting additional data to publish more comprehensive results.

Asthma affects more than 300 million people worldwide.1 While many of these cases can achieve control with standard therapy, 5% to 10% of these cases are classified as severe asthma, remaining poorly controlled despite treatment with inhaled corticosteroids (ICS) and long-acting β agonists (LABA).2 These patients also account for the majority of morbidity and mortality associated with the disease, with increased hospitalizations, intensive care unit (ICU) stays, detrimental adverse effects of oral corticosteroids (OCS), and lower quality of life.3-6 Additionally, the financial repercussions of severe asthma are notable; in the United States, the estimated cost of asthma management is $82 billion annually, with $3 billion accounting for asthma-related work/school absences.7

In the past several years, the use of anti-immunoglobulin E (IgE), anti-interleukin-4 (IL-4), and anti-IL-5 biologic agents for severe asthma has been shown to decrease asthma exacerbations, improve lung function, reduce corticosteroid use, and decrease hospitalizations, especially for type 2 helper T cell (TH2-high) asthma.8-10 However, clinicians have observed significant barriers to the implementation and widespread use of biologics, including insurance coverage, long wait times, follow-up, and limited access for lower income groups.11,12

This article describes a unique model for a severe asthma clinic located at the Washington DC Veterans Affairs Medical Center (WDCVAMC) that is dually staffed by an allergist and pulmonologist. This clinic uses biologic agents for patients with difficult-to-treat asthma, many of whom require repeated or prolonged steroid use, in addition to prolonged and recurrent hospitalizations for exacerbations. The objective of this clinic is to provide a standardized approach to the management of severe asthma with the perspective of both an allergist and pulmonologist, thereby reducing the need to schedule appointments with multiple specialties and reducing delays in initiating biologics. This article presents the preliminary findings of 30 months of severe asthma management with various biologic agents, examining the impact of these therapies on hospitalizations, asthma exacerbations, ICU stays, and OCS use. The findings of this study support the benefits of biologics and suggest that the use of these agents within a dually staffed clinic may be a particularly effective model through which to manage severe asthma.

Background

Asthma affects approximately 20 million adults in the United States.13 Veterans are a population particularly impacted by asthma. Between 2015 and 2018, 10.9% of all veterans reported being diagnosed with asthma and 5.1% stated that they currently have asthma, compared with 13.4% and 8.0% of nonveterans, respectively.14 Veterans are susceptible to many of the factors that can trigger exacerbations while engaging in military service, such as chemical and environmental exposures both abroad and domestically.15,16 Additionally, medication adherence is often challenging among the veteran population, particularly with more involved therapy, such as inhaler use.17 Such factors contribute to asthma exacerbations, with 2.9% of veterans reporting at least 1 asthma exacerbation in the past 12 months.14

Over the past several years, the development and use of biologic agents have transformed the management of severe asthma.8 Before the development of biologic agents for severe asthma, treatment options for patients were limited. While OCS are frequently used for asthma exacerbations, they are associated with a multiplicity of undesirable adverse effects, including weight gain, mood lability, gastrointestinal upset, hyperglycemia, risk of bone fractures, and hypertension.18-20 The regular use of OCS are particularly problematic among other medical comorbidities commonly affecting the veteran population, such as diabetes and hypertension.21-22

The WDCVAMC severe allergy clinic used 3 biologic agents: omalizumab (anti-IgE), benralizumab (anti-IL-5), and agent dupilumab (anti-IL-4). These medications have shown significant improvements in quality of life, reduction in asthma exacerbations and hospitalizations, and decreased use of OCS.8,9 While research has firmly established the medical benefits of the use of biologic agents in severe asthma, several barriers exist in implementing widespread use.11,12

 

 



In Gelhorn and colleagues’ study examining both physician and patient challenges in the use of biologics for severe asthma, scheduling, administrative time, and insurance costs were found to be major barriers to the use of these medications.12 Patients expressed a preference for the administration of these medications in a specialist’s office but cited long wait times and scheduling difficulties as barriers. One of the most notable challenges from the physician perspective was the difficulty in obtaining reimbursement from insurance companies, requiring them to devote significant portions of time to prior authorizations and documentation.12

This article examines a dual specialty clinic that focuses on the treatment of severe asthma with biologic agents. This model is unique for several reasons. First, given the US Department of Veterans Affairs (VA) health care model, the health care practitioners (HCPs) in this clinic can avoid much of the administrative burden of obtaining reimbursement or working with insurance companies. Additionally, by dedicating specific days to the severe asthma clinic, patients do not experience long wait times to see both an allergist and pulmonologist. By seeing both clinicians, concurrent allergic and pulmonary issues can be addressed in the same visit, rather than delaying treatment by waiting on 2 specialist appointments.

Severe Asthma Clinic

The severe asthma clinic was started in September 2017 by a pulmonologist and an allergist at WDCVAMC. After experiencing substantial delays with the initiation of biologics for their patients and multiple referrals between their clinics, these physicians wanted to start a dually staffed asthma clinic to specifically focus on evaluating and treating severe asthma. A dedicated severe asthma clinic allowed the allergist and pulmonologist to streamline resources and collaborate to advocate for patients with the pharmacy section. Additionally, patients can benefit from the perspective of both specialists, as both the pulmonologist and allergist evaluate each patient and discuss the next steps of management.

This clinic is composed of 4 registered nurses, an allergist, and a pulmonologist. Clinic is held twice monthly through both telemedicine and in-office visits. The VA has strict guidelines for the use of certain biologics, including blood eosinophil count > 150 cells/µL, failure of traditional therapy, and frequent use of OCS. Additionally, to ensure these biologic agents are prescribed to patients that will benefit from them, the patients enrolled in this clinic are already on maximum therapy for their asthma, meaning all other therapeutic options (inhalers and oral medications) are being used. The clinic services all patients with severe asthma, not just patients who are on biologic therapy. Often, patients are referred to the severe allergy clinic late in their disease course given a lack of familiarity with biologic agents from prescribers and both institutional and insurance barriers.

Before the COVID-19 pandemic, spirometry and fractional exhaled nitric oxide (FENO) tests were recorded at each visit. Initially during the pandemic, the clinic transitioned to primarily telemedicine visits due to patients’ hesitance to seek in-person care. More recently, the clinic has transitioned back to primarily office visits; patients are seen in clinic on average every 3 months. At each visit, the patient is seen by both the pulmonologist and allergist. Additionally, the nursing staff reviews inhaler adherence with patients, spacer use, documents, Asthma Control Test (ACT) scores, and schedules follow-up visits.

Every 4 to 8 weeks, patients receive biologics agent at the WDCVAMC infusion center depending on the agent. The infusion center also instructs patients how to handle self-administered medications, like benralizumab, if the patient expresses a preference for taking it at home. Omalizumab has a boxed warning for anaphylaxis, although the other biologics in this study have a low risk of anaphylaxis. All patients receiving omalizumab, benralizumab, and dupilumab were provided with epinephrine injection devices in case of an allergic reaction and were taught how to use them in the clinic.23,24

 

 



If patients continued to experience asthma exacerbations after the initiation of a biologic, a change in agent was considered after 4 to 6 months. Additionally, a complete blood count, respiratory allergy panel, and pulmonary function tests (PFTs) were completed.

If a patient experienced an allergic reaction, the biologic agent was stopped. All patients had access to secure messaging to both the allergist and pulmonologist at this clinic. Figure 1 illustrates the general flow of our severe asthma clinic.

Clinic Patients

Preliminary data were obtained from a retrospective chart review of 15 patients enrolled in the severe asthma clinic over 30 months. The inclusion criteria for chart review consisted of patients aged > 18 years receiving a biologic agent for > 3 months for the treatment of severe asthma. The outcomes examined included steroid use, emergency department (ED) visits, hospitalizations, FEV1, and ICU stays.

Seven patients used benralizumab, 6 used dupilumab, and 2 used omalizumab (Table).

Of the patients examined, 8 had been on a biologic agent for 1 to 2 years while a smaller number of patients had been taking a biologic agent for less than a year (n = 2) or > 2 years (n = 5). Seven patients were referred to the specialty asthma clinic by a VA pulmonologist, 4 were referred by a hospitalist, 3 by an otolaryngologist, and 3 by their primary care physician.

 

 


There was a notable clinical improvement in these patients. Before starting a biologic agent, all the patients in this study were prescribed steroids at least once a year for an asthma exacerbation, with a mean of 4.2 steroid tapers per year.

After starting a biologic, only 3 of 15 patients required steroids for an exacerbation, with an average of 0.6 steroid tapers per year (Figure 2). Additionally, there was notable improvement observed in patients’ FEV1, with a mean of 10% after the initiation of a biologic (Figure 3).

The initiation of a biologic agent also resulted in fewer ED visits and hospitalizations. Two patients had an ED visit for an asthma exacerbation since starting a biologic agent and 1 patient had a hospital admission for an asthma exacerbation. No patients were hospitalized in the ICU after starting a biologic agent.

Discussion

The 15 patients in this initial data were referred to the severe asthma clinic by pulmonology, ear, nose, and throat (ENT), primary care, and a hospitalist during an in-patient stay. As the enrollment in our clinic grows, an increasing number of patients are referred from the allergy clinic as well. Patients in the severe asthma clinic also are referred by regional centers as news of the clinic is spread by word of mouth to surrounding VA facilities. As our clinic gains the capacity to serve more patients, we hope to contact WDCVAMC primary care, pulmonology, allergy, and ENT departments to raise awareness of the clinic.

Benralizumab and dupilumab were the most used agents in this preliminary data. This finding was largely due to the ability of patients to self-administer benralizumab, which was particularly beneficial during the COVID-19 pandemic. Of note, 5 patients in this study switched from another biologic agent to benralizumab due to the ability to self-administer. Three of 5 patients that required steroids after initiating benralizumab used fewer steroids than they had previously. This finding suggests benralizumab may be the preferred agent when travel time to health care is a challenge, reducing the need for frequent clinic visits and transportation.

This preliminary data supports previous studies that have demonstrated that biologic agents improve clinical outcomes by reducing asthma exacerbations, OCS use, hospitalizations, and ICU stays for patients on all 4 biologic agents. In addition to improving patient health through avoiding complications of prolonged OCS use and hospital stays, the decrease in ED visits and hospitalizations provides a substantial cost reduction to the health care system.  

 

 



These findings highlight the strength of a unique model of a combined allergy/pulmonary clinic. Before this combined clinic model, both pulmonology and allergy clinics noted delays in the initiation of biologics for patients who were potential candidates. Impediments include referrals between each specialty for evaluation of concurrent pulmonary conditions or allergy testing, overlap in asthma management, and a delay in coordination with the pharmacy department to start biologic agents. A dedicated severe asthma clinic staffed by both an allergist and pulmonologist provides a convenient option for patients to be seen by both specialists, reducing the need for separate appointments with each specialty, transportation to those appointments, and clinical time. This is particularly beneficial in a clinic such as this model, as this clinic serves patients from 4 states and Washington, DC. An additional benefit of this model is trained staff who directly communicate with the pharmacy in the initiation of these agents, allocate time to educating patients in biologic use, and coordinate follow-up.

Limitations

There were several limitations to this report. First, the number of patients examined in this preliminary data set is small. Due to the COVID-19 pandemic, there was a limited ability to see patients in person, and patients were seen exclusively over telemedicine for several months. For this reason, collecting data such as patient surveys and laboratory work following the initiation of a biologic was a challenge. Additionally, during the height of COVID-19, WDCVAMC did not perform aerosolizing procedures, such as PFTs and FENOs; thus, peak flows were obtained instead. Examining metrics, such as FENOs and IgE levels, and expanding PFT data would provide additional insight into the impact of biologic agents on clinical outcomes. Patient survey data in the form of ACTs or satisfaction surveys would also yield important data examining the impact of this clinic design and biologic use on patient experience. As of December 2022, 114 patients are enrolled in the clinic. We are working to collect the above laboratory results and spirometry for these patients so that these results can be published with a more robust data set. Another limitation of the information presented is that it is a retrospective data analysis; the data collected was contingent upon documentation and the assumption that these patients were exclusively receiving care through the VA. For example, steroid use before and after initiation of biologic was taken from asthma clinic notes and the patient’s medication list. Therefore, there is a possibility that not all instances were accounted for if that patient sought care outside the VA or whether it was not documented in a follow-up note.

Conclusions

The model of a combined allergy/pulmonology clinic can be particularly efficacious in the treatment of severe asthma, as it reduces the need for multiple appointments with different specialties, reduces wait time before starting a biologic agent, and offers the perspective of 2 specialists. This kind of model could be an example to many clinics in the VA. With a rapid increase in telemedicine due to the COVID-19 pandemic, multiple physicians consulting simultaneously is becoming a more feasible possibility across multiple specialties. As the use of biologics becomes more widespread, a combined clinic design is an efficient and promising method to improve severe asthma management.

This preliminary data continue to support previous research that shows biologic agents have led to better clinical outcomes through the reduction of asthma exacerbations, hospitalizations, and improved PFTs. While this initial data set highlights the results for 15 patients, there are 86 patients currently enrolled in this clinic. We are collecting additional data to publish more comprehensive results.

References

1. Lambrecht BN, Hammad H. The immunology of asthma. Nat Immunol. 2015;16(1):45-56. doi:10.1038/ni.3049

2. Moore WC, Bleecker ER, Curran-Everett D, et al. Characterization of the severe asthma phenotype by the National Heart, Lung, and Blood Institute’s Severe Asthma Research Program. J Allergy Clin Immunol. 2007;119(2):405-413. doi:10.1016/j.jaci.2006.11.639

3. Barnes PJ, Jonsson B, Klim JB. The costs of asthma. Eur Respir J. 1996;9(4):636-642. doi:10.1183/09031936.96.09040636

4. Bourdin A, Charriot J, Boissin C, et al. Will the asthma revolution fostered by biologics also benefit adult ICU patients?. Allergy. 2021;76(8):2395-2406. doi:10.1111/all.14688

5. Lloyd A, Price D, Brown R. The impact of asthma exacerbations on health-related quality of life in moderate to severe asthma patients in the UK. Prim Care Respir J. 2007;16(1):22-27. doi:10.3132/pcrj.2007.00002

6. Eisner MD, Yelin EH, Katz PP, Lactao G, Iribarren C, Blanc PD. Risk factors for work disability in severe adult asthma. Am J Med. 2006;119(10):884-891. doi:10.1016/j.amjmed.2006.01.016

7. Nurmagambetov T, Kuwahara R, Garbe P. The Economic Burden of Asthma in the United States, 2008-2013. Ann Am Thorac Soc. 2018;15(3):348-356. doi:10.1513/AnnalsATS.201703-259OC

8. McGregor MC, Krings JG, Nair P, Castro M. Role of biologics in asthma. Am J Respir Crit Care Med. 2019;199(4):433-445. doi:10.1164/rccm.201810-1944CI

9. Bice JB, Leechawengwongs E, Montanaro A. Biologic targeted therapy in allergic asthma. Ann Allergy Asthma Immunol. 2014;112(2):108-115. doi:10.1016/j.anai.2013.12.013

10. Darveaux J, Busse WW. Biologics in asthma--the next step toward personalized treatment. J Allergy Clin Immunol Pract. 2015;3(2):152-161. doi:10.1016/j.jaip.2014.09.014

11. Inselman JW, Jeffery MM, Maddux JT, Shah ND, Rank MA. Trends and disparities in asthma biologic use in the United States. J Allergy Clin Immunol Pract. 2020;8(2):549-554.e1. doi:10.1016/j.jaip.2019.08.024

12. Gelhorn HL, Balantac Z, Ambrose CS, Chung YN, Stone B. Patient and physician preferences for attributes of biologic medications for severe asthma. Patient Prefer Adherence. 2019;13:1253-1268. Published 2019 Jul 25. doi:10.2147/PPA.S198953

13. Centers for Disease Control and Prevention, National Center for Environmental Health. 2019 National Health Interview Survey (NHIS) data. Accessed December 6, 2022. https://www.cdc.gov/asthma/nhis/2019/data.htm

14. Zelaya CE BP, Moy E. Crude and age-adjusted percent distribution of respondent-assessed health status among adults aged 20 and over, by veteran status and other selected characteristics: United States, 2015-2018. National Center for Health Statistic. Updated June 19, 2020. Accessed December 12, 2022. https://www.cdc.gov/nchs/nhis/veterans_health_statistics/tables.htm

15. Szema AM, Peters MC, Weissinger KM, Gagliano CA, Chen JJ. New-onset asthma among soldiers serving in Iraq and Afghanistan. Allergy Asthma Proc. 2010;31(5):67-71. doi:10.2500/aap.2010.31.3383

16. Yi SW, Hong JS, Ohrr H, Yi JJ. Agent Orange exposure and disease prevalence in Korean Vietnam veterans: the Korean veterans health study. Environ Res. 2014;133:56-65. doi:10.1016/j.envres.2014.04.027

17. Huetsch JC, Uman JE, Udris EM, Au DH. Predictors of adherence to inhaled medications among veterans with COPD. J Gen Intern Med. 2012;27(11):1506-1512. doi:10.1007/s11606-012-2130-5

18. Mundell L, Lindemann R, Douglas J. Monitoring long-term oral corticosteroids. BMJ Open Qual. 2017;6(2):e000209. Published 2017 Nov 8. doi:10.1136/bmjoq-2017-000209

19. Van Staa TP, Leufkens HG, Abenhaim L, Zhang B, Cooper C. Use of oral corticosteroids and risk of fractures. J Bone Miner Res. 2005;20(8):1487-1486. doi:10.1359/jbmr.2005.20.8.1486

20. Warrington TP, Bostwick JM. Psychiatric adverse effects of corticosteroids. Mayo Clin Proc. 2006;81(10):1361-1367. doi:10.4065/81.10.1361

21. Miller DR, Safford MM, Pogach LM. Who has diabetes? Best estimates of diabetes prevalence in the Department of Veterans Affairs based on computerized patient data. Diabetes Care. 2004;27(suppl 2):B10-B21. doi:10.2337/diacare.27.suppl_2.b10

22. Acharya T, Tringali S, Singh M, Huang J. Resistant hypertension and associated comorbidities in a Veterans Affairs population. J Clin Hypertens (Greenwich). 2014;16(10):741-745. doi:10.1111/jch.12410

23. Dupixent (dupilumab). Prescribing information. Sanofi and Regeneron Pharmaceuticals; 2022. Accessed December 6, 2022. https://www.dupixenthcp.com/asthma/efficacy/safety-data

24. Li L, Wang Z, Cui L, Xu Y, Guan K, Zhao B. Anaphylactic risk related to omalizumab, benralizumab, reslizumab, mepolizumab, and dupilumab. Clin Transl Allergy. 2021;11(4):e12038. Published 2021 Jun 3. doi:10.1002/clt2.12038

References

1. Lambrecht BN, Hammad H. The immunology of asthma. Nat Immunol. 2015;16(1):45-56. doi:10.1038/ni.3049

2. Moore WC, Bleecker ER, Curran-Everett D, et al. Characterization of the severe asthma phenotype by the National Heart, Lung, and Blood Institute’s Severe Asthma Research Program. J Allergy Clin Immunol. 2007;119(2):405-413. doi:10.1016/j.jaci.2006.11.639

3. Barnes PJ, Jonsson B, Klim JB. The costs of asthma. Eur Respir J. 1996;9(4):636-642. doi:10.1183/09031936.96.09040636

4. Bourdin A, Charriot J, Boissin C, et al. Will the asthma revolution fostered by biologics also benefit adult ICU patients?. Allergy. 2021;76(8):2395-2406. doi:10.1111/all.14688

5. Lloyd A, Price D, Brown R. The impact of asthma exacerbations on health-related quality of life in moderate to severe asthma patients in the UK. Prim Care Respir J. 2007;16(1):22-27. doi:10.3132/pcrj.2007.00002

6. Eisner MD, Yelin EH, Katz PP, Lactao G, Iribarren C, Blanc PD. Risk factors for work disability in severe adult asthma. Am J Med. 2006;119(10):884-891. doi:10.1016/j.amjmed.2006.01.016

7. Nurmagambetov T, Kuwahara R, Garbe P. The Economic Burden of Asthma in the United States, 2008-2013. Ann Am Thorac Soc. 2018;15(3):348-356. doi:10.1513/AnnalsATS.201703-259OC

8. McGregor MC, Krings JG, Nair P, Castro M. Role of biologics in asthma. Am J Respir Crit Care Med. 2019;199(4):433-445. doi:10.1164/rccm.201810-1944CI

9. Bice JB, Leechawengwongs E, Montanaro A. Biologic targeted therapy in allergic asthma. Ann Allergy Asthma Immunol. 2014;112(2):108-115. doi:10.1016/j.anai.2013.12.013

10. Darveaux J, Busse WW. Biologics in asthma--the next step toward personalized treatment. J Allergy Clin Immunol Pract. 2015;3(2):152-161. doi:10.1016/j.jaip.2014.09.014

11. Inselman JW, Jeffery MM, Maddux JT, Shah ND, Rank MA. Trends and disparities in asthma biologic use in the United States. J Allergy Clin Immunol Pract. 2020;8(2):549-554.e1. doi:10.1016/j.jaip.2019.08.024

12. Gelhorn HL, Balantac Z, Ambrose CS, Chung YN, Stone B. Patient and physician preferences for attributes of biologic medications for severe asthma. Patient Prefer Adherence. 2019;13:1253-1268. Published 2019 Jul 25. doi:10.2147/PPA.S198953

13. Centers for Disease Control and Prevention, National Center for Environmental Health. 2019 National Health Interview Survey (NHIS) data. Accessed December 6, 2022. https://www.cdc.gov/asthma/nhis/2019/data.htm

14. Zelaya CE BP, Moy E. Crude and age-adjusted percent distribution of respondent-assessed health status among adults aged 20 and over, by veteran status and other selected characteristics: United States, 2015-2018. National Center for Health Statistic. Updated June 19, 2020. Accessed December 12, 2022. https://www.cdc.gov/nchs/nhis/veterans_health_statistics/tables.htm

15. Szema AM, Peters MC, Weissinger KM, Gagliano CA, Chen JJ. New-onset asthma among soldiers serving in Iraq and Afghanistan. Allergy Asthma Proc. 2010;31(5):67-71. doi:10.2500/aap.2010.31.3383

16. Yi SW, Hong JS, Ohrr H, Yi JJ. Agent Orange exposure and disease prevalence in Korean Vietnam veterans: the Korean veterans health study. Environ Res. 2014;133:56-65. doi:10.1016/j.envres.2014.04.027

17. Huetsch JC, Uman JE, Udris EM, Au DH. Predictors of adherence to inhaled medications among veterans with COPD. J Gen Intern Med. 2012;27(11):1506-1512. doi:10.1007/s11606-012-2130-5

18. Mundell L, Lindemann R, Douglas J. Monitoring long-term oral corticosteroids. BMJ Open Qual. 2017;6(2):e000209. Published 2017 Nov 8. doi:10.1136/bmjoq-2017-000209

19. Van Staa TP, Leufkens HG, Abenhaim L, Zhang B, Cooper C. Use of oral corticosteroids and risk of fractures. J Bone Miner Res. 2005;20(8):1487-1486. doi:10.1359/jbmr.2005.20.8.1486

20. Warrington TP, Bostwick JM. Psychiatric adverse effects of corticosteroids. Mayo Clin Proc. 2006;81(10):1361-1367. doi:10.4065/81.10.1361

21. Miller DR, Safford MM, Pogach LM. Who has diabetes? Best estimates of diabetes prevalence in the Department of Veterans Affairs based on computerized patient data. Diabetes Care. 2004;27(suppl 2):B10-B21. doi:10.2337/diacare.27.suppl_2.b10

22. Acharya T, Tringali S, Singh M, Huang J. Resistant hypertension and associated comorbidities in a Veterans Affairs population. J Clin Hypertens (Greenwich). 2014;16(10):741-745. doi:10.1111/jch.12410

23. Dupixent (dupilumab). Prescribing information. Sanofi and Regeneron Pharmaceuticals; 2022. Accessed December 6, 2022. https://www.dupixenthcp.com/asthma/efficacy/safety-data

24. Li L, Wang Z, Cui L, Xu Y, Guan K, Zhao B. Anaphylactic risk related to omalizumab, benralizumab, reslizumab, mepolizumab, and dupilumab. Clin Transl Allergy. 2021;11(4):e12038. Published 2021 Jun 3. doi:10.1002/clt2.12038

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Transition to Tenecteplase From t-PA for Acute Ischemic Stroke at Walter Reed National Military Medical Center

Article Type
Changed
Thu, 07/13/2023 - 17:31

Tissue plasminogen activator (t-PA) has been the standard IV thrombolytic used in acute ischemic stroke treatment since its US Food and Drug Administration (FDA) approval in 1995. Trials have established this drug’s efficacy in the treatment of acute ischemic stroke and the appropriate patient population for therapy.1-3 Published guidelines and experiences have made clear that a written protocol with extensive personnel training is important to deliver this care properly.4

Tenecteplase has been available for use in the treatment of acute myocardial infarction (MI) and studied in acute ischemic strokes since 2000. Recent large multicenter trials have suggested tenecteplase may work better than t-PA in the recanalization of large vessel occlusions (LVOs) and have provided guidance on proper dosing in acute ischemic stroke victims.5-8 Compared with t-PA, tenecteplase has a longer half-life, is more fibrin specific (causing less coagulopathy), and is more resistant to endogenous plasminogen activator inhibitor.9,10 Using tenecteplase for acute ischemic stroke is simpler as a single dose bolus rather than a bolus followed by a 1-hour infusion with t-PA. Immediate mechanical thrombectomy for LVO is less complicated without the 1-hour t-PA infusion.5,6 Tenecteplase use also allows for nonthrombectomy hospitals to accelerate transfer times for patients who need thrombectomy following thrombolysis by eliminating the need for critical care nurse–staffed ambulances for interfacility transfer.11 Tenecteplase also is cheaper: Tenecteplase costs $3748 per vial, whereas t-PA costs $5800 per vial equating to roughly a $2000 savings per patient.12,13 Finally, the pharmacy formulary is simplified by using a single thrombolytic agent for both cardiac and neurologic emergencies.

Tenecteplase does have some drawbacks to consider. Currently, tenecteplase is not approved by the FDA for the indication of acute ischemic stroke, though the drug is endorsed by the American Heart Association stroke guidelines of 2019 as an alternative to t-PA.14 There is no stroke-specific preparation of the drug, leading to potential dosing errors. Therefore, a systematic process to safely transition from t-PA to tenecteplase for acute ischemic stroke was undertaken at Walter Reed National Military Medical Center (WRNMMC) in Bethesda, Maryland. Here, we report the process required in making a complex switch in thrombolytic medication along with the potential benefits of making this transition.

OBSERVATIONS

The process to implement tenecteplase required extensive training and education for staff physicians, nurses, pharmacists, radiologists, trainees, and the rapid response team. Our institution administered IV thrombolytic drugs up to 25 times annually to acute ischemic stroke victims, meaning we had to train personnel extensively and repeatedly.

In preparation for the transition to tenecteplase, hospital leadership gathered staff for multidisciplinary administrative meetings that included neurology, emergency medicine, intensive care, pharmacy, radiology, and nursing departments. The purpose of these meetings was to establish a standard operating procedure (SOP) to ensure a safe transition. This process began in May 2020 and involved regular meetings to draft and revise our SOP. Additionally, several leadership and training sessions were held over a 6-month period. Stroke boxes were developed that contained the required evaluation tools, consent forms, medications (tenecteplase and treatments for known complications), dosing cards, and instructions. Final approval of the updated acute ischemic stroke hospital policy was obtained in November 2020 and signed by the above departments.

 

 

All inclusion and exclusion criteria were determined to be the same for tenecteplase as they were for t-PA with the notable exception that the WAKE-UP trial protocol would not be supported until further evidence became available.9 The results of the WAKE-UP trial had previously been used at WRNMMC to justify administration of t-PA in patients who awoke with symptoms of acute ischemic stroke, the last known well was unclear or > 4.5 hours, and for whom a magnetic resonance imaging (MRI) of the brain could be obtained rapidly. Based on the WAKE-UP trial, if the MRI scan of the brain in these patients demonstrated restricted diffusion without fluid attenuated inversion recovery (FLAIR) signal changes (diffusion-weighted [DWI]-FLAIR mismatch sign), this indicated that the stroke had likely occurred recently, and it was safe to administer t-PA. This allowed for administration of t-PA outside the standard treatment window of 4.5 hours from last known well, especially in the cases of patients who awoke with symptoms.

Since safety data are not yet available for the use of tenecteplase in this fashion, the WAKE-UP trial protocol was not used as an inclusion criterion. The informed consent form was modified, and the following scenarios were outlined: (1) If the patient or surrogate is immediately available to consent, paper consent will be documented with the additional note that tenecteplase is being used off-label; and (2) If the patient cannot consent and a surrogate is not immediately available, the medicine will be used emergently as long as the neurology resident and attending physicians agree.15

Risk mitigation was considered carefully. The stroke box described above is stocked and maintained by the pharmacy as we have transitioned to using designated pharmacists for the storage and preparation of tenecteplase. We highly recommend the use of designated pharmacists or emergency department pharmacists in this manner to avoid dosing errors.7,16 Since the current pharmacy-provided tenecteplase bottle contains twice the maximum dose indicated for ischemic stroke, only a 5 mL syringe is included in the stroke box to ensure a maximum dose of 25 mg is drawn up after reconstitution. Dosing card charts were made like existing dosing card charts for t-PA to quickly calculate the 0.25 mg/kg dose. In training, the difference in dosing in ischemic stroke was emphasized. Finally, pharmacy has taken responsibility for dosing the medication during stroke codes.

Any medical personnel at WRNMMC can initiate a stroke code by sending a page to the neurology consult service (Figure).

A neurology resident or staff will then ensure that all the correct next steps are completed to properly triage the patient. This includes a physical examination, vital signs, laboratory workup, and computed tomography (CT)–based imaging. Treatment decision is based on a standard set of criteria. These include imaging findings on noncontrasted head CT and CT angiography head and neck, disabling symptoms, presentation within standard treatment window, and lack of contraindications. Infusion of tenecteplase obviates the need for an IV pump and thus opens an IV site for alternate uses if needed. Removal of the infusion phase eliminates delays in mechanical thrombectomy in cases of LVO. Treatment with mechanical thrombectomy is based on evidence of LVO on CT angiography head and neck on arrival and discussion with the on-call interventionalist.

TRANSITION AND RESULTS

From November 2020 to December 2021, 10 patients have been treated in total at WRNMMC (Table).

One case was treated under the WAKE-UP trial despite protocol and considered to be an outlier. All patients other than the 1 outlier were treated within the standard 4.5-hour window and underwent noncontrast head CT as the initial study. CT angiography head and neck was performed in 7 cases (70%). One case occurred periprocedurally and had a 0 minute time to presentation. One patient strongly believed to be related to ischemic stroke ultimately demonstrated no signal on DWI. Involved vascular territories included the middle cerebral artery (n = 4), pons (n = 2), and multifocal (n = 1). One treated case was determined to be LVO and had mechanical thrombectomy with complete recanalization before intervention. Two of the treated patients were later determined to be stroke mimics. While the number of patients treated thus far is small, these initial results support both the safety and efficacy of tenecteplase use for acute ischemic stroke and indicate a successful transition.

CONCLUSIONS

The available evidence supports the transition from t-PA to tenecteplase for acute ischemic stroke. The successful transition required months of preparation involving multidisciplinary meetings between neurology, nursing, pharmacy, radiology, rapid response teams, critical care, and emergency medicine departments. Safeguards must be implemented to avoid a tenecteplase dosing error that can lead to potentially life-threatening adverse effects. The results at WRNMMC thus far are promising for safety and efficacy. Several process improvements are planned: a hospital-wide overhead page will accompany the direct page to neurology; other team members, including radiology and pharmacy, will be included on the acute stroke alert; and a stroke-specific paging application will be implemented to better track real-time stroke metrics and improve flow. These measures mirror processes that are occurring in institutions that treat acute stroke patients.

References

1. Lees KR, Bluhmki E, von Kummer R, et al. Time to treatment with intravenous alteplase and outcome in stroke: an updated pooled analysis of ECASS, ATLANTIS, NINDS, and EPITHET trials. Lancet. 2010;375(9727):1695-1703. doi:10.1016/S0140-6736(10)60491-6

2. National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. Tissue plasminogen activator for acute ischemic stroke. N Engl J Med. 1995;333(24):1581- 1587. doi:10.1056/NEJM199512143332401

3. Hacke W, Donnan G, Fieschi C, et al. Association of outcome with early stroke treatment: pooled analysis of ATLANTIS, ECASS, and NINDS rt-PA stroke trials. Lancet. 2004;363(9411):768-774. doi:10.1016/S0140-6736(04)15692-4

4. Jauch EC, Saver JL, Adams HP Jr, et al. Guidelines for the early management of patients with acute ischemic stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013;44(3):870-947. doi:10.1161/STR.0b013e318284056a

5. Campbell B, Mitchell P, Churilov L, et al. Tenecteplase versus alteplase before thrombectomy for ischemic stroke. N Engl J Med. 2018;378(17):1573-1582. doi:10.1056/nejmoa1716405

6. Yang P, Zhang Y, Zhang L, et al. Endovascular thrombectomy with or without intravenous alteplase in acute stroke. N Engl J Med. 2020;382(21):1981-1993. doi:10.1056/NEJMoa2001123

7. Menon BK, Buck BH, Singh N, et al. Intravenous tenecteplase compared with alteplase for acute ischaemic stroke in Canada (AcT): a pragmatic, multicentre, open-label, registry-linked, randomised, controlled, noninferiority trial. Lancet. 2022;400(10347):161-169. doi:10.1016/S0140-6736(22)01054-6

8. Campbell BCV, Mitchell PJ, Churilov L, et al. Effect of intravenous tenecteplase dose on cerebral reperfusion before thrombectomy in patients with large vessel occlusion ischemic stroke: the EXTEND-IA TNK part 2 randomized clinical trial. JAMA. 2020;323(13):1257- 1265. doi:10.1001/jama.2020.1511

9. Warach SJ, Dula AN, Milling TJ Jr. Tenecteplase thrombolysis for acute ischemic stroke. Stroke. 2020;51(11):3440- 3451. doi:10.1161/STROKEAHA.120.029749

10. Huang X, Moreton FC, Kalladka D, et al. Coagulation and fibrinolytic activity of tenecteplase and alteplase in acute ischemic stroke. Stroke. 2015;46(12):3543-3546. doi:10.1161/STROKEAHA.115.011290

11. Burgos AM, Saver JL. Evidence that tenecteplase is noninferior to alteplase for acute ischemic stroke: meta-analysis of 5 randomized trials. Stroke. 2019;50(8):2156-2162. doi:10.1161/STROKEAHA.119.025080

12. Potla N, Ganti L. Tenecteplase vs. alteplase for acute ischemic stroke: a systematic review. Int J Emerg Med. 2022;15(1). doi:10.1186/s12245-021-00399-w

13. Warach SJ, Winegar A, Ottenbacher A, Miller C, Gibson D. Abstract WMP52: reduced hospital costs for ischemic stroke treated with tenecteplase. Stroke. 2022;53(suppl 1):AWMP52. doi:10.1161/str.53.suppl_1.WMP52

14. Powers WJ, Rabinstein AA, Ackerson T, et al. Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2019;50(12):e344-e418. doi:10.1161/str.0000000000000211

15. Faris H, Dewar B, Dowlatshahi D, et al. Ethical justification for deferral of consent in the AcT trial for acute ischemic stroke. Stroke. 2022;53(7):2420-2423. doi:10.1161/strokeaha.122.038760

16. Kvistad CE, Næss H, Helleberg BH, et al. Tenecteplase versus alteplase for the management of acute ischaemic stroke in Norway (NOR-TEST 2, part A): a phase 3, randomised, open-label, blinded endpoint, non-inferiority trial. Lancet Neurol. 2022;21(6):511-519. doi:10.1016/S1474-4422(22)00124-7

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The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

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Cole Denkensohn ([email protected])

Author disclosures
The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Ethics and consent
Data were obtained through a quality improvement project, and no identifying information was used. Given this, institutional review board approval was not deemed necessary.

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CPT Cole P. Denkensohn, MD, MC, USAa; CPT Javed L. Khanni, MD, MC, USAa; John Y. Choi, MD, MPHa
Correspondence:
Cole Denkensohn ([email protected])

Author disclosures
The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Ethics and consent
Data were obtained through a quality improvement project, and no identifying information was used. Given this, institutional review board approval was not deemed necessary.

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Related Articles

Tissue plasminogen activator (t-PA) has been the standard IV thrombolytic used in acute ischemic stroke treatment since its US Food and Drug Administration (FDA) approval in 1995. Trials have established this drug’s efficacy in the treatment of acute ischemic stroke and the appropriate patient population for therapy.1-3 Published guidelines and experiences have made clear that a written protocol with extensive personnel training is important to deliver this care properly.4

Tenecteplase has been available for use in the treatment of acute myocardial infarction (MI) and studied in acute ischemic strokes since 2000. Recent large multicenter trials have suggested tenecteplase may work better than t-PA in the recanalization of large vessel occlusions (LVOs) and have provided guidance on proper dosing in acute ischemic stroke victims.5-8 Compared with t-PA, tenecteplase has a longer half-life, is more fibrin specific (causing less coagulopathy), and is more resistant to endogenous plasminogen activator inhibitor.9,10 Using tenecteplase for acute ischemic stroke is simpler as a single dose bolus rather than a bolus followed by a 1-hour infusion with t-PA. Immediate mechanical thrombectomy for LVO is less complicated without the 1-hour t-PA infusion.5,6 Tenecteplase use also allows for nonthrombectomy hospitals to accelerate transfer times for patients who need thrombectomy following thrombolysis by eliminating the need for critical care nurse–staffed ambulances for interfacility transfer.11 Tenecteplase also is cheaper: Tenecteplase costs $3748 per vial, whereas t-PA costs $5800 per vial equating to roughly a $2000 savings per patient.12,13 Finally, the pharmacy formulary is simplified by using a single thrombolytic agent for both cardiac and neurologic emergencies.

Tenecteplase does have some drawbacks to consider. Currently, tenecteplase is not approved by the FDA for the indication of acute ischemic stroke, though the drug is endorsed by the American Heart Association stroke guidelines of 2019 as an alternative to t-PA.14 There is no stroke-specific preparation of the drug, leading to potential dosing errors. Therefore, a systematic process to safely transition from t-PA to tenecteplase for acute ischemic stroke was undertaken at Walter Reed National Military Medical Center (WRNMMC) in Bethesda, Maryland. Here, we report the process required in making a complex switch in thrombolytic medication along with the potential benefits of making this transition.

OBSERVATIONS

The process to implement tenecteplase required extensive training and education for staff physicians, nurses, pharmacists, radiologists, trainees, and the rapid response team. Our institution administered IV thrombolytic drugs up to 25 times annually to acute ischemic stroke victims, meaning we had to train personnel extensively and repeatedly.

In preparation for the transition to tenecteplase, hospital leadership gathered staff for multidisciplinary administrative meetings that included neurology, emergency medicine, intensive care, pharmacy, radiology, and nursing departments. The purpose of these meetings was to establish a standard operating procedure (SOP) to ensure a safe transition. This process began in May 2020 and involved regular meetings to draft and revise our SOP. Additionally, several leadership and training sessions were held over a 6-month period. Stroke boxes were developed that contained the required evaluation tools, consent forms, medications (tenecteplase and treatments for known complications), dosing cards, and instructions. Final approval of the updated acute ischemic stroke hospital policy was obtained in November 2020 and signed by the above departments.

 

 

All inclusion and exclusion criteria were determined to be the same for tenecteplase as they were for t-PA with the notable exception that the WAKE-UP trial protocol would not be supported until further evidence became available.9 The results of the WAKE-UP trial had previously been used at WRNMMC to justify administration of t-PA in patients who awoke with symptoms of acute ischemic stroke, the last known well was unclear or > 4.5 hours, and for whom a magnetic resonance imaging (MRI) of the brain could be obtained rapidly. Based on the WAKE-UP trial, if the MRI scan of the brain in these patients demonstrated restricted diffusion without fluid attenuated inversion recovery (FLAIR) signal changes (diffusion-weighted [DWI]-FLAIR mismatch sign), this indicated that the stroke had likely occurred recently, and it was safe to administer t-PA. This allowed for administration of t-PA outside the standard treatment window of 4.5 hours from last known well, especially in the cases of patients who awoke with symptoms.

Since safety data are not yet available for the use of tenecteplase in this fashion, the WAKE-UP trial protocol was not used as an inclusion criterion. The informed consent form was modified, and the following scenarios were outlined: (1) If the patient or surrogate is immediately available to consent, paper consent will be documented with the additional note that tenecteplase is being used off-label; and (2) If the patient cannot consent and a surrogate is not immediately available, the medicine will be used emergently as long as the neurology resident and attending physicians agree.15

Risk mitigation was considered carefully. The stroke box described above is stocked and maintained by the pharmacy as we have transitioned to using designated pharmacists for the storage and preparation of tenecteplase. We highly recommend the use of designated pharmacists or emergency department pharmacists in this manner to avoid dosing errors.7,16 Since the current pharmacy-provided tenecteplase bottle contains twice the maximum dose indicated for ischemic stroke, only a 5 mL syringe is included in the stroke box to ensure a maximum dose of 25 mg is drawn up after reconstitution. Dosing card charts were made like existing dosing card charts for t-PA to quickly calculate the 0.25 mg/kg dose. In training, the difference in dosing in ischemic stroke was emphasized. Finally, pharmacy has taken responsibility for dosing the medication during stroke codes.

Any medical personnel at WRNMMC can initiate a stroke code by sending a page to the neurology consult service (Figure).

A neurology resident or staff will then ensure that all the correct next steps are completed to properly triage the patient. This includes a physical examination, vital signs, laboratory workup, and computed tomography (CT)–based imaging. Treatment decision is based on a standard set of criteria. These include imaging findings on noncontrasted head CT and CT angiography head and neck, disabling symptoms, presentation within standard treatment window, and lack of contraindications. Infusion of tenecteplase obviates the need for an IV pump and thus opens an IV site for alternate uses if needed. Removal of the infusion phase eliminates delays in mechanical thrombectomy in cases of LVO. Treatment with mechanical thrombectomy is based on evidence of LVO on CT angiography head and neck on arrival and discussion with the on-call interventionalist.

TRANSITION AND RESULTS

From November 2020 to December 2021, 10 patients have been treated in total at WRNMMC (Table).

One case was treated under the WAKE-UP trial despite protocol and considered to be an outlier. All patients other than the 1 outlier were treated within the standard 4.5-hour window and underwent noncontrast head CT as the initial study. CT angiography head and neck was performed in 7 cases (70%). One case occurred periprocedurally and had a 0 minute time to presentation. One patient strongly believed to be related to ischemic stroke ultimately demonstrated no signal on DWI. Involved vascular territories included the middle cerebral artery (n = 4), pons (n = 2), and multifocal (n = 1). One treated case was determined to be LVO and had mechanical thrombectomy with complete recanalization before intervention. Two of the treated patients were later determined to be stroke mimics. While the number of patients treated thus far is small, these initial results support both the safety and efficacy of tenecteplase use for acute ischemic stroke and indicate a successful transition.

CONCLUSIONS

The available evidence supports the transition from t-PA to tenecteplase for acute ischemic stroke. The successful transition required months of preparation involving multidisciplinary meetings between neurology, nursing, pharmacy, radiology, rapid response teams, critical care, and emergency medicine departments. Safeguards must be implemented to avoid a tenecteplase dosing error that can lead to potentially life-threatening adverse effects. The results at WRNMMC thus far are promising for safety and efficacy. Several process improvements are planned: a hospital-wide overhead page will accompany the direct page to neurology; other team members, including radiology and pharmacy, will be included on the acute stroke alert; and a stroke-specific paging application will be implemented to better track real-time stroke metrics and improve flow. These measures mirror processes that are occurring in institutions that treat acute stroke patients.

Tissue plasminogen activator (t-PA) has been the standard IV thrombolytic used in acute ischemic stroke treatment since its US Food and Drug Administration (FDA) approval in 1995. Trials have established this drug’s efficacy in the treatment of acute ischemic stroke and the appropriate patient population for therapy.1-3 Published guidelines and experiences have made clear that a written protocol with extensive personnel training is important to deliver this care properly.4

Tenecteplase has been available for use in the treatment of acute myocardial infarction (MI) and studied in acute ischemic strokes since 2000. Recent large multicenter trials have suggested tenecteplase may work better than t-PA in the recanalization of large vessel occlusions (LVOs) and have provided guidance on proper dosing in acute ischemic stroke victims.5-8 Compared with t-PA, tenecteplase has a longer half-life, is more fibrin specific (causing less coagulopathy), and is more resistant to endogenous plasminogen activator inhibitor.9,10 Using tenecteplase for acute ischemic stroke is simpler as a single dose bolus rather than a bolus followed by a 1-hour infusion with t-PA. Immediate mechanical thrombectomy for LVO is less complicated without the 1-hour t-PA infusion.5,6 Tenecteplase use also allows for nonthrombectomy hospitals to accelerate transfer times for patients who need thrombectomy following thrombolysis by eliminating the need for critical care nurse–staffed ambulances for interfacility transfer.11 Tenecteplase also is cheaper: Tenecteplase costs $3748 per vial, whereas t-PA costs $5800 per vial equating to roughly a $2000 savings per patient.12,13 Finally, the pharmacy formulary is simplified by using a single thrombolytic agent for both cardiac and neurologic emergencies.

Tenecteplase does have some drawbacks to consider. Currently, tenecteplase is not approved by the FDA for the indication of acute ischemic stroke, though the drug is endorsed by the American Heart Association stroke guidelines of 2019 as an alternative to t-PA.14 There is no stroke-specific preparation of the drug, leading to potential dosing errors. Therefore, a systematic process to safely transition from t-PA to tenecteplase for acute ischemic stroke was undertaken at Walter Reed National Military Medical Center (WRNMMC) in Bethesda, Maryland. Here, we report the process required in making a complex switch in thrombolytic medication along with the potential benefits of making this transition.

OBSERVATIONS

The process to implement tenecteplase required extensive training and education for staff physicians, nurses, pharmacists, radiologists, trainees, and the rapid response team. Our institution administered IV thrombolytic drugs up to 25 times annually to acute ischemic stroke victims, meaning we had to train personnel extensively and repeatedly.

In preparation for the transition to tenecteplase, hospital leadership gathered staff for multidisciplinary administrative meetings that included neurology, emergency medicine, intensive care, pharmacy, radiology, and nursing departments. The purpose of these meetings was to establish a standard operating procedure (SOP) to ensure a safe transition. This process began in May 2020 and involved regular meetings to draft and revise our SOP. Additionally, several leadership and training sessions were held over a 6-month period. Stroke boxes were developed that contained the required evaluation tools, consent forms, medications (tenecteplase and treatments for known complications), dosing cards, and instructions. Final approval of the updated acute ischemic stroke hospital policy was obtained in November 2020 and signed by the above departments.

 

 

All inclusion and exclusion criteria were determined to be the same for tenecteplase as they were for t-PA with the notable exception that the WAKE-UP trial protocol would not be supported until further evidence became available.9 The results of the WAKE-UP trial had previously been used at WRNMMC to justify administration of t-PA in patients who awoke with symptoms of acute ischemic stroke, the last known well was unclear or > 4.5 hours, and for whom a magnetic resonance imaging (MRI) of the brain could be obtained rapidly. Based on the WAKE-UP trial, if the MRI scan of the brain in these patients demonstrated restricted diffusion without fluid attenuated inversion recovery (FLAIR) signal changes (diffusion-weighted [DWI]-FLAIR mismatch sign), this indicated that the stroke had likely occurred recently, and it was safe to administer t-PA. This allowed for administration of t-PA outside the standard treatment window of 4.5 hours from last known well, especially in the cases of patients who awoke with symptoms.

Since safety data are not yet available for the use of tenecteplase in this fashion, the WAKE-UP trial protocol was not used as an inclusion criterion. The informed consent form was modified, and the following scenarios were outlined: (1) If the patient or surrogate is immediately available to consent, paper consent will be documented with the additional note that tenecteplase is being used off-label; and (2) If the patient cannot consent and a surrogate is not immediately available, the medicine will be used emergently as long as the neurology resident and attending physicians agree.15

Risk mitigation was considered carefully. The stroke box described above is stocked and maintained by the pharmacy as we have transitioned to using designated pharmacists for the storage and preparation of tenecteplase. We highly recommend the use of designated pharmacists or emergency department pharmacists in this manner to avoid dosing errors.7,16 Since the current pharmacy-provided tenecteplase bottle contains twice the maximum dose indicated for ischemic stroke, only a 5 mL syringe is included in the stroke box to ensure a maximum dose of 25 mg is drawn up after reconstitution. Dosing card charts were made like existing dosing card charts for t-PA to quickly calculate the 0.25 mg/kg dose. In training, the difference in dosing in ischemic stroke was emphasized. Finally, pharmacy has taken responsibility for dosing the medication during stroke codes.

Any medical personnel at WRNMMC can initiate a stroke code by sending a page to the neurology consult service (Figure).

A neurology resident or staff will then ensure that all the correct next steps are completed to properly triage the patient. This includes a physical examination, vital signs, laboratory workup, and computed tomography (CT)–based imaging. Treatment decision is based on a standard set of criteria. These include imaging findings on noncontrasted head CT and CT angiography head and neck, disabling symptoms, presentation within standard treatment window, and lack of contraindications. Infusion of tenecteplase obviates the need for an IV pump and thus opens an IV site for alternate uses if needed. Removal of the infusion phase eliminates delays in mechanical thrombectomy in cases of LVO. Treatment with mechanical thrombectomy is based on evidence of LVO on CT angiography head and neck on arrival and discussion with the on-call interventionalist.

TRANSITION AND RESULTS

From November 2020 to December 2021, 10 patients have been treated in total at WRNMMC (Table).

One case was treated under the WAKE-UP trial despite protocol and considered to be an outlier. All patients other than the 1 outlier were treated within the standard 4.5-hour window and underwent noncontrast head CT as the initial study. CT angiography head and neck was performed in 7 cases (70%). One case occurred periprocedurally and had a 0 minute time to presentation. One patient strongly believed to be related to ischemic stroke ultimately demonstrated no signal on DWI. Involved vascular territories included the middle cerebral artery (n = 4), pons (n = 2), and multifocal (n = 1). One treated case was determined to be LVO and had mechanical thrombectomy with complete recanalization before intervention. Two of the treated patients were later determined to be stroke mimics. While the number of patients treated thus far is small, these initial results support both the safety and efficacy of tenecteplase use for acute ischemic stroke and indicate a successful transition.

CONCLUSIONS

The available evidence supports the transition from t-PA to tenecteplase for acute ischemic stroke. The successful transition required months of preparation involving multidisciplinary meetings between neurology, nursing, pharmacy, radiology, rapid response teams, critical care, and emergency medicine departments. Safeguards must be implemented to avoid a tenecteplase dosing error that can lead to potentially life-threatening adverse effects. The results at WRNMMC thus far are promising for safety and efficacy. Several process improvements are planned: a hospital-wide overhead page will accompany the direct page to neurology; other team members, including radiology and pharmacy, will be included on the acute stroke alert; and a stroke-specific paging application will be implemented to better track real-time stroke metrics and improve flow. These measures mirror processes that are occurring in institutions that treat acute stroke patients.

References

1. Lees KR, Bluhmki E, von Kummer R, et al. Time to treatment with intravenous alteplase and outcome in stroke: an updated pooled analysis of ECASS, ATLANTIS, NINDS, and EPITHET trials. Lancet. 2010;375(9727):1695-1703. doi:10.1016/S0140-6736(10)60491-6

2. National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. Tissue plasminogen activator for acute ischemic stroke. N Engl J Med. 1995;333(24):1581- 1587. doi:10.1056/NEJM199512143332401

3. Hacke W, Donnan G, Fieschi C, et al. Association of outcome with early stroke treatment: pooled analysis of ATLANTIS, ECASS, and NINDS rt-PA stroke trials. Lancet. 2004;363(9411):768-774. doi:10.1016/S0140-6736(04)15692-4

4. Jauch EC, Saver JL, Adams HP Jr, et al. Guidelines for the early management of patients with acute ischemic stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013;44(3):870-947. doi:10.1161/STR.0b013e318284056a

5. Campbell B, Mitchell P, Churilov L, et al. Tenecteplase versus alteplase before thrombectomy for ischemic stroke. N Engl J Med. 2018;378(17):1573-1582. doi:10.1056/nejmoa1716405

6. Yang P, Zhang Y, Zhang L, et al. Endovascular thrombectomy with or without intravenous alteplase in acute stroke. N Engl J Med. 2020;382(21):1981-1993. doi:10.1056/NEJMoa2001123

7. Menon BK, Buck BH, Singh N, et al. Intravenous tenecteplase compared with alteplase for acute ischaemic stroke in Canada (AcT): a pragmatic, multicentre, open-label, registry-linked, randomised, controlled, noninferiority trial. Lancet. 2022;400(10347):161-169. doi:10.1016/S0140-6736(22)01054-6

8. Campbell BCV, Mitchell PJ, Churilov L, et al. Effect of intravenous tenecteplase dose on cerebral reperfusion before thrombectomy in patients with large vessel occlusion ischemic stroke: the EXTEND-IA TNK part 2 randomized clinical trial. JAMA. 2020;323(13):1257- 1265. doi:10.1001/jama.2020.1511

9. Warach SJ, Dula AN, Milling TJ Jr. Tenecteplase thrombolysis for acute ischemic stroke. Stroke. 2020;51(11):3440- 3451. doi:10.1161/STROKEAHA.120.029749

10. Huang X, Moreton FC, Kalladka D, et al. Coagulation and fibrinolytic activity of tenecteplase and alteplase in acute ischemic stroke. Stroke. 2015;46(12):3543-3546. doi:10.1161/STROKEAHA.115.011290

11. Burgos AM, Saver JL. Evidence that tenecteplase is noninferior to alteplase for acute ischemic stroke: meta-analysis of 5 randomized trials. Stroke. 2019;50(8):2156-2162. doi:10.1161/STROKEAHA.119.025080

12. Potla N, Ganti L. Tenecteplase vs. alteplase for acute ischemic stroke: a systematic review. Int J Emerg Med. 2022;15(1). doi:10.1186/s12245-021-00399-w

13. Warach SJ, Winegar A, Ottenbacher A, Miller C, Gibson D. Abstract WMP52: reduced hospital costs for ischemic stroke treated with tenecteplase. Stroke. 2022;53(suppl 1):AWMP52. doi:10.1161/str.53.suppl_1.WMP52

14. Powers WJ, Rabinstein AA, Ackerson T, et al. Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2019;50(12):e344-e418. doi:10.1161/str.0000000000000211

15. Faris H, Dewar B, Dowlatshahi D, et al. Ethical justification for deferral of consent in the AcT trial for acute ischemic stroke. Stroke. 2022;53(7):2420-2423. doi:10.1161/strokeaha.122.038760

16. Kvistad CE, Næss H, Helleberg BH, et al. Tenecteplase versus alteplase for the management of acute ischaemic stroke in Norway (NOR-TEST 2, part A): a phase 3, randomised, open-label, blinded endpoint, non-inferiority trial. Lancet Neurol. 2022;21(6):511-519. doi:10.1016/S1474-4422(22)00124-7

References

1. Lees KR, Bluhmki E, von Kummer R, et al. Time to treatment with intravenous alteplase and outcome in stroke: an updated pooled analysis of ECASS, ATLANTIS, NINDS, and EPITHET trials. Lancet. 2010;375(9727):1695-1703. doi:10.1016/S0140-6736(10)60491-6

2. National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. Tissue plasminogen activator for acute ischemic stroke. N Engl J Med. 1995;333(24):1581- 1587. doi:10.1056/NEJM199512143332401

3. Hacke W, Donnan G, Fieschi C, et al. Association of outcome with early stroke treatment: pooled analysis of ATLANTIS, ECASS, and NINDS rt-PA stroke trials. Lancet. 2004;363(9411):768-774. doi:10.1016/S0140-6736(04)15692-4

4. Jauch EC, Saver JL, Adams HP Jr, et al. Guidelines for the early management of patients with acute ischemic stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013;44(3):870-947. doi:10.1161/STR.0b013e318284056a

5. Campbell B, Mitchell P, Churilov L, et al. Tenecteplase versus alteplase before thrombectomy for ischemic stroke. N Engl J Med. 2018;378(17):1573-1582. doi:10.1056/nejmoa1716405

6. Yang P, Zhang Y, Zhang L, et al. Endovascular thrombectomy with or without intravenous alteplase in acute stroke. N Engl J Med. 2020;382(21):1981-1993. doi:10.1056/NEJMoa2001123

7. Menon BK, Buck BH, Singh N, et al. Intravenous tenecteplase compared with alteplase for acute ischaemic stroke in Canada (AcT): a pragmatic, multicentre, open-label, registry-linked, randomised, controlled, noninferiority trial. Lancet. 2022;400(10347):161-169. doi:10.1016/S0140-6736(22)01054-6

8. Campbell BCV, Mitchell PJ, Churilov L, et al. Effect of intravenous tenecteplase dose on cerebral reperfusion before thrombectomy in patients with large vessel occlusion ischemic stroke: the EXTEND-IA TNK part 2 randomized clinical trial. JAMA. 2020;323(13):1257- 1265. doi:10.1001/jama.2020.1511

9. Warach SJ, Dula AN, Milling TJ Jr. Tenecteplase thrombolysis for acute ischemic stroke. Stroke. 2020;51(11):3440- 3451. doi:10.1161/STROKEAHA.120.029749

10. Huang X, Moreton FC, Kalladka D, et al. Coagulation and fibrinolytic activity of tenecteplase and alteplase in acute ischemic stroke. Stroke. 2015;46(12):3543-3546. doi:10.1161/STROKEAHA.115.011290

11. Burgos AM, Saver JL. Evidence that tenecteplase is noninferior to alteplase for acute ischemic stroke: meta-analysis of 5 randomized trials. Stroke. 2019;50(8):2156-2162. doi:10.1161/STROKEAHA.119.025080

12. Potla N, Ganti L. Tenecteplase vs. alteplase for acute ischemic stroke: a systematic review. Int J Emerg Med. 2022;15(1). doi:10.1186/s12245-021-00399-w

13. Warach SJ, Winegar A, Ottenbacher A, Miller C, Gibson D. Abstract WMP52: reduced hospital costs for ischemic stroke treated with tenecteplase. Stroke. 2022;53(suppl 1):AWMP52. doi:10.1161/str.53.suppl_1.WMP52

14. Powers WJ, Rabinstein AA, Ackerson T, et al. Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2019;50(12):e344-e418. doi:10.1161/str.0000000000000211

15. Faris H, Dewar B, Dowlatshahi D, et al. Ethical justification for deferral of consent in the AcT trial for acute ischemic stroke. Stroke. 2022;53(7):2420-2423. doi:10.1161/strokeaha.122.038760

16. Kvistad CE, Næss H, Helleberg BH, et al. Tenecteplase versus alteplase for the management of acute ischaemic stroke in Norway (NOR-TEST 2, part A): a phase 3, randomised, open-label, blinded endpoint, non-inferiority trial. Lancet Neurol. 2022;21(6):511-519. doi:10.1016/S1474-4422(22)00124-7

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A Transdisciplinary Program for Care of Veterans With Neurocognitive Disorders

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Dementia is a devastating condition resulting in major functional, emotional, and financial impact on patients, their caregivers, and families. Approximately 6.5 million Americans are living with Alzheimer disease (AD), the most common of many causes of dementia.1 The prevalence of AD could increase to 12.7 million Americans by 2050 as the population ages.1 Studies suggest that dementia, also known as major neurocognitive disorder, is common and underdiagnosed among US veterans, a population with a mean age of 65 years.2 During cognitive screening, memory impairment is present in approximately 20% of veterans aged ≥ 75 years who have not been diagnosed with a neurocognitive disorder.3 In addition, veterans might be particularly vulnerable to dementia at an earlier age than the general population because of vascular risk factors and traumatic brain injuries.4 These concerns highlight the need for effective dementia care programs at US Department of Veterans Affairs (VA) facilities.

The US health care system often does not adequately address the needs of patients with dementia and their caregivers.5 Dementia care requires specialized medical care among collaborating professionals and caregiver and psychosocial interventions and services. However, the US health care system is fragmented with different clinicians and services siloed into separate practices and most dementia care occurring in primary care settings.6 Primary care professionals (PCPs) often are uncomfortable diagnosing and managing dementia because of time constraints, lack of expertise and training, and inability to deal with the range of care needs.7 PCPs do not identify approximately 42% of their patients with dementia and, when recognized, do not adhere to dementia care guidelines and address caregiver needs.8-10 Research indicates that caregiver support improves dementia care by teaching behavioral management skills and caregiver coping strategies, allowing patients to stay at home and delay institutionalization.6,11,12 Clinicians underuse available resources and do not incorporate them in their patient care.10 These community services benefit patients and caregivers and significantly improve the overall quality of care.6

Memory clinics have emerged to address these deficiencies when managing dementia.13 The most effective memory clinics maximize the use of specialists with different expertise in dementia care, particularly integrated programs where disciplines function together rather than independently.1,5,14 Systematic reviews and meta-analyses have documented the effectiveness of collaborative care management programs.11,12,15 Integration of dementia care management is associated with earlier diagnosis and interventions, decreased functional and cognitive symptom severity, decreased or delayed institutionalization, improved quality of life for patients and caregivers, enhanced overall quality of care and cost-effectiveness, and better integration of community services.11,12,14-19 In these programs, designating a dementia care manager (DCM) as the patient’s advocate facilitates the integrated structure, increases the quality of care, helps caregivers, facilitates adherence to dementia practice guidelines, and prevents behavioral and psychological symptoms of dementia (BPSD).1,6,11,12,20,21

The best interprofessional model for dementia care might be the transdisciplinary model that includes a DCM. To meet the specific demands of dementia care, there must be a high level of interprofessional collaboration rather than multiple health care professionals (HCPs) delivering care in isolation—an approach that is time consuming and often difficult to implement.22 Whereas multidisciplinary care refers to delivery of parallel services and interdisciplinary care implies a joint formulation, transdisciplinary care aims to maximize integration of HCPs and their specific expertise and contributions through interactions and discussions that deliver focused input to the lead physician. The transdisciplinary model addresses needs that often are missed and can minimize disparities in the quality of dementia care.23 A DCM is an integral part of our program, facilitating understanding and implementation of the final care plan and providing long-term follow-up and care. We outline a conference-centered transdisciplinary dementia care model with a social worker as DCM (SW-DCM) at our VA medical center.

Program Description

In 2020, the VA Greater Los Angeles Healthcare System (VAGLAHS) in California established a multispecialty clinic dedicated to evaluation and treatment of veterans with memory and neurocognitive disorders and to provide support for their caregivers and families. With the agreement of leadership in mental health, neurology, and geriatrics services on the importance of collaboration for dementia care, the psychiatry and neurology services created a joint Memory and Neurobehavior Clinic, which completed its first 2 years of operation as a full-day program. In recent months, the clinic has scheduled 24 veterans per day, approximately 50% new evaluations and 50% follow-up patients, with wait times of < 2 months. There is a mean of 12 intake or lead physicians who could attend sessions in the morning, afternoon, or both. The general clinic flow consists of a 2-hour intake evaluation of new referrals by the lead physician followed by a clinic conference with transdisciplinary discussion. The DCM then follows up with the veteran/caregiver presenting a final care plan individualized to the veterans, caregivers, and families.

The Memory and Neurobehavior team includes behavioral neurologists, geriatric psychiatrists, neuropsychologists, geriatric fellows, advanced clinical nurses, and social workers who function as the DCM (Table 1).

In addition, regular meetings of the VAGLAHS dementia committee allow involvement with other professionals (physical, occupational, and speech therapists, an audiologist, an optometrist, and a dietitian) who routinely consult with veterans in the clinic. The Memory and Neurobehavior Clinic also includes trainees from different disciplines, fulfilling the VA’s role in educating future clinicians in managing neurocognitive disorders. These trainees are residents in neurology and psychiatry; fellows in behavioral neurology, geriatric psychiatry, and geriatric medicine; neuropsychology interns; medical students; and nurse practitioner students.

 

 

Procedures

Before the office visit, the coordinating geriatric psychiatrist triages veterans to neurology, psychiatry, or geriatric physicians based on the clinical presentation, history of neurologic signs or symptoms, BPSD or psychiatric history, functional decline, or comorbid medical illnesses. Although veterans often have overlapping concerns, the triage process aims to coordinate the intake evaluations with the most indicated and available specialist with the intention to notify the other specialists during the transdisciplinary conference.

Referrals to the program occur from many sources, notably from primary care (70.8%), mental health (16.7%), and specialty clinics (12.5%). The clinic also receives referrals from the affiliated Veterans Cognitive Assessment and Management Program, which provides dementia evaluation and support via telehealth screening. This VAGLAHS program services a diverse population of veterans: 87% male; 43% aged > 65 years (75% in our clinic); 51% non-Hispanic White; 19% non-Hispanic African American; 16% Hispanic; 4% Asian; and 1% Native American. This population receives care at regional VA medical centers and community-based outpatient clinics over a wide geographic service area.

The initial standardized assessments by intake or lead physicians includes mental status screening with the Montreal Cognitive Assessment (with certified clinicians), the Neurobehavioral Status Examination for a more detailed assessment of cognitive domains, the Columbia-Suicide Severity Rating Scale, the Patient Health Questionnaire for depression screening, and assessment for impairments in instrumental or basic activities of daily living. This initial evaluation aims to apply clinical guidelines and diagnostic criteria for the differential diagnosis of neurocognitive disorders, determine eligibility for cognitive-enhancing medications and techniques, assess for BPSD and the need for nonpharmacologic or pharmacologic interventions, determine functional status, and evaluate the need for supervision, safety concerns, and evidence of neglect or abuse.

As part of its mission, the clinic is charged with implementing the VA Dementia System of Care (DSOC). The stated goals of the DSOC are to provide individualized person-centered dementia care to help veterans experiencing dementia and their caregivers maintain a positive and optimal quality of life and create an environment where VA medical center staff understand the health care needs of veterans with dementia and their caregivers’ role. As part of this initiative, the clinic includes (1) coordination of care through a SW-DCM; (2)

an education plan disseminating information on early signs of dementia to medical center clinicians; (3) evaluation of veterans and caregivers for VA benefits and care services (Table 2); and (4) collaboration with dementia committees at our VA, Veterans Integrated Service Network, and national levels.

 

 

Transdisciplinary Conference

Clinic conferences are held after the veterans are seen. Staff gather to discuss the patient and review management. All team members are present, as well as the head of the clinical clerical staff who can facilitate appointments, make lobby and wait times more bearable for our patients and caregivers, and help manage emergencies. Although this is an in-person conference, the COVID-19 pandemic has allowed us to include staff who screen at remote sites via videoconferencing, similar to other VA programs.24 The Memory and Neurobehavior Clinic has two ≤ 90-minute conferences daily. The lead physicians and their senior attendings present the new intake evaluations (4-6 at each conference session) with a preliminary formulation and questions for discussion. The moderator solicits contributions from the different disciplines, going from one to the next and recording their responses for each veteran. Further specialists are available for consultation through the conference mechanism if necessary. The final assessment is reviewed, a diagnosis is established, and a tailored, individualized care plan for adjusting or optimizing the veteran’s care is presented to the lead physician who makes the final determination. At the close of the conference, the team’s discussion is recorded along with the lead physician’s original detailed intake evaluation. Currently, the records go into the Computerized Patient Record System, but we are making plans to transition to Cerner as it is implemented.

During the discussion, team members review several areas of consideration. If there is neuroimaging, neurologists review the images projected on a large computer screen. Team members also will assess for the need to obtain biomarker studies, such as blood, cerebrospinal fluid, or positron emission tomography. Psychiatrists could review management of BPSD and use of psychotropic agents, and neuropsychologists might consider the need for more precise cognitive testing and whether a capacity assessment is indicated. Social work might bring up the need for a durable power of attorney as well as applicable caregiver and community resources. Geriatric medicine and nursing could provide input into medical management and care and the ability of veterans and caregivers to follow the prescribed regimen. Further areas of discussion include driving safety and restrictions on driving (as required in California) and the presence of guns in the home. Finally, brief education is provided in short 10-to-15-minute lectures covering pertinent topics so staff remain up-to-date in this changing field.

Postconference Continuity

After the conference, the SW-DCM continues to provide support throughout the disease course, helping veterans and their caregivers understand and follow through on the team’s recommendations. The SW-DCM, who is experienced and trained in case management, forms an ongoing relationship with the veterans and their caregivers and remains an advocate for their care. The SW-DCM communicates the final plan by phone and, when necessary, requests the lead physician to call to clarify any poorly understood or technical aspects of the care plan. About 50% of our veterans—primarily those who do not have a neurocognitive disorder or have mild cognitive impairment—return to their PCPs with our care plan consultation; about 25% are already enrolled in geriatric and other programs with long-term follow-up. The assigned SW-DCM follows up with the remaining veterans and caregivers regularly by phone, facilitates communication with other team members, and endeavors to assure postvisit continuity of care and support during advancing stages of the disease. In addition, the SW-DCM can provide supportive counseling and psychotherapy for stressed caregivers, refer to support groups and cognitive rehabilitation programs, and help develop long-term goals and consideration for supervised living environments. The nurse specialist participates with follow-up calls regarding medications and scheduled tests and appointments, clearing up confusion about instructions, avoiding medication errors, and providing education in dementia care. Both social worker and nurse are present throughout the week, reachable by phone, and, in turn, able to contact the clinic physicians for veterans’ needs.

Discussion

Because of the heterogenous medical and psychosocial needs of veterans with dementia and their caregivers, a transdisciplinary team with a dedicated DCM might offer the most effective and efficient model for dementia care. We present a transdisciplinary program that incorporates dementia specialists in a single evaluation by maximizing their time through a conference-centered program. Our program involves neurologists, psychiatrists, geriatricians, psychologists, nurses, and social workers collaborating and communicating to enact effective dementia care. It further meets the goals of the VA-DSOC in implementing individualized patient and caregiver care.

This transdisciplinary model addresses a number of issues, starting with the differential diagnosis of underlying neurologic conditions. Within the transdisciplinary team, the neurologist can provide specific insights into any neurologic findings and illnesses, such as Alzheimer disease and other neurodegenerative dementias, vascular dementia syndromes, normal pressure hydrocephalus, Creutzfeldt-Jakob disease, neurosyphilis, and others. Most veterans with dementia experience BPSD at some point during of their illness. The psychiatrists on the transdisciplinary team can maximize management of BPSD with nonpharmacologic interventions and the fewest and least aversive psychoactive medications. Our program also addresses the need for more precise cognitive evaluation. Neuropsychologists are present and available for administrating neuropsychologic tests and interpreting cognitive performance and any earlier neuropsychologic testing. This model also cares for the caregivers and assesses their needs. The social worker—as well as other members of the team—can provide caregivers with strategies for coping with disruptive and other behaviors related to dementia, counsel them on how to manage the veteran’s functional decline, and aid in establishing a safe living space. Because the social worker serves as a DCM, these coping and adjustment questions occupy significant clinical attention between appointments. This transdisciplinary model places the patient’s illness in the context of their functional status, diagnoses, and medications. The team geriatrician and the nurse specialist are indispensable resources. The clinic conference provides a teaching venue for staff and trainees and a mechanism to discuss new developments in dementia care, such as the increasing need to assess individuals with mild cognitive impairment.25 This model depends on the DCM’s invaluable role in ensuring implementation of the dementia care plan and continuity of care.

Conclusions

We describe effective dementia care with a transdisciplinary team in a conference setting and with the participation of a dedicated DCM.5 To date, this program appears to be an efficient, sustainable application of the limited resources allocated to dementia care. Nevertheless, we are collecting data to compare with performance measures, track use, and assess the programs effects on continuity of care. We look forward to presenting metrics from our program that show improvement in the health care for veterans experiencing a devastating and increasingly common disorder.

References

1. 2022 Alzheimer’s disease facts and figures. Alzheimers Dement. 2022;18(4):700-789. doi:10.1002/alz.12638

2. National Center for Veterans Analysis and Statistics. Profile of veterans: 2016. Accessed October 12, 2022. https://www.va.gov/vetdata/docs/SpecialReports/Profile_of_Veterans_2016.pdf

3. Chodosh J, Sultzer DL, Lee ML, et al. Memory impairment among primary care veterans. Aging Ment Health. 2007;11(4):444-450. doi:10.1080/13607860601086272

4. Kennedy E, Panahi S, Stewart IJ, et al. Traumatic brain injury and early onset dementia in post 9-11 veterans. Brain Inj. 2022;36(5):620-627. doi:10.1080/02699052.2022.20338465. Heintz H, Monette P, Epstein-Lubow G, Smith L, Rowlett S, Forester BP. Emerging collaborative care models for dementia care in the primary care setting: a narrative review. Am J Geriatr Psychiatry. 2020;28(3):320-330. doi:10.1016/j.jagp.2019.07.015

6. Reuben DB, Evertson LC, Wenger NS, et al. The University of California at Los Angeles Alzheimer’s and Dementia Care program for comprehensive, coordinated, patient-centered care: preliminary data. J Am Geriatr Soc. 2013;61(12):2214-2218. doi:10.1111/jgs.12562

7. Apesoa-Varano EC, Barker JC, Hinton L. Curing and caring: the work of primary care physicians with dementia patients. Qual Health Res. 2011;21(11):1469-1483. doi:10.1177/1049732311412788

8. Creavin ST, Noel-Storr AH, Langdon RJ, et al. Clinical judgement by primary care physicians for the diagnosis of all-cause dementia or cognitive impairment in symptomatic people. Cochrane Database Syst Rev. 2022;6:CD012558. doi:10.1002/14651858.CD012558.pub2

9. Sivananthan SN, Puyat JH, McGrail KM. Variations in self-reported practice of physicians providing clinical care to individuals with dementia: a systematic review. J Am Geriatr Soc. 2013;61(8):1277-1285. doi:10.1111/jgs.12368

10. Rosen CS, Chow HC, Greenbaum MA, et al. How well are clinicians following dementia practice guidelines? Alzheimer Dis Assoc Disord. 2002;16(1):15-23. doi:10.1097/00002093-200201000-00003

11. Reilly S, Miranda-Castillo C, Malouf R, et al. Case management approaches to home support for people with dementia. Cochrane Database Syst Rev. 2015;1:CD008345. doi:10.1002/14651858.CD008345.pub2

12. Tam-Tham H, Cepoiu-Martin M, Ronksley PE, Maxwell CJ, Hemmelgarn BR. Dementia case management and risk of long-term care placement: a systematic review and meta-analysis. Int J Geriatr Psychiatry. 2013;28(9):889-902. doi:10.1002/gps.3906

13. Jolley D, Benbow SM, Grizzell M. Memory clinics. Postgrad Med J. 2006;82(965):199-206. doi:10.1136/pgmj.2005.040592

14. Muhlichen F, Michalowsky B, Radke A, et al. Tasks and activities of an effective collaborative dementia care management program in German primary care. J Alzheimers Dis. 2022;87(4):1615-1625. doi:10.3233/JAD-215656

15. Somme D, Trouve H, Drame M, Gagnon D, Couturier Y, Saint-Jean O. Analysis of case management programs for patients with dementia: a systematic review. Alzheimers Dement. 2012;8(5):426-436. doi:10.1016/j.jalz.2011.06.004

16. Ramakers IH, Verhey FR. Development of memory clinics in the Netherlands: 1998 to 2009. Aging Ment Health. 2011;15(1):34-39. doi:10.1080/13607863.2010.519321

17. LaMantia MA, Alder CA, Callahan CM, et al. The aging brain care medical home: preliminary data. J Am Geriatr Soc. 2015;63(6):1209-1213. doi:10.1111/jgs.13447

18. Rubinsztein JS, van Rensburg MJ, Al-Salihy Z, et al. A memory clinic v. traditional community mental health team service: comparison of costs and quality. BJPsych Bull. 2015;39(1):6-11. doi:10.1192/pb.bp.113.044263

19. Lee L, Hillier LM, Harvey D. Integrating community services into primary care: improving the quality of dementia care. Neurodegener Dis Manag. 2014;4(1):11-21. doi:10.2217/nmt.13.72

20. Bass DM, Judge KS, Snow AL, et al. Caregiver outcomes of partners in dementia care: effect of a care coordination program for veterans with dementia and their family members and friends. J Am Geriatr Soc. 2013;61(8):1377-1386. doi:10.1111/jgs.12362

21. Callahan CM, Boustani MA, Unverzagt FW, et al. Effectiveness of collaborative care for older adults with Alzheimer disease in primary care: a randomized controlled trial. JAMA. 2006;295(18):2148-2157. doi:10.1001/jama.295.18.2148

22. Leggett A, Connell C, Dubin L, et al. Dementia care across a tertiary care health system: what exists now and what needs to change. J Am Med Dir Assoc. 2019;20(10):1307-12 e1. doi:10.1016/j.jamda.2019.04.006

23. Brown AF, Vassar SD, Connor KI, Vickrey BG. Collaborative care management reduces disparities in dementia care quality for caregivers with less education. J Am Geriatr Soc. 2013;61(2):243-251. doi:10.1111/jgs.12079

24. Powers BB, Homer MC, Morone N, Edmonds N, Rossi MI. Creation of an interprofessional teledementia clinic for rural veterans: preliminary data. J Am Geriatr Soc. 2017;65(5):1092-1099. doi:10.1111/jgs.14839

25. Galvin JE, Aisen P, Langbaum JB, et al. Early stages of Alzheimer’s Disease: evolving the care team for optimal patient management. Front Neurol. 2020;11:592302. doi:10.3389/fneur.2020.592302

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Mario F. Mendez, MD, PhDa,b; Rebecca A. Melrose, PhDa,b; Denise G. Feil, MDa,b; Kelsey A. Holiday, PhDa,b; Marianne Hunt, LCSWa; Ali Najafian Jazi, MDa; Sukh L. Lamba, RN-BCa; Michael E. Mahler, MDa,b; Daniel E. Okobi, MD, PhDa,b; Hans F. Von Walter, MDa,b
Correspondence:
Mario Mendez ([email protected])

aVeterans Affairs Greater Los Angeles, California
bUniversity of California, Los Angeles

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Ethics

This program description is not classified as research, and thus did not require institutional review board approval.

 

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Mario F. Mendez, MD, PhDa,b; Rebecca A. Melrose, PhDa,b; Denise G. Feil, MDa,b; Kelsey A. Holiday, PhDa,b; Marianne Hunt, LCSWa; Ali Najafian Jazi, MDa; Sukh L. Lamba, RN-BCa; Michael E. Mahler, MDa,b; Daniel E. Okobi, MD, PhDa,b; Hans F. Von Walter, MDa,b
Correspondence:
Mario Mendez ([email protected])

aVeterans Affairs Greater Los Angeles, California
bUniversity of California, Los Angeles

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Ethics

This program description is not classified as research, and thus did not require institutional review board approval.

 

Author and Disclosure Information

Mario F. Mendez, MD, PhDa,b; Rebecca A. Melrose, PhDa,b; Denise G. Feil, MDa,b; Kelsey A. Holiday, PhDa,b; Marianne Hunt, LCSWa; Ali Najafian Jazi, MDa; Sukh L. Lamba, RN-BCa; Michael E. Mahler, MDa,b; Daniel E. Okobi, MD, PhDa,b; Hans F. Von Walter, MDa,b
Correspondence:
Mario Mendez ([email protected])

aVeterans Affairs Greater Los Angeles, California
bUniversity of California, Los Angeles

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Ethics

This program description is not classified as research, and thus did not require institutional review board approval.

 

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Related Articles

Dementia is a devastating condition resulting in major functional, emotional, and financial impact on patients, their caregivers, and families. Approximately 6.5 million Americans are living with Alzheimer disease (AD), the most common of many causes of dementia.1 The prevalence of AD could increase to 12.7 million Americans by 2050 as the population ages.1 Studies suggest that dementia, also known as major neurocognitive disorder, is common and underdiagnosed among US veterans, a population with a mean age of 65 years.2 During cognitive screening, memory impairment is present in approximately 20% of veterans aged ≥ 75 years who have not been diagnosed with a neurocognitive disorder.3 In addition, veterans might be particularly vulnerable to dementia at an earlier age than the general population because of vascular risk factors and traumatic brain injuries.4 These concerns highlight the need for effective dementia care programs at US Department of Veterans Affairs (VA) facilities.

The US health care system often does not adequately address the needs of patients with dementia and their caregivers.5 Dementia care requires specialized medical care among collaborating professionals and caregiver and psychosocial interventions and services. However, the US health care system is fragmented with different clinicians and services siloed into separate practices and most dementia care occurring in primary care settings.6 Primary care professionals (PCPs) often are uncomfortable diagnosing and managing dementia because of time constraints, lack of expertise and training, and inability to deal with the range of care needs.7 PCPs do not identify approximately 42% of their patients with dementia and, when recognized, do not adhere to dementia care guidelines and address caregiver needs.8-10 Research indicates that caregiver support improves dementia care by teaching behavioral management skills and caregiver coping strategies, allowing patients to stay at home and delay institutionalization.6,11,12 Clinicians underuse available resources and do not incorporate them in their patient care.10 These community services benefit patients and caregivers and significantly improve the overall quality of care.6

Memory clinics have emerged to address these deficiencies when managing dementia.13 The most effective memory clinics maximize the use of specialists with different expertise in dementia care, particularly integrated programs where disciplines function together rather than independently.1,5,14 Systematic reviews and meta-analyses have documented the effectiveness of collaborative care management programs.11,12,15 Integration of dementia care management is associated with earlier diagnosis and interventions, decreased functional and cognitive symptom severity, decreased or delayed institutionalization, improved quality of life for patients and caregivers, enhanced overall quality of care and cost-effectiveness, and better integration of community services.11,12,14-19 In these programs, designating a dementia care manager (DCM) as the patient’s advocate facilitates the integrated structure, increases the quality of care, helps caregivers, facilitates adherence to dementia practice guidelines, and prevents behavioral and psychological symptoms of dementia (BPSD).1,6,11,12,20,21

The best interprofessional model for dementia care might be the transdisciplinary model that includes a DCM. To meet the specific demands of dementia care, there must be a high level of interprofessional collaboration rather than multiple health care professionals (HCPs) delivering care in isolation—an approach that is time consuming and often difficult to implement.22 Whereas multidisciplinary care refers to delivery of parallel services and interdisciplinary care implies a joint formulation, transdisciplinary care aims to maximize integration of HCPs and their specific expertise and contributions through interactions and discussions that deliver focused input to the lead physician. The transdisciplinary model addresses needs that often are missed and can minimize disparities in the quality of dementia care.23 A DCM is an integral part of our program, facilitating understanding and implementation of the final care plan and providing long-term follow-up and care. We outline a conference-centered transdisciplinary dementia care model with a social worker as DCM (SW-DCM) at our VA medical center.

Program Description

In 2020, the VA Greater Los Angeles Healthcare System (VAGLAHS) in California established a multispecialty clinic dedicated to evaluation and treatment of veterans with memory and neurocognitive disorders and to provide support for their caregivers and families. With the agreement of leadership in mental health, neurology, and geriatrics services on the importance of collaboration for dementia care, the psychiatry and neurology services created a joint Memory and Neurobehavior Clinic, which completed its first 2 years of operation as a full-day program. In recent months, the clinic has scheduled 24 veterans per day, approximately 50% new evaluations and 50% follow-up patients, with wait times of < 2 months. There is a mean of 12 intake or lead physicians who could attend sessions in the morning, afternoon, or both. The general clinic flow consists of a 2-hour intake evaluation of new referrals by the lead physician followed by a clinic conference with transdisciplinary discussion. The DCM then follows up with the veteran/caregiver presenting a final care plan individualized to the veterans, caregivers, and families.

The Memory and Neurobehavior team includes behavioral neurologists, geriatric psychiatrists, neuropsychologists, geriatric fellows, advanced clinical nurses, and social workers who function as the DCM (Table 1).

In addition, regular meetings of the VAGLAHS dementia committee allow involvement with other professionals (physical, occupational, and speech therapists, an audiologist, an optometrist, and a dietitian) who routinely consult with veterans in the clinic. The Memory and Neurobehavior Clinic also includes trainees from different disciplines, fulfilling the VA’s role in educating future clinicians in managing neurocognitive disorders. These trainees are residents in neurology and psychiatry; fellows in behavioral neurology, geriatric psychiatry, and geriatric medicine; neuropsychology interns; medical students; and nurse practitioner students.

 

 

Procedures

Before the office visit, the coordinating geriatric psychiatrist triages veterans to neurology, psychiatry, or geriatric physicians based on the clinical presentation, history of neurologic signs or symptoms, BPSD or psychiatric history, functional decline, or comorbid medical illnesses. Although veterans often have overlapping concerns, the triage process aims to coordinate the intake evaluations with the most indicated and available specialist with the intention to notify the other specialists during the transdisciplinary conference.

Referrals to the program occur from many sources, notably from primary care (70.8%), mental health (16.7%), and specialty clinics (12.5%). The clinic also receives referrals from the affiliated Veterans Cognitive Assessment and Management Program, which provides dementia evaluation and support via telehealth screening. This VAGLAHS program services a diverse population of veterans: 87% male; 43% aged > 65 years (75% in our clinic); 51% non-Hispanic White; 19% non-Hispanic African American; 16% Hispanic; 4% Asian; and 1% Native American. This population receives care at regional VA medical centers and community-based outpatient clinics over a wide geographic service area.

The initial standardized assessments by intake or lead physicians includes mental status screening with the Montreal Cognitive Assessment (with certified clinicians), the Neurobehavioral Status Examination for a more detailed assessment of cognitive domains, the Columbia-Suicide Severity Rating Scale, the Patient Health Questionnaire for depression screening, and assessment for impairments in instrumental or basic activities of daily living. This initial evaluation aims to apply clinical guidelines and diagnostic criteria for the differential diagnosis of neurocognitive disorders, determine eligibility for cognitive-enhancing medications and techniques, assess for BPSD and the need for nonpharmacologic or pharmacologic interventions, determine functional status, and evaluate the need for supervision, safety concerns, and evidence of neglect or abuse.

As part of its mission, the clinic is charged with implementing the VA Dementia System of Care (DSOC). The stated goals of the DSOC are to provide individualized person-centered dementia care to help veterans experiencing dementia and their caregivers maintain a positive and optimal quality of life and create an environment where VA medical center staff understand the health care needs of veterans with dementia and their caregivers’ role. As part of this initiative, the clinic includes (1) coordination of care through a SW-DCM; (2)

an education plan disseminating information on early signs of dementia to medical center clinicians; (3) evaluation of veterans and caregivers for VA benefits and care services (Table 2); and (4) collaboration with dementia committees at our VA, Veterans Integrated Service Network, and national levels.

 

 

Transdisciplinary Conference

Clinic conferences are held after the veterans are seen. Staff gather to discuss the patient and review management. All team members are present, as well as the head of the clinical clerical staff who can facilitate appointments, make lobby and wait times more bearable for our patients and caregivers, and help manage emergencies. Although this is an in-person conference, the COVID-19 pandemic has allowed us to include staff who screen at remote sites via videoconferencing, similar to other VA programs.24 The Memory and Neurobehavior Clinic has two ≤ 90-minute conferences daily. The lead physicians and their senior attendings present the new intake evaluations (4-6 at each conference session) with a preliminary formulation and questions for discussion. The moderator solicits contributions from the different disciplines, going from one to the next and recording their responses for each veteran. Further specialists are available for consultation through the conference mechanism if necessary. The final assessment is reviewed, a diagnosis is established, and a tailored, individualized care plan for adjusting or optimizing the veteran’s care is presented to the lead physician who makes the final determination. At the close of the conference, the team’s discussion is recorded along with the lead physician’s original detailed intake evaluation. Currently, the records go into the Computerized Patient Record System, but we are making plans to transition to Cerner as it is implemented.

During the discussion, team members review several areas of consideration. If there is neuroimaging, neurologists review the images projected on a large computer screen. Team members also will assess for the need to obtain biomarker studies, such as blood, cerebrospinal fluid, or positron emission tomography. Psychiatrists could review management of BPSD and use of psychotropic agents, and neuropsychologists might consider the need for more precise cognitive testing and whether a capacity assessment is indicated. Social work might bring up the need for a durable power of attorney as well as applicable caregiver and community resources. Geriatric medicine and nursing could provide input into medical management and care and the ability of veterans and caregivers to follow the prescribed regimen. Further areas of discussion include driving safety and restrictions on driving (as required in California) and the presence of guns in the home. Finally, brief education is provided in short 10-to-15-minute lectures covering pertinent topics so staff remain up-to-date in this changing field.

Postconference Continuity

After the conference, the SW-DCM continues to provide support throughout the disease course, helping veterans and their caregivers understand and follow through on the team’s recommendations. The SW-DCM, who is experienced and trained in case management, forms an ongoing relationship with the veterans and their caregivers and remains an advocate for their care. The SW-DCM communicates the final plan by phone and, when necessary, requests the lead physician to call to clarify any poorly understood or technical aspects of the care plan. About 50% of our veterans—primarily those who do not have a neurocognitive disorder or have mild cognitive impairment—return to their PCPs with our care plan consultation; about 25% are already enrolled in geriatric and other programs with long-term follow-up. The assigned SW-DCM follows up with the remaining veterans and caregivers regularly by phone, facilitates communication with other team members, and endeavors to assure postvisit continuity of care and support during advancing stages of the disease. In addition, the SW-DCM can provide supportive counseling and psychotherapy for stressed caregivers, refer to support groups and cognitive rehabilitation programs, and help develop long-term goals and consideration for supervised living environments. The nurse specialist participates with follow-up calls regarding medications and scheduled tests and appointments, clearing up confusion about instructions, avoiding medication errors, and providing education in dementia care. Both social worker and nurse are present throughout the week, reachable by phone, and, in turn, able to contact the clinic physicians for veterans’ needs.

Discussion

Because of the heterogenous medical and psychosocial needs of veterans with dementia and their caregivers, a transdisciplinary team with a dedicated DCM might offer the most effective and efficient model for dementia care. We present a transdisciplinary program that incorporates dementia specialists in a single evaluation by maximizing their time through a conference-centered program. Our program involves neurologists, psychiatrists, geriatricians, psychologists, nurses, and social workers collaborating and communicating to enact effective dementia care. It further meets the goals of the VA-DSOC in implementing individualized patient and caregiver care.

This transdisciplinary model addresses a number of issues, starting with the differential diagnosis of underlying neurologic conditions. Within the transdisciplinary team, the neurologist can provide specific insights into any neurologic findings and illnesses, such as Alzheimer disease and other neurodegenerative dementias, vascular dementia syndromes, normal pressure hydrocephalus, Creutzfeldt-Jakob disease, neurosyphilis, and others. Most veterans with dementia experience BPSD at some point during of their illness. The psychiatrists on the transdisciplinary team can maximize management of BPSD with nonpharmacologic interventions and the fewest and least aversive psychoactive medications. Our program also addresses the need for more precise cognitive evaluation. Neuropsychologists are present and available for administrating neuropsychologic tests and interpreting cognitive performance and any earlier neuropsychologic testing. This model also cares for the caregivers and assesses their needs. The social worker—as well as other members of the team—can provide caregivers with strategies for coping with disruptive and other behaviors related to dementia, counsel them on how to manage the veteran’s functional decline, and aid in establishing a safe living space. Because the social worker serves as a DCM, these coping and adjustment questions occupy significant clinical attention between appointments. This transdisciplinary model places the patient’s illness in the context of their functional status, diagnoses, and medications. The team geriatrician and the nurse specialist are indispensable resources. The clinic conference provides a teaching venue for staff and trainees and a mechanism to discuss new developments in dementia care, such as the increasing need to assess individuals with mild cognitive impairment.25 This model depends on the DCM’s invaluable role in ensuring implementation of the dementia care plan and continuity of care.

Conclusions

We describe effective dementia care with a transdisciplinary team in a conference setting and with the participation of a dedicated DCM.5 To date, this program appears to be an efficient, sustainable application of the limited resources allocated to dementia care. Nevertheless, we are collecting data to compare with performance measures, track use, and assess the programs effects on continuity of care. We look forward to presenting metrics from our program that show improvement in the health care for veterans experiencing a devastating and increasingly common disorder.

Dementia is a devastating condition resulting in major functional, emotional, and financial impact on patients, their caregivers, and families. Approximately 6.5 million Americans are living with Alzheimer disease (AD), the most common of many causes of dementia.1 The prevalence of AD could increase to 12.7 million Americans by 2050 as the population ages.1 Studies suggest that dementia, also known as major neurocognitive disorder, is common and underdiagnosed among US veterans, a population with a mean age of 65 years.2 During cognitive screening, memory impairment is present in approximately 20% of veterans aged ≥ 75 years who have not been diagnosed with a neurocognitive disorder.3 In addition, veterans might be particularly vulnerable to dementia at an earlier age than the general population because of vascular risk factors and traumatic brain injuries.4 These concerns highlight the need for effective dementia care programs at US Department of Veterans Affairs (VA) facilities.

The US health care system often does not adequately address the needs of patients with dementia and their caregivers.5 Dementia care requires specialized medical care among collaborating professionals and caregiver and psychosocial interventions and services. However, the US health care system is fragmented with different clinicians and services siloed into separate practices and most dementia care occurring in primary care settings.6 Primary care professionals (PCPs) often are uncomfortable diagnosing and managing dementia because of time constraints, lack of expertise and training, and inability to deal with the range of care needs.7 PCPs do not identify approximately 42% of their patients with dementia and, when recognized, do not adhere to dementia care guidelines and address caregiver needs.8-10 Research indicates that caregiver support improves dementia care by teaching behavioral management skills and caregiver coping strategies, allowing patients to stay at home and delay institutionalization.6,11,12 Clinicians underuse available resources and do not incorporate them in their patient care.10 These community services benefit patients and caregivers and significantly improve the overall quality of care.6

Memory clinics have emerged to address these deficiencies when managing dementia.13 The most effective memory clinics maximize the use of specialists with different expertise in dementia care, particularly integrated programs where disciplines function together rather than independently.1,5,14 Systematic reviews and meta-analyses have documented the effectiveness of collaborative care management programs.11,12,15 Integration of dementia care management is associated with earlier diagnosis and interventions, decreased functional and cognitive symptom severity, decreased or delayed institutionalization, improved quality of life for patients and caregivers, enhanced overall quality of care and cost-effectiveness, and better integration of community services.11,12,14-19 In these programs, designating a dementia care manager (DCM) as the patient’s advocate facilitates the integrated structure, increases the quality of care, helps caregivers, facilitates adherence to dementia practice guidelines, and prevents behavioral and psychological symptoms of dementia (BPSD).1,6,11,12,20,21

The best interprofessional model for dementia care might be the transdisciplinary model that includes a DCM. To meet the specific demands of dementia care, there must be a high level of interprofessional collaboration rather than multiple health care professionals (HCPs) delivering care in isolation—an approach that is time consuming and often difficult to implement.22 Whereas multidisciplinary care refers to delivery of parallel services and interdisciplinary care implies a joint formulation, transdisciplinary care aims to maximize integration of HCPs and their specific expertise and contributions through interactions and discussions that deliver focused input to the lead physician. The transdisciplinary model addresses needs that often are missed and can minimize disparities in the quality of dementia care.23 A DCM is an integral part of our program, facilitating understanding and implementation of the final care plan and providing long-term follow-up and care. We outline a conference-centered transdisciplinary dementia care model with a social worker as DCM (SW-DCM) at our VA medical center.

Program Description

In 2020, the VA Greater Los Angeles Healthcare System (VAGLAHS) in California established a multispecialty clinic dedicated to evaluation and treatment of veterans with memory and neurocognitive disorders and to provide support for their caregivers and families. With the agreement of leadership in mental health, neurology, and geriatrics services on the importance of collaboration for dementia care, the psychiatry and neurology services created a joint Memory and Neurobehavior Clinic, which completed its first 2 years of operation as a full-day program. In recent months, the clinic has scheduled 24 veterans per day, approximately 50% new evaluations and 50% follow-up patients, with wait times of < 2 months. There is a mean of 12 intake or lead physicians who could attend sessions in the morning, afternoon, or both. The general clinic flow consists of a 2-hour intake evaluation of new referrals by the lead physician followed by a clinic conference with transdisciplinary discussion. The DCM then follows up with the veteran/caregiver presenting a final care plan individualized to the veterans, caregivers, and families.

The Memory and Neurobehavior team includes behavioral neurologists, geriatric psychiatrists, neuropsychologists, geriatric fellows, advanced clinical nurses, and social workers who function as the DCM (Table 1).

In addition, regular meetings of the VAGLAHS dementia committee allow involvement with other professionals (physical, occupational, and speech therapists, an audiologist, an optometrist, and a dietitian) who routinely consult with veterans in the clinic. The Memory and Neurobehavior Clinic also includes trainees from different disciplines, fulfilling the VA’s role in educating future clinicians in managing neurocognitive disorders. These trainees are residents in neurology and psychiatry; fellows in behavioral neurology, geriatric psychiatry, and geriatric medicine; neuropsychology interns; medical students; and nurse practitioner students.

 

 

Procedures

Before the office visit, the coordinating geriatric psychiatrist triages veterans to neurology, psychiatry, or geriatric physicians based on the clinical presentation, history of neurologic signs or symptoms, BPSD or psychiatric history, functional decline, or comorbid medical illnesses. Although veterans often have overlapping concerns, the triage process aims to coordinate the intake evaluations with the most indicated and available specialist with the intention to notify the other specialists during the transdisciplinary conference.

Referrals to the program occur from many sources, notably from primary care (70.8%), mental health (16.7%), and specialty clinics (12.5%). The clinic also receives referrals from the affiliated Veterans Cognitive Assessment and Management Program, which provides dementia evaluation and support via telehealth screening. This VAGLAHS program services a diverse population of veterans: 87% male; 43% aged > 65 years (75% in our clinic); 51% non-Hispanic White; 19% non-Hispanic African American; 16% Hispanic; 4% Asian; and 1% Native American. This population receives care at regional VA medical centers and community-based outpatient clinics over a wide geographic service area.

The initial standardized assessments by intake or lead physicians includes mental status screening with the Montreal Cognitive Assessment (with certified clinicians), the Neurobehavioral Status Examination for a more detailed assessment of cognitive domains, the Columbia-Suicide Severity Rating Scale, the Patient Health Questionnaire for depression screening, and assessment for impairments in instrumental or basic activities of daily living. This initial evaluation aims to apply clinical guidelines and diagnostic criteria for the differential diagnosis of neurocognitive disorders, determine eligibility for cognitive-enhancing medications and techniques, assess for BPSD and the need for nonpharmacologic or pharmacologic interventions, determine functional status, and evaluate the need for supervision, safety concerns, and evidence of neglect or abuse.

As part of its mission, the clinic is charged with implementing the VA Dementia System of Care (DSOC). The stated goals of the DSOC are to provide individualized person-centered dementia care to help veterans experiencing dementia and their caregivers maintain a positive and optimal quality of life and create an environment where VA medical center staff understand the health care needs of veterans with dementia and their caregivers’ role. As part of this initiative, the clinic includes (1) coordination of care through a SW-DCM; (2)

an education plan disseminating information on early signs of dementia to medical center clinicians; (3) evaluation of veterans and caregivers for VA benefits and care services (Table 2); and (4) collaboration with dementia committees at our VA, Veterans Integrated Service Network, and national levels.

 

 

Transdisciplinary Conference

Clinic conferences are held after the veterans are seen. Staff gather to discuss the patient and review management. All team members are present, as well as the head of the clinical clerical staff who can facilitate appointments, make lobby and wait times more bearable for our patients and caregivers, and help manage emergencies. Although this is an in-person conference, the COVID-19 pandemic has allowed us to include staff who screen at remote sites via videoconferencing, similar to other VA programs.24 The Memory and Neurobehavior Clinic has two ≤ 90-minute conferences daily. The lead physicians and their senior attendings present the new intake evaluations (4-6 at each conference session) with a preliminary formulation and questions for discussion. The moderator solicits contributions from the different disciplines, going from one to the next and recording their responses for each veteran. Further specialists are available for consultation through the conference mechanism if necessary. The final assessment is reviewed, a diagnosis is established, and a tailored, individualized care plan for adjusting or optimizing the veteran’s care is presented to the lead physician who makes the final determination. At the close of the conference, the team’s discussion is recorded along with the lead physician’s original detailed intake evaluation. Currently, the records go into the Computerized Patient Record System, but we are making plans to transition to Cerner as it is implemented.

During the discussion, team members review several areas of consideration. If there is neuroimaging, neurologists review the images projected on a large computer screen. Team members also will assess for the need to obtain biomarker studies, such as blood, cerebrospinal fluid, or positron emission tomography. Psychiatrists could review management of BPSD and use of psychotropic agents, and neuropsychologists might consider the need for more precise cognitive testing and whether a capacity assessment is indicated. Social work might bring up the need for a durable power of attorney as well as applicable caregiver and community resources. Geriatric medicine and nursing could provide input into medical management and care and the ability of veterans and caregivers to follow the prescribed regimen. Further areas of discussion include driving safety and restrictions on driving (as required in California) and the presence of guns in the home. Finally, brief education is provided in short 10-to-15-minute lectures covering pertinent topics so staff remain up-to-date in this changing field.

Postconference Continuity

After the conference, the SW-DCM continues to provide support throughout the disease course, helping veterans and their caregivers understand and follow through on the team’s recommendations. The SW-DCM, who is experienced and trained in case management, forms an ongoing relationship with the veterans and their caregivers and remains an advocate for their care. The SW-DCM communicates the final plan by phone and, when necessary, requests the lead physician to call to clarify any poorly understood or technical aspects of the care plan. About 50% of our veterans—primarily those who do not have a neurocognitive disorder or have mild cognitive impairment—return to their PCPs with our care plan consultation; about 25% are already enrolled in geriatric and other programs with long-term follow-up. The assigned SW-DCM follows up with the remaining veterans and caregivers regularly by phone, facilitates communication with other team members, and endeavors to assure postvisit continuity of care and support during advancing stages of the disease. In addition, the SW-DCM can provide supportive counseling and psychotherapy for stressed caregivers, refer to support groups and cognitive rehabilitation programs, and help develop long-term goals and consideration for supervised living environments. The nurse specialist participates with follow-up calls regarding medications and scheduled tests and appointments, clearing up confusion about instructions, avoiding medication errors, and providing education in dementia care. Both social worker and nurse are present throughout the week, reachable by phone, and, in turn, able to contact the clinic physicians for veterans’ needs.

Discussion

Because of the heterogenous medical and psychosocial needs of veterans with dementia and their caregivers, a transdisciplinary team with a dedicated DCM might offer the most effective and efficient model for dementia care. We present a transdisciplinary program that incorporates dementia specialists in a single evaluation by maximizing their time through a conference-centered program. Our program involves neurologists, psychiatrists, geriatricians, psychologists, nurses, and social workers collaborating and communicating to enact effective dementia care. It further meets the goals of the VA-DSOC in implementing individualized patient and caregiver care.

This transdisciplinary model addresses a number of issues, starting with the differential diagnosis of underlying neurologic conditions. Within the transdisciplinary team, the neurologist can provide specific insights into any neurologic findings and illnesses, such as Alzheimer disease and other neurodegenerative dementias, vascular dementia syndromes, normal pressure hydrocephalus, Creutzfeldt-Jakob disease, neurosyphilis, and others. Most veterans with dementia experience BPSD at some point during of their illness. The psychiatrists on the transdisciplinary team can maximize management of BPSD with nonpharmacologic interventions and the fewest and least aversive psychoactive medications. Our program also addresses the need for more precise cognitive evaluation. Neuropsychologists are present and available for administrating neuropsychologic tests and interpreting cognitive performance and any earlier neuropsychologic testing. This model also cares for the caregivers and assesses their needs. The social worker—as well as other members of the team—can provide caregivers with strategies for coping with disruptive and other behaviors related to dementia, counsel them on how to manage the veteran’s functional decline, and aid in establishing a safe living space. Because the social worker serves as a DCM, these coping and adjustment questions occupy significant clinical attention between appointments. This transdisciplinary model places the patient’s illness in the context of their functional status, diagnoses, and medications. The team geriatrician and the nurse specialist are indispensable resources. The clinic conference provides a teaching venue for staff and trainees and a mechanism to discuss new developments in dementia care, such as the increasing need to assess individuals with mild cognitive impairment.25 This model depends on the DCM’s invaluable role in ensuring implementation of the dementia care plan and continuity of care.

Conclusions

We describe effective dementia care with a transdisciplinary team in a conference setting and with the participation of a dedicated DCM.5 To date, this program appears to be an efficient, sustainable application of the limited resources allocated to dementia care. Nevertheless, we are collecting data to compare with performance measures, track use, and assess the programs effects on continuity of care. We look forward to presenting metrics from our program that show improvement in the health care for veterans experiencing a devastating and increasingly common disorder.

References

1. 2022 Alzheimer’s disease facts and figures. Alzheimers Dement. 2022;18(4):700-789. doi:10.1002/alz.12638

2. National Center for Veterans Analysis and Statistics. Profile of veterans: 2016. Accessed October 12, 2022. https://www.va.gov/vetdata/docs/SpecialReports/Profile_of_Veterans_2016.pdf

3. Chodosh J, Sultzer DL, Lee ML, et al. Memory impairment among primary care veterans. Aging Ment Health. 2007;11(4):444-450. doi:10.1080/13607860601086272

4. Kennedy E, Panahi S, Stewart IJ, et al. Traumatic brain injury and early onset dementia in post 9-11 veterans. Brain Inj. 2022;36(5):620-627. doi:10.1080/02699052.2022.20338465. Heintz H, Monette P, Epstein-Lubow G, Smith L, Rowlett S, Forester BP. Emerging collaborative care models for dementia care in the primary care setting: a narrative review. Am J Geriatr Psychiatry. 2020;28(3):320-330. doi:10.1016/j.jagp.2019.07.015

6. Reuben DB, Evertson LC, Wenger NS, et al. The University of California at Los Angeles Alzheimer’s and Dementia Care program for comprehensive, coordinated, patient-centered care: preliminary data. J Am Geriatr Soc. 2013;61(12):2214-2218. doi:10.1111/jgs.12562

7. Apesoa-Varano EC, Barker JC, Hinton L. Curing and caring: the work of primary care physicians with dementia patients. Qual Health Res. 2011;21(11):1469-1483. doi:10.1177/1049732311412788

8. Creavin ST, Noel-Storr AH, Langdon RJ, et al. Clinical judgement by primary care physicians for the diagnosis of all-cause dementia or cognitive impairment in symptomatic people. Cochrane Database Syst Rev. 2022;6:CD012558. doi:10.1002/14651858.CD012558.pub2

9. Sivananthan SN, Puyat JH, McGrail KM. Variations in self-reported practice of physicians providing clinical care to individuals with dementia: a systematic review. J Am Geriatr Soc. 2013;61(8):1277-1285. doi:10.1111/jgs.12368

10. Rosen CS, Chow HC, Greenbaum MA, et al. How well are clinicians following dementia practice guidelines? Alzheimer Dis Assoc Disord. 2002;16(1):15-23. doi:10.1097/00002093-200201000-00003

11. Reilly S, Miranda-Castillo C, Malouf R, et al. Case management approaches to home support for people with dementia. Cochrane Database Syst Rev. 2015;1:CD008345. doi:10.1002/14651858.CD008345.pub2

12. Tam-Tham H, Cepoiu-Martin M, Ronksley PE, Maxwell CJ, Hemmelgarn BR. Dementia case management and risk of long-term care placement: a systematic review and meta-analysis. Int J Geriatr Psychiatry. 2013;28(9):889-902. doi:10.1002/gps.3906

13. Jolley D, Benbow SM, Grizzell M. Memory clinics. Postgrad Med J. 2006;82(965):199-206. doi:10.1136/pgmj.2005.040592

14. Muhlichen F, Michalowsky B, Radke A, et al. Tasks and activities of an effective collaborative dementia care management program in German primary care. J Alzheimers Dis. 2022;87(4):1615-1625. doi:10.3233/JAD-215656

15. Somme D, Trouve H, Drame M, Gagnon D, Couturier Y, Saint-Jean O. Analysis of case management programs for patients with dementia: a systematic review. Alzheimers Dement. 2012;8(5):426-436. doi:10.1016/j.jalz.2011.06.004

16. Ramakers IH, Verhey FR. Development of memory clinics in the Netherlands: 1998 to 2009. Aging Ment Health. 2011;15(1):34-39. doi:10.1080/13607863.2010.519321

17. LaMantia MA, Alder CA, Callahan CM, et al. The aging brain care medical home: preliminary data. J Am Geriatr Soc. 2015;63(6):1209-1213. doi:10.1111/jgs.13447

18. Rubinsztein JS, van Rensburg MJ, Al-Salihy Z, et al. A memory clinic v. traditional community mental health team service: comparison of costs and quality. BJPsych Bull. 2015;39(1):6-11. doi:10.1192/pb.bp.113.044263

19. Lee L, Hillier LM, Harvey D. Integrating community services into primary care: improving the quality of dementia care. Neurodegener Dis Manag. 2014;4(1):11-21. doi:10.2217/nmt.13.72

20. Bass DM, Judge KS, Snow AL, et al. Caregiver outcomes of partners in dementia care: effect of a care coordination program for veterans with dementia and their family members and friends. J Am Geriatr Soc. 2013;61(8):1377-1386. doi:10.1111/jgs.12362

21. Callahan CM, Boustani MA, Unverzagt FW, et al. Effectiveness of collaborative care for older adults with Alzheimer disease in primary care: a randomized controlled trial. JAMA. 2006;295(18):2148-2157. doi:10.1001/jama.295.18.2148

22. Leggett A, Connell C, Dubin L, et al. Dementia care across a tertiary care health system: what exists now and what needs to change. J Am Med Dir Assoc. 2019;20(10):1307-12 e1. doi:10.1016/j.jamda.2019.04.006

23. Brown AF, Vassar SD, Connor KI, Vickrey BG. Collaborative care management reduces disparities in dementia care quality for caregivers with less education. J Am Geriatr Soc. 2013;61(2):243-251. doi:10.1111/jgs.12079

24. Powers BB, Homer MC, Morone N, Edmonds N, Rossi MI. Creation of an interprofessional teledementia clinic for rural veterans: preliminary data. J Am Geriatr Soc. 2017;65(5):1092-1099. doi:10.1111/jgs.14839

25. Galvin JE, Aisen P, Langbaum JB, et al. Early stages of Alzheimer’s Disease: evolving the care team for optimal patient management. Front Neurol. 2020;11:592302. doi:10.3389/fneur.2020.592302

References

1. 2022 Alzheimer’s disease facts and figures. Alzheimers Dement. 2022;18(4):700-789. doi:10.1002/alz.12638

2. National Center for Veterans Analysis and Statistics. Profile of veterans: 2016. Accessed October 12, 2022. https://www.va.gov/vetdata/docs/SpecialReports/Profile_of_Veterans_2016.pdf

3. Chodosh J, Sultzer DL, Lee ML, et al. Memory impairment among primary care veterans. Aging Ment Health. 2007;11(4):444-450. doi:10.1080/13607860601086272

4. Kennedy E, Panahi S, Stewart IJ, et al. Traumatic brain injury and early onset dementia in post 9-11 veterans. Brain Inj. 2022;36(5):620-627. doi:10.1080/02699052.2022.20338465. Heintz H, Monette P, Epstein-Lubow G, Smith L, Rowlett S, Forester BP. Emerging collaborative care models for dementia care in the primary care setting: a narrative review. Am J Geriatr Psychiatry. 2020;28(3):320-330. doi:10.1016/j.jagp.2019.07.015

6. Reuben DB, Evertson LC, Wenger NS, et al. The University of California at Los Angeles Alzheimer’s and Dementia Care program for comprehensive, coordinated, patient-centered care: preliminary data. J Am Geriatr Soc. 2013;61(12):2214-2218. doi:10.1111/jgs.12562

7. Apesoa-Varano EC, Barker JC, Hinton L. Curing and caring: the work of primary care physicians with dementia patients. Qual Health Res. 2011;21(11):1469-1483. doi:10.1177/1049732311412788

8. Creavin ST, Noel-Storr AH, Langdon RJ, et al. Clinical judgement by primary care physicians for the diagnosis of all-cause dementia or cognitive impairment in symptomatic people. Cochrane Database Syst Rev. 2022;6:CD012558. doi:10.1002/14651858.CD012558.pub2

9. Sivananthan SN, Puyat JH, McGrail KM. Variations in self-reported practice of physicians providing clinical care to individuals with dementia: a systematic review. J Am Geriatr Soc. 2013;61(8):1277-1285. doi:10.1111/jgs.12368

10. Rosen CS, Chow HC, Greenbaum MA, et al. How well are clinicians following dementia practice guidelines? Alzheimer Dis Assoc Disord. 2002;16(1):15-23. doi:10.1097/00002093-200201000-00003

11. Reilly S, Miranda-Castillo C, Malouf R, et al. Case management approaches to home support for people with dementia. Cochrane Database Syst Rev. 2015;1:CD008345. doi:10.1002/14651858.CD008345.pub2

12. Tam-Tham H, Cepoiu-Martin M, Ronksley PE, Maxwell CJ, Hemmelgarn BR. Dementia case management and risk of long-term care placement: a systematic review and meta-analysis. Int J Geriatr Psychiatry. 2013;28(9):889-902. doi:10.1002/gps.3906

13. Jolley D, Benbow SM, Grizzell M. Memory clinics. Postgrad Med J. 2006;82(965):199-206. doi:10.1136/pgmj.2005.040592

14. Muhlichen F, Michalowsky B, Radke A, et al. Tasks and activities of an effective collaborative dementia care management program in German primary care. J Alzheimers Dis. 2022;87(4):1615-1625. doi:10.3233/JAD-215656

15. Somme D, Trouve H, Drame M, Gagnon D, Couturier Y, Saint-Jean O. Analysis of case management programs for patients with dementia: a systematic review. Alzheimers Dement. 2012;8(5):426-436. doi:10.1016/j.jalz.2011.06.004

16. Ramakers IH, Verhey FR. Development of memory clinics in the Netherlands: 1998 to 2009. Aging Ment Health. 2011;15(1):34-39. doi:10.1080/13607863.2010.519321

17. LaMantia MA, Alder CA, Callahan CM, et al. The aging brain care medical home: preliminary data. J Am Geriatr Soc. 2015;63(6):1209-1213. doi:10.1111/jgs.13447

18. Rubinsztein JS, van Rensburg MJ, Al-Salihy Z, et al. A memory clinic v. traditional community mental health team service: comparison of costs and quality. BJPsych Bull. 2015;39(1):6-11. doi:10.1192/pb.bp.113.044263

19. Lee L, Hillier LM, Harvey D. Integrating community services into primary care: improving the quality of dementia care. Neurodegener Dis Manag. 2014;4(1):11-21. doi:10.2217/nmt.13.72

20. Bass DM, Judge KS, Snow AL, et al. Caregiver outcomes of partners in dementia care: effect of a care coordination program for veterans with dementia and their family members and friends. J Am Geriatr Soc. 2013;61(8):1377-1386. doi:10.1111/jgs.12362

21. Callahan CM, Boustani MA, Unverzagt FW, et al. Effectiveness of collaborative care for older adults with Alzheimer disease in primary care: a randomized controlled trial. JAMA. 2006;295(18):2148-2157. doi:10.1001/jama.295.18.2148

22. Leggett A, Connell C, Dubin L, et al. Dementia care across a tertiary care health system: what exists now and what needs to change. J Am Med Dir Assoc. 2019;20(10):1307-12 e1. doi:10.1016/j.jamda.2019.04.006

23. Brown AF, Vassar SD, Connor KI, Vickrey BG. Collaborative care management reduces disparities in dementia care quality for caregivers with less education. J Am Geriatr Soc. 2013;61(2):243-251. doi:10.1111/jgs.12079

24. Powers BB, Homer MC, Morone N, Edmonds N, Rossi MI. Creation of an interprofessional teledementia clinic for rural veterans: preliminary data. J Am Geriatr Soc. 2017;65(5):1092-1099. doi:10.1111/jgs.14839

25. Galvin JE, Aisen P, Langbaum JB, et al. Early stages of Alzheimer’s Disease: evolving the care team for optimal patient management. Front Neurol. 2020;11:592302. doi:10.3389/fneur.2020.592302

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Improving Patient Access to the My HealtheVet Electronic Patient Portal for Veterans

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Patient portals are secure online website tools that provide patient access to personal health information (PHI). Access to online PHI improves health equity and satisfies the meaningful use objectives of the Medicare electronic health record (EHR) incentive program.1,2 Through patient portals, individuals can access PHI records and current diagnoses, request and reschedule appointments, locate test results, track trends for vital signs and laboratory values, refill medications, and communicate directly with the health care team through secure messaging. This alternative method of communication with the team is associated with increased patient satisfaction.3 Patients reported improved patient engagement in health care self-management and decision making, as well as strengthened relationships with their health care team.4

Background

One well-documented strategy to improve portal use includes the development of a nurse champion to facilitate enrollment during the clinic visit.5 Patient perceptions of portal value increased after education by a health care professional (HCP) and assistance in enrollment to familiarize patients with the platform for ongoing use.5 Use of patient portals has been associated with favorable outcomes in chronic disease management. Patients with diabetes mellitus who regularly use patient portals for prescription refills and secure messaging have demonstrated improved glycemic control, medication adherence, and associated health parameters compared with nonusers.5-7 In patients with congestive heart failure, meaningful patient portal use results in fewer emergency department visits, fewer hospital admissions, lower readmission rates, and reduced unscheduled and no-show visits.8-11

Patient portal access is a quality improvement (QI) measure that meets Medicare and Medicaid meaningful use requirements that is designed to improve collaboration between HCPs and patients through EHRs. Despite legislation, uptake of patient portal access has been slow, especially among older adults.10,12,13 Barriers to patient portal registration and use include patient lack of awareness, perceived or actual digital illiteracy, mistrust in privacy precautions, lack of user-friendly interfaces, lack of internet or technology, HCP bias and workload, and misperceptions of usefulness.9,10,12,14 The HCPs most likely to facilitate the use of patient portals, typically include nurse practitioners (NPs), nurses, and medical residents.10,15 Patient portal platforms promote the partnership of these disciplines with the veteran to help the patient better manage their health. Despite the benefits and widespread integration of patient portals in health care systems, socioeconomic inequalities and HCP attitudes contribute to persistent disparities in its adoption by underserved populations. The veteran population is often faced with additional barriers to health care access with regard to geographic location, advanced age, trauma, disabilities, mental health challenges, and homelessness.10,16 These barriers require unique approaches to maximize the use of technologic advances.17 Advanced age contributes to low rates of patient portal enrollment and lack of digital platform use, thus creating a digital divide.11,12

The digital divide is described as the gap between those persons who use technology including computers and internet, and those persons who do not because of social and geographic barriers.16 It contributes to a growing health disparity in both access to care and quality of care especially for rural veterans. About 25% of the US population lacks fixed broadband at home; these individuals are more likely to be racial minorities, older, widowed, or to have lower levels of education.18,19 Veterans are disproportionately represented in these demographic categories.20 According to the US Department of Veterans Affairs (VA) Office of Rural Health, the percentage of rural veterans enrolled in the VA health care system (58%) is significantly higher than enrollment of urban veterans (38%); additionally, 27% of rural veterans do not access the internet at home.21

My HealtheVet

The VA plays an integral part in increasing virtual access to care, from the introduction of My Healthevet (MHV) in 2003 to the distribution of iPad tablets to vulnerable veterans during the COVID-19 pandemic.22,23 Due to COVID-19, the need for VA patient access to the internet and VA Video-Connect (VVC) telehealth services increased significantly.22 Access to internet and hardware supporting use of VVC and MHV has been facilitated by the Digital Divide Consult, a VA program launched in 2020 to increase access to telehealth services.24 The VA has distributed > 26,000 cellular-enabled tablets and provided > 50,000 veterans with connectivity in collaboration with various private sector companies.22 Patients report that MHV facilitates engagement in health care through improved access to EHRs and expedited communication with the health care team.4

MHV is a secure online tool that provides patients access to PHI. MHV aims to empower veterans to take charge of their health by improving communication with HCPs, setting patient goals, and offering health and well-being resources.25,26 In a study of outpatients at a large urban multisite health care system, < 35% of patients on 16 medical resident panels were enrolled in a patient portal.15 MHV internal national metrics show increasing registration and active users of the patient portal, yet locally, disparities in the use of the portal by rural and older veterans exist.

The Local Problem

A review of the registration process at a rural VA clinic revealed barriers to facilitating the veteran registration process at the point of care. Clinical reminders exist within the EHR to prompt clinicians at the point of care to improve quality of care. At the New England Healthcare System (Veterans Integrated Service Network [VISN] 1), a patient portal clinical reminder prompts staff to encourage veterans to register. Anecdotal data obtained from primary care staff interviews at a rural VA primary care clinic in Vermont revealed low clinician confidence in completing the clinical reminder, a lack of knowledge of MHV, and lack of time to educate veterans about the benefits of MHV.

 

 

Despite availability of a registration process at the point of care and clinical staff assigned to provide registration information to the veteran, access to the patient portal among veterans at this clinic remained low. This QI project aimed to increase patient portal enrollment of veterans in MHV in a single NP patient panel of 100 patients from a baseline of 33% by 10% in a 3-month time frame.  

Implementation

Before implementing the first Plan-Do-Study-Act (PDSA) cycle, we established the baseline data for 1 patient panel to be 33%. A retrospective review of the NP resident’s panel of 100 revealed 33 veterans were enrolled in MHV, providing a setting for process improvement. Evaluation of potential enrollment data for the panel population revealed unenrolled veterans were primarily aged ≥ 65 years. A rapid cycle QI (RCQI) strategy using the PDSA method was used to identify, implement, and measure changes over a 3-month time frame in 1 NP patient panel.14

The RCQI process included establishing baseline data and 3 PDSA cycles that evaluated the current state of patient access to the electronic patient portal, elucidated patient barriers to registration, assessed the processes for point-of-care enrollment, and developed strategies to improve the process and increase veteran enrollment. The QI project team included an NP resident as the project manager and MHV champion, a clinical faculty mentor at the site, a telehealth coordinator, an MHV coordinator, clinic registered nurse (RN), and clinic licensed nursing assistant (LNA). The RN and LNA additionally served as MHV champions as the project progressed.

PDSA Cycles

The objective for PDSA cycle 1 was to evaluate the process of patient registration and assess the impact on NP workload and clinic workflow over a 4-week period to improve veteran enrollment. Data were collected in a spreadsheet to track the number of veterans enrolled, time frame to enroll, and field notes that the NP resident recorded about the experience. The NP resident was trained in registration methods by the MHV coordinator. Several barriers to the registration process were identified: The process resulted in a change of the clinic visit closure focus, the clinic room was blocked for use by another patient, veterans had difficulty generating a unique username and password, veterans were unfamiliar with basic tablet accessibility and use, and additional time was required if incorrect information was entered. The veterans displayed low confidence in using tablet technology and were unaware of the patient portal or its usefulness. After discussion of the process with the project team, recommendations were made to address challenges, including an RN-led registration process. The first PDSA cycle increased the total patient panel enrollment by 4 veterans to 37%.

In PDSA cycle 2 after the NP visit, patients who agreed to register for the MHV portal were introduced to the tablet. The registration process was completed by the patient with the RN prior to the patient checkout. Once patient registration was completed, the veteran met the MHV coordinator and upgraded to a premium account, which provided full access to portal features. Electronic messaging was tested by the MHV coordinator and veteran to validate patient understanding. Although preloading demographic information improved accessibility issues, time was still required for the RN to orient the veteran to the tablet, provide additional directions, and answer questions.

The registration process reduced NP time commitment but added to the RN time burden and disrupted workflow; and clinic room access continued to be an issue. The wait time for the veteran to register in the clinic remained dependent on the availability of the RN. The decision was to move the registration process to the initial patient rooming assignment in the clinic and was transitioned from RN to LNA, prior to the NP-veteran encounter. Four additional veterans registered in the second PDSA cycle, and total enrollment increased to 41%, an overall 8% increase from baseline.

In the third PDSA cycle the patient enrollment process was managed by the clinic LNA using scripted information about MHV prior to the veteran encounter. A partially preloaded tablet was offered to the veteran to register with MHV during the rooming process, and written and oral instruction were provided to the veteran. The time required for each veteran to register for MHV averaged 10 minutes, and the veteran was able to register while waiting for the NP to enter the room. Typical LNA tasks included greeting patients, updating health records, completing clinical reminders with the veteran, obtaining vital signs, and addressing questions. The LNA introduced the veteran to MHV using scripted information and supported them in registering for MHV prior to the NP-veteran encounter. Registration at point of care during the rooming process was well received by both the LNA and veterans. The LNA reported the process was efficient and did not add excessive time to the LNA workflow. The LNA reported verbal patient satisfaction and registration was facilitated for 6 veterans during the 4-week period. 

 

 



Registration during point of care was reported as feasible and sustainable by the LNA. Upgrading the patient to a premium MHV account was transitioned to the MHV coordinator. All veterans seen during the 4-week period were approached about registration; if the veteran declined, written at-home step-by-step instructions were provided. A replacement electronic clinical reminder was proposed to the VISN clinical reminders team for review and was pilot tested by the primary care clinical team. The third PDSA cycle increased the total patient panel enrollment to 47%, an overall 14% increase from baseline. Six new veteran users were added during PDSA cycle 3.

Discussion

The project team successfully used a RCQI method with a PDSA strategy to improve patient access to the MHV portal and increased veteran enrollment by 14% on 1 NP resident patient panel. The project evaluated clinic workflow regarding veteran patient portal registration, uncovered inefficiencies, and developed improved processes to increase veteran access to the patient portal. Results were positively impacted through the recognition of inefficiencies and initiation of new processes to engage veterans in the portal registration process. Familiarizing the entire clinical team with the clinical reminder and registration process raised the awareness of a digital divide consult and the utility of the portal in patient care. The project provided an opportunity to evaluate veterans’ digital literacy, digital access to send and receive messages, and to provide coaching as needed. Sequential PDSA cycles employed audit and feedback, information preloading, multimodal teaching strategies (verbal, print, hands-on tablet learning), scripting, staff interviews, time studies, and workflow evaluation to improve processes. An MHV champion led the team, monitored the progress, set deadlines, and effectively communicated project performance.

Limitations

Project limitations included the single-site location, its small sample size, and the short 3-month implementation time frame. The patient panel was representative of other NP resident patient panels at the facility but may not be representative of other VA facilities.

Ethical Considerations

Patient confidentiality was maintained throughout the registration and data collection process. The project team (NP, RN, LNA) received training and written instructions on protection of patient confidentiality by the MHV coordinator prior to assisting veterans with the registration process. Privacy was maintained, no patient identifiers were collected or viewed, and no assistance was provided for username, password, or security questions. The tablet was password protected and secured, used only by the project team when veteran was interested in point-of-care portal registration.

Sustainability

QI projects require ongoing systemic efforts to enhance sustainability.26,27 The project team used the PDSA methodology to stimulate the design of new workflow processes to engage staff and veterans in portal registration. Several actions were taken to promote sustainability for veteran portal registration and improve access to health care for rural and underserved veterans. First, printed instructions and website link are available in the clinic intake and examination rooms. Staff are equipped with patient education discussion points about the portal. A tablet is available in the clinic to encourage veterans to sign up. A clinical reminder is in place to encourage portal registration. A designated super-user is available to help new patient portal users register and navigate the system. Outcomes of the QI project were presented at 2 separate VISN 1 nursing grand rounds and reported to the MHV coordinator and telehealth coordinator to promote dialogue among staff and raise awareness of challenges to veteran MHV access.

Conclusions

Reviewing patient portal registration processes at the local level is essential to improve veteran access. This QI project proposed a realistic and scalable solution to implementing and improving patient enrollment to MHV in primary care clinics. Integrating measurement of patient registration into the daily routine of the clinic empowers the entire clinical team to improve the quality of access to patient portal.

The project team worked together to accomplish a shared goal, using errors as opportunities to improve the process, while using available staff without compromising significant time or resources. Engaging the entire team to audit processes and designating one member of the team as an MHV champion to provide feedback is critical to the sustainability of point-of-care registration in the MHV patient portal. Multifaceted approaches to maximizing the use of technology lessens the digital divide for veterans who are faced with geographical and social barriers to health care access.

Acknowledgments

We thank the Office of Academic Affiliations and the US Department of Veterans Affairs Nursing Academic Partnerships in Graduate Education Nurse Practitioner residency program and clinical faculty and the affiliated University of Vermont faculty mentor/quality improvement coach for the support of the project.

References

1. Centers for Medicare and Medicaid Services. Promoting interoperability programs. Updated October 6, 2022. Accessed November 3, 2022. https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms

2. American Hospital Association. Goals of the Medicare and Medicaid electronic health records programs. Accessed November 3, 2022. https://www.aha.org/websites/2009-12-11-goals-medicare-and-medicaid-electronic-health-records-programs

3. Rozenblum R, Donzé J, Hockey PM, et al. The impact of medical informatics on patient satisfaction: a USA-based literature review. Int J Med Inform. 2013;82(3):141-158. doi:10.1016/j.ijmedinf.2012.12.008

4. Stewart MT, Hogan TP, Nicklas J, et al. The promise of patient portals for individuals living with chronic illness: qualitative study identifying pathways of patient engagement. J Med Internet Res. 2020;22(7):e17744. Published 2020 Jul 17. doi:10.2196/17744

5. Harris LT, Haneuse SJ, Martin DP, Ralston JD. Diabetes quality of care and outpatient utilization associated with electronic patient-provider messaging: a cross-sectional analysis. Diabetes Care. 2009;32(7):1182-1187. doi:10.2337/dc08-1771

6. Robinson SA, Zocchi MS, Netherton D, et al. Secure messaging, diabetes self-management, and the importance of patient autonomy: a mixed methods study. J Gen Intern Med. 2020;35(10):2955-2962. doi:10.1007/s11606-020-05834-x

7. Zocchi MS, Robinson SA, Ash AS, et al. Patient portal engagement and diabetes management among new portal users in the Veterans Health Administration. J Am Med Inform Assoc. 2021;28(10):2176-2183. doi:10.1093/jamia/ocab115

8. Bao C, Bardhan IR, Singh H, Meyer BA, Kirksey K. Patient-provider engagement and its impact on health outcomes: a longitudinal study of patient portal use. MIS Quarterly. 2020;44(2):699-723. doi:10.25300/MISQ/2020/14180

9. Grossman LV, Masterson Creber RM, Benda NC, Wright D, Vawdrey DK, Ancker JS. Interventions to increase patient portal use in vulnerable populations: a systematic review. J Am Med Informs Assoc. 2019;26(8-9):855-870. doi:10.1093/jamia/ocz023

10. Zhao JY, Song B, Anand E, et al. Barriers, facilitators, and solutions to optimal patient portal and personal health record use: a systematic review of the literature. AMIA Annu Symp Proc. 2018;2017:1913-1922. Published 2018 Apr 16.

11. Zhong X, Park J, Liang M, et al. Characteristics of patients using different patient portal functions and the impact on primary care service utilization and appointment adherence: retrospective observational study. J Med Internet Res. 2020;22(2):e14410. Published 2020 Feb 25. doi:10.2196/14410

12. Krishnaswami A, Beavers C, Dorsch MP, et al. Gerotechnology for older adults with cardiovascular diseases. J Am Coll Cardiol. 2020;76(22):2650-2670. doi:10.1016/j.jacc.2020.09.606

13. Fix GM, Hogan TP, Amante DJ, McInnes DK, Nazi KM, Simon SR. Encouraging patient portal use in the patient-centered medical home: three stakeholder perspectives. J Med Internet Res. 2016;18(11):e308. Published 2016 Nov 22. doi:10.2196/jmir.6488

14. Ancker JS, Nosal S, Hauser D, Way C, Calman N. Access policy and the digital divide in patient access to medical records. Health Policy Technol. 2016;6(3-11). doi:10.1016/j.hlpt.2016.11.004

15. Rhudy C, Broxterman J, Stewart S, et al. Improving patient portal enrolment in an academic resident continuity clinic: quality improvement made simple. BMJ Open Qual. 2019;8(2):e000430. Published 2019 Apr 25. doi:10.1136/bmjoq-2018-000430

16. Kontos E, Blake KD, Chou WY, Prestin A. Predictors of eHealth usage: insights on the digital divide from the Health Information National Trends Survey 2012. J Med Internet Res. 2014;16(7):e172. Published 2014 Jul 16. doi:10.2196/jmir.3117

17. National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Population Health and Public Health Practice. The state of health disparities in the United States. In: Baciu A, Negussie Y, Geller A, et al, eds. Communities in Action: Pathways to Health Equity. National Academies Press (US); January 11, 2017. Accessed November 3, 2022. https://www.ncbi.nlm.nih.gov/books/NBK425848/

18. Pew Research Center. Internet/broadband fact sheet. Updated April 7, 2021. Accessed November 3, 2022. https://www.pewresearch.org/internet/fact-sheet/internet-broadband

19. Roberts ET, Mehrotra A. Assessment of disparities in digital access among Medicare beneficiaries and implications for telemedicine. JAMA Intern Med. 2020;180(10):1386-1389. doi:10.1001/jamainternmed.2020.2666

20. US Department of Veterans Affairs, National Center for Veterans Analysis and Statistics. Veteran population. Updated September 7, 2022. Accessed November 3, 2022. https://www.va.gov/vetdata/veteran_population.asp

21. US Department of Veterans Affairs, Office of Rural Health. Rural veterans health care challenges. Updated March 31, 2022. Accessed November 3, 2022. https://www.ruralhealth.va.gov/aboutus/ruralvets.asp

22. US Department of Veterans Affairs, Office of Public and Intergovernmental Affairs. VA expands veteran access to telehealth with iPad services. Press release. September 15, 2020. Accessed November 3, 2022. https://www.va.gov/opa/pressrel/pressrelease.cfm?id=5521

23. Zulman DM, Wong EP, Slightam C, et al. Making connections: National implementation of video telehealth tablets to address access barriers in veterans. JAMIA Open. 2019;2(3):323-329. doi:10.1093/jamiaopen/ooz024

24. Malone NC, Williams MM, Smith Fawzi MC, et al. Mobile health clinics in the United States. Int J Equity Health. 2020;19(1):40. doi:10.1186/s12939-020-1135-7

25. US Department of Veterans Affairs. How to use My HealtheVet. Accessed November 3, 2022. https://www.myhealth.va.gov/mhv-portal-web/how-to-use-mhv

26. US Department of Veterans Affairs, Veterans Health Administration, Office of Patient Centered Care and Cultural Transformation. Whole health for life. 2017. Accessed November 3, 2022. https://www.va.gov/wholehealth/docs/2017-AR-Vet-Facing_FNL-W508.pdf27. Mortimer F, Isherwood J, Wilkinson A, Vaux E. Sustainability in quality improvement: redefining value. Future Healthc J. 2018;5(2):88-93. doi:10.7861/futurehosp.5-2-88

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Corinne Roberto, DNP, APRN, AGNP-Ca; Melanie Keiffer, DNP, APRN, ANP-BC, CNEb,c; Melanie Black, MSN, APRN, AGNP-Cd; Carol Williams-Suich, MSN, APRN, FNP-BC, GNP-BCb,d; Karen Grunewald, DNP, APRN, ANP-BCb,e
Correspondence:
Corinne Roberto ([email protected])

aVeterans Health Administration Community-Based Outpatient Clinic, Bend, Oregon
bUniversity of Vermont College of Nursing and Health Sciences Burlingoton
cVeterans Health Administration, Burlington, Vermont
dWhite River Junction Veterans Affairs Medical Center, Vermont
eVeterans Health Administration Community-Based Outpatient Clinic, Burlington, Vermont

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

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This project is a quality improvement and program evaluation; formal ethics approval was not required.

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Corinne Roberto, DNP, APRN, AGNP-Ca; Melanie Keiffer, DNP, APRN, ANP-BC, CNEb,c; Melanie Black, MSN, APRN, AGNP-Cd; Carol Williams-Suich, MSN, APRN, FNP-BC, GNP-BCb,d; Karen Grunewald, DNP, APRN, ANP-BCb,e
Correspondence:
Corinne Roberto ([email protected])

aVeterans Health Administration Community-Based Outpatient Clinic, Bend, Oregon
bUniversity of Vermont College of Nursing and Health Sciences Burlingoton
cVeterans Health Administration, Burlington, Vermont
dWhite River Junction Veterans Affairs Medical Center, Vermont
eVeterans Health Administration Community-Based Outpatient Clinic, Burlington, Vermont

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Ethics and consent

This project is a quality improvement and program evaluation; formal ethics approval was not required.

Author and Disclosure Information

Corinne Roberto, DNP, APRN, AGNP-Ca; Melanie Keiffer, DNP, APRN, ANP-BC, CNEb,c; Melanie Black, MSN, APRN, AGNP-Cd; Carol Williams-Suich, MSN, APRN, FNP-BC, GNP-BCb,d; Karen Grunewald, DNP, APRN, ANP-BCb,e
Correspondence:
Corinne Roberto ([email protected])

aVeterans Health Administration Community-Based Outpatient Clinic, Bend, Oregon
bUniversity of Vermont College of Nursing and Health Sciences Burlingoton
cVeterans Health Administration, Burlington, Vermont
dWhite River Junction Veterans Affairs Medical Center, Vermont
eVeterans Health Administration Community-Based Outpatient Clinic, Burlington, Vermont

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Ethics and consent

This project is a quality improvement and program evaluation; formal ethics approval was not required.

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Patient portals are secure online website tools that provide patient access to personal health information (PHI). Access to online PHI improves health equity and satisfies the meaningful use objectives of the Medicare electronic health record (EHR) incentive program.1,2 Through patient portals, individuals can access PHI records and current diagnoses, request and reschedule appointments, locate test results, track trends for vital signs and laboratory values, refill medications, and communicate directly with the health care team through secure messaging. This alternative method of communication with the team is associated with increased patient satisfaction.3 Patients reported improved patient engagement in health care self-management and decision making, as well as strengthened relationships with their health care team.4

Background

One well-documented strategy to improve portal use includes the development of a nurse champion to facilitate enrollment during the clinic visit.5 Patient perceptions of portal value increased after education by a health care professional (HCP) and assistance in enrollment to familiarize patients with the platform for ongoing use.5 Use of patient portals has been associated with favorable outcomes in chronic disease management. Patients with diabetes mellitus who regularly use patient portals for prescription refills and secure messaging have demonstrated improved glycemic control, medication adherence, and associated health parameters compared with nonusers.5-7 In patients with congestive heart failure, meaningful patient portal use results in fewer emergency department visits, fewer hospital admissions, lower readmission rates, and reduced unscheduled and no-show visits.8-11

Patient portal access is a quality improvement (QI) measure that meets Medicare and Medicaid meaningful use requirements that is designed to improve collaboration between HCPs and patients through EHRs. Despite legislation, uptake of patient portal access has been slow, especially among older adults.10,12,13 Barriers to patient portal registration and use include patient lack of awareness, perceived or actual digital illiteracy, mistrust in privacy precautions, lack of user-friendly interfaces, lack of internet or technology, HCP bias and workload, and misperceptions of usefulness.9,10,12,14 The HCPs most likely to facilitate the use of patient portals, typically include nurse practitioners (NPs), nurses, and medical residents.10,15 Patient portal platforms promote the partnership of these disciplines with the veteran to help the patient better manage their health. Despite the benefits and widespread integration of patient portals in health care systems, socioeconomic inequalities and HCP attitudes contribute to persistent disparities in its adoption by underserved populations. The veteran population is often faced with additional barriers to health care access with regard to geographic location, advanced age, trauma, disabilities, mental health challenges, and homelessness.10,16 These barriers require unique approaches to maximize the use of technologic advances.17 Advanced age contributes to low rates of patient portal enrollment and lack of digital platform use, thus creating a digital divide.11,12

The digital divide is described as the gap between those persons who use technology including computers and internet, and those persons who do not because of social and geographic barriers.16 It contributes to a growing health disparity in both access to care and quality of care especially for rural veterans. About 25% of the US population lacks fixed broadband at home; these individuals are more likely to be racial minorities, older, widowed, or to have lower levels of education.18,19 Veterans are disproportionately represented in these demographic categories.20 According to the US Department of Veterans Affairs (VA) Office of Rural Health, the percentage of rural veterans enrolled in the VA health care system (58%) is significantly higher than enrollment of urban veterans (38%); additionally, 27% of rural veterans do not access the internet at home.21

My HealtheVet

The VA plays an integral part in increasing virtual access to care, from the introduction of My Healthevet (MHV) in 2003 to the distribution of iPad tablets to vulnerable veterans during the COVID-19 pandemic.22,23 Due to COVID-19, the need for VA patient access to the internet and VA Video-Connect (VVC) telehealth services increased significantly.22 Access to internet and hardware supporting use of VVC and MHV has been facilitated by the Digital Divide Consult, a VA program launched in 2020 to increase access to telehealth services.24 The VA has distributed > 26,000 cellular-enabled tablets and provided > 50,000 veterans with connectivity in collaboration with various private sector companies.22 Patients report that MHV facilitates engagement in health care through improved access to EHRs and expedited communication with the health care team.4

MHV is a secure online tool that provides patients access to PHI. MHV aims to empower veterans to take charge of their health by improving communication with HCPs, setting patient goals, and offering health and well-being resources.25,26 In a study of outpatients at a large urban multisite health care system, < 35% of patients on 16 medical resident panels were enrolled in a patient portal.15 MHV internal national metrics show increasing registration and active users of the patient portal, yet locally, disparities in the use of the portal by rural and older veterans exist.

The Local Problem

A review of the registration process at a rural VA clinic revealed barriers to facilitating the veteran registration process at the point of care. Clinical reminders exist within the EHR to prompt clinicians at the point of care to improve quality of care. At the New England Healthcare System (Veterans Integrated Service Network [VISN] 1), a patient portal clinical reminder prompts staff to encourage veterans to register. Anecdotal data obtained from primary care staff interviews at a rural VA primary care clinic in Vermont revealed low clinician confidence in completing the clinical reminder, a lack of knowledge of MHV, and lack of time to educate veterans about the benefits of MHV.

 

 

Despite availability of a registration process at the point of care and clinical staff assigned to provide registration information to the veteran, access to the patient portal among veterans at this clinic remained low. This QI project aimed to increase patient portal enrollment of veterans in MHV in a single NP patient panel of 100 patients from a baseline of 33% by 10% in a 3-month time frame.  

Implementation

Before implementing the first Plan-Do-Study-Act (PDSA) cycle, we established the baseline data for 1 patient panel to be 33%. A retrospective review of the NP resident’s panel of 100 revealed 33 veterans were enrolled in MHV, providing a setting for process improvement. Evaluation of potential enrollment data for the panel population revealed unenrolled veterans were primarily aged ≥ 65 years. A rapid cycle QI (RCQI) strategy using the PDSA method was used to identify, implement, and measure changes over a 3-month time frame in 1 NP patient panel.14

The RCQI process included establishing baseline data and 3 PDSA cycles that evaluated the current state of patient access to the electronic patient portal, elucidated patient barriers to registration, assessed the processes for point-of-care enrollment, and developed strategies to improve the process and increase veteran enrollment. The QI project team included an NP resident as the project manager and MHV champion, a clinical faculty mentor at the site, a telehealth coordinator, an MHV coordinator, clinic registered nurse (RN), and clinic licensed nursing assistant (LNA). The RN and LNA additionally served as MHV champions as the project progressed.

PDSA Cycles

The objective for PDSA cycle 1 was to evaluate the process of patient registration and assess the impact on NP workload and clinic workflow over a 4-week period to improve veteran enrollment. Data were collected in a spreadsheet to track the number of veterans enrolled, time frame to enroll, and field notes that the NP resident recorded about the experience. The NP resident was trained in registration methods by the MHV coordinator. Several barriers to the registration process were identified: The process resulted in a change of the clinic visit closure focus, the clinic room was blocked for use by another patient, veterans had difficulty generating a unique username and password, veterans were unfamiliar with basic tablet accessibility and use, and additional time was required if incorrect information was entered. The veterans displayed low confidence in using tablet technology and were unaware of the patient portal or its usefulness. After discussion of the process with the project team, recommendations were made to address challenges, including an RN-led registration process. The first PDSA cycle increased the total patient panel enrollment by 4 veterans to 37%.

In PDSA cycle 2 after the NP visit, patients who agreed to register for the MHV portal were introduced to the tablet. The registration process was completed by the patient with the RN prior to the patient checkout. Once patient registration was completed, the veteran met the MHV coordinator and upgraded to a premium account, which provided full access to portal features. Electronic messaging was tested by the MHV coordinator and veteran to validate patient understanding. Although preloading demographic information improved accessibility issues, time was still required for the RN to orient the veteran to the tablet, provide additional directions, and answer questions.

The registration process reduced NP time commitment but added to the RN time burden and disrupted workflow; and clinic room access continued to be an issue. The wait time for the veteran to register in the clinic remained dependent on the availability of the RN. The decision was to move the registration process to the initial patient rooming assignment in the clinic and was transitioned from RN to LNA, prior to the NP-veteran encounter. Four additional veterans registered in the second PDSA cycle, and total enrollment increased to 41%, an overall 8% increase from baseline.

In the third PDSA cycle the patient enrollment process was managed by the clinic LNA using scripted information about MHV prior to the veteran encounter. A partially preloaded tablet was offered to the veteran to register with MHV during the rooming process, and written and oral instruction were provided to the veteran. The time required for each veteran to register for MHV averaged 10 minutes, and the veteran was able to register while waiting for the NP to enter the room. Typical LNA tasks included greeting patients, updating health records, completing clinical reminders with the veteran, obtaining vital signs, and addressing questions. The LNA introduced the veteran to MHV using scripted information and supported them in registering for MHV prior to the NP-veteran encounter. Registration at point of care during the rooming process was well received by both the LNA and veterans. The LNA reported the process was efficient and did not add excessive time to the LNA workflow. The LNA reported verbal patient satisfaction and registration was facilitated for 6 veterans during the 4-week period. 

 

 



Registration during point of care was reported as feasible and sustainable by the LNA. Upgrading the patient to a premium MHV account was transitioned to the MHV coordinator. All veterans seen during the 4-week period were approached about registration; if the veteran declined, written at-home step-by-step instructions were provided. A replacement electronic clinical reminder was proposed to the VISN clinical reminders team for review and was pilot tested by the primary care clinical team. The third PDSA cycle increased the total patient panel enrollment to 47%, an overall 14% increase from baseline. Six new veteran users were added during PDSA cycle 3.

Discussion

The project team successfully used a RCQI method with a PDSA strategy to improve patient access to the MHV portal and increased veteran enrollment by 14% on 1 NP resident patient panel. The project evaluated clinic workflow regarding veteran patient portal registration, uncovered inefficiencies, and developed improved processes to increase veteran access to the patient portal. Results were positively impacted through the recognition of inefficiencies and initiation of new processes to engage veterans in the portal registration process. Familiarizing the entire clinical team with the clinical reminder and registration process raised the awareness of a digital divide consult and the utility of the portal in patient care. The project provided an opportunity to evaluate veterans’ digital literacy, digital access to send and receive messages, and to provide coaching as needed. Sequential PDSA cycles employed audit and feedback, information preloading, multimodal teaching strategies (verbal, print, hands-on tablet learning), scripting, staff interviews, time studies, and workflow evaluation to improve processes. An MHV champion led the team, monitored the progress, set deadlines, and effectively communicated project performance.

Limitations

Project limitations included the single-site location, its small sample size, and the short 3-month implementation time frame. The patient panel was representative of other NP resident patient panels at the facility but may not be representative of other VA facilities.

Ethical Considerations

Patient confidentiality was maintained throughout the registration and data collection process. The project team (NP, RN, LNA) received training and written instructions on protection of patient confidentiality by the MHV coordinator prior to assisting veterans with the registration process. Privacy was maintained, no patient identifiers were collected or viewed, and no assistance was provided for username, password, or security questions. The tablet was password protected and secured, used only by the project team when veteran was interested in point-of-care portal registration.

Sustainability

QI projects require ongoing systemic efforts to enhance sustainability.26,27 The project team used the PDSA methodology to stimulate the design of new workflow processes to engage staff and veterans in portal registration. Several actions were taken to promote sustainability for veteran portal registration and improve access to health care for rural and underserved veterans. First, printed instructions and website link are available in the clinic intake and examination rooms. Staff are equipped with patient education discussion points about the portal. A tablet is available in the clinic to encourage veterans to sign up. A clinical reminder is in place to encourage portal registration. A designated super-user is available to help new patient portal users register and navigate the system. Outcomes of the QI project were presented at 2 separate VISN 1 nursing grand rounds and reported to the MHV coordinator and telehealth coordinator to promote dialogue among staff and raise awareness of challenges to veteran MHV access.

Conclusions

Reviewing patient portal registration processes at the local level is essential to improve veteran access. This QI project proposed a realistic and scalable solution to implementing and improving patient enrollment to MHV in primary care clinics. Integrating measurement of patient registration into the daily routine of the clinic empowers the entire clinical team to improve the quality of access to patient portal.

The project team worked together to accomplish a shared goal, using errors as opportunities to improve the process, while using available staff without compromising significant time or resources. Engaging the entire team to audit processes and designating one member of the team as an MHV champion to provide feedback is critical to the sustainability of point-of-care registration in the MHV patient portal. Multifaceted approaches to maximizing the use of technology lessens the digital divide for veterans who are faced with geographical and social barriers to health care access.

Acknowledgments

We thank the Office of Academic Affiliations and the US Department of Veterans Affairs Nursing Academic Partnerships in Graduate Education Nurse Practitioner residency program and clinical faculty and the affiliated University of Vermont faculty mentor/quality improvement coach for the support of the project.

Patient portals are secure online website tools that provide patient access to personal health information (PHI). Access to online PHI improves health equity and satisfies the meaningful use objectives of the Medicare electronic health record (EHR) incentive program.1,2 Through patient portals, individuals can access PHI records and current diagnoses, request and reschedule appointments, locate test results, track trends for vital signs and laboratory values, refill medications, and communicate directly with the health care team through secure messaging. This alternative method of communication with the team is associated with increased patient satisfaction.3 Patients reported improved patient engagement in health care self-management and decision making, as well as strengthened relationships with their health care team.4

Background

One well-documented strategy to improve portal use includes the development of a nurse champion to facilitate enrollment during the clinic visit.5 Patient perceptions of portal value increased after education by a health care professional (HCP) and assistance in enrollment to familiarize patients with the platform for ongoing use.5 Use of patient portals has been associated with favorable outcomes in chronic disease management. Patients with diabetes mellitus who regularly use patient portals for prescription refills and secure messaging have demonstrated improved glycemic control, medication adherence, and associated health parameters compared with nonusers.5-7 In patients with congestive heart failure, meaningful patient portal use results in fewer emergency department visits, fewer hospital admissions, lower readmission rates, and reduced unscheduled and no-show visits.8-11

Patient portal access is a quality improvement (QI) measure that meets Medicare and Medicaid meaningful use requirements that is designed to improve collaboration between HCPs and patients through EHRs. Despite legislation, uptake of patient portal access has been slow, especially among older adults.10,12,13 Barriers to patient portal registration and use include patient lack of awareness, perceived or actual digital illiteracy, mistrust in privacy precautions, lack of user-friendly interfaces, lack of internet or technology, HCP bias and workload, and misperceptions of usefulness.9,10,12,14 The HCPs most likely to facilitate the use of patient portals, typically include nurse practitioners (NPs), nurses, and medical residents.10,15 Patient portal platforms promote the partnership of these disciplines with the veteran to help the patient better manage their health. Despite the benefits and widespread integration of patient portals in health care systems, socioeconomic inequalities and HCP attitudes contribute to persistent disparities in its adoption by underserved populations. The veteran population is often faced with additional barriers to health care access with regard to geographic location, advanced age, trauma, disabilities, mental health challenges, and homelessness.10,16 These barriers require unique approaches to maximize the use of technologic advances.17 Advanced age contributes to low rates of patient portal enrollment and lack of digital platform use, thus creating a digital divide.11,12

The digital divide is described as the gap between those persons who use technology including computers and internet, and those persons who do not because of social and geographic barriers.16 It contributes to a growing health disparity in both access to care and quality of care especially for rural veterans. About 25% of the US population lacks fixed broadband at home; these individuals are more likely to be racial minorities, older, widowed, or to have lower levels of education.18,19 Veterans are disproportionately represented in these demographic categories.20 According to the US Department of Veterans Affairs (VA) Office of Rural Health, the percentage of rural veterans enrolled in the VA health care system (58%) is significantly higher than enrollment of urban veterans (38%); additionally, 27% of rural veterans do not access the internet at home.21

My HealtheVet

The VA plays an integral part in increasing virtual access to care, from the introduction of My Healthevet (MHV) in 2003 to the distribution of iPad tablets to vulnerable veterans during the COVID-19 pandemic.22,23 Due to COVID-19, the need for VA patient access to the internet and VA Video-Connect (VVC) telehealth services increased significantly.22 Access to internet and hardware supporting use of VVC and MHV has been facilitated by the Digital Divide Consult, a VA program launched in 2020 to increase access to telehealth services.24 The VA has distributed > 26,000 cellular-enabled tablets and provided > 50,000 veterans with connectivity in collaboration with various private sector companies.22 Patients report that MHV facilitates engagement in health care through improved access to EHRs and expedited communication with the health care team.4

MHV is a secure online tool that provides patients access to PHI. MHV aims to empower veterans to take charge of their health by improving communication with HCPs, setting patient goals, and offering health and well-being resources.25,26 In a study of outpatients at a large urban multisite health care system, < 35% of patients on 16 medical resident panels were enrolled in a patient portal.15 MHV internal national metrics show increasing registration and active users of the patient portal, yet locally, disparities in the use of the portal by rural and older veterans exist.

The Local Problem

A review of the registration process at a rural VA clinic revealed barriers to facilitating the veteran registration process at the point of care. Clinical reminders exist within the EHR to prompt clinicians at the point of care to improve quality of care. At the New England Healthcare System (Veterans Integrated Service Network [VISN] 1), a patient portal clinical reminder prompts staff to encourage veterans to register. Anecdotal data obtained from primary care staff interviews at a rural VA primary care clinic in Vermont revealed low clinician confidence in completing the clinical reminder, a lack of knowledge of MHV, and lack of time to educate veterans about the benefits of MHV.

 

 

Despite availability of a registration process at the point of care and clinical staff assigned to provide registration information to the veteran, access to the patient portal among veterans at this clinic remained low. This QI project aimed to increase patient portal enrollment of veterans in MHV in a single NP patient panel of 100 patients from a baseline of 33% by 10% in a 3-month time frame.  

Implementation

Before implementing the first Plan-Do-Study-Act (PDSA) cycle, we established the baseline data for 1 patient panel to be 33%. A retrospective review of the NP resident’s panel of 100 revealed 33 veterans were enrolled in MHV, providing a setting for process improvement. Evaluation of potential enrollment data for the panel population revealed unenrolled veterans were primarily aged ≥ 65 years. A rapid cycle QI (RCQI) strategy using the PDSA method was used to identify, implement, and measure changes over a 3-month time frame in 1 NP patient panel.14

The RCQI process included establishing baseline data and 3 PDSA cycles that evaluated the current state of patient access to the electronic patient portal, elucidated patient barriers to registration, assessed the processes for point-of-care enrollment, and developed strategies to improve the process and increase veteran enrollment. The QI project team included an NP resident as the project manager and MHV champion, a clinical faculty mentor at the site, a telehealth coordinator, an MHV coordinator, clinic registered nurse (RN), and clinic licensed nursing assistant (LNA). The RN and LNA additionally served as MHV champions as the project progressed.

PDSA Cycles

The objective for PDSA cycle 1 was to evaluate the process of patient registration and assess the impact on NP workload and clinic workflow over a 4-week period to improve veteran enrollment. Data were collected in a spreadsheet to track the number of veterans enrolled, time frame to enroll, and field notes that the NP resident recorded about the experience. The NP resident was trained in registration methods by the MHV coordinator. Several barriers to the registration process were identified: The process resulted in a change of the clinic visit closure focus, the clinic room was blocked for use by another patient, veterans had difficulty generating a unique username and password, veterans were unfamiliar with basic tablet accessibility and use, and additional time was required if incorrect information was entered. The veterans displayed low confidence in using tablet technology and were unaware of the patient portal or its usefulness. After discussion of the process with the project team, recommendations were made to address challenges, including an RN-led registration process. The first PDSA cycle increased the total patient panel enrollment by 4 veterans to 37%.

In PDSA cycle 2 after the NP visit, patients who agreed to register for the MHV portal were introduced to the tablet. The registration process was completed by the patient with the RN prior to the patient checkout. Once patient registration was completed, the veteran met the MHV coordinator and upgraded to a premium account, which provided full access to portal features. Electronic messaging was tested by the MHV coordinator and veteran to validate patient understanding. Although preloading demographic information improved accessibility issues, time was still required for the RN to orient the veteran to the tablet, provide additional directions, and answer questions.

The registration process reduced NP time commitment but added to the RN time burden and disrupted workflow; and clinic room access continued to be an issue. The wait time for the veteran to register in the clinic remained dependent on the availability of the RN. The decision was to move the registration process to the initial patient rooming assignment in the clinic and was transitioned from RN to LNA, prior to the NP-veteran encounter. Four additional veterans registered in the second PDSA cycle, and total enrollment increased to 41%, an overall 8% increase from baseline.

In the third PDSA cycle the patient enrollment process was managed by the clinic LNA using scripted information about MHV prior to the veteran encounter. A partially preloaded tablet was offered to the veteran to register with MHV during the rooming process, and written and oral instruction were provided to the veteran. The time required for each veteran to register for MHV averaged 10 minutes, and the veteran was able to register while waiting for the NP to enter the room. Typical LNA tasks included greeting patients, updating health records, completing clinical reminders with the veteran, obtaining vital signs, and addressing questions. The LNA introduced the veteran to MHV using scripted information and supported them in registering for MHV prior to the NP-veteran encounter. Registration at point of care during the rooming process was well received by both the LNA and veterans. The LNA reported the process was efficient and did not add excessive time to the LNA workflow. The LNA reported verbal patient satisfaction and registration was facilitated for 6 veterans during the 4-week period. 

 

 



Registration during point of care was reported as feasible and sustainable by the LNA. Upgrading the patient to a premium MHV account was transitioned to the MHV coordinator. All veterans seen during the 4-week period were approached about registration; if the veteran declined, written at-home step-by-step instructions were provided. A replacement electronic clinical reminder was proposed to the VISN clinical reminders team for review and was pilot tested by the primary care clinical team. The third PDSA cycle increased the total patient panel enrollment to 47%, an overall 14% increase from baseline. Six new veteran users were added during PDSA cycle 3.

Discussion

The project team successfully used a RCQI method with a PDSA strategy to improve patient access to the MHV portal and increased veteran enrollment by 14% on 1 NP resident patient panel. The project evaluated clinic workflow regarding veteran patient portal registration, uncovered inefficiencies, and developed improved processes to increase veteran access to the patient portal. Results were positively impacted through the recognition of inefficiencies and initiation of new processes to engage veterans in the portal registration process. Familiarizing the entire clinical team with the clinical reminder and registration process raised the awareness of a digital divide consult and the utility of the portal in patient care. The project provided an opportunity to evaluate veterans’ digital literacy, digital access to send and receive messages, and to provide coaching as needed. Sequential PDSA cycles employed audit and feedback, information preloading, multimodal teaching strategies (verbal, print, hands-on tablet learning), scripting, staff interviews, time studies, and workflow evaluation to improve processes. An MHV champion led the team, monitored the progress, set deadlines, and effectively communicated project performance.

Limitations

Project limitations included the single-site location, its small sample size, and the short 3-month implementation time frame. The patient panel was representative of other NP resident patient panels at the facility but may not be representative of other VA facilities.

Ethical Considerations

Patient confidentiality was maintained throughout the registration and data collection process. The project team (NP, RN, LNA) received training and written instructions on protection of patient confidentiality by the MHV coordinator prior to assisting veterans with the registration process. Privacy was maintained, no patient identifiers were collected or viewed, and no assistance was provided for username, password, or security questions. The tablet was password protected and secured, used only by the project team when veteran was interested in point-of-care portal registration.

Sustainability

QI projects require ongoing systemic efforts to enhance sustainability.26,27 The project team used the PDSA methodology to stimulate the design of new workflow processes to engage staff and veterans in portal registration. Several actions were taken to promote sustainability for veteran portal registration and improve access to health care for rural and underserved veterans. First, printed instructions and website link are available in the clinic intake and examination rooms. Staff are equipped with patient education discussion points about the portal. A tablet is available in the clinic to encourage veterans to sign up. A clinical reminder is in place to encourage portal registration. A designated super-user is available to help new patient portal users register and navigate the system. Outcomes of the QI project were presented at 2 separate VISN 1 nursing grand rounds and reported to the MHV coordinator and telehealth coordinator to promote dialogue among staff and raise awareness of challenges to veteran MHV access.

Conclusions

Reviewing patient portal registration processes at the local level is essential to improve veteran access. This QI project proposed a realistic and scalable solution to implementing and improving patient enrollment to MHV in primary care clinics. Integrating measurement of patient registration into the daily routine of the clinic empowers the entire clinical team to improve the quality of access to patient portal.

The project team worked together to accomplish a shared goal, using errors as opportunities to improve the process, while using available staff without compromising significant time or resources. Engaging the entire team to audit processes and designating one member of the team as an MHV champion to provide feedback is critical to the sustainability of point-of-care registration in the MHV patient portal. Multifaceted approaches to maximizing the use of technology lessens the digital divide for veterans who are faced with geographical and social barriers to health care access.

Acknowledgments

We thank the Office of Academic Affiliations and the US Department of Veterans Affairs Nursing Academic Partnerships in Graduate Education Nurse Practitioner residency program and clinical faculty and the affiliated University of Vermont faculty mentor/quality improvement coach for the support of the project.

References

1. Centers for Medicare and Medicaid Services. Promoting interoperability programs. Updated October 6, 2022. Accessed November 3, 2022. https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms

2. American Hospital Association. Goals of the Medicare and Medicaid electronic health records programs. Accessed November 3, 2022. https://www.aha.org/websites/2009-12-11-goals-medicare-and-medicaid-electronic-health-records-programs

3. Rozenblum R, Donzé J, Hockey PM, et al. The impact of medical informatics on patient satisfaction: a USA-based literature review. Int J Med Inform. 2013;82(3):141-158. doi:10.1016/j.ijmedinf.2012.12.008

4. Stewart MT, Hogan TP, Nicklas J, et al. The promise of patient portals for individuals living with chronic illness: qualitative study identifying pathways of patient engagement. J Med Internet Res. 2020;22(7):e17744. Published 2020 Jul 17. doi:10.2196/17744

5. Harris LT, Haneuse SJ, Martin DP, Ralston JD. Diabetes quality of care and outpatient utilization associated with electronic patient-provider messaging: a cross-sectional analysis. Diabetes Care. 2009;32(7):1182-1187. doi:10.2337/dc08-1771

6. Robinson SA, Zocchi MS, Netherton D, et al. Secure messaging, diabetes self-management, and the importance of patient autonomy: a mixed methods study. J Gen Intern Med. 2020;35(10):2955-2962. doi:10.1007/s11606-020-05834-x

7. Zocchi MS, Robinson SA, Ash AS, et al. Patient portal engagement and diabetes management among new portal users in the Veterans Health Administration. J Am Med Inform Assoc. 2021;28(10):2176-2183. doi:10.1093/jamia/ocab115

8. Bao C, Bardhan IR, Singh H, Meyer BA, Kirksey K. Patient-provider engagement and its impact on health outcomes: a longitudinal study of patient portal use. MIS Quarterly. 2020;44(2):699-723. doi:10.25300/MISQ/2020/14180

9. Grossman LV, Masterson Creber RM, Benda NC, Wright D, Vawdrey DK, Ancker JS. Interventions to increase patient portal use in vulnerable populations: a systematic review. J Am Med Informs Assoc. 2019;26(8-9):855-870. doi:10.1093/jamia/ocz023

10. Zhao JY, Song B, Anand E, et al. Barriers, facilitators, and solutions to optimal patient portal and personal health record use: a systematic review of the literature. AMIA Annu Symp Proc. 2018;2017:1913-1922. Published 2018 Apr 16.

11. Zhong X, Park J, Liang M, et al. Characteristics of patients using different patient portal functions and the impact on primary care service utilization and appointment adherence: retrospective observational study. J Med Internet Res. 2020;22(2):e14410. Published 2020 Feb 25. doi:10.2196/14410

12. Krishnaswami A, Beavers C, Dorsch MP, et al. Gerotechnology for older adults with cardiovascular diseases. J Am Coll Cardiol. 2020;76(22):2650-2670. doi:10.1016/j.jacc.2020.09.606

13. Fix GM, Hogan TP, Amante DJ, McInnes DK, Nazi KM, Simon SR. Encouraging patient portal use in the patient-centered medical home: three stakeholder perspectives. J Med Internet Res. 2016;18(11):e308. Published 2016 Nov 22. doi:10.2196/jmir.6488

14. Ancker JS, Nosal S, Hauser D, Way C, Calman N. Access policy and the digital divide in patient access to medical records. Health Policy Technol. 2016;6(3-11). doi:10.1016/j.hlpt.2016.11.004

15. Rhudy C, Broxterman J, Stewart S, et al. Improving patient portal enrolment in an academic resident continuity clinic: quality improvement made simple. BMJ Open Qual. 2019;8(2):e000430. Published 2019 Apr 25. doi:10.1136/bmjoq-2018-000430

16. Kontos E, Blake KD, Chou WY, Prestin A. Predictors of eHealth usage: insights on the digital divide from the Health Information National Trends Survey 2012. J Med Internet Res. 2014;16(7):e172. Published 2014 Jul 16. doi:10.2196/jmir.3117

17. National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Population Health and Public Health Practice. The state of health disparities in the United States. In: Baciu A, Negussie Y, Geller A, et al, eds. Communities in Action: Pathways to Health Equity. National Academies Press (US); January 11, 2017. Accessed November 3, 2022. https://www.ncbi.nlm.nih.gov/books/NBK425848/

18. Pew Research Center. Internet/broadband fact sheet. Updated April 7, 2021. Accessed November 3, 2022. https://www.pewresearch.org/internet/fact-sheet/internet-broadband

19. Roberts ET, Mehrotra A. Assessment of disparities in digital access among Medicare beneficiaries and implications for telemedicine. JAMA Intern Med. 2020;180(10):1386-1389. doi:10.1001/jamainternmed.2020.2666

20. US Department of Veterans Affairs, National Center for Veterans Analysis and Statistics. Veteran population. Updated September 7, 2022. Accessed November 3, 2022. https://www.va.gov/vetdata/veteran_population.asp

21. US Department of Veterans Affairs, Office of Rural Health. Rural veterans health care challenges. Updated March 31, 2022. Accessed November 3, 2022. https://www.ruralhealth.va.gov/aboutus/ruralvets.asp

22. US Department of Veterans Affairs, Office of Public and Intergovernmental Affairs. VA expands veteran access to telehealth with iPad services. Press release. September 15, 2020. Accessed November 3, 2022. https://www.va.gov/opa/pressrel/pressrelease.cfm?id=5521

23. Zulman DM, Wong EP, Slightam C, et al. Making connections: National implementation of video telehealth tablets to address access barriers in veterans. JAMIA Open. 2019;2(3):323-329. doi:10.1093/jamiaopen/ooz024

24. Malone NC, Williams MM, Smith Fawzi MC, et al. Mobile health clinics in the United States. Int J Equity Health. 2020;19(1):40. doi:10.1186/s12939-020-1135-7

25. US Department of Veterans Affairs. How to use My HealtheVet. Accessed November 3, 2022. https://www.myhealth.va.gov/mhv-portal-web/how-to-use-mhv

26. US Department of Veterans Affairs, Veterans Health Administration, Office of Patient Centered Care and Cultural Transformation. Whole health for life. 2017. Accessed November 3, 2022. https://www.va.gov/wholehealth/docs/2017-AR-Vet-Facing_FNL-W508.pdf27. Mortimer F, Isherwood J, Wilkinson A, Vaux E. Sustainability in quality improvement: redefining value. Future Healthc J. 2018;5(2):88-93. doi:10.7861/futurehosp.5-2-88

References

1. Centers for Medicare and Medicaid Services. Promoting interoperability programs. Updated October 6, 2022. Accessed November 3, 2022. https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms

2. American Hospital Association. Goals of the Medicare and Medicaid electronic health records programs. Accessed November 3, 2022. https://www.aha.org/websites/2009-12-11-goals-medicare-and-medicaid-electronic-health-records-programs

3. Rozenblum R, Donzé J, Hockey PM, et al. The impact of medical informatics on patient satisfaction: a USA-based literature review. Int J Med Inform. 2013;82(3):141-158. doi:10.1016/j.ijmedinf.2012.12.008

4. Stewart MT, Hogan TP, Nicklas J, et al. The promise of patient portals for individuals living with chronic illness: qualitative study identifying pathways of patient engagement. J Med Internet Res. 2020;22(7):e17744. Published 2020 Jul 17. doi:10.2196/17744

5. Harris LT, Haneuse SJ, Martin DP, Ralston JD. Diabetes quality of care and outpatient utilization associated with electronic patient-provider messaging: a cross-sectional analysis. Diabetes Care. 2009;32(7):1182-1187. doi:10.2337/dc08-1771

6. Robinson SA, Zocchi MS, Netherton D, et al. Secure messaging, diabetes self-management, and the importance of patient autonomy: a mixed methods study. J Gen Intern Med. 2020;35(10):2955-2962. doi:10.1007/s11606-020-05834-x

7. Zocchi MS, Robinson SA, Ash AS, et al. Patient portal engagement and diabetes management among new portal users in the Veterans Health Administration. J Am Med Inform Assoc. 2021;28(10):2176-2183. doi:10.1093/jamia/ocab115

8. Bao C, Bardhan IR, Singh H, Meyer BA, Kirksey K. Patient-provider engagement and its impact on health outcomes: a longitudinal study of patient portal use. MIS Quarterly. 2020;44(2):699-723. doi:10.25300/MISQ/2020/14180

9. Grossman LV, Masterson Creber RM, Benda NC, Wright D, Vawdrey DK, Ancker JS. Interventions to increase patient portal use in vulnerable populations: a systematic review. J Am Med Informs Assoc. 2019;26(8-9):855-870. doi:10.1093/jamia/ocz023

10. Zhao JY, Song B, Anand E, et al. Barriers, facilitators, and solutions to optimal patient portal and personal health record use: a systematic review of the literature. AMIA Annu Symp Proc. 2018;2017:1913-1922. Published 2018 Apr 16.

11. Zhong X, Park J, Liang M, et al. Characteristics of patients using different patient portal functions and the impact on primary care service utilization and appointment adherence: retrospective observational study. J Med Internet Res. 2020;22(2):e14410. Published 2020 Feb 25. doi:10.2196/14410

12. Krishnaswami A, Beavers C, Dorsch MP, et al. Gerotechnology for older adults with cardiovascular diseases. J Am Coll Cardiol. 2020;76(22):2650-2670. doi:10.1016/j.jacc.2020.09.606

13. Fix GM, Hogan TP, Amante DJ, McInnes DK, Nazi KM, Simon SR. Encouraging patient portal use in the patient-centered medical home: three stakeholder perspectives. J Med Internet Res. 2016;18(11):e308. Published 2016 Nov 22. doi:10.2196/jmir.6488

14. Ancker JS, Nosal S, Hauser D, Way C, Calman N. Access policy and the digital divide in patient access to medical records. Health Policy Technol. 2016;6(3-11). doi:10.1016/j.hlpt.2016.11.004

15. Rhudy C, Broxterman J, Stewart S, et al. Improving patient portal enrolment in an academic resident continuity clinic: quality improvement made simple. BMJ Open Qual. 2019;8(2):e000430. Published 2019 Apr 25. doi:10.1136/bmjoq-2018-000430

16. Kontos E, Blake KD, Chou WY, Prestin A. Predictors of eHealth usage: insights on the digital divide from the Health Information National Trends Survey 2012. J Med Internet Res. 2014;16(7):e172. Published 2014 Jul 16. doi:10.2196/jmir.3117

17. National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Population Health and Public Health Practice. The state of health disparities in the United States. In: Baciu A, Negussie Y, Geller A, et al, eds. Communities in Action: Pathways to Health Equity. National Academies Press (US); January 11, 2017. Accessed November 3, 2022. https://www.ncbi.nlm.nih.gov/books/NBK425848/

18. Pew Research Center. Internet/broadband fact sheet. Updated April 7, 2021. Accessed November 3, 2022. https://www.pewresearch.org/internet/fact-sheet/internet-broadband

19. Roberts ET, Mehrotra A. Assessment of disparities in digital access among Medicare beneficiaries and implications for telemedicine. JAMA Intern Med. 2020;180(10):1386-1389. doi:10.1001/jamainternmed.2020.2666

20. US Department of Veterans Affairs, National Center for Veterans Analysis and Statistics. Veteran population. Updated September 7, 2022. Accessed November 3, 2022. https://www.va.gov/vetdata/veteran_population.asp

21. US Department of Veterans Affairs, Office of Rural Health. Rural veterans health care challenges. Updated March 31, 2022. Accessed November 3, 2022. https://www.ruralhealth.va.gov/aboutus/ruralvets.asp

22. US Department of Veterans Affairs, Office of Public and Intergovernmental Affairs. VA expands veteran access to telehealth with iPad services. Press release. September 15, 2020. Accessed November 3, 2022. https://www.va.gov/opa/pressrel/pressrelease.cfm?id=5521

23. Zulman DM, Wong EP, Slightam C, et al. Making connections: National implementation of video telehealth tablets to address access barriers in veterans. JAMIA Open. 2019;2(3):323-329. doi:10.1093/jamiaopen/ooz024

24. Malone NC, Williams MM, Smith Fawzi MC, et al. Mobile health clinics in the United States. Int J Equity Health. 2020;19(1):40. doi:10.1186/s12939-020-1135-7

25. US Department of Veterans Affairs. How to use My HealtheVet. Accessed November 3, 2022. https://www.myhealth.va.gov/mhv-portal-web/how-to-use-mhv

26. US Department of Veterans Affairs, Veterans Health Administration, Office of Patient Centered Care and Cultural Transformation. Whole health for life. 2017. Accessed November 3, 2022. https://www.va.gov/wholehealth/docs/2017-AR-Vet-Facing_FNL-W508.pdf27. Mortimer F, Isherwood J, Wilkinson A, Vaux E. Sustainability in quality improvement: redefining value. Future Healthc J. 2018;5(2):88-93. doi:10.7861/futurehosp.5-2-88

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Evaluation of a Pharmacist-Driven Ambulatory Aspirin Deprescribing Protocol

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The use of low-dose aspirin for the primary prevention of cardiovascular disease (CVD) morbidity and mortality continues to be controversial, particularly for older adults. Recently published, robust randomized controlled trials have revealed less cardiovascular benefit from aspirin for primary prevention compared with previous trials; additionally, an increased risk of major bleeding events has been notably more prevalent in older adults.1-5 These trials have suggested that preventative aspirin use in older adults confers less benefit than other therapies for decreasing atherosclerotic CVD (ASCVD) risk, including blood pressure (BP) control, cholesterol management, and tobacco cessation.1,6

A recent meta-analysis indicated a composite cardiovascular risk reduction in patients aged 53 to 74 years taking aspirin vs no aspirin; however, this benefit was offset with an even greater increased risk of major bleeding.7 This trend was consistent regardless of stratification by 10-year ASCVD risk or presence of diabetes mellitus (DM) diagnosis.7,8 Additionally, the recently published Aspirin in Reducing Events in the Elderly (ASPREE) trial studied the impacts of aspirin use in healthy adults aged ≥ 70 years and aged ≥ 65 years among Black and Hispanic adults.4 The study concluded that the risk of major bleeding with aspirin use was even higher vs the potential cardiovascular benefit in older adults.4

With this emerging evidence, guidelines have been updated to represent the need for risk vs benefit considerations regarding aspirin use for primary prevention in older adults.1,9,10 The most recent guideline update from the American College of Cardiology and American Heart Association (ACC/AHA) recommends against the routine use of aspirin in patients aged > 70 years or those with bleeding risk factors.1 The guideline recommends considering aspirin use for patients ages 40 to 70 years only after a patient-specific risk vs benefit discussion.1 Furthermore, the 2020 American Diabetes Association guideline recommends considering aspirin use for primary prevention in adults with DM between ages 50 and 70 only after a risk vs benefit discussion of patient-specific bleeding risk factors and ASCVD risk-enhancing factors.10

Despite the demonstrated risks for bleeding with the routine use of aspirin, studies indicate that aspirin continues to be used commonly among older adults, often when unnecessary. In the 2017 National Health Interview Survey, about 23% of adults aged > 40 years in the United States without CVD used aspirin daily, and 23% of these did so without recommendation from a health care professional.11 Furthermore, nearly half of adults ages ≥ 70 years and nearly one-quarter of adults with a history of peptic ulcer disease used aspirin daily.11 Although the most recent guidelines from the ACC/AHA do not recommend a 10-year ASCVD risk threshold for therapy, one study illustrated that 12% of older adult patients were inappropriately prescribed aspirin for primary prevention despite a 10-year ASCVD risk of < 6%.1,12 These studies highlight the large proportion of individuals, particularly older adults, who may be inappropriately taking aspirin for primary prevention.

Deprescribing Program

Deprescribing potentially inappropriate medications (PIMs) is particularly important in the older adult population, as these individuals experience a high risk of adverse effects (AEs), polypharmacy, cognitive decline, and falls related to medication use.6,13-17 Evidence suggests that mortality outcomes are improved with the implementation of targeted deprescribing efforts based on patient-specific factors.18 Additionally, deprescribing unnecessary medications may improve adherence to other essential medications and reduce financial burdens.19 Pharmacists play a crucial role among health care professionals in the implementation of deprescribing practices, and studies have shown that physicians are highly accepting of pharmacists’ deprescribing recommendations.13,20-22

Despite the evidence for the benefits of deprescribing, limited data are available regarding the impact and feasibility of a targeted aspirin deprescribing approach by nonphysician practitioners.23 The objective of this study was to implement and evaluate the success of a pharmacist-driven aspirin deprescribing protocol for older adults in a primary care setting.

This aspirin deprescribing protocol was developed by ambulatory care clinical pharmacist or clinical pharmacist practitioners (CPPs), at the William S. Middleton Memorial Veterans Hospital in Madison, Wisconsin. Within the US Department of Veterans Affairs (VA) health care system, CPPs work under a broad scope of practice with the ability to independently prescribe and monitor medications. The protocol was reviewed by physician stakeholders in both primary care and cardiology and a list was generated, including patients from 2 primary care panels aged ≥ 70 years with aspirin on their medication list, either as a prescription or over-the-counter medication, using the VA Information System Technology and Architecture. A CPP or supervised pharmacy intern identified patients from this list who were appropriate for risk/benefit discussions regarding the discontinuation of aspirin. Patients were excluded from the intervention if they had a history of clinical ASCVD, including myocardial infarction (MI), stable or unstable angina, coronary artery disease (CAD), coronary or other arterial revascularization, cerebrovascular accident (CVA), transient ischemic accident (TIA), or peripheral artery disease (PAD), or another documented indication for aspirin use, including pain, flushing (with niacin use), venous thromboembolism prophylaxis, valvular heart disease, or acute or recurrent pericarditis.

 

 



After identifying eligible patients, a CPP or pharmacy intern contacted patients by telephone, following a script to guide conversation. All patients were screened for potential appropriate aspirin indications, particularly any history of MI, CAD, CVA, TIA, PAD, or other clinical ASCVD. The patient was asked about their rationale for taking aspirin and patient-specific ASCVD risk-enhancing factors and bleeding risk factors and educated them on lifestyle modalities to reduce ASCVD risk, using the script as a guide. ASCVD risk-enhancing factors included family history of premature MI, inability to achieve BP goal, DM with the inability to achieve blood glucose or hemoglobin A1c goal, tobacco use, or inadequate statin therapy. Bleeding risk factors included a history of gastrointestinal bleed or peptic ulcer disease, concurrent use of medications that increase bleeding risk, chronic kidney disease, or thrombocytopenia.

Through shared decision making with careful consideration of these factors, we reached a conclusion with each patient to either continue or to deprescribe aspirin. Each discussion was documented in the electronic health record (EHR) using a standard documentation template (eAppendix, available at doi:10.12788/fp.0320). The patient’s medication list also was updated to reflect changes in aspirin use. For patients who declined deprescribing, the CPP or pharmacy intern asked the patient for their primary reason for preferring to continue aspirin, which was subsequently categorized as one of the following: no prior concerns with bleeding, concerns about a future cardiovascular event, wishing to discuss further with their primary care practitioner (PCP), or identifying an appropriate use for aspirin not evident through record review. For the patients who wished to further discuss the issue with their PCP before deprescribing, the patient’s PCP was notified of this preference by a record alert to the note documenting the encounter, and the patient was also encouraged to follow up about this issue. A voicemail was left if the patient did not answer requesting a call back, and a second attempt was made within 2 weeks.

Data Collected

We collected data to assess the proportion of patients for whom aspirin for primary prevention was discontinued. For patients who declined deprescribing, we documented the rationale for continuing aspirin. Additionally, the feasibility of implementation was assessed, including pharmacist time spent on each record review and intervention. Descriptive statistics were generated to evaluate baseline characteristics and intervention outcomes. The time to completion of these tasks was summarized with descriptive statistics.

We reviewed 459 patient records, and 110 were determined eligible for risk/benefit discussions.

The mean (range) age of the patients contacted was 75 (70-93) years (Table). Telephone calls were attempted to these 110 patients, resulting in an 86% reach rate. Of the 94 patients reached, 45 (48%) agreed to aspirin deprescribing and 29 (31%) declined deprescribing. Seventeen (18%) patients had previously stopped taking aspirin, which required medication reconciliation to remove aspirin from the medication list. Three (3%) patients preferred to stay on aspirin and agreed to stay on aspirin on reduced dosage.

Patients had various reasons for declining deprescribing, including 8 (28%) who had no prior concerns with bleeding while on aspirin and 6 (21%) who were concerned about a future cardiovascular event. Of those who declined aspirin deprescribing, 6 (21%) wished to further discuss the issue with their PCP. In 9 (31%) patients an alternative appropriate indication for aspirin was identified through discussion. In these cases, the indication for aspirin was documented and updated in the EHR.

Most patients (87%) contacted reported taking low-dose aspirin 81 mg daily, while 10% reported taking higher doses (range, 162-325) and 3% on an as-needed basis. In all 3 patients who agreed to dose reduction, the initial dose of 325 mg daily was reduced to 81 mg daily.

 

 



Results of the time-study analysis for each intervention indicated that a pharmacy intern or pharmacist spent about 2 minutes reviewing the record of each patient to determine eligibility for risk/benefit discussions. The 110 patients identified as eligible were 24% of the 459 records reviewed. An average (range) of 12 (6-20) minutes was spent on the telephone call plus documentation for each patient contacted. Additionally, we estimated that CPPs and pharmacy interns spent an approximate combined 12 hours in the development and review of materials for this program, including the protocol, script, and documentation templates. This also included about 1 hour to identify appropriate parameters for, and generate, the eligible patient list.

Discussion

The implementation of a pharmacist-driven aspirin deprescribing protocol for older adults in a primary care setting led to the discontinuation of inappropriate aspirin use in nearly half of older adults contacted. Furthermore, opportunities were identified to update medication lists to reflect previously self-discontinued aspirin for older adults. Just over one-quarter of those contacted declined to discontinue or reduce their aspirin dose. It is hypothesized that with these targeted deprescribing interventions, overall risk reduction for bleeding and polypharmacy will be observed for older adults.1

In addition to deprescribing aspirin, CPPs used shared decision making to initiate risk/benefit discussions and to educate on targeted lifestyle modifications to lower ASCVD risk. While not all patients agreed to discontinue aspirin, all were provided education that may empower them to engage in future discussions with PCPs regarding appropriate aspirin use. Previous pharmacist-led deprescribing initiatives for proton pump inhibitors and other PIMs have indicated that a large percentage of patients who opt to further discuss a deprescribing concern with their PCPs ultimately resulted in deprescribing outcomes.24,25 Additionally, a recent trial examining pharmacist-led deprescribing of 4 common PIMs in older adults compared the impact of pharmacists leading educational interventions directly to patients with pharmacists making deprescribing recommendations to physicians. Deprescribing was more successful when patients were involved in the decision-making process.26

Limitations

Although this quality improvement initiative resulted in the deprescribing of inappropriate aspirin for many older adults, a limitation is the small sample size within a single institution. The population of male veterans also may limit generalizability to nonmale and nonveteran older adults. As the protocol was initiated within a limited number of primary care teams initially, future implementation into additional primary care teams will increase the number of older adults impacted by risk/benefit discussions regarding aspirin use. This work may not be generalizable to other health care systems. Many patients within the VA receive both their primary and specialty care within the system, which facilitates communication and collaboration between primary and specialty practitioners. The protocol may require workflow adjustments for patients receiving care within multiple systems. Additionally, although the deprescribing protocol was created in collaboration with physicians, CPPs within the VA work under a broad scope of practice that includes independent medication prescribing, deprescribing, and monitoring. This may be a consideration when implementing similar protocols at other sites, as collaborative practice agreements may need to be in place.

Future Directions

The time required to complete these interventions was generally feasible, though this intervention would require some workflow alteration to be incorporated routinely into a CPP’s schedule. The telephone calls were completed as isolated interventions and were not incorporated into existing scheduled primary care appointments. In the future, the aspirin deprescribing protocol could be incorporated into existing pharmacist-led primary care appointments. Based on the outcomes of this study, CPPs are leading an initiative to develop an aspirin deprescribing clinical reminder tool, which may be quickly inserted into a progress note within the EHR and may be incorporated into any primary care visit led by a CPP or PCP.

Conclusions

This study demonstrates that a pharmacist-led aspirin deprescribing protocol in the ambulatory care pharmacy setting was successful in the discontinuation of unnecessary aspirin use in older adults. The protocol also provided opportunities for education on ASCVD risk reduction in all older adults reached. These findings highlight the role of pharmacists in deprescribing PIMs for older adults and identifying opportunities to further streamline risk/benefit discussions on aspirin deprescribing potential within primary care visits.

References

1. Arnett DK, Blumenthal RS, Albert MA, et al. 2019 ACC/AHA guideline on the primary prevention of cardiovascular disease: a report of the American College of Cardiology/American Heart Association Task Force on clinical practice guidelines. Circulation. 2019;140(11):e596-e646. doi:10.1161/CIR.0000000000000678

2. Gaziano JM, Brotons C, Coppolecchia R, et al. Use of aspirin to reduce risk of initial vascular events in patients at moderate risk of cardiovascular disease (ARRIVE): a randomized, double-blind, placebo-controlled trial. Lancet. 2018;392(10152):1036-1046. doi:10.1016/S0140-6736(18)31924-X

3. Bowman L, Mafham M, et al; ASCEND Study Collaborative Group. Effects of aspirin for primary prevention in persons with diabetes mellitus. N Engl J Med. 2018;379(16):1529-1539. doi:10.1056/NEJMoa1804988

4. McNeil JJ, Wolfe R, Woods, RL, et al. Effect of aspirin on cardiovascular events and bleeding in the healthy elderly. N Engl J Med. 2018;379(16):1509-1518. doi:10.1056/NEJMoa1805819

5. García Rodríguez LA, Martín-Pérez M, Hennekens CH, Rothwell PM, Lanas A. Bleeding risk with long-term low-dose aspirin: a systematic review of observational studies. PloS One. 2016;11(8):e0160046. doi:10.1371/journal.pone.0160046

6. Gallagher P, Ryan C, Byrne S, Kennedy J, O’Mahony D. STOPP (Screening Tool of Older Person’s Prescriptions) and START (Screening Tool to Alert doctors to Right Treatment): consensus validation. Int J Clin Pharmacol Ther. 2008;46(2):72-83. doi:10.5414/cpp46072

7. Zheng SL, Roddick AJ. Association of aspirin use for primary prevention with cardiovascular events and bleeding events: a systematic review and meta-analysis. JAMA. 2019;321(3):277-287. doi:10.1001/jama.2018.20578

8. Patrono C, Baigent C. Role of aspirin in primary prevention of cardiovascular disease. Nat Rev Cardiol. 2019;16(11):675-686. doi:10.1038/s41569-019-0225-y

9. Bibbins-Domingo K; U.S. Preventative Services Task Force. Aspirin use for the primary prevention of cardiovascular disease and colorectal cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2016;164(12):836-845. doi:10.7326/M16-0577

10. American Diabetes Association. Classification and diagnosis of diabetes: standards of medical care in diabetes-2020. Diabetes Care. 2020;43(suppl 1):S14-S31. doi:10.2337/dc20-S002

11. O’Brien CW, Juraschek SP, Wee CC. Prevalence of aspirin use for primary prevention of cardiovascular disease in the United States: results from the 2017 National Health Interview Survey. Ann Intern Med. 2019;171(8):596-598. doi:10.7326/M19-0953

12. Hira RS, Kennedy K, Nambi V, et al. Frequency and practice-level variation in inappropriate aspirin use for the primary prevention of cardiovascular disease: insights from the National Cardiovascular Disease Registry’s Practice Innovation and Clinical Excellence registry. J Am Coll Cardiol. 2015;65(2):111-121. doi:10.1016/j.jacc.2014.10.035

13. Cheong ST, Ng TM, Tan KT. Pharmacist-initiated deprescribing in hospitalized elderly: prevalence and acceptance by physicians. Eur J Hosp Pharm. 2018;25(e1):e35-e39. doi:10.1136/ejhpharm-2017-001251

14. Dyck MJ. Evidence-based administrative guideline: quality improvement in nursing homes. J Gerontol Nurs. 2005;31(2):4-10. doi:10.3928/0098-9134-20050201-04

15. Zullo AR, Gray SL, Holmes HM, Marcum ZA. Screening for medication appropriateness in older adults. Clin Geriatr Med. 2018;34(1):39-54. doi:10.1016/j.cger.2017.09.003

16. American Geriatrics Society. 2019 updated AGS Beers Criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2019;67(4):674-694. doi:10.1111/jgs.15767

17. Shah BM, Hajjar ER. Polypharmacy, adverse drug reactions, and geriatric syndromes. Clin Geriatr Med. 2012;28(2):173-186. doi:10.1016/j.cger.2012.01.002

18. Page AT, Clifford RM, Potter K, Schwartz D, Etherton-Beer CD. The feasibility and effect of deprescribing in older adults on mortality and health: a systematic review and meta-analysis. Br J Clin Pharmacol. 2016;82(3):583-623. doi:10.1111/bcp.12975

19. Reeve E, Shakib S, Hendrix I, Roberts MS, Wiese MD. The benefits and harms of deprescribing. Med J Aust. 2014;201(7):386-389. doi:10.5694/mja13.00200

20. Ailabouni NJ, Marcum ZA, Schmader KE, Gray SL. Medication use quality and safety in older adults: 2018 update. J Am Geriatr Soc. 2019;67(12):2458-2462. doi:10.1111/jgs.16243

21. Frank C, Weir E. Deprescribing for older patients. CMAJ. 2014;186(18):1369-1376. doi:10.1503/cmaj.131873

22. Clark CM, LaValley SA, Singh R, Mustafa E, Monte SV, Wahler RG Jr. A pharmacist-led program to facilitate deprescribing in a primary care clinic. J Am Pharm Assoc (2003). 2020;60(1):105-111. doi:10.1016/j.japh.2019.09.011

23. Folks B, Leblanc WG, Staton EW, Pace WD. Reconsidering low-dose aspirin therapy for cardiovascular disease: a study protocol for physician and patient behavioral change. Implement Sci. 2011;6:65. Published 2011 Jun 26. doi:10.1186/1748-5908-6-65

24. Odenthal DR, Philbrick AM, Harris IM. Successful deprescribing of unnecessary proton pump inhibitors in a primary care clinic. J Am Pharm Assoc. 2020;60(1):100-104. doi:10.1016/j.japh.2019.08.012

25. Duncan, P. Duerden M, Payne RA. Deprescribing: a primary care perspective. Eur J Hosp Pharm. 2017;24(1):37-42. doi:10.1136/ejhpharm-2016-000967

26. Martin P, Tamblyn R, Benedetti A, Ahmed S, Tannenbaum C. Effect of a pharmacist-led educational intervention on inappropriate medication prescriptions in older adults: the D-PRESCRIBE randomized clinical trial. JAMA. 2018;320(18):1889-1898. doi:10.1001/jama.2018.16131

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Katherine Rothbauer, PharmDa; Magdalena Siodlak, PharmD, BCACPa; Emma Dreischmeier, PharmDa; Trisha Seys Ranola, PharmD, BCGP, CDCESa,b; Lauren Welch, PharmD, BCGPa
Correspondence:
Katherine Rothbauer ([email protected])

aWilliam S. Middleton Memorial Veterans Hospital, Madison, Wisconsin
bUniversity of Wisconsin, Madison School of Pharmacy

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Ethics and consent

This project did not meet the federal definition of research pursuant to 45 CFR §46. The University of Wisconsin-Madison Quality Improvement Program Evaluation Self-Certification Tool was used to confirm this project did not require institutional review board approval.

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Katherine Rothbauer, PharmDa; Magdalena Siodlak, PharmD, BCACPa; Emma Dreischmeier, PharmDa; Trisha Seys Ranola, PharmD, BCGP, CDCESa,b; Lauren Welch, PharmD, BCGPa
Correspondence:
Katherine Rothbauer ([email protected])

aWilliam S. Middleton Memorial Veterans Hospital, Madison, Wisconsin
bUniversity of Wisconsin, Madison School of Pharmacy

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Ethics and consent

This project did not meet the federal definition of research pursuant to 45 CFR §46. The University of Wisconsin-Madison Quality Improvement Program Evaluation Self-Certification Tool was used to confirm this project did not require institutional review board approval.

Author and Disclosure Information

Katherine Rothbauer, PharmDa; Magdalena Siodlak, PharmD, BCACPa; Emma Dreischmeier, PharmDa; Trisha Seys Ranola, PharmD, BCGP, CDCESa,b; Lauren Welch, PharmD, BCGPa
Correspondence:
Katherine Rothbauer ([email protected])

aWilliam S. Middleton Memorial Veterans Hospital, Madison, Wisconsin
bUniversity of Wisconsin, Madison School of Pharmacy

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Ethics and consent

This project did not meet the federal definition of research pursuant to 45 CFR §46. The University of Wisconsin-Madison Quality Improvement Program Evaluation Self-Certification Tool was used to confirm this project did not require institutional review board approval.

Article PDF
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The use of low-dose aspirin for the primary prevention of cardiovascular disease (CVD) morbidity and mortality continues to be controversial, particularly for older adults. Recently published, robust randomized controlled trials have revealed less cardiovascular benefit from aspirin for primary prevention compared with previous trials; additionally, an increased risk of major bleeding events has been notably more prevalent in older adults.1-5 These trials have suggested that preventative aspirin use in older adults confers less benefit than other therapies for decreasing atherosclerotic CVD (ASCVD) risk, including blood pressure (BP) control, cholesterol management, and tobacco cessation.1,6

A recent meta-analysis indicated a composite cardiovascular risk reduction in patients aged 53 to 74 years taking aspirin vs no aspirin; however, this benefit was offset with an even greater increased risk of major bleeding.7 This trend was consistent regardless of stratification by 10-year ASCVD risk or presence of diabetes mellitus (DM) diagnosis.7,8 Additionally, the recently published Aspirin in Reducing Events in the Elderly (ASPREE) trial studied the impacts of aspirin use in healthy adults aged ≥ 70 years and aged ≥ 65 years among Black and Hispanic adults.4 The study concluded that the risk of major bleeding with aspirin use was even higher vs the potential cardiovascular benefit in older adults.4

With this emerging evidence, guidelines have been updated to represent the need for risk vs benefit considerations regarding aspirin use for primary prevention in older adults.1,9,10 The most recent guideline update from the American College of Cardiology and American Heart Association (ACC/AHA) recommends against the routine use of aspirin in patients aged > 70 years or those with bleeding risk factors.1 The guideline recommends considering aspirin use for patients ages 40 to 70 years only after a patient-specific risk vs benefit discussion.1 Furthermore, the 2020 American Diabetes Association guideline recommends considering aspirin use for primary prevention in adults with DM between ages 50 and 70 only after a risk vs benefit discussion of patient-specific bleeding risk factors and ASCVD risk-enhancing factors.10

Despite the demonstrated risks for bleeding with the routine use of aspirin, studies indicate that aspirin continues to be used commonly among older adults, often when unnecessary. In the 2017 National Health Interview Survey, about 23% of adults aged > 40 years in the United States without CVD used aspirin daily, and 23% of these did so without recommendation from a health care professional.11 Furthermore, nearly half of adults ages ≥ 70 years and nearly one-quarter of adults with a history of peptic ulcer disease used aspirin daily.11 Although the most recent guidelines from the ACC/AHA do not recommend a 10-year ASCVD risk threshold for therapy, one study illustrated that 12% of older adult patients were inappropriately prescribed aspirin for primary prevention despite a 10-year ASCVD risk of < 6%.1,12 These studies highlight the large proportion of individuals, particularly older adults, who may be inappropriately taking aspirin for primary prevention.

Deprescribing Program

Deprescribing potentially inappropriate medications (PIMs) is particularly important in the older adult population, as these individuals experience a high risk of adverse effects (AEs), polypharmacy, cognitive decline, and falls related to medication use.6,13-17 Evidence suggests that mortality outcomes are improved with the implementation of targeted deprescribing efforts based on patient-specific factors.18 Additionally, deprescribing unnecessary medications may improve adherence to other essential medications and reduce financial burdens.19 Pharmacists play a crucial role among health care professionals in the implementation of deprescribing practices, and studies have shown that physicians are highly accepting of pharmacists’ deprescribing recommendations.13,20-22

Despite the evidence for the benefits of deprescribing, limited data are available regarding the impact and feasibility of a targeted aspirin deprescribing approach by nonphysician practitioners.23 The objective of this study was to implement and evaluate the success of a pharmacist-driven aspirin deprescribing protocol for older adults in a primary care setting.

This aspirin deprescribing protocol was developed by ambulatory care clinical pharmacist or clinical pharmacist practitioners (CPPs), at the William S. Middleton Memorial Veterans Hospital in Madison, Wisconsin. Within the US Department of Veterans Affairs (VA) health care system, CPPs work under a broad scope of practice with the ability to independently prescribe and monitor medications. The protocol was reviewed by physician stakeholders in both primary care and cardiology and a list was generated, including patients from 2 primary care panels aged ≥ 70 years with aspirin on their medication list, either as a prescription or over-the-counter medication, using the VA Information System Technology and Architecture. A CPP or supervised pharmacy intern identified patients from this list who were appropriate for risk/benefit discussions regarding the discontinuation of aspirin. Patients were excluded from the intervention if they had a history of clinical ASCVD, including myocardial infarction (MI), stable or unstable angina, coronary artery disease (CAD), coronary or other arterial revascularization, cerebrovascular accident (CVA), transient ischemic accident (TIA), or peripheral artery disease (PAD), or another documented indication for aspirin use, including pain, flushing (with niacin use), venous thromboembolism prophylaxis, valvular heart disease, or acute or recurrent pericarditis.

 

 



After identifying eligible patients, a CPP or pharmacy intern contacted patients by telephone, following a script to guide conversation. All patients were screened for potential appropriate aspirin indications, particularly any history of MI, CAD, CVA, TIA, PAD, or other clinical ASCVD. The patient was asked about their rationale for taking aspirin and patient-specific ASCVD risk-enhancing factors and bleeding risk factors and educated them on lifestyle modalities to reduce ASCVD risk, using the script as a guide. ASCVD risk-enhancing factors included family history of premature MI, inability to achieve BP goal, DM with the inability to achieve blood glucose or hemoglobin A1c goal, tobacco use, or inadequate statin therapy. Bleeding risk factors included a history of gastrointestinal bleed or peptic ulcer disease, concurrent use of medications that increase bleeding risk, chronic kidney disease, or thrombocytopenia.

Through shared decision making with careful consideration of these factors, we reached a conclusion with each patient to either continue or to deprescribe aspirin. Each discussion was documented in the electronic health record (EHR) using a standard documentation template (eAppendix, available at doi:10.12788/fp.0320). The patient’s medication list also was updated to reflect changes in aspirin use. For patients who declined deprescribing, the CPP or pharmacy intern asked the patient for their primary reason for preferring to continue aspirin, which was subsequently categorized as one of the following: no prior concerns with bleeding, concerns about a future cardiovascular event, wishing to discuss further with their primary care practitioner (PCP), or identifying an appropriate use for aspirin not evident through record review. For the patients who wished to further discuss the issue with their PCP before deprescribing, the patient’s PCP was notified of this preference by a record alert to the note documenting the encounter, and the patient was also encouraged to follow up about this issue. A voicemail was left if the patient did not answer requesting a call back, and a second attempt was made within 2 weeks.

Data Collected

We collected data to assess the proportion of patients for whom aspirin for primary prevention was discontinued. For patients who declined deprescribing, we documented the rationale for continuing aspirin. Additionally, the feasibility of implementation was assessed, including pharmacist time spent on each record review and intervention. Descriptive statistics were generated to evaluate baseline characteristics and intervention outcomes. The time to completion of these tasks was summarized with descriptive statistics.

We reviewed 459 patient records, and 110 were determined eligible for risk/benefit discussions.

The mean (range) age of the patients contacted was 75 (70-93) years (Table). Telephone calls were attempted to these 110 patients, resulting in an 86% reach rate. Of the 94 patients reached, 45 (48%) agreed to aspirin deprescribing and 29 (31%) declined deprescribing. Seventeen (18%) patients had previously stopped taking aspirin, which required medication reconciliation to remove aspirin from the medication list. Three (3%) patients preferred to stay on aspirin and agreed to stay on aspirin on reduced dosage.

Patients had various reasons for declining deprescribing, including 8 (28%) who had no prior concerns with bleeding while on aspirin and 6 (21%) who were concerned about a future cardiovascular event. Of those who declined aspirin deprescribing, 6 (21%) wished to further discuss the issue with their PCP. In 9 (31%) patients an alternative appropriate indication for aspirin was identified through discussion. In these cases, the indication for aspirin was documented and updated in the EHR.

Most patients (87%) contacted reported taking low-dose aspirin 81 mg daily, while 10% reported taking higher doses (range, 162-325) and 3% on an as-needed basis. In all 3 patients who agreed to dose reduction, the initial dose of 325 mg daily was reduced to 81 mg daily.

 

 



Results of the time-study analysis for each intervention indicated that a pharmacy intern or pharmacist spent about 2 minutes reviewing the record of each patient to determine eligibility for risk/benefit discussions. The 110 patients identified as eligible were 24% of the 459 records reviewed. An average (range) of 12 (6-20) minutes was spent on the telephone call plus documentation for each patient contacted. Additionally, we estimated that CPPs and pharmacy interns spent an approximate combined 12 hours in the development and review of materials for this program, including the protocol, script, and documentation templates. This also included about 1 hour to identify appropriate parameters for, and generate, the eligible patient list.

Discussion

The implementation of a pharmacist-driven aspirin deprescribing protocol for older adults in a primary care setting led to the discontinuation of inappropriate aspirin use in nearly half of older adults contacted. Furthermore, opportunities were identified to update medication lists to reflect previously self-discontinued aspirin for older adults. Just over one-quarter of those contacted declined to discontinue or reduce their aspirin dose. It is hypothesized that with these targeted deprescribing interventions, overall risk reduction for bleeding and polypharmacy will be observed for older adults.1

In addition to deprescribing aspirin, CPPs used shared decision making to initiate risk/benefit discussions and to educate on targeted lifestyle modifications to lower ASCVD risk. While not all patients agreed to discontinue aspirin, all were provided education that may empower them to engage in future discussions with PCPs regarding appropriate aspirin use. Previous pharmacist-led deprescribing initiatives for proton pump inhibitors and other PIMs have indicated that a large percentage of patients who opt to further discuss a deprescribing concern with their PCPs ultimately resulted in deprescribing outcomes.24,25 Additionally, a recent trial examining pharmacist-led deprescribing of 4 common PIMs in older adults compared the impact of pharmacists leading educational interventions directly to patients with pharmacists making deprescribing recommendations to physicians. Deprescribing was more successful when patients were involved in the decision-making process.26

Limitations

Although this quality improvement initiative resulted in the deprescribing of inappropriate aspirin for many older adults, a limitation is the small sample size within a single institution. The population of male veterans also may limit generalizability to nonmale and nonveteran older adults. As the protocol was initiated within a limited number of primary care teams initially, future implementation into additional primary care teams will increase the number of older adults impacted by risk/benefit discussions regarding aspirin use. This work may not be generalizable to other health care systems. Many patients within the VA receive both their primary and specialty care within the system, which facilitates communication and collaboration between primary and specialty practitioners. The protocol may require workflow adjustments for patients receiving care within multiple systems. Additionally, although the deprescribing protocol was created in collaboration with physicians, CPPs within the VA work under a broad scope of practice that includes independent medication prescribing, deprescribing, and monitoring. This may be a consideration when implementing similar protocols at other sites, as collaborative practice agreements may need to be in place.

Future Directions

The time required to complete these interventions was generally feasible, though this intervention would require some workflow alteration to be incorporated routinely into a CPP’s schedule. The telephone calls were completed as isolated interventions and were not incorporated into existing scheduled primary care appointments. In the future, the aspirin deprescribing protocol could be incorporated into existing pharmacist-led primary care appointments. Based on the outcomes of this study, CPPs are leading an initiative to develop an aspirin deprescribing clinical reminder tool, which may be quickly inserted into a progress note within the EHR and may be incorporated into any primary care visit led by a CPP or PCP.

Conclusions

This study demonstrates that a pharmacist-led aspirin deprescribing protocol in the ambulatory care pharmacy setting was successful in the discontinuation of unnecessary aspirin use in older adults. The protocol also provided opportunities for education on ASCVD risk reduction in all older adults reached. These findings highlight the role of pharmacists in deprescribing PIMs for older adults and identifying opportunities to further streamline risk/benefit discussions on aspirin deprescribing potential within primary care visits.

The use of low-dose aspirin for the primary prevention of cardiovascular disease (CVD) morbidity and mortality continues to be controversial, particularly for older adults. Recently published, robust randomized controlled trials have revealed less cardiovascular benefit from aspirin for primary prevention compared with previous trials; additionally, an increased risk of major bleeding events has been notably more prevalent in older adults.1-5 These trials have suggested that preventative aspirin use in older adults confers less benefit than other therapies for decreasing atherosclerotic CVD (ASCVD) risk, including blood pressure (BP) control, cholesterol management, and tobacco cessation.1,6

A recent meta-analysis indicated a composite cardiovascular risk reduction in patients aged 53 to 74 years taking aspirin vs no aspirin; however, this benefit was offset with an even greater increased risk of major bleeding.7 This trend was consistent regardless of stratification by 10-year ASCVD risk or presence of diabetes mellitus (DM) diagnosis.7,8 Additionally, the recently published Aspirin in Reducing Events in the Elderly (ASPREE) trial studied the impacts of aspirin use in healthy adults aged ≥ 70 years and aged ≥ 65 years among Black and Hispanic adults.4 The study concluded that the risk of major bleeding with aspirin use was even higher vs the potential cardiovascular benefit in older adults.4

With this emerging evidence, guidelines have been updated to represent the need for risk vs benefit considerations regarding aspirin use for primary prevention in older adults.1,9,10 The most recent guideline update from the American College of Cardiology and American Heart Association (ACC/AHA) recommends against the routine use of aspirin in patients aged > 70 years or those with bleeding risk factors.1 The guideline recommends considering aspirin use for patients ages 40 to 70 years only after a patient-specific risk vs benefit discussion.1 Furthermore, the 2020 American Diabetes Association guideline recommends considering aspirin use for primary prevention in adults with DM between ages 50 and 70 only after a risk vs benefit discussion of patient-specific bleeding risk factors and ASCVD risk-enhancing factors.10

Despite the demonstrated risks for bleeding with the routine use of aspirin, studies indicate that aspirin continues to be used commonly among older adults, often when unnecessary. In the 2017 National Health Interview Survey, about 23% of adults aged > 40 years in the United States without CVD used aspirin daily, and 23% of these did so without recommendation from a health care professional.11 Furthermore, nearly half of adults ages ≥ 70 years and nearly one-quarter of adults with a history of peptic ulcer disease used aspirin daily.11 Although the most recent guidelines from the ACC/AHA do not recommend a 10-year ASCVD risk threshold for therapy, one study illustrated that 12% of older adult patients were inappropriately prescribed aspirin for primary prevention despite a 10-year ASCVD risk of < 6%.1,12 These studies highlight the large proportion of individuals, particularly older adults, who may be inappropriately taking aspirin for primary prevention.

Deprescribing Program

Deprescribing potentially inappropriate medications (PIMs) is particularly important in the older adult population, as these individuals experience a high risk of adverse effects (AEs), polypharmacy, cognitive decline, and falls related to medication use.6,13-17 Evidence suggests that mortality outcomes are improved with the implementation of targeted deprescribing efforts based on patient-specific factors.18 Additionally, deprescribing unnecessary medications may improve adherence to other essential medications and reduce financial burdens.19 Pharmacists play a crucial role among health care professionals in the implementation of deprescribing practices, and studies have shown that physicians are highly accepting of pharmacists’ deprescribing recommendations.13,20-22

Despite the evidence for the benefits of deprescribing, limited data are available regarding the impact and feasibility of a targeted aspirin deprescribing approach by nonphysician practitioners.23 The objective of this study was to implement and evaluate the success of a pharmacist-driven aspirin deprescribing protocol for older adults in a primary care setting.

This aspirin deprescribing protocol was developed by ambulatory care clinical pharmacist or clinical pharmacist practitioners (CPPs), at the William S. Middleton Memorial Veterans Hospital in Madison, Wisconsin. Within the US Department of Veterans Affairs (VA) health care system, CPPs work under a broad scope of practice with the ability to independently prescribe and monitor medications. The protocol was reviewed by physician stakeholders in both primary care and cardiology and a list was generated, including patients from 2 primary care panels aged ≥ 70 years with aspirin on their medication list, either as a prescription or over-the-counter medication, using the VA Information System Technology and Architecture. A CPP or supervised pharmacy intern identified patients from this list who were appropriate for risk/benefit discussions regarding the discontinuation of aspirin. Patients were excluded from the intervention if they had a history of clinical ASCVD, including myocardial infarction (MI), stable or unstable angina, coronary artery disease (CAD), coronary or other arterial revascularization, cerebrovascular accident (CVA), transient ischemic accident (TIA), or peripheral artery disease (PAD), or another documented indication for aspirin use, including pain, flushing (with niacin use), venous thromboembolism prophylaxis, valvular heart disease, or acute or recurrent pericarditis.

 

 



After identifying eligible patients, a CPP or pharmacy intern contacted patients by telephone, following a script to guide conversation. All patients were screened for potential appropriate aspirin indications, particularly any history of MI, CAD, CVA, TIA, PAD, or other clinical ASCVD. The patient was asked about their rationale for taking aspirin and patient-specific ASCVD risk-enhancing factors and bleeding risk factors and educated them on lifestyle modalities to reduce ASCVD risk, using the script as a guide. ASCVD risk-enhancing factors included family history of premature MI, inability to achieve BP goal, DM with the inability to achieve blood glucose or hemoglobin A1c goal, tobacco use, or inadequate statin therapy. Bleeding risk factors included a history of gastrointestinal bleed or peptic ulcer disease, concurrent use of medications that increase bleeding risk, chronic kidney disease, or thrombocytopenia.

Through shared decision making with careful consideration of these factors, we reached a conclusion with each patient to either continue or to deprescribe aspirin. Each discussion was documented in the electronic health record (EHR) using a standard documentation template (eAppendix, available at doi:10.12788/fp.0320). The patient’s medication list also was updated to reflect changes in aspirin use. For patients who declined deprescribing, the CPP or pharmacy intern asked the patient for their primary reason for preferring to continue aspirin, which was subsequently categorized as one of the following: no prior concerns with bleeding, concerns about a future cardiovascular event, wishing to discuss further with their primary care practitioner (PCP), or identifying an appropriate use for aspirin not evident through record review. For the patients who wished to further discuss the issue with their PCP before deprescribing, the patient’s PCP was notified of this preference by a record alert to the note documenting the encounter, and the patient was also encouraged to follow up about this issue. A voicemail was left if the patient did not answer requesting a call back, and a second attempt was made within 2 weeks.

Data Collected

We collected data to assess the proportion of patients for whom aspirin for primary prevention was discontinued. For patients who declined deprescribing, we documented the rationale for continuing aspirin. Additionally, the feasibility of implementation was assessed, including pharmacist time spent on each record review and intervention. Descriptive statistics were generated to evaluate baseline characteristics and intervention outcomes. The time to completion of these tasks was summarized with descriptive statistics.

We reviewed 459 patient records, and 110 were determined eligible for risk/benefit discussions.

The mean (range) age of the patients contacted was 75 (70-93) years (Table). Telephone calls were attempted to these 110 patients, resulting in an 86% reach rate. Of the 94 patients reached, 45 (48%) agreed to aspirin deprescribing and 29 (31%) declined deprescribing. Seventeen (18%) patients had previously stopped taking aspirin, which required medication reconciliation to remove aspirin from the medication list. Three (3%) patients preferred to stay on aspirin and agreed to stay on aspirin on reduced dosage.

Patients had various reasons for declining deprescribing, including 8 (28%) who had no prior concerns with bleeding while on aspirin and 6 (21%) who were concerned about a future cardiovascular event. Of those who declined aspirin deprescribing, 6 (21%) wished to further discuss the issue with their PCP. In 9 (31%) patients an alternative appropriate indication for aspirin was identified through discussion. In these cases, the indication for aspirin was documented and updated in the EHR.

Most patients (87%) contacted reported taking low-dose aspirin 81 mg daily, while 10% reported taking higher doses (range, 162-325) and 3% on an as-needed basis. In all 3 patients who agreed to dose reduction, the initial dose of 325 mg daily was reduced to 81 mg daily.

 

 



Results of the time-study analysis for each intervention indicated that a pharmacy intern or pharmacist spent about 2 minutes reviewing the record of each patient to determine eligibility for risk/benefit discussions. The 110 patients identified as eligible were 24% of the 459 records reviewed. An average (range) of 12 (6-20) minutes was spent on the telephone call plus documentation for each patient contacted. Additionally, we estimated that CPPs and pharmacy interns spent an approximate combined 12 hours in the development and review of materials for this program, including the protocol, script, and documentation templates. This also included about 1 hour to identify appropriate parameters for, and generate, the eligible patient list.

Discussion

The implementation of a pharmacist-driven aspirin deprescribing protocol for older adults in a primary care setting led to the discontinuation of inappropriate aspirin use in nearly half of older adults contacted. Furthermore, opportunities were identified to update medication lists to reflect previously self-discontinued aspirin for older adults. Just over one-quarter of those contacted declined to discontinue or reduce their aspirin dose. It is hypothesized that with these targeted deprescribing interventions, overall risk reduction for bleeding and polypharmacy will be observed for older adults.1

In addition to deprescribing aspirin, CPPs used shared decision making to initiate risk/benefit discussions and to educate on targeted lifestyle modifications to lower ASCVD risk. While not all patients agreed to discontinue aspirin, all were provided education that may empower them to engage in future discussions with PCPs regarding appropriate aspirin use. Previous pharmacist-led deprescribing initiatives for proton pump inhibitors and other PIMs have indicated that a large percentage of patients who opt to further discuss a deprescribing concern with their PCPs ultimately resulted in deprescribing outcomes.24,25 Additionally, a recent trial examining pharmacist-led deprescribing of 4 common PIMs in older adults compared the impact of pharmacists leading educational interventions directly to patients with pharmacists making deprescribing recommendations to physicians. Deprescribing was more successful when patients were involved in the decision-making process.26

Limitations

Although this quality improvement initiative resulted in the deprescribing of inappropriate aspirin for many older adults, a limitation is the small sample size within a single institution. The population of male veterans also may limit generalizability to nonmale and nonveteran older adults. As the protocol was initiated within a limited number of primary care teams initially, future implementation into additional primary care teams will increase the number of older adults impacted by risk/benefit discussions regarding aspirin use. This work may not be generalizable to other health care systems. Many patients within the VA receive both their primary and specialty care within the system, which facilitates communication and collaboration between primary and specialty practitioners. The protocol may require workflow adjustments for patients receiving care within multiple systems. Additionally, although the deprescribing protocol was created in collaboration with physicians, CPPs within the VA work under a broad scope of practice that includes independent medication prescribing, deprescribing, and monitoring. This may be a consideration when implementing similar protocols at other sites, as collaborative practice agreements may need to be in place.

Future Directions

The time required to complete these interventions was generally feasible, though this intervention would require some workflow alteration to be incorporated routinely into a CPP’s schedule. The telephone calls were completed as isolated interventions and were not incorporated into existing scheduled primary care appointments. In the future, the aspirin deprescribing protocol could be incorporated into existing pharmacist-led primary care appointments. Based on the outcomes of this study, CPPs are leading an initiative to develop an aspirin deprescribing clinical reminder tool, which may be quickly inserted into a progress note within the EHR and may be incorporated into any primary care visit led by a CPP or PCP.

Conclusions

This study demonstrates that a pharmacist-led aspirin deprescribing protocol in the ambulatory care pharmacy setting was successful in the discontinuation of unnecessary aspirin use in older adults. The protocol also provided opportunities for education on ASCVD risk reduction in all older adults reached. These findings highlight the role of pharmacists in deprescribing PIMs for older adults and identifying opportunities to further streamline risk/benefit discussions on aspirin deprescribing potential within primary care visits.

References

1. Arnett DK, Blumenthal RS, Albert MA, et al. 2019 ACC/AHA guideline on the primary prevention of cardiovascular disease: a report of the American College of Cardiology/American Heart Association Task Force on clinical practice guidelines. Circulation. 2019;140(11):e596-e646. doi:10.1161/CIR.0000000000000678

2. Gaziano JM, Brotons C, Coppolecchia R, et al. Use of aspirin to reduce risk of initial vascular events in patients at moderate risk of cardiovascular disease (ARRIVE): a randomized, double-blind, placebo-controlled trial. Lancet. 2018;392(10152):1036-1046. doi:10.1016/S0140-6736(18)31924-X

3. Bowman L, Mafham M, et al; ASCEND Study Collaborative Group. Effects of aspirin for primary prevention in persons with diabetes mellitus. N Engl J Med. 2018;379(16):1529-1539. doi:10.1056/NEJMoa1804988

4. McNeil JJ, Wolfe R, Woods, RL, et al. Effect of aspirin on cardiovascular events and bleeding in the healthy elderly. N Engl J Med. 2018;379(16):1509-1518. doi:10.1056/NEJMoa1805819

5. García Rodríguez LA, Martín-Pérez M, Hennekens CH, Rothwell PM, Lanas A. Bleeding risk with long-term low-dose aspirin: a systematic review of observational studies. PloS One. 2016;11(8):e0160046. doi:10.1371/journal.pone.0160046

6. Gallagher P, Ryan C, Byrne S, Kennedy J, O’Mahony D. STOPP (Screening Tool of Older Person’s Prescriptions) and START (Screening Tool to Alert doctors to Right Treatment): consensus validation. Int J Clin Pharmacol Ther. 2008;46(2):72-83. doi:10.5414/cpp46072

7. Zheng SL, Roddick AJ. Association of aspirin use for primary prevention with cardiovascular events and bleeding events: a systematic review and meta-analysis. JAMA. 2019;321(3):277-287. doi:10.1001/jama.2018.20578

8. Patrono C, Baigent C. Role of aspirin in primary prevention of cardiovascular disease. Nat Rev Cardiol. 2019;16(11):675-686. doi:10.1038/s41569-019-0225-y

9. Bibbins-Domingo K; U.S. Preventative Services Task Force. Aspirin use for the primary prevention of cardiovascular disease and colorectal cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2016;164(12):836-845. doi:10.7326/M16-0577

10. American Diabetes Association. Classification and diagnosis of diabetes: standards of medical care in diabetes-2020. Diabetes Care. 2020;43(suppl 1):S14-S31. doi:10.2337/dc20-S002

11. O’Brien CW, Juraschek SP, Wee CC. Prevalence of aspirin use for primary prevention of cardiovascular disease in the United States: results from the 2017 National Health Interview Survey. Ann Intern Med. 2019;171(8):596-598. doi:10.7326/M19-0953

12. Hira RS, Kennedy K, Nambi V, et al. Frequency and practice-level variation in inappropriate aspirin use for the primary prevention of cardiovascular disease: insights from the National Cardiovascular Disease Registry’s Practice Innovation and Clinical Excellence registry. J Am Coll Cardiol. 2015;65(2):111-121. doi:10.1016/j.jacc.2014.10.035

13. Cheong ST, Ng TM, Tan KT. Pharmacist-initiated deprescribing in hospitalized elderly: prevalence and acceptance by physicians. Eur J Hosp Pharm. 2018;25(e1):e35-e39. doi:10.1136/ejhpharm-2017-001251

14. Dyck MJ. Evidence-based administrative guideline: quality improvement in nursing homes. J Gerontol Nurs. 2005;31(2):4-10. doi:10.3928/0098-9134-20050201-04

15. Zullo AR, Gray SL, Holmes HM, Marcum ZA. Screening for medication appropriateness in older adults. Clin Geriatr Med. 2018;34(1):39-54. doi:10.1016/j.cger.2017.09.003

16. American Geriatrics Society. 2019 updated AGS Beers Criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2019;67(4):674-694. doi:10.1111/jgs.15767

17. Shah BM, Hajjar ER. Polypharmacy, adverse drug reactions, and geriatric syndromes. Clin Geriatr Med. 2012;28(2):173-186. doi:10.1016/j.cger.2012.01.002

18. Page AT, Clifford RM, Potter K, Schwartz D, Etherton-Beer CD. The feasibility and effect of deprescribing in older adults on mortality and health: a systematic review and meta-analysis. Br J Clin Pharmacol. 2016;82(3):583-623. doi:10.1111/bcp.12975

19. Reeve E, Shakib S, Hendrix I, Roberts MS, Wiese MD. The benefits and harms of deprescribing. Med J Aust. 2014;201(7):386-389. doi:10.5694/mja13.00200

20. Ailabouni NJ, Marcum ZA, Schmader KE, Gray SL. Medication use quality and safety in older adults: 2018 update. J Am Geriatr Soc. 2019;67(12):2458-2462. doi:10.1111/jgs.16243

21. Frank C, Weir E. Deprescribing for older patients. CMAJ. 2014;186(18):1369-1376. doi:10.1503/cmaj.131873

22. Clark CM, LaValley SA, Singh R, Mustafa E, Monte SV, Wahler RG Jr. A pharmacist-led program to facilitate deprescribing in a primary care clinic. J Am Pharm Assoc (2003). 2020;60(1):105-111. doi:10.1016/j.japh.2019.09.011

23. Folks B, Leblanc WG, Staton EW, Pace WD. Reconsidering low-dose aspirin therapy for cardiovascular disease: a study protocol for physician and patient behavioral change. Implement Sci. 2011;6:65. Published 2011 Jun 26. doi:10.1186/1748-5908-6-65

24. Odenthal DR, Philbrick AM, Harris IM. Successful deprescribing of unnecessary proton pump inhibitors in a primary care clinic. J Am Pharm Assoc. 2020;60(1):100-104. doi:10.1016/j.japh.2019.08.012

25. Duncan, P. Duerden M, Payne RA. Deprescribing: a primary care perspective. Eur J Hosp Pharm. 2017;24(1):37-42. doi:10.1136/ejhpharm-2016-000967

26. Martin P, Tamblyn R, Benedetti A, Ahmed S, Tannenbaum C. Effect of a pharmacist-led educational intervention on inappropriate medication prescriptions in older adults: the D-PRESCRIBE randomized clinical trial. JAMA. 2018;320(18):1889-1898. doi:10.1001/jama.2018.16131

References

1. Arnett DK, Blumenthal RS, Albert MA, et al. 2019 ACC/AHA guideline on the primary prevention of cardiovascular disease: a report of the American College of Cardiology/American Heart Association Task Force on clinical practice guidelines. Circulation. 2019;140(11):e596-e646. doi:10.1161/CIR.0000000000000678

2. Gaziano JM, Brotons C, Coppolecchia R, et al. Use of aspirin to reduce risk of initial vascular events in patients at moderate risk of cardiovascular disease (ARRIVE): a randomized, double-blind, placebo-controlled trial. Lancet. 2018;392(10152):1036-1046. doi:10.1016/S0140-6736(18)31924-X

3. Bowman L, Mafham M, et al; ASCEND Study Collaborative Group. Effects of aspirin for primary prevention in persons with diabetes mellitus. N Engl J Med. 2018;379(16):1529-1539. doi:10.1056/NEJMoa1804988

4. McNeil JJ, Wolfe R, Woods, RL, et al. Effect of aspirin on cardiovascular events and bleeding in the healthy elderly. N Engl J Med. 2018;379(16):1509-1518. doi:10.1056/NEJMoa1805819

5. García Rodríguez LA, Martín-Pérez M, Hennekens CH, Rothwell PM, Lanas A. Bleeding risk with long-term low-dose aspirin: a systematic review of observational studies. PloS One. 2016;11(8):e0160046. doi:10.1371/journal.pone.0160046

6. Gallagher P, Ryan C, Byrne S, Kennedy J, O’Mahony D. STOPP (Screening Tool of Older Person’s Prescriptions) and START (Screening Tool to Alert doctors to Right Treatment): consensus validation. Int J Clin Pharmacol Ther. 2008;46(2):72-83. doi:10.5414/cpp46072

7. Zheng SL, Roddick AJ. Association of aspirin use for primary prevention with cardiovascular events and bleeding events: a systematic review and meta-analysis. JAMA. 2019;321(3):277-287. doi:10.1001/jama.2018.20578

8. Patrono C, Baigent C. Role of aspirin in primary prevention of cardiovascular disease. Nat Rev Cardiol. 2019;16(11):675-686. doi:10.1038/s41569-019-0225-y

9. Bibbins-Domingo K; U.S. Preventative Services Task Force. Aspirin use for the primary prevention of cardiovascular disease and colorectal cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2016;164(12):836-845. doi:10.7326/M16-0577

10. American Diabetes Association. Classification and diagnosis of diabetes: standards of medical care in diabetes-2020. Diabetes Care. 2020;43(suppl 1):S14-S31. doi:10.2337/dc20-S002

11. O’Brien CW, Juraschek SP, Wee CC. Prevalence of aspirin use for primary prevention of cardiovascular disease in the United States: results from the 2017 National Health Interview Survey. Ann Intern Med. 2019;171(8):596-598. doi:10.7326/M19-0953

12. Hira RS, Kennedy K, Nambi V, et al. Frequency and practice-level variation in inappropriate aspirin use for the primary prevention of cardiovascular disease: insights from the National Cardiovascular Disease Registry’s Practice Innovation and Clinical Excellence registry. J Am Coll Cardiol. 2015;65(2):111-121. doi:10.1016/j.jacc.2014.10.035

13. Cheong ST, Ng TM, Tan KT. Pharmacist-initiated deprescribing in hospitalized elderly: prevalence and acceptance by physicians. Eur J Hosp Pharm. 2018;25(e1):e35-e39. doi:10.1136/ejhpharm-2017-001251

14. Dyck MJ. Evidence-based administrative guideline: quality improvement in nursing homes. J Gerontol Nurs. 2005;31(2):4-10. doi:10.3928/0098-9134-20050201-04

15. Zullo AR, Gray SL, Holmes HM, Marcum ZA. Screening for medication appropriateness in older adults. Clin Geriatr Med. 2018;34(1):39-54. doi:10.1016/j.cger.2017.09.003

16. American Geriatrics Society. 2019 updated AGS Beers Criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2019;67(4):674-694. doi:10.1111/jgs.15767

17. Shah BM, Hajjar ER. Polypharmacy, adverse drug reactions, and geriatric syndromes. Clin Geriatr Med. 2012;28(2):173-186. doi:10.1016/j.cger.2012.01.002

18. Page AT, Clifford RM, Potter K, Schwartz D, Etherton-Beer CD. The feasibility and effect of deprescribing in older adults on mortality and health: a systematic review and meta-analysis. Br J Clin Pharmacol. 2016;82(3):583-623. doi:10.1111/bcp.12975

19. Reeve E, Shakib S, Hendrix I, Roberts MS, Wiese MD. The benefits and harms of deprescribing. Med J Aust. 2014;201(7):386-389. doi:10.5694/mja13.00200

20. Ailabouni NJ, Marcum ZA, Schmader KE, Gray SL. Medication use quality and safety in older adults: 2018 update. J Am Geriatr Soc. 2019;67(12):2458-2462. doi:10.1111/jgs.16243

21. Frank C, Weir E. Deprescribing for older patients. CMAJ. 2014;186(18):1369-1376. doi:10.1503/cmaj.131873

22. Clark CM, LaValley SA, Singh R, Mustafa E, Monte SV, Wahler RG Jr. A pharmacist-led program to facilitate deprescribing in a primary care clinic. J Am Pharm Assoc (2003). 2020;60(1):105-111. doi:10.1016/j.japh.2019.09.011

23. Folks B, Leblanc WG, Staton EW, Pace WD. Reconsidering low-dose aspirin therapy for cardiovascular disease: a study protocol for physician and patient behavioral change. Implement Sci. 2011;6:65. Published 2011 Jun 26. doi:10.1186/1748-5908-6-65

24. Odenthal DR, Philbrick AM, Harris IM. Successful deprescribing of unnecessary proton pump inhibitors in a primary care clinic. J Am Pharm Assoc. 2020;60(1):100-104. doi:10.1016/j.japh.2019.08.012

25. Duncan, P. Duerden M, Payne RA. Deprescribing: a primary care perspective. Eur J Hosp Pharm. 2017;24(1):37-42. doi:10.1136/ejhpharm-2016-000967

26. Martin P, Tamblyn R, Benedetti A, Ahmed S, Tannenbaum C. Effect of a pharmacist-led educational intervention on inappropriate medication prescriptions in older adults: the D-PRESCRIBE randomized clinical trial. JAMA. 2018;320(18):1889-1898. doi:10.1001/jama.2018.16131

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Preoperative Insulin Intensification to Improve Day of Surgery Blood Glucose Control

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Perioperative hyperglycemia, defined as blood glucose levels ≥ 180 mg/dL in the immediate pre- and postoperative period, is associated with increased postoperative morbidity, including infections, preoperative interventions, and in-hospital mortality.1-3 Despite being identified as a barrier to optimal perioperative glycemic control, limited evidence is available on patient or health care practitioner (HCP) adherence to preoperative insulin protocols.4-6

Background

Despite mounting evidence of the advantages of maintaining perioperative glucose levels between 80 and 180 mg/dL, available guidelines vary in their recommendations for long-acting basal insulin dosing.7-10 The Society of Ambulatory Anesthesia suggests using 100% of the prescribed evening dosage of long-acting basal insulin dose on the night before surgery in patients without a history of nocturnal or morning hypoglycemia (category 2A evidence).9 However, the revised 2016 United Kingdom National Health Service consensus guideline recommends using 80% to 100% of the prescribed evening dosage of long-acting basal insulin dose on the night before surgery.7 The 2022 American Diabetes Association references an observational study of patients with type 2 DM (T2DM) treated with evening-only, long-acting glargine insulin, indicating that the optimal basal insulin dose on the evening before surgery is about 75% of the outpatient dose.5,10 However, in a randomized, prospective open trial of patients with DM treated with evening-only long-acting basal insulin, no significant difference was noted in the target day of surgery (DOS) glucose levels among different dosing strategies on the evening before surgery.6 Presently, the optimal dose of long-acting insulin analogs on the evening before surgery is unknown.

Additionally, little is known about the other factors that influence perioperative glycemic control. Several barriers to optimal perioperative care of patients with DM have been identified, including lack of prioritization by HCPs, lack of knowledge about current evidence-based recommendations, and lack of patient information and involvement.4 To determine the effect of patient adherence to preoperative medication instructions on postoperative outcome, a cross-sectional study assessed surgical patients admitted to the postanesthetic care unit (PACU) and found that only 70% of patients with insulin-treated DM took their medications preoperatively. Additionally, 23% of nonadherent patients who omitted their medications either did not understand or forgot preoperative medication management instructions. Preoperative DM medication omission was associated with higher rates of hyperglycemia in the PACU (23.8% vs 3.6%; P = .02).11 Importantly, to our knowledge, the extent of HCP adherence to DM management protocols and the subsequent effect on DOS hyperglycemia has not been examined until now.For patients with DM treated with an evening dose of long-acting basal insulin (ie, either once-daily long-acting basal insulin in the evening or twice-daily long-acting basal insulin, both morning and evening) presenting for elective noncardiac surgery, our aim was to decrease the rate of DOS hyperglycemia from 29% (our baseline) to 15% by intensifying the dose of insulin on the evening before surgery without increasing the rate of hypoglycemia. We also sought to determine the rates of HCP adherence to our insulin protocols as well as patients’ self-reported adherence to HCP instructions over the course of this quality improvement (QI) initiative.

Quality Improvement Program

Our surgical department consists of 11 surgical subspecialties that performed approximately 4400 noncardiac surgeries in 2019. All patients undergoing elective surgery are evaluated in the preoperative clinic, which is staffed by an anesthesiology professional (attending and resident physicians, nurse practitioners, and physician assistants) and internal medicine attending physicians. At the preoperative visit, each patient is evaluated by anesthesiology; medically complex patients may also be referred to an internal medicine professional for further risk stratification and optimization before surgery.

At the preoperative clinic visit, HCPs prepare written patient instructions for the preoperative management of medications, including glucose-lowering medications, based on a DM management protocol that was implemented in 2016 for the preoperative management of insulin, noninsulin injectable agents, and oral hyperglycemic agents. According to this protocol, patients with DM treated with evening long-acting basal insulin (eg, glargine insulin) are instructed to take 50% of their usual evening dose the evening before surgery. A preoperative clinic nurse reviews the final preoperative medication instructions with the patient at the end of the clinic visit. Patients are also instructed to avoid oral intake other than water and necessary medications after midnight before surgery regardless of the time of surgery. On the DOS, the patient’s blood glucose level is measured on arrival to the presurgical area.

Our QI initiative focused only on the dose of self-administered, long-acting basal insulin on the evening before surgery. The effect of the morning of surgery long-acting insulin dose on the DOS glucose levels largely depends on the timing of surgery, which is variable; therefore, we did not target this dose for our initiative. Patients receiving intermediate-acting neutral protamine Hagedorn (NPH) insulin were excluded because our protocol does not recommend a dose reduction for NPH insulin on the evening before surgery.

 

 



We developed a comprehensive driver diagram to help elucidate the different factors contributing to DOS hyperglycemia and to guide specific QI interventions.12 Some of the identified contributors to DOS hyperglycemia, such as the length of preoperative fasting and timing of surgery, are unpredictable and were deemed difficult to address preoperatively. Other contributors to DOS hyperglycemia, such as outpatient DM management, often require interventions over several months, which is well beyond the time usually allotted for preoperative evaluation and optimization. On the other hand, immediate preoperative insulin dosing directly affects DOS glycemic control; therefore, improvement of the preoperative insulin management protocol to optimize the dosage on the evening before surgery was considered to be an achievable QI goal with the potential for decreasing the rate of DOS hyperglycemia in patients presenting for elective noncardiac surgery.

We used the Model for Understanding Success in Quality (MUSIQ) as a framework to identify key contextual factors that may affect the success of our QI project.13 Limited resource availability and difficulty with dissemination of protocol changes in the preoperative clinic were determined to be potential barriers to the successful implementation of our QI initiative. Nonetheless, senior leadership support, microsystem QI culture, QI team skills, and physician involvement supported the implementation. The revised Standards for Quality Improvement Reporting Excellence (SQUIRE 2.0) guidelines were followed for this study.14

Interventions

With stakeholder input from anesthesiology, internal medicine, endocrinology, and nursing, we designed an intervention to iteratively change the HCP protocol instructions for long-acting insulin dosing on the evening before surgery. In phase 1 of the study (October 1, 2018, to March 11, 2019), we obtained baseline data on the rates of DOS hyperglycemia (blood glucose ≥ 180 mg/dL) and hypoglycemia (blood glucose < 80 mg/dL), as well as patient and HCP adherence rates to our existing preoperative DM protocol. For phase 2 (March 12, 2019, to July 22, 2019), the preoperative DM management protocol was changed to increase the dose of long-acting basal insulin on the evening before surgery for patients with hemoglobin A1c (HbA1c) levels > 8% from 50% of the usual outpatient dose to 100%. Finally, in phase 3 (July 23, 2019, to March 12, 2020), the protocol was changed to increase the dose of long-acting basal insulin on the evening before surgery for patients with HbA1c levels ≤ 8% from 50% of the usual outpatient dose to 75% while sustaining the phase 2 change. Preoperative HCPs were informed of the protocol changes in person and were provided with electronic and hard copies of each new protocol.

Protocol

We used a prospective cohort design of 424 consecutive patients with DM who presented for preoperative evaluation for elective noncardiac surgery between October 1, 2018, and March 12, 2020. For the subset of 195 patients treated with an evening dose of long-acting basal insulin, we examined the effect of intensification of this preoperative basal insulin dose on DOS hyperglycemia and hypoglycemia, HCP adherence to iterative changes of the protocol, and patient adherence to HCP instructions on preoperative medication dosing. The QI project was concluded when elective surgeries were paused due to the COVID-19 pandemic.

We created a standardized preoperative data collection form that included information on the most recent HbA1c, time, dose, and type of patient-administered insulin on the evening before surgery, and DOS blood glucose level. A preoperative clinic nurse completed the standardized preoperative data collection form. The HCP’s preoperative medication instructions and the preoperative data collection forms were gathered for review and data analysis.

 

 



The primary outcome was DOS hyperglycemia (blood glucose levels ≥ 180 mg/dL). We monitored the rate of DOS hypoglycemia (blood glucose levels < 80 mg/dL) as a balancing measure to ensure safety with long-acting basal insulin intensification. Although hypoglycemia is defined as a blood glucose level < 70 mg/dL, a target glucose range of 80 mg/dL to 180 mg/dL is recommended during the perioperative period.8 Therefore, we chose a more conservative definition of hypoglycemia (blood glucose levels < 80 mg/dL) to adhere to the recommended perioperative glucose target range.

Process measures included HCP adherence to each protocol change, which was assessed by comparing written preoperative patient instructions to the current protocol. Similarly, patient adherence to HCP-recommended long-acting basal insulin dosing was assessed by comparing written preoperative patient instructions to the patient’s self-reported time and dose of long-acting basal insulin on the evening before surgery. For any discrepancy between the HCP instructions and protocol or HCP-recommended dose and patient self-reported dose of long-acting basal insulin, a detailed chart review was performed to determine the etiology.

Statistical Analysis

We used the statistical process p-control chart to assess the effect of iterative changes to the preoperative long-acting basal insulin protocol on DOS hyperglycemia. The proportion defective (rate of DOS hyperglycemia) was plotted against time to determine whether the observed variations in the rate of DOS hyperglycemia over time were attributable to random common causes or special causes because of our intervention. The lower control limit (LCL) and upper control limit (UCL) define the limits of expected outcome measures in a stable process prior to introducing changes and were set at 3 SDs from the mean to balance the likelihood of type I (false-positive) and type II (false-negative) errors. Because of the variable interval sample sizes, we used the CRITBINOM function of Microsoft Excel to calculate the exact UCL satisfying the 3 SD limits of 0.99865.15 The Shewhart rules (outliers, runs or shifts, trends, sawtooth) were used to analyze the p-control chart to identify special cause signals resulting from our interventions.16 We used the statistical process t-control chart to record the time (days) between the few occurrences of DOS hypoglycemia because cases of hypoglycemia were rare.

Ethical Consideration

The Human Research Protection Program, Associate Chief of Staff for Research and Development, and Quality, Safety, and Values department reviewed this project in accordance with the Veterans Health Administration Program Guide 1200.21 and determined that it was a nonresearch operations activity; thus, approval by an institutional review board was not needed. The authors declare no competing interests.

Patient Outcomes

We prospectively followed 424 consecutive patients with DM undergoing elective noncardiac surgery from the time of the preoperative clinic evaluation until DOS; 195 patients were on evening

long-acting basal insulin on an outpatient basis (eAppendix 1, available at doi:10.2788/fp.0335). The preoperative HbA1c was measured a mean (SD) of 52 (61) days prior to surgery (range, 0-344). During phase 1, baseline information on DOS glucose levels and adherence to the existing preoperative DM management protocol was obtained; 57 (29%) patients treated with evening, long-acting basal insulin were hyperglycemic. Of 106 patients with DM, 4 (3.7%) had hypoglycemia. Just 2 (3.5%) of 57 insulin-treated patients had hypoglycemia. In phases 2 and 3, iterative intensifications of the long-acting basal insulin dose on the evening before surgery were implemented. The statistical process p-control chart (Figure 1)
shows that protocol changes had no special cause effect on the rate of DOS hyperglycemia in any phase. One outlier was identified (week 70), but careful review of data from weeks 68 through 72 did not reveal any special cause events or process changes that could explain this finding. In particular, HCP adherence to the protocol was stable during this period. Patient adherence to HCP instructions did not affect glycemic control on the DOS.

 

 

A subgroup analysis of DOS glucose levels in insulin-treated patients with preoperative HbA1c levels > 8% did not demonstrate a change in the rate of

DOS hyperglycemia with intensification of the dose of long-acting basal insulin on the evening before surgery (Figure 2). However, analysis of the statistical process p-control chart of this subgroup identified 2 outliers of DOS hyperglycemia in weeks 36 through 40 followed by a downward trend in the rate for weeks 40 through 64. A 12% decrease (89% vs 77%) in HCP adherence to the protocol after the phase 2 change (weeks 24-44) was observed immediately preceding the unusually high rate of DOS hyperglycemia in patients with HbA1c > 8%. With ongoing QI efforts and education, HCP adherence improved to 88% after the phase 3 change, correlating with the observed trend of improved DOS hyperglycemia rates.

Only 7 of 424 (1.7%) patients with DM and 4 of 195 (2.1%) patients treated with evening, long-acting basal insulin had marked hyperglycemia (DOS glucose levels ≥ 300 mg/dL). Only 1 patient who was not on outpatient insulin treatment had surgery canceled for hyperglycemia.
Clinically significant hypoglycemia (blood glucose level < 80 mg/dL) was rare (n = 6). The average time between hypoglycemic events was 52 days and was not affected by intensification of the evening, long-acting basal insulin dose (eAppendix 2, available at doi:10.2788/fp.0335). Variations in the measured time between rare events of hypoglycemia are explained by common cause or random variation, as the individual values did not approach or exceed the 3 SD limits set by the UCL and LCL.

Overall, 89% of the HCPs followed the preoperative insulin protocol. HCP adherence to the protocol decreased to 77% after the phase 2 change, often related to deviations from the protocol or when a prior version was used. By the end of phase 3, HCP adherence returned to the baseline rate (88%). Patient adherence to medication instructions was not affected by protocol changes (86% throughout the study period). Prospective data collection was briefly interrupted between January 18, 2019, and March 5, 2019, while designing our phase 2 intervention. We were unable to track the total number of eligible patients during this time, but were able to identify 8 insulin-treated patients with DM who underwent elective noncardiac surgery and included their data in phase 1.

Discussion

The management and prevention of immediate perioperative hyperglycemia and glycemic variability have attracted attention as evidence has mounted for their association with postoperative morbidity and mortality.1,2,17 Available guidelines for preventing DOS hyperglycemia vary in their recommendations for preoperative insulin management.7-10 Notably, concerns about iatrogenic hypoglycemia often hinder efforts to lower rates of DOS hyperglycemia.4 We successfully implemented an iterative intensification protocol for preoperative long-acting basal insulin doses on the evening before surgery but did not observe a lower rate of hyperglycemia. Importantly, we also did not observe a higher rate of hypoglycemia on the DOS, as observed in a previous study.5

The observational study by Demma and colleagues found that patients receiving 75% of their evening, long-acting basal insulin dose were significantly more likely to achieve target blood glucose levels of 100 to 180 mg/dL than patients receiving no insulin at all (78% vs 0%; P = .001). However, no significant difference was noted when this group was compared with patients receiving 50% of their evening, long-acting basal insulin doses (78% vs 70%; P = .56). This is more clinically pertinent as it is generally accepted that the evening, long-acting insulin dose should not be entirely withheld on the evening before surgery.5

 

 



These findings are consistent with our observation that the rate of DOS hyperglycemia did not decrease with intensification of the evening, long-acting insulin dose from 50% to 100% of the prescribed dose in patients with HbA1c levels > 8% (phase 2) and 50% to 75% of the prescribed dose in patients with HbA1c levels ≤ 8% (phase 3). In the study by Demma and colleagues, few patients presented with preoperative hypoglycemia (2.7%) but all had received 100% of their evening, long-acting basal insulin dose, suggesting a significant increase in the rate of hypoglycemia compared with patients receiving lower doses of insulin (P = .01).5 However, long-term DM control as assessed by HbA1c level was available for < 10% of the patients, making it difficult to evaluate the effect of overall DM control on the results.5 In our study, preoperative HbA1c levels were available for 99.5% of the patients and only those with HbA1c levels > 8% received 100% of their evening, long-acting insulin dose on the evening before surgery. Notably, we did not observe a higher rate of hypoglycemia in this patient population, indicating that preoperative insulin dose intensification is safe for this subgroup.

Although HCP adherence to perioperative DM management protocols has been identified as a predominant barrier to the delivery of optimal perioperative DM care, prior studies of various preoperative insulin protocols to reduce perioperative hyperglycemia have not reported HCP adherence to their insulin protocols or its effect on DOS hyperglycemia.4-6 Additionally, patient adherence to HCP instructions is a key factor identified in our driver diagram that may influence DOS hyperglycemia, a hypothesis that is supported by a prior cross-sectional study showing an increased rate of hyperglycemia in the PACU with omission of preoperative DM medication.11 In our study, patient adherence to preoperative medication management instructions was higher than reported previously and remained consistently high regardless of protocol changes, which may explain why patient adherence did not affect the rate of DOS hyperglycemia.

Although not part of our study protocol, our preoperative HCPs routinely prepare written patient instructions for the preoperative management of medications for all patients, which likely explains higher patient adherence to instructions in our study than seen in the previous study where written instructions were only encouraged.11 However, HCP adherence to the protocol decreased after our phase 2 changes and was associated with a transient increase in DOS hyperglycemia rates. The DOS hyperglycemia rates returned to baseline levels with ongoing QI efforts and education to improve HCP adherence to protocol.

Limitations

Our QI initiative had several limitations. Nearly all patients were male veterans with T2DM, and most were older (range, 50-89 years). This limits the generalizability to women, younger patients, and people with type 1 DM. Additionally, our data collection relied on completion and collection of the preoperative form by different HCPs, allowing for sampling bias if some patients with DM undergoing elective noncardiac surgery were missed. Furthermore, although we could verify HCP adherence to the preoperative DM management protocols by reviewing their written instructions, we relied on patients’ self-reported adherence to the preoperative instructions. Finally, we did not evaluate postoperative blood glucose levels because the effect of intraoperative factors such as fluid, insulin, and glucocorticoid administration on postoperative glucose levels are variable. To the best of our knowledge, no other major systematic changes occurred in the preoperative care of patients with DM during the study period.

Conclusions

The findings of our QI initiative suggest that HCP adherence to preoperative DM management protocols may be a key contributor to DOS hyperglycemia and that ensuring HCP adherence may be as important as preoperative insulin dose adjustments. To our knowledge, this is the first study to report rates of HCP adherence to preoperative DM management protocols and its effect on DOS hyperglycemia. We will focus future QI efforts on optimizing HCP adherence to preoperative DM management protocols at our institution.

Acknowledgments

We thank our endocrinology expert, Dr. Kristina Utzschneider, for her guidance in designing this improvement project and our academic research coach, Dr. Helene Starks, for her help in editing the manuscript.

References

1. van den Boom W, Schroeder RA, Manning MW, Setji TL, Fiestan GO, Dunson DB. Effect of A1c and glucose on postoperative mortality in noncardiac and cardiac surgeries. Diabetes Care. 2018;41(4):782-788. doi:10.2337/dc17-2232

2. Punthakee Z, Iglesias PP, Alonso-Coello P, et al. Association of preoperative glucose concentration with myocardial injury and death after non-cardiac surgery (GlucoVISION): a prospective cohort study. Lancet Diabetes Endocrinol. 2018;6(10):790-797. doi:10.1016/S2213-8587(18)30205-5

3. Kwon S, Thompson R, Dellinger P, Yanez D, Farrohki E, Flum D. Importance of perioperative glycemic control in general surgery: a report from the Surgical Care and Outcomes Assessment Program. Ann Surg. 2013;257(1):8-14. doi:10.1097/SLA.0b013e31827b6bbc

4. Hommel I, van Gurp PJ, den Broeder AA, et al. Reactive rather than proactive diabetes management in the perioperative period. Horm Metab Res. 2017;49(7):527-533. doi:10.1055/s-0043-105501

5. Demma LJ, Carlson KT, Duggan EW, Morrow JG 3rd, Umpierrez G. Effect of basal insulin dosage on blood glucose concentration in ambulatory surgery patients with type 2 diabetes. J Clin Anesth. 2017;36:184-188. doi:10.1016/j.jclinane.2016.10.003

6. Rosenblatt SI, Dukatz T, Jahn R, et al. Insulin glargine dosing before next-day surgery: comparing three strategies. J Clin Anesth. 2012;24(8):610-617. doi:10.1016/j.jclinane.2012.02.010

7. Dhatariya K, Levy N, Flanagen D, et al; Joint British Diabetes Societies for Inpatient Care. Management of adults with diabetes undergoing surgery and elective procedures: improving standards. Summary. Published 2011. Revised March 2016. Accessed October 31, 2022. https://www.diabetes.org.uk/resources-s3/2017-09/Surgical%20guideline%202015%20-%20summary%20FINAL%20amended%20Mar%202016.pdf

8. American Diabetes Association. 15. Diabetes care in the hospital: standards of medical care in diabetes–2021. Diabetes Care. 2021;44(suppl 1):S211-S220. doi:10.2337/dc21-S015

9. Joshi GP, Chung F, Vann MA, et al; Society for Ambulatory Anesthesia. Society for Ambulatory Anesthesia consensus statement on perioperative blood glucose management in diabetic patients undergoing ambulatory surgery. Anesth Analg. 2010;111(6):1378-1387. doi:10.1213/ANE.0b013e3181f9c288

10. American Diabetes Association Professional Practice Committee. 16. Diabetes care in the hospital: standards of medical care in diabetes–2022. Diabetes Care. 2021;45(suppl 1):S244-S253. doi:10.2337/dc22-S016

11. Notaras AP, Demetriou E, Galvin J, Ben-Menachem E. A cross-sectional study of preoperative medication adherence and early postoperative recovery. J Clin Anesth. 2016;35:129-135. doi:10.1016/j.jclinane.2016.07.007

12. Bennett B, Provost L. What’s your theory? Driver diagram serves as tool for building and testing theories for improvement. Quality Progress. 2015;48(7):36-43. Accessed August 31, 2022. http://www.apiweb.org/QP_whats-your-theory_201507.pdf

13. Kaplan HC, Provost LP, Froehle CM, Margolis PA. The Model for Understanding Success in Quality (MUSIQ): building a theory of context in healthcare quality improvement. BMJ Qual Saf. 2012;21(1):13-20. doi:10.1136/bmjqs-2011-000010

14. Ogrinc G, Davies L, Goodman D, Batalden P, Davidoff F, Stevens D. SQUIRE 2.0 (Standards for QUality Improvement Reporting Excellence): revised publication guidelines from a detailed consensus process. BMJ Qual Saf. 2016;25(12):986-992. doi:10.1136/bmjqs-2015-004411

15. Duclos A, Voirin N. The p-control chart: a tool for care improvement. Int J Qual Health Care. 2010;22(5):402-407. doi:10.1093/intqhc/mzq037

16. Cheung YY, Jung B, Sohn JH, Ogrinc G. Quality initiatives: statistical control charts: simplifying the analysis of data for quality improvement. Radiographics. 2012;32(7):2113-2126. doi:10.1148/rg.327125713

17. Simha V, Shah P. Perioperative glucose control in patients with diabetes undergoing elective surgery. JAMA. 2019;321(4):399. doi:10.1001/jama.2018.20922

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Mehraneh Khalighi, MDa,b; Nancy M. Yazici, RNa; Paul B. Cornia, MDa,b
Correspondence:
Mehraneh Khalighi ([email protected])

aVeterans Affairs Puget Sound Health Care System, Seattle, Washington
bUniversity of Washington, Seattle

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Ethics and consent

The Human Research Protection Program, Associate Chief of Staff for Research and Development, and Quality, Safety, and Values department at the Department of Veterans Affairs Puget Sound Health Care Systems reviewed this project in accordance with the Veterans Health Administration Program Guide 1200.21, and determined that it was a nonresearch, operations activity; thus, approval by an institutional review board was not needed.

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Mehraneh Khalighi, MDa,b; Nancy M. Yazici, RNa; Paul B. Cornia, MDa,b
Correspondence:
Mehraneh Khalighi ([email protected])

aVeterans Affairs Puget Sound Health Care System, Seattle, Washington
bUniversity of Washington, Seattle

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Ethics and consent

The Human Research Protection Program, Associate Chief of Staff for Research and Development, and Quality, Safety, and Values department at the Department of Veterans Affairs Puget Sound Health Care Systems reviewed this project in accordance with the Veterans Health Administration Program Guide 1200.21, and determined that it was a nonresearch, operations activity; thus, approval by an institutional review board was not needed.

Author and Disclosure Information

Mehraneh Khalighi, MDa,b; Nancy M. Yazici, RNa; Paul B. Cornia, MDa,b
Correspondence:
Mehraneh Khalighi ([email protected])

aVeterans Affairs Puget Sound Health Care System, Seattle, Washington
bUniversity of Washington, Seattle

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Ethics and consent

The Human Research Protection Program, Associate Chief of Staff for Research and Development, and Quality, Safety, and Values department at the Department of Veterans Affairs Puget Sound Health Care Systems reviewed this project in accordance with the Veterans Health Administration Program Guide 1200.21, and determined that it was a nonresearch, operations activity; thus, approval by an institutional review board was not needed.

Article PDF
Article PDF

Perioperative hyperglycemia, defined as blood glucose levels ≥ 180 mg/dL in the immediate pre- and postoperative period, is associated with increased postoperative morbidity, including infections, preoperative interventions, and in-hospital mortality.1-3 Despite being identified as a barrier to optimal perioperative glycemic control, limited evidence is available on patient or health care practitioner (HCP) adherence to preoperative insulin protocols.4-6

Background

Despite mounting evidence of the advantages of maintaining perioperative glucose levels between 80 and 180 mg/dL, available guidelines vary in their recommendations for long-acting basal insulin dosing.7-10 The Society of Ambulatory Anesthesia suggests using 100% of the prescribed evening dosage of long-acting basal insulin dose on the night before surgery in patients without a history of nocturnal or morning hypoglycemia (category 2A evidence).9 However, the revised 2016 United Kingdom National Health Service consensus guideline recommends using 80% to 100% of the prescribed evening dosage of long-acting basal insulin dose on the night before surgery.7 The 2022 American Diabetes Association references an observational study of patients with type 2 DM (T2DM) treated with evening-only, long-acting glargine insulin, indicating that the optimal basal insulin dose on the evening before surgery is about 75% of the outpatient dose.5,10 However, in a randomized, prospective open trial of patients with DM treated with evening-only long-acting basal insulin, no significant difference was noted in the target day of surgery (DOS) glucose levels among different dosing strategies on the evening before surgery.6 Presently, the optimal dose of long-acting insulin analogs on the evening before surgery is unknown.

Additionally, little is known about the other factors that influence perioperative glycemic control. Several barriers to optimal perioperative care of patients with DM have been identified, including lack of prioritization by HCPs, lack of knowledge about current evidence-based recommendations, and lack of patient information and involvement.4 To determine the effect of patient adherence to preoperative medication instructions on postoperative outcome, a cross-sectional study assessed surgical patients admitted to the postanesthetic care unit (PACU) and found that only 70% of patients with insulin-treated DM took their medications preoperatively. Additionally, 23% of nonadherent patients who omitted their medications either did not understand or forgot preoperative medication management instructions. Preoperative DM medication omission was associated with higher rates of hyperglycemia in the PACU (23.8% vs 3.6%; P = .02).11 Importantly, to our knowledge, the extent of HCP adherence to DM management protocols and the subsequent effect on DOS hyperglycemia has not been examined until now.For patients with DM treated with an evening dose of long-acting basal insulin (ie, either once-daily long-acting basal insulin in the evening or twice-daily long-acting basal insulin, both morning and evening) presenting for elective noncardiac surgery, our aim was to decrease the rate of DOS hyperglycemia from 29% (our baseline) to 15% by intensifying the dose of insulin on the evening before surgery without increasing the rate of hypoglycemia. We also sought to determine the rates of HCP adherence to our insulin protocols as well as patients’ self-reported adherence to HCP instructions over the course of this quality improvement (QI) initiative.

Quality Improvement Program

Our surgical department consists of 11 surgical subspecialties that performed approximately 4400 noncardiac surgeries in 2019. All patients undergoing elective surgery are evaluated in the preoperative clinic, which is staffed by an anesthesiology professional (attending and resident physicians, nurse practitioners, and physician assistants) and internal medicine attending physicians. At the preoperative visit, each patient is evaluated by anesthesiology; medically complex patients may also be referred to an internal medicine professional for further risk stratification and optimization before surgery.

At the preoperative clinic visit, HCPs prepare written patient instructions for the preoperative management of medications, including glucose-lowering medications, based on a DM management protocol that was implemented in 2016 for the preoperative management of insulin, noninsulin injectable agents, and oral hyperglycemic agents. According to this protocol, patients with DM treated with evening long-acting basal insulin (eg, glargine insulin) are instructed to take 50% of their usual evening dose the evening before surgery. A preoperative clinic nurse reviews the final preoperative medication instructions with the patient at the end of the clinic visit. Patients are also instructed to avoid oral intake other than water and necessary medications after midnight before surgery regardless of the time of surgery. On the DOS, the patient’s blood glucose level is measured on arrival to the presurgical area.

Our QI initiative focused only on the dose of self-administered, long-acting basal insulin on the evening before surgery. The effect of the morning of surgery long-acting insulin dose on the DOS glucose levels largely depends on the timing of surgery, which is variable; therefore, we did not target this dose for our initiative. Patients receiving intermediate-acting neutral protamine Hagedorn (NPH) insulin were excluded because our protocol does not recommend a dose reduction for NPH insulin on the evening before surgery.

 

 



We developed a comprehensive driver diagram to help elucidate the different factors contributing to DOS hyperglycemia and to guide specific QI interventions.12 Some of the identified contributors to DOS hyperglycemia, such as the length of preoperative fasting and timing of surgery, are unpredictable and were deemed difficult to address preoperatively. Other contributors to DOS hyperglycemia, such as outpatient DM management, often require interventions over several months, which is well beyond the time usually allotted for preoperative evaluation and optimization. On the other hand, immediate preoperative insulin dosing directly affects DOS glycemic control; therefore, improvement of the preoperative insulin management protocol to optimize the dosage on the evening before surgery was considered to be an achievable QI goal with the potential for decreasing the rate of DOS hyperglycemia in patients presenting for elective noncardiac surgery.

We used the Model for Understanding Success in Quality (MUSIQ) as a framework to identify key contextual factors that may affect the success of our QI project.13 Limited resource availability and difficulty with dissemination of protocol changes in the preoperative clinic were determined to be potential barriers to the successful implementation of our QI initiative. Nonetheless, senior leadership support, microsystem QI culture, QI team skills, and physician involvement supported the implementation. The revised Standards for Quality Improvement Reporting Excellence (SQUIRE 2.0) guidelines were followed for this study.14

Interventions

With stakeholder input from anesthesiology, internal medicine, endocrinology, and nursing, we designed an intervention to iteratively change the HCP protocol instructions for long-acting insulin dosing on the evening before surgery. In phase 1 of the study (October 1, 2018, to March 11, 2019), we obtained baseline data on the rates of DOS hyperglycemia (blood glucose ≥ 180 mg/dL) and hypoglycemia (blood glucose < 80 mg/dL), as well as patient and HCP adherence rates to our existing preoperative DM protocol. For phase 2 (March 12, 2019, to July 22, 2019), the preoperative DM management protocol was changed to increase the dose of long-acting basal insulin on the evening before surgery for patients with hemoglobin A1c (HbA1c) levels > 8% from 50% of the usual outpatient dose to 100%. Finally, in phase 3 (July 23, 2019, to March 12, 2020), the protocol was changed to increase the dose of long-acting basal insulin on the evening before surgery for patients with HbA1c levels ≤ 8% from 50% of the usual outpatient dose to 75% while sustaining the phase 2 change. Preoperative HCPs were informed of the protocol changes in person and were provided with electronic and hard copies of each new protocol.

Protocol

We used a prospective cohort design of 424 consecutive patients with DM who presented for preoperative evaluation for elective noncardiac surgery between October 1, 2018, and March 12, 2020. For the subset of 195 patients treated with an evening dose of long-acting basal insulin, we examined the effect of intensification of this preoperative basal insulin dose on DOS hyperglycemia and hypoglycemia, HCP adherence to iterative changes of the protocol, and patient adherence to HCP instructions on preoperative medication dosing. The QI project was concluded when elective surgeries were paused due to the COVID-19 pandemic.

We created a standardized preoperative data collection form that included information on the most recent HbA1c, time, dose, and type of patient-administered insulin on the evening before surgery, and DOS blood glucose level. A preoperative clinic nurse completed the standardized preoperative data collection form. The HCP’s preoperative medication instructions and the preoperative data collection forms were gathered for review and data analysis.

 

 



The primary outcome was DOS hyperglycemia (blood glucose levels ≥ 180 mg/dL). We monitored the rate of DOS hypoglycemia (blood glucose levels < 80 mg/dL) as a balancing measure to ensure safety with long-acting basal insulin intensification. Although hypoglycemia is defined as a blood glucose level < 70 mg/dL, a target glucose range of 80 mg/dL to 180 mg/dL is recommended during the perioperative period.8 Therefore, we chose a more conservative definition of hypoglycemia (blood glucose levels < 80 mg/dL) to adhere to the recommended perioperative glucose target range.

Process measures included HCP adherence to each protocol change, which was assessed by comparing written preoperative patient instructions to the current protocol. Similarly, patient adherence to HCP-recommended long-acting basal insulin dosing was assessed by comparing written preoperative patient instructions to the patient’s self-reported time and dose of long-acting basal insulin on the evening before surgery. For any discrepancy between the HCP instructions and protocol or HCP-recommended dose and patient self-reported dose of long-acting basal insulin, a detailed chart review was performed to determine the etiology.

Statistical Analysis

We used the statistical process p-control chart to assess the effect of iterative changes to the preoperative long-acting basal insulin protocol on DOS hyperglycemia. The proportion defective (rate of DOS hyperglycemia) was plotted against time to determine whether the observed variations in the rate of DOS hyperglycemia over time were attributable to random common causes or special causes because of our intervention. The lower control limit (LCL) and upper control limit (UCL) define the limits of expected outcome measures in a stable process prior to introducing changes and were set at 3 SDs from the mean to balance the likelihood of type I (false-positive) and type II (false-negative) errors. Because of the variable interval sample sizes, we used the CRITBINOM function of Microsoft Excel to calculate the exact UCL satisfying the 3 SD limits of 0.99865.15 The Shewhart rules (outliers, runs or shifts, trends, sawtooth) were used to analyze the p-control chart to identify special cause signals resulting from our interventions.16 We used the statistical process t-control chart to record the time (days) between the few occurrences of DOS hypoglycemia because cases of hypoglycemia were rare.

Ethical Consideration

The Human Research Protection Program, Associate Chief of Staff for Research and Development, and Quality, Safety, and Values department reviewed this project in accordance with the Veterans Health Administration Program Guide 1200.21 and determined that it was a nonresearch operations activity; thus, approval by an institutional review board was not needed. The authors declare no competing interests.

Patient Outcomes

We prospectively followed 424 consecutive patients with DM undergoing elective noncardiac surgery from the time of the preoperative clinic evaluation until DOS; 195 patients were on evening

long-acting basal insulin on an outpatient basis (eAppendix 1, available at doi:10.2788/fp.0335). The preoperative HbA1c was measured a mean (SD) of 52 (61) days prior to surgery (range, 0-344). During phase 1, baseline information on DOS glucose levels and adherence to the existing preoperative DM management protocol was obtained; 57 (29%) patients treated with evening, long-acting basal insulin were hyperglycemic. Of 106 patients with DM, 4 (3.7%) had hypoglycemia. Just 2 (3.5%) of 57 insulin-treated patients had hypoglycemia. In phases 2 and 3, iterative intensifications of the long-acting basal insulin dose on the evening before surgery were implemented. The statistical process p-control chart (Figure 1)
shows that protocol changes had no special cause effect on the rate of DOS hyperglycemia in any phase. One outlier was identified (week 70), but careful review of data from weeks 68 through 72 did not reveal any special cause events or process changes that could explain this finding. In particular, HCP adherence to the protocol was stable during this period. Patient adherence to HCP instructions did not affect glycemic control on the DOS.

 

 

A subgroup analysis of DOS glucose levels in insulin-treated patients with preoperative HbA1c levels > 8% did not demonstrate a change in the rate of

DOS hyperglycemia with intensification of the dose of long-acting basal insulin on the evening before surgery (Figure 2). However, analysis of the statistical process p-control chart of this subgroup identified 2 outliers of DOS hyperglycemia in weeks 36 through 40 followed by a downward trend in the rate for weeks 40 through 64. A 12% decrease (89% vs 77%) in HCP adherence to the protocol after the phase 2 change (weeks 24-44) was observed immediately preceding the unusually high rate of DOS hyperglycemia in patients with HbA1c > 8%. With ongoing QI efforts and education, HCP adherence improved to 88% after the phase 3 change, correlating with the observed trend of improved DOS hyperglycemia rates.

Only 7 of 424 (1.7%) patients with DM and 4 of 195 (2.1%) patients treated with evening, long-acting basal insulin had marked hyperglycemia (DOS glucose levels ≥ 300 mg/dL). Only 1 patient who was not on outpatient insulin treatment had surgery canceled for hyperglycemia.
Clinically significant hypoglycemia (blood glucose level < 80 mg/dL) was rare (n = 6). The average time between hypoglycemic events was 52 days and was not affected by intensification of the evening, long-acting basal insulin dose (eAppendix 2, available at doi:10.2788/fp.0335). Variations in the measured time between rare events of hypoglycemia are explained by common cause or random variation, as the individual values did not approach or exceed the 3 SD limits set by the UCL and LCL.

Overall, 89% of the HCPs followed the preoperative insulin protocol. HCP adherence to the protocol decreased to 77% after the phase 2 change, often related to deviations from the protocol or when a prior version was used. By the end of phase 3, HCP adherence returned to the baseline rate (88%). Patient adherence to medication instructions was not affected by protocol changes (86% throughout the study period). Prospective data collection was briefly interrupted between January 18, 2019, and March 5, 2019, while designing our phase 2 intervention. We were unable to track the total number of eligible patients during this time, but were able to identify 8 insulin-treated patients with DM who underwent elective noncardiac surgery and included their data in phase 1.

Discussion

The management and prevention of immediate perioperative hyperglycemia and glycemic variability have attracted attention as evidence has mounted for their association with postoperative morbidity and mortality.1,2,17 Available guidelines for preventing DOS hyperglycemia vary in their recommendations for preoperative insulin management.7-10 Notably, concerns about iatrogenic hypoglycemia often hinder efforts to lower rates of DOS hyperglycemia.4 We successfully implemented an iterative intensification protocol for preoperative long-acting basal insulin doses on the evening before surgery but did not observe a lower rate of hyperglycemia. Importantly, we also did not observe a higher rate of hypoglycemia on the DOS, as observed in a previous study.5

The observational study by Demma and colleagues found that patients receiving 75% of their evening, long-acting basal insulin dose were significantly more likely to achieve target blood glucose levels of 100 to 180 mg/dL than patients receiving no insulin at all (78% vs 0%; P = .001). However, no significant difference was noted when this group was compared with patients receiving 50% of their evening, long-acting basal insulin doses (78% vs 70%; P = .56). This is more clinically pertinent as it is generally accepted that the evening, long-acting insulin dose should not be entirely withheld on the evening before surgery.5

 

 



These findings are consistent with our observation that the rate of DOS hyperglycemia did not decrease with intensification of the evening, long-acting insulin dose from 50% to 100% of the prescribed dose in patients with HbA1c levels > 8% (phase 2) and 50% to 75% of the prescribed dose in patients with HbA1c levels ≤ 8% (phase 3). In the study by Demma and colleagues, few patients presented with preoperative hypoglycemia (2.7%) but all had received 100% of their evening, long-acting basal insulin dose, suggesting a significant increase in the rate of hypoglycemia compared with patients receiving lower doses of insulin (P = .01).5 However, long-term DM control as assessed by HbA1c level was available for < 10% of the patients, making it difficult to evaluate the effect of overall DM control on the results.5 In our study, preoperative HbA1c levels were available for 99.5% of the patients and only those with HbA1c levels > 8% received 100% of their evening, long-acting insulin dose on the evening before surgery. Notably, we did not observe a higher rate of hypoglycemia in this patient population, indicating that preoperative insulin dose intensification is safe for this subgroup.

Although HCP adherence to perioperative DM management protocols has been identified as a predominant barrier to the delivery of optimal perioperative DM care, prior studies of various preoperative insulin protocols to reduce perioperative hyperglycemia have not reported HCP adherence to their insulin protocols or its effect on DOS hyperglycemia.4-6 Additionally, patient adherence to HCP instructions is a key factor identified in our driver diagram that may influence DOS hyperglycemia, a hypothesis that is supported by a prior cross-sectional study showing an increased rate of hyperglycemia in the PACU with omission of preoperative DM medication.11 In our study, patient adherence to preoperative medication management instructions was higher than reported previously and remained consistently high regardless of protocol changes, which may explain why patient adherence did not affect the rate of DOS hyperglycemia.

Although not part of our study protocol, our preoperative HCPs routinely prepare written patient instructions for the preoperative management of medications for all patients, which likely explains higher patient adherence to instructions in our study than seen in the previous study where written instructions were only encouraged.11 However, HCP adherence to the protocol decreased after our phase 2 changes and was associated with a transient increase in DOS hyperglycemia rates. The DOS hyperglycemia rates returned to baseline levels with ongoing QI efforts and education to improve HCP adherence to protocol.

Limitations

Our QI initiative had several limitations. Nearly all patients were male veterans with T2DM, and most were older (range, 50-89 years). This limits the generalizability to women, younger patients, and people with type 1 DM. Additionally, our data collection relied on completion and collection of the preoperative form by different HCPs, allowing for sampling bias if some patients with DM undergoing elective noncardiac surgery were missed. Furthermore, although we could verify HCP adherence to the preoperative DM management protocols by reviewing their written instructions, we relied on patients’ self-reported adherence to the preoperative instructions. Finally, we did not evaluate postoperative blood glucose levels because the effect of intraoperative factors such as fluid, insulin, and glucocorticoid administration on postoperative glucose levels are variable. To the best of our knowledge, no other major systematic changes occurred in the preoperative care of patients with DM during the study period.

Conclusions

The findings of our QI initiative suggest that HCP adherence to preoperative DM management protocols may be a key contributor to DOS hyperglycemia and that ensuring HCP adherence may be as important as preoperative insulin dose adjustments. To our knowledge, this is the first study to report rates of HCP adherence to preoperative DM management protocols and its effect on DOS hyperglycemia. We will focus future QI efforts on optimizing HCP adherence to preoperative DM management protocols at our institution.

Acknowledgments

We thank our endocrinology expert, Dr. Kristina Utzschneider, for her guidance in designing this improvement project and our academic research coach, Dr. Helene Starks, for her help in editing the manuscript.

Perioperative hyperglycemia, defined as blood glucose levels ≥ 180 mg/dL in the immediate pre- and postoperative period, is associated with increased postoperative morbidity, including infections, preoperative interventions, and in-hospital mortality.1-3 Despite being identified as a barrier to optimal perioperative glycemic control, limited evidence is available on patient or health care practitioner (HCP) adherence to preoperative insulin protocols.4-6

Background

Despite mounting evidence of the advantages of maintaining perioperative glucose levels between 80 and 180 mg/dL, available guidelines vary in their recommendations for long-acting basal insulin dosing.7-10 The Society of Ambulatory Anesthesia suggests using 100% of the prescribed evening dosage of long-acting basal insulin dose on the night before surgery in patients without a history of nocturnal or morning hypoglycemia (category 2A evidence).9 However, the revised 2016 United Kingdom National Health Service consensus guideline recommends using 80% to 100% of the prescribed evening dosage of long-acting basal insulin dose on the night before surgery.7 The 2022 American Diabetes Association references an observational study of patients with type 2 DM (T2DM) treated with evening-only, long-acting glargine insulin, indicating that the optimal basal insulin dose on the evening before surgery is about 75% of the outpatient dose.5,10 However, in a randomized, prospective open trial of patients with DM treated with evening-only long-acting basal insulin, no significant difference was noted in the target day of surgery (DOS) glucose levels among different dosing strategies on the evening before surgery.6 Presently, the optimal dose of long-acting insulin analogs on the evening before surgery is unknown.

Additionally, little is known about the other factors that influence perioperative glycemic control. Several barriers to optimal perioperative care of patients with DM have been identified, including lack of prioritization by HCPs, lack of knowledge about current evidence-based recommendations, and lack of patient information and involvement.4 To determine the effect of patient adherence to preoperative medication instructions on postoperative outcome, a cross-sectional study assessed surgical patients admitted to the postanesthetic care unit (PACU) and found that only 70% of patients with insulin-treated DM took their medications preoperatively. Additionally, 23% of nonadherent patients who omitted their medications either did not understand or forgot preoperative medication management instructions. Preoperative DM medication omission was associated with higher rates of hyperglycemia in the PACU (23.8% vs 3.6%; P = .02).11 Importantly, to our knowledge, the extent of HCP adherence to DM management protocols and the subsequent effect on DOS hyperglycemia has not been examined until now.For patients with DM treated with an evening dose of long-acting basal insulin (ie, either once-daily long-acting basal insulin in the evening or twice-daily long-acting basal insulin, both morning and evening) presenting for elective noncardiac surgery, our aim was to decrease the rate of DOS hyperglycemia from 29% (our baseline) to 15% by intensifying the dose of insulin on the evening before surgery without increasing the rate of hypoglycemia. We also sought to determine the rates of HCP adherence to our insulin protocols as well as patients’ self-reported adherence to HCP instructions over the course of this quality improvement (QI) initiative.

Quality Improvement Program

Our surgical department consists of 11 surgical subspecialties that performed approximately 4400 noncardiac surgeries in 2019. All patients undergoing elective surgery are evaluated in the preoperative clinic, which is staffed by an anesthesiology professional (attending and resident physicians, nurse practitioners, and physician assistants) and internal medicine attending physicians. At the preoperative visit, each patient is evaluated by anesthesiology; medically complex patients may also be referred to an internal medicine professional for further risk stratification and optimization before surgery.

At the preoperative clinic visit, HCPs prepare written patient instructions for the preoperative management of medications, including glucose-lowering medications, based on a DM management protocol that was implemented in 2016 for the preoperative management of insulin, noninsulin injectable agents, and oral hyperglycemic agents. According to this protocol, patients with DM treated with evening long-acting basal insulin (eg, glargine insulin) are instructed to take 50% of their usual evening dose the evening before surgery. A preoperative clinic nurse reviews the final preoperative medication instructions with the patient at the end of the clinic visit. Patients are also instructed to avoid oral intake other than water and necessary medications after midnight before surgery regardless of the time of surgery. On the DOS, the patient’s blood glucose level is measured on arrival to the presurgical area.

Our QI initiative focused only on the dose of self-administered, long-acting basal insulin on the evening before surgery. The effect of the morning of surgery long-acting insulin dose on the DOS glucose levels largely depends on the timing of surgery, which is variable; therefore, we did not target this dose for our initiative. Patients receiving intermediate-acting neutral protamine Hagedorn (NPH) insulin were excluded because our protocol does not recommend a dose reduction for NPH insulin on the evening before surgery.

 

 



We developed a comprehensive driver diagram to help elucidate the different factors contributing to DOS hyperglycemia and to guide specific QI interventions.12 Some of the identified contributors to DOS hyperglycemia, such as the length of preoperative fasting and timing of surgery, are unpredictable and were deemed difficult to address preoperatively. Other contributors to DOS hyperglycemia, such as outpatient DM management, often require interventions over several months, which is well beyond the time usually allotted for preoperative evaluation and optimization. On the other hand, immediate preoperative insulin dosing directly affects DOS glycemic control; therefore, improvement of the preoperative insulin management protocol to optimize the dosage on the evening before surgery was considered to be an achievable QI goal with the potential for decreasing the rate of DOS hyperglycemia in patients presenting for elective noncardiac surgery.

We used the Model for Understanding Success in Quality (MUSIQ) as a framework to identify key contextual factors that may affect the success of our QI project.13 Limited resource availability and difficulty with dissemination of protocol changes in the preoperative clinic were determined to be potential barriers to the successful implementation of our QI initiative. Nonetheless, senior leadership support, microsystem QI culture, QI team skills, and physician involvement supported the implementation. The revised Standards for Quality Improvement Reporting Excellence (SQUIRE 2.0) guidelines were followed for this study.14

Interventions

With stakeholder input from anesthesiology, internal medicine, endocrinology, and nursing, we designed an intervention to iteratively change the HCP protocol instructions for long-acting insulin dosing on the evening before surgery. In phase 1 of the study (October 1, 2018, to March 11, 2019), we obtained baseline data on the rates of DOS hyperglycemia (blood glucose ≥ 180 mg/dL) and hypoglycemia (blood glucose < 80 mg/dL), as well as patient and HCP adherence rates to our existing preoperative DM protocol. For phase 2 (March 12, 2019, to July 22, 2019), the preoperative DM management protocol was changed to increase the dose of long-acting basal insulin on the evening before surgery for patients with hemoglobin A1c (HbA1c) levels > 8% from 50% of the usual outpatient dose to 100%. Finally, in phase 3 (July 23, 2019, to March 12, 2020), the protocol was changed to increase the dose of long-acting basal insulin on the evening before surgery for patients with HbA1c levels ≤ 8% from 50% of the usual outpatient dose to 75% while sustaining the phase 2 change. Preoperative HCPs were informed of the protocol changes in person and were provided with electronic and hard copies of each new protocol.

Protocol

We used a prospective cohort design of 424 consecutive patients with DM who presented for preoperative evaluation for elective noncardiac surgery between October 1, 2018, and March 12, 2020. For the subset of 195 patients treated with an evening dose of long-acting basal insulin, we examined the effect of intensification of this preoperative basal insulin dose on DOS hyperglycemia and hypoglycemia, HCP adherence to iterative changes of the protocol, and patient adherence to HCP instructions on preoperative medication dosing. The QI project was concluded when elective surgeries were paused due to the COVID-19 pandemic.

We created a standardized preoperative data collection form that included information on the most recent HbA1c, time, dose, and type of patient-administered insulin on the evening before surgery, and DOS blood glucose level. A preoperative clinic nurse completed the standardized preoperative data collection form. The HCP’s preoperative medication instructions and the preoperative data collection forms were gathered for review and data analysis.

 

 



The primary outcome was DOS hyperglycemia (blood glucose levels ≥ 180 mg/dL). We monitored the rate of DOS hypoglycemia (blood glucose levels < 80 mg/dL) as a balancing measure to ensure safety with long-acting basal insulin intensification. Although hypoglycemia is defined as a blood glucose level < 70 mg/dL, a target glucose range of 80 mg/dL to 180 mg/dL is recommended during the perioperative period.8 Therefore, we chose a more conservative definition of hypoglycemia (blood glucose levels < 80 mg/dL) to adhere to the recommended perioperative glucose target range.

Process measures included HCP adherence to each protocol change, which was assessed by comparing written preoperative patient instructions to the current protocol. Similarly, patient adherence to HCP-recommended long-acting basal insulin dosing was assessed by comparing written preoperative patient instructions to the patient’s self-reported time and dose of long-acting basal insulin on the evening before surgery. For any discrepancy between the HCP instructions and protocol or HCP-recommended dose and patient self-reported dose of long-acting basal insulin, a detailed chart review was performed to determine the etiology.

Statistical Analysis

We used the statistical process p-control chart to assess the effect of iterative changes to the preoperative long-acting basal insulin protocol on DOS hyperglycemia. The proportion defective (rate of DOS hyperglycemia) was plotted against time to determine whether the observed variations in the rate of DOS hyperglycemia over time were attributable to random common causes or special causes because of our intervention. The lower control limit (LCL) and upper control limit (UCL) define the limits of expected outcome measures in a stable process prior to introducing changes and were set at 3 SDs from the mean to balance the likelihood of type I (false-positive) and type II (false-negative) errors. Because of the variable interval sample sizes, we used the CRITBINOM function of Microsoft Excel to calculate the exact UCL satisfying the 3 SD limits of 0.99865.15 The Shewhart rules (outliers, runs or shifts, trends, sawtooth) were used to analyze the p-control chart to identify special cause signals resulting from our interventions.16 We used the statistical process t-control chart to record the time (days) between the few occurrences of DOS hypoglycemia because cases of hypoglycemia were rare.

Ethical Consideration

The Human Research Protection Program, Associate Chief of Staff for Research and Development, and Quality, Safety, and Values department reviewed this project in accordance with the Veterans Health Administration Program Guide 1200.21 and determined that it was a nonresearch operations activity; thus, approval by an institutional review board was not needed. The authors declare no competing interests.

Patient Outcomes

We prospectively followed 424 consecutive patients with DM undergoing elective noncardiac surgery from the time of the preoperative clinic evaluation until DOS; 195 patients were on evening

long-acting basal insulin on an outpatient basis (eAppendix 1, available at doi:10.2788/fp.0335). The preoperative HbA1c was measured a mean (SD) of 52 (61) days prior to surgery (range, 0-344). During phase 1, baseline information on DOS glucose levels and adherence to the existing preoperative DM management protocol was obtained; 57 (29%) patients treated with evening, long-acting basal insulin were hyperglycemic. Of 106 patients with DM, 4 (3.7%) had hypoglycemia. Just 2 (3.5%) of 57 insulin-treated patients had hypoglycemia. In phases 2 and 3, iterative intensifications of the long-acting basal insulin dose on the evening before surgery were implemented. The statistical process p-control chart (Figure 1)
shows that protocol changes had no special cause effect on the rate of DOS hyperglycemia in any phase. One outlier was identified (week 70), but careful review of data from weeks 68 through 72 did not reveal any special cause events or process changes that could explain this finding. In particular, HCP adherence to the protocol was stable during this period. Patient adherence to HCP instructions did not affect glycemic control on the DOS.

 

 

A subgroup analysis of DOS glucose levels in insulin-treated patients with preoperative HbA1c levels > 8% did not demonstrate a change in the rate of

DOS hyperglycemia with intensification of the dose of long-acting basal insulin on the evening before surgery (Figure 2). However, analysis of the statistical process p-control chart of this subgroup identified 2 outliers of DOS hyperglycemia in weeks 36 through 40 followed by a downward trend in the rate for weeks 40 through 64. A 12% decrease (89% vs 77%) in HCP adherence to the protocol after the phase 2 change (weeks 24-44) was observed immediately preceding the unusually high rate of DOS hyperglycemia in patients with HbA1c > 8%. With ongoing QI efforts and education, HCP adherence improved to 88% after the phase 3 change, correlating with the observed trend of improved DOS hyperglycemia rates.

Only 7 of 424 (1.7%) patients with DM and 4 of 195 (2.1%) patients treated with evening, long-acting basal insulin had marked hyperglycemia (DOS glucose levels ≥ 300 mg/dL). Only 1 patient who was not on outpatient insulin treatment had surgery canceled for hyperglycemia.
Clinically significant hypoglycemia (blood glucose level < 80 mg/dL) was rare (n = 6). The average time between hypoglycemic events was 52 days and was not affected by intensification of the evening, long-acting basal insulin dose (eAppendix 2, available at doi:10.2788/fp.0335). Variations in the measured time between rare events of hypoglycemia are explained by common cause or random variation, as the individual values did not approach or exceed the 3 SD limits set by the UCL and LCL.

Overall, 89% of the HCPs followed the preoperative insulin protocol. HCP adherence to the protocol decreased to 77% after the phase 2 change, often related to deviations from the protocol or when a prior version was used. By the end of phase 3, HCP adherence returned to the baseline rate (88%). Patient adherence to medication instructions was not affected by protocol changes (86% throughout the study period). Prospective data collection was briefly interrupted between January 18, 2019, and March 5, 2019, while designing our phase 2 intervention. We were unable to track the total number of eligible patients during this time, but were able to identify 8 insulin-treated patients with DM who underwent elective noncardiac surgery and included their data in phase 1.

Discussion

The management and prevention of immediate perioperative hyperglycemia and glycemic variability have attracted attention as evidence has mounted for their association with postoperative morbidity and mortality.1,2,17 Available guidelines for preventing DOS hyperglycemia vary in their recommendations for preoperative insulin management.7-10 Notably, concerns about iatrogenic hypoglycemia often hinder efforts to lower rates of DOS hyperglycemia.4 We successfully implemented an iterative intensification protocol for preoperative long-acting basal insulin doses on the evening before surgery but did not observe a lower rate of hyperglycemia. Importantly, we also did not observe a higher rate of hypoglycemia on the DOS, as observed in a previous study.5

The observational study by Demma and colleagues found that patients receiving 75% of their evening, long-acting basal insulin dose were significantly more likely to achieve target blood glucose levels of 100 to 180 mg/dL than patients receiving no insulin at all (78% vs 0%; P = .001). However, no significant difference was noted when this group was compared with patients receiving 50% of their evening, long-acting basal insulin doses (78% vs 70%; P = .56). This is more clinically pertinent as it is generally accepted that the evening, long-acting insulin dose should not be entirely withheld on the evening before surgery.5

 

 



These findings are consistent with our observation that the rate of DOS hyperglycemia did not decrease with intensification of the evening, long-acting insulin dose from 50% to 100% of the prescribed dose in patients with HbA1c levels > 8% (phase 2) and 50% to 75% of the prescribed dose in patients with HbA1c levels ≤ 8% (phase 3). In the study by Demma and colleagues, few patients presented with preoperative hypoglycemia (2.7%) but all had received 100% of their evening, long-acting basal insulin dose, suggesting a significant increase in the rate of hypoglycemia compared with patients receiving lower doses of insulin (P = .01).5 However, long-term DM control as assessed by HbA1c level was available for < 10% of the patients, making it difficult to evaluate the effect of overall DM control on the results.5 In our study, preoperative HbA1c levels were available for 99.5% of the patients and only those with HbA1c levels > 8% received 100% of their evening, long-acting insulin dose on the evening before surgery. Notably, we did not observe a higher rate of hypoglycemia in this patient population, indicating that preoperative insulin dose intensification is safe for this subgroup.

Although HCP adherence to perioperative DM management protocols has been identified as a predominant barrier to the delivery of optimal perioperative DM care, prior studies of various preoperative insulin protocols to reduce perioperative hyperglycemia have not reported HCP adherence to their insulin protocols or its effect on DOS hyperglycemia.4-6 Additionally, patient adherence to HCP instructions is a key factor identified in our driver diagram that may influence DOS hyperglycemia, a hypothesis that is supported by a prior cross-sectional study showing an increased rate of hyperglycemia in the PACU with omission of preoperative DM medication.11 In our study, patient adherence to preoperative medication management instructions was higher than reported previously and remained consistently high regardless of protocol changes, which may explain why patient adherence did not affect the rate of DOS hyperglycemia.

Although not part of our study protocol, our preoperative HCPs routinely prepare written patient instructions for the preoperative management of medications for all patients, which likely explains higher patient adherence to instructions in our study than seen in the previous study where written instructions were only encouraged.11 However, HCP adherence to the protocol decreased after our phase 2 changes and was associated with a transient increase in DOS hyperglycemia rates. The DOS hyperglycemia rates returned to baseline levels with ongoing QI efforts and education to improve HCP adherence to protocol.

Limitations

Our QI initiative had several limitations. Nearly all patients were male veterans with T2DM, and most were older (range, 50-89 years). This limits the generalizability to women, younger patients, and people with type 1 DM. Additionally, our data collection relied on completion and collection of the preoperative form by different HCPs, allowing for sampling bias if some patients with DM undergoing elective noncardiac surgery were missed. Furthermore, although we could verify HCP adherence to the preoperative DM management protocols by reviewing their written instructions, we relied on patients’ self-reported adherence to the preoperative instructions. Finally, we did not evaluate postoperative blood glucose levels because the effect of intraoperative factors such as fluid, insulin, and glucocorticoid administration on postoperative glucose levels are variable. To the best of our knowledge, no other major systematic changes occurred in the preoperative care of patients with DM during the study period.

Conclusions

The findings of our QI initiative suggest that HCP adherence to preoperative DM management protocols may be a key contributor to DOS hyperglycemia and that ensuring HCP adherence may be as important as preoperative insulin dose adjustments. To our knowledge, this is the first study to report rates of HCP adherence to preoperative DM management protocols and its effect on DOS hyperglycemia. We will focus future QI efforts on optimizing HCP adherence to preoperative DM management protocols at our institution.

Acknowledgments

We thank our endocrinology expert, Dr. Kristina Utzschneider, for her guidance in designing this improvement project and our academic research coach, Dr. Helene Starks, for her help in editing the manuscript.

References

1. van den Boom W, Schroeder RA, Manning MW, Setji TL, Fiestan GO, Dunson DB. Effect of A1c and glucose on postoperative mortality in noncardiac and cardiac surgeries. Diabetes Care. 2018;41(4):782-788. doi:10.2337/dc17-2232

2. Punthakee Z, Iglesias PP, Alonso-Coello P, et al. Association of preoperative glucose concentration with myocardial injury and death after non-cardiac surgery (GlucoVISION): a prospective cohort study. Lancet Diabetes Endocrinol. 2018;6(10):790-797. doi:10.1016/S2213-8587(18)30205-5

3. Kwon S, Thompson R, Dellinger P, Yanez D, Farrohki E, Flum D. Importance of perioperative glycemic control in general surgery: a report from the Surgical Care and Outcomes Assessment Program. Ann Surg. 2013;257(1):8-14. doi:10.1097/SLA.0b013e31827b6bbc

4. Hommel I, van Gurp PJ, den Broeder AA, et al. Reactive rather than proactive diabetes management in the perioperative period. Horm Metab Res. 2017;49(7):527-533. doi:10.1055/s-0043-105501

5. Demma LJ, Carlson KT, Duggan EW, Morrow JG 3rd, Umpierrez G. Effect of basal insulin dosage on blood glucose concentration in ambulatory surgery patients with type 2 diabetes. J Clin Anesth. 2017;36:184-188. doi:10.1016/j.jclinane.2016.10.003

6. Rosenblatt SI, Dukatz T, Jahn R, et al. Insulin glargine dosing before next-day surgery: comparing three strategies. J Clin Anesth. 2012;24(8):610-617. doi:10.1016/j.jclinane.2012.02.010

7. Dhatariya K, Levy N, Flanagen D, et al; Joint British Diabetes Societies for Inpatient Care. Management of adults with diabetes undergoing surgery and elective procedures: improving standards. Summary. Published 2011. Revised March 2016. Accessed October 31, 2022. https://www.diabetes.org.uk/resources-s3/2017-09/Surgical%20guideline%202015%20-%20summary%20FINAL%20amended%20Mar%202016.pdf

8. American Diabetes Association. 15. Diabetes care in the hospital: standards of medical care in diabetes–2021. Diabetes Care. 2021;44(suppl 1):S211-S220. doi:10.2337/dc21-S015

9. Joshi GP, Chung F, Vann MA, et al; Society for Ambulatory Anesthesia. Society for Ambulatory Anesthesia consensus statement on perioperative blood glucose management in diabetic patients undergoing ambulatory surgery. Anesth Analg. 2010;111(6):1378-1387. doi:10.1213/ANE.0b013e3181f9c288

10. American Diabetes Association Professional Practice Committee. 16. Diabetes care in the hospital: standards of medical care in diabetes–2022. Diabetes Care. 2021;45(suppl 1):S244-S253. doi:10.2337/dc22-S016

11. Notaras AP, Demetriou E, Galvin J, Ben-Menachem E. A cross-sectional study of preoperative medication adherence and early postoperative recovery. J Clin Anesth. 2016;35:129-135. doi:10.1016/j.jclinane.2016.07.007

12. Bennett B, Provost L. What’s your theory? Driver diagram serves as tool for building and testing theories for improvement. Quality Progress. 2015;48(7):36-43. Accessed August 31, 2022. http://www.apiweb.org/QP_whats-your-theory_201507.pdf

13. Kaplan HC, Provost LP, Froehle CM, Margolis PA. The Model for Understanding Success in Quality (MUSIQ): building a theory of context in healthcare quality improvement. BMJ Qual Saf. 2012;21(1):13-20. doi:10.1136/bmjqs-2011-000010

14. Ogrinc G, Davies L, Goodman D, Batalden P, Davidoff F, Stevens D. SQUIRE 2.0 (Standards for QUality Improvement Reporting Excellence): revised publication guidelines from a detailed consensus process. BMJ Qual Saf. 2016;25(12):986-992. doi:10.1136/bmjqs-2015-004411

15. Duclos A, Voirin N. The p-control chart: a tool for care improvement. Int J Qual Health Care. 2010;22(5):402-407. doi:10.1093/intqhc/mzq037

16. Cheung YY, Jung B, Sohn JH, Ogrinc G. Quality initiatives: statistical control charts: simplifying the analysis of data for quality improvement. Radiographics. 2012;32(7):2113-2126. doi:10.1148/rg.327125713

17. Simha V, Shah P. Perioperative glucose control in patients with diabetes undergoing elective surgery. JAMA. 2019;321(4):399. doi:10.1001/jama.2018.20922

References

1. van den Boom W, Schroeder RA, Manning MW, Setji TL, Fiestan GO, Dunson DB. Effect of A1c and glucose on postoperative mortality in noncardiac and cardiac surgeries. Diabetes Care. 2018;41(4):782-788. doi:10.2337/dc17-2232

2. Punthakee Z, Iglesias PP, Alonso-Coello P, et al. Association of preoperative glucose concentration with myocardial injury and death after non-cardiac surgery (GlucoVISION): a prospective cohort study. Lancet Diabetes Endocrinol. 2018;6(10):790-797. doi:10.1016/S2213-8587(18)30205-5

3. Kwon S, Thompson R, Dellinger P, Yanez D, Farrohki E, Flum D. Importance of perioperative glycemic control in general surgery: a report from the Surgical Care and Outcomes Assessment Program. Ann Surg. 2013;257(1):8-14. doi:10.1097/SLA.0b013e31827b6bbc

4. Hommel I, van Gurp PJ, den Broeder AA, et al. Reactive rather than proactive diabetes management in the perioperative period. Horm Metab Res. 2017;49(7):527-533. doi:10.1055/s-0043-105501

5. Demma LJ, Carlson KT, Duggan EW, Morrow JG 3rd, Umpierrez G. Effect of basal insulin dosage on blood glucose concentration in ambulatory surgery patients with type 2 diabetes. J Clin Anesth. 2017;36:184-188. doi:10.1016/j.jclinane.2016.10.003

6. Rosenblatt SI, Dukatz T, Jahn R, et al. Insulin glargine dosing before next-day surgery: comparing three strategies. J Clin Anesth. 2012;24(8):610-617. doi:10.1016/j.jclinane.2012.02.010

7. Dhatariya K, Levy N, Flanagen D, et al; Joint British Diabetes Societies for Inpatient Care. Management of adults with diabetes undergoing surgery and elective procedures: improving standards. Summary. Published 2011. Revised March 2016. Accessed October 31, 2022. https://www.diabetes.org.uk/resources-s3/2017-09/Surgical%20guideline%202015%20-%20summary%20FINAL%20amended%20Mar%202016.pdf

8. American Diabetes Association. 15. Diabetes care in the hospital: standards of medical care in diabetes–2021. Diabetes Care. 2021;44(suppl 1):S211-S220. doi:10.2337/dc21-S015

9. Joshi GP, Chung F, Vann MA, et al; Society for Ambulatory Anesthesia. Society for Ambulatory Anesthesia consensus statement on perioperative blood glucose management in diabetic patients undergoing ambulatory surgery. Anesth Analg. 2010;111(6):1378-1387. doi:10.1213/ANE.0b013e3181f9c288

10. American Diabetes Association Professional Practice Committee. 16. Diabetes care in the hospital: standards of medical care in diabetes–2022. Diabetes Care. 2021;45(suppl 1):S244-S253. doi:10.2337/dc22-S016

11. Notaras AP, Demetriou E, Galvin J, Ben-Menachem E. A cross-sectional study of preoperative medication adherence and early postoperative recovery. J Clin Anesth. 2016;35:129-135. doi:10.1016/j.jclinane.2016.07.007

12. Bennett B, Provost L. What’s your theory? Driver diagram serves as tool for building and testing theories for improvement. Quality Progress. 2015;48(7):36-43. Accessed August 31, 2022. http://www.apiweb.org/QP_whats-your-theory_201507.pdf

13. Kaplan HC, Provost LP, Froehle CM, Margolis PA. The Model for Understanding Success in Quality (MUSIQ): building a theory of context in healthcare quality improvement. BMJ Qual Saf. 2012;21(1):13-20. doi:10.1136/bmjqs-2011-000010

14. Ogrinc G, Davies L, Goodman D, Batalden P, Davidoff F, Stevens D. SQUIRE 2.0 (Standards for QUality Improvement Reporting Excellence): revised publication guidelines from a detailed consensus process. BMJ Qual Saf. 2016;25(12):986-992. doi:10.1136/bmjqs-2015-004411

15. Duclos A, Voirin N. The p-control chart: a tool for care improvement. Int J Qual Health Care. 2010;22(5):402-407. doi:10.1093/intqhc/mzq037

16. Cheung YY, Jung B, Sohn JH, Ogrinc G. Quality initiatives: statistical control charts: simplifying the analysis of data for quality improvement. Radiographics. 2012;32(7):2113-2126. doi:10.1148/rg.327125713

17. Simha V, Shah P. Perioperative glucose control in patients with diabetes undergoing elective surgery. JAMA. 2019;321(4):399. doi:10.1001/jama.2018.20922

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More Than a Health Fair: Preventive Health Care During COVID-19 Vaccine Events

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Shortly into the COVID-19 pandemic, Dr. Robert Califf, the commissioner of the US Food and Drug Administration, warned of a coming tsunami of chronic diseases, exacerbated by missed care during the pandemic.1 According to a Centers for Disease Control and Prevention (CDC) survey, more than 30% of adults reported delaying or avoiding routine medical care in the first 6 months of 2020. This rate was highest in people with comorbidities.2 Multiple studies demonstrated declines in hypertension care, hemoglobin A1c testing, mammography, and colon cancer screening.3-5 There has been a resultant increase in colon cancer complications, wounds, and amputations.6,7 The United Kingdom is expected to have a 7.9% to 16.6% increase in future deaths due to breast and colorectal cancer (CRC).8 The World Health Organization estimates an excess 14.9 million people died in 2020 and 2021, either directly from or indirectly related to COVID-19.9

Due to the large-scale conversion from face-to-face care to telehealth modalities, COVID-19 vaccination events offered a unique opportunity to perform preventive health care that requires in-person visits, since most US adults have sought vaccination. However, vaccine events may not reach people most at risk for COVID-19 or chronic disease. Groups of Americans with lower vaccination rates were concerned about driving times and missing work to get the vaccine.10

Distance and travel time may be a particular challenge in Hawaii. Oahu is considered rural by the US Department of Veterans Affairs (VA); some communities are 80 minutes away from the VA Pacific Islands Health Care System (VAPIHCS) main facility. Oahu has approximately 150 veterans experiencing homelessness who may not have transportation to vaccine events. Additionally, VAPIHCS serves veterans that may be at higher risk of not receiving COVID-19 vaccination. Racial and ethnic minority residents have lower vaccination rates, yet are at a higher risk of COVID-19 infection and complications, and through the pandemic, this vaccination gap worsened.11,12 More than 10% of the population of Hawaii is Native Hawaiian or Pacific Islander, and this population is at elevated risk for diabetes mellitus, hypertension, and COVID-19 mortality.13-16

Health Fair Program

The VA provides clinical reminders in its electronic health record (EHR) that are specified by age, gender assigned at birth, and comorbidities. The clinical reminder program is intended to provide clinically relevant reminders for preventive care at the point of care. Veterans with overdue clinical reminders can be identified by name and address, allowing for the creation of health fair events that were directed towards communities with veterans with clinical reminders, including COVID-19 vaccination need. A team of health care professionals from VAPIHCS conceived of a health fair program to increase the reach of vaccine events and include preventive care in partnership with the VAPIHCS Vet Center Program, local communities, U.S.VETS, and the Hawaii Institute of Health Services (HIHS). We sought to determine which services could be offered in community settings; large vaccine events; and at homeless emergency, transitional, or permanent housing. We tracked veterans who received care in the different locations of the directed health fair.

This project was determined to be a quality improvement initiative by the VAPIHCS Office of Research and Development. It was jointly planned by the VAPIHCS pharmacy, infectious diseases, Vet Center Program, and homeless team to make the COVID-19 vaccines available to more rural and to veterans experiencing homelessness, and in response to a decline in facility face-to-face visits. Monthly meetings were held to select sites within zip codes with higher numbers of open clinical reminders and lower vaccination uptake. Informatics developed a list of clinical reminders by zip code for care performed at face-to-face visits.

Partners

The Vet Center Program, suicide prevention coordinator, and the homeless outreach team have a mandate to perform outreach events.17,18 These services collaborate with community partners to locate sites for events. The team was able to leverage these contacts to set up sites for events. The Vet Center Program readjustment counselor and the suicide prevention coordinator provide mental health counseling. The Vet Center counsels on veteran benefits. They supplied a mobile van with WiFi, counseling and examination spaces, and refrigeration, which became the mobile clinic for the preventive care offered at events. The homeless program works with multiple community partners. They contract with HIHS and U.S.VETS to provide emergency and permanent housing for veterans. Each event is reviewed with HIHS and U.S.VETS staff for permission to be on site. The suicide prevention coordinator or the Vet Center readjustment counselor and the homeless team became regular attendees of events. The homeless team provided resources for housing or food insecurity.

 

 

Preventive Health Measures

The VA clinical reminder system supports caregivers for both preventive health care and chronic condition management.19 Clinical reminders appear as due in the EHR, and reminder reports can be run by clinical informatics to determine groups of patients who have not had a reminder completed. The following reminders were completed: vaccinations (including COVID-19), CRC screening, diabetic foot check and teaching of foot care, diabetic retinal consultations, laboratory studies (lipids, hemoglobin A1c, microalbumin), mammogram and pap smear referrals, mental health reminders, homeless and food insecurity screening, HIV and hepatitis C testing, and blood pressure (BP) measurement. Health records were reviewed 3 months after each event to determine whether they were completed by the veteran. Additionally, we determined whether BP was controlled (< 130/80 mm Hg).

Settings

Large urban event. The first setting for the health fair was a large vaccination event near the VAPIHCS center in April 2021. Attendance was solicited by VEText, phone calls, and social media advertisements. At check-in, veterans with relevant open clinical reminders were invited to receive preventive health care during the 15-minute monitoring period after the COVID-19 vaccine. The Vet Center Program stationed the mobile van outside the vaccination event, where a physician and a clinical pharmacy specialist (CPS) did assessments, completed reminders, and entered follow-up requests for about 4 hours. A medical support assistant registered veterans who had never signed up for VA health care.

Community Settings. Nine events occurred at least monthly between March and September 2021 at 4 different sites in Oahu. Texts and phone calls were used to solicit attendance; there was no prior publicity on social media. Community events required scheduling resources; this required about 30 hours of medical staff assistant time. Seven sites were visited for about 3 hours each. A physician, pharmacy technician, and CPS conducted assessments, completed reminders, and entered follow-up requests. A medical support assistant registered veterans who had never signed up for VA health care.

Homeless veteran outreach. Five events occurred at 2 homeless veteran housing sites between August 2021 and January 2022. These sites were emergency housing sites (2 events) and transitional and permanent housing (2 events). U.S.VETS and HIHS contacted veterans living in those settings to promote the event. A physician, registered nurse, licensed practical nurse, and CPS conducted assessments, completed reminders, and entered follow-up requests. A medical support assistant registered veterans that had never signed up for VA health care. Each event lasted approximate 3 hours.

Process Quality Improvement

After the CDC changed recommendations to allow concurrent vaccination with the COVID-19 vaccine, we added other vaccinations to the events. This occurred during the course of community events. In June of 2021, there was a health advisory concerning hepatitis A among people experiencing homelessness in Oahu, so hepatitis vaccinations were added for events for veterans.20

Veterans Served

The EHR was used to determine demographics, open clinical reminders, and attendance at follow-up. Simple descriptive statistics were performed in Microsoft Excel. A total of 115 veterans were seen for preventive health visits, and 404 clinical reminders were completed. Seven hundred veterans attended the large centrally located vaccine event and 43 agreed to have a preventive health visit. Thirty-eight veterans had a preventive health visit at homeless outreach events and 34 veterans had a preventive health visit at the community events. Veterans at community

and homeless events were more likely to be Native Hawaiian/Pacific Islander (47% and 32%, respectively) than at the urban vaccine event (14%) (Table 1).

 

 

Of the 166 vaccines given, 73 were for COVID-19. Besides vaccination,

204 clinical reminders total were completed at the event (Table 2). Hypertension was the most common reminder with 52 completed; 29 veterans had BP in the hypertensive range. BP cuffs were provided to 19 veterans and CPS follow-up appointments were scheduled for 24 veterans. Of 22 homeless and food insecurity screens, 4 were positive and services and resources were provided. One veteran obtained emergency housing the same day.

Veteran follow-up or completion
of recommended services allowed 34 more reminders to be closed (Table 3), with high follow-up for referrals (76%). Within 3 months of an initial BP screen, 22 veterans had at least 1 follow-up with a pharmacist, 17 had BP controlled, and the BP of 5 veterans remained elevated. Screenings revealed abnormal health findings: CRC screening revealed CRC, 6 of the 11 completed laboratory results had an actionable finding, and all diabetic retinal referrals showed retinal disease. Poor follow-up was seen for diabetic high-risk foot referrals and HIV care.

Discussion

This program provided evidence that adding preventive screenings to vaccine events may help reach veterans who may have missed important preventive care due to the COVID-19 pandemic. The involvement of clinical informatics service allowed the outreach to be targeted to communities with incomplete clinical reminders. Interventions that could not be completed at the event had high levels of follow-up by veterans with important findings. The presence of a physician or nurse and a CPS allowed for point-of-care testing, as well as entering orders for medication, laboratory tests, and consultations. The attendance by representatives from the Vet Center, suicide prevention, and homeless services allowed counseling regarding benefits, and mental health follow-up. We believe that we were able to reach communities of veterans with unmet preventive needs and had higher risk of severe COVID-19, given the high numbers with open clinical reminders, the number of vaccines provided, and the high percentage of racial and ethnic minority veterans at events in the community. Our program experience provides some evidence that mobile and pop-up vaccination clinics may be beneficial for screening and managing chronic diseases, as proposed elsewhere.21-24

Strengths of this intervention include that we were able to show a high level of follow-up for recommended medical care as well as the results of our interventions. We have found no similar articles that provide data on completion of follow-up appointments after a health fair. A prior study showed only 23% to 63% of participants at a health fair reported having a recommended follow-up discussion with doctors, but the study reported no outcome of completed cancer screenings.25

Limitations

Weaknesses include the fact that health fair events may reach only healthy people, since attendees generally report better health and better health behaviors than nonattendees.26,27 We felt this was more problematic for the large-scale urban event and that offering rural events and events in homeless housing improved the reach. Future efforts will involve the use of social media and mailings to solicit attendance. To improve follow-up, future work will include adding to the events: phlebotomy or expanded point-of-care testing; specialty care telehealth capability; cervical cancer screen self-collection; and tele-retinal services.

Conclusions

This program provided evidence that directed, preventive screening can be performed in outreach settings paired with vaccine events. These vaccination events in rural and homeless settings reached communities with demonstrable COVID-19 vaccination and other preventive care needs. This approach could be used to help veterans catch up on needed preventive care.

Acknowledgments

Veterans Affairs Pacific Islands Health Care System: Anthony Chance, LCSW; Nicholas Chang, PharmD; Andrew Dahlburg, LCSW; Wilminia G. Ellorimo-Gil, RN; Paul Guillory, RN; Wendy D. Joy; Arthur Minor, LCSW; Avalua Smith; Jessica Spurrier, RN. Veterans Health Administration Vet Center Program: Rolly O. Alvarado; Edmond G. DeGuzman; Richard T. Teel. Hawaii Institute for Human Services. U.S.VETS.

References

1. Califf RM. Avoiding the coming tsunami of common, chronic disease: What the lessons of the COVID-19 pandemic can teach us. Circulation. 2021;143(19):1831-1834. doi:10.1161/CIRCULATIONAHA.121.053461

2. Czeisler MÉ, Marynak K, Clarke KEN, et al. Delay or avoidance of medical care because of COVID-19-related concerns - United States, June 2020. MMWR Morb Mortal Wkly Rep. 2020;69(36):1250-1257. doi:10.15585/mmwr.mm6936a4

3. European Society of Hypertension Corona-virus Disease 19 Task Force. The corona-virus disease 2019 pandemic compromised routine care for hypertension: a survey conducted among excellence centers of the European Society of Hypertension. J Hypertens. 2021;39(1):190-195. doi:10.1097/HJH.0000000000002703

4. Whaley CM, Pera MF, Cantor J, et al. Changes in health services use among commercially insured US populations during the COVID-19 pandemic. JAMA Netw Open. 2020;3(11):e2024984. doi:10.1001/jamanetworkopen.2020.24984

5. Song H, Bergman A, Chen AT, et al. Disruptions in preventive care: mammograms during the COVID-19 pandemic. Health Serv Res. 2021;56(1):95-101. doi:10.1111/1475-6773.13596

6. Shinkwin M, Silva L, Vogel I, et al. COVID-19 and the emergency presentation of colorectal cancer. Colorectal Dis. 2021;23(8):2014-2019. doi:10.1111/codi.15662

7. Rogers LC, Snyder RJ, Joseph WS. Diabetes-related amputations: a pandemic within a pandemic. J Am Podiatr Med Assoc. 2020;20-248. doi:10.7547/20-248

8. Maringe C, Spicer J, Morris M, et al. The impact of the COVID-19 pandemic on cancer deaths due to delays in diagnosis in England, UK: a national, population-based, modelling study. Lancet Oncol. 2020;21(8):1023-1034. doi:10.1016/S1470-2045(20)30388-0

9. World Health Organization. 14.9 million excess deaths associated with the COVID-19 pandemic in 2020 and 2021. May 5, 2022. Accessed August 31, 2022. https://www.who.int/news/item/05-05-2022-14.9-million-excess-deaths-were-associated-with-the-covid-19-pandemic-in-2020-and-2021

10. Padamsee TJ, Bond RM, Dixon GN, et al. Changes in COVID-19 vaccine hesitancy among Black and White individuals in the US. JAMA Netw Open. 2022;5(1):e2144470. doi:10.1001/jamanetworkopen.2021.44470

11. Barry V, Dasgupta S, Weller DL, et al. Patterns in COVID-19 vaccination coverage, by social vulnerability and urbanicity - United States, December 14, 2020-May 1, 2021. MMWR Morb Mortal Wkly Rep. 2021;70(22):818-824. doi:10.15585/mmwr.mm7022e1

12. Baack BN, Abad N, Yankey D, et al. COVID-19 vaccination coverage and intent among adults aged 18-39 years - United States, March-May 2021. MMWR Morb Mortal Wkly Rep. 2021;70(25):928-933. doi:10.15585/mmwr.mm7025e2

13. United States Census Bureau. QuickFacts Hawaii. July 7, 2021. Accessed August 31, 2022. https://www.census.gov/quickfacts/HI

14. Hawaii Health Data Warehouse. Diabetes - Adult. November 23, 2021. Updated July 31, 2022. Accessed August 31, 2022. https://hhdw.org/report/indicator/summary/DXDiabetesAA.html

15. Hawaii Health Data Warehouse. High Blood Pressure, Adult. November 23, 2021. Accessed August 31, 2022. https://hhdw.org/report/indicator/summary/DXBPHighAA.html

16. Penaia CS, Morey BN, Thomas KB, et al. Disparities in Native Hawaiian and Pacific Islander COVID-19 mortality: a community-driven data response. Am J Public Health. 2021;111(S2):S49-S52. doi:10.2105/AJPH.2021.306370

17. US Department of Veterans Affairs, Veterans Health Administration. VHA Handbook 1500.02 Readjustment Counseling Services (RCS) Vet Center Program. January 26, 2021. Accessed September 7, 2022. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9168

18. US Department of Veterans Affairs, Veterans Health Administration. VHA Directive 1162.08 Health Care for Veterans Homeless Outreach Services. February 18, 2022. Accessed September 7, 2022. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9673

19. US Department of Veterans Affairs. Clinical Reminders Version 2.0. Clinician Guide. October 2006. Accessed August 31, 2022. https://www.va.gov/vdl/documents/clinical/cprs-clinical_reminders/pxrm_2_4_um.pdf

20. Hawaii Department of Health. Hepatitis A Cases on Oahu and Maui. June 21, 2021. Accessed August 31, 2022. https://health.hawaii.gov/docd/files/2021/06/Medical-Advisory-HepA-June-21-2021.pdf

21. Hamel L, Lopes L, Sparks G, et al. KFF COVID-19 vaccine monitor: January 2022. January 28, 2022. Accessed August 31, 2022. https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-january-2022

22. Mast C, Munoz del Rio A. Delayed cancer screenings—a second look. Epic Research Network. July 17, 2020. Accessed August 31, 2022. https://epicresearch.org/articles/delayed-cancer-screenings-a-second-look

23. Shaukat A, Church T. Colorectal cancer screening in the USA in the wake of COVID-19. Lancet Gastroenterol Hepatol. 2020;5(8):726-727. doi:10.1016/S2468-1253(20)30191-6

24. Crespo J, Lazarus JV, Iruzubieta P, García F, García-Samaniego J; Alliance for the elimination of viral hepatitis in Spain. Let’s leverage SARS-CoV2 vaccination to screen for hepatitis C in Spain, in Europe, around the world. J Hepatol. 2021;75(1):224-226. doi:10.1016/j.jhep.2021.03.009

25. Escoffery C, Liang S, Rodgers K, et al. Process evaluation of health fairs promoting cancer screenings. BMC Cancer. 2017;17(1):865. doi:10.1186/s12885-017-3867-3

26. Waller PR, Crow C, Sands D, Becker H. Health related attitudes and health promoting behaviors: differences between health fair attenders and a community group. Am J Health Promot. 1988;3(1):17-32. doi:10.4278/0890-1171-3.1.17

27. Price JH, O’Connell J, Kukulka G. Preventive health behaviors related to the ten leading causes of mortality of health-fair attenders and nonattenders. Psychol Rep. 1985;56(1):131-135. doi:10.2466/pr0.1985.56.1.131

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aVeterans Affairs Pacific Islands Health Care System, Honolulu, Hawaii

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The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

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The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

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aVeterans Affairs Pacific Islands Health Care System, Honolulu, Hawaii

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The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

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Correspondence: Kathryn Ryder ([email protected])

aVeterans Affairs Pacific Islands Health Care System, Honolulu, Hawaii

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Ethics and consent

The Veterans Affairs Pacific Islands Health Care System Research and Development approved this as a quality Improvement project and exempt from institutional review board approval.

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Shortly into the COVID-19 pandemic, Dr. Robert Califf, the commissioner of the US Food and Drug Administration, warned of a coming tsunami of chronic diseases, exacerbated by missed care during the pandemic.1 According to a Centers for Disease Control and Prevention (CDC) survey, more than 30% of adults reported delaying or avoiding routine medical care in the first 6 months of 2020. This rate was highest in people with comorbidities.2 Multiple studies demonstrated declines in hypertension care, hemoglobin A1c testing, mammography, and colon cancer screening.3-5 There has been a resultant increase in colon cancer complications, wounds, and amputations.6,7 The United Kingdom is expected to have a 7.9% to 16.6% increase in future deaths due to breast and colorectal cancer (CRC).8 The World Health Organization estimates an excess 14.9 million people died in 2020 and 2021, either directly from or indirectly related to COVID-19.9

Due to the large-scale conversion from face-to-face care to telehealth modalities, COVID-19 vaccination events offered a unique opportunity to perform preventive health care that requires in-person visits, since most US adults have sought vaccination. However, vaccine events may not reach people most at risk for COVID-19 or chronic disease. Groups of Americans with lower vaccination rates were concerned about driving times and missing work to get the vaccine.10

Distance and travel time may be a particular challenge in Hawaii. Oahu is considered rural by the US Department of Veterans Affairs (VA); some communities are 80 minutes away from the VA Pacific Islands Health Care System (VAPIHCS) main facility. Oahu has approximately 150 veterans experiencing homelessness who may not have transportation to vaccine events. Additionally, VAPIHCS serves veterans that may be at higher risk of not receiving COVID-19 vaccination. Racial and ethnic minority residents have lower vaccination rates, yet are at a higher risk of COVID-19 infection and complications, and through the pandemic, this vaccination gap worsened.11,12 More than 10% of the population of Hawaii is Native Hawaiian or Pacific Islander, and this population is at elevated risk for diabetes mellitus, hypertension, and COVID-19 mortality.13-16

Health Fair Program

The VA provides clinical reminders in its electronic health record (EHR) that are specified by age, gender assigned at birth, and comorbidities. The clinical reminder program is intended to provide clinically relevant reminders for preventive care at the point of care. Veterans with overdue clinical reminders can be identified by name and address, allowing for the creation of health fair events that were directed towards communities with veterans with clinical reminders, including COVID-19 vaccination need. A team of health care professionals from VAPIHCS conceived of a health fair program to increase the reach of vaccine events and include preventive care in partnership with the VAPIHCS Vet Center Program, local communities, U.S.VETS, and the Hawaii Institute of Health Services (HIHS). We sought to determine which services could be offered in community settings; large vaccine events; and at homeless emergency, transitional, or permanent housing. We tracked veterans who received care in the different locations of the directed health fair.

This project was determined to be a quality improvement initiative by the VAPIHCS Office of Research and Development. It was jointly planned by the VAPIHCS pharmacy, infectious diseases, Vet Center Program, and homeless team to make the COVID-19 vaccines available to more rural and to veterans experiencing homelessness, and in response to a decline in facility face-to-face visits. Monthly meetings were held to select sites within zip codes with higher numbers of open clinical reminders and lower vaccination uptake. Informatics developed a list of clinical reminders by zip code for care performed at face-to-face visits.

Partners

The Vet Center Program, suicide prevention coordinator, and the homeless outreach team have a mandate to perform outreach events.17,18 These services collaborate with community partners to locate sites for events. The team was able to leverage these contacts to set up sites for events. The Vet Center Program readjustment counselor and the suicide prevention coordinator provide mental health counseling. The Vet Center counsels on veteran benefits. They supplied a mobile van with WiFi, counseling and examination spaces, and refrigeration, which became the mobile clinic for the preventive care offered at events. The homeless program works with multiple community partners. They contract with HIHS and U.S.VETS to provide emergency and permanent housing for veterans. Each event is reviewed with HIHS and U.S.VETS staff for permission to be on site. The suicide prevention coordinator or the Vet Center readjustment counselor and the homeless team became regular attendees of events. The homeless team provided resources for housing or food insecurity.

 

 

Preventive Health Measures

The VA clinical reminder system supports caregivers for both preventive health care and chronic condition management.19 Clinical reminders appear as due in the EHR, and reminder reports can be run by clinical informatics to determine groups of patients who have not had a reminder completed. The following reminders were completed: vaccinations (including COVID-19), CRC screening, diabetic foot check and teaching of foot care, diabetic retinal consultations, laboratory studies (lipids, hemoglobin A1c, microalbumin), mammogram and pap smear referrals, mental health reminders, homeless and food insecurity screening, HIV and hepatitis C testing, and blood pressure (BP) measurement. Health records were reviewed 3 months after each event to determine whether they were completed by the veteran. Additionally, we determined whether BP was controlled (< 130/80 mm Hg).

Settings

Large urban event. The first setting for the health fair was a large vaccination event near the VAPIHCS center in April 2021. Attendance was solicited by VEText, phone calls, and social media advertisements. At check-in, veterans with relevant open clinical reminders were invited to receive preventive health care during the 15-minute monitoring period after the COVID-19 vaccine. The Vet Center Program stationed the mobile van outside the vaccination event, where a physician and a clinical pharmacy specialist (CPS) did assessments, completed reminders, and entered follow-up requests for about 4 hours. A medical support assistant registered veterans who had never signed up for VA health care.

Community Settings. Nine events occurred at least monthly between March and September 2021 at 4 different sites in Oahu. Texts and phone calls were used to solicit attendance; there was no prior publicity on social media. Community events required scheduling resources; this required about 30 hours of medical staff assistant time. Seven sites were visited for about 3 hours each. A physician, pharmacy technician, and CPS conducted assessments, completed reminders, and entered follow-up requests. A medical support assistant registered veterans who had never signed up for VA health care.

Homeless veteran outreach. Five events occurred at 2 homeless veteran housing sites between August 2021 and January 2022. These sites were emergency housing sites (2 events) and transitional and permanent housing (2 events). U.S.VETS and HIHS contacted veterans living in those settings to promote the event. A physician, registered nurse, licensed practical nurse, and CPS conducted assessments, completed reminders, and entered follow-up requests. A medical support assistant registered veterans that had never signed up for VA health care. Each event lasted approximate 3 hours.

Process Quality Improvement

After the CDC changed recommendations to allow concurrent vaccination with the COVID-19 vaccine, we added other vaccinations to the events. This occurred during the course of community events. In June of 2021, there was a health advisory concerning hepatitis A among people experiencing homelessness in Oahu, so hepatitis vaccinations were added for events for veterans.20

Veterans Served

The EHR was used to determine demographics, open clinical reminders, and attendance at follow-up. Simple descriptive statistics were performed in Microsoft Excel. A total of 115 veterans were seen for preventive health visits, and 404 clinical reminders were completed. Seven hundred veterans attended the large centrally located vaccine event and 43 agreed to have a preventive health visit. Thirty-eight veterans had a preventive health visit at homeless outreach events and 34 veterans had a preventive health visit at the community events. Veterans at community

and homeless events were more likely to be Native Hawaiian/Pacific Islander (47% and 32%, respectively) than at the urban vaccine event (14%) (Table 1).

 

 

Of the 166 vaccines given, 73 were for COVID-19. Besides vaccination,

204 clinical reminders total were completed at the event (Table 2). Hypertension was the most common reminder with 52 completed; 29 veterans had BP in the hypertensive range. BP cuffs were provided to 19 veterans and CPS follow-up appointments were scheduled for 24 veterans. Of 22 homeless and food insecurity screens, 4 were positive and services and resources were provided. One veteran obtained emergency housing the same day.

Veteran follow-up or completion
of recommended services allowed 34 more reminders to be closed (Table 3), with high follow-up for referrals (76%). Within 3 months of an initial BP screen, 22 veterans had at least 1 follow-up with a pharmacist, 17 had BP controlled, and the BP of 5 veterans remained elevated. Screenings revealed abnormal health findings: CRC screening revealed CRC, 6 of the 11 completed laboratory results had an actionable finding, and all diabetic retinal referrals showed retinal disease. Poor follow-up was seen for diabetic high-risk foot referrals and HIV care.

Discussion

This program provided evidence that adding preventive screenings to vaccine events may help reach veterans who may have missed important preventive care due to the COVID-19 pandemic. The involvement of clinical informatics service allowed the outreach to be targeted to communities with incomplete clinical reminders. Interventions that could not be completed at the event had high levels of follow-up by veterans with important findings. The presence of a physician or nurse and a CPS allowed for point-of-care testing, as well as entering orders for medication, laboratory tests, and consultations. The attendance by representatives from the Vet Center, suicide prevention, and homeless services allowed counseling regarding benefits, and mental health follow-up. We believe that we were able to reach communities of veterans with unmet preventive needs and had higher risk of severe COVID-19, given the high numbers with open clinical reminders, the number of vaccines provided, and the high percentage of racial and ethnic minority veterans at events in the community. Our program experience provides some evidence that mobile and pop-up vaccination clinics may be beneficial for screening and managing chronic diseases, as proposed elsewhere.21-24

Strengths of this intervention include that we were able to show a high level of follow-up for recommended medical care as well as the results of our interventions. We have found no similar articles that provide data on completion of follow-up appointments after a health fair. A prior study showed only 23% to 63% of participants at a health fair reported having a recommended follow-up discussion with doctors, but the study reported no outcome of completed cancer screenings.25

Limitations

Weaknesses include the fact that health fair events may reach only healthy people, since attendees generally report better health and better health behaviors than nonattendees.26,27 We felt this was more problematic for the large-scale urban event and that offering rural events and events in homeless housing improved the reach. Future efforts will involve the use of social media and mailings to solicit attendance. To improve follow-up, future work will include adding to the events: phlebotomy or expanded point-of-care testing; specialty care telehealth capability; cervical cancer screen self-collection; and tele-retinal services.

Conclusions

This program provided evidence that directed, preventive screening can be performed in outreach settings paired with vaccine events. These vaccination events in rural and homeless settings reached communities with demonstrable COVID-19 vaccination and other preventive care needs. This approach could be used to help veterans catch up on needed preventive care.

Acknowledgments

Veterans Affairs Pacific Islands Health Care System: Anthony Chance, LCSW; Nicholas Chang, PharmD; Andrew Dahlburg, LCSW; Wilminia G. Ellorimo-Gil, RN; Paul Guillory, RN; Wendy D. Joy; Arthur Minor, LCSW; Avalua Smith; Jessica Spurrier, RN. Veterans Health Administration Vet Center Program: Rolly O. Alvarado; Edmond G. DeGuzman; Richard T. Teel. Hawaii Institute for Human Services. U.S.VETS.

Shortly into the COVID-19 pandemic, Dr. Robert Califf, the commissioner of the US Food and Drug Administration, warned of a coming tsunami of chronic diseases, exacerbated by missed care during the pandemic.1 According to a Centers for Disease Control and Prevention (CDC) survey, more than 30% of adults reported delaying or avoiding routine medical care in the first 6 months of 2020. This rate was highest in people with comorbidities.2 Multiple studies demonstrated declines in hypertension care, hemoglobin A1c testing, mammography, and colon cancer screening.3-5 There has been a resultant increase in colon cancer complications, wounds, and amputations.6,7 The United Kingdom is expected to have a 7.9% to 16.6% increase in future deaths due to breast and colorectal cancer (CRC).8 The World Health Organization estimates an excess 14.9 million people died in 2020 and 2021, either directly from or indirectly related to COVID-19.9

Due to the large-scale conversion from face-to-face care to telehealth modalities, COVID-19 vaccination events offered a unique opportunity to perform preventive health care that requires in-person visits, since most US adults have sought vaccination. However, vaccine events may not reach people most at risk for COVID-19 or chronic disease. Groups of Americans with lower vaccination rates were concerned about driving times and missing work to get the vaccine.10

Distance and travel time may be a particular challenge in Hawaii. Oahu is considered rural by the US Department of Veterans Affairs (VA); some communities are 80 minutes away from the VA Pacific Islands Health Care System (VAPIHCS) main facility. Oahu has approximately 150 veterans experiencing homelessness who may not have transportation to vaccine events. Additionally, VAPIHCS serves veterans that may be at higher risk of not receiving COVID-19 vaccination. Racial and ethnic minority residents have lower vaccination rates, yet are at a higher risk of COVID-19 infection and complications, and through the pandemic, this vaccination gap worsened.11,12 More than 10% of the population of Hawaii is Native Hawaiian or Pacific Islander, and this population is at elevated risk for diabetes mellitus, hypertension, and COVID-19 mortality.13-16

Health Fair Program

The VA provides clinical reminders in its electronic health record (EHR) that are specified by age, gender assigned at birth, and comorbidities. The clinical reminder program is intended to provide clinically relevant reminders for preventive care at the point of care. Veterans with overdue clinical reminders can be identified by name and address, allowing for the creation of health fair events that were directed towards communities with veterans with clinical reminders, including COVID-19 vaccination need. A team of health care professionals from VAPIHCS conceived of a health fair program to increase the reach of vaccine events and include preventive care in partnership with the VAPIHCS Vet Center Program, local communities, U.S.VETS, and the Hawaii Institute of Health Services (HIHS). We sought to determine which services could be offered in community settings; large vaccine events; and at homeless emergency, transitional, or permanent housing. We tracked veterans who received care in the different locations of the directed health fair.

This project was determined to be a quality improvement initiative by the VAPIHCS Office of Research and Development. It was jointly planned by the VAPIHCS pharmacy, infectious diseases, Vet Center Program, and homeless team to make the COVID-19 vaccines available to more rural and to veterans experiencing homelessness, and in response to a decline in facility face-to-face visits. Monthly meetings were held to select sites within zip codes with higher numbers of open clinical reminders and lower vaccination uptake. Informatics developed a list of clinical reminders by zip code for care performed at face-to-face visits.

Partners

The Vet Center Program, suicide prevention coordinator, and the homeless outreach team have a mandate to perform outreach events.17,18 These services collaborate with community partners to locate sites for events. The team was able to leverage these contacts to set up sites for events. The Vet Center Program readjustment counselor and the suicide prevention coordinator provide mental health counseling. The Vet Center counsels on veteran benefits. They supplied a mobile van with WiFi, counseling and examination spaces, and refrigeration, which became the mobile clinic for the preventive care offered at events. The homeless program works with multiple community partners. They contract with HIHS and U.S.VETS to provide emergency and permanent housing for veterans. Each event is reviewed with HIHS and U.S.VETS staff for permission to be on site. The suicide prevention coordinator or the Vet Center readjustment counselor and the homeless team became regular attendees of events. The homeless team provided resources for housing or food insecurity.

 

 

Preventive Health Measures

The VA clinical reminder system supports caregivers for both preventive health care and chronic condition management.19 Clinical reminders appear as due in the EHR, and reminder reports can be run by clinical informatics to determine groups of patients who have not had a reminder completed. The following reminders were completed: vaccinations (including COVID-19), CRC screening, diabetic foot check and teaching of foot care, diabetic retinal consultations, laboratory studies (lipids, hemoglobin A1c, microalbumin), mammogram and pap smear referrals, mental health reminders, homeless and food insecurity screening, HIV and hepatitis C testing, and blood pressure (BP) measurement. Health records were reviewed 3 months after each event to determine whether they were completed by the veteran. Additionally, we determined whether BP was controlled (< 130/80 mm Hg).

Settings

Large urban event. The first setting for the health fair was a large vaccination event near the VAPIHCS center in April 2021. Attendance was solicited by VEText, phone calls, and social media advertisements. At check-in, veterans with relevant open clinical reminders were invited to receive preventive health care during the 15-minute monitoring period after the COVID-19 vaccine. The Vet Center Program stationed the mobile van outside the vaccination event, where a physician and a clinical pharmacy specialist (CPS) did assessments, completed reminders, and entered follow-up requests for about 4 hours. A medical support assistant registered veterans who had never signed up for VA health care.

Community Settings. Nine events occurred at least monthly between March and September 2021 at 4 different sites in Oahu. Texts and phone calls were used to solicit attendance; there was no prior publicity on social media. Community events required scheduling resources; this required about 30 hours of medical staff assistant time. Seven sites were visited for about 3 hours each. A physician, pharmacy technician, and CPS conducted assessments, completed reminders, and entered follow-up requests. A medical support assistant registered veterans who had never signed up for VA health care.

Homeless veteran outreach. Five events occurred at 2 homeless veteran housing sites between August 2021 and January 2022. These sites were emergency housing sites (2 events) and transitional and permanent housing (2 events). U.S.VETS and HIHS contacted veterans living in those settings to promote the event. A physician, registered nurse, licensed practical nurse, and CPS conducted assessments, completed reminders, and entered follow-up requests. A medical support assistant registered veterans that had never signed up for VA health care. Each event lasted approximate 3 hours.

Process Quality Improvement

After the CDC changed recommendations to allow concurrent vaccination with the COVID-19 vaccine, we added other vaccinations to the events. This occurred during the course of community events. In June of 2021, there was a health advisory concerning hepatitis A among people experiencing homelessness in Oahu, so hepatitis vaccinations were added for events for veterans.20

Veterans Served

The EHR was used to determine demographics, open clinical reminders, and attendance at follow-up. Simple descriptive statistics were performed in Microsoft Excel. A total of 115 veterans were seen for preventive health visits, and 404 clinical reminders were completed. Seven hundred veterans attended the large centrally located vaccine event and 43 agreed to have a preventive health visit. Thirty-eight veterans had a preventive health visit at homeless outreach events and 34 veterans had a preventive health visit at the community events. Veterans at community

and homeless events were more likely to be Native Hawaiian/Pacific Islander (47% and 32%, respectively) than at the urban vaccine event (14%) (Table 1).

 

 

Of the 166 vaccines given, 73 were for COVID-19. Besides vaccination,

204 clinical reminders total were completed at the event (Table 2). Hypertension was the most common reminder with 52 completed; 29 veterans had BP in the hypertensive range. BP cuffs were provided to 19 veterans and CPS follow-up appointments were scheduled for 24 veterans. Of 22 homeless and food insecurity screens, 4 were positive and services and resources were provided. One veteran obtained emergency housing the same day.

Veteran follow-up or completion
of recommended services allowed 34 more reminders to be closed (Table 3), with high follow-up for referrals (76%). Within 3 months of an initial BP screen, 22 veterans had at least 1 follow-up with a pharmacist, 17 had BP controlled, and the BP of 5 veterans remained elevated. Screenings revealed abnormal health findings: CRC screening revealed CRC, 6 of the 11 completed laboratory results had an actionable finding, and all diabetic retinal referrals showed retinal disease. Poor follow-up was seen for diabetic high-risk foot referrals and HIV care.

Discussion

This program provided evidence that adding preventive screenings to vaccine events may help reach veterans who may have missed important preventive care due to the COVID-19 pandemic. The involvement of clinical informatics service allowed the outreach to be targeted to communities with incomplete clinical reminders. Interventions that could not be completed at the event had high levels of follow-up by veterans with important findings. The presence of a physician or nurse and a CPS allowed for point-of-care testing, as well as entering orders for medication, laboratory tests, and consultations. The attendance by representatives from the Vet Center, suicide prevention, and homeless services allowed counseling regarding benefits, and mental health follow-up. We believe that we were able to reach communities of veterans with unmet preventive needs and had higher risk of severe COVID-19, given the high numbers with open clinical reminders, the number of vaccines provided, and the high percentage of racial and ethnic minority veterans at events in the community. Our program experience provides some evidence that mobile and pop-up vaccination clinics may be beneficial for screening and managing chronic diseases, as proposed elsewhere.21-24

Strengths of this intervention include that we were able to show a high level of follow-up for recommended medical care as well as the results of our interventions. We have found no similar articles that provide data on completion of follow-up appointments after a health fair. A prior study showed only 23% to 63% of participants at a health fair reported having a recommended follow-up discussion with doctors, but the study reported no outcome of completed cancer screenings.25

Limitations

Weaknesses include the fact that health fair events may reach only healthy people, since attendees generally report better health and better health behaviors than nonattendees.26,27 We felt this was more problematic for the large-scale urban event and that offering rural events and events in homeless housing improved the reach. Future efforts will involve the use of social media and mailings to solicit attendance. To improve follow-up, future work will include adding to the events: phlebotomy or expanded point-of-care testing; specialty care telehealth capability; cervical cancer screen self-collection; and tele-retinal services.

Conclusions

This program provided evidence that directed, preventive screening can be performed in outreach settings paired with vaccine events. These vaccination events in rural and homeless settings reached communities with demonstrable COVID-19 vaccination and other preventive care needs. This approach could be used to help veterans catch up on needed preventive care.

Acknowledgments

Veterans Affairs Pacific Islands Health Care System: Anthony Chance, LCSW; Nicholas Chang, PharmD; Andrew Dahlburg, LCSW; Wilminia G. Ellorimo-Gil, RN; Paul Guillory, RN; Wendy D. Joy; Arthur Minor, LCSW; Avalua Smith; Jessica Spurrier, RN. Veterans Health Administration Vet Center Program: Rolly O. Alvarado; Edmond G. DeGuzman; Richard T. Teel. Hawaii Institute for Human Services. U.S.VETS.

References

1. Califf RM. Avoiding the coming tsunami of common, chronic disease: What the lessons of the COVID-19 pandemic can teach us. Circulation. 2021;143(19):1831-1834. doi:10.1161/CIRCULATIONAHA.121.053461

2. Czeisler MÉ, Marynak K, Clarke KEN, et al. Delay or avoidance of medical care because of COVID-19-related concerns - United States, June 2020. MMWR Morb Mortal Wkly Rep. 2020;69(36):1250-1257. doi:10.15585/mmwr.mm6936a4

3. European Society of Hypertension Corona-virus Disease 19 Task Force. The corona-virus disease 2019 pandemic compromised routine care for hypertension: a survey conducted among excellence centers of the European Society of Hypertension. J Hypertens. 2021;39(1):190-195. doi:10.1097/HJH.0000000000002703

4. Whaley CM, Pera MF, Cantor J, et al. Changes in health services use among commercially insured US populations during the COVID-19 pandemic. JAMA Netw Open. 2020;3(11):e2024984. doi:10.1001/jamanetworkopen.2020.24984

5. Song H, Bergman A, Chen AT, et al. Disruptions in preventive care: mammograms during the COVID-19 pandemic. Health Serv Res. 2021;56(1):95-101. doi:10.1111/1475-6773.13596

6. Shinkwin M, Silva L, Vogel I, et al. COVID-19 and the emergency presentation of colorectal cancer. Colorectal Dis. 2021;23(8):2014-2019. doi:10.1111/codi.15662

7. Rogers LC, Snyder RJ, Joseph WS. Diabetes-related amputations: a pandemic within a pandemic. J Am Podiatr Med Assoc. 2020;20-248. doi:10.7547/20-248

8. Maringe C, Spicer J, Morris M, et al. The impact of the COVID-19 pandemic on cancer deaths due to delays in diagnosis in England, UK: a national, population-based, modelling study. Lancet Oncol. 2020;21(8):1023-1034. doi:10.1016/S1470-2045(20)30388-0

9. World Health Organization. 14.9 million excess deaths associated with the COVID-19 pandemic in 2020 and 2021. May 5, 2022. Accessed August 31, 2022. https://www.who.int/news/item/05-05-2022-14.9-million-excess-deaths-were-associated-with-the-covid-19-pandemic-in-2020-and-2021

10. Padamsee TJ, Bond RM, Dixon GN, et al. Changes in COVID-19 vaccine hesitancy among Black and White individuals in the US. JAMA Netw Open. 2022;5(1):e2144470. doi:10.1001/jamanetworkopen.2021.44470

11. Barry V, Dasgupta S, Weller DL, et al. Patterns in COVID-19 vaccination coverage, by social vulnerability and urbanicity - United States, December 14, 2020-May 1, 2021. MMWR Morb Mortal Wkly Rep. 2021;70(22):818-824. doi:10.15585/mmwr.mm7022e1

12. Baack BN, Abad N, Yankey D, et al. COVID-19 vaccination coverage and intent among adults aged 18-39 years - United States, March-May 2021. MMWR Morb Mortal Wkly Rep. 2021;70(25):928-933. doi:10.15585/mmwr.mm7025e2

13. United States Census Bureau. QuickFacts Hawaii. July 7, 2021. Accessed August 31, 2022. https://www.census.gov/quickfacts/HI

14. Hawaii Health Data Warehouse. Diabetes - Adult. November 23, 2021. Updated July 31, 2022. Accessed August 31, 2022. https://hhdw.org/report/indicator/summary/DXDiabetesAA.html

15. Hawaii Health Data Warehouse. High Blood Pressure, Adult. November 23, 2021. Accessed August 31, 2022. https://hhdw.org/report/indicator/summary/DXBPHighAA.html

16. Penaia CS, Morey BN, Thomas KB, et al. Disparities in Native Hawaiian and Pacific Islander COVID-19 mortality: a community-driven data response. Am J Public Health. 2021;111(S2):S49-S52. doi:10.2105/AJPH.2021.306370

17. US Department of Veterans Affairs, Veterans Health Administration. VHA Handbook 1500.02 Readjustment Counseling Services (RCS) Vet Center Program. January 26, 2021. Accessed September 7, 2022. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9168

18. US Department of Veterans Affairs, Veterans Health Administration. VHA Directive 1162.08 Health Care for Veterans Homeless Outreach Services. February 18, 2022. Accessed September 7, 2022. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9673

19. US Department of Veterans Affairs. Clinical Reminders Version 2.0. Clinician Guide. October 2006. Accessed August 31, 2022. https://www.va.gov/vdl/documents/clinical/cprs-clinical_reminders/pxrm_2_4_um.pdf

20. Hawaii Department of Health. Hepatitis A Cases on Oahu and Maui. June 21, 2021. Accessed August 31, 2022. https://health.hawaii.gov/docd/files/2021/06/Medical-Advisory-HepA-June-21-2021.pdf

21. Hamel L, Lopes L, Sparks G, et al. KFF COVID-19 vaccine monitor: January 2022. January 28, 2022. Accessed August 31, 2022. https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-january-2022

22. Mast C, Munoz del Rio A. Delayed cancer screenings—a second look. Epic Research Network. July 17, 2020. Accessed August 31, 2022. https://epicresearch.org/articles/delayed-cancer-screenings-a-second-look

23. Shaukat A, Church T. Colorectal cancer screening in the USA in the wake of COVID-19. Lancet Gastroenterol Hepatol. 2020;5(8):726-727. doi:10.1016/S2468-1253(20)30191-6

24. Crespo J, Lazarus JV, Iruzubieta P, García F, García-Samaniego J; Alliance for the elimination of viral hepatitis in Spain. Let’s leverage SARS-CoV2 vaccination to screen for hepatitis C in Spain, in Europe, around the world. J Hepatol. 2021;75(1):224-226. doi:10.1016/j.jhep.2021.03.009

25. Escoffery C, Liang S, Rodgers K, et al. Process evaluation of health fairs promoting cancer screenings. BMC Cancer. 2017;17(1):865. doi:10.1186/s12885-017-3867-3

26. Waller PR, Crow C, Sands D, Becker H. Health related attitudes and health promoting behaviors: differences between health fair attenders and a community group. Am J Health Promot. 1988;3(1):17-32. doi:10.4278/0890-1171-3.1.17

27. Price JH, O’Connell J, Kukulka G. Preventive health behaviors related to the ten leading causes of mortality of health-fair attenders and nonattenders. Psychol Rep. 1985;56(1):131-135. doi:10.2466/pr0.1985.56.1.131

References

1. Califf RM. Avoiding the coming tsunami of common, chronic disease: What the lessons of the COVID-19 pandemic can teach us. Circulation. 2021;143(19):1831-1834. doi:10.1161/CIRCULATIONAHA.121.053461

2. Czeisler MÉ, Marynak K, Clarke KEN, et al. Delay or avoidance of medical care because of COVID-19-related concerns - United States, June 2020. MMWR Morb Mortal Wkly Rep. 2020;69(36):1250-1257. doi:10.15585/mmwr.mm6936a4

3. European Society of Hypertension Corona-virus Disease 19 Task Force. The corona-virus disease 2019 pandemic compromised routine care for hypertension: a survey conducted among excellence centers of the European Society of Hypertension. J Hypertens. 2021;39(1):190-195. doi:10.1097/HJH.0000000000002703

4. Whaley CM, Pera MF, Cantor J, et al. Changes in health services use among commercially insured US populations during the COVID-19 pandemic. JAMA Netw Open. 2020;3(11):e2024984. doi:10.1001/jamanetworkopen.2020.24984

5. Song H, Bergman A, Chen AT, et al. Disruptions in preventive care: mammograms during the COVID-19 pandemic. Health Serv Res. 2021;56(1):95-101. doi:10.1111/1475-6773.13596

6. Shinkwin M, Silva L, Vogel I, et al. COVID-19 and the emergency presentation of colorectal cancer. Colorectal Dis. 2021;23(8):2014-2019. doi:10.1111/codi.15662

7. Rogers LC, Snyder RJ, Joseph WS. Diabetes-related amputations: a pandemic within a pandemic. J Am Podiatr Med Assoc. 2020;20-248. doi:10.7547/20-248

8. Maringe C, Spicer J, Morris M, et al. The impact of the COVID-19 pandemic on cancer deaths due to delays in diagnosis in England, UK: a national, population-based, modelling study. Lancet Oncol. 2020;21(8):1023-1034. doi:10.1016/S1470-2045(20)30388-0

9. World Health Organization. 14.9 million excess deaths associated with the COVID-19 pandemic in 2020 and 2021. May 5, 2022. Accessed August 31, 2022. https://www.who.int/news/item/05-05-2022-14.9-million-excess-deaths-were-associated-with-the-covid-19-pandemic-in-2020-and-2021

10. Padamsee TJ, Bond RM, Dixon GN, et al. Changes in COVID-19 vaccine hesitancy among Black and White individuals in the US. JAMA Netw Open. 2022;5(1):e2144470. doi:10.1001/jamanetworkopen.2021.44470

11. Barry V, Dasgupta S, Weller DL, et al. Patterns in COVID-19 vaccination coverage, by social vulnerability and urbanicity - United States, December 14, 2020-May 1, 2021. MMWR Morb Mortal Wkly Rep. 2021;70(22):818-824. doi:10.15585/mmwr.mm7022e1

12. Baack BN, Abad N, Yankey D, et al. COVID-19 vaccination coverage and intent among adults aged 18-39 years - United States, March-May 2021. MMWR Morb Mortal Wkly Rep. 2021;70(25):928-933. doi:10.15585/mmwr.mm7025e2

13. United States Census Bureau. QuickFacts Hawaii. July 7, 2021. Accessed August 31, 2022. https://www.census.gov/quickfacts/HI

14. Hawaii Health Data Warehouse. Diabetes - Adult. November 23, 2021. Updated July 31, 2022. Accessed August 31, 2022. https://hhdw.org/report/indicator/summary/DXDiabetesAA.html

15. Hawaii Health Data Warehouse. High Blood Pressure, Adult. November 23, 2021. Accessed August 31, 2022. https://hhdw.org/report/indicator/summary/DXBPHighAA.html

16. Penaia CS, Morey BN, Thomas KB, et al. Disparities in Native Hawaiian and Pacific Islander COVID-19 mortality: a community-driven data response. Am J Public Health. 2021;111(S2):S49-S52. doi:10.2105/AJPH.2021.306370

17. US Department of Veterans Affairs, Veterans Health Administration. VHA Handbook 1500.02 Readjustment Counseling Services (RCS) Vet Center Program. January 26, 2021. Accessed September 7, 2022. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9168

18. US Department of Veterans Affairs, Veterans Health Administration. VHA Directive 1162.08 Health Care for Veterans Homeless Outreach Services. February 18, 2022. Accessed September 7, 2022. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9673

19. US Department of Veterans Affairs. Clinical Reminders Version 2.0. Clinician Guide. October 2006. Accessed August 31, 2022. https://www.va.gov/vdl/documents/clinical/cprs-clinical_reminders/pxrm_2_4_um.pdf

20. Hawaii Department of Health. Hepatitis A Cases on Oahu and Maui. June 21, 2021. Accessed August 31, 2022. https://health.hawaii.gov/docd/files/2021/06/Medical-Advisory-HepA-June-21-2021.pdf

21. Hamel L, Lopes L, Sparks G, et al. KFF COVID-19 vaccine monitor: January 2022. January 28, 2022. Accessed August 31, 2022. https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-january-2022

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24. Crespo J, Lazarus JV, Iruzubieta P, García F, García-Samaniego J; Alliance for the elimination of viral hepatitis in Spain. Let’s leverage SARS-CoV2 vaccination to screen for hepatitis C in Spain, in Europe, around the world. J Hepatol. 2021;75(1):224-226. doi:10.1016/j.jhep.2021.03.009

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26. Waller PR, Crow C, Sands D, Becker H. Health related attitudes and health promoting behaviors: differences between health fair attenders and a community group. Am J Health Promot. 1988;3(1):17-32. doi:10.4278/0890-1171-3.1.17

27. Price JH, O’Connell J, Kukulka G. Preventive health behaviors related to the ten leading causes of mortality of health-fair attenders and nonattenders. Psychol Rep. 1985;56(1):131-135. doi:10.2466/pr0.1985.56.1.131

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