Program Profile

Quality improvement (QI) initiatives within the US Department of Veterans Affairs (VA) play an important role in enhancing health care for veterans.^1,2 While effective QI programs are often developed, veterans benefit only if they receive care at sites where the program is offered.³ It is estimated only 1% to 5% of patients receive benefit from evidence-based programs, limiting the opportunity for widespread impact.^4,5

The Chronic Obstructive Pulmonary Disease (COPD) Coordinated Access to Reduce Exacerbations (CARE) Academy is a national training program designed to promote the adoption of a COPD primary care service.⁶ The Academy was created and iteratively refined by VA staff to include both clinical training emphasizing COPD management and program implementation strategies. Training programs such as COPD CARE are commonly described as a method to support adoption of health care services, but there is no consensus on a universal approach to training design.

This article describes COPD CARE training and implementation strategies (Table). The Academy began as a training program at 1 VA medical center (VAMC) and has expanded to 49 diverse VAMCs. The Academy illustrates how implementation strategies can be leveraged to develop pragmatic and impactful training. Highlights from the Academy's 9-year history are outlined in this article.

COPD CARE

One in 4 veterans have a COPD diagnosis, and the 5-year mortality rate following a COPD flare is ≥ 50%.^7,8 In 2015, a pharmacy resident designed and piloted COPD CARE, a program that used evidence-based practice to optimize management of the disease.^9,10

The COPD CARE program is delivered by interprofessional team members. It includes a postacute care call completed 48 hours postdischarge, a wellness visit (face-to-face or virtual) 1 month postdischarge, and a follow-up visit scheduled 2 months postdischarge. Clinical pharmacist practitioners (CPPs) prescribe and collaborate with the COPD CARE health care team. Evidence-based practices embedded within COPD CARE include treatment optimization, symptom evaluation, severity staging, vaccination promotion, referrals, tobacco treatment, and comorbidity management.^11-16 The initial COPD CARE pilot demonstrated promising results; patients received timely care and high rates of COPD best practices.¹¹

Academy Design and Implementation

Initial COPD CARE training was tailored to the culture, context, and workflow of the William S. Middleton Memorial Veteran’s Hospital in Madison, Wisconsin. Further service expansion required integration of implementation strategies that enable learners to apply and adapt content to fit different processes, staffing, and patient needs.

Formal Implementation Blueprint

A key aspect of the Academy is the integration of a formal implementation blueprint that includes training goals, scope, and key milestones to guide implementation. The Academy blueprint includes 4 phased training workbooks: (1) preimplementation support from local stakeholders; (2) integration of COPD CARE operational infrastructure into workflows; (3) preparing clinical champions; and (4) leading clinical training (Figure 1). Five weekly 1-hour synchronous virtual discussions are used for learning the workbook content that include learning objectives and opportunities to strategize how to overcome implementation barriers.

Promoting and Facilitating Implementation

As clinicians apply content from the Academy to install informatics tools, coordinate clinical training, and build relationships across service lines, implementation barriers may occur. A learning collaborative allows peer-mentorship and shared problem solving. The Academy learning collaborative includes attendees across multiple VAMCs, allowing for diverse perspectives and cross-site learning. Within the field of dissemination and implementation science, this process of shared problem-solving to support individuals is referred to as implementation facilitation.¹⁷ Academy facilitators with prior experience provide a unique perspective and external facilitation from outside local VAMCs. Academy learners form local teams to engage in shared decision-making when applying Academy content. Following Academy completion, learning collaboratives continue to meet monthly to share clinical insights and operational updates.

Local Champions Promote Adaptability

One or more local champions were identified at each VAMC who were focused on the implementation of clinical training content and operational implementation of Academy content.¹⁸ Champions have helped develop adaptations of Academy content, such as integrating telehealth nursing within the COPD CARE referral process, which have become new best practices. Champions attend Academy sessions, which provide an opportunity to share adaptations to meet local needs.¹⁹

Using a Train-The-Trainer Model

Clinical training was designed to be dynamic and included video modeling, such as recorded examples of CPPs conducting COPD CARE visits and video clips highlighting clinical content. Each learner received a clinical workbook summarizing the content. The champion shares discussion questions to relate training content to the local clinical practice setting. The combination of live training, with videos of clinic visits and case-based discussion was intended to address differing learning styles. Clinical training was delivered using a train-the-trainer model led by the local champion, which allows clinicians with expertise to tailor their training. The use of a train-the-trainer model was intended to promote local buy-in and was often completed by frontline clinicians.

Informatics note templates provide clinicians with information needed to deliver training content during clinic visits. Direct hyperlinks to symptomatic scoring tools, resources to promote evidence-based medication optimization, and patient education resources were embedded within the electronic health record note templates. Direct links to consults for COPD referrals services discussed during clinical training were also included to promote ease of care coordination and awareness of referral opportunities. The integration of clinical training with informatics note template support was intentional to directly relate clinical training to clinical care delivery.

Audit and Feedback

To inform COPD CARE practice, the Academy included informatics infrastructure that allowed for timely local quality monitoring. Electronic health record note templates with embedded data fields track COPD CARE service implementation, including timely completion of patient visits, completion of patient medication reviews, appropriate testing, symptom assessment, and interventions made. Champions can organize template installation and integrate templates into COPD CARE clinical training. Data are included on a COPD CARE implementation dashboard.

An audit and feedback process is allows for the review of performance metrics and development of action plans.^20,21 Data reports from note templates are described during the Academy, along with resources to help teams enhance delivery of their program based on performance metrics.

Building a Coalition

Within VA primary care, clinical care delivery is optimized through a team-based coalition of clinicians using the patient aligned care team (PACT) framework. The VA patient-centered team-based care delivery model, patient facilitates coordination of patient referrals, including patient review, scheduling, and completion of patient visits.²²

Partnerships with VA Pharmacy Benefits Manager, VA Diffusion of Excellence, VA Quality Enhancement Research Initiative, VA Office of Pulmonary Medicine, and the VA Office of Rural Health have facilitated COPD CARE successes. Collaborations with VA Centers of Innovation helped benchmark the Academy’s impact. An academic partnership with the University of Wisconsin-Madison was established in 2017 and has provided evaluation expertise and leadership as the Academy has been iteratively developed, and revised.

Preliminary Metrics

COPD CARE has delivered > 2000 visits. CPPs have delivered COPD care, with a mean 9.4 of 10 best practices per patient visit. Improvements in veteran COPD symptoms have also been observed following COPD CARE patient visits.

DISCUSSION

The COPD CARE Academy was developed to promote rapid scale-up of a complex, team-based COPD service delivered during veteran care transitions. The implementation blueprint for the Academy is multifaceted and integrates both clinical-focused and implementation-focused infrastructure to apply training content.²³ A randomized control trial evaluating the efficacy of training modalities found a need to expand implementation blueprints beyond clinical training alone, as training by itself may not be sufficient to change behavior.²⁴ VA staff designed the Academy using clinical- and implementation-focused content within its implementation blueprint. Key components included leveraging clinical champions, using a train-the-trainer approach, and incorporating facilitation strategies to overcome adoption barriers.

Lewis et al emphasize matching implementation strategies to barriers within VA staff who identify care coordination as a key challenge.²³ The informatics infrastructure developed for Academy learners, including standardized note templates, video modeling examples of clinic visits, and data capture for audit and feedback, was designed to complement clinical training and standardize service workflows (Figure 2). There are opportunities to explore how to optimize technology in the Academy.

While Academy clinical training specifically focuses on COPD management, many implementation strategies can be considered to promote care delivery services for other chronic conditions. The Academy blueprint and implementation infrastructure, are strategies that may be considered within and outside the federal health care system. The opportunity for adaptations to Academy training enables clinical champions to promote tailored content to the needs of each unique VAMC. The translation of Academy implementation strategies for new chronic conditions will similarly require adaptations at each VAMC to promote adoption of content.

CONCLUSIONS

COPD CARE Academy is an example of the collaborative spirit within VA, and the opportunity for further advancement of health care programs. The VA is a national leader in Learning Health Systems implementation, in which “science, informatics, incentives and culture are aligned for continuous improvement and innovation.”^25,26 There are many opportunities for VA staff to learn from one another to form partnerships between leaders, clinicians, and scientists to optimize health care delivery and further the VA’s work as a learning health system.

Quality improvement (QI) initiatives within the US Department of Veterans Affairs (VA) play an important role in enhancing health care for veterans.^1,2 While effective QI programs are often developed, veterans benefit only if they receive care at sites where the program is offered.³ It is estimated only 1% to 5% of patients receive benefit from evidence-based programs, limiting the opportunity for widespread impact.^4,5

The Chronic Obstructive Pulmonary Disease (COPD) Coordinated Access to Reduce Exacerbations (CARE) Academy is a national training program designed to promote the adoption of a COPD primary care service.⁶ The Academy was created and iteratively refined by VA staff to include both clinical training emphasizing COPD management and program implementation strategies. Training programs such as COPD CARE are commonly described as a method to support adoption of health care services, but there is no consensus on a universal approach to training design.

This article describes COPD CARE training and implementation strategies (Table). The Academy began as a training program at 1 VA medical center (VAMC) and has expanded to 49 diverse VAMCs. The Academy illustrates how implementation strategies can be leveraged to develop pragmatic and impactful training. Highlights from the Academy's 9-year history are outlined in this article.

COPD CARE

One in 4 veterans have a COPD diagnosis, and the 5-year mortality rate following a COPD flare is ≥ 50%.^7,8 In 2015, a pharmacy resident designed and piloted COPD CARE, a program that used evidence-based practice to optimize management of the disease.^9,10

The COPD CARE program is delivered by interprofessional team members. It includes a postacute care call completed 48 hours postdischarge, a wellness visit (face-to-face or virtual) 1 month postdischarge, and a follow-up visit scheduled 2 months postdischarge. Clinical pharmacist practitioners (CPPs) prescribe and collaborate with the COPD CARE health care team. Evidence-based practices embedded within COPD CARE include treatment optimization, symptom evaluation, severity staging, vaccination promotion, referrals, tobacco treatment, and comorbidity management.^11-16 The initial COPD CARE pilot demonstrated promising results; patients received timely care and high rates of COPD best practices.¹¹

Academy Design and Implementation

Initial COPD CARE training was tailored to the culture, context, and workflow of the William S. Middleton Memorial Veteran’s Hospital in Madison, Wisconsin. Further service expansion required integration of implementation strategies that enable learners to apply and adapt content to fit different processes, staffing, and patient needs.

Formal Implementation Blueprint

A key aspect of the Academy is the integration of a formal implementation blueprint that includes training goals, scope, and key milestones to guide implementation. The Academy blueprint includes 4 phased training workbooks: (1) preimplementation support from local stakeholders; (2) integration of COPD CARE operational infrastructure into workflows; (3) preparing clinical champions; and (4) leading clinical training (Figure 1). Five weekly 1-hour synchronous virtual discussions are used for learning the workbook content that include learning objectives and opportunities to strategize how to overcome implementation barriers.

Promoting and Facilitating Implementation

As clinicians apply content from the Academy to install informatics tools, coordinate clinical training, and build relationships across service lines, implementation barriers may occur. A learning collaborative allows peer-mentorship and shared problem solving. The Academy learning collaborative includes attendees across multiple VAMCs, allowing for diverse perspectives and cross-site learning. Within the field of dissemination and implementation science, this process of shared problem-solving to support individuals is referred to as implementation facilitation.¹⁷ Academy facilitators with prior experience provide a unique perspective and external facilitation from outside local VAMCs. Academy learners form local teams to engage in shared decision-making when applying Academy content. Following Academy completion, learning collaboratives continue to meet monthly to share clinical insights and operational updates.

Local Champions Promote Adaptability

One or more local champions were identified at each VAMC who were focused on the implementation of clinical training content and operational implementation of Academy content.¹⁸ Champions have helped develop adaptations of Academy content, such as integrating telehealth nursing within the COPD CARE referral process, which have become new best practices. Champions attend Academy sessions, which provide an opportunity to share adaptations to meet local needs.¹⁹

Using a Train-The-Trainer Model

Clinical training was designed to be dynamic and included video modeling, such as recorded examples of CPPs conducting COPD CARE visits and video clips highlighting clinical content. Each learner received a clinical workbook summarizing the content. The champion shares discussion questions to relate training content to the local clinical practice setting. The combination of live training, with videos of clinic visits and case-based discussion was intended to address differing learning styles. Clinical training was delivered using a train-the-trainer model led by the local champion, which allows clinicians with expertise to tailor their training. The use of a train-the-trainer model was intended to promote local buy-in and was often completed by frontline clinicians.

Informatics note templates provide clinicians with information needed to deliver training content during clinic visits. Direct hyperlinks to symptomatic scoring tools, resources to promote evidence-based medication optimization, and patient education resources were embedded within the electronic health record note templates. Direct links to consults for COPD referrals services discussed during clinical training were also included to promote ease of care coordination and awareness of referral opportunities. The integration of clinical training with informatics note template support was intentional to directly relate clinical training to clinical care delivery.

Audit and Feedback

To inform COPD CARE practice, the Academy included informatics infrastructure that allowed for timely local quality monitoring. Electronic health record note templates with embedded data fields track COPD CARE service implementation, including timely completion of patient visits, completion of patient medication reviews, appropriate testing, symptom assessment, and interventions made. Champions can organize template installation and integrate templates into COPD CARE clinical training. Data are included on a COPD CARE implementation dashboard.

An audit and feedback process is allows for the review of performance metrics and development of action plans.^20,21 Data reports from note templates are described during the Academy, along with resources to help teams enhance delivery of their program based on performance metrics.

Building a Coalition

Within VA primary care, clinical care delivery is optimized through a team-based coalition of clinicians using the patient aligned care team (PACT) framework. The VA patient-centered team-based care delivery model, patient facilitates coordination of patient referrals, including patient review, scheduling, and completion of patient visits.²²

Partnerships with VA Pharmacy Benefits Manager, VA Diffusion of Excellence, VA Quality Enhancement Research Initiative, VA Office of Pulmonary Medicine, and the VA Office of Rural Health have facilitated COPD CARE successes. Collaborations with VA Centers of Innovation helped benchmark the Academy’s impact. An academic partnership with the University of Wisconsin-Madison was established in 2017 and has provided evaluation expertise and leadership as the Academy has been iteratively developed, and revised.

Preliminary Metrics

COPD CARE has delivered > 2000 visits. CPPs have delivered COPD care, with a mean 9.4 of 10 best practices per patient visit. Improvements in veteran COPD symptoms have also been observed following COPD CARE patient visits.

DISCUSSION

The COPD CARE Academy was developed to promote rapid scale-up of a complex, team-based COPD service delivered during veteran care transitions. The implementation blueprint for the Academy is multifaceted and integrates both clinical-focused and implementation-focused infrastructure to apply training content.²³ A randomized control trial evaluating the efficacy of training modalities found a need to expand implementation blueprints beyond clinical training alone, as training by itself may not be sufficient to change behavior.²⁴ VA staff designed the Academy using clinical- and implementation-focused content within its implementation blueprint. Key components included leveraging clinical champions, using a train-the-trainer approach, and incorporating facilitation strategies to overcome adoption barriers.

Lewis et al emphasize matching implementation strategies to barriers within VA staff who identify care coordination as a key challenge.²³ The informatics infrastructure developed for Academy learners, including standardized note templates, video modeling examples of clinic visits, and data capture for audit and feedback, was designed to complement clinical training and standardize service workflows (Figure 2). There are opportunities to explore how to optimize technology in the Academy.

While Academy clinical training specifically focuses on COPD management, many implementation strategies can be considered to promote care delivery services for other chronic conditions. The Academy blueprint and implementation infrastructure, are strategies that may be considered within and outside the federal health care system. The opportunity for adaptations to Academy training enables clinical champions to promote tailored content to the needs of each unique VAMC. The translation of Academy implementation strategies for new chronic conditions will similarly require adaptations at each VAMC to promote adoption of content.

CONCLUSIONS

COPD CARE Academy is an example of the collaborative spirit within VA, and the opportunity for further advancement of health care programs. The VA is a national leader in Learning Health Systems implementation, in which “science, informatics, incentives and culture are aligned for continuous improvement and innovation.”^25,26 There are many opportunities for VA staff to learn from one another to form partnerships between leaders, clinicians, and scientists to optimize health care delivery and further the VA’s work as a learning health system.

Quality improvement (QI) initiatives within the US Department of Veterans Affairs (VA) play an important role in enhancing health care for veterans.^1,2 While effective QI programs are often developed, veterans benefit only if they receive care at sites where the program is offered.³ It is estimated only 1% to 5% of patients receive benefit from evidence-based programs, limiting the opportunity for widespread impact.^4,5

The Chronic Obstructive Pulmonary Disease (COPD) Coordinated Access to Reduce Exacerbations (CARE) Academy is a national training program designed to promote the adoption of a COPD primary care service.⁶ The Academy was created and iteratively refined by VA staff to include both clinical training emphasizing COPD management and program implementation strategies. Training programs such as COPD CARE are commonly described as a method to support adoption of health care services, but there is no consensus on a universal approach to training design.

This article describes COPD CARE training and implementation strategies (Table). The Academy began as a training program at 1 VA medical center (VAMC) and has expanded to 49 diverse VAMCs. The Academy illustrates how implementation strategies can be leveraged to develop pragmatic and impactful training. Highlights from the Academy's 9-year history are outlined in this article.

COPD CARE

One in 4 veterans have a COPD diagnosis, and the 5-year mortality rate following a COPD flare is ≥ 50%.^7,8 In 2015, a pharmacy resident designed and piloted COPD CARE, a program that used evidence-based practice to optimize management of the disease.^9,10

The COPD CARE program is delivered by interprofessional team members. It includes a postacute care call completed 48 hours postdischarge, a wellness visit (face-to-face or virtual) 1 month postdischarge, and a follow-up visit scheduled 2 months postdischarge. Clinical pharmacist practitioners (CPPs) prescribe and collaborate with the COPD CARE health care team. Evidence-based practices embedded within COPD CARE include treatment optimization, symptom evaluation, severity staging, vaccination promotion, referrals, tobacco treatment, and comorbidity management.^11-16 The initial COPD CARE pilot demonstrated promising results; patients received timely care and high rates of COPD best practices.¹¹

Academy Design and Implementation

Initial COPD CARE training was tailored to the culture, context, and workflow of the William S. Middleton Memorial Veteran’s Hospital in Madison, Wisconsin. Further service expansion required integration of implementation strategies that enable learners to apply and adapt content to fit different processes, staffing, and patient needs.

Formal Implementation Blueprint

A key aspect of the Academy is the integration of a formal implementation blueprint that includes training goals, scope, and key milestones to guide implementation. The Academy blueprint includes 4 phased training workbooks: (1) preimplementation support from local stakeholders; (2) integration of COPD CARE operational infrastructure into workflows; (3) preparing clinical champions; and (4) leading clinical training (Figure 1). Five weekly 1-hour synchronous virtual discussions are used for learning the workbook content that include learning objectives and opportunities to strategize how to overcome implementation barriers.

Promoting and Facilitating Implementation

As clinicians apply content from the Academy to install informatics tools, coordinate clinical training, and build relationships across service lines, implementation barriers may occur. A learning collaborative allows peer-mentorship and shared problem solving. The Academy learning collaborative includes attendees across multiple VAMCs, allowing for diverse perspectives and cross-site learning. Within the field of dissemination and implementation science, this process of shared problem-solving to support individuals is referred to as implementation facilitation.¹⁷ Academy facilitators with prior experience provide a unique perspective and external facilitation from outside local VAMCs. Academy learners form local teams to engage in shared decision-making when applying Academy content. Following Academy completion, learning collaboratives continue to meet monthly to share clinical insights and operational updates.

Local Champions Promote Adaptability

One or more local champions were identified at each VAMC who were focused on the implementation of clinical training content and operational implementation of Academy content.¹⁸ Champions have helped develop adaptations of Academy content, such as integrating telehealth nursing within the COPD CARE referral process, which have become new best practices. Champions attend Academy sessions, which provide an opportunity to share adaptations to meet local needs.¹⁹

Using a Train-The-Trainer Model

Clinical training was designed to be dynamic and included video modeling, such as recorded examples of CPPs conducting COPD CARE visits and video clips highlighting clinical content. Each learner received a clinical workbook summarizing the content. The champion shares discussion questions to relate training content to the local clinical practice setting. The combination of live training, with videos of clinic visits and case-based discussion was intended to address differing learning styles. Clinical training was delivered using a train-the-trainer model led by the local champion, which allows clinicians with expertise to tailor their training. The use of a train-the-trainer model was intended to promote local buy-in and was often completed by frontline clinicians.

Informatics note templates provide clinicians with information needed to deliver training content during clinic visits. Direct hyperlinks to symptomatic scoring tools, resources to promote evidence-based medication optimization, and patient education resources were embedded within the electronic health record note templates. Direct links to consults for COPD referrals services discussed during clinical training were also included to promote ease of care coordination and awareness of referral opportunities. The integration of clinical training with informatics note template support was intentional to directly relate clinical training to clinical care delivery.

Audit and Feedback

To inform COPD CARE practice, the Academy included informatics infrastructure that allowed for timely local quality monitoring. Electronic health record note templates with embedded data fields track COPD CARE service implementation, including timely completion of patient visits, completion of patient medication reviews, appropriate testing, symptom assessment, and interventions made. Champions can organize template installation and integrate templates into COPD CARE clinical training. Data are included on a COPD CARE implementation dashboard.

An audit and feedback process is allows for the review of performance metrics and development of action plans.^20,21 Data reports from note templates are described during the Academy, along with resources to help teams enhance delivery of their program based on performance metrics.

Building a Coalition

Within VA primary care, clinical care delivery is optimized through a team-based coalition of clinicians using the patient aligned care team (PACT) framework. The VA patient-centered team-based care delivery model, patient facilitates coordination of patient referrals, including patient review, scheduling, and completion of patient visits.²²

Partnerships with VA Pharmacy Benefits Manager, VA Diffusion of Excellence, VA Quality Enhancement Research Initiative, VA Office of Pulmonary Medicine, and the VA Office of Rural Health have facilitated COPD CARE successes. Collaborations with VA Centers of Innovation helped benchmark the Academy’s impact. An academic partnership with the University of Wisconsin-Madison was established in 2017 and has provided evaluation expertise and leadership as the Academy has been iteratively developed, and revised.

Preliminary Metrics

COPD CARE has delivered > 2000 visits. CPPs have delivered COPD care, with a mean 9.4 of 10 best practices per patient visit. Improvements in veteran COPD symptoms have also been observed following COPD CARE patient visits.

DISCUSSION

The COPD CARE Academy was developed to promote rapid scale-up of a complex, team-based COPD service delivered during veteran care transitions. The implementation blueprint for the Academy is multifaceted and integrates both clinical-focused and implementation-focused infrastructure to apply training content.²³ A randomized control trial evaluating the efficacy of training modalities found a need to expand implementation blueprints beyond clinical training alone, as training by itself may not be sufficient to change behavior.²⁴ VA staff designed the Academy using clinical- and implementation-focused content within its implementation blueprint. Key components included leveraging clinical champions, using a train-the-trainer approach, and incorporating facilitation strategies to overcome adoption barriers.

Lewis et al emphasize matching implementation strategies to barriers within VA staff who identify care coordination as a key challenge.²³ The informatics infrastructure developed for Academy learners, including standardized note templates, video modeling examples of clinic visits, and data capture for audit and feedback, was designed to complement clinical training and standardize service workflows (Figure 2). There are opportunities to explore how to optimize technology in the Academy.

While Academy clinical training specifically focuses on COPD management, many implementation strategies can be considered to promote care delivery services for other chronic conditions. The Academy blueprint and implementation infrastructure, are strategies that may be considered within and outside the federal health care system. The opportunity for adaptations to Academy training enables clinical champions to promote tailored content to the needs of each unique VAMC. The translation of Academy implementation strategies for new chronic conditions will similarly require adaptations at each VAMC to promote adoption of content.

CONCLUSIONS

COPD CARE Academy is an example of the collaborative spirit within VA, and the opportunity for further advancement of health care programs. The VA is a national leader in Learning Health Systems implementation, in which “science, informatics, incentives and culture are aligned for continuous improvement and innovation.”^25,26 There are many opportunities for VA staff to learn from one another to form partnerships between leaders, clinicians, and scientists to optimize health care delivery and further the VA’s work as a learning health system.

Medroxyprogesterone acetate is an injectable medication indicated for contraception and management of endometriosis-associated pain in females of reproductive age.¹ Medroxyprogesterone inhibits gonadotropin secretion, which prevents follicular maturation and ovulation. This leads to endometrial thinning and a contraceptive effect. Adverse drug reactions (ADRs), such as weight gain, menstrual bleeding irregularities, and bone loss appear to be dose- and time-related. Two formulations of medroxyprogesterone acetate are available: 150 mg depot medroxyprogesterone acetate intramuscular (DMPA-IM) and 104 mg DMPA subcutaneous (DMPA-SC).² Originally, medroxyprogesterone acetate injections required administration by a health care worker. While the current labeling for DMPA-SC still indicates a requirement for administration by a health care worker, data show that the medication can be safe and effective when self-administered.³

Self-Administered Contraception

The 2019 World Health Organization (WHO) guideline on self-care interventions recommends making self-administered injectable contraception available to individuals of reproductive age.³ The WHO recommendation is based on evidence from the Depo Self-Administration Study, which included 401 patients randomized 1:1 to receive self-administered or clinic-administered DMPA-SC. This study concluded that self-administration improved continuation of contraception.⁴

The North Florida/South Georgia Veterans Health System (NFSGVHS) is the largest US Department of Veterans Affairs (VA) health care system, serving > 22,000 female veterans. All primary care practitioners (PCP) have been trained in women’s health (WH). 

The WH patient-aligned care team (PACT) clinical pharmacy practitioner (CPP) proposed using DMPA-SC for outpatient self-administration to increase access, improve patient satisfaction, and reduce burden on patients and nurses for administration appointments. The Pharmacy and Therapeutics Committee (P&T), WH Medical Director, and Chief of Gynecology approved the proposal. DMPA-SC was added to the ordering menu with order sets. The order set included instructions that outlined the 12-week dosing interval, instructions to contact the prescriber if the injection was > 2 weeks overdue (aligning with dosing recommendations for administration every 12 to 14 weeks), and an optional order for a home pregnancy test if necessary. These instructions were designed to ensure proper self-administration of the medication and timely follow-up care. 

The gynecology and PACT health care practitioners (HCPs), including physicians, pharmacists, nurses, and medical assistants, received DMPA-SC education, which consisted of a review of medication, ADRs, contraindications, and administration. An NFSGVHS procedure was developed to ensure patients received self-administration education. DMPA-SC prescriptions were mailed to patients with scheduled nursing appointments. The patient would then bring DMPA-SC to the nursing appointment where they received administration instruction and completed the first injection under nurse supervision to ensure appropriate technique. Patients were offered supplementary educational documents and a calendar to keep track of injection days. The patients were responsible for ordering refills and administering subsequent injections at home. Once all stakeholders received education and order sets were in place, prescribers and nurses could begin offering the option for initiation of self-administered DMPA-SC to patients. All conversions or new prescriptions were initiated by prescribers as a part of usual care.

Medication Use Evaluation

A medication use evaluation was conducted about 1 year after the rollout to assess use, adherence, and impact of DMPA-SC for patient-self administration as a new contraceptive option for NFSGVHS patients.

A retrospective chart review was conducted for patients dispensed DMPA-SC from June 1, 2022, to July 1, 2023. Baseline body mass index (BMI), recorded prior to initiation of DMPA-SC, was compared with the most recent BMI on record at the completion of the study to evaluate weight change. Nursing visit attendance for the first injection was also assessed. Adherence was evaluated by reviewing the date of the initial DMPA-SC prescription, the date of the patient's first nursing visit, and subsequent refill patterns. A 2-week margin of error was established to account for the flexibility within the recommended dosing interval and delays in postal service delivery.

Forty patients were initiated on DMPA-SC for patient self-administration. The mean age of patients was 37.2 years. All 40 patients were female. Twenty-two patients (55%) identified as Black, 17 (43%) as White, and 1 (3%) as Asian. The majority (90%) of patients were non-Hispanic. The mean baseline BMI was 30 and BMI after DMPA-SC initiation was 30.4.

Twenty-eight (70%) patients had a nursing appointment, adhering to the NFSGVHS protocol. Five patients (13%) discontinued use and switched to DMPA-IM administered by an HCP and 4 (10%) discontinued use following an ADR (hives, mood changes, bruising, and menometrorrhagia). Of the 31 patients who continued therapy, 25 (81%) were refilling appropriately (Table). 

Six patients with unidentified reasons for nonadherence were contacted to determine if there were unmet contraceptive needs. This subgroup included patients with an active prescription for DMPA-SC that did not meet refill expectations. Nonadherence was mostly due to forgetfulness, however 1 patient was unable to refill her DMPA-SC in a timely manner due to an outside hospital admission and another was unreachable. These conversations were documented in the electronic health record (EHR) and all patients requesting follow-up, reinitiation of therapy, or alternative regimens, the appropriate parties were notified to coordinate care.

Discussion

The uptake in DMPA-SC prescribing suggests prescribers and patients have embraced self-administration as an option for contraception. Most patients were appropriately scheduled for nursing appointments to reinforce education and ensure appropriate self-injection technique, as outlined in the NFSGVHS procedure.

The need to improve adherence to NFSGVHS procedure was identified because not all patients had scheduled nursing appointments. This is concerning because some patients may have started self-injecting DMPA-SC without proper education, which could lead to improper injection technique and diminished effectiveness. Nursing appointments ensure appropriate self-injection techniques and reinforce the importance of refilling every 12 weeks for proper effectiveness. Nonadherence to contraceptive therapy may result in unintended pregnancy, although no pregnancies were reported by patients in this study. Pharmacist involvement in DMPA-SC initiation and follow-up monitoring may help ensure adherence to local procedure for initiation and improve patient adherence. 

There is limited evidence comparing weight gain related to DMPA-SC vs DMPA-IM. However, in a small, 2-year, randomized study, weight changes were considered comparable for both cohorts with a mean increase of 3.5 kg in the DMPA-IM group vs 3.4 kg in the DMPA-SC group.⁵ While our analysis did not formally evaluate weight changes, BMI data were collected to evaluate for evidence of weight change. The duration of therapy varied per patient and may not have been long enough to see comparable weight changes. 

Strengths of this project include the use of the PACT multidisciplinary approach in primary care including physicians, pharmacists, and nurses. The NFSGVHS EHR is comprehensive, and data including appointments and pharmacy refill information was readily available for collection and evaluation. Limitations included inconsistent documentation in the patient’s EHR which made collection of some data difficult.

Cost Estimates

NFSGVHS had 231 patients prescribed DMPA-IM at the time of DMPA-SC rollout and 40 patients initiated DMPA-SC therapy in the first year. There are possible cost savings associated with the use of DMPA-SC compared to DMPA-IM. Although DMPA-IM costs about $120 annually and DMPA-SC costs about $252 annually, this does not account for indirect costs such as supplies, overhead cost, nursing visits, and patient travel.⁶ Additionally, allowing patients to self-administer the DMPA-SC injection at home provides nurses time to care for other patients.

Moving forward, the PACT and gynecology teams will receive instruction on the importance of adhering to NFSGVHS procedures to ensure new patients prescribed DMPA-SC receive education and present for nursing appointments to ensure appropriate self-injection.

DMPA has historically been administered in the clinic setting by an HCP; therefore, the prescriber was available to assess adherence to therapy based on patient’s attendance to scheduled clinic appointments. Some prescribers may feel apprehensive about shifting the onus of medication adherence to the patient when prescribing DMPA-SC. However, this model is comparable to any other prescription form of birth control, such as combined hormonal contraceptive pills, where the prescriber expects the patient to take the medication as prescribed and refill their prescriptions in a timely manner to avoid gaps in therapy. The findings of this project suggest the majority of patients who were prescribed self-administered DMPA-SC for contraception were adherent to therapy. The utility of self-administration of DMPA-SC for other labeled or off-label indications was not evaluated; however, it is possible that patients who are motivated to self-administer the medication (regardless of indication) would also demonstrate similar adherence rates.

Conclusions

The majority of patients who started DMPA-SC tolerated the medication well and continued to refill therapy within the recommended time period. Patient self-administration of DMPA-SC can enhance access by removing barriers to administration, increase patient autonomy and contraceptive continuation rates. Overall, the increase in DMPA-SC prescriptions suggests that patients and HCPs support the option for DMPA-SC self-administration at NFSGVHS.

Medroxyprogesterone acetate is an injectable medication indicated for contraception and management of endometriosis-associated pain in females of reproductive age.¹ Medroxyprogesterone inhibits gonadotropin secretion, which prevents follicular maturation and ovulation. This leads to endometrial thinning and a contraceptive effect. Adverse drug reactions (ADRs), such as weight gain, menstrual bleeding irregularities, and bone loss appear to be dose- and time-related. Two formulations of medroxyprogesterone acetate are available: 150 mg depot medroxyprogesterone acetate intramuscular (DMPA-IM) and 104 mg DMPA subcutaneous (DMPA-SC).² Originally, medroxyprogesterone acetate injections required administration by a health care worker. While the current labeling for DMPA-SC still indicates a requirement for administration by a health care worker, data show that the medication can be safe and effective when self-administered.³

Self-Administered Contraception

The 2019 World Health Organization (WHO) guideline on self-care interventions recommends making self-administered injectable contraception available to individuals of reproductive age.³ The WHO recommendation is based on evidence from the Depo Self-Administration Study, which included 401 patients randomized 1:1 to receive self-administered or clinic-administered DMPA-SC. This study concluded that self-administration improved continuation of contraception.⁴

The North Florida/South Georgia Veterans Health System (NFSGVHS) is the largest US Department of Veterans Affairs (VA) health care system, serving > 22,000 female veterans. All primary care practitioners (PCP) have been trained in women’s health (WH). 

The WH patient-aligned care team (PACT) clinical pharmacy practitioner (CPP) proposed using DMPA-SC for outpatient self-administration to increase access, improve patient satisfaction, and reduce burden on patients and nurses for administration appointments. The Pharmacy and Therapeutics Committee (P&T), WH Medical Director, and Chief of Gynecology approved the proposal. DMPA-SC was added to the ordering menu with order sets. The order set included instructions that outlined the 12-week dosing interval, instructions to contact the prescriber if the injection was > 2 weeks overdue (aligning with dosing recommendations for administration every 12 to 14 weeks), and an optional order for a home pregnancy test if necessary. These instructions were designed to ensure proper self-administration of the medication and timely follow-up care. 

The gynecology and PACT health care practitioners (HCPs), including physicians, pharmacists, nurses, and medical assistants, received DMPA-SC education, which consisted of a review of medication, ADRs, contraindications, and administration. An NFSGVHS procedure was developed to ensure patients received self-administration education. DMPA-SC prescriptions were mailed to patients with scheduled nursing appointments. The patient would then bring DMPA-SC to the nursing appointment where they received administration instruction and completed the first injection under nurse supervision to ensure appropriate technique. Patients were offered supplementary educational documents and a calendar to keep track of injection days. The patients were responsible for ordering refills and administering subsequent injections at home. Once all stakeholders received education and order sets were in place, prescribers and nurses could begin offering the option for initiation of self-administered DMPA-SC to patients. All conversions or new prescriptions were initiated by prescribers as a part of usual care.

Medication Use Evaluation

A medication use evaluation was conducted about 1 year after the rollout to assess use, adherence, and impact of DMPA-SC for patient-self administration as a new contraceptive option for NFSGVHS patients.

A retrospective chart review was conducted for patients dispensed DMPA-SC from June 1, 2022, to July 1, 2023. Baseline body mass index (BMI), recorded prior to initiation of DMPA-SC, was compared with the most recent BMI on record at the completion of the study to evaluate weight change. Nursing visit attendance for the first injection was also assessed. Adherence was evaluated by reviewing the date of the initial DMPA-SC prescription, the date of the patient's first nursing visit, and subsequent refill patterns. A 2-week margin of error was established to account for the flexibility within the recommended dosing interval and delays in postal service delivery.

Forty patients were initiated on DMPA-SC for patient self-administration. The mean age of patients was 37.2 years. All 40 patients were female. Twenty-two patients (55%) identified as Black, 17 (43%) as White, and 1 (3%) as Asian. The majority (90%) of patients were non-Hispanic. The mean baseline BMI was 30 and BMI after DMPA-SC initiation was 30.4.

Twenty-eight (70%) patients had a nursing appointment, adhering to the NFSGVHS protocol. Five patients (13%) discontinued use and switched to DMPA-IM administered by an HCP and 4 (10%) discontinued use following an ADR (hives, mood changes, bruising, and menometrorrhagia). Of the 31 patients who continued therapy, 25 (81%) were refilling appropriately (Table). 

Six patients with unidentified reasons for nonadherence were contacted to determine if there were unmet contraceptive needs. This subgroup included patients with an active prescription for DMPA-SC that did not meet refill expectations. Nonadherence was mostly due to forgetfulness, however 1 patient was unable to refill her DMPA-SC in a timely manner due to an outside hospital admission and another was unreachable. These conversations were documented in the electronic health record (EHR) and all patients requesting follow-up, reinitiation of therapy, or alternative regimens, the appropriate parties were notified to coordinate care.

Discussion

The uptake in DMPA-SC prescribing suggests prescribers and patients have embraced self-administration as an option for contraception. Most patients were appropriately scheduled for nursing appointments to reinforce education and ensure appropriate self-injection technique, as outlined in the NFSGVHS procedure.

The need to improve adherence to NFSGVHS procedure was identified because not all patients had scheduled nursing appointments. This is concerning because some patients may have started self-injecting DMPA-SC without proper education, which could lead to improper injection technique and diminished effectiveness. Nursing appointments ensure appropriate self-injection techniques and reinforce the importance of refilling every 12 weeks for proper effectiveness. Nonadherence to contraceptive therapy may result in unintended pregnancy, although no pregnancies were reported by patients in this study. Pharmacist involvement in DMPA-SC initiation and follow-up monitoring may help ensure adherence to local procedure for initiation and improve patient adherence. 

There is limited evidence comparing weight gain related to DMPA-SC vs DMPA-IM. However, in a small, 2-year, randomized study, weight changes were considered comparable for both cohorts with a mean increase of 3.5 kg in the DMPA-IM group vs 3.4 kg in the DMPA-SC group.⁵ While our analysis did not formally evaluate weight changes, BMI data were collected to evaluate for evidence of weight change. The duration of therapy varied per patient and may not have been long enough to see comparable weight changes. 

Strengths of this project include the use of the PACT multidisciplinary approach in primary care including physicians, pharmacists, and nurses. The NFSGVHS EHR is comprehensive, and data including appointments and pharmacy refill information was readily available for collection and evaluation. Limitations included inconsistent documentation in the patient’s EHR which made collection of some data difficult.

Cost Estimates

NFSGVHS had 231 patients prescribed DMPA-IM at the time of DMPA-SC rollout and 40 patients initiated DMPA-SC therapy in the first year. There are possible cost savings associated with the use of DMPA-SC compared to DMPA-IM. Although DMPA-IM costs about $120 annually and DMPA-SC costs about $252 annually, this does not account for indirect costs such as supplies, overhead cost, nursing visits, and patient travel.⁶ Additionally, allowing patients to self-administer the DMPA-SC injection at home provides nurses time to care for other patients.

Moving forward, the PACT and gynecology teams will receive instruction on the importance of adhering to NFSGVHS procedures to ensure new patients prescribed DMPA-SC receive education and present for nursing appointments to ensure appropriate self-injection.

DMPA has historically been administered in the clinic setting by an HCP; therefore, the prescriber was available to assess adherence to therapy based on patient’s attendance to scheduled clinic appointments. Some prescribers may feel apprehensive about shifting the onus of medication adherence to the patient when prescribing DMPA-SC. However, this model is comparable to any other prescription form of birth control, such as combined hormonal contraceptive pills, where the prescriber expects the patient to take the medication as prescribed and refill their prescriptions in a timely manner to avoid gaps in therapy. The findings of this project suggest the majority of patients who were prescribed self-administered DMPA-SC for contraception were adherent to therapy. The utility of self-administration of DMPA-SC for other labeled or off-label indications was not evaluated; however, it is possible that patients who are motivated to self-administer the medication (regardless of indication) would also demonstrate similar adherence rates.

Conclusions

The majority of patients who started DMPA-SC tolerated the medication well and continued to refill therapy within the recommended time period. Patient self-administration of DMPA-SC can enhance access by removing barriers to administration, increase patient autonomy and contraceptive continuation rates. Overall, the increase in DMPA-SC prescriptions suggests that patients and HCPs support the option for DMPA-SC self-administration at NFSGVHS.

Medroxyprogesterone acetate is an injectable medication indicated for contraception and management of endometriosis-associated pain in females of reproductive age.¹ Medroxyprogesterone inhibits gonadotropin secretion, which prevents follicular maturation and ovulation. This leads to endometrial thinning and a contraceptive effect. Adverse drug reactions (ADRs), such as weight gain, menstrual bleeding irregularities, and bone loss appear to be dose- and time-related. Two formulations of medroxyprogesterone acetate are available: 150 mg depot medroxyprogesterone acetate intramuscular (DMPA-IM) and 104 mg DMPA subcutaneous (DMPA-SC).² Originally, medroxyprogesterone acetate injections required administration by a health care worker. While the current labeling for DMPA-SC still indicates a requirement for administration by a health care worker, data show that the medication can be safe and effective when self-administered.³

Self-Administered Contraception

The 2019 World Health Organization (WHO) guideline on self-care interventions recommends making self-administered injectable contraception available to individuals of reproductive age.³ The WHO recommendation is based on evidence from the Depo Self-Administration Study, which included 401 patients randomized 1:1 to receive self-administered or clinic-administered DMPA-SC. This study concluded that self-administration improved continuation of contraception.⁴

The North Florida/South Georgia Veterans Health System (NFSGVHS) is the largest US Department of Veterans Affairs (VA) health care system, serving > 22,000 female veterans. All primary care practitioners (PCP) have been trained in women’s health (WH). 

The WH patient-aligned care team (PACT) clinical pharmacy practitioner (CPP) proposed using DMPA-SC for outpatient self-administration to increase access, improve patient satisfaction, and reduce burden on patients and nurses for administration appointments. The Pharmacy and Therapeutics Committee (P&T), WH Medical Director, and Chief of Gynecology approved the proposal. DMPA-SC was added to the ordering menu with order sets. The order set included instructions that outlined the 12-week dosing interval, instructions to contact the prescriber if the injection was > 2 weeks overdue (aligning with dosing recommendations for administration every 12 to 14 weeks), and an optional order for a home pregnancy test if necessary. These instructions were designed to ensure proper self-administration of the medication and timely follow-up care. 

The gynecology and PACT health care practitioners (HCPs), including physicians, pharmacists, nurses, and medical assistants, received DMPA-SC education, which consisted of a review of medication, ADRs, contraindications, and administration. An NFSGVHS procedure was developed to ensure patients received self-administration education. DMPA-SC prescriptions were mailed to patients with scheduled nursing appointments. The patient would then bring DMPA-SC to the nursing appointment where they received administration instruction and completed the first injection under nurse supervision to ensure appropriate technique. Patients were offered supplementary educational documents and a calendar to keep track of injection days. The patients were responsible for ordering refills and administering subsequent injections at home. Once all stakeholders received education and order sets were in place, prescribers and nurses could begin offering the option for initiation of self-administered DMPA-SC to patients. All conversions or new prescriptions were initiated by prescribers as a part of usual care.

Medication Use Evaluation

A medication use evaluation was conducted about 1 year after the rollout to assess use, adherence, and impact of DMPA-SC for patient-self administration as a new contraceptive option for NFSGVHS patients.

A retrospective chart review was conducted for patients dispensed DMPA-SC from June 1, 2022, to July 1, 2023. Baseline body mass index (BMI), recorded prior to initiation of DMPA-SC, was compared with the most recent BMI on record at the completion of the study to evaluate weight change. Nursing visit attendance for the first injection was also assessed. Adherence was evaluated by reviewing the date of the initial DMPA-SC prescription, the date of the patient's first nursing visit, and subsequent refill patterns. A 2-week margin of error was established to account for the flexibility within the recommended dosing interval and delays in postal service delivery.

Forty patients were initiated on DMPA-SC for patient self-administration. The mean age of patients was 37.2 years. All 40 patients were female. Twenty-two patients (55%) identified as Black, 17 (43%) as White, and 1 (3%) as Asian. The majority (90%) of patients were non-Hispanic. The mean baseline BMI was 30 and BMI after DMPA-SC initiation was 30.4.

Twenty-eight (70%) patients had a nursing appointment, adhering to the NFSGVHS protocol. Five patients (13%) discontinued use and switched to DMPA-IM administered by an HCP and 4 (10%) discontinued use following an ADR (hives, mood changes, bruising, and menometrorrhagia). Of the 31 patients who continued therapy, 25 (81%) were refilling appropriately (Table). 

Six patients with unidentified reasons for nonadherence were contacted to determine if there were unmet contraceptive needs. This subgroup included patients with an active prescription for DMPA-SC that did not meet refill expectations. Nonadherence was mostly due to forgetfulness, however 1 patient was unable to refill her DMPA-SC in a timely manner due to an outside hospital admission and another was unreachable. These conversations were documented in the electronic health record (EHR) and all patients requesting follow-up, reinitiation of therapy, or alternative regimens, the appropriate parties were notified to coordinate care.

Discussion

The uptake in DMPA-SC prescribing suggests prescribers and patients have embraced self-administration as an option for contraception. Most patients were appropriately scheduled for nursing appointments to reinforce education and ensure appropriate self-injection technique, as outlined in the NFSGVHS procedure.

The need to improve adherence to NFSGVHS procedure was identified because not all patients had scheduled nursing appointments. This is concerning because some patients may have started self-injecting DMPA-SC without proper education, which could lead to improper injection technique and diminished effectiveness. Nursing appointments ensure appropriate self-injection techniques and reinforce the importance of refilling every 12 weeks for proper effectiveness. Nonadherence to contraceptive therapy may result in unintended pregnancy, although no pregnancies were reported by patients in this study. Pharmacist involvement in DMPA-SC initiation and follow-up monitoring may help ensure adherence to local procedure for initiation and improve patient adherence. 

There is limited evidence comparing weight gain related to DMPA-SC vs DMPA-IM. However, in a small, 2-year, randomized study, weight changes were considered comparable for both cohorts with a mean increase of 3.5 kg in the DMPA-IM group vs 3.4 kg in the DMPA-SC group.⁵ While our analysis did not formally evaluate weight changes, BMI data were collected to evaluate for evidence of weight change. The duration of therapy varied per patient and may not have been long enough to see comparable weight changes. 

Strengths of this project include the use of the PACT multidisciplinary approach in primary care including physicians, pharmacists, and nurses. The NFSGVHS EHR is comprehensive, and data including appointments and pharmacy refill information was readily available for collection and evaluation. Limitations included inconsistent documentation in the patient’s EHR which made collection of some data difficult.

Cost Estimates

NFSGVHS had 231 patients prescribed DMPA-IM at the time of DMPA-SC rollout and 40 patients initiated DMPA-SC therapy in the first year. There are possible cost savings associated with the use of DMPA-SC compared to DMPA-IM. Although DMPA-IM costs about $120 annually and DMPA-SC costs about $252 annually, this does not account for indirect costs such as supplies, overhead cost, nursing visits, and patient travel.⁶ Additionally, allowing patients to self-administer the DMPA-SC injection at home provides nurses time to care for other patients.

Moving forward, the PACT and gynecology teams will receive instruction on the importance of adhering to NFSGVHS procedures to ensure new patients prescribed DMPA-SC receive education and present for nursing appointments to ensure appropriate self-injection.

DMPA has historically been administered in the clinic setting by an HCP; therefore, the prescriber was available to assess adherence to therapy based on patient’s attendance to scheduled clinic appointments. Some prescribers may feel apprehensive about shifting the onus of medication adherence to the patient when prescribing DMPA-SC. However, this model is comparable to any other prescription form of birth control, such as combined hormonal contraceptive pills, where the prescriber expects the patient to take the medication as prescribed and refill their prescriptions in a timely manner to avoid gaps in therapy. The findings of this project suggest the majority of patients who were prescribed self-administered DMPA-SC for contraception were adherent to therapy. The utility of self-administration of DMPA-SC for other labeled or off-label indications was not evaluated; however, it is possible that patients who are motivated to self-administer the medication (regardless of indication) would also demonstrate similar adherence rates.

Conclusions

The majority of patients who started DMPA-SC tolerated the medication well and continued to refill therapy within the recommended time period. Patient self-administration of DMPA-SC can enhance access by removing barriers to administration, increase patient autonomy and contraceptive continuation rates. Overall, the increase in DMPA-SC prescriptions suggests that patients and HCPs support the option for DMPA-SC self-administration at NFSGVHS.

Penicillin allergy is common in the United States. About 9.0% to 13.8% of patients have a diagnosed penicillin allergy documented in their electronic health record. The annual incidence rates is 1.1% in males and 1.4% in females.^1,2

Penicillin hypersensitivity likely wanes over time. A 1981 study found that 93% of patients who experienced an allergic reaction to penicillin had a positive skin test 7 to 12 months postreaction, but only 22% still had a positive test after 10 years.³ Confirmed type 1 hypersensitivity penicillin allergies, as demonstrated by positive skin prick testing, also are decreasing over time.⁴ Furthermore, many patients’ reactions may have been misdiagnosed as a penicillin allergy. Upon actual confirmatory testing of penicillin allergy, only 8.5% to 13.8% of patients believed to have a penicillin allergy were positive on skin prick testing of penicillin products.^5,6 A 2024 US study found that 11% of individuals with a history of a penicillin reaction tested positive on skin testing.⁷ 

The positive predictive value of penicillin allergy skin testing is poorly defined due to the ethical dilemma of orally challenging a patient who demonstrates skin test reactivity. Due to its high negative predictive value (NPV), skin prick combined with intradermal testing has been the gold-standard test in cases of clinical concern.⁶ Patients with positive skin testing are assumed to be truly positive, and therefore penicillin allergic, even though false-positive results to penicillin skin testing are known to occur.⁸ 

Misdiagnosis of penicillin allergy carries substantial clinical and economic consequences. A 2011 study suggested a statistically significant 1.8% increased absolute risk of mortality and 5.5% increased absolute risk of intensive care unit admission for those labeled with penicillin allergy and admitted for an infection.⁹ Another study found a 14% increase in mortality associated with the diagnosis of penicillin allergy.¹⁰ In a 2014 case-control study, penicillin allergy also was associated with a 23.4% greater risk of Clostridioides difficile, 14.1% more methicillin-resistant Staphylococcus aureus, and 30.1% more vancomycin-resistant enterococci infections.¹¹Direct cost savings during an inpatient admission for infection were as much as $609 per patient with additional indirect cost savings of up to $4254 per admission.¹² When viewed from the perspective of a health care system, these costs quickly accumulate, negatively impacting the fiscal stability of our patients and placing additional financial strain on an over-burdened system. 

If 10% of US patients have penicillin allergy labels, then about 33 million patients might be eligible for delabeling. There are only 6309 board-certified allergists actively practicing in the US, which could amount to about 5231 potential penicillin challenges per allergist, not even including the 3.3 million new patients per year (assuming a 1% incidence).¹³ Clarifying each patient’s tolerance of penicillin products will clearly require nonallergist cooperation.  

The 2022 drug allergy practice parameter update recommends several consensus-based statements (CBSs) to directly address penicillin allergy.¹⁴ This guideline recommends proactive efforts to delabel patients with a reported penicillin allergy (CBS 4); advise against testing in cases where the history is inconsistent with a true allergic reaction, though a challenge may be offered (CBS 5); skin testing for those with a history of anaphylaxis or a recent reaction (CBS 6); advise against multiple-day penicillin challenges (CBS 7); advise against skin testing for pediatric patients with benign cutaneous reactions (CBS 8); and recommends direct oral challenge for adults with distant or benign cutaneous reactions (CBS 9). These recommendations create a potentially high demand for delabeling with allergy specialists. One potential solution is to perform direct oral challenges in primary care, emergency departments, and urgent care clinics.  

Evidence supporting the safety of direct oral penicillin challenges in low-risk patients was initially noted in the allergy community, but now evidence for their use in primary care clinics is growing—including in children.¹⁵ In a military-specific population, an amoxicillin challenge of Marine recruits with suspected penicillin allergy revealed that only 1.5% of those challenged acutely reacted and should be considered allergic to penicillin.¹⁶ Historically, in order to refute the diagnosis of penicillin allergy, an allergist would order penicillin skin prick testing. If the test was negative, an allergist would proceed to intradermal testing and if negative again (NPV of 97.9%), proceed to a graded oral challenge.⁶ However, this process is not fully reproducible in most clinics because the minor determinants mixture used in skin testing is not commercially available.¹⁷ Additionally, the full skin testing procedure requires specialized training, is more time-consuming, causes more discomfort, lacks US Food and Drug Administration approval for children, and has a higher cost ($220 per test for each patient as of 2016).¹⁸ As such, the movement toward direct oral challenges is progressing. Nonetheless, the best method for primary care or emergency department clinicians to determine who the appropriate patients are for this procedure has not been fully established. Risk tools have been created in the past to help delineate low-risk patients who would be appropriate for direct oral amoxicillin challenges, but these were not widely replicated or validated.¹⁹ The PEN-FAST standardized risk score was first published in 2020 and has since been validated in different groups with additional safety data. This scoring system ranges from 0 to 5 points, assigning 2 points for a penicillin reaction within the past five (F) years, 2 points for angioedema/anaphylaxis (A) or a severe (S) cutaneous reaction, and 1 point if treatment (T) was required for the reaction. A score < 3 is considered low-risk and safe for direct oral challenge, although most of the safety data are in patients with a score of 0 or 1.²⁰ The PEN-FAST guided direct oral challenge with an NPV of 96.3% has now been prospectively shown to be noninferior to standard skin prick test/intradermal test/graded challenge for low-risk patients with a PEN-FAST score < 3.²¹ The PEN-FAST validating study was conducted predominantly with an Australian population of adult White women, but now it also has been validated in children aged > 12 years, as well as in European and North American cohorts.^22-24

Air Force Delabeling Program

This article describes a method for proactively, safely, and efficiently delabeling penicillin allergic patients at an Air Force clinic. This quality improvement (QI) report provides a successful model for penicillin allergy delabeling, illustrates lessons learned, and suggests next steps toward improving patient options for an invaluable antibiotic class.

The first step was to proactively delabel penicillin allergy from a population of active duty service members and their dependents. Electronic health record (EHR) allergy search functions are a helpful tool in finding patients with allergy labels. The Kadena Medical Clinic, in Okinawa, Japan, uses the Military Health System GENESIS EHR, which includes a discern reporting portal with a patient allergy search that creates a patient-specific medication allergy report. To compile the most complete database of patients with a penicillin allergy, all 15 potential allergy search options for “penicillin” were selected, as were 4 relevant options for amoxicillin (including options with clavulanate). Including so many options for specific penicillin medication allergies helps add specificity to the diagnosis in the EHR but can make aggregation of data more difficult. The report allowed all these specific medications to be selected at once for a particular clinic. However, the report did not populate patients with the allergy listed in other fields or free text.  

The complete compiled list was manually reviewed for high-risk patients with severe cutaneous adverse reactions (SCARs) of any age. Patients with pregnancy, unsuitable medical histories (ie, severe asthma), or taking β-blockers were excluded. Patients remaining on the list were contacted by telephone and offered appointments during a single week that was dedicated to penicillin allergy delabeling. Allergists in the Air Force are assigned to a region where they offer allergy services at clinics without a regular allergist. The allergist for the region traveled to the QI site for a 1-week campaign at an estimated cost of $4600. When the patients were contacted, they were briefly informed of the goal of the penicillin delabeling campaign, and if interested, they were scheduled for 1 of 50 available appointments that week. Patients were contacted with enough lead time to stop oral antihistamines (OAH) for ≥ 7 days before the appointment.  

Patients were given an intake questionnaire and interviewed about their penicillin allergy history. This questionnaire inquired about the nature of the allergy, mental and physical health impacts of the allergy label, PEN-FAST scoring questions, and posttest attitude toward delabeling, if applicable. Patients with a PEN-FAST score < 3 were offered direct, graded oral challenge or the standard skin prick, followed by intradermal, followed by graded oral challenge protocol. Patients with PEN-FAST scores of ≥ 3 were offered skin testing prior to oral challenge protocol. Patients could decline further testing. If patients wished to proceed, they were asked to complete a written informed consent document.  

Oral challenges followed a 10%/90% protocol, beginning with 50 mg of liquid amoxicillin followed by 450 mg after 15 minutes, as long as the patient remained asymptomatic. Challenge forms are available in the eAppendix . After receiving the 450-mg amoxicillin dose, the patient remained in the clinic for 60 minutes before a final clinical evaluation. If the patient remained asymptomatic after this period, the penicillin or amoxicillin allergy was marked as resolved in the EHR. The patients were given contact information for the clinic for follow-up if a delayed reaction was noted and they wished the medication allergy to be re-entered. An EHR encounter note was created for each patient detailing the allergy testing and delabeling.  

This campaign was conducted at a basic life support-only facility by a single clinician without medical technician support. An allergic reaction medication kit was available and contained OAHs, intramuscular antihistamines, intramuscular epinephrine, intramuscular corticosteroids, and short-acting β-agonists for nebulization. The facility also had an urgent care room (staffed by primary care practitioners [PCPs]) that could help establish intravenous access and administer fluids if necessary and had previously established plans for emergency patient transport to a higher level of care, if necessary.

Program Outcomes

A list of 65 patients that included both active-duty service members and dependents with penicillin or amoxicillin allergy was created. This list was reviewed by an allergist to identify high-risk individuals, which required about 90 minutes. Two patients (3%) were excluded; 1 had a history of SCAR to penicillin and 1 had a complex medical history requiring continued OAH use. Sixty-three patients were contacted via telephone, and 29 patients (46%) scheduled an appointment. One patient (2%) was identified as penicillin-tolerant during the booking process, and the penicillin allergy was removed without testing (Figure 1).

Of the 29 scheduled patients, 5 patients (17%) failed to present for care. Of the potential appointments set aside for the program, only 42% were used. One patient (4%) who was seen in clinic was delabeled based on history alone as they had previously successfully tolerated a course of amoxicillin. Four patients (17%) declined further testing with a PEN-FAST score > 2 due to a clear history of acute immunoglobulin (Ig) E-mediated reaction to a penicillin product within the past year. One patient (4%) was unable to be tested due to ongoing OAH use and 1 patient (4%) declined further penicillin testing after the discussion about risks, benefits, and alternatives to the procedures offered.  

Of the 24 patients who arrived for a clinic appointment, 17 (71%) underwent penicillin allergy delabeling testing: 14 (82%) underwent direct challenge, and 3 (18%) underwent the skin testing before oral amoxicillin challenge procedure. Of the 17 who were tested, 16 (94%) tolerated a total dose of 500 mg of oral amoxicillin within the 1-hour observation period. One tested patient (6%) in the direct oral challenge group experienced an adverse reaction that was described as dull headache and hand tremor after the 50-mg dose; although it self-resolved within 15 minutes, this prompted the patient to discontinue the challenge. This adverse reaction was determined to be very unlikely IgE-mediated. None of the 3 patients who underwent the skin testing before oral challenge protocol experienced an adverse drug reaction (ADR). None of the 17 patients who received any oral amoxicillin required follow-up or reported a delayed cutaneous ADR to the challenge. No OAHs or epinephrine were used for any of the challenges. 

Data collected from patient questionnaires displayed perceived health impacts of a penicillin allergy on the patient population. Patients reported a variety of ADRs to previous administration of penicillin products: 17 (71%) reported urticaria, 2 (8%) reported anaphylaxis, and 3 (13%) were unable to recall the reaction (Figure 2). Nine patients (38%) felt their initial reaction was distressing. Fifteen patients (88%) felt relief following negative testing (Table).

Discussion

To our knowledge, this was the first documented proactive penicillin delabeling QI project in a military clinic treating both active-duty service members and their dependents, modeled on the 2022 drug allergy guidelines.¹⁴ Several interesting lessons were learned that may improve future similar QI projects. Only 46% of patients identified as having penicillin allergy presented for evaluation, leaving 42% of available appointments unused. Without prior data on anticipated participation rates, these data provide a crude benchmark for utilization rates, which can inform future resource planning. While attempts were made to contact each patient, additional efforts to publicize the penicillin allergy delabeling campaign would have been useful to improve efficiency.

In addition, when patients with a PEN-FAST score of < 3 were educated about the risks and benefits of each procedure and offered the direct oral graded challenge and skin testing prior to oral challenge, 82% preferred the direct challenge. None of the patients who experienced a penicillin ADR in the past year wished to undergo skin testing or oral challenge, though each was educated on penicillin allergy and the possibility of testing in the future, making each encounter beneficial. Of the 17 patients tested, 16 (94%) tolerated oral amoxicillin and 1 (6%) experienced a mild, self-resolving ADR that was very unlikely of an IgE-mediated origin. Additionally, while plans and preparations for ADRs to the challenges were available, none were required. Patient questionnaires demonstrated the heterogeneity of previous ADRs and their attitude toward their allergy diagnosis. The positive impact of delabeling on patient well-being noted by 88% of patients reinforced the benefit of the effort.  

This project was limited by a relatively small sample size, which may not have been large enough to detect ADRs, especially IgE-mediated allergic reactions. Herein lies the importance of having clinicians equipped to treat allergic ADRs to conduct penicillin challenges in the primary care setting. It is prudent to ensure not only proper training of physicians performing these challenges, but also appropriate equipment, medication, and response personnel. Medications that are useful include epinephrine, OAHs, albuterol, steroids, and intravenous fluids.  

Having a response area and plan are essential to ensure appropriate care in the rare instance of allergic ADRs progressing to anaphylaxis. In rare cases, emergency medical services may be required and having a plan with appropriate response and transport time is essential to patient safety. This may not be practical in more rural or smaller practices. In those scenarios, it may be helpful to partner with a larger practice to send patients for delabeling or to use clinical space in closer proximity to emergency services. Perhaps an ideal setting might be urgent or emergent care centers due to high acuity resources and frequent prescription of amoxicillin antibiotics; however, this may be complicated by concurrent infections raising the incidence of delayed benign eruptions with amoxicillin ingestion and complicating the patient’s allergy records. Further training of urgent and emergent care practitioners would be helpful for proper patient education regarding antibiotic-associated reactions.  

Full testing integration into other primary care clinics may be limited due to the specialized training required for complete skin testing. Nevertheless, as shown in this project, most patients may be delabeled based on a PEN-FAST evaluation followed by oral challenge alone. Incorporation in other QI projects could involve continuing medical education to train staff physicians on PEN-FAST, teaching primary care residents during training, and site visits by allergists to train local physicians on testing. This project involved training 2 PCPs to conduct skin and oral challenge testing using PEN-FAST to guide clinical decision-making with an allergist available for consultation if needed. Future projects might model a similar approach or perhaps focus on training more physicians on oral challenges alone to reach a high percentage of the target population.

Conclusions

This project demonstrates a safe, efficient, and cost-effective model for penicillin allergy delabeling in clinics without regular access to allergy services. The use of PEN-FAST allows a quick and simple method to screen patients with penicillin allergy to meet the goals of the 2022 CBSs, but data are still accumulating to validate this method of screening across populations. This project demonstrates additional support for the use of PEN-FAST, while illustrating appropriate education regarding oral testing technique and its limitations.

Using an EHR report limited the patients in the testing pool and subsequent sample size. This suggests that a primary care identification-driven enrollment in testing may offer even more benefit both in allergy detection and education of testing benefits. Oral challenges are more cost effective, shorter in duration, and have fewer training requirements when compared with antecedent skin testing, making them an ideal option for PCPs in a clinic setting. Trained PCPs may opt to offer periodic appointments for delabeling, or offer days dedicated to delabeling as many patients as possible. Penicillin delabeling is an urgent and expansive charge; this study offers a replicable model for executing this important task.

Penicillin allergy is common in the United States. About 9.0% to 13.8% of patients have a diagnosed penicillin allergy documented in their electronic health record. The annual incidence rates is 1.1% in males and 1.4% in females.^1,2

Penicillin hypersensitivity likely wanes over time. A 1981 study found that 93% of patients who experienced an allergic reaction to penicillin had a positive skin test 7 to 12 months postreaction, but only 22% still had a positive test after 10 years.³ Confirmed type 1 hypersensitivity penicillin allergies, as demonstrated by positive skin prick testing, also are decreasing over time.⁴ Furthermore, many patients’ reactions may have been misdiagnosed as a penicillin allergy. Upon actual confirmatory testing of penicillin allergy, only 8.5% to 13.8% of patients believed to have a penicillin allergy were positive on skin prick testing of penicillin products.^5,6 A 2024 US study found that 11% of individuals with a history of a penicillin reaction tested positive on skin testing.⁷ 

The positive predictive value of penicillin allergy skin testing is poorly defined due to the ethical dilemma of orally challenging a patient who demonstrates skin test reactivity. Due to its high negative predictive value (NPV), skin prick combined with intradermal testing has been the gold-standard test in cases of clinical concern.⁶ Patients with positive skin testing are assumed to be truly positive, and therefore penicillin allergic, even though false-positive results to penicillin skin testing are known to occur.⁸ 

Misdiagnosis of penicillin allergy carries substantial clinical and economic consequences. A 2011 study suggested a statistically significant 1.8% increased absolute risk of mortality and 5.5% increased absolute risk of intensive care unit admission for those labeled with penicillin allergy and admitted for an infection.⁹ Another study found a 14% increase in mortality associated with the diagnosis of penicillin allergy.¹⁰ In a 2014 case-control study, penicillin allergy also was associated with a 23.4% greater risk of Clostridioides difficile, 14.1% more methicillin-resistant Staphylococcus aureus, and 30.1% more vancomycin-resistant enterococci infections.¹¹Direct cost savings during an inpatient admission for infection were as much as $609 per patient with additional indirect cost savings of up to $4254 per admission.¹² When viewed from the perspective of a health care system, these costs quickly accumulate, negatively impacting the fiscal stability of our patients and placing additional financial strain on an over-burdened system. 

If 10% of US patients have penicillin allergy labels, then about 33 million patients might be eligible for delabeling. There are only 6309 board-certified allergists actively practicing in the US, which could amount to about 5231 potential penicillin challenges per allergist, not even including the 3.3 million new patients per year (assuming a 1% incidence).¹³ Clarifying each patient’s tolerance of penicillin products will clearly require nonallergist cooperation.  

The 2022 drug allergy practice parameter update recommends several consensus-based statements (CBSs) to directly address penicillin allergy.¹⁴ This guideline recommends proactive efforts to delabel patients with a reported penicillin allergy (CBS 4); advise against testing in cases where the history is inconsistent with a true allergic reaction, though a challenge may be offered (CBS 5); skin testing for those with a history of anaphylaxis or a recent reaction (CBS 6); advise against multiple-day penicillin challenges (CBS 7); advise against skin testing for pediatric patients with benign cutaneous reactions (CBS 8); and recommends direct oral challenge for adults with distant or benign cutaneous reactions (CBS 9). These recommendations create a potentially high demand for delabeling with allergy specialists. One potential solution is to perform direct oral challenges in primary care, emergency departments, and urgent care clinics.  

Evidence supporting the safety of direct oral penicillin challenges in low-risk patients was initially noted in the allergy community, but now evidence for their use in primary care clinics is growing—including in children.¹⁵ In a military-specific population, an amoxicillin challenge of Marine recruits with suspected penicillin allergy revealed that only 1.5% of those challenged acutely reacted and should be considered allergic to penicillin.¹⁶ Historically, in order to refute the diagnosis of penicillin allergy, an allergist would order penicillin skin prick testing. If the test was negative, an allergist would proceed to intradermal testing and if negative again (NPV of 97.9%), proceed to a graded oral challenge.⁶ However, this process is not fully reproducible in most clinics because the minor determinants mixture used in skin testing is not commercially available.¹⁷ Additionally, the full skin testing procedure requires specialized training, is more time-consuming, causes more discomfort, lacks US Food and Drug Administration approval for children, and has a higher cost ($220 per test for each patient as of 2016).¹⁸ As such, the movement toward direct oral challenges is progressing. Nonetheless, the best method for primary care or emergency department clinicians to determine who the appropriate patients are for this procedure has not been fully established. Risk tools have been created in the past to help delineate low-risk patients who would be appropriate for direct oral amoxicillin challenges, but these were not widely replicated or validated.¹⁹ The PEN-FAST standardized risk score was first published in 2020 and has since been validated in different groups with additional safety data. This scoring system ranges from 0 to 5 points, assigning 2 points for a penicillin reaction within the past five (F) years, 2 points for angioedema/anaphylaxis (A) or a severe (S) cutaneous reaction, and 1 point if treatment (T) was required for the reaction. A score < 3 is considered low-risk and safe for direct oral challenge, although most of the safety data are in patients with a score of 0 or 1.²⁰ The PEN-FAST guided direct oral challenge with an NPV of 96.3% has now been prospectively shown to be noninferior to standard skin prick test/intradermal test/graded challenge for low-risk patients with a PEN-FAST score < 3.²¹ The PEN-FAST validating study was conducted predominantly with an Australian population of adult White women, but now it also has been validated in children aged > 12 years, as well as in European and North American cohorts.^22-24

Air Force Delabeling Program

This article describes a method for proactively, safely, and efficiently delabeling penicillin allergic patients at an Air Force clinic. This quality improvement (QI) report provides a successful model for penicillin allergy delabeling, illustrates lessons learned, and suggests next steps toward improving patient options for an invaluable antibiotic class.

The first step was to proactively delabel penicillin allergy from a population of active duty service members and their dependents. Electronic health record (EHR) allergy search functions are a helpful tool in finding patients with allergy labels. The Kadena Medical Clinic, in Okinawa, Japan, uses the Military Health System GENESIS EHR, which includes a discern reporting portal with a patient allergy search that creates a patient-specific medication allergy report. To compile the most complete database of patients with a penicillin allergy, all 15 potential allergy search options for “penicillin” were selected, as were 4 relevant options for amoxicillin (including options with clavulanate). Including so many options for specific penicillin medication allergies helps add specificity to the diagnosis in the EHR but can make aggregation of data more difficult. The report allowed all these specific medications to be selected at once for a particular clinic. However, the report did not populate patients with the allergy listed in other fields or free text.  

The complete compiled list was manually reviewed for high-risk patients with severe cutaneous adverse reactions (SCARs) of any age. Patients with pregnancy, unsuitable medical histories (ie, severe asthma), or taking β-blockers were excluded. Patients remaining on the list were contacted by telephone and offered appointments during a single week that was dedicated to penicillin allergy delabeling. Allergists in the Air Force are assigned to a region where they offer allergy services at clinics without a regular allergist. The allergist for the region traveled to the QI site for a 1-week campaign at an estimated cost of $4600. When the patients were contacted, they were briefly informed of the goal of the penicillin delabeling campaign, and if interested, they were scheduled for 1 of 50 available appointments that week. Patients were contacted with enough lead time to stop oral antihistamines (OAH) for ≥ 7 days before the appointment.  

Patients were given an intake questionnaire and interviewed about their penicillin allergy history. This questionnaire inquired about the nature of the allergy, mental and physical health impacts of the allergy label, PEN-FAST scoring questions, and posttest attitude toward delabeling, if applicable. Patients with a PEN-FAST score < 3 were offered direct, graded oral challenge or the standard skin prick, followed by intradermal, followed by graded oral challenge protocol. Patients with PEN-FAST scores of ≥ 3 were offered skin testing prior to oral challenge protocol. Patients could decline further testing. If patients wished to proceed, they were asked to complete a written informed consent document.  

Oral challenges followed a 10%/90% protocol, beginning with 50 mg of liquid amoxicillin followed by 450 mg after 15 minutes, as long as the patient remained asymptomatic. Challenge forms are available in the eAppendix . After receiving the 450-mg amoxicillin dose, the patient remained in the clinic for 60 minutes before a final clinical evaluation. If the patient remained asymptomatic after this period, the penicillin or amoxicillin allergy was marked as resolved in the EHR. The patients were given contact information for the clinic for follow-up if a delayed reaction was noted and they wished the medication allergy to be re-entered. An EHR encounter note was created for each patient detailing the allergy testing and delabeling.  

This campaign was conducted at a basic life support-only facility by a single clinician without medical technician support. An allergic reaction medication kit was available and contained OAHs, intramuscular antihistamines, intramuscular epinephrine, intramuscular corticosteroids, and short-acting β-agonists for nebulization. The facility also had an urgent care room (staffed by primary care practitioners [PCPs]) that could help establish intravenous access and administer fluids if necessary and had previously established plans for emergency patient transport to a higher level of care, if necessary.

Program Outcomes

A list of 65 patients that included both active-duty service members and dependents with penicillin or amoxicillin allergy was created. This list was reviewed by an allergist to identify high-risk individuals, which required about 90 minutes. Two patients (3%) were excluded; 1 had a history of SCAR to penicillin and 1 had a complex medical history requiring continued OAH use. Sixty-three patients were contacted via telephone, and 29 patients (46%) scheduled an appointment. One patient (2%) was identified as penicillin-tolerant during the booking process, and the penicillin allergy was removed without testing (Figure 1).

Of the 29 scheduled patients, 5 patients (17%) failed to present for care. Of the potential appointments set aside for the program, only 42% were used. One patient (4%) who was seen in clinic was delabeled based on history alone as they had previously successfully tolerated a course of amoxicillin. Four patients (17%) declined further testing with a PEN-FAST score > 2 due to a clear history of acute immunoglobulin (Ig) E-mediated reaction to a penicillin product within the past year. One patient (4%) was unable to be tested due to ongoing OAH use and 1 patient (4%) declined further penicillin testing after the discussion about risks, benefits, and alternatives to the procedures offered.  

Of the 24 patients who arrived for a clinic appointment, 17 (71%) underwent penicillin allergy delabeling testing: 14 (82%) underwent direct challenge, and 3 (18%) underwent the skin testing before oral amoxicillin challenge procedure. Of the 17 who were tested, 16 (94%) tolerated a total dose of 500 mg of oral amoxicillin within the 1-hour observation period. One tested patient (6%) in the direct oral challenge group experienced an adverse reaction that was described as dull headache and hand tremor after the 50-mg dose; although it self-resolved within 15 minutes, this prompted the patient to discontinue the challenge. This adverse reaction was determined to be very unlikely IgE-mediated. None of the 3 patients who underwent the skin testing before oral challenge protocol experienced an adverse drug reaction (ADR). None of the 17 patients who received any oral amoxicillin required follow-up or reported a delayed cutaneous ADR to the challenge. No OAHs or epinephrine were used for any of the challenges. 

Data collected from patient questionnaires displayed perceived health impacts of a penicillin allergy on the patient population. Patients reported a variety of ADRs to previous administration of penicillin products: 17 (71%) reported urticaria, 2 (8%) reported anaphylaxis, and 3 (13%) were unable to recall the reaction (Figure 2). Nine patients (38%) felt their initial reaction was distressing. Fifteen patients (88%) felt relief following negative testing (Table).

Discussion

To our knowledge, this was the first documented proactive penicillin delabeling QI project in a military clinic treating both active-duty service members and their dependents, modeled on the 2022 drug allergy guidelines.¹⁴ Several interesting lessons were learned that may improve future similar QI projects. Only 46% of patients identified as having penicillin allergy presented for evaluation, leaving 42% of available appointments unused. Without prior data on anticipated participation rates, these data provide a crude benchmark for utilization rates, which can inform future resource planning. While attempts were made to contact each patient, additional efforts to publicize the penicillin allergy delabeling campaign would have been useful to improve efficiency.

In addition, when patients with a PEN-FAST score of < 3 were educated about the risks and benefits of each procedure and offered the direct oral graded challenge and skin testing prior to oral challenge, 82% preferred the direct challenge. None of the patients who experienced a penicillin ADR in the past year wished to undergo skin testing or oral challenge, though each was educated on penicillin allergy and the possibility of testing in the future, making each encounter beneficial. Of the 17 patients tested, 16 (94%) tolerated oral amoxicillin and 1 (6%) experienced a mild, self-resolving ADR that was very unlikely of an IgE-mediated origin. Additionally, while plans and preparations for ADRs to the challenges were available, none were required. Patient questionnaires demonstrated the heterogeneity of previous ADRs and their attitude toward their allergy diagnosis. The positive impact of delabeling on patient well-being noted by 88% of patients reinforced the benefit of the effort.  

This project was limited by a relatively small sample size, which may not have been large enough to detect ADRs, especially IgE-mediated allergic reactions. Herein lies the importance of having clinicians equipped to treat allergic ADRs to conduct penicillin challenges in the primary care setting. It is prudent to ensure not only proper training of physicians performing these challenges, but also appropriate equipment, medication, and response personnel. Medications that are useful include epinephrine, OAHs, albuterol, steroids, and intravenous fluids.  

Having a response area and plan are essential to ensure appropriate care in the rare instance of allergic ADRs progressing to anaphylaxis. In rare cases, emergency medical services may be required and having a plan with appropriate response and transport time is essential to patient safety. This may not be practical in more rural or smaller practices. In those scenarios, it may be helpful to partner with a larger practice to send patients for delabeling or to use clinical space in closer proximity to emergency services. Perhaps an ideal setting might be urgent or emergent care centers due to high acuity resources and frequent prescription of amoxicillin antibiotics; however, this may be complicated by concurrent infections raising the incidence of delayed benign eruptions with amoxicillin ingestion and complicating the patient’s allergy records. Further training of urgent and emergent care practitioners would be helpful for proper patient education regarding antibiotic-associated reactions.  

Full testing integration into other primary care clinics may be limited due to the specialized training required for complete skin testing. Nevertheless, as shown in this project, most patients may be delabeled based on a PEN-FAST evaluation followed by oral challenge alone. Incorporation in other QI projects could involve continuing medical education to train staff physicians on PEN-FAST, teaching primary care residents during training, and site visits by allergists to train local physicians on testing. This project involved training 2 PCPs to conduct skin and oral challenge testing using PEN-FAST to guide clinical decision-making with an allergist available for consultation if needed. Future projects might model a similar approach or perhaps focus on training more physicians on oral challenges alone to reach a high percentage of the target population.

Conclusions

This project demonstrates a safe, efficient, and cost-effective model for penicillin allergy delabeling in clinics without regular access to allergy services. The use of PEN-FAST allows a quick and simple method to screen patients with penicillin allergy to meet the goals of the 2022 CBSs, but data are still accumulating to validate this method of screening across populations. This project demonstrates additional support for the use of PEN-FAST, while illustrating appropriate education regarding oral testing technique and its limitations.

Using an EHR report limited the patients in the testing pool and subsequent sample size. This suggests that a primary care identification-driven enrollment in testing may offer even more benefit both in allergy detection and education of testing benefits. Oral challenges are more cost effective, shorter in duration, and have fewer training requirements when compared with antecedent skin testing, making them an ideal option for PCPs in a clinic setting. Trained PCPs may opt to offer periodic appointments for delabeling, or offer days dedicated to delabeling as many patients as possible. Penicillin delabeling is an urgent and expansive charge; this study offers a replicable model for executing this important task.

Penicillin allergy is common in the United States. About 9.0% to 13.8% of patients have a diagnosed penicillin allergy documented in their electronic health record. The annual incidence rates is 1.1% in males and 1.4% in females.^1,2

Penicillin hypersensitivity likely wanes over time. A 1981 study found that 93% of patients who experienced an allergic reaction to penicillin had a positive skin test 7 to 12 months postreaction, but only 22% still had a positive test after 10 years.³ Confirmed type 1 hypersensitivity penicillin allergies, as demonstrated by positive skin prick testing, also are decreasing over time.⁴ Furthermore, many patients’ reactions may have been misdiagnosed as a penicillin allergy. Upon actual confirmatory testing of penicillin allergy, only 8.5% to 13.8% of patients believed to have a penicillin allergy were positive on skin prick testing of penicillin products.^5,6 A 2024 US study found that 11% of individuals with a history of a penicillin reaction tested positive on skin testing.⁷ 

The positive predictive value of penicillin allergy skin testing is poorly defined due to the ethical dilemma of orally challenging a patient who demonstrates skin test reactivity. Due to its high negative predictive value (NPV), skin prick combined with intradermal testing has been the gold-standard test in cases of clinical concern.⁶ Patients with positive skin testing are assumed to be truly positive, and therefore penicillin allergic, even though false-positive results to penicillin skin testing are known to occur.⁸ 

Misdiagnosis of penicillin allergy carries substantial clinical and economic consequences. A 2011 study suggested a statistically significant 1.8% increased absolute risk of mortality and 5.5% increased absolute risk of intensive care unit admission for those labeled with penicillin allergy and admitted for an infection.⁹ Another study found a 14% increase in mortality associated with the diagnosis of penicillin allergy.¹⁰ In a 2014 case-control study, penicillin allergy also was associated with a 23.4% greater risk of Clostridioides difficile, 14.1% more methicillin-resistant Staphylococcus aureus, and 30.1% more vancomycin-resistant enterococci infections.¹¹Direct cost savings during an inpatient admission for infection were as much as $609 per patient with additional indirect cost savings of up to $4254 per admission.¹² When viewed from the perspective of a health care system, these costs quickly accumulate, negatively impacting the fiscal stability of our patients and placing additional financial strain on an over-burdened system. 

If 10% of US patients have penicillin allergy labels, then about 33 million patients might be eligible for delabeling. There are only 6309 board-certified allergists actively practicing in the US, which could amount to about 5231 potential penicillin challenges per allergist, not even including the 3.3 million new patients per year (assuming a 1% incidence).¹³ Clarifying each patient’s tolerance of penicillin products will clearly require nonallergist cooperation.  

The 2022 drug allergy practice parameter update recommends several consensus-based statements (CBSs) to directly address penicillin allergy.¹⁴ This guideline recommends proactive efforts to delabel patients with a reported penicillin allergy (CBS 4); advise against testing in cases where the history is inconsistent with a true allergic reaction, though a challenge may be offered (CBS 5); skin testing for those with a history of anaphylaxis or a recent reaction (CBS 6); advise against multiple-day penicillin challenges (CBS 7); advise against skin testing for pediatric patients with benign cutaneous reactions (CBS 8); and recommends direct oral challenge for adults with distant or benign cutaneous reactions (CBS 9). These recommendations create a potentially high demand for delabeling with allergy specialists. One potential solution is to perform direct oral challenges in primary care, emergency departments, and urgent care clinics.  

Evidence supporting the safety of direct oral penicillin challenges in low-risk patients was initially noted in the allergy community, but now evidence for their use in primary care clinics is growing—including in children.¹⁵ In a military-specific population, an amoxicillin challenge of Marine recruits with suspected penicillin allergy revealed that only 1.5% of those challenged acutely reacted and should be considered allergic to penicillin.¹⁶ Historically, in order to refute the diagnosis of penicillin allergy, an allergist would order penicillin skin prick testing. If the test was negative, an allergist would proceed to intradermal testing and if negative again (NPV of 97.9%), proceed to a graded oral challenge.⁶ However, this process is not fully reproducible in most clinics because the minor determinants mixture used in skin testing is not commercially available.¹⁷ Additionally, the full skin testing procedure requires specialized training, is more time-consuming, causes more discomfort, lacks US Food and Drug Administration approval for children, and has a higher cost ($220 per test for each patient as of 2016).¹⁸ As such, the movement toward direct oral challenges is progressing. Nonetheless, the best method for primary care or emergency department clinicians to determine who the appropriate patients are for this procedure has not been fully established. Risk tools have been created in the past to help delineate low-risk patients who would be appropriate for direct oral amoxicillin challenges, but these were not widely replicated or validated.¹⁹ The PEN-FAST standardized risk score was first published in 2020 and has since been validated in different groups with additional safety data. This scoring system ranges from 0 to 5 points, assigning 2 points for a penicillin reaction within the past five (F) years, 2 points for angioedema/anaphylaxis (A) or a severe (S) cutaneous reaction, and 1 point if treatment (T) was required for the reaction. A score < 3 is considered low-risk and safe for direct oral challenge, although most of the safety data are in patients with a score of 0 or 1.²⁰ The PEN-FAST guided direct oral challenge with an NPV of 96.3% has now been prospectively shown to be noninferior to standard skin prick test/intradermal test/graded challenge for low-risk patients with a PEN-FAST score < 3.²¹ The PEN-FAST validating study was conducted predominantly with an Australian population of adult White women, but now it also has been validated in children aged > 12 years, as well as in European and North American cohorts.^22-24

Air Force Delabeling Program

This article describes a method for proactively, safely, and efficiently delabeling penicillin allergic patients at an Air Force clinic. This quality improvement (QI) report provides a successful model for penicillin allergy delabeling, illustrates lessons learned, and suggests next steps toward improving patient options for an invaluable antibiotic class.

The first step was to proactively delabel penicillin allergy from a population of active duty service members and their dependents. Electronic health record (EHR) allergy search functions are a helpful tool in finding patients with allergy labels. The Kadena Medical Clinic, in Okinawa, Japan, uses the Military Health System GENESIS EHR, which includes a discern reporting portal with a patient allergy search that creates a patient-specific medication allergy report. To compile the most complete database of patients with a penicillin allergy, all 15 potential allergy search options for “penicillin” were selected, as were 4 relevant options for amoxicillin (including options with clavulanate). Including so many options for specific penicillin medication allergies helps add specificity to the diagnosis in the EHR but can make aggregation of data more difficult. The report allowed all these specific medications to be selected at once for a particular clinic. However, the report did not populate patients with the allergy listed in other fields or free text.  

The complete compiled list was manually reviewed for high-risk patients with severe cutaneous adverse reactions (SCARs) of any age. Patients with pregnancy, unsuitable medical histories (ie, severe asthma), or taking β-blockers were excluded. Patients remaining on the list were contacted by telephone and offered appointments during a single week that was dedicated to penicillin allergy delabeling. Allergists in the Air Force are assigned to a region where they offer allergy services at clinics without a regular allergist. The allergist for the region traveled to the QI site for a 1-week campaign at an estimated cost of $4600. When the patients were contacted, they were briefly informed of the goal of the penicillin delabeling campaign, and if interested, they were scheduled for 1 of 50 available appointments that week. Patients were contacted with enough lead time to stop oral antihistamines (OAH) for ≥ 7 days before the appointment.  

Patients were given an intake questionnaire and interviewed about their penicillin allergy history. This questionnaire inquired about the nature of the allergy, mental and physical health impacts of the allergy label, PEN-FAST scoring questions, and posttest attitude toward delabeling, if applicable. Patients with a PEN-FAST score < 3 were offered direct, graded oral challenge or the standard skin prick, followed by intradermal, followed by graded oral challenge protocol. Patients with PEN-FAST scores of ≥ 3 were offered skin testing prior to oral challenge protocol. Patients could decline further testing. If patients wished to proceed, they were asked to complete a written informed consent document.  

Oral challenges followed a 10%/90% protocol, beginning with 50 mg of liquid amoxicillin followed by 450 mg after 15 minutes, as long as the patient remained asymptomatic. Challenge forms are available in the eAppendix . After receiving the 450-mg amoxicillin dose, the patient remained in the clinic for 60 minutes before a final clinical evaluation. If the patient remained asymptomatic after this period, the penicillin or amoxicillin allergy was marked as resolved in the EHR. The patients were given contact information for the clinic for follow-up if a delayed reaction was noted and they wished the medication allergy to be re-entered. An EHR encounter note was created for each patient detailing the allergy testing and delabeling.  

This campaign was conducted at a basic life support-only facility by a single clinician without medical technician support. An allergic reaction medication kit was available and contained OAHs, intramuscular antihistamines, intramuscular epinephrine, intramuscular corticosteroids, and short-acting β-agonists for nebulization. The facility also had an urgent care room (staffed by primary care practitioners [PCPs]) that could help establish intravenous access and administer fluids if necessary and had previously established plans for emergency patient transport to a higher level of care, if necessary.

Program Outcomes

A list of 65 patients that included both active-duty service members and dependents with penicillin or amoxicillin allergy was created. This list was reviewed by an allergist to identify high-risk individuals, which required about 90 minutes. Two patients (3%) were excluded; 1 had a history of SCAR to penicillin and 1 had a complex medical history requiring continued OAH use. Sixty-three patients were contacted via telephone, and 29 patients (46%) scheduled an appointment. One patient (2%) was identified as penicillin-tolerant during the booking process, and the penicillin allergy was removed without testing (Figure 1).

Of the 29 scheduled patients, 5 patients (17%) failed to present for care. Of the potential appointments set aside for the program, only 42% were used. One patient (4%) who was seen in clinic was delabeled based on history alone as they had previously successfully tolerated a course of amoxicillin. Four patients (17%) declined further testing with a PEN-FAST score > 2 due to a clear history of acute immunoglobulin (Ig) E-mediated reaction to a penicillin product within the past year. One patient (4%) was unable to be tested due to ongoing OAH use and 1 patient (4%) declined further penicillin testing after the discussion about risks, benefits, and alternatives to the procedures offered.  

Of the 24 patients who arrived for a clinic appointment, 17 (71%) underwent penicillin allergy delabeling testing: 14 (82%) underwent direct challenge, and 3 (18%) underwent the skin testing before oral amoxicillin challenge procedure. Of the 17 who were tested, 16 (94%) tolerated a total dose of 500 mg of oral amoxicillin within the 1-hour observation period. One tested patient (6%) in the direct oral challenge group experienced an adverse reaction that was described as dull headache and hand tremor after the 50-mg dose; although it self-resolved within 15 minutes, this prompted the patient to discontinue the challenge. This adverse reaction was determined to be very unlikely IgE-mediated. None of the 3 patients who underwent the skin testing before oral challenge protocol experienced an adverse drug reaction (ADR). None of the 17 patients who received any oral amoxicillin required follow-up or reported a delayed cutaneous ADR to the challenge. No OAHs or epinephrine were used for any of the challenges. 

Data collected from patient questionnaires displayed perceived health impacts of a penicillin allergy on the patient population. Patients reported a variety of ADRs to previous administration of penicillin products: 17 (71%) reported urticaria, 2 (8%) reported anaphylaxis, and 3 (13%) were unable to recall the reaction (Figure 2). Nine patients (38%) felt their initial reaction was distressing. Fifteen patients (88%) felt relief following negative testing (Table).

Discussion

To our knowledge, this was the first documented proactive penicillin delabeling QI project in a military clinic treating both active-duty service members and their dependents, modeled on the 2022 drug allergy guidelines.¹⁴ Several interesting lessons were learned that may improve future similar QI projects. Only 46% of patients identified as having penicillin allergy presented for evaluation, leaving 42% of available appointments unused. Without prior data on anticipated participation rates, these data provide a crude benchmark for utilization rates, which can inform future resource planning. While attempts were made to contact each patient, additional efforts to publicize the penicillin allergy delabeling campaign would have been useful to improve efficiency.

In addition, when patients with a PEN-FAST score of < 3 were educated about the risks and benefits of each procedure and offered the direct oral graded challenge and skin testing prior to oral challenge, 82% preferred the direct challenge. None of the patients who experienced a penicillin ADR in the past year wished to undergo skin testing or oral challenge, though each was educated on penicillin allergy and the possibility of testing in the future, making each encounter beneficial. Of the 17 patients tested, 16 (94%) tolerated oral amoxicillin and 1 (6%) experienced a mild, self-resolving ADR that was very unlikely of an IgE-mediated origin. Additionally, while plans and preparations for ADRs to the challenges were available, none were required. Patient questionnaires demonstrated the heterogeneity of previous ADRs and their attitude toward their allergy diagnosis. The positive impact of delabeling on patient well-being noted by 88% of patients reinforced the benefit of the effort.  

This project was limited by a relatively small sample size, which may not have been large enough to detect ADRs, especially IgE-mediated allergic reactions. Herein lies the importance of having clinicians equipped to treat allergic ADRs to conduct penicillin challenges in the primary care setting. It is prudent to ensure not only proper training of physicians performing these challenges, but also appropriate equipment, medication, and response personnel. Medications that are useful include epinephrine, OAHs, albuterol, steroids, and intravenous fluids.  

Having a response area and plan are essential to ensure appropriate care in the rare instance of allergic ADRs progressing to anaphylaxis. In rare cases, emergency medical services may be required and having a plan with appropriate response and transport time is essential to patient safety. This may not be practical in more rural or smaller practices. In those scenarios, it may be helpful to partner with a larger practice to send patients for delabeling or to use clinical space in closer proximity to emergency services. Perhaps an ideal setting might be urgent or emergent care centers due to high acuity resources and frequent prescription of amoxicillin antibiotics; however, this may be complicated by concurrent infections raising the incidence of delayed benign eruptions with amoxicillin ingestion and complicating the patient’s allergy records. Further training of urgent and emergent care practitioners would be helpful for proper patient education regarding antibiotic-associated reactions.  

Full testing integration into other primary care clinics may be limited due to the specialized training required for complete skin testing. Nevertheless, as shown in this project, most patients may be delabeled based on a PEN-FAST evaluation followed by oral challenge alone. Incorporation in other QI projects could involve continuing medical education to train staff physicians on PEN-FAST, teaching primary care residents during training, and site visits by allergists to train local physicians on testing. This project involved training 2 PCPs to conduct skin and oral challenge testing using PEN-FAST to guide clinical decision-making with an allergist available for consultation if needed. Future projects might model a similar approach or perhaps focus on training more physicians on oral challenges alone to reach a high percentage of the target population.

Conclusions

This project demonstrates a safe, efficient, and cost-effective model for penicillin allergy delabeling in clinics without regular access to allergy services. The use of PEN-FAST allows a quick and simple method to screen patients with penicillin allergy to meet the goals of the 2022 CBSs, but data are still accumulating to validate this method of screening across populations. This project demonstrates additional support for the use of PEN-FAST, while illustrating appropriate education regarding oral testing technique and its limitations.

Using an EHR report limited the patients in the testing pool and subsequent sample size. This suggests that a primary care identification-driven enrollment in testing may offer even more benefit both in allergy detection and education of testing benefits. Oral challenges are more cost effective, shorter in duration, and have fewer training requirements when compared with antecedent skin testing, making them an ideal option for PCPs in a clinic setting. Trained PCPs may opt to offer periodic appointments for delabeling, or offer days dedicated to delabeling as many patients as possible. Penicillin delabeling is an urgent and expansive charge; this study offers a replicable model for executing this important task.

Veterans experiencing homelessness are at an elevated risk for adverse health outcomes, including suicide. This population also experiences chronic health conditions (eg, cardiovascular disease and sexually transmitted infections) and psychiatric conditions (eg, substance use disorders and posttraumatic stress disorder) with a greater propensity than veterans without history of homelessness.^1,2 Similarly, veterans experiencing homelessness often report concurrent stressors, such as justice involvement and unemployment, which further impact social functioning.³

The US Department of Veterans Affairs (VA) offers a range of health and social services to veterans experiencing homelessness. These programs are designed to respond to the multifactorial challenges faced by this population and are aimed at achieving sustained, permanent housing.⁴ To facilitate this effort, these programs provide targeted and tailored health (eg, primary care) and social (eg, case management and vocational rehabilitation) services to address barriers to housing stability (eg, substance use, serious mental illness, interacting with the criminal legal system, and unemployment).

Despite the availability of these programs, engaging veterans in VA services—whether in general or tailored for those experiencing or at risk for homelessness—remains challenging. Many veterans at risk for or experiencing homelessness overuse service settings that provide immediate care, such as urgent care or emergency departments (EDs).^5,6 These individuals often visit an ED to augment or complement medical care they received in an outpatient setting, which can result in an elevated health care burden as well as impacted provision of treatment, especially surrounding care for chronic conditions (eg, cardiovascular health or serious mental illness).^7-9

VA EDs offer urgent care and emergency services and often serve as a point of entry for veterans experiencing homelessness.¹⁰ They offer veterans expedient access to care that can address immediate needs (eg, substance use withdrawal, pain management, and suicide risk). EDs may be easier to access given they have longer hours of operation and patients can present without a scheduled appointment. VA EDs are an important point to identify homelessness and connect individuals to social service resources and outpatient health care referrals (eg, primary care and mental health).^4,11

Some clinicians experience uncertainty in navigating or providing care for veterans experiencing or at risk for homelessness. A qualitative study conducted outside the VA found many clinicians did not know how to approach clinical conversations among unstably housed individuals, particularly when they discussed how to manage care for complex health conditions in the context of ongoing case management challenges, such as discharge planning.12 Another study found that clinicians working with individuals experiencing homelessness may have limited prior training or experience treating these patients.¹³ As a result, these clinicians may be unaware of available social services or unknowingly have biases that negatively impact care. Research remains limited surrounding beliefs about and methods of enhancing care among VA clinicians working with veterans experiencing homelessness in the ED.

This multiphase pilot study sought to understand service delivery processes and gaps in VA ED settings. Phase 1 examined ED clinician perceptions of care, facilitators, and barriers to providing care (including suicide risk assessments) and making postdischarge outpatient referrals among VA ED clinicians who regularly work with veterans experiencing homelessness. Phase 2 used this information to develop a clinical psychoeducational resource to enhance post-ED access to care for veterans experiencing or at risk for homelessness.

QUALITATIVE INTERVIEWS

Semistructured qualitative interviews were conducted with 11 VA ED clinicians from 6 Veteran Integrated Service Networks between August 2022 and February 2023. Clinicians were eligible if they currently worked within a VA ED setting (including urgent care) and indicated that some of their patients were veterans experiencing homelessness. All health care practitioners (HCPs) participated in an interview and a postinterview self-report survey that assessed demographic and job-related characteristics. Eight HCPs identified as female and 3 identified as male. All clinicians identified as White and 3 as Hispanic or Latino. Eight clinicians were licensed clinical social workers, 2 were ED nurses, and 1 was an ED physician.

After each clinician provided informed consent, they were invited to complete a telephone or Microsoft Teams interview. All interviews were recorded and subsequently transcribed. Interviews explored clinicians’ experiences caring for veterans experiencing homelessness, with a focus on services provided within the ED, as well as mandated ED screenings such as a suicide risk assessment. Interview questions also addressed postdischarge knowledge and experiences with referrals to VA health services (eg, primary care, mental health) and social services (eg, housing programs). Interviews lasted 30 to 90 minutes.

Recruitment ended after attaining sufficient thematic data, accomplished via an information power approach to sampling. This occurred when the study aims, sample characteristics, existing theory, and depth and quality of interviews dynamically informed the decision to cease recruitment of additional participants.^14,15 Given the scope of study (examining service delivery and knowledge gaps), the specificity of the targeted sample (VA ED clinicians providing care to veterans experiencing homelessness), the level of pre-existing theoretical background informing the study aims, and depth and quality of interview dialogue, this information power approach provides justification for attaining small sample sizes. Following the interview, HCPs completed a demographic questionnaire. Participants were not compensated.

Data Analysis

Directed content analysis was used to analyze qualitative data, with the framework method employed as an analytic instrument to facilitate analysis.^16-18 Analysts engaged in bracketing and discussed reflexivity before data analysis to reflect on personal subjectivities and reduce potential bias.^19,20

A prototype coding framework was developed that enabled coders to meaningfully summarize and condense data within transcripts into varying domains, categories, or topics found within the interview guide. Domain examples included clinical backgrounds, suicide risk and assessment protocols among veterans experiencing homelessness, beliefs about service delivery for veterans experiencing homelessness, and barriers and facilitators that may impact their ability to provide post-ED discharge care. Coders discussed the findings and if there was a need to modify templates. All transcripts were double coded. Once complete, individual templates were merged into a unified Microsoft Excel sheet, which allowed for more discrete analyses, enabling analysts to examine trends across content areas within the dataset.

Clinical Resource Development

HCPs were queried regarding available outpatient resources for post-ED care (eg, printed discharge paperwork and best practice alerts or automated workflows within the electronic health record). Resources used by participants were examined, as well as which resources clinicians thought would help them care for veterans experiencing homelessness. Noted gaps were used to develop a tailored resource for clinicians who treat veterans experiencing homelessness in the ED. This resource was created with the intention it could inform all ED clinicians, with the option for personalization to align with the needs of local services, based on needed content areas identified (eg, emergency shelters and suicide prevention resources).

Resource development followed an information systems research (ISR) framework that used a 3-pronged process of identifying circumstances for how a tool is developed, the problems it aims to address, and the knowledge that informs its development, implementation, and evaluation.^21,22 Initial wireframes of the resource were provided via email to 10 subject matter experts (SMEs) in veteran suicide prevention, emergency medicine, and homeless programs. SMEs were identified via professional listservs, VA program office leadership, literature searches of similar research, and snowball sampling. Solicited feedback on the resource from the SMEs included its design, language, tone, flow, format, and content (ideation and prototyping). The feedback was collated and used to revise the resource. SMEs then reviewed and provided feedback on the revised resource. This iterative cycle (prototype review, commentary, ideation, prototype review) continued until the SMEs offered no additional edits to the resource. In total, 7 iterations of the resource were developed, critiqued, and revised.

INTERVIEW RESULTS

Compassion Fatigue

Many participants expressed concerns about compassion fatigue among VA ED clinicians. Those interviewed indicated that treating veterans experiencing homelessness sometimes led to the development of what they described as a “callus,” a “sixth sense,” or an inherent sense of “suspicion” or distrust. These feelings resulted from concerns about an individual’s secondary gain or potential hidden agenda (eg, a veteran reporting suicidal ideation to attain shelter on a cold night), with clinicians not wanting to feel as if they were taken advantage of or deceived.

Many clinicians noted that compassion fatigue resulted from witnessing the same veterans experiencing homelessness routinely use emergency services for nonemergent or nonmedical needs. Some also expressed that over time this may result in them becoming less empathetic when caring for veterans experiencing homelessness. They hypothesized that clinicians may experience burnout, which could potentially result in a lack of curiosity and concern about a veteran’s risk for suicide or need for social services. Others may “take things for granted,” leading them to discount stressors that are “very real to the patient, this person.”

Clinicians indicated that such sentiments may impact overall care. Potential negative consequences included stigmatization of veterans experiencing homelessness, incomplete or partial suicide risk screenings with this population, inattentive or impersonal care, and expedited discharge from the ED without appropriate safety planning or social service referrals. Clinicians interviewed intended to find ways to combat compassion fatigue and maintain a commitment to provide comprehensive care to all veterans, including those experiencing homelessness. They felt conflict between a lack of empathy for individuals experiencing homelessness and becoming numb to the problem due to overexposure. However, these clinicians remained committed to providing care to these veterans and fighting to maintain the purpose of recovery-focused care.

Knowledge Gaps on Available Services

While many clinicians knew of general resources available to veterans experiencing homelessness, few had detailed information on where to seek consults for other homeless programs, who to contact regarding these services, when they were available, or how to refer to them. Many reported feeling uneasy when discharging veterans experiencing homelessness from care, often being unable to provide local, comprehensive referrals to support their needs and ensure their well-being. These sentiments were compounded when the veteran reported suicidal thoughts or recent suicidal behavior; clinicians felt concerned about the methods to engage these individuals into evidence-based mental health care within the context of unstable housing arrangements.

Some clinicians appeared to lack awareness of the wide array of VA homeless programming. Most could acknowledge at least some aspects of available programming (eg, the US Department of Housing and Urban Development– VA Supportive Housing program), while others were unaware of services tailored to the needs of those experiencing homelessness (eg, homeless patient aligned care teams), or of services targeting concurrent psychosocial stressors (eg, Veterans Justice Programs). Interviewees hypothesized this as being particularly notable among clinicians who are new to the VA or those who work in VA settings as part of their graduate or medical school training. Those aware of the services were uncertain of the referral process, relying on a single social worker or nurse to connect individuals experiencing homelessness to health and social services.

Interviewed clinicians noted that suicide risk screening of veterans experiencing homelessness was only performed by a limited number of individuals within the ED. Some did not feel sufficiently trained, comfortable, or knowledgeable about how to navigate care for veterans experiencing homelessness and at risk of suicide. Clinicians described “an uncomfortableness about suicidal ideation, where people just freeze up” and “don’t know what to do and don’t know what to say.”

Lack of Tangible Resources, Trainings, and Referrals

HCPs reported occasionally lacking the necessary clinical resources and information in the ED to properly support veterans experiencing homelessness and suicidal ideation. Common concerns included case management and discharge planning, as well as navigating health factors, such as elevated suicide risk. Some HCPs felt the local resources they do have access to—discharge packets or other forms of patient information—were not always tailored for the needs (eg, transportation) or abilities of veterans experiencing homelessness. One noted: “We give them a sheet of paper with some resources, which they don’t have the skills to follow up [with] anyway.”

Many interviewees wished for additional training in working with veterans experiencing homelessness. They reported that prior training from the VA Talent Management System or through unit-based programming could assist in educating clinicians on homeless services and suicide risk assessment. When queried on what training they had received, many noted there was “no formal training on what the VA offers homeless vets,” leading many to describe it as on-the-job training. This appeared especially among newer clinicians, who reported they were reliant upon learning from other, more senior staff within the ED.

The absence of training further illustrates the issue of institutional knowledge on these services and referrals, which was often confined to a single individual or team. Not having readily accessible resources, training, or information appropriate for all skill levels and positions within the ED hindered the ability of HCPs to connect veterans experiencing homelessness with social services to ensure their health and safety postdischarge: “If we had a better knowledge base of what the VA offers and the steps to go through in order to get the veteran set up for those things, it would be helpful.”

CLINICAL RESOURCE

A psychoeducational resource was developed for HCPs treating veterans experiencing homelessness (Figure). The resource was designed to mitigate compassion fatigue and recenter attention on the VA commitment to care while emphasizing the need to be responsive to the concerns of these individuals. Initial wireframes of the resource were developed by a small group of authors in review and appraisal of qualitative findings (EP, RH). These wireframes were developed to broadly illustrate the arrangement/structure of content, range of resources to potentially include (eg, available VA homeless programs or consultation resources), and to draft initial wording and phrasing. Subject matter expert feedback refined these wireframes, providing commentary on specific programs to include or exclude, changes and alterations to the design and flow of the resource, and edits to language, word choice, and tone over numerous iterations.

Given that many ED HCPs presented concerns surrounding secondary gain in the context of suicide risk, this resource focused on suicide risk. At the top of the resource, it states “Veterans at risk for homelessness experience more than double the risk for suicide than stably housed veterans.”²³ Also at the top, the resource states: “For many, the last health care visit prior to suicide is often with VA emergency services."²⁴ The goal of these statements was to educate users on the elevated risk for suicide in veterans experiencing homelessness and their role in preventing such deaths.

Text in this section emphasizes that every veteran deserves the best care possible and recenters HCP attention on providing quality, comprehensive care regardless of housing status. The inclusion of this material was prioritized given the concerns expressed regarding compassion fatigue and suspicions of secondary gain (eg, a veteran reporting suicidal ideation to attain shelter or respite from outside conditions).

The resource also attempts to address high rates of emergency service by veterans experiencing homelessness: “Due to challenges with accessing care, Veterans experiencing homelessness may use emergency or urgent care services more frequently than other Veterans.”²⁵ The resource also indicates that VA resources are available to help homeless and at-risk veterans to acquire stable housing, employment, and engage in healthcare, which are outlined with specific contact information. Given the breadth of local and VA services, a portion of the resource is dedicated to local health and social services available for veterans experiencing homelessness. HCPs complete the first page, which is devoted to local homeless service and program resources.

Following SME consultation, the list of programs provided underwent a series of iterations. The program types listed are deemed to be of greatest benefit to veterans experiencing homelessness and most consulted by HCPs. Including VA and non-VA emergency shelters allows clinicians flexible options if a particular shelter is full, closed, or would not meet the veteran’s needs or preference (eg, lack of childcare or does not allow pets). The second column of this section is left intentionally blank; here, the HCP is to list a local point-of- contact at each program. This encourages clinical teams to seek out and make direct contact with these programs and establish (in)formal relationships with them. The HCP then completes the third column with contact information.

Once completed, the resource acts as a living document. Clinicians and SMEs consulted for this study expressed the desire to have an easily accessible resource that can be updated based on necessary changes (eg, emergency shelter address or hours of operation). The resource can be housed within each local VA emergency or urgent care service setting alongside other available clinical tools.

While local resources are the primary focus, interviewees also suggested that some HCPs are not aware of the available VA services . This material, found on the back of the resource, provides a general overview of services available through VA homeless programs. SME consultation and discussion led to selecting the 5 listed categories: housing services, health care services, case management, employment services, and justice-related programming, each with a brief description.

Information for the National Call Center for Homeless Veterans, community service hotline, and Veterans Crisis Line are included on the front page. These hotlines and phone numbers are always available for veterans experiencing homelessness, enabling them to make these connections themselves, if desired. Additionally, given the challenges noted by some HCPs in performing suicide risk screening, evaluation, and intervention, a prompt for the VA Suicide Risk Management Consultation service was also included on the back page.

Creating a Shared and Local Resource

This clinical resource was developed to establish a centralized, shared, local resource available to VA ED HCPs who lacked knowledge of available services or reported discomfort conducting suicide risk screening for veterans experiencing homelessness. In many cases, ED referrals to homeless programs and suicide prevention care was assigned to a single individual, often a nurse or social worker. As a result, an undue amount of work and strain was placed on these individuals, as this forced them to act as the sole bridge between care in the ED and postdischarge social (eg, homeless programs) and mental health (eg, suicide prevention) services. The creation of a unified, easily accessible document aimed to distribute this responsibility more equitably across ED staff.

DISCUSSION

This project intended to develop a clinician resource to support VA ED clinicians caring for veterans experiencing homelessness and their access to services postdischarge. Qualitative interviews provided insights into the burnout and compassion fatigue present in these settings, as well as the challenges and needs regarding knowledge of local and VA services. Emphasis was placed on leveraging extant resources and subject matter expertise to develop a resource capable of providing brief and informative guidance.

This resource is particularly relevant for HCPs new to the VA, including trainees and new hires, who may be less aware of VA and local social services. It has the potential to reduce the burden on VA ED staff to provide guidance and recommendations surrounding postdischarge social services. The resource acknowledges homeless programming focused on social determinants of health that can destabilize housing (eg, legal or occupational challenges). This can incentivize clinicians to discuss these programs with veterans to facilitate their ability to navigate complex health and psychosocial challenges.

HCPs interviewed for this study indicated their apprehension regarding suicide risk screening and evaluation, a process currently mandated within VA ED settings.²⁶ This may be compounded among HCPs with minimal mental health training or those who have worked in community-based settings where such screening and evaluation efforts are not required. The resource reminds clinicians of available VA consultation services, which can provide additional training, clinical guidance, and review of existing local ED processes.

While the resource was directly informed by qualitative interviews conducted with VA emergency service HCPs and developed through an iterative process with SMEs, further research is necessary to determine its effectiveness at increasing access to health and social services among veterans experiencing homelessness. The resource has not been used by HCPs working in these settings to examine uptake or sustained use, nor clinicians’ perceptions of its utility, including acceptability and feasibility; these are important next steps to understand if the resource is functioning as intended.

Compassion fatigue, as well as associated sequelae (eg, burnout, distress, and psychiatric symptoms), is well-documented among individuals working with individuals experiencing homelessness, including VA HCPs.^27-30 Such experiences are likely driven by several factors, including the clinical complexity and service needs of this veteran population. Although compassion fatigue was noted by many clinicians interviewed for this study, it is unclear if the resource alone would address factors driving compassion fatigue, or if additional programming or services may be necessary.

Limitations

The resource requires local HCPs to routinely update its content (eg, establishment of a new emergency shelter in the community or change in hours or contact information of an existing one), which may be challenging. This is especially true as it relates to community resources, which may be more likely to change than national VA programming.

This resource was initially developed following qualitative interviews with a small sample of VA HCPs (explicitly those working within ED settings) and may not be representative of all HCPs engaged in VA care with veterans experiencing homelessness. The perspectives and experiences of those interviewed do not represent the views of all VA ED HCPs and may differ from the perspectives of those in regions with unique cultural and regional considerations.³¹

Given that most of the interviewees were social workers in EDs engaged in care for veterans experiencing homelessness, these findings and informational needs may differ among other types of HCPs who provide services for veterans experiencing homelessness in other settings. Content in the resource was included based on clinician input, and may not reflect the perspectives of veterans, who may perceive some resources as more important (eg, access to primary care or dental services).²⁸

CONCLUSIONS

This project represents the culmination of qualitative interviews and SME input to develop a free-to-use clinician resource to facilitate service delivery and connection to services following discharge from VA EDs for veterans experiencing homelessness. Serving as a template, this resource can be customized to increase knowledge of local VA and community resources to support these individuals. Continued refinement and piloting of this resource to evaluate acceptability, implementation barriers, and use remains warranted.

Veterans experiencing homelessness are at an elevated risk for adverse health outcomes, including suicide. This population also experiences chronic health conditions (eg, cardiovascular disease and sexually transmitted infections) and psychiatric conditions (eg, substance use disorders and posttraumatic stress disorder) with a greater propensity than veterans without history of homelessness.^1,2 Similarly, veterans experiencing homelessness often report concurrent stressors, such as justice involvement and unemployment, which further impact social functioning.³

The US Department of Veterans Affairs (VA) offers a range of health and social services to veterans experiencing homelessness. These programs are designed to respond to the multifactorial challenges faced by this population and are aimed at achieving sustained, permanent housing.⁴ To facilitate this effort, these programs provide targeted and tailored health (eg, primary care) and social (eg, case management and vocational rehabilitation) services to address barriers to housing stability (eg, substance use, serious mental illness, interacting with the criminal legal system, and unemployment).

Despite the availability of these programs, engaging veterans in VA services—whether in general or tailored for those experiencing or at risk for homelessness—remains challenging. Many veterans at risk for or experiencing homelessness overuse service settings that provide immediate care, such as urgent care or emergency departments (EDs).^5,6 These individuals often visit an ED to augment or complement medical care they received in an outpatient setting, which can result in an elevated health care burden as well as impacted provision of treatment, especially surrounding care for chronic conditions (eg, cardiovascular health or serious mental illness).^7-9

VA EDs offer urgent care and emergency services and often serve as a point of entry for veterans experiencing homelessness.¹⁰ They offer veterans expedient access to care that can address immediate needs (eg, substance use withdrawal, pain management, and suicide risk). EDs may be easier to access given they have longer hours of operation and patients can present without a scheduled appointment. VA EDs are an important point to identify homelessness and connect individuals to social service resources and outpatient health care referrals (eg, primary care and mental health).^4,11

Some clinicians experience uncertainty in navigating or providing care for veterans experiencing or at risk for homelessness. A qualitative study conducted outside the VA found many clinicians did not know how to approach clinical conversations among unstably housed individuals, particularly when they discussed how to manage care for complex health conditions in the context of ongoing case management challenges, such as discharge planning.12 Another study found that clinicians working with individuals experiencing homelessness may have limited prior training or experience treating these patients.¹³ As a result, these clinicians may be unaware of available social services or unknowingly have biases that negatively impact care. Research remains limited surrounding beliefs about and methods of enhancing care among VA clinicians working with veterans experiencing homelessness in the ED.

This multiphase pilot study sought to understand service delivery processes and gaps in VA ED settings. Phase 1 examined ED clinician perceptions of care, facilitators, and barriers to providing care (including suicide risk assessments) and making postdischarge outpatient referrals among VA ED clinicians who regularly work with veterans experiencing homelessness. Phase 2 used this information to develop a clinical psychoeducational resource to enhance post-ED access to care for veterans experiencing or at risk for homelessness.

QUALITATIVE INTERVIEWS

Semistructured qualitative interviews were conducted with 11 VA ED clinicians from 6 Veteran Integrated Service Networks between August 2022 and February 2023. Clinicians were eligible if they currently worked within a VA ED setting (including urgent care) and indicated that some of their patients were veterans experiencing homelessness. All health care practitioners (HCPs) participated in an interview and a postinterview self-report survey that assessed demographic and job-related characteristics. Eight HCPs identified as female and 3 identified as male. All clinicians identified as White and 3 as Hispanic or Latino. Eight clinicians were licensed clinical social workers, 2 were ED nurses, and 1 was an ED physician.

After each clinician provided informed consent, they were invited to complete a telephone or Microsoft Teams interview. All interviews were recorded and subsequently transcribed. Interviews explored clinicians’ experiences caring for veterans experiencing homelessness, with a focus on services provided within the ED, as well as mandated ED screenings such as a suicide risk assessment. Interview questions also addressed postdischarge knowledge and experiences with referrals to VA health services (eg, primary care, mental health) and social services (eg, housing programs). Interviews lasted 30 to 90 minutes.

Recruitment ended after attaining sufficient thematic data, accomplished via an information power approach to sampling. This occurred when the study aims, sample characteristics, existing theory, and depth and quality of interviews dynamically informed the decision to cease recruitment of additional participants.^14,15 Given the scope of study (examining service delivery and knowledge gaps), the specificity of the targeted sample (VA ED clinicians providing care to veterans experiencing homelessness), the level of pre-existing theoretical background informing the study aims, and depth and quality of interview dialogue, this information power approach provides justification for attaining small sample sizes. Following the interview, HCPs completed a demographic questionnaire. Participants were not compensated.

Data Analysis

Directed content analysis was used to analyze qualitative data, with the framework method employed as an analytic instrument to facilitate analysis.^16-18 Analysts engaged in bracketing and discussed reflexivity before data analysis to reflect on personal subjectivities and reduce potential bias.^19,20

A prototype coding framework was developed that enabled coders to meaningfully summarize and condense data within transcripts into varying domains, categories, or topics found within the interview guide. Domain examples included clinical backgrounds, suicide risk and assessment protocols among veterans experiencing homelessness, beliefs about service delivery for veterans experiencing homelessness, and barriers and facilitators that may impact their ability to provide post-ED discharge care. Coders discussed the findings and if there was a need to modify templates. All transcripts were double coded. Once complete, individual templates were merged into a unified Microsoft Excel sheet, which allowed for more discrete analyses, enabling analysts to examine trends across content areas within the dataset.

Clinical Resource Development

HCPs were queried regarding available outpatient resources for post-ED care (eg, printed discharge paperwork and best practice alerts or automated workflows within the electronic health record). Resources used by participants were examined, as well as which resources clinicians thought would help them care for veterans experiencing homelessness. Noted gaps were used to develop a tailored resource for clinicians who treat veterans experiencing homelessness in the ED. This resource was created with the intention it could inform all ED clinicians, with the option for personalization to align with the needs of local services, based on needed content areas identified (eg, emergency shelters and suicide prevention resources).

Resource development followed an information systems research (ISR) framework that used a 3-pronged process of identifying circumstances for how a tool is developed, the problems it aims to address, and the knowledge that informs its development, implementation, and evaluation.^21,22 Initial wireframes of the resource were provided via email to 10 subject matter experts (SMEs) in veteran suicide prevention, emergency medicine, and homeless programs. SMEs were identified via professional listservs, VA program office leadership, literature searches of similar research, and snowball sampling. Solicited feedback on the resource from the SMEs included its design, language, tone, flow, format, and content (ideation and prototyping). The feedback was collated and used to revise the resource. SMEs then reviewed and provided feedback on the revised resource. This iterative cycle (prototype review, commentary, ideation, prototype review) continued until the SMEs offered no additional edits to the resource. In total, 7 iterations of the resource were developed, critiqued, and revised.

INTERVIEW RESULTS

Compassion Fatigue

Many participants expressed concerns about compassion fatigue among VA ED clinicians. Those interviewed indicated that treating veterans experiencing homelessness sometimes led to the development of what they described as a “callus,” a “sixth sense,” or an inherent sense of “suspicion” or distrust. These feelings resulted from concerns about an individual’s secondary gain or potential hidden agenda (eg, a veteran reporting suicidal ideation to attain shelter on a cold night), with clinicians not wanting to feel as if they were taken advantage of or deceived.

Many clinicians noted that compassion fatigue resulted from witnessing the same veterans experiencing homelessness routinely use emergency services for nonemergent or nonmedical needs. Some also expressed that over time this may result in them becoming less empathetic when caring for veterans experiencing homelessness. They hypothesized that clinicians may experience burnout, which could potentially result in a lack of curiosity and concern about a veteran’s risk for suicide or need for social services. Others may “take things for granted,” leading them to discount stressors that are “very real to the patient, this person.”

Clinicians indicated that such sentiments may impact overall care. Potential negative consequences included stigmatization of veterans experiencing homelessness, incomplete or partial suicide risk screenings with this population, inattentive or impersonal care, and expedited discharge from the ED without appropriate safety planning or social service referrals. Clinicians interviewed intended to find ways to combat compassion fatigue and maintain a commitment to provide comprehensive care to all veterans, including those experiencing homelessness. They felt conflict between a lack of empathy for individuals experiencing homelessness and becoming numb to the problem due to overexposure. However, these clinicians remained committed to providing care to these veterans and fighting to maintain the purpose of recovery-focused care.

Knowledge Gaps on Available Services

While many clinicians knew of general resources available to veterans experiencing homelessness, few had detailed information on where to seek consults for other homeless programs, who to contact regarding these services, when they were available, or how to refer to them. Many reported feeling uneasy when discharging veterans experiencing homelessness from care, often being unable to provide local, comprehensive referrals to support their needs and ensure their well-being. These sentiments were compounded when the veteran reported suicidal thoughts or recent suicidal behavior; clinicians felt concerned about the methods to engage these individuals into evidence-based mental health care within the context of unstable housing arrangements.

Some clinicians appeared to lack awareness of the wide array of VA homeless programming. Most could acknowledge at least some aspects of available programming (eg, the US Department of Housing and Urban Development– VA Supportive Housing program), while others were unaware of services tailored to the needs of those experiencing homelessness (eg, homeless patient aligned care teams), or of services targeting concurrent psychosocial stressors (eg, Veterans Justice Programs). Interviewees hypothesized this as being particularly notable among clinicians who are new to the VA or those who work in VA settings as part of their graduate or medical school training. Those aware of the services were uncertain of the referral process, relying on a single social worker or nurse to connect individuals experiencing homelessness to health and social services.

Interviewed clinicians noted that suicide risk screening of veterans experiencing homelessness was only performed by a limited number of individuals within the ED. Some did not feel sufficiently trained, comfortable, or knowledgeable about how to navigate care for veterans experiencing homelessness and at risk of suicide. Clinicians described “an uncomfortableness about suicidal ideation, where people just freeze up” and “don’t know what to do and don’t know what to say.”

Lack of Tangible Resources, Trainings, and Referrals

HCPs reported occasionally lacking the necessary clinical resources and information in the ED to properly support veterans experiencing homelessness and suicidal ideation. Common concerns included case management and discharge planning, as well as navigating health factors, such as elevated suicide risk. Some HCPs felt the local resources they do have access to—discharge packets or other forms of patient information—were not always tailored for the needs (eg, transportation) or abilities of veterans experiencing homelessness. One noted: “We give them a sheet of paper with some resources, which they don’t have the skills to follow up [with] anyway.”

Many interviewees wished for additional training in working with veterans experiencing homelessness. They reported that prior training from the VA Talent Management System or through unit-based programming could assist in educating clinicians on homeless services and suicide risk assessment. When queried on what training they had received, many noted there was “no formal training on what the VA offers homeless vets,” leading many to describe it as on-the-job training. This appeared especially among newer clinicians, who reported they were reliant upon learning from other, more senior staff within the ED.

The absence of training further illustrates the issue of institutional knowledge on these services and referrals, which was often confined to a single individual or team. Not having readily accessible resources, training, or information appropriate for all skill levels and positions within the ED hindered the ability of HCPs to connect veterans experiencing homelessness with social services to ensure their health and safety postdischarge: “If we had a better knowledge base of what the VA offers and the steps to go through in order to get the veteran set up for those things, it would be helpful.”

CLINICAL RESOURCE

A psychoeducational resource was developed for HCPs treating veterans experiencing homelessness (Figure). The resource was designed to mitigate compassion fatigue and recenter attention on the VA commitment to care while emphasizing the need to be responsive to the concerns of these individuals. Initial wireframes of the resource were developed by a small group of authors in review and appraisal of qualitative findings (EP, RH). These wireframes were developed to broadly illustrate the arrangement/structure of content, range of resources to potentially include (eg, available VA homeless programs or consultation resources), and to draft initial wording and phrasing. Subject matter expert feedback refined these wireframes, providing commentary on specific programs to include or exclude, changes and alterations to the design and flow of the resource, and edits to language, word choice, and tone over numerous iterations.

Given that many ED HCPs presented concerns surrounding secondary gain in the context of suicide risk, this resource focused on suicide risk. At the top of the resource, it states “Veterans at risk for homelessness experience more than double the risk for suicide than stably housed veterans.”²³ Also at the top, the resource states: “For many, the last health care visit prior to suicide is often with VA emergency services."²⁴ The goal of these statements was to educate users on the elevated risk for suicide in veterans experiencing homelessness and their role in preventing such deaths.

Text in this section emphasizes that every veteran deserves the best care possible and recenters HCP attention on providing quality, comprehensive care regardless of housing status. The inclusion of this material was prioritized given the concerns expressed regarding compassion fatigue and suspicions of secondary gain (eg, a veteran reporting suicidal ideation to attain shelter or respite from outside conditions).

The resource also attempts to address high rates of emergency service by veterans experiencing homelessness: “Due to challenges with accessing care, Veterans experiencing homelessness may use emergency or urgent care services more frequently than other Veterans.”²⁵ The resource also indicates that VA resources are available to help homeless and at-risk veterans to acquire stable housing, employment, and engage in healthcare, which are outlined with specific contact information. Given the breadth of local and VA services, a portion of the resource is dedicated to local health and social services available for veterans experiencing homelessness. HCPs complete the first page, which is devoted to local homeless service and program resources.

Following SME consultation, the list of programs provided underwent a series of iterations. The program types listed are deemed to be of greatest benefit to veterans experiencing homelessness and most consulted by HCPs. Including VA and non-VA emergency shelters allows clinicians flexible options if a particular shelter is full, closed, or would not meet the veteran’s needs or preference (eg, lack of childcare or does not allow pets). The second column of this section is left intentionally blank; here, the HCP is to list a local point-of- contact at each program. This encourages clinical teams to seek out and make direct contact with these programs and establish (in)formal relationships with them. The HCP then completes the third column with contact information.

Once completed, the resource acts as a living document. Clinicians and SMEs consulted for this study expressed the desire to have an easily accessible resource that can be updated based on necessary changes (eg, emergency shelter address or hours of operation). The resource can be housed within each local VA emergency or urgent care service setting alongside other available clinical tools.

While local resources are the primary focus, interviewees also suggested that some HCPs are not aware of the available VA services . This material, found on the back of the resource, provides a general overview of services available through VA homeless programs. SME consultation and discussion led to selecting the 5 listed categories: housing services, health care services, case management, employment services, and justice-related programming, each with a brief description.

Information for the National Call Center for Homeless Veterans, community service hotline, and Veterans Crisis Line are included on the front page. These hotlines and phone numbers are always available for veterans experiencing homelessness, enabling them to make these connections themselves, if desired. Additionally, given the challenges noted by some HCPs in performing suicide risk screening, evaluation, and intervention, a prompt for the VA Suicide Risk Management Consultation service was also included on the back page.

Creating a Shared and Local Resource

This clinical resource was developed to establish a centralized, shared, local resource available to VA ED HCPs who lacked knowledge of available services or reported discomfort conducting suicide risk screening for veterans experiencing homelessness. In many cases, ED referrals to homeless programs and suicide prevention care was assigned to a single individual, often a nurse or social worker. As a result, an undue amount of work and strain was placed on these individuals, as this forced them to act as the sole bridge between care in the ED and postdischarge social (eg, homeless programs) and mental health (eg, suicide prevention) services. The creation of a unified, easily accessible document aimed to distribute this responsibility more equitably across ED staff.

DISCUSSION

This project intended to develop a clinician resource to support VA ED clinicians caring for veterans experiencing homelessness and their access to services postdischarge. Qualitative interviews provided insights into the burnout and compassion fatigue present in these settings, as well as the challenges and needs regarding knowledge of local and VA services. Emphasis was placed on leveraging extant resources and subject matter expertise to develop a resource capable of providing brief and informative guidance.

This resource is particularly relevant for HCPs new to the VA, including trainees and new hires, who may be less aware of VA and local social services. It has the potential to reduce the burden on VA ED staff to provide guidance and recommendations surrounding postdischarge social services. The resource acknowledges homeless programming focused on social determinants of health that can destabilize housing (eg, legal or occupational challenges). This can incentivize clinicians to discuss these programs with veterans to facilitate their ability to navigate complex health and psychosocial challenges.

HCPs interviewed for this study indicated their apprehension regarding suicide risk screening and evaluation, a process currently mandated within VA ED settings.²⁶ This may be compounded among HCPs with minimal mental health training or those who have worked in community-based settings where such screening and evaluation efforts are not required. The resource reminds clinicians of available VA consultation services, which can provide additional training, clinical guidance, and review of existing local ED processes.

While the resource was directly informed by qualitative interviews conducted with VA emergency service HCPs and developed through an iterative process with SMEs, further research is necessary to determine its effectiveness at increasing access to health and social services among veterans experiencing homelessness. The resource has not been used by HCPs working in these settings to examine uptake or sustained use, nor clinicians’ perceptions of its utility, including acceptability and feasibility; these are important next steps to understand if the resource is functioning as intended.

Compassion fatigue, as well as associated sequelae (eg, burnout, distress, and psychiatric symptoms), is well-documented among individuals working with individuals experiencing homelessness, including VA HCPs.^27-30 Such experiences are likely driven by several factors, including the clinical complexity and service needs of this veteran population. Although compassion fatigue was noted by many clinicians interviewed for this study, it is unclear if the resource alone would address factors driving compassion fatigue, or if additional programming or services may be necessary.

Limitations

The resource requires local HCPs to routinely update its content (eg, establishment of a new emergency shelter in the community or change in hours or contact information of an existing one), which may be challenging. This is especially true as it relates to community resources, which may be more likely to change than national VA programming.

This resource was initially developed following qualitative interviews with a small sample of VA HCPs (explicitly those working within ED settings) and may not be representative of all HCPs engaged in VA care with veterans experiencing homelessness. The perspectives and experiences of those interviewed do not represent the views of all VA ED HCPs and may differ from the perspectives of those in regions with unique cultural and regional considerations.³¹

Given that most of the interviewees were social workers in EDs engaged in care for veterans experiencing homelessness, these findings and informational needs may differ among other types of HCPs who provide services for veterans experiencing homelessness in other settings. Content in the resource was included based on clinician input, and may not reflect the perspectives of veterans, who may perceive some resources as more important (eg, access to primary care or dental services).²⁸

CONCLUSIONS

This project represents the culmination of qualitative interviews and SME input to develop a free-to-use clinician resource to facilitate service delivery and connection to services following discharge from VA EDs for veterans experiencing homelessness. Serving as a template, this resource can be customized to increase knowledge of local VA and community resources to support these individuals. Continued refinement and piloting of this resource to evaluate acceptability, implementation barriers, and use remains warranted.

Veterans experiencing homelessness are at an elevated risk for adverse health outcomes, including suicide. This population also experiences chronic health conditions (eg, cardiovascular disease and sexually transmitted infections) and psychiatric conditions (eg, substance use disorders and posttraumatic stress disorder) with a greater propensity than veterans without history of homelessness.^1,2 Similarly, veterans experiencing homelessness often report concurrent stressors, such as justice involvement and unemployment, which further impact social functioning.³

The US Department of Veterans Affairs (VA) offers a range of health and social services to veterans experiencing homelessness. These programs are designed to respond to the multifactorial challenges faced by this population and are aimed at achieving sustained, permanent housing.⁴ To facilitate this effort, these programs provide targeted and tailored health (eg, primary care) and social (eg, case management and vocational rehabilitation) services to address barriers to housing stability (eg, substance use, serious mental illness, interacting with the criminal legal system, and unemployment).

Despite the availability of these programs, engaging veterans in VA services—whether in general or tailored for those experiencing or at risk for homelessness—remains challenging. Many veterans at risk for or experiencing homelessness overuse service settings that provide immediate care, such as urgent care or emergency departments (EDs).^5,6 These individuals often visit an ED to augment or complement medical care they received in an outpatient setting, which can result in an elevated health care burden as well as impacted provision of treatment, especially surrounding care for chronic conditions (eg, cardiovascular health or serious mental illness).^7-9

VA EDs offer urgent care and emergency services and often serve as a point of entry for veterans experiencing homelessness.¹⁰ They offer veterans expedient access to care that can address immediate needs (eg, substance use withdrawal, pain management, and suicide risk). EDs may be easier to access given they have longer hours of operation and patients can present without a scheduled appointment. VA EDs are an important point to identify homelessness and connect individuals to social service resources and outpatient health care referrals (eg, primary care and mental health).^4,11

Some clinicians experience uncertainty in navigating or providing care for veterans experiencing or at risk for homelessness. A qualitative study conducted outside the VA found many clinicians did not know how to approach clinical conversations among unstably housed individuals, particularly when they discussed how to manage care for complex health conditions in the context of ongoing case management challenges, such as discharge planning.12 Another study found that clinicians working with individuals experiencing homelessness may have limited prior training or experience treating these patients.¹³ As a result, these clinicians may be unaware of available social services or unknowingly have biases that negatively impact care. Research remains limited surrounding beliefs about and methods of enhancing care among VA clinicians working with veterans experiencing homelessness in the ED.

This multiphase pilot study sought to understand service delivery processes and gaps in VA ED settings. Phase 1 examined ED clinician perceptions of care, facilitators, and barriers to providing care (including suicide risk assessments) and making postdischarge outpatient referrals among VA ED clinicians who regularly work with veterans experiencing homelessness. Phase 2 used this information to develop a clinical psychoeducational resource to enhance post-ED access to care for veterans experiencing or at risk for homelessness.

QUALITATIVE INTERVIEWS

Semistructured qualitative interviews were conducted with 11 VA ED clinicians from 6 Veteran Integrated Service Networks between August 2022 and February 2023. Clinicians were eligible if they currently worked within a VA ED setting (including urgent care) and indicated that some of their patients were veterans experiencing homelessness. All health care practitioners (HCPs) participated in an interview and a postinterview self-report survey that assessed demographic and job-related characteristics. Eight HCPs identified as female and 3 identified as male. All clinicians identified as White and 3 as Hispanic or Latino. Eight clinicians were licensed clinical social workers, 2 were ED nurses, and 1 was an ED physician.

After each clinician provided informed consent, they were invited to complete a telephone or Microsoft Teams interview. All interviews were recorded and subsequently transcribed. Interviews explored clinicians’ experiences caring for veterans experiencing homelessness, with a focus on services provided within the ED, as well as mandated ED screenings such as a suicide risk assessment. Interview questions also addressed postdischarge knowledge and experiences with referrals to VA health services (eg, primary care, mental health) and social services (eg, housing programs). Interviews lasted 30 to 90 minutes.

Recruitment ended after attaining sufficient thematic data, accomplished via an information power approach to sampling. This occurred when the study aims, sample characteristics, existing theory, and depth and quality of interviews dynamically informed the decision to cease recruitment of additional participants.^14,15 Given the scope of study (examining service delivery and knowledge gaps), the specificity of the targeted sample (VA ED clinicians providing care to veterans experiencing homelessness), the level of pre-existing theoretical background informing the study aims, and depth and quality of interview dialogue, this information power approach provides justification for attaining small sample sizes. Following the interview, HCPs completed a demographic questionnaire. Participants were not compensated.

Data Analysis

Directed content analysis was used to analyze qualitative data, with the framework method employed as an analytic instrument to facilitate analysis.^16-18 Analysts engaged in bracketing and discussed reflexivity before data analysis to reflect on personal subjectivities and reduce potential bias.^19,20

A prototype coding framework was developed that enabled coders to meaningfully summarize and condense data within transcripts into varying domains, categories, or topics found within the interview guide. Domain examples included clinical backgrounds, suicide risk and assessment protocols among veterans experiencing homelessness, beliefs about service delivery for veterans experiencing homelessness, and barriers and facilitators that may impact their ability to provide post-ED discharge care. Coders discussed the findings and if there was a need to modify templates. All transcripts were double coded. Once complete, individual templates were merged into a unified Microsoft Excel sheet, which allowed for more discrete analyses, enabling analysts to examine trends across content areas within the dataset.

Clinical Resource Development

HCPs were queried regarding available outpatient resources for post-ED care (eg, printed discharge paperwork and best practice alerts or automated workflows within the electronic health record). Resources used by participants were examined, as well as which resources clinicians thought would help them care for veterans experiencing homelessness. Noted gaps were used to develop a tailored resource for clinicians who treat veterans experiencing homelessness in the ED. This resource was created with the intention it could inform all ED clinicians, with the option for personalization to align with the needs of local services, based on needed content areas identified (eg, emergency shelters and suicide prevention resources).

Resource development followed an information systems research (ISR) framework that used a 3-pronged process of identifying circumstances for how a tool is developed, the problems it aims to address, and the knowledge that informs its development, implementation, and evaluation.^21,22 Initial wireframes of the resource were provided via email to 10 subject matter experts (SMEs) in veteran suicide prevention, emergency medicine, and homeless programs. SMEs were identified via professional listservs, VA program office leadership, literature searches of similar research, and snowball sampling. Solicited feedback on the resource from the SMEs included its design, language, tone, flow, format, and content (ideation and prototyping). The feedback was collated and used to revise the resource. SMEs then reviewed and provided feedback on the revised resource. This iterative cycle (prototype review, commentary, ideation, prototype review) continued until the SMEs offered no additional edits to the resource. In total, 7 iterations of the resource were developed, critiqued, and revised.

INTERVIEW RESULTS

Compassion Fatigue

Many participants expressed concerns about compassion fatigue among VA ED clinicians. Those interviewed indicated that treating veterans experiencing homelessness sometimes led to the development of what they described as a “callus,” a “sixth sense,” or an inherent sense of “suspicion” or distrust. These feelings resulted from concerns about an individual’s secondary gain or potential hidden agenda (eg, a veteran reporting suicidal ideation to attain shelter on a cold night), with clinicians not wanting to feel as if they were taken advantage of or deceived.

Many clinicians noted that compassion fatigue resulted from witnessing the same veterans experiencing homelessness routinely use emergency services for nonemergent or nonmedical needs. Some also expressed that over time this may result in them becoming less empathetic when caring for veterans experiencing homelessness. They hypothesized that clinicians may experience burnout, which could potentially result in a lack of curiosity and concern about a veteran’s risk for suicide or need for social services. Others may “take things for granted,” leading them to discount stressors that are “very real to the patient, this person.”

Clinicians indicated that such sentiments may impact overall care. Potential negative consequences included stigmatization of veterans experiencing homelessness, incomplete or partial suicide risk screenings with this population, inattentive or impersonal care, and expedited discharge from the ED without appropriate safety planning or social service referrals. Clinicians interviewed intended to find ways to combat compassion fatigue and maintain a commitment to provide comprehensive care to all veterans, including those experiencing homelessness. They felt conflict between a lack of empathy for individuals experiencing homelessness and becoming numb to the problem due to overexposure. However, these clinicians remained committed to providing care to these veterans and fighting to maintain the purpose of recovery-focused care.

Knowledge Gaps on Available Services

While many clinicians knew of general resources available to veterans experiencing homelessness, few had detailed information on where to seek consults for other homeless programs, who to contact regarding these services, when they were available, or how to refer to them. Many reported feeling uneasy when discharging veterans experiencing homelessness from care, often being unable to provide local, comprehensive referrals to support their needs and ensure their well-being. These sentiments were compounded when the veteran reported suicidal thoughts or recent suicidal behavior; clinicians felt concerned about the methods to engage these individuals into evidence-based mental health care within the context of unstable housing arrangements.

Some clinicians appeared to lack awareness of the wide array of VA homeless programming. Most could acknowledge at least some aspects of available programming (eg, the US Department of Housing and Urban Development– VA Supportive Housing program), while others were unaware of services tailored to the needs of those experiencing homelessness (eg, homeless patient aligned care teams), or of services targeting concurrent psychosocial stressors (eg, Veterans Justice Programs). Interviewees hypothesized this as being particularly notable among clinicians who are new to the VA or those who work in VA settings as part of their graduate or medical school training. Those aware of the services were uncertain of the referral process, relying on a single social worker or nurse to connect individuals experiencing homelessness to health and social services.

Interviewed clinicians noted that suicide risk screening of veterans experiencing homelessness was only performed by a limited number of individuals within the ED. Some did not feel sufficiently trained, comfortable, or knowledgeable about how to navigate care for veterans experiencing homelessness and at risk of suicide. Clinicians described “an uncomfortableness about suicidal ideation, where people just freeze up” and “don’t know what to do and don’t know what to say.”

Lack of Tangible Resources, Trainings, and Referrals

HCPs reported occasionally lacking the necessary clinical resources and information in the ED to properly support veterans experiencing homelessness and suicidal ideation. Common concerns included case management and discharge planning, as well as navigating health factors, such as elevated suicide risk. Some HCPs felt the local resources they do have access to—discharge packets or other forms of patient information—were not always tailored for the needs (eg, transportation) or abilities of veterans experiencing homelessness. One noted: “We give them a sheet of paper with some resources, which they don’t have the skills to follow up [with] anyway.”

Many interviewees wished for additional training in working with veterans experiencing homelessness. They reported that prior training from the VA Talent Management System or through unit-based programming could assist in educating clinicians on homeless services and suicide risk assessment. When queried on what training they had received, many noted there was “no formal training on what the VA offers homeless vets,” leading many to describe it as on-the-job training. This appeared especially among newer clinicians, who reported they were reliant upon learning from other, more senior staff within the ED.

The absence of training further illustrates the issue of institutional knowledge on these services and referrals, which was often confined to a single individual or team. Not having readily accessible resources, training, or information appropriate for all skill levels and positions within the ED hindered the ability of HCPs to connect veterans experiencing homelessness with social services to ensure their health and safety postdischarge: “If we had a better knowledge base of what the VA offers and the steps to go through in order to get the veteran set up for those things, it would be helpful.”

CLINICAL RESOURCE

A psychoeducational resource was developed for HCPs treating veterans experiencing homelessness (Figure). The resource was designed to mitigate compassion fatigue and recenter attention on the VA commitment to care while emphasizing the need to be responsive to the concerns of these individuals. Initial wireframes of the resource were developed by a small group of authors in review and appraisal of qualitative findings (EP, RH). These wireframes were developed to broadly illustrate the arrangement/structure of content, range of resources to potentially include (eg, available VA homeless programs or consultation resources), and to draft initial wording and phrasing. Subject matter expert feedback refined these wireframes, providing commentary on specific programs to include or exclude, changes and alterations to the design and flow of the resource, and edits to language, word choice, and tone over numerous iterations.

Given that many ED HCPs presented concerns surrounding secondary gain in the context of suicide risk, this resource focused on suicide risk. At the top of the resource, it states “Veterans at risk for homelessness experience more than double the risk for suicide than stably housed veterans.”²³ Also at the top, the resource states: “For many, the last health care visit prior to suicide is often with VA emergency services."²⁴ The goal of these statements was to educate users on the elevated risk for suicide in veterans experiencing homelessness and their role in preventing such deaths.

Text in this section emphasizes that every veteran deserves the best care possible and recenters HCP attention on providing quality, comprehensive care regardless of housing status. The inclusion of this material was prioritized given the concerns expressed regarding compassion fatigue and suspicions of secondary gain (eg, a veteran reporting suicidal ideation to attain shelter or respite from outside conditions).

The resource also attempts to address high rates of emergency service by veterans experiencing homelessness: “Due to challenges with accessing care, Veterans experiencing homelessness may use emergency or urgent care services more frequently than other Veterans.”²⁵ The resource also indicates that VA resources are available to help homeless and at-risk veterans to acquire stable housing, employment, and engage in healthcare, which are outlined with specific contact information. Given the breadth of local and VA services, a portion of the resource is dedicated to local health and social services available for veterans experiencing homelessness. HCPs complete the first page, which is devoted to local homeless service and program resources.

Following SME consultation, the list of programs provided underwent a series of iterations. The program types listed are deemed to be of greatest benefit to veterans experiencing homelessness and most consulted by HCPs. Including VA and non-VA emergency shelters allows clinicians flexible options if a particular shelter is full, closed, or would not meet the veteran’s needs or preference (eg, lack of childcare or does not allow pets). The second column of this section is left intentionally blank; here, the HCP is to list a local point-of- contact at each program. This encourages clinical teams to seek out and make direct contact with these programs and establish (in)formal relationships with them. The HCP then completes the third column with contact information.

Once completed, the resource acts as a living document. Clinicians and SMEs consulted for this study expressed the desire to have an easily accessible resource that can be updated based on necessary changes (eg, emergency shelter address or hours of operation). The resource can be housed within each local VA emergency or urgent care service setting alongside other available clinical tools.

While local resources are the primary focus, interviewees also suggested that some HCPs are not aware of the available VA services . This material, found on the back of the resource, provides a general overview of services available through VA homeless programs. SME consultation and discussion led to selecting the 5 listed categories: housing services, health care services, case management, employment services, and justice-related programming, each with a brief description.

Information for the National Call Center for Homeless Veterans, community service hotline, and Veterans Crisis Line are included on the front page. These hotlines and phone numbers are always available for veterans experiencing homelessness, enabling them to make these connections themselves, if desired. Additionally, given the challenges noted by some HCPs in performing suicide risk screening, evaluation, and intervention, a prompt for the VA Suicide Risk Management Consultation service was also included on the back page.

Creating a Shared and Local Resource

This clinical resource was developed to establish a centralized, shared, local resource available to VA ED HCPs who lacked knowledge of available services or reported discomfort conducting suicide risk screening for veterans experiencing homelessness. In many cases, ED referrals to homeless programs and suicide prevention care was assigned to a single individual, often a nurse or social worker. As a result, an undue amount of work and strain was placed on these individuals, as this forced them to act as the sole bridge between care in the ED and postdischarge social (eg, homeless programs) and mental health (eg, suicide prevention) services. The creation of a unified, easily accessible document aimed to distribute this responsibility more equitably across ED staff.

DISCUSSION

This project intended to develop a clinician resource to support VA ED clinicians caring for veterans experiencing homelessness and their access to services postdischarge. Qualitative interviews provided insights into the burnout and compassion fatigue present in these settings, as well as the challenges and needs regarding knowledge of local and VA services. Emphasis was placed on leveraging extant resources and subject matter expertise to develop a resource capable of providing brief and informative guidance.

This resource is particularly relevant for HCPs new to the VA, including trainees and new hires, who may be less aware of VA and local social services. It has the potential to reduce the burden on VA ED staff to provide guidance and recommendations surrounding postdischarge social services. The resource acknowledges homeless programming focused on social determinants of health that can destabilize housing (eg, legal or occupational challenges). This can incentivize clinicians to discuss these programs with veterans to facilitate their ability to navigate complex health and psychosocial challenges.

HCPs interviewed for this study indicated their apprehension regarding suicide risk screening and evaluation, a process currently mandated within VA ED settings.²⁶ This may be compounded among HCPs with minimal mental health training or those who have worked in community-based settings where such screening and evaluation efforts are not required. The resource reminds clinicians of available VA consultation services, which can provide additional training, clinical guidance, and review of existing local ED processes.

While the resource was directly informed by qualitative interviews conducted with VA emergency service HCPs and developed through an iterative process with SMEs, further research is necessary to determine its effectiveness at increasing access to health and social services among veterans experiencing homelessness. The resource has not been used by HCPs working in these settings to examine uptake or sustained use, nor clinicians’ perceptions of its utility, including acceptability and feasibility; these are important next steps to understand if the resource is functioning as intended.

Compassion fatigue, as well as associated sequelae (eg, burnout, distress, and psychiatric symptoms), is well-documented among individuals working with individuals experiencing homelessness, including VA HCPs.^27-30 Such experiences are likely driven by several factors, including the clinical complexity and service needs of this veteran population. Although compassion fatigue was noted by many clinicians interviewed for this study, it is unclear if the resource alone would address factors driving compassion fatigue, or if additional programming or services may be necessary.

Limitations

The resource requires local HCPs to routinely update its content (eg, establishment of a new emergency shelter in the community or change in hours or contact information of an existing one), which may be challenging. This is especially true as it relates to community resources, which may be more likely to change than national VA programming.

This resource was initially developed following qualitative interviews with a small sample of VA HCPs (explicitly those working within ED settings) and may not be representative of all HCPs engaged in VA care with veterans experiencing homelessness. The perspectives and experiences of those interviewed do not represent the views of all VA ED HCPs and may differ from the perspectives of those in regions with unique cultural and regional considerations.³¹

Given that most of the interviewees were social workers in EDs engaged in care for veterans experiencing homelessness, these findings and informational needs may differ among other types of HCPs who provide services for veterans experiencing homelessness in other settings. Content in the resource was included based on clinician input, and may not reflect the perspectives of veterans, who may perceive some resources as more important (eg, access to primary care or dental services).²⁸

CONCLUSIONS

This project represents the culmination of qualitative interviews and SME input to develop a free-to-use clinician resource to facilitate service delivery and connection to services following discharge from VA EDs for veterans experiencing homelessness. Serving as a template, this resource can be customized to increase knowledge of local VA and community resources to support these individuals. Continued refinement and piloting of this resource to evaluate acceptability, implementation barriers, and use remains warranted.

The landmark Crossing the Quality Chasm report from the National Academy of Medicine identified patient- centered care as essential to health care quality. The report defines patientcentered care as “respectful of and responsive to individual patient preferences, needs, and values.”¹ Many health care systems, including the Veterans Health Administration, are transforming to a patient-centered model of care.² The US Department of Veterans Affairs (VA) Whole Health System of Care initiative is a system-wide, cultural transformation. Within whole health, what matters most to the patient—including their preferences, needs, and values—is foundational to health care and meant to be essential in every clinical encounter. Whole health implementation includes a progressive rollout with health care practitioner (HCP) trainings across the VA.²

Shared decision-making (SDM) is a different but aligned patient-centered care concept. SDM is a process through which a decision or care plan, based on patients’ preferences, needs, and values, is made or developed.^3-5 SDM is ideal in situations with equipoise (decisions with equivalent choices), individualized risks, and/or greater uncertainty of the net benefit, such as with lung cancer screening (LCS).³ SDM for LCS is required by the US Centers for Medicare and Medicaid Services and has been adopted by many US health care systems, including the VA.^6,7 Early detection of lung cancer can reduce death by 20% at the population level.⁸ However, at the patient level there is wide variation in the risk of developing lung cancer and a range of potential harms.⁸ LCS follow-up procedures may be more invasive than with other cancer screenings. Thus, there is concern about the risk of false-positive results leading to unnecessary care or complications.⁸ Given this balance between benefit and harm and the differing patient value on the trade-offs of LCS, an individualized, patient-centered approach is essential when deciding whether LCS is the right choice for a specific patient.

Despite the importance of LCS SDM, observational studies have shown poor implementation in clinical encounters.^9,10 HCP barriers include competing demands, limited time, lack of familiarity with and training in SDM, and beliefs biasing screening over no screening.^11-13 Additionally, HCPs may assume that patients want them to make the decision. However, research has shown that patients actually want to be more involved in their health care decisions.¹⁴ One suggested strategy to overcome these barriers is aligning SDM for LCS within an organization’s broader patient-centered initiatives.¹⁵

This project sought to align the need for SDM for LCS and the broader VA whole health initiative as part of a multilevel strategy to implement SDM for LCS across Veterans Integrated Service Network (VISN) 1.¹⁶

This article addresses HCP-level barriers. HCPs targeted are those typically involved in LCS. The VA utilizes LCS coordinators (LCSCs) in both centralized or consult models (in which LCSCs are involved in all aspects of screening) and hybrid models (in which primary care practitioners and LCSCs are both engaged in LCS tasks). The goal of this program was to generate areas of conceptual alignment between SDM and whole health as a first step in integrating these VA initiatives. This work was conducted as a foundation for an SDM for lung cancer HCP training and consultation initiative.

ALIGNMENT PROCESS

We reviewed relevant literature and resources for SDM and whole health. In reviewing the SDM literature, we included a sample of the most widely cited literature on the topic, and focused primarily on the systematic review by Bomhof-Roordink et al.^4,5,17,18 This review provided a synthesis of SDM elements across SDM models and identified 53 different elements clustered into 24 components.⁴ The most common components were present in at least half of all SDM published models, including: make the decision, patient preferences, tailor information, deliberate, create choice awareness, and learn about the patient. Bomhof-Roordink et al provided the guiding framework for this conceptualization of SDM because that study included the available recent published SDM models.⁴

Second, published literature on VA whole health along with supplemental promotional and training materials were reviewed. The whole health materials included 2 sets of training slides developed for VA HCPs (available to VA employees): Implementing Whole Health in Clinical Care, which is focused on HCPs’ work with patients, and Whole Health for You and Me, which is about HCPs’ personal well-being.¹⁹ We also reviewed a publication describing the history of whole health and patient-facing online whole health tools.^2,19

Each document was reviewed for key elements related to SDM, patient-centered care, and whole health. Using the 53 elements identified by Bomhof-Roordink et al, we reviewed and compared each element to the whole health materials to create the integrated model of SDM and whole health. We iteratively discussed and organized the elements until we reached consensus.

SDM and Whole Health Alignment

We created an integrated model of SDM for LCS within the context of the VA whole health initiative. This integrated model is directed at HCPs who would likely engage patients in discussions of LCS, including primary care practitioners and nurse coordinators. The model includes 3 steps for HCPs to follow that align SDM within whole health: (1) frame the conversation and partner with the patient; (2) share clinical perspective and elicit patient values; and (3) deliberate and decide together. For each step, the SDM elements, whole health elements, and integration of SDM and whole health are provided. Table 1 provides an overview of the similarities and differences between SDM and whole health. Example phrases that merge SDM and whole health for HCPs to use in patient conversations about LCS are included in Table 2.

STEP 1. FRAME THE CONVERSATION AND PARTNER WITH THE PATIENT

Shared decision-making. Traditional SDM literature includes an initial step of letting patients know that there is a choice to be made between ≥ 2 clinical options.⁴ Ancillary elements of this first step include asking patients their preferences about the degree to which they want to be involved in SDM and about how they like to receive information (eg, verbal, written, video). These steps open the SDM conversation and ensure the patient and HCP are on the same page before moving forward. For example, the US Agency for Healthcare Research and Quality SHARE model’s first step is for HCPs to communicate that choices exist and to invite the patient to be involved in decisions.²⁰ Similarly, Elwyn’s 3-step SDM model begins with establishing that a choice exists and inviting patient input on making that choice.¹⁷

Whole health. Patients are encouraged to play an active role in their health care. Through whole health programs such as Taking Charge of My Life and Health, patients explore their values and set self-care goals.²¹ HCP whole health trainings teach and reinforce communication skills, including SDM, listening skills, and motivational interviewing.¹⁹

Shared decision-making/whole health integration. SDM and whole health both prioritize respect, compassion, and patients’ expertise. They focus on the patient-HCP relationship with an emphasis on fostering egalitarian interactions. HCPs frame the SDM conversation and partner with the patient so they know what to expect and who will be involved. This conversation is framed from the outset as a collaborative discussion. HCPs empower the patient to play an active role in decision-making and help them understand why their engagement is critical.

STEP 2. SHARE CLINICAL PERSPECTIVE AND ELICIT PATIENT VALUES

Shared decision-making. HCPs share clinical perspective on LCS tailored to individual patients while explicitly inviting the patient to share their preferences and values when thinking about whether to undergo LCS. HCPs give a balanced description of LCS, including the benefits and harms, tailored to the patient’s unique information needs and questions. Sharing clinical perspective also includes describing treatment options, the most common element across SDM models.⁴ Decision aids, which provide unbiased information and include a values clarification exercise, may be helpful in sharing clinical perspectives and clarifying patient values related to the trade-offs of LCS.²² For example, the VA National Center for Health Promotion and Disease Prevention developed a LCS decision aid to be used for SDM for LCS.

Whole health. The conversation shifts from “What is the matter with you?” to “What matters to you?” starting with the patient’s goals and priorities rather than disease prevention, diagnosis, and treatment.² Several whole health tools exist, including the Personal Health Inventory, used to identify what matters most to patients and understand their current well-being and self-care.²³ Using the inventory, the patient and their health care team develop the patient’s personal health plan.²⁴ Additionally, whole health trains HCPs to reflect on their own attitudes and biases when providing clinical care.

Shared decision-making/whole health integration. The LCS conversation can build on other whole health-related conversations with a HCP or other team members. HCPs can reference the patient’s personal health plan for documentation of the patient’s preferences, values, and goals in the electronic medical record. During this process, HCPs can give space for patients to discuss factors in their life and experiences that impact their perspective and decision-making. For example, patient concerns could be explored here, including fear of a cancer diagnosis, stigma around smoking, and fears around the screening and/or treatment process. HCPs may ask, “What matters most to you when making this decision?” Finally, by sharing clinical information, HCPs will focus on patient values to help overcome their own biases toward a desire for LCS. HCPs, similar to the rest of the US public, tend to hold highly favorable attitudes toward cancer screening as well as misconceptions about the magnitude of benefits from screening.¹³

STEP 3. DELIBERATE AND DECIDE TOGETHER

Shared decision-making. Decision-making is almost always considered the last SDM step.⁴ In the final step, the patient and HCP discuss the options (ie, to screen or not to screen) considering the patient’s values and preferences, and patients decide with their HCP whether they will undergo LCS. Patients may decide they need more time to think about these options. As part of deliberation, HCPs assess what other information patients may need to arrive at a decision. Family members, friends, or peers may be included in making the final decision.

Whole health. In Whole health, decisions also may include the entire health care team and other individuals important to the patient (eg, family, friends). Integration across different health care settings is also considered a key whole health element. Finally, whole health focuses on long-term relationships with patients; thus, the LCS SDM process is situated within longer term relationship building and patient empowerment, both of which will facilitate partnering with the patient in future conversations about other decisions.

Shared decision-making/whole health integration. Both SDM and whole health emphasize partnership with the patient in making a final decision. There is also focus on decision-making as an ongoing process. Deciding whether LCS is the best choice might include naming and addressing emotions, voicing questions not raised, and exploring whether screening fits the patient’s goals, values, and life context. HCPs may give guidance, but patients retain the authority to make decisions. The goal is to empower patients to know that the only right decision is the one right for them and they will be supported.

Limitations

This article describes a VA practice program and was not a formal research study. Further work is needed to evaluate the presented strategies. Additionally, we did not conduct a systematic literature review and thus elements of SDM and whole health may not be exhaustive.

CONCLUSIONS

This article describes the alignment of 2 distinct VA initiatives, whole health and SDM for LCS. The goal was to reduce known barriers to SDM, such as competing demands, limited time, and lack of familiarity with and training in SDM.^11-13 These concepts are well aligned. This integrated model is the first step in informing the development of a HCP training program and materials as part of a multilevel strategy that our team is using to implement SDM for LCS in VISN 1.16 The final training and materials resulting from this work were delivered to LCSCs in 3 ways: (1) a series of 3 interactive group training sessions, including didactic elements, role play, and time for open discussion; (2) 1-on-1 academic detailing; and (3) educational handouts. In academic detailing, a member of the research team trained in academic detailing met virtually with each nurse coordinator, identified that individual’s barriers to SDM, and used the training materials to highlight messages to overcome those barriers; follow-up calls provided a forum for discussing progress and overcoming additional challenges. Although this article focused specifically on whole health and SDM, the conceptual alignment process strategy can be applied to other implementations of multiple initiatives.

The landmark Crossing the Quality Chasm report from the National Academy of Medicine identified patient- centered care as essential to health care quality. The report defines patientcentered care as “respectful of and responsive to individual patient preferences, needs, and values.”¹ Many health care systems, including the Veterans Health Administration, are transforming to a patient-centered model of care.² The US Department of Veterans Affairs (VA) Whole Health System of Care initiative is a system-wide, cultural transformation. Within whole health, what matters most to the patient—including their preferences, needs, and values—is foundational to health care and meant to be essential in every clinical encounter. Whole health implementation includes a progressive rollout with health care practitioner (HCP) trainings across the VA.²

Shared decision-making (SDM) is a different but aligned patient-centered care concept. SDM is a process through which a decision or care plan, based on patients’ preferences, needs, and values, is made or developed.^3-5 SDM is ideal in situations with equipoise (decisions with equivalent choices), individualized risks, and/or greater uncertainty of the net benefit, such as with lung cancer screening (LCS).³ SDM for LCS is required by the US Centers for Medicare and Medicaid Services and has been adopted by many US health care systems, including the VA.^6,7 Early detection of lung cancer can reduce death by 20% at the population level.⁸ However, at the patient level there is wide variation in the risk of developing lung cancer and a range of potential harms.⁸ LCS follow-up procedures may be more invasive than with other cancer screenings. Thus, there is concern about the risk of false-positive results leading to unnecessary care or complications.⁸ Given this balance between benefit and harm and the differing patient value on the trade-offs of LCS, an individualized, patient-centered approach is essential when deciding whether LCS is the right choice for a specific patient.

Despite the importance of LCS SDM, observational studies have shown poor implementation in clinical encounters.^9,10 HCP barriers include competing demands, limited time, lack of familiarity with and training in SDM, and beliefs biasing screening over no screening.^11-13 Additionally, HCPs may assume that patients want them to make the decision. However, research has shown that patients actually want to be more involved in their health care decisions.¹⁴ One suggested strategy to overcome these barriers is aligning SDM for LCS within an organization’s broader patient-centered initiatives.¹⁵

This project sought to align the need for SDM for LCS and the broader VA whole health initiative as part of a multilevel strategy to implement SDM for LCS across Veterans Integrated Service Network (VISN) 1.¹⁶

This article addresses HCP-level barriers. HCPs targeted are those typically involved in LCS. The VA utilizes LCS coordinators (LCSCs) in both centralized or consult models (in which LCSCs are involved in all aspects of screening) and hybrid models (in which primary care practitioners and LCSCs are both engaged in LCS tasks). The goal of this program was to generate areas of conceptual alignment between SDM and whole health as a first step in integrating these VA initiatives. This work was conducted as a foundation for an SDM for lung cancer HCP training and consultation initiative.

ALIGNMENT PROCESS

We reviewed relevant literature and resources for SDM and whole health. In reviewing the SDM literature, we included a sample of the most widely cited literature on the topic, and focused primarily on the systematic review by Bomhof-Roordink et al.^4,5,17,18 This review provided a synthesis of SDM elements across SDM models and identified 53 different elements clustered into 24 components.⁴ The most common components were present in at least half of all SDM published models, including: make the decision, patient preferences, tailor information, deliberate, create choice awareness, and learn about the patient. Bomhof-Roordink et al provided the guiding framework for this conceptualization of SDM because that study included the available recent published SDM models.⁴

Second, published literature on VA whole health along with supplemental promotional and training materials were reviewed. The whole health materials included 2 sets of training slides developed for VA HCPs (available to VA employees): Implementing Whole Health in Clinical Care, which is focused on HCPs’ work with patients, and Whole Health for You and Me, which is about HCPs’ personal well-being.¹⁹ We also reviewed a publication describing the history of whole health and patient-facing online whole health tools.^2,19

Each document was reviewed for key elements related to SDM, patient-centered care, and whole health. Using the 53 elements identified by Bomhof-Roordink et al, we reviewed and compared each element to the whole health materials to create the integrated model of SDM and whole health. We iteratively discussed and organized the elements until we reached consensus.

SDM and Whole Health Alignment

We created an integrated model of SDM for LCS within the context of the VA whole health initiative. This integrated model is directed at HCPs who would likely engage patients in discussions of LCS, including primary care practitioners and nurse coordinators. The model includes 3 steps for HCPs to follow that align SDM within whole health: (1) frame the conversation and partner with the patient; (2) share clinical perspective and elicit patient values; and (3) deliberate and decide together. For each step, the SDM elements, whole health elements, and integration of SDM and whole health are provided. Table 1 provides an overview of the similarities and differences between SDM and whole health. Example phrases that merge SDM and whole health for HCPs to use in patient conversations about LCS are included in Table 2.

STEP 1. FRAME THE CONVERSATION AND PARTNER WITH THE PATIENT

Shared decision-making. Traditional SDM literature includes an initial step of letting patients know that there is a choice to be made between ≥ 2 clinical options.⁴ Ancillary elements of this first step include asking patients their preferences about the degree to which they want to be involved in SDM and about how they like to receive information (eg, verbal, written, video). These steps open the SDM conversation and ensure the patient and HCP are on the same page before moving forward. For example, the US Agency for Healthcare Research and Quality SHARE model’s first step is for HCPs to communicate that choices exist and to invite the patient to be involved in decisions.²⁰ Similarly, Elwyn’s 3-step SDM model begins with establishing that a choice exists and inviting patient input on making that choice.¹⁷

Whole health. Patients are encouraged to play an active role in their health care. Through whole health programs such as Taking Charge of My Life and Health, patients explore their values and set self-care goals.²¹ HCP whole health trainings teach and reinforce communication skills, including SDM, listening skills, and motivational interviewing.¹⁹

Shared decision-making/whole health integration. SDM and whole health both prioritize respect, compassion, and patients’ expertise. They focus on the patient-HCP relationship with an emphasis on fostering egalitarian interactions. HCPs frame the SDM conversation and partner with the patient so they know what to expect and who will be involved. This conversation is framed from the outset as a collaborative discussion. HCPs empower the patient to play an active role in decision-making and help them understand why their engagement is critical.

STEP 2. SHARE CLINICAL PERSPECTIVE AND ELICIT PATIENT VALUES

Shared decision-making. HCPs share clinical perspective on LCS tailored to individual patients while explicitly inviting the patient to share their preferences and values when thinking about whether to undergo LCS. HCPs give a balanced description of LCS, including the benefits and harms, tailored to the patient’s unique information needs and questions. Sharing clinical perspective also includes describing treatment options, the most common element across SDM models.⁴ Decision aids, which provide unbiased information and include a values clarification exercise, may be helpful in sharing clinical perspectives and clarifying patient values related to the trade-offs of LCS.²² For example, the VA National Center for Health Promotion and Disease Prevention developed a LCS decision aid to be used for SDM for LCS.

Whole health. The conversation shifts from “What is the matter with you?” to “What matters to you?” starting with the patient’s goals and priorities rather than disease prevention, diagnosis, and treatment.² Several whole health tools exist, including the Personal Health Inventory, used to identify what matters most to patients and understand their current well-being and self-care.²³ Using the inventory, the patient and their health care team develop the patient’s personal health plan.²⁴ Additionally, whole health trains HCPs to reflect on their own attitudes and biases when providing clinical care.

Shared decision-making/whole health integration. The LCS conversation can build on other whole health-related conversations with a HCP or other team members. HCPs can reference the patient’s personal health plan for documentation of the patient’s preferences, values, and goals in the electronic medical record. During this process, HCPs can give space for patients to discuss factors in their life and experiences that impact their perspective and decision-making. For example, patient concerns could be explored here, including fear of a cancer diagnosis, stigma around smoking, and fears around the screening and/or treatment process. HCPs may ask, “What matters most to you when making this decision?” Finally, by sharing clinical information, HCPs will focus on patient values to help overcome their own biases toward a desire for LCS. HCPs, similar to the rest of the US public, tend to hold highly favorable attitudes toward cancer screening as well as misconceptions about the magnitude of benefits from screening.¹³

STEP 3. DELIBERATE AND DECIDE TOGETHER

Shared decision-making. Decision-making is almost always considered the last SDM step.⁴ In the final step, the patient and HCP discuss the options (ie, to screen or not to screen) considering the patient’s values and preferences, and patients decide with their HCP whether they will undergo LCS. Patients may decide they need more time to think about these options. As part of deliberation, HCPs assess what other information patients may need to arrive at a decision. Family members, friends, or peers may be included in making the final decision.

Whole health. In Whole health, decisions also may include the entire health care team and other individuals important to the patient (eg, family, friends). Integration across different health care settings is also considered a key whole health element. Finally, whole health focuses on long-term relationships with patients; thus, the LCS SDM process is situated within longer term relationship building and patient empowerment, both of which will facilitate partnering with the patient in future conversations about other decisions.

Shared decision-making/whole health integration. Both SDM and whole health emphasize partnership with the patient in making a final decision. There is also focus on decision-making as an ongoing process. Deciding whether LCS is the best choice might include naming and addressing emotions, voicing questions not raised, and exploring whether screening fits the patient’s goals, values, and life context. HCPs may give guidance, but patients retain the authority to make decisions. The goal is to empower patients to know that the only right decision is the one right for them and they will be supported.

Limitations

This article describes a VA practice program and was not a formal research study. Further work is needed to evaluate the presented strategies. Additionally, we did not conduct a systematic literature review and thus elements of SDM and whole health may not be exhaustive.

CONCLUSIONS

This article describes the alignment of 2 distinct VA initiatives, whole health and SDM for LCS. The goal was to reduce known barriers to SDM, such as competing demands, limited time, and lack of familiarity with and training in SDM.^11-13 These concepts are well aligned. This integrated model is the first step in informing the development of a HCP training program and materials as part of a multilevel strategy that our team is using to implement SDM for LCS in VISN 1.16 The final training and materials resulting from this work were delivered to LCSCs in 3 ways: (1) a series of 3 interactive group training sessions, including didactic elements, role play, and time for open discussion; (2) 1-on-1 academic detailing; and (3) educational handouts. In academic detailing, a member of the research team trained in academic detailing met virtually with each nurse coordinator, identified that individual’s barriers to SDM, and used the training materials to highlight messages to overcome those barriers; follow-up calls provided a forum for discussing progress and overcoming additional challenges. Although this article focused specifically on whole health and SDM, the conceptual alignment process strategy can be applied to other implementations of multiple initiatives.

The landmark Crossing the Quality Chasm report from the National Academy of Medicine identified patient- centered care as essential to health care quality. The report defines patientcentered care as “respectful of and responsive to individual patient preferences, needs, and values.”¹ Many health care systems, including the Veterans Health Administration, are transforming to a patient-centered model of care.² The US Department of Veterans Affairs (VA) Whole Health System of Care initiative is a system-wide, cultural transformation. Within whole health, what matters most to the patient—including their preferences, needs, and values—is foundational to health care and meant to be essential in every clinical encounter. Whole health implementation includes a progressive rollout with health care practitioner (HCP) trainings across the VA.²

Shared decision-making (SDM) is a different but aligned patient-centered care concept. SDM is a process through which a decision or care plan, based on patients’ preferences, needs, and values, is made or developed.^3-5 SDM is ideal in situations with equipoise (decisions with equivalent choices), individualized risks, and/or greater uncertainty of the net benefit, such as with lung cancer screening (LCS).³ SDM for LCS is required by the US Centers for Medicare and Medicaid Services and has been adopted by many US health care systems, including the VA.^6,7 Early detection of lung cancer can reduce death by 20% at the population level.⁸ However, at the patient level there is wide variation in the risk of developing lung cancer and a range of potential harms.⁸ LCS follow-up procedures may be more invasive than with other cancer screenings. Thus, there is concern about the risk of false-positive results leading to unnecessary care or complications.⁸ Given this balance between benefit and harm and the differing patient value on the trade-offs of LCS, an individualized, patient-centered approach is essential when deciding whether LCS is the right choice for a specific patient.

Despite the importance of LCS SDM, observational studies have shown poor implementation in clinical encounters.^9,10 HCP barriers include competing demands, limited time, lack of familiarity with and training in SDM, and beliefs biasing screening over no screening.^11-13 Additionally, HCPs may assume that patients want them to make the decision. However, research has shown that patients actually want to be more involved in their health care decisions.¹⁴ One suggested strategy to overcome these barriers is aligning SDM for LCS within an organization’s broader patient-centered initiatives.¹⁵

This project sought to align the need for SDM for LCS and the broader VA whole health initiative as part of a multilevel strategy to implement SDM for LCS across Veterans Integrated Service Network (VISN) 1.¹⁶

This article addresses HCP-level barriers. HCPs targeted are those typically involved in LCS. The VA utilizes LCS coordinators (LCSCs) in both centralized or consult models (in which LCSCs are involved in all aspects of screening) and hybrid models (in which primary care practitioners and LCSCs are both engaged in LCS tasks). The goal of this program was to generate areas of conceptual alignment between SDM and whole health as a first step in integrating these VA initiatives. This work was conducted as a foundation for an SDM for lung cancer HCP training and consultation initiative.

ALIGNMENT PROCESS

We reviewed relevant literature and resources for SDM and whole health. In reviewing the SDM literature, we included a sample of the most widely cited literature on the topic, and focused primarily on the systematic review by Bomhof-Roordink et al.^4,5,17,18 This review provided a synthesis of SDM elements across SDM models and identified 53 different elements clustered into 24 components.⁴ The most common components were present in at least half of all SDM published models, including: make the decision, patient preferences, tailor information, deliberate, create choice awareness, and learn about the patient. Bomhof-Roordink et al provided the guiding framework for this conceptualization of SDM because that study included the available recent published SDM models.⁴

Second, published literature on VA whole health along with supplemental promotional and training materials were reviewed. The whole health materials included 2 sets of training slides developed for VA HCPs (available to VA employees): Implementing Whole Health in Clinical Care, which is focused on HCPs’ work with patients, and Whole Health for You and Me, which is about HCPs’ personal well-being.¹⁹ We also reviewed a publication describing the history of whole health and patient-facing online whole health tools.^2,19

Each document was reviewed for key elements related to SDM, patient-centered care, and whole health. Using the 53 elements identified by Bomhof-Roordink et al, we reviewed and compared each element to the whole health materials to create the integrated model of SDM and whole health. We iteratively discussed and organized the elements until we reached consensus.

SDM and Whole Health Alignment

We created an integrated model of SDM for LCS within the context of the VA whole health initiative. This integrated model is directed at HCPs who would likely engage patients in discussions of LCS, including primary care practitioners and nurse coordinators. The model includes 3 steps for HCPs to follow that align SDM within whole health: (1) frame the conversation and partner with the patient; (2) share clinical perspective and elicit patient values; and (3) deliberate and decide together. For each step, the SDM elements, whole health elements, and integration of SDM and whole health are provided. Table 1 provides an overview of the similarities and differences between SDM and whole health. Example phrases that merge SDM and whole health for HCPs to use in patient conversations about LCS are included in Table 2.

STEP 1. FRAME THE CONVERSATION AND PARTNER WITH THE PATIENT

Shared decision-making. Traditional SDM literature includes an initial step of letting patients know that there is a choice to be made between ≥ 2 clinical options.⁴ Ancillary elements of this first step include asking patients their preferences about the degree to which they want to be involved in SDM and about how they like to receive information (eg, verbal, written, video). These steps open the SDM conversation and ensure the patient and HCP are on the same page before moving forward. For example, the US Agency for Healthcare Research and Quality SHARE model’s first step is for HCPs to communicate that choices exist and to invite the patient to be involved in decisions.²⁰ Similarly, Elwyn’s 3-step SDM model begins with establishing that a choice exists and inviting patient input on making that choice.¹⁷

Whole health. Patients are encouraged to play an active role in their health care. Through whole health programs such as Taking Charge of My Life and Health, patients explore their values and set self-care goals.²¹ HCP whole health trainings teach and reinforce communication skills, including SDM, listening skills, and motivational interviewing.¹⁹

Shared decision-making/whole health integration. SDM and whole health both prioritize respect, compassion, and patients’ expertise. They focus on the patient-HCP relationship with an emphasis on fostering egalitarian interactions. HCPs frame the SDM conversation and partner with the patient so they know what to expect and who will be involved. This conversation is framed from the outset as a collaborative discussion. HCPs empower the patient to play an active role in decision-making and help them understand why their engagement is critical.

STEP 2. SHARE CLINICAL PERSPECTIVE AND ELICIT PATIENT VALUES

Shared decision-making. HCPs share clinical perspective on LCS tailored to individual patients while explicitly inviting the patient to share their preferences and values when thinking about whether to undergo LCS. HCPs give a balanced description of LCS, including the benefits and harms, tailored to the patient’s unique information needs and questions. Sharing clinical perspective also includes describing treatment options, the most common element across SDM models.⁴ Decision aids, which provide unbiased information and include a values clarification exercise, may be helpful in sharing clinical perspectives and clarifying patient values related to the trade-offs of LCS.²² For example, the VA National Center for Health Promotion and Disease Prevention developed a LCS decision aid to be used for SDM for LCS.

Whole health. The conversation shifts from “What is the matter with you?” to “What matters to you?” starting with the patient’s goals and priorities rather than disease prevention, diagnosis, and treatment.² Several whole health tools exist, including the Personal Health Inventory, used to identify what matters most to patients and understand their current well-being and self-care.²³ Using the inventory, the patient and their health care team develop the patient’s personal health plan.²⁴ Additionally, whole health trains HCPs to reflect on their own attitudes and biases when providing clinical care.

Shared decision-making/whole health integration. The LCS conversation can build on other whole health-related conversations with a HCP or other team members. HCPs can reference the patient’s personal health plan for documentation of the patient’s preferences, values, and goals in the electronic medical record. During this process, HCPs can give space for patients to discuss factors in their life and experiences that impact their perspective and decision-making. For example, patient concerns could be explored here, including fear of a cancer diagnosis, stigma around smoking, and fears around the screening and/or treatment process. HCPs may ask, “What matters most to you when making this decision?” Finally, by sharing clinical information, HCPs will focus on patient values to help overcome their own biases toward a desire for LCS. HCPs, similar to the rest of the US public, tend to hold highly favorable attitudes toward cancer screening as well as misconceptions about the magnitude of benefits from screening.¹³

STEP 3. DELIBERATE AND DECIDE TOGETHER

Shared decision-making. Decision-making is almost always considered the last SDM step.⁴ In the final step, the patient and HCP discuss the options (ie, to screen or not to screen) considering the patient’s values and preferences, and patients decide with their HCP whether they will undergo LCS. Patients may decide they need more time to think about these options. As part of deliberation, HCPs assess what other information patients may need to arrive at a decision. Family members, friends, or peers may be included in making the final decision.

Whole health. In Whole health, decisions also may include the entire health care team and other individuals important to the patient (eg, family, friends). Integration across different health care settings is also considered a key whole health element. Finally, whole health focuses on long-term relationships with patients; thus, the LCS SDM process is situated within longer term relationship building and patient empowerment, both of which will facilitate partnering with the patient in future conversations about other decisions.

Shared decision-making/whole health integration. Both SDM and whole health emphasize partnership with the patient in making a final decision. There is also focus on decision-making as an ongoing process. Deciding whether LCS is the best choice might include naming and addressing emotions, voicing questions not raised, and exploring whether screening fits the patient’s goals, values, and life context. HCPs may give guidance, but patients retain the authority to make decisions. The goal is to empower patients to know that the only right decision is the one right for them and they will be supported.

Limitations

This article describes a VA practice program and was not a formal research study. Further work is needed to evaluate the presented strategies. Additionally, we did not conduct a systematic literature review and thus elements of SDM and whole health may not be exhaustive.

CONCLUSIONS

This article describes the alignment of 2 distinct VA initiatives, whole health and SDM for LCS. The goal was to reduce known barriers to SDM, such as competing demands, limited time, and lack of familiarity with and training in SDM.^11-13 These concepts are well aligned. This integrated model is the first step in informing the development of a HCP training program and materials as part of a multilevel strategy that our team is using to implement SDM for LCS in VISN 1.16 The final training and materials resulting from this work were delivered to LCSCs in 3 ways: (1) a series of 3 interactive group training sessions, including didactic elements, role play, and time for open discussion; (2) 1-on-1 academic detailing; and (3) educational handouts. In academic detailing, a member of the research team trained in academic detailing met virtually with each nurse coordinator, identified that individual’s barriers to SDM, and used the training materials to highlight messages to overcome those barriers; follow-up calls provided a forum for discussing progress and overcoming additional challenges. Although this article focused specifically on whole health and SDM, the conceptual alignment process strategy can be applied to other implementations of multiple initiatives.

Peer-review, evidence-based, detailed gene/drug clinical practice guidelines suggest that genetic variations can impact how individuals metabolize medications, which is sometimes included in medication prescribing information.^1-3 Pharmacogenomic testing identifies genetic markers so medication selection and dosing can be tailored to each individual by identifying whether a specific medication is likely to be safe and effective prior to prescribing.⁴

Pharmacogenomics can be a valuable tool for personalizing medicine but has had suboptimal implementation since its discovery. The US Department of Veterans Affairs (VA) health care system reviewed the implementation of the Pharmacogenomic Testing for Veterans (PHASER) program. This review identified clinician barriers pre- and post-PHASER program implementation; staffing issues, competing clinical priorities, and inadequate PHASER program resources were the most frequently reported barriers to implementation of pharmacogenomic testing.⁵

Another evaluation of the implementation of the PHASER program that surveyed VA patients found that patients could be separated into 3 groups. Acceptors of pharmacogenomic testing emphasized potential health benefits of testing. Patients that declined testing often cited concerns for genetic information affecting insurance coverage, being misused, or being susceptible to data breach. The third group—identified as contemplators—reported the need for clinician outreach to impact their decision on whether or not to receive pharmacogenomic testing.⁶ These studies suggest that removing barriers by providing ample pharmacogenomics resources to clinicians, in addition to detailed training on how to offer and follow up with patients regarding pharmacogenomic testing, is crucial to successful implementation of the PHASER program.

PHASER

In 2019, the VA began working with Sanford Health to establish the PHASER program and offer pharmacogenomic testing. PHASER has since expanded to 25 VA medical centers, including the VA Central Ohio Healthcare System (VACOHCS).^7,8 Pharmacogenomic testing through PHASER is conducted using a standardized laboratory panel that includes 12 different medication classes.⁹ The drug classes include certain anti-infective, anticoagulant, antiplatelet, cardiovascular, cholesterol, gastrointestinal, mental health, neurological, oncology, pain, transplant, and other miscellaneous medications. Medications are correlated to each class and assessed for therapeutic impacts based on gene panel results.

Clinical recommendations for medication-gene interactions can range from monitoring for increased risk of adverse effects or therapeutic failure to recommending avoiding a medication. For example, patients who test positive for the HLA-B gene have significantly increased risk of hypersensitivity to abacavir, an HIV treatment.¹⁰

Similarly, patients who cannot adequately metabolize cytochrome P450 2C19 should consider avoiding clopidogrel as they are unlikely to convert clopidogrel to its active prodrug, which reduces its effectiveness.¹¹ Pharmacists can play a critical role educating patients about pharmacogenomic testing, especially within hematology and oncology.¹² Patients can benefit from this testing even if they are not currently taking medications with known concerns as they could be prescribed in the future. The SLCO1B1 gene-drug test, for example, can identify risk for statin-associated muscle symptoms.¹³

Clinical pharmacist practitioners (CPPs) can increase access to genetic testing because they interact with patients in a variety of settings and can order this laboratory test.^12,14 Recent research has demonstrated that most VA patients carry ≥ 1 genetic variant that may influence medication decisions and that half of veterans are prescribed a medication with known gene-drug interactions.¹⁵ CPP ordering of pharmacogenomic tests at the VACOHCS outpatient clinic was evaluated through collection of baseline data from March 8, 2023, to September 8, 2023. A goal was identified to increase orders by 50% for a patient care quality improvement initiative and use CPPs to increase access to pharmacogenomic testing. The purpose of this quality improvement initiative was to expand access to pharmacogenomic testing through process implementation and improvement within CPP-led clinic settings.

Gap Analysis

Lean Six Sigma A3 methodology was used to identify ways to increase the use of pharmacogenomic testing for veterans at VACOHCS and develop an improved process for increased ordering of pharmacogenomic testing. Lean Six Sigma A3 methodology is a stepwise approach to process improvement that helps identify gaps in efficiency, sustainable changes, and eliminate waste.¹⁶ Baseline data were collected from March 8, 2023, to September 8, 2023, to determine the frequency of CPPs ordering pharmacogenomic laboratory panels during clinic appointments. The ordering of pharmacogenomic panels was monitored by the VACOHCS PHASER coordinator.

CPPs were surveyed to identify perceived barriers to PHASER implementation. A gap analysis was conducted using Lean Six Sigma A3 methodology. Gap analyses use lean tools such as a Fishbone Diagram to illustrate and identify the gap between current state and ideal state. (Figure 1).The following barriers were identified: lack of clinician education materials, lack of a standardized patient screening process, time constraints on patient education and ordering, higher priority clinical needs, forgetting to order, lack of comfort with pharmacogenomics ordering and education, lack of support for the initiative, and increased workload and burnout. Among these perceived barriers, higher priority clinical needs, forgetting to order, and time constraints ranked highest in importance among CPPs. 

In line with Lean Six Sigma A3 methodology, several tests of change were used to improve pharmacogenomic testing ordering. These changes focused on increasing patient and clinician awareness, facilitating discussion, educating clinicians, and simplifying documentation to ease time constraints. Several strategies were employed postimplementation (Figure 2). Prefilled templates simplified documentation. These templates helped identify patients without pharmacogenomic testing, provided reminders, and saved documentation time during visits. CPPs also received training and materials on PHASER ordering and documentation within encounter notes. Additionally, patient-directed advertisements were displayed in CPP examination rooms to help inspire and facilitate discussion between veterans and CPPs.

Process Improvement Data

The quality improvement project goal was to increase PHASER orders by 50% after 3 months. PHASER orders increased from 87 at baseline (March 8, 2023, to September 8, 2023) to 196 during the intervention (November 16, 2023, to February 16, 2024), a 125% increase. Changes were consistent and sustained with 65 orders the first month, 67 orders the second month, and 64 orders the third month.

Discussion

Using Lean Six Sigma A3 methodology for a quality improvement process to increase PHASER orders by CPPs revealed barriers and guided potential solutions to overcome these barriers. Interventions included additional CPP training and ordering, tools for easier identification of potential patients, documentation best practices, patient-directed advertisements to facilitate conversations. These interventions required about 8 hours for preparation, distribution, development, and interpretation of surveys, education, and documentation materials. The financial impact of these interventions was already included in allotted office materials budgeted and provided. Additional funding was not needed to provide patient-directed advertisements or education materials. The VACOHCS pharmacogenomics CPP discusses PHASER test results with patients at a separate appointment.

Future directions include educating other CPPs to assist in discussing results with veterans. Overall, the changes implemented to improve the PHASER ordering process were low effort and exemplify the ease of streamlining future initiatives, allowing for sustained optimal implementation of pharmacogenomic testing.

Conclusions

A quality improvement initiative resulted in increased PHASER orders and a clearly defined process, allowing for a continued increase and sustained support. Perceived barriers were identified, and the changes implemented were often low effort but exhibited a sustained impact. The insights gleaned from this process will shape future process development initiatives and continue to sustain pharmacogenomic testing ordering by CPPs. This process will be extended to other VACOHCS clinical departments to further support increased access to pharmacogenomic testing, reduce medication trial and error, and reduce hospitalizations from adverse effects for veterans.

Peer-review, evidence-based, detailed gene/drug clinical practice guidelines suggest that genetic variations can impact how individuals metabolize medications, which is sometimes included in medication prescribing information.^1-3 Pharmacogenomic testing identifies genetic markers so medication selection and dosing can be tailored to each individual by identifying whether a specific medication is likely to be safe and effective prior to prescribing.⁴

Pharmacogenomics can be a valuable tool for personalizing medicine but has had suboptimal implementation since its discovery. The US Department of Veterans Affairs (VA) health care system reviewed the implementation of the Pharmacogenomic Testing for Veterans (PHASER) program. This review identified clinician barriers pre- and post-PHASER program implementation; staffing issues, competing clinical priorities, and inadequate PHASER program resources were the most frequently reported barriers to implementation of pharmacogenomic testing.⁵

Another evaluation of the implementation of the PHASER program that surveyed VA patients found that patients could be separated into 3 groups. Acceptors of pharmacogenomic testing emphasized potential health benefits of testing. Patients that declined testing often cited concerns for genetic information affecting insurance coverage, being misused, or being susceptible to data breach. The third group—identified as contemplators—reported the need for clinician outreach to impact their decision on whether or not to receive pharmacogenomic testing.⁶ These studies suggest that removing barriers by providing ample pharmacogenomics resources to clinicians, in addition to detailed training on how to offer and follow up with patients regarding pharmacogenomic testing, is crucial to successful implementation of the PHASER program.

PHASER

In 2019, the VA began working with Sanford Health to establish the PHASER program and offer pharmacogenomic testing. PHASER has since expanded to 25 VA medical centers, including the VA Central Ohio Healthcare System (VACOHCS).^7,8 Pharmacogenomic testing through PHASER is conducted using a standardized laboratory panel that includes 12 different medication classes.⁹ The drug classes include certain anti-infective, anticoagulant, antiplatelet, cardiovascular, cholesterol, gastrointestinal, mental health, neurological, oncology, pain, transplant, and other miscellaneous medications. Medications are correlated to each class and assessed for therapeutic impacts based on gene panel results.

Clinical recommendations for medication-gene interactions can range from monitoring for increased risk of adverse effects or therapeutic failure to recommending avoiding a medication. For example, patients who test positive for the HLA-B gene have significantly increased risk of hypersensitivity to abacavir, an HIV treatment.¹⁰

Similarly, patients who cannot adequately metabolize cytochrome P450 2C19 should consider avoiding clopidogrel as they are unlikely to convert clopidogrel to its active prodrug, which reduces its effectiveness.¹¹ Pharmacists can play a critical role educating patients about pharmacogenomic testing, especially within hematology and oncology.¹² Patients can benefit from this testing even if they are not currently taking medications with known concerns as they could be prescribed in the future. The SLCO1B1 gene-drug test, for example, can identify risk for statin-associated muscle symptoms.¹³

Clinical pharmacist practitioners (CPPs) can increase access to genetic testing because they interact with patients in a variety of settings and can order this laboratory test.^12,14 Recent research has demonstrated that most VA patients carry ≥ 1 genetic variant that may influence medication decisions and that half of veterans are prescribed a medication with known gene-drug interactions.¹⁵ CPP ordering of pharmacogenomic tests at the VACOHCS outpatient clinic was evaluated through collection of baseline data from March 8, 2023, to September 8, 2023. A goal was identified to increase orders by 50% for a patient care quality improvement initiative and use CPPs to increase access to pharmacogenomic testing. The purpose of this quality improvement initiative was to expand access to pharmacogenomic testing through process implementation and improvement within CPP-led clinic settings.

Gap Analysis

Lean Six Sigma A3 methodology was used to identify ways to increase the use of pharmacogenomic testing for veterans at VACOHCS and develop an improved process for increased ordering of pharmacogenomic testing. Lean Six Sigma A3 methodology is a stepwise approach to process improvement that helps identify gaps in efficiency, sustainable changes, and eliminate waste.¹⁶ Baseline data were collected from March 8, 2023, to September 8, 2023, to determine the frequency of CPPs ordering pharmacogenomic laboratory panels during clinic appointments. The ordering of pharmacogenomic panels was monitored by the VACOHCS PHASER coordinator.

CPPs were surveyed to identify perceived barriers to PHASER implementation. A gap analysis was conducted using Lean Six Sigma A3 methodology. Gap analyses use lean tools such as a Fishbone Diagram to illustrate and identify the gap between current state and ideal state. (Figure 1).The following barriers were identified: lack of clinician education materials, lack of a standardized patient screening process, time constraints on patient education and ordering, higher priority clinical needs, forgetting to order, lack of comfort with pharmacogenomics ordering and education, lack of support for the initiative, and increased workload and burnout. Among these perceived barriers, higher priority clinical needs, forgetting to order, and time constraints ranked highest in importance among CPPs. 

In line with Lean Six Sigma A3 methodology, several tests of change were used to improve pharmacogenomic testing ordering. These changes focused on increasing patient and clinician awareness, facilitating discussion, educating clinicians, and simplifying documentation to ease time constraints. Several strategies were employed postimplementation (Figure 2). Prefilled templates simplified documentation. These templates helped identify patients without pharmacogenomic testing, provided reminders, and saved documentation time during visits. CPPs also received training and materials on PHASER ordering and documentation within encounter notes. Additionally, patient-directed advertisements were displayed in CPP examination rooms to help inspire and facilitate discussion between veterans and CPPs.

Process Improvement Data

The quality improvement project goal was to increase PHASER orders by 50% after 3 months. PHASER orders increased from 87 at baseline (March 8, 2023, to September 8, 2023) to 196 during the intervention (November 16, 2023, to February 16, 2024), a 125% increase. Changes were consistent and sustained with 65 orders the first month, 67 orders the second month, and 64 orders the third month.

Discussion

Using Lean Six Sigma A3 methodology for a quality improvement process to increase PHASER orders by CPPs revealed barriers and guided potential solutions to overcome these barriers. Interventions included additional CPP training and ordering, tools for easier identification of potential patients, documentation best practices, patient-directed advertisements to facilitate conversations. These interventions required about 8 hours for preparation, distribution, development, and interpretation of surveys, education, and documentation materials. The financial impact of these interventions was already included in allotted office materials budgeted and provided. Additional funding was not needed to provide patient-directed advertisements or education materials. The VACOHCS pharmacogenomics CPP discusses PHASER test results with patients at a separate appointment.

Future directions include educating other CPPs to assist in discussing results with veterans. Overall, the changes implemented to improve the PHASER ordering process were low effort and exemplify the ease of streamlining future initiatives, allowing for sustained optimal implementation of pharmacogenomic testing.

Conclusions

A quality improvement initiative resulted in increased PHASER orders and a clearly defined process, allowing for a continued increase and sustained support. Perceived barriers were identified, and the changes implemented were often low effort but exhibited a sustained impact. The insights gleaned from this process will shape future process development initiatives and continue to sustain pharmacogenomic testing ordering by CPPs. This process will be extended to other VACOHCS clinical departments to further support increased access to pharmacogenomic testing, reduce medication trial and error, and reduce hospitalizations from adverse effects for veterans.

Peer-review, evidence-based, detailed gene/drug clinical practice guidelines suggest that genetic variations can impact how individuals metabolize medications, which is sometimes included in medication prescribing information.^1-3 Pharmacogenomic testing identifies genetic markers so medication selection and dosing can be tailored to each individual by identifying whether a specific medication is likely to be safe and effective prior to prescribing.⁴

Pharmacogenomics can be a valuable tool for personalizing medicine but has had suboptimal implementation since its discovery. The US Department of Veterans Affairs (VA) health care system reviewed the implementation of the Pharmacogenomic Testing for Veterans (PHASER) program. This review identified clinician barriers pre- and post-PHASER program implementation; staffing issues, competing clinical priorities, and inadequate PHASER program resources were the most frequently reported barriers to implementation of pharmacogenomic testing.⁵

Another evaluation of the implementation of the PHASER program that surveyed VA patients found that patients could be separated into 3 groups. Acceptors of pharmacogenomic testing emphasized potential health benefits of testing. Patients that declined testing often cited concerns for genetic information affecting insurance coverage, being misused, or being susceptible to data breach. The third group—identified as contemplators—reported the need for clinician outreach to impact their decision on whether or not to receive pharmacogenomic testing.⁶ These studies suggest that removing barriers by providing ample pharmacogenomics resources to clinicians, in addition to detailed training on how to offer and follow up with patients regarding pharmacogenomic testing, is crucial to successful implementation of the PHASER program.

PHASER

In 2019, the VA began working with Sanford Health to establish the PHASER program and offer pharmacogenomic testing. PHASER has since expanded to 25 VA medical centers, including the VA Central Ohio Healthcare System (VACOHCS).^7,8 Pharmacogenomic testing through PHASER is conducted using a standardized laboratory panel that includes 12 different medication classes.⁹ The drug classes include certain anti-infective, anticoagulant, antiplatelet, cardiovascular, cholesterol, gastrointestinal, mental health, neurological, oncology, pain, transplant, and other miscellaneous medications. Medications are correlated to each class and assessed for therapeutic impacts based on gene panel results.

Clinical recommendations for medication-gene interactions can range from monitoring for increased risk of adverse effects or therapeutic failure to recommending avoiding a medication. For example, patients who test positive for the HLA-B gene have significantly increased risk of hypersensitivity to abacavir, an HIV treatment.¹⁰

Similarly, patients who cannot adequately metabolize cytochrome P450 2C19 should consider avoiding clopidogrel as they are unlikely to convert clopidogrel to its active prodrug, which reduces its effectiveness.¹¹ Pharmacists can play a critical role educating patients about pharmacogenomic testing, especially within hematology and oncology.¹² Patients can benefit from this testing even if they are not currently taking medications with known concerns as they could be prescribed in the future. The SLCO1B1 gene-drug test, for example, can identify risk for statin-associated muscle symptoms.¹³

Clinical pharmacist practitioners (CPPs) can increase access to genetic testing because they interact with patients in a variety of settings and can order this laboratory test.^12,14 Recent research has demonstrated that most VA patients carry ≥ 1 genetic variant that may influence medication decisions and that half of veterans are prescribed a medication with known gene-drug interactions.¹⁵ CPP ordering of pharmacogenomic tests at the VACOHCS outpatient clinic was evaluated through collection of baseline data from March 8, 2023, to September 8, 2023. A goal was identified to increase orders by 50% for a patient care quality improvement initiative and use CPPs to increase access to pharmacogenomic testing. The purpose of this quality improvement initiative was to expand access to pharmacogenomic testing through process implementation and improvement within CPP-led clinic settings.

Gap Analysis

Lean Six Sigma A3 methodology was used to identify ways to increase the use of pharmacogenomic testing for veterans at VACOHCS and develop an improved process for increased ordering of pharmacogenomic testing. Lean Six Sigma A3 methodology is a stepwise approach to process improvement that helps identify gaps in efficiency, sustainable changes, and eliminate waste.¹⁶ Baseline data were collected from March 8, 2023, to September 8, 2023, to determine the frequency of CPPs ordering pharmacogenomic laboratory panels during clinic appointments. The ordering of pharmacogenomic panels was monitored by the VACOHCS PHASER coordinator.

CPPs were surveyed to identify perceived barriers to PHASER implementation. A gap analysis was conducted using Lean Six Sigma A3 methodology. Gap analyses use lean tools such as a Fishbone Diagram to illustrate and identify the gap between current state and ideal state. (Figure 1).The following barriers were identified: lack of clinician education materials, lack of a standardized patient screening process, time constraints on patient education and ordering, higher priority clinical needs, forgetting to order, lack of comfort with pharmacogenomics ordering and education, lack of support for the initiative, and increased workload and burnout. Among these perceived barriers, higher priority clinical needs, forgetting to order, and time constraints ranked highest in importance among CPPs. 

In line with Lean Six Sigma A3 methodology, several tests of change were used to improve pharmacogenomic testing ordering. These changes focused on increasing patient and clinician awareness, facilitating discussion, educating clinicians, and simplifying documentation to ease time constraints. Several strategies were employed postimplementation (Figure 2). Prefilled templates simplified documentation. These templates helped identify patients without pharmacogenomic testing, provided reminders, and saved documentation time during visits. CPPs also received training and materials on PHASER ordering and documentation within encounter notes. Additionally, patient-directed advertisements were displayed in CPP examination rooms to help inspire and facilitate discussion between veterans and CPPs.

Process Improvement Data

The quality improvement project goal was to increase PHASER orders by 50% after 3 months. PHASER orders increased from 87 at baseline (March 8, 2023, to September 8, 2023) to 196 during the intervention (November 16, 2023, to February 16, 2024), a 125% increase. Changes were consistent and sustained with 65 orders the first month, 67 orders the second month, and 64 orders the third month.

Discussion

Using Lean Six Sigma A3 methodology for a quality improvement process to increase PHASER orders by CPPs revealed barriers and guided potential solutions to overcome these barriers. Interventions included additional CPP training and ordering, tools for easier identification of potential patients, documentation best practices, patient-directed advertisements to facilitate conversations. These interventions required about 8 hours for preparation, distribution, development, and interpretation of surveys, education, and documentation materials. The financial impact of these interventions was already included in allotted office materials budgeted and provided. Additional funding was not needed to provide patient-directed advertisements or education materials. The VACOHCS pharmacogenomics CPP discusses PHASER test results with patients at a separate appointment.

Future directions include educating other CPPs to assist in discussing results with veterans. Overall, the changes implemented to improve the PHASER ordering process were low effort and exemplify the ease of streamlining future initiatives, allowing for sustained optimal implementation of pharmacogenomic testing.

Conclusions

A quality improvement initiative resulted in increased PHASER orders and a clearly defined process, allowing for a continued increase and sustained support. Perceived barriers were identified, and the changes implemented were often low effort but exhibited a sustained impact. The insights gleaned from this process will shape future process development initiatives and continue to sustain pharmacogenomic testing ordering by CPPs. This process will be extended to other VACOHCS clinical departments to further support increased access to pharmacogenomic testing, reduce medication trial and error, and reduce hospitalizations from adverse effects for veterans.

Statins are widely used to reduce low-density lipoprotein (LDL) and non-high-density lipoprotein (HDL) levels for the prevention of atherosclerotic cardiovascular disease (ASCVD).¹ However, despite maximally tolerated statin therapy, many patients may not reach their LDL and non-HDL goals. Some patients may experience adverse events (AEs), particularly muscle-related AEs, which can limit the use of these medications.

The 2022 American College of Cardiology (ACC) expert consensus pathway recommends a goal LDL of < 55 mg/dL in very high-risk patients, defined as those with a history of multiple major ASCVD events or 1 major ASCVD event and multiple high-risk conditions.² Major ASCVD events include acute coronary syndrome within 12 months, history of myocardial infarction (MI) or ischemic stroke, and symptomatic peripheral arterial disease (ie, claudication with ankle-brachial index < 0.85 or previous revascularization or amputation). Factors for being considered high risk include age > 65 years, heterozygous familial hypercholesterolemia, history of prior coronary artery bypass surgery or percutaneous coronary intervention outside the major ASCVD events, diabetes, hypertension, chronic kidney disease (CKD) (estimated glomerular filtration rate [eGFR] 15-59 mL/min/1.73 m²), current smoking, persistently elevated LDL cholesterol (LDL-C) levels despite maximally tolerated statin therapy and ezetimibe, and history of congestive heart failure.² For these patients, statin therapy alone may not achieve LDL goal. 

The ACC recommends ezetimibe as the initial nonstatin therapy in patients who are not at their goal LDL.² Ezetimibe works by inhibiting Niemann-Pick C1-Like 1 protein, which causes reduced cholesterol absorption in the small intestine.^2,3 Previous studies have shown the benefit of ezetimibe for LDL reduction and ASCVD prevention.^4-7 The 2015 IMPROVE-IT study found the combination of simvastatin and ezetimibe resulted in a significantly lower risk of cardiovascular events than simvastatin monotherapy. IMPROVE-IT also reported a further clinical benefit when lower LDL targets (ie, < 55 mg/dL) are achieved, which aligns with the expert consensus pathway recommendations for a lower LDL goal for very high-risk patients.^2,5

The RACING trial found that treatment with a moderate-intensity statin and ezetimibe was noninferior to treatment with a high-intensity statin for the primary outcome of occurrence of cardiovascular death, major cardiovascular events, or nonfatal stroke within 3 years. The combination of moderate-intensity statin and ezetimibe achieved lower LDL-C levels and lower incidence of drug intolerance compared to high intensity statin monotherapy.⁶ The SHARP-CKD study assessed major atherosclerotic events in patients with CKD who had no history of MI or coronary revascularization. The study found that lowering LDL-C with the combination of simvastatin plus ezetimibe safely reduces the risk of major atherosclerotic events in a wide range of patients with CKD.⁷

Lastly, the 2019 EWTOPIA 75 study found that ezetimibe noted a statistically significant reduction in the incidence of the composite of sudden cardiac death, MI, coronary revascularization, or stroke compared to placebo. Ezetimibe showed benefits in preventing ASCVD events independently of statin therapy.⁸ These clinical trials provided evidence for the efficacy of ezetimibe for secondary or primary prevention of ASCVD, patients with CKD, and patients who are not at their LDL goal despite maximally tolerated statin therapy.

Reductions in LDL levels with ezetimibe are reported to be 15% to 19% for monotherapy and 13% to 25% when used in combination with a statin.⁴ Given that the ACC now recommends lower LDL goals, patients may need additional lowering despite taking maximally tolerated statin therapy.² Additionally, the package insert for ezetimibe reports increased area under the curve (AUC) values of ezetimibe and its metabolites in patients with severe renal disease. It is anticipated that ezetimibe may show an increased reduction of LDL and non-HDL, but there may also be an increased risk for muscle-related AEs.³

This quality-assurance quality improvement project investigated the use of ezetimibe in patients with CKD to determine whether there is further LDL and non-HDL reduction in this patient population. It sought to determine the LDL and non-HDL percentage reduction in patients with and without CKD at the Wilkes-Barre Veterans Affairs Medical Center (WBVAMC) and whether there is an increased risk for muscle-related AEs. Determining the percentage reduction of LDL and non-HDL within this population can help increase use of ezetimibe in patients not at their LDL or non-HDL goal or for those patients unable to tolerate statin therapy.

Methods

This single-center retrospective chart review investigated patients prescribed ezetimibe by a patient aligned care team (PACT) pharmacist at WBVAMC between September 1, 2021, and September 1, 2023. This project was determined to be nonresearch by the Veterans Integrated Service Network 4 multisite institutional review board. Patients were excluded from the review if they started taking ezetimibe outside of the prespecified time frame, if ezetimibe was initiated by a non-WBVAMC PACT pharmacist, or if there was no follow-up lipid panel obtained within 6 months of initiation of ezetimibe.

The primary outcomes were to determine the percentage mean change in LDL and non-HDL reduction and the incidence of muscle-related AEs after initiation of ezetimibe in patients without CKD. The secondary outcomes were to determine the percentage mean change in LDL and non-HDL levels and the incidence of muscle-related AEs after initiation of ezetimibe in patients with CKD. For this study, CKD was defined as a patient having an eGFR 15 to 60 ml/min/1.73 m². Non-HDL is the combination of LDL-C and very LDL-C and represents all potentially atherogenic particles. The 2022 Expert Consensus Pathway included non-HDL goals in addition to LDL goals.² Non-HDL cholesterol levels can be used for patients with elevated triglycerides where LDL levels may not be as accurate. To account for instances of elevated triglycerides, this study assessed changes in both LDL and non-HDL levels.

Data were collected from the US Department of Veterans Affairs (VA) Computerized Patient Record System (CPRS) and recorded in a spreadsheet. Collected data included age, sex, race, concomitant cholesterol-lowering medications (statin, proprotein convertase subtilisin/kexin type 9 [PCSK9] inhibitor, bempedoic acid, fish oil, niacin, bile acid sequestrants, and fibrates), baseline lipid panel, lipid panel within 6 months of ezetimibe initiation, and eGFR level. If the patient’s LDL or non-HDL levels worsened on the follow-up lipid panel, their baseline LDL and non-HDL levels were used to calculate the percentage reduction; thus, the percentage reduction would be 0%. This strategy was used in prior research, notably the IMPROVE-IT and SHARP-CKD trials. 

Ezetimibe 5 mg once daily was used in this study based on a 2008 VA study that evaluated the use of ezetimibe 5 mg vs ezetimibe 10 mg and the percentage reduction of LDL with each dose. The study found no significant difference between the 5 mg and 10 mg dose.⁹ Most patients included in this study received the 5 mg dose.

Results

This retrospective chart review consisted of 173 patients, 137 (79.2%) without CKD and 36 (20.8%) with CKD at baseline. The mean age was 69.6 years, 155 (89.6%) patients were male, and 18 (10.4%) were female. There were 164 concomitant medications, including 115 patients prescribed a statin and 38 patients prescribed fish oil (Table 1).

Patients without CKD had mean reductions in LDL levels of 23.5% and non-HDL levels of 21.7% (Figure). Patients who had an increase in LDL and non-HDL levels were excluded to control for potential confounding factors such as dietary changes, discontinuation of ezetimibe therapy, nonadherence to ezetimibe, and medication changes that impacted follow-up laboratory tests such as discontinuation of a statin. Fifteen patients experienced an increase in LDL or non-HDL levels. After excluding these patients, those without CKD had a mean reduction in LDL levels of 28.0% and non-HDL levels of 25.5%. Nineteen (13.9%) patients without CKD experienced a muscle-related AE (Table 2). One patient discontinued ezetimibe and statin use following a Lyme disease diagnosis due to concerns over potential muscle-related AEs. 

Patients with CKD had a mean reduction in LDL and non-HDL levels of 27.0% and 24.8%, respectively. Patients with an increase in LDL or non-HDL levels were also excluded to help control for potential confounding factors. After excluding 4 patients with increased LDL and non-HDL levels, the mean reduction in LDL and non-HDL levels was 30.5% and 27.5%, respectively. Five (13.9%) patients with CKD experienced muscle-related AEs thought to be due to ezetimibe. Other AEs (eg, urticaria, diarrhea, reflux, dizziness, headache, upset stomach) were reported that led to discontinuation of ezetimibe, but only muscle-related AEs were analyzed.

Discussion

This retrospective chart review found larger reductions in LDL and non-HDL levels for patients with CKD than reported in the literature.⁴ Based on the findings that indicate a greater cholesterol reduction with ezetimibe, the results suggest an underutilization of ezetimibe in clinical practice, which may be due to clinicians favoring statin therapy and overlooking ezetimibe as a viable option based on recommendation in earlier guidelines. The 2022 guidelines transitioned from a statin focus to a focus on LDL targets and goals.²

According to the ACC, there is evidence to support a direct relationship between LDL-C levels, atherosclerosis progression, and ASCVD event risk.² Absolute LDL-C level reduction is directly associated with ASCVD risk reduction which supports the LDL hypothesis. There appears to be no specific LDL-C level below which benefit ceases.² This suggests that lower LDL-C targets (< 55 mg/dL) should be used when clinically indicated. Many patients are either unable to reach their goal LDL levels with statin monotherapy or are unable to tolerate statin therapy at higher doses, which may require additional pharmacotherapy to reach goal LDL-C. The ACC expert consensus pathway recommends ezetimibe as the initial add-on treatment to statins.² The RACING trial showed the benefit of adding ezetimibe to a moderate-intensity statin vs increasing to a high-intensity statin dose. This trial found patients had lower LDL levels and lower rates of intolerances, which further supports ezetimibe use.⁶

This quality improvement project assessed LDL and non-HDL level reduction in patients with CKD. As anticipated, there was greater reduction in LDL and non-HDL levels seen in patients with CKD. The SHARP-CKD trial also found reductions in LDL levels with ezetimibe in patients with CKD.⁷ Given the reduction in LDL and non-HDL levels with ezetimibe in patients with or without CKD, add-on therapy of ezetimibe should be recommended for patients who do not achieve their LDL goals with statin therapy or for patients who intolerant to statin therapy. 

The ezetimibe package insert reports myalgias incidence to be < 5% in patients and research has shown up to a 20% incidence of muscle-related AEs with statin therapy.^3,10 Based on the package information reporting increased AUC values of ezetimibe and its metabolites in patients with severe renal disease, it was anticipated there may be an increased risk of muscle-related AEs in patients with CKD.³ However, this study found the same incidence of muscle-related AEs in patients with and without CKD. Previous research on statin-intolerant patients found the incidence of muscle-related AEs with ezetimibe to be 23.0% and 28.8%.^11,12 This increased incidence of muscle-related AEs may be the result of including patients with a history of statin intolerance. Collectively, data from clinical trials and this study indicate that patients with prior intolerances to statins appear to have a higher likelihood of developing a muscle-related AEs with ezetimibe.^11,12 Clinicians and patients should be educated on the potential for these AEs and be aware that the likelihood may be greater if there is a history of statin intolerance. To our knowledge, this was the first study to evaluate muscle-related AEs with ezetimibe in patients with and without CKD.

Limitations

This retrospective chart review was performed over a prespecified period and only patients initiated on ezetimibe by a PACT pharmacist were included. This study did not assess the percentage of LDL reduction in patients on concomitant statins vs those who were not on concomitant statins. The study only included 173 patients. Additionally, the study was primarily composed of White men and may not be representative of other populations. In addition, veterans may not be representative of the general population given their high comorbidity burden and other exposures. Some reported muscle-related AEs associated with ezetimibe may be attributed to the nocebo effect.

Conclusions

The results of this retrospective chart review suggest there may be a larger mean reduction in LDL and non-HDL levels seen with ezetimibe therapy than reported within the literature. There was a larger mean reduction in LDL and non-HDL levels in patients with CKD than in patients without CKD. Additionally, there were the same rates of muscle-related AEs with ezetimibe therapy in patients with and without CKD. The rates of muscle-related AEs with ezetimibe therapy were higher than reported in the medication’s package insert, but lower than reported in literature that included statin-intolerant patients. These results indicate there may be a benefit to an increase in use of ezetimibe in clinical practice due to its increased effectiveness and safety in patients with and without CKD. Ultimately, this can help patients achieve their LDL goals as recommended by ACC clinical practice guidelines.

Statins are widely used to reduce low-density lipoprotein (LDL) and non-high-density lipoprotein (HDL) levels for the prevention of atherosclerotic cardiovascular disease (ASCVD).¹ However, despite maximally tolerated statin therapy, many patients may not reach their LDL and non-HDL goals. Some patients may experience adverse events (AEs), particularly muscle-related AEs, which can limit the use of these medications.

The 2022 American College of Cardiology (ACC) expert consensus pathway recommends a goal LDL of < 55 mg/dL in very high-risk patients, defined as those with a history of multiple major ASCVD events or 1 major ASCVD event and multiple high-risk conditions.² Major ASCVD events include acute coronary syndrome within 12 months, history of myocardial infarction (MI) or ischemic stroke, and symptomatic peripheral arterial disease (ie, claudication with ankle-brachial index < 0.85 or previous revascularization or amputation). Factors for being considered high risk include age > 65 years, heterozygous familial hypercholesterolemia, history of prior coronary artery bypass surgery or percutaneous coronary intervention outside the major ASCVD events, diabetes, hypertension, chronic kidney disease (CKD) (estimated glomerular filtration rate [eGFR] 15-59 mL/min/1.73 m²), current smoking, persistently elevated LDL cholesterol (LDL-C) levels despite maximally tolerated statin therapy and ezetimibe, and history of congestive heart failure.² For these patients, statin therapy alone may not achieve LDL goal. 

The ACC recommends ezetimibe as the initial nonstatin therapy in patients who are not at their goal LDL.² Ezetimibe works by inhibiting Niemann-Pick C1-Like 1 protein, which causes reduced cholesterol absorption in the small intestine.^2,3 Previous studies have shown the benefit of ezetimibe for LDL reduction and ASCVD prevention.^4-7 The 2015 IMPROVE-IT study found the combination of simvastatin and ezetimibe resulted in a significantly lower risk of cardiovascular events than simvastatin monotherapy. IMPROVE-IT also reported a further clinical benefit when lower LDL targets (ie, < 55 mg/dL) are achieved, which aligns with the expert consensus pathway recommendations for a lower LDL goal for very high-risk patients.^2,5

The RACING trial found that treatment with a moderate-intensity statin and ezetimibe was noninferior to treatment with a high-intensity statin for the primary outcome of occurrence of cardiovascular death, major cardiovascular events, or nonfatal stroke within 3 years. The combination of moderate-intensity statin and ezetimibe achieved lower LDL-C levels and lower incidence of drug intolerance compared to high intensity statin monotherapy.⁶ The SHARP-CKD study assessed major atherosclerotic events in patients with CKD who had no history of MI or coronary revascularization. The study found that lowering LDL-C with the combination of simvastatin plus ezetimibe safely reduces the risk of major atherosclerotic events in a wide range of patients with CKD.⁷

Lastly, the 2019 EWTOPIA 75 study found that ezetimibe noted a statistically significant reduction in the incidence of the composite of sudden cardiac death, MI, coronary revascularization, or stroke compared to placebo. Ezetimibe showed benefits in preventing ASCVD events independently of statin therapy.⁸ These clinical trials provided evidence for the efficacy of ezetimibe for secondary or primary prevention of ASCVD, patients with CKD, and patients who are not at their LDL goal despite maximally tolerated statin therapy.

Reductions in LDL levels with ezetimibe are reported to be 15% to 19% for monotherapy and 13% to 25% when used in combination with a statin.⁴ Given that the ACC now recommends lower LDL goals, patients may need additional lowering despite taking maximally tolerated statin therapy.² Additionally, the package insert for ezetimibe reports increased area under the curve (AUC) values of ezetimibe and its metabolites in patients with severe renal disease. It is anticipated that ezetimibe may show an increased reduction of LDL and non-HDL, but there may also be an increased risk for muscle-related AEs.³

This quality-assurance quality improvement project investigated the use of ezetimibe in patients with CKD to determine whether there is further LDL and non-HDL reduction in this patient population. It sought to determine the LDL and non-HDL percentage reduction in patients with and without CKD at the Wilkes-Barre Veterans Affairs Medical Center (WBVAMC) and whether there is an increased risk for muscle-related AEs. Determining the percentage reduction of LDL and non-HDL within this population can help increase use of ezetimibe in patients not at their LDL or non-HDL goal or for those patients unable to tolerate statin therapy.

Methods

This single-center retrospective chart review investigated patients prescribed ezetimibe by a patient aligned care team (PACT) pharmacist at WBVAMC between September 1, 2021, and September 1, 2023. This project was determined to be nonresearch by the Veterans Integrated Service Network 4 multisite institutional review board. Patients were excluded from the review if they started taking ezetimibe outside of the prespecified time frame, if ezetimibe was initiated by a non-WBVAMC PACT pharmacist, or if there was no follow-up lipid panel obtained within 6 months of initiation of ezetimibe.

The primary outcomes were to determine the percentage mean change in LDL and non-HDL reduction and the incidence of muscle-related AEs after initiation of ezetimibe in patients without CKD. The secondary outcomes were to determine the percentage mean change in LDL and non-HDL levels and the incidence of muscle-related AEs after initiation of ezetimibe in patients with CKD. For this study, CKD was defined as a patient having an eGFR 15 to 60 ml/min/1.73 m². Non-HDL is the combination of LDL-C and very LDL-C and represents all potentially atherogenic particles. The 2022 Expert Consensus Pathway included non-HDL goals in addition to LDL goals.² Non-HDL cholesterol levels can be used for patients with elevated triglycerides where LDL levels may not be as accurate. To account for instances of elevated triglycerides, this study assessed changes in both LDL and non-HDL levels.

Data were collected from the US Department of Veterans Affairs (VA) Computerized Patient Record System (CPRS) and recorded in a spreadsheet. Collected data included age, sex, race, concomitant cholesterol-lowering medications (statin, proprotein convertase subtilisin/kexin type 9 [PCSK9] inhibitor, bempedoic acid, fish oil, niacin, bile acid sequestrants, and fibrates), baseline lipid panel, lipid panel within 6 months of ezetimibe initiation, and eGFR level. If the patient’s LDL or non-HDL levels worsened on the follow-up lipid panel, their baseline LDL and non-HDL levels were used to calculate the percentage reduction; thus, the percentage reduction would be 0%. This strategy was used in prior research, notably the IMPROVE-IT and SHARP-CKD trials. 

Ezetimibe 5 mg once daily was used in this study based on a 2008 VA study that evaluated the use of ezetimibe 5 mg vs ezetimibe 10 mg and the percentage reduction of LDL with each dose. The study found no significant difference between the 5 mg and 10 mg dose.⁹ Most patients included in this study received the 5 mg dose.

Results

This retrospective chart review consisted of 173 patients, 137 (79.2%) without CKD and 36 (20.8%) with CKD at baseline. The mean age was 69.6 years, 155 (89.6%) patients were male, and 18 (10.4%) were female. There were 164 concomitant medications, including 115 patients prescribed a statin and 38 patients prescribed fish oil (Table 1).

Patients without CKD had mean reductions in LDL levels of 23.5% and non-HDL levels of 21.7% (Figure). Patients who had an increase in LDL and non-HDL levels were excluded to control for potential confounding factors such as dietary changes, discontinuation of ezetimibe therapy, nonadherence to ezetimibe, and medication changes that impacted follow-up laboratory tests such as discontinuation of a statin. Fifteen patients experienced an increase in LDL or non-HDL levels. After excluding these patients, those without CKD had a mean reduction in LDL levels of 28.0% and non-HDL levels of 25.5%. Nineteen (13.9%) patients without CKD experienced a muscle-related AE (Table 2). One patient discontinued ezetimibe and statin use following a Lyme disease diagnosis due to concerns over potential muscle-related AEs. 

Patients with CKD had a mean reduction in LDL and non-HDL levels of 27.0% and 24.8%, respectively. Patients with an increase in LDL or non-HDL levels were also excluded to help control for potential confounding factors. After excluding 4 patients with increased LDL and non-HDL levels, the mean reduction in LDL and non-HDL levels was 30.5% and 27.5%, respectively. Five (13.9%) patients with CKD experienced muscle-related AEs thought to be due to ezetimibe. Other AEs (eg, urticaria, diarrhea, reflux, dizziness, headache, upset stomach) were reported that led to discontinuation of ezetimibe, but only muscle-related AEs were analyzed.

Discussion

This retrospective chart review found larger reductions in LDL and non-HDL levels for patients with CKD than reported in the literature.⁴ Based on the findings that indicate a greater cholesterol reduction with ezetimibe, the results suggest an underutilization of ezetimibe in clinical practice, which may be due to clinicians favoring statin therapy and overlooking ezetimibe as a viable option based on recommendation in earlier guidelines. The 2022 guidelines transitioned from a statin focus to a focus on LDL targets and goals.²

According to the ACC, there is evidence to support a direct relationship between LDL-C levels, atherosclerosis progression, and ASCVD event risk.² Absolute LDL-C level reduction is directly associated with ASCVD risk reduction which supports the LDL hypothesis. There appears to be no specific LDL-C level below which benefit ceases.² This suggests that lower LDL-C targets (< 55 mg/dL) should be used when clinically indicated. Many patients are either unable to reach their goal LDL levels with statin monotherapy or are unable to tolerate statin therapy at higher doses, which may require additional pharmacotherapy to reach goal LDL-C. The ACC expert consensus pathway recommends ezetimibe as the initial add-on treatment to statins.² The RACING trial showed the benefit of adding ezetimibe to a moderate-intensity statin vs increasing to a high-intensity statin dose. This trial found patients had lower LDL levels and lower rates of intolerances, which further supports ezetimibe use.⁶

This quality improvement project assessed LDL and non-HDL level reduction in patients with CKD. As anticipated, there was greater reduction in LDL and non-HDL levels seen in patients with CKD. The SHARP-CKD trial also found reductions in LDL levels with ezetimibe in patients with CKD.⁷ Given the reduction in LDL and non-HDL levels with ezetimibe in patients with or without CKD, add-on therapy of ezetimibe should be recommended for patients who do not achieve their LDL goals with statin therapy or for patients who intolerant to statin therapy. 

The ezetimibe package insert reports myalgias incidence to be < 5% in patients and research has shown up to a 20% incidence of muscle-related AEs with statin therapy.^3,10 Based on the package information reporting increased AUC values of ezetimibe and its metabolites in patients with severe renal disease, it was anticipated there may be an increased risk of muscle-related AEs in patients with CKD.³ However, this study found the same incidence of muscle-related AEs in patients with and without CKD. Previous research on statin-intolerant patients found the incidence of muscle-related AEs with ezetimibe to be 23.0% and 28.8%.^11,12 This increased incidence of muscle-related AEs may be the result of including patients with a history of statin intolerance. Collectively, data from clinical trials and this study indicate that patients with prior intolerances to statins appear to have a higher likelihood of developing a muscle-related AEs with ezetimibe.^11,12 Clinicians and patients should be educated on the potential for these AEs and be aware that the likelihood may be greater if there is a history of statin intolerance. To our knowledge, this was the first study to evaluate muscle-related AEs with ezetimibe in patients with and without CKD.

Limitations

This retrospective chart review was performed over a prespecified period and only patients initiated on ezetimibe by a PACT pharmacist were included. This study did not assess the percentage of LDL reduction in patients on concomitant statins vs those who were not on concomitant statins. The study only included 173 patients. Additionally, the study was primarily composed of White men and may not be representative of other populations. In addition, veterans may not be representative of the general population given their high comorbidity burden and other exposures. Some reported muscle-related AEs associated with ezetimibe may be attributed to the nocebo effect.

Conclusions

The results of this retrospective chart review suggest there may be a larger mean reduction in LDL and non-HDL levels seen with ezetimibe therapy than reported within the literature. There was a larger mean reduction in LDL and non-HDL levels in patients with CKD than in patients without CKD. Additionally, there were the same rates of muscle-related AEs with ezetimibe therapy in patients with and without CKD. The rates of muscle-related AEs with ezetimibe therapy were higher than reported in the medication’s package insert, but lower than reported in literature that included statin-intolerant patients. These results indicate there may be a benefit to an increase in use of ezetimibe in clinical practice due to its increased effectiveness and safety in patients with and without CKD. Ultimately, this can help patients achieve their LDL goals as recommended by ACC clinical practice guidelines.

Statins are widely used to reduce low-density lipoprotein (LDL) and non-high-density lipoprotein (HDL) levels for the prevention of atherosclerotic cardiovascular disease (ASCVD).¹ However, despite maximally tolerated statin therapy, many patients may not reach their LDL and non-HDL goals. Some patients may experience adverse events (AEs), particularly muscle-related AEs, which can limit the use of these medications.

The 2022 American College of Cardiology (ACC) expert consensus pathway recommends a goal LDL of < 55 mg/dL in very high-risk patients, defined as those with a history of multiple major ASCVD events or 1 major ASCVD event and multiple high-risk conditions.² Major ASCVD events include acute coronary syndrome within 12 months, history of myocardial infarction (MI) or ischemic stroke, and symptomatic peripheral arterial disease (ie, claudication with ankle-brachial index < 0.85 or previous revascularization or amputation). Factors for being considered high risk include age > 65 years, heterozygous familial hypercholesterolemia, history of prior coronary artery bypass surgery or percutaneous coronary intervention outside the major ASCVD events, diabetes, hypertension, chronic kidney disease (CKD) (estimated glomerular filtration rate [eGFR] 15-59 mL/min/1.73 m²), current smoking, persistently elevated LDL cholesterol (LDL-C) levels despite maximally tolerated statin therapy and ezetimibe, and history of congestive heart failure.² For these patients, statin therapy alone may not achieve LDL goal. 

The ACC recommends ezetimibe as the initial nonstatin therapy in patients who are not at their goal LDL.² Ezetimibe works by inhibiting Niemann-Pick C1-Like 1 protein, which causes reduced cholesterol absorption in the small intestine.^2,3 Previous studies have shown the benefit of ezetimibe for LDL reduction and ASCVD prevention.^4-7 The 2015 IMPROVE-IT study found the combination of simvastatin and ezetimibe resulted in a significantly lower risk of cardiovascular events than simvastatin monotherapy. IMPROVE-IT also reported a further clinical benefit when lower LDL targets (ie, < 55 mg/dL) are achieved, which aligns with the expert consensus pathway recommendations for a lower LDL goal for very high-risk patients.^2,5

The RACING trial found that treatment with a moderate-intensity statin and ezetimibe was noninferior to treatment with a high-intensity statin for the primary outcome of occurrence of cardiovascular death, major cardiovascular events, or nonfatal stroke within 3 years. The combination of moderate-intensity statin and ezetimibe achieved lower LDL-C levels and lower incidence of drug intolerance compared to high intensity statin monotherapy.⁶ The SHARP-CKD study assessed major atherosclerotic events in patients with CKD who had no history of MI or coronary revascularization. The study found that lowering LDL-C with the combination of simvastatin plus ezetimibe safely reduces the risk of major atherosclerotic events in a wide range of patients with CKD.⁷

Lastly, the 2019 EWTOPIA 75 study found that ezetimibe noted a statistically significant reduction in the incidence of the composite of sudden cardiac death, MI, coronary revascularization, or stroke compared to placebo. Ezetimibe showed benefits in preventing ASCVD events independently of statin therapy.⁸ These clinical trials provided evidence for the efficacy of ezetimibe for secondary or primary prevention of ASCVD, patients with CKD, and patients who are not at their LDL goal despite maximally tolerated statin therapy.

Reductions in LDL levels with ezetimibe are reported to be 15% to 19% for monotherapy and 13% to 25% when used in combination with a statin.⁴ Given that the ACC now recommends lower LDL goals, patients may need additional lowering despite taking maximally tolerated statin therapy.² Additionally, the package insert for ezetimibe reports increased area under the curve (AUC) values of ezetimibe and its metabolites in patients with severe renal disease. It is anticipated that ezetimibe may show an increased reduction of LDL and non-HDL, but there may also be an increased risk for muscle-related AEs.³

This quality-assurance quality improvement project investigated the use of ezetimibe in patients with CKD to determine whether there is further LDL and non-HDL reduction in this patient population. It sought to determine the LDL and non-HDL percentage reduction in patients with and without CKD at the Wilkes-Barre Veterans Affairs Medical Center (WBVAMC) and whether there is an increased risk for muscle-related AEs. Determining the percentage reduction of LDL and non-HDL within this population can help increase use of ezetimibe in patients not at their LDL or non-HDL goal or for those patients unable to tolerate statin therapy.

Methods

This single-center retrospective chart review investigated patients prescribed ezetimibe by a patient aligned care team (PACT) pharmacist at WBVAMC between September 1, 2021, and September 1, 2023. This project was determined to be nonresearch by the Veterans Integrated Service Network 4 multisite institutional review board. Patients were excluded from the review if they started taking ezetimibe outside of the prespecified time frame, if ezetimibe was initiated by a non-WBVAMC PACT pharmacist, or if there was no follow-up lipid panel obtained within 6 months of initiation of ezetimibe.

The primary outcomes were to determine the percentage mean change in LDL and non-HDL reduction and the incidence of muscle-related AEs after initiation of ezetimibe in patients without CKD. The secondary outcomes were to determine the percentage mean change in LDL and non-HDL levels and the incidence of muscle-related AEs after initiation of ezetimibe in patients with CKD. For this study, CKD was defined as a patient having an eGFR 15 to 60 ml/min/1.73 m². Non-HDL is the combination of LDL-C and very LDL-C and represents all potentially atherogenic particles. The 2022 Expert Consensus Pathway included non-HDL goals in addition to LDL goals.² Non-HDL cholesterol levels can be used for patients with elevated triglycerides where LDL levels may not be as accurate. To account for instances of elevated triglycerides, this study assessed changes in both LDL and non-HDL levels.

Data were collected from the US Department of Veterans Affairs (VA) Computerized Patient Record System (CPRS) and recorded in a spreadsheet. Collected data included age, sex, race, concomitant cholesterol-lowering medications (statin, proprotein convertase subtilisin/kexin type 9 [PCSK9] inhibitor, bempedoic acid, fish oil, niacin, bile acid sequestrants, and fibrates), baseline lipid panel, lipid panel within 6 months of ezetimibe initiation, and eGFR level. If the patient’s LDL or non-HDL levels worsened on the follow-up lipid panel, their baseline LDL and non-HDL levels were used to calculate the percentage reduction; thus, the percentage reduction would be 0%. This strategy was used in prior research, notably the IMPROVE-IT and SHARP-CKD trials. 

Ezetimibe 5 mg once daily was used in this study based on a 2008 VA study that evaluated the use of ezetimibe 5 mg vs ezetimibe 10 mg and the percentage reduction of LDL with each dose. The study found no significant difference between the 5 mg and 10 mg dose.⁹ Most patients included in this study received the 5 mg dose.

Results

This retrospective chart review consisted of 173 patients, 137 (79.2%) without CKD and 36 (20.8%) with CKD at baseline. The mean age was 69.6 years, 155 (89.6%) patients were male, and 18 (10.4%) were female. There were 164 concomitant medications, including 115 patients prescribed a statin and 38 patients prescribed fish oil (Table 1).

Patients without CKD had mean reductions in LDL levels of 23.5% and non-HDL levels of 21.7% (Figure). Patients who had an increase in LDL and non-HDL levels were excluded to control for potential confounding factors such as dietary changes, discontinuation of ezetimibe therapy, nonadherence to ezetimibe, and medication changes that impacted follow-up laboratory tests such as discontinuation of a statin. Fifteen patients experienced an increase in LDL or non-HDL levels. After excluding these patients, those without CKD had a mean reduction in LDL levels of 28.0% and non-HDL levels of 25.5%. Nineteen (13.9%) patients without CKD experienced a muscle-related AE (Table 2). One patient discontinued ezetimibe and statin use following a Lyme disease diagnosis due to concerns over potential muscle-related AEs. 

Patients with CKD had a mean reduction in LDL and non-HDL levels of 27.0% and 24.8%, respectively. Patients with an increase in LDL or non-HDL levels were also excluded to help control for potential confounding factors. After excluding 4 patients with increased LDL and non-HDL levels, the mean reduction in LDL and non-HDL levels was 30.5% and 27.5%, respectively. Five (13.9%) patients with CKD experienced muscle-related AEs thought to be due to ezetimibe. Other AEs (eg, urticaria, diarrhea, reflux, dizziness, headache, upset stomach) were reported that led to discontinuation of ezetimibe, but only muscle-related AEs were analyzed.

Discussion

This retrospective chart review found larger reductions in LDL and non-HDL levels for patients with CKD than reported in the literature.⁴ Based on the findings that indicate a greater cholesterol reduction with ezetimibe, the results suggest an underutilization of ezetimibe in clinical practice, which may be due to clinicians favoring statin therapy and overlooking ezetimibe as a viable option based on recommendation in earlier guidelines. The 2022 guidelines transitioned from a statin focus to a focus on LDL targets and goals.²

According to the ACC, there is evidence to support a direct relationship between LDL-C levels, atherosclerosis progression, and ASCVD event risk.² Absolute LDL-C level reduction is directly associated with ASCVD risk reduction which supports the LDL hypothesis. There appears to be no specific LDL-C level below which benefit ceases.² This suggests that lower LDL-C targets (< 55 mg/dL) should be used when clinically indicated. Many patients are either unable to reach their goal LDL levels with statin monotherapy or are unable to tolerate statin therapy at higher doses, which may require additional pharmacotherapy to reach goal LDL-C. The ACC expert consensus pathway recommends ezetimibe as the initial add-on treatment to statins.² The RACING trial showed the benefit of adding ezetimibe to a moderate-intensity statin vs increasing to a high-intensity statin dose. This trial found patients had lower LDL levels and lower rates of intolerances, which further supports ezetimibe use.⁶

This quality improvement project assessed LDL and non-HDL level reduction in patients with CKD. As anticipated, there was greater reduction in LDL and non-HDL levels seen in patients with CKD. The SHARP-CKD trial also found reductions in LDL levels with ezetimibe in patients with CKD.⁷ Given the reduction in LDL and non-HDL levels with ezetimibe in patients with or without CKD, add-on therapy of ezetimibe should be recommended for patients who do not achieve their LDL goals with statin therapy or for patients who intolerant to statin therapy. 

The ezetimibe package insert reports myalgias incidence to be < 5% in patients and research has shown up to a 20% incidence of muscle-related AEs with statin therapy.^3,10 Based on the package information reporting increased AUC values of ezetimibe and its metabolites in patients with severe renal disease, it was anticipated there may be an increased risk of muscle-related AEs in patients with CKD.³ However, this study found the same incidence of muscle-related AEs in patients with and without CKD. Previous research on statin-intolerant patients found the incidence of muscle-related AEs with ezetimibe to be 23.0% and 28.8%.^11,12 This increased incidence of muscle-related AEs may be the result of including patients with a history of statin intolerance. Collectively, data from clinical trials and this study indicate that patients with prior intolerances to statins appear to have a higher likelihood of developing a muscle-related AEs with ezetimibe.^11,12 Clinicians and patients should be educated on the potential for these AEs and be aware that the likelihood may be greater if there is a history of statin intolerance. To our knowledge, this was the first study to evaluate muscle-related AEs with ezetimibe in patients with and without CKD.

Limitations

This retrospective chart review was performed over a prespecified period and only patients initiated on ezetimibe by a PACT pharmacist were included. This study did not assess the percentage of LDL reduction in patients on concomitant statins vs those who were not on concomitant statins. The study only included 173 patients. Additionally, the study was primarily composed of White men and may not be representative of other populations. In addition, veterans may not be representative of the general population given their high comorbidity burden and other exposures. Some reported muscle-related AEs associated with ezetimibe may be attributed to the nocebo effect.

Conclusions

The results of this retrospective chart review suggest there may be a larger mean reduction in LDL and non-HDL levels seen with ezetimibe therapy than reported within the literature. There was a larger mean reduction in LDL and non-HDL levels in patients with CKD than in patients without CKD. Additionally, there were the same rates of muscle-related AEs with ezetimibe therapy in patients with and without CKD. The rates of muscle-related AEs with ezetimibe therapy were higher than reported in the medication’s package insert, but lower than reported in literature that included statin-intolerant patients. These results indicate there may be a benefit to an increase in use of ezetimibe in clinical practice due to its increased effectiveness and safety in patients with and without CKD. Ultimately, this can help patients achieve their LDL goals as recommended by ACC clinical practice guidelines.

Comprehensive genomic profiling (CGP) is becoming progressively common and appropriate as the array of molecular targets expands. However, most hospital laboratories in the United States do not perform CGP assays in-house; instead, these tests are sent to reference laboratories. As evidenced by Inal et al, only a minority of guideline-indicated molecular testing is performed.¹

The workload associated with referral testing is a barrier to increased use of such tests; streamlined processes in pathology might increase molecular test use. At 6 high-complexity US Department of Veterans Affairs (VA) medical centers (VAMCs) (Manhattan, Los Angeles, San Diego, Denver, Kansas City, and Salisbury, Maryland) ranging from 150 to 750 beds, a consult process for anatomic pathology molecular testing has increased test utilization, appropriateness of orders, standardization of reporting, and efficiency of care. This report comprehensively describes and maps the anatomic pathology molecular testing consult process at a VAMC. We present areas of inefficiency and a target state process map that incorporates best practices.

MOLECULAR TESTING CONSULT PROCESS

At the Kansas City VAMC (KCVAMC), a consult process for anatomic pathology molecular testing was introduced in 2021. Prior to this, requesting anatomic pathology molecular testing was not standardized. A variety of opportunities and methods were used for requests (eg, phone, page, Teams message, email, Computerized Patient Record System alert; or in-person during tumor board, an office meeting, or in passing). Requests were not documented in a standardized way, resulting in duplicate requests. Testing status and updates were documented outside the medical record, so requests for status updates (via various opportunities and methods) were common and redundant. Data from the year preceding consult implementation and the year following consult implementation have demonstrated increased test utilization, appropriateness of orders, standardization of reporting, and efficiency of care.

Consult Request

The precision oncology testing process starts with a health care practitioner (HCP) request on behalf of any physician or advanced practice registered nurse. It can be placed by any health care employee and directed to a designated employee in the pathology department. The request is ultimately reviewed by a pathologist (Figure 1). At KCVAMC, this request comes in the form of a consult in the electronic health record (EHR) from the ordering HCP to a pathologist. The KCVAMC pathology consult form was previously published with a discussion of the rationale for this process as opposed to a laboratory order process.² This consult form ensures ordering HCPs supply all necessary information for the pathologist to approve the request and order the test without needing to, in most cases, contact the ordering HCP for clarification or additional information. The form asks the ordering HCP to specify which test is being requested and why. Within the Veterans Health Administration (VHA) there are local and national contracts with many laboratories with hundreds of precision oncology tests to choose from. Consulting with a pathologist is necessary to determine which test is most appropriate.

The precision oncology consult form cannot be submitted without completing all required fields. It also contains indications for the test the ordering HCP selects to minimize unintentionally inappropriate orders. The form asks which tissue the requestor expects the test to be performed on. The requestor must provide contact information for the originating institution when the tissue was collected outside the VHA. The consult form also asks whether another anatomic site is accessible and could be biopsied without unacceptable risk or impracticality, should all previously collected tissue be insufficient. For CGP requests, this allows the pathologist to determine the appropriateness of liquid biopsy without having to reach out to the ordering HCP or wait for the question to be addressed at a tumor board. When a companion diagnostic is available for a test, the ordering HCP is asked which drug will be used so that the most appropriate assay is chosen.

Consult Review

Pathology service involvement begins with pathologist review of the consult form to ensure that the correct test is indicated. Depending on the resources and preferences at a site, consults can be directed to and reviewed by the pathologist associated with the corresponding pathology specimen or to a single pathologist or group of pathologists charged with attending to consults.

The patient’s EHR is reviewed to verify that the test has not already been performed and to determine which tissue to review. Previous surgical pathology reports are examined to assess whether sufficient tissue is available for testing, which may be determined without the need for direct slide examination. Pathologists often use wording such as “rare cells” or in some cases specify that there are not enough lesional cells for ancillary testing. In biopsy reports, the percentage of tissue occupied by lesional cells or the greatest linear length of tumor cells is often documented. As for quality, pathologists may note that a specimen is largely necrotic, and gross descriptions will indicate if a specimen was compromised for molecular analysis by exposure to fixatives such as Bouin’s solution, B-5, or decalcifying agents that contain strong acids.

Tissue Retrieval

If, after such evaluation, the test is indicated and there is tissue that could be sufficient for testing, retrieval of the tissue is pursued. For in-house cases, the pathologist reviews the corresponding surgical pathology report to determine which blocks and slides to pull from the archives. In the cancer checklist, some pathologists specify the best block for subsequent ancillary studies. From the final diagnosis and gross description, the pathologist can determine which blocks are most likely to contain lesional tissue. These slides are retrieved from the archives.

For cases collected at an outside institution (other VHA facility or non-VHA facility/institution), the outside institution must be contacted to retrieve the needed slides and blocks. The phone numbers, fax numbers, email addresses, and mailing addresses for outside institutions are housed in an electronic file and are specific to the point of contact for such requests. Maintaining a record of contacts increases efficiency of the overall process; gathering contact information and successfully requesting tissue often involves multiple automated answering systems, misdirected calls, and failed attempts.

Tissue Review

After retrieving in-house tissue, the pathologist can proceed directly to slide review. For outside cases, the case must first be accessioned so that after review of the slides the pathologist can issue a report to confirm the outside diagnosis. In reviewing the slides, the pathologist looks to see that the diagnosis is correct, that there is a sufficient number of lesional cells in a section, that the lesional cells are of a sufficient concentration in a section, or subsection of the section that could be dissected, and that the cells are viable. Depending on the requested assay and the familiarity of the pathologist with that assay, the pathologist may need to look up the technical requirements of the assay and capabilities of the testing company. Assays vary in sensitivity and require differing amounts and concentrations of tumor. Some companies will dissect tissue, others will not.

If there is sufficient tissue in the material reviewed, the corresponding blocks are retrieved from in-house archives or requests are placed for outside blocks or unstained slides. If there was not enough tissue for testing, the same process is repeated to retrieve and evaluate any other specimens the patient may have. If there are no other specimens to review, this is simply communicated to the ordering HCP via the consult. If the patient is a candidate for liquid biopsy—ie, current specimens are of insufficient quality and/or quantity and a new tissue sample cannot be obtained due to unacceptable risk or impracticality—the order is placed at this time.

Tissue Transport and Testing

Unstained slides need to be cut unless blocks are sent. Slides, blocks, reports, and requisition forms are packaged for transport. An accession number is created for the precision oncology molecular laboratory test in the clinical laboratory section of the EHR system. The clinical laboratory accession number provides a way of tracking sendout testing status. The case is accessioned just prior to placement in the mail so that when an accession number appears in the EHR, the ordering HCP knows the case has been sent out. When results are received, the clinical laboratory accession is completed and a comment is added to indicate where in the EHR to find the report or, when applicable, notes that testing failed.

RESULT REPORTING

When a result becomes available, the report file is downloaded from the vendor portal. This full report is securely transmitted to the ordering HCP. The file is then scanned into the EHR. Additionally, salient findings from the report are abstracted by the pathologist for inclusion as a supplement to the anatomic pathology case. This step ensures that this information travels with the anatomic pathology report if the patient’s care is transferred elsewhere. Templates are used to ensure essential data is captured based on the type of test. The template reminds the pathologist to comment on things such as variants that may represent clonal hematopoiesis, variants that may be germline, and variants that qualify a patient for germline testing. Even with the template, the pathologist must spend significant time reviewing the chart for things such as personal cancer history, other medical history, other masses on imaging, family history, previous surgical pathology reports, and previous molecular testing.

If results are suboptimal, recommendations for repeat testing are made based on the consult response to the question of repeat biopsy feasibility and review of previous pathology reports. The final consult report is added as a consult note, the consult is completed, and the original vendor report file is associated with the consult note in the EHR.

Ancillary Testing Technician

Due to chronic KCVAMC understaffing in the clerical office, gross room, and histology, most of the consult tasks are performed by a pathologist. In an ideal scenario, the pathology staff would divide its time between a pathologist and another dedicated laboratory position, such as an ancillary testing technician (ATT). The ATT can assume responsibilities that do not require the expertise of a pathologist (Figure 2). In such a process, the only steps that would require a pathologist would be review of requests and slides and completion of the interpretive report. All other steps could be accomplished by someone who lacks certifications, laboratory experience, or postsecondary education.

The ATT can receive the requests and retrieve slides and blocks. After slides have been reviewed by a pathologist, the pathologist can inform the ATT which slides or blocks testing will be performed on, provide any additional necessary information for completing the order, and answer any questions. For send-out tests, this allows the ATT to independently complete online portal forms and all other physical requirements prior to delivery of the slides and blocks to specimen processors in the laboratory.

ATTs can keep the ordering HCPs informed of status and be identified as the point of contact for all status inquiries. ATTs can receive results and get outside reports scanned into the EHR. Finally, ATTs can use pathologistdesigned templates to transpose information from outside reports such that a provisional report is prepared and a pathologist does not spend time duplicating information from the outside report. The pathologist can then complete the report with information requiring medical judgment that enhances care.

Optimal Pathologist Involvement

Only 3 steps in the process (request review, tissue review, and completion of an interpretive report) require a pathologist, which are necessary for optimal care and to address barriers to precision oncology.3 While the laboratory may consume only 5% of a health system budget, optimal laboratory use could prevent as much as 30% of avoidable costs.4 These estimates are widely recognized and addressed by campaigns such as Choosing Wisely, as well as programming of alerts and hard stops in EHR systems to reduce duplicate or otherwise inappropriate orders. The tests associated with precision oncology, such as CGP assays, require more nuanced consideration that is best achieved through pathology consultation. In vetting requests for such tests, the pathologist needs information that ordering HCPs do not routinely provide when ordering other tests. A consult asking for such information allows an ordering HCP to efficiently convey this information without having to call the laboratory to circumvent a hard stop.

Regardless of whether a formal electronic consult is used, pathologists must be involved in the review of requests. Creation of an original in-house report also provides an opportunity for pathologists to offer their expertise and maximize the contribution of pathology to patient care. If outside (other VHA facility or non-VHA facility/institution) reports are simply scanned into the EHR without review and issuance of an interpretive report by an in-house pathologist, then an interpretation by a pathologist with access to the patient’s complete chart is never provided. Testing companies are not provided with every patient diagnosis, so in patients with multiple neoplastic conditions, a report may seem to indicate that a detected mutation is from 1 tumor when it is actually from another. Even when all known diagnoses are considered, a variant may be detected that the medical record could reveal to indicate a new diagnosis.

Variation in reporting between companies necessitates pathologist review to standardize care. Some companies indicate which variants may represent clonal hematopoiesis, while others will simply list the pathogenic variants. An oncologist who sees a high volume of hematolymphoid neoplasia may recognize which variants may represent clonal hematopoiesis, but others may not. Reports from the same company may vary, and their interpretation often requires a pathologist's expertise. For example, even if a sample meets the technical requirements for analysis, the report may indicate that the quality or quantity of DNA has reduced the sensitivity for genomic alteration detection. A pathologist would know how to use this information in deciding how to proceed. In a situation where quantity was the issue, the pathologist may know there is additional tissue that could be sent for testing. If quality is the issue, the pathologist may know that additional blocks from the same case likely have the same quality of DNA and would also be unsuitable for testing.

Pathologist input is necessary for precision oncology testing. Some tasks that would ideally be completed by a molecular pathologist (eg, creation of reports to indicate which variants may represent clonal hematopoiesis of indeterminate potential) may be sufficiently completed by a pathologist without fellowship training in molecular pathology.

There are about 15,000 full-time pathologists in the US.⁴ In the 20 years since molecular genetic pathology was formally recognized as a specialty, there have been < 500 pathologists who have pursued fellowship training in this specialty.5 With the inundation of molecular variants uncovered by routine next-generation sequencing (NGS), there are too few fellowship-trained molecular pathologists to provide all such aforementioned input; it is incumbent on surgical pathologists in general to take on such responsibilities.

Consult Implementation Data

These results support the feasibility and effectiveness of the consult process. Prior to consult implementation, many requests were not compliant with VHA National Precision Oncology Program (NPOP) testing guidelines. Since enactment of the consult, > 90% of requests have been in compliance. In the year preceding the consult (January 2020 to December 2021), 55 of 211 (26.1%) metastatic lung and prostate cancers samples eligible for NGS were tested and 126 (59.7%) NGS vendor reports were scanned into the EHR. The mean time from metastasis to NGS result was 151 days. In the year following enactment of the consult (January 2021 to December 2022), 168 of 224 (75.0%) of metastatic lung and prostate cancers eligible for NGS were tested and all 224 NGS vendor reports were scanned into the EHR. The mean time from metastasis to NGS result was 83 days. These data indicate that the practices recommended increase test use, appropriateness of orders, standardization of reporting, and efficiency of care.

CONCLUSIONS

Processing precision oncology testing requires substantial work for pathology departments. Laboratory workforce shortages and ever-expanding indications necessitate additional study of pathology processes to manage increasing workload and maintain the highest quality of cancer care through maximal efficiency and the development of appropriate staffing models. The use of a consult for anatomic pathology molecular testing is one process that can increase test use, appropriateness of orders, standardization of reporting, and efficiency of care. This report provides a comprehensive description and mapping of the process, highlights best practices, identifies inefficiencies, and provides a description and mapping of a target state.

Comprehensive genomic profiling (CGP) is becoming progressively common and appropriate as the array of molecular targets expands. However, most hospital laboratories in the United States do not perform CGP assays in-house; instead, these tests are sent to reference laboratories. As evidenced by Inal et al, only a minority of guideline-indicated molecular testing is performed.¹

The workload associated with referral testing is a barrier to increased use of such tests; streamlined processes in pathology might increase molecular test use. At 6 high-complexity US Department of Veterans Affairs (VA) medical centers (VAMCs) (Manhattan, Los Angeles, San Diego, Denver, Kansas City, and Salisbury, Maryland) ranging from 150 to 750 beds, a consult process for anatomic pathology molecular testing has increased test utilization, appropriateness of orders, standardization of reporting, and efficiency of care. This report comprehensively describes and maps the anatomic pathology molecular testing consult process at a VAMC. We present areas of inefficiency and a target state process map that incorporates best practices.

MOLECULAR TESTING CONSULT PROCESS

At the Kansas City VAMC (KCVAMC), a consult process for anatomic pathology molecular testing was introduced in 2021. Prior to this, requesting anatomic pathology molecular testing was not standardized. A variety of opportunities and methods were used for requests (eg, phone, page, Teams message, email, Computerized Patient Record System alert; or in-person during tumor board, an office meeting, or in passing). Requests were not documented in a standardized way, resulting in duplicate requests. Testing status and updates were documented outside the medical record, so requests for status updates (via various opportunities and methods) were common and redundant. Data from the year preceding consult implementation and the year following consult implementation have demonstrated increased test utilization, appropriateness of orders, standardization of reporting, and efficiency of care.

Consult Request

The precision oncology testing process starts with a health care practitioner (HCP) request on behalf of any physician or advanced practice registered nurse. It can be placed by any health care employee and directed to a designated employee in the pathology department. The request is ultimately reviewed by a pathologist (Figure 1). At KCVAMC, this request comes in the form of a consult in the electronic health record (EHR) from the ordering HCP to a pathologist. The KCVAMC pathology consult form was previously published with a discussion of the rationale for this process as opposed to a laboratory order process.² This consult form ensures ordering HCPs supply all necessary information for the pathologist to approve the request and order the test without needing to, in most cases, contact the ordering HCP for clarification or additional information. The form asks the ordering HCP to specify which test is being requested and why. Within the Veterans Health Administration (VHA) there are local and national contracts with many laboratories with hundreds of precision oncology tests to choose from. Consulting with a pathologist is necessary to determine which test is most appropriate.

The precision oncology consult form cannot be submitted without completing all required fields. It also contains indications for the test the ordering HCP selects to minimize unintentionally inappropriate orders. The form asks which tissue the requestor expects the test to be performed on. The requestor must provide contact information for the originating institution when the tissue was collected outside the VHA. The consult form also asks whether another anatomic site is accessible and could be biopsied without unacceptable risk or impracticality, should all previously collected tissue be insufficient. For CGP requests, this allows the pathologist to determine the appropriateness of liquid biopsy without having to reach out to the ordering HCP or wait for the question to be addressed at a tumor board. When a companion diagnostic is available for a test, the ordering HCP is asked which drug will be used so that the most appropriate assay is chosen.

Consult Review

Pathology service involvement begins with pathologist review of the consult form to ensure that the correct test is indicated. Depending on the resources and preferences at a site, consults can be directed to and reviewed by the pathologist associated with the corresponding pathology specimen or to a single pathologist or group of pathologists charged with attending to consults.

The patient’s EHR is reviewed to verify that the test has not already been performed and to determine which tissue to review. Previous surgical pathology reports are examined to assess whether sufficient tissue is available for testing, which may be determined without the need for direct slide examination. Pathologists often use wording such as “rare cells” or in some cases specify that there are not enough lesional cells for ancillary testing. In biopsy reports, the percentage of tissue occupied by lesional cells or the greatest linear length of tumor cells is often documented. As for quality, pathologists may note that a specimen is largely necrotic, and gross descriptions will indicate if a specimen was compromised for molecular analysis by exposure to fixatives such as Bouin’s solution, B-5, or decalcifying agents that contain strong acids.

Tissue Retrieval

If, after such evaluation, the test is indicated and there is tissue that could be sufficient for testing, retrieval of the tissue is pursued. For in-house cases, the pathologist reviews the corresponding surgical pathology report to determine which blocks and slides to pull from the archives. In the cancer checklist, some pathologists specify the best block for subsequent ancillary studies. From the final diagnosis and gross description, the pathologist can determine which blocks are most likely to contain lesional tissue. These slides are retrieved from the archives.

For cases collected at an outside institution (other VHA facility or non-VHA facility/institution), the outside institution must be contacted to retrieve the needed slides and blocks. The phone numbers, fax numbers, email addresses, and mailing addresses for outside institutions are housed in an electronic file and are specific to the point of contact for such requests. Maintaining a record of contacts increases efficiency of the overall process; gathering contact information and successfully requesting tissue often involves multiple automated answering systems, misdirected calls, and failed attempts.

Tissue Review

After retrieving in-house tissue, the pathologist can proceed directly to slide review. For outside cases, the case must first be accessioned so that after review of the slides the pathologist can issue a report to confirm the outside diagnosis. In reviewing the slides, the pathologist looks to see that the diagnosis is correct, that there is a sufficient number of lesional cells in a section, that the lesional cells are of a sufficient concentration in a section, or subsection of the section that could be dissected, and that the cells are viable. Depending on the requested assay and the familiarity of the pathologist with that assay, the pathologist may need to look up the technical requirements of the assay and capabilities of the testing company. Assays vary in sensitivity and require differing amounts and concentrations of tumor. Some companies will dissect tissue, others will not.

If there is sufficient tissue in the material reviewed, the corresponding blocks are retrieved from in-house archives or requests are placed for outside blocks or unstained slides. If there was not enough tissue for testing, the same process is repeated to retrieve and evaluate any other specimens the patient may have. If there are no other specimens to review, this is simply communicated to the ordering HCP via the consult. If the patient is a candidate for liquid biopsy—ie, current specimens are of insufficient quality and/or quantity and a new tissue sample cannot be obtained due to unacceptable risk or impracticality—the order is placed at this time.

Tissue Transport and Testing

Unstained slides need to be cut unless blocks are sent. Slides, blocks, reports, and requisition forms are packaged for transport. An accession number is created for the precision oncology molecular laboratory test in the clinical laboratory section of the EHR system. The clinical laboratory accession number provides a way of tracking sendout testing status. The case is accessioned just prior to placement in the mail so that when an accession number appears in the EHR, the ordering HCP knows the case has been sent out. When results are received, the clinical laboratory accession is completed and a comment is added to indicate where in the EHR to find the report or, when applicable, notes that testing failed.

RESULT REPORTING

When a result becomes available, the report file is downloaded from the vendor portal. This full report is securely transmitted to the ordering HCP. The file is then scanned into the EHR. Additionally, salient findings from the report are abstracted by the pathologist for inclusion as a supplement to the anatomic pathology case. This step ensures that this information travels with the anatomic pathology report if the patient’s care is transferred elsewhere. Templates are used to ensure essential data is captured based on the type of test. The template reminds the pathologist to comment on things such as variants that may represent clonal hematopoiesis, variants that may be germline, and variants that qualify a patient for germline testing. Even with the template, the pathologist must spend significant time reviewing the chart for things such as personal cancer history, other medical history, other masses on imaging, family history, previous surgical pathology reports, and previous molecular testing.

If results are suboptimal, recommendations for repeat testing are made based on the consult response to the question of repeat biopsy feasibility and review of previous pathology reports. The final consult report is added as a consult note, the consult is completed, and the original vendor report file is associated with the consult note in the EHR.

Ancillary Testing Technician

Due to chronic KCVAMC understaffing in the clerical office, gross room, and histology, most of the consult tasks are performed by a pathologist. In an ideal scenario, the pathology staff would divide its time between a pathologist and another dedicated laboratory position, such as an ancillary testing technician (ATT). The ATT can assume responsibilities that do not require the expertise of a pathologist (Figure 2). In such a process, the only steps that would require a pathologist would be review of requests and slides and completion of the interpretive report. All other steps could be accomplished by someone who lacks certifications, laboratory experience, or postsecondary education.

The ATT can receive the requests and retrieve slides and blocks. After slides have been reviewed by a pathologist, the pathologist can inform the ATT which slides or blocks testing will be performed on, provide any additional necessary information for completing the order, and answer any questions. For send-out tests, this allows the ATT to independently complete online portal forms and all other physical requirements prior to delivery of the slides and blocks to specimen processors in the laboratory.

ATTs can keep the ordering HCPs informed of status and be identified as the point of contact for all status inquiries. ATTs can receive results and get outside reports scanned into the EHR. Finally, ATTs can use pathologistdesigned templates to transpose information from outside reports such that a provisional report is prepared and a pathologist does not spend time duplicating information from the outside report. The pathologist can then complete the report with information requiring medical judgment that enhances care.

Optimal Pathologist Involvement

Only 3 steps in the process (request review, tissue review, and completion of an interpretive report) require a pathologist, which are necessary for optimal care and to address barriers to precision oncology.3 While the laboratory may consume only 5% of a health system budget, optimal laboratory use could prevent as much as 30% of avoidable costs.4 These estimates are widely recognized and addressed by campaigns such as Choosing Wisely, as well as programming of alerts and hard stops in EHR systems to reduce duplicate or otherwise inappropriate orders. The tests associated with precision oncology, such as CGP assays, require more nuanced consideration that is best achieved through pathology consultation. In vetting requests for such tests, the pathologist needs information that ordering HCPs do not routinely provide when ordering other tests. A consult asking for such information allows an ordering HCP to efficiently convey this information without having to call the laboratory to circumvent a hard stop.

Regardless of whether a formal electronic consult is used, pathologists must be involved in the review of requests. Creation of an original in-house report also provides an opportunity for pathologists to offer their expertise and maximize the contribution of pathology to patient care. If outside (other VHA facility or non-VHA facility/institution) reports are simply scanned into the EHR without review and issuance of an interpretive report by an in-house pathologist, then an interpretation by a pathologist with access to the patient’s complete chart is never provided. Testing companies are not provided with every patient diagnosis, so in patients with multiple neoplastic conditions, a report may seem to indicate that a detected mutation is from 1 tumor when it is actually from another. Even when all known diagnoses are considered, a variant may be detected that the medical record could reveal to indicate a new diagnosis.

Variation in reporting between companies necessitates pathologist review to standardize care. Some companies indicate which variants may represent clonal hematopoiesis, while others will simply list the pathogenic variants. An oncologist who sees a high volume of hematolymphoid neoplasia may recognize which variants may represent clonal hematopoiesis, but others may not. Reports from the same company may vary, and their interpretation often requires a pathologist's expertise. For example, even if a sample meets the technical requirements for analysis, the report may indicate that the quality or quantity of DNA has reduced the sensitivity for genomic alteration detection. A pathologist would know how to use this information in deciding how to proceed. In a situation where quantity was the issue, the pathologist may know there is additional tissue that could be sent for testing. If quality is the issue, the pathologist may know that additional blocks from the same case likely have the same quality of DNA and would also be unsuitable for testing.

Pathologist input is necessary for precision oncology testing. Some tasks that would ideally be completed by a molecular pathologist (eg, creation of reports to indicate which variants may represent clonal hematopoiesis of indeterminate potential) may be sufficiently completed by a pathologist without fellowship training in molecular pathology.

There are about 15,000 full-time pathologists in the US.⁴ In the 20 years since molecular genetic pathology was formally recognized as a specialty, there have been < 500 pathologists who have pursued fellowship training in this specialty.5 With the inundation of molecular variants uncovered by routine next-generation sequencing (NGS), there are too few fellowship-trained molecular pathologists to provide all such aforementioned input; it is incumbent on surgical pathologists in general to take on such responsibilities.

Consult Implementation Data

These results support the feasibility and effectiveness of the consult process. Prior to consult implementation, many requests were not compliant with VHA National Precision Oncology Program (NPOP) testing guidelines. Since enactment of the consult, > 90% of requests have been in compliance. In the year preceding the consult (January 2020 to December 2021), 55 of 211 (26.1%) metastatic lung and prostate cancers samples eligible for NGS were tested and 126 (59.7%) NGS vendor reports were scanned into the EHR. The mean time from metastasis to NGS result was 151 days. In the year following enactment of the consult (January 2021 to December 2022), 168 of 224 (75.0%) of metastatic lung and prostate cancers eligible for NGS were tested and all 224 NGS vendor reports were scanned into the EHR. The mean time from metastasis to NGS result was 83 days. These data indicate that the practices recommended increase test use, appropriateness of orders, standardization of reporting, and efficiency of care.

CONCLUSIONS

Processing precision oncology testing requires substantial work for pathology departments. Laboratory workforce shortages and ever-expanding indications necessitate additional study of pathology processes to manage increasing workload and maintain the highest quality of cancer care through maximal efficiency and the development of appropriate staffing models. The use of a consult for anatomic pathology molecular testing is one process that can increase test use, appropriateness of orders, standardization of reporting, and efficiency of care. This report provides a comprehensive description and mapping of the process, highlights best practices, identifies inefficiencies, and provides a description and mapping of a target state.

Comprehensive genomic profiling (CGP) is becoming progressively common and appropriate as the array of molecular targets expands. However, most hospital laboratories in the United States do not perform CGP assays in-house; instead, these tests are sent to reference laboratories. As evidenced by Inal et al, only a minority of guideline-indicated molecular testing is performed.¹

The workload associated with referral testing is a barrier to increased use of such tests; streamlined processes in pathology might increase molecular test use. At 6 high-complexity US Department of Veterans Affairs (VA) medical centers (VAMCs) (Manhattan, Los Angeles, San Diego, Denver, Kansas City, and Salisbury, Maryland) ranging from 150 to 750 beds, a consult process for anatomic pathology molecular testing has increased test utilization, appropriateness of orders, standardization of reporting, and efficiency of care. This report comprehensively describes and maps the anatomic pathology molecular testing consult process at a VAMC. We present areas of inefficiency and a target state process map that incorporates best practices.

MOLECULAR TESTING CONSULT PROCESS

At the Kansas City VAMC (KCVAMC), a consult process for anatomic pathology molecular testing was introduced in 2021. Prior to this, requesting anatomic pathology molecular testing was not standardized. A variety of opportunities and methods were used for requests (eg, phone, page, Teams message, email, Computerized Patient Record System alert; or in-person during tumor board, an office meeting, or in passing). Requests were not documented in a standardized way, resulting in duplicate requests. Testing status and updates were documented outside the medical record, so requests for status updates (via various opportunities and methods) were common and redundant. Data from the year preceding consult implementation and the year following consult implementation have demonstrated increased test utilization, appropriateness of orders, standardization of reporting, and efficiency of care.

Consult Request

The precision oncology testing process starts with a health care practitioner (HCP) request on behalf of any physician or advanced practice registered nurse. It can be placed by any health care employee and directed to a designated employee in the pathology department. The request is ultimately reviewed by a pathologist (Figure 1). At KCVAMC, this request comes in the form of a consult in the electronic health record (EHR) from the ordering HCP to a pathologist. The KCVAMC pathology consult form was previously published with a discussion of the rationale for this process as opposed to a laboratory order process.² This consult form ensures ordering HCPs supply all necessary information for the pathologist to approve the request and order the test without needing to, in most cases, contact the ordering HCP for clarification or additional information. The form asks the ordering HCP to specify which test is being requested and why. Within the Veterans Health Administration (VHA) there are local and national contracts with many laboratories with hundreds of precision oncology tests to choose from. Consulting with a pathologist is necessary to determine which test is most appropriate.

The precision oncology consult form cannot be submitted without completing all required fields. It also contains indications for the test the ordering HCP selects to minimize unintentionally inappropriate orders. The form asks which tissue the requestor expects the test to be performed on. The requestor must provide contact information for the originating institution when the tissue was collected outside the VHA. The consult form also asks whether another anatomic site is accessible and could be biopsied without unacceptable risk or impracticality, should all previously collected tissue be insufficient. For CGP requests, this allows the pathologist to determine the appropriateness of liquid biopsy without having to reach out to the ordering HCP or wait for the question to be addressed at a tumor board. When a companion diagnostic is available for a test, the ordering HCP is asked which drug will be used so that the most appropriate assay is chosen.

Consult Review

Pathology service involvement begins with pathologist review of the consult form to ensure that the correct test is indicated. Depending on the resources and preferences at a site, consults can be directed to and reviewed by the pathologist associated with the corresponding pathology specimen or to a single pathologist or group of pathologists charged with attending to consults.

The patient’s EHR is reviewed to verify that the test has not already been performed and to determine which tissue to review. Previous surgical pathology reports are examined to assess whether sufficient tissue is available for testing, which may be determined without the need for direct slide examination. Pathologists often use wording such as “rare cells” or in some cases specify that there are not enough lesional cells for ancillary testing. In biopsy reports, the percentage of tissue occupied by lesional cells or the greatest linear length of tumor cells is often documented. As for quality, pathologists may note that a specimen is largely necrotic, and gross descriptions will indicate if a specimen was compromised for molecular analysis by exposure to fixatives such as Bouin’s solution, B-5, or decalcifying agents that contain strong acids.

Tissue Retrieval

If, after such evaluation, the test is indicated and there is tissue that could be sufficient for testing, retrieval of the tissue is pursued. For in-house cases, the pathologist reviews the corresponding surgical pathology report to determine which blocks and slides to pull from the archives. In the cancer checklist, some pathologists specify the best block for subsequent ancillary studies. From the final diagnosis and gross description, the pathologist can determine which blocks are most likely to contain lesional tissue. These slides are retrieved from the archives.

For cases collected at an outside institution (other VHA facility or non-VHA facility/institution), the outside institution must be contacted to retrieve the needed slides and blocks. The phone numbers, fax numbers, email addresses, and mailing addresses for outside institutions are housed in an electronic file and are specific to the point of contact for such requests. Maintaining a record of contacts increases efficiency of the overall process; gathering contact information and successfully requesting tissue often involves multiple automated answering systems, misdirected calls, and failed attempts.

Tissue Review

After retrieving in-house tissue, the pathologist can proceed directly to slide review. For outside cases, the case must first be accessioned so that after review of the slides the pathologist can issue a report to confirm the outside diagnosis. In reviewing the slides, the pathologist looks to see that the diagnosis is correct, that there is a sufficient number of lesional cells in a section, that the lesional cells are of a sufficient concentration in a section, or subsection of the section that could be dissected, and that the cells are viable. Depending on the requested assay and the familiarity of the pathologist with that assay, the pathologist may need to look up the technical requirements of the assay and capabilities of the testing company. Assays vary in sensitivity and require differing amounts and concentrations of tumor. Some companies will dissect tissue, others will not.

If there is sufficient tissue in the material reviewed, the corresponding blocks are retrieved from in-house archives or requests are placed for outside blocks or unstained slides. If there was not enough tissue for testing, the same process is repeated to retrieve and evaluate any other specimens the patient may have. If there are no other specimens to review, this is simply communicated to the ordering HCP via the consult. If the patient is a candidate for liquid biopsy—ie, current specimens are of insufficient quality and/or quantity and a new tissue sample cannot be obtained due to unacceptable risk or impracticality—the order is placed at this time.

Tissue Transport and Testing

Unstained slides need to be cut unless blocks are sent. Slides, blocks, reports, and requisition forms are packaged for transport. An accession number is created for the precision oncology molecular laboratory test in the clinical laboratory section of the EHR system. The clinical laboratory accession number provides a way of tracking sendout testing status. The case is accessioned just prior to placement in the mail so that when an accession number appears in the EHR, the ordering HCP knows the case has been sent out. When results are received, the clinical laboratory accession is completed and a comment is added to indicate where in the EHR to find the report or, when applicable, notes that testing failed.

RESULT REPORTING

When a result becomes available, the report file is downloaded from the vendor portal. This full report is securely transmitted to the ordering HCP. The file is then scanned into the EHR. Additionally, salient findings from the report are abstracted by the pathologist for inclusion as a supplement to the anatomic pathology case. This step ensures that this information travels with the anatomic pathology report if the patient’s care is transferred elsewhere. Templates are used to ensure essential data is captured based on the type of test. The template reminds the pathologist to comment on things such as variants that may represent clonal hematopoiesis, variants that may be germline, and variants that qualify a patient for germline testing. Even with the template, the pathologist must spend significant time reviewing the chart for things such as personal cancer history, other medical history, other masses on imaging, family history, previous surgical pathology reports, and previous molecular testing.

If results are suboptimal, recommendations for repeat testing are made based on the consult response to the question of repeat biopsy feasibility and review of previous pathology reports. The final consult report is added as a consult note, the consult is completed, and the original vendor report file is associated with the consult note in the EHR.

Ancillary Testing Technician

Due to chronic KCVAMC understaffing in the clerical office, gross room, and histology, most of the consult tasks are performed by a pathologist. In an ideal scenario, the pathology staff would divide its time between a pathologist and another dedicated laboratory position, such as an ancillary testing technician (ATT). The ATT can assume responsibilities that do not require the expertise of a pathologist (Figure 2). In such a process, the only steps that would require a pathologist would be review of requests and slides and completion of the interpretive report. All other steps could be accomplished by someone who lacks certifications, laboratory experience, or postsecondary education.

The ATT can receive the requests and retrieve slides and blocks. After slides have been reviewed by a pathologist, the pathologist can inform the ATT which slides or blocks testing will be performed on, provide any additional necessary information for completing the order, and answer any questions. For send-out tests, this allows the ATT to independently complete online portal forms and all other physical requirements prior to delivery of the slides and blocks to specimen processors in the laboratory.

ATTs can keep the ordering HCPs informed of status and be identified as the point of contact for all status inquiries. ATTs can receive results and get outside reports scanned into the EHR. Finally, ATTs can use pathologistdesigned templates to transpose information from outside reports such that a provisional report is prepared and a pathologist does not spend time duplicating information from the outside report. The pathologist can then complete the report with information requiring medical judgment that enhances care.

Optimal Pathologist Involvement

Only 3 steps in the process (request review, tissue review, and completion of an interpretive report) require a pathologist, which are necessary for optimal care and to address barriers to precision oncology.3 While the laboratory may consume only 5% of a health system budget, optimal laboratory use could prevent as much as 30% of avoidable costs.4 These estimates are widely recognized and addressed by campaigns such as Choosing Wisely, as well as programming of alerts and hard stops in EHR systems to reduce duplicate or otherwise inappropriate orders. The tests associated with precision oncology, such as CGP assays, require more nuanced consideration that is best achieved through pathology consultation. In vetting requests for such tests, the pathologist needs information that ordering HCPs do not routinely provide when ordering other tests. A consult asking for such information allows an ordering HCP to efficiently convey this information without having to call the laboratory to circumvent a hard stop.

Regardless of whether a formal electronic consult is used, pathologists must be involved in the review of requests. Creation of an original in-house report also provides an opportunity for pathologists to offer their expertise and maximize the contribution of pathology to patient care. If outside (other VHA facility or non-VHA facility/institution) reports are simply scanned into the EHR without review and issuance of an interpretive report by an in-house pathologist, then an interpretation by a pathologist with access to the patient’s complete chart is never provided. Testing companies are not provided with every patient diagnosis, so in patients with multiple neoplastic conditions, a report may seem to indicate that a detected mutation is from 1 tumor when it is actually from another. Even when all known diagnoses are considered, a variant may be detected that the medical record could reveal to indicate a new diagnosis.

Variation in reporting between companies necessitates pathologist review to standardize care. Some companies indicate which variants may represent clonal hematopoiesis, while others will simply list the pathogenic variants. An oncologist who sees a high volume of hematolymphoid neoplasia may recognize which variants may represent clonal hematopoiesis, but others may not. Reports from the same company may vary, and their interpretation often requires a pathologist's expertise. For example, even if a sample meets the technical requirements for analysis, the report may indicate that the quality or quantity of DNA has reduced the sensitivity for genomic alteration detection. A pathologist would know how to use this information in deciding how to proceed. In a situation where quantity was the issue, the pathologist may know there is additional tissue that could be sent for testing. If quality is the issue, the pathologist may know that additional blocks from the same case likely have the same quality of DNA and would also be unsuitable for testing.

Pathologist input is necessary for precision oncology testing. Some tasks that would ideally be completed by a molecular pathologist (eg, creation of reports to indicate which variants may represent clonal hematopoiesis of indeterminate potential) may be sufficiently completed by a pathologist without fellowship training in molecular pathology.

There are about 15,000 full-time pathologists in the US.⁴ In the 20 years since molecular genetic pathology was formally recognized as a specialty, there have been < 500 pathologists who have pursued fellowship training in this specialty.5 With the inundation of molecular variants uncovered by routine next-generation sequencing (NGS), there are too few fellowship-trained molecular pathologists to provide all such aforementioned input; it is incumbent on surgical pathologists in general to take on such responsibilities.

Consult Implementation Data

These results support the feasibility and effectiveness of the consult process. Prior to consult implementation, many requests were not compliant with VHA National Precision Oncology Program (NPOP) testing guidelines. Since enactment of the consult, > 90% of requests have been in compliance. In the year preceding the consult (January 2020 to December 2021), 55 of 211 (26.1%) metastatic lung and prostate cancers samples eligible for NGS were tested and 126 (59.7%) NGS vendor reports were scanned into the EHR. The mean time from metastasis to NGS result was 151 days. In the year following enactment of the consult (January 2021 to December 2022), 168 of 224 (75.0%) of metastatic lung and prostate cancers eligible for NGS were tested and all 224 NGS vendor reports were scanned into the EHR. The mean time from metastasis to NGS result was 83 days. These data indicate that the practices recommended increase test use, appropriateness of orders, standardization of reporting, and efficiency of care.

CONCLUSIONS

Processing precision oncology testing requires substantial work for pathology departments. Laboratory workforce shortages and ever-expanding indications necessitate additional study of pathology processes to manage increasing workload and maintain the highest quality of cancer care through maximal efficiency and the development of appropriate staffing models. The use of a consult for anatomic pathology molecular testing is one process that can increase test use, appropriateness of orders, standardization of reporting, and efficiency of care. This report provides a comprehensive description and mapping of the process, highlights best practices, identifies inefficiencies, and provides a description and mapping of a target state.

Suicide prevention is the leading clinical priority for the US Department of Veterans Affairs (VA).¹ An average of 18 veterans died by suicide each day in 2021.² Numerous risk factors for veteran suicide have been identified, including mental health disorders, comorbidities, access to firearms, and potentially lethal medications.^3-5 To better understand groups of patients at risk of suicide in medical settings, the authors have previously compared demographic and clinical risk factors between patients who died by suicide by using firearms or other means with matched patients who did not die by suicide (control group) to examine the impact of lack of social support, financial stress,⁶ legal problems,⁷ homelessness,⁸ and discrimination.⁹ The number of cooccurring risk factors a veteran experiences is associated with a greater likelihood of suicide attempts over time.¹⁰ In addition, some risk factors are social and environmental risk factors known as social determinants of health (SDoH), including financial stability and access to health care, food, housing, and education. ¹¹ SDoH may influence health outcomes more broadly and are associated with greater risk of suicide.^12,13

The VA offers programming to address suicide risk factors. However, not all veterans are eligible for VA care. Further, some veterans prefer to obtain non-VA services in their communities. Providing veterans with community resources that address risk factors, particularly SDoH, may be a worthwhile strategy for reducing suicide. Such resources have demonstrated success; for example, greater use of housing services was associated with a reduced risk for suicide-related mortality among unhoused veterans.¹²

The challenges that veterans experience can go beyond the scope of services the VA provides. For example, while the VA provides some services related to homelessness, justice involvement, and assistance with home loans, these services are often limited. Other services for veterans to address SDoH may require access to community resources, including food banks, employment assistance, respite and childcare services, and transportation assistance. Some veterans also may have experienced institutional betrayal, which could be a barrier to VA care and may motivate veterans to address their needs in the community.¹⁴ Veterans therefore may need a range of services beyond those within the VA. Leveraging community resources for veterans at risk for suicide is critical, as these resources may help to mitigate suicide risk.

An emerging emphasis of the VA is improving coordination with community partners to prevent veteran suicide. In 2019, the VA launched an improved Veterans Community Care Program, which implemented portions of the VA MISSION Act of 2018 to create additional connection to community care for VA-enrolled veterans. This includes assisting veterans in gaining access to specialty services not offered at a local VA medical center (VAMC), getting access to services sooner, and receiving care if they do not live near a VAMC.¹⁵ In addition, the COMPACT Act allows veterans in acute suicidal crisis to receive emergency health care through either VA or non-VA facilities at no cost.¹⁶ The VA National Strategy for Preventing Veteran Suicide 2018-2028 is a 10-year plan to reduce veteran suicide rates that includes initiatives to increase connections between VA and community agencies.¹⁷ A suicide prevention community toolkit is available online for health care professionals (HCPs) (and others, including employers) outside of the VA who may be unfamiliar with best practices for working with veterans at risk for suicide.¹⁸

The challenge, however, is that there is often a lack of “connectedness” between VA suicide prevention coordinators and community resources to address suicide risk factors and related social determinants of health. These services include, but are not limited to suicide prevention, mental health counseling (particularly no/low-cost services), unemployment resources, financial assistance and counseling, housing assistance, and identity-related supportive spaces. A major stumbling block in connecting resources with veterans (regardless of discharge status) who need them is there is no single, national organization with a comprehensive, community-based network that can serve in this intermediary role.

Community asset mapping (CAM), also known as asset mapping or environmental scanning, is a way to bridge the gap.¹⁹ CAM provides a method for identifying and aligning community resources relative to a specific need.²⁰ CAM may be used to build community relationships in service of veteran suicide prevention. This process can help individuals learn about and make use of organizations and services within their communities. CAM also helps connect HCPs so they can network, exchange ideas, and collaborate with an eye toward increasing the availability of services and enhancing care coordination. CAM also allows community members (eg, leaders, organizations, individuals) to identify possible gaps in services that address suicide risk factors and solve these problems.

This article details CAM for suicide prevention, which can be utilized by the VA and community organizations alike. Within the VA, CAM can be used by HCPs and administrators, such as VA community engagement and partnership coordinators, to identify potential partnering organizations. For those who serve veterans outside of the VA, CAM can be used to connect at-risk individuals to resources that can enhance their care. This process can help increase the overall knowledge of, and access to, community resources.

COMMUNITY ASSET MAPPING

The University of California, Los Angeles Center for Health Policy Research provides 6 steps for the CAM process.²¹ These steps include: (1) defining the boundaries of people and places that comprise the community; (2) identifying people and organizations who share similar interests and goals; (3) determining the assets to include; (4) creating an inventory of all organizations’ assets; (5) creating an inventory of individuals’ assets; and (6) organizing the assets on a map. To address the needs of the veteran population, we’ve taken these 6 steps and adapted them to create a CAM for veterans at risk for suicide (Figure). The discussion that follows details how these steps can be implemented to identify community resources that address social determinants of health that may contribute to suicide risk. The goal is to prevent veteran suicide.

Step 1: Define Community Reach. The first step is to identify the geographical boundaries of the community. This may include all veterans within a catchment area (eg, veterans within 60 miles of a VAMC). Defining the geographical parameters of the community will provide structure to the effort so that the resource list is as comprehensive as possible.

Steps 2 and 3: Identify Community Members with Shared Goals; Identify Assets. It is important to identify community members who share similar interests and goals, including people with specific knowledge and skills, organizations with particular goals, and community partners with a broad reach. To begin building a list of referrals, reach out to colleagues within the VA system who are familiar with community resources for those with suicide risk factors. The local VA Transition and Care Management (TCM) office is a resource that connects those transitioning from military to civilian sectors with needed resources, and thus may be a helpful resource while building a CAM. Additionally, each office has a transition patient advocate, who is trained to resolve care-related concerns and may be familiar with community resources.

VA HCPs that can assist include Community Engagement and Partnership Coordinators, Suicide Prevention Coordinators, Local Recovery Coordinators, and substance abuse counselors. In addition, VA patient services, patient safety, and public affairs office staff—as well as VA Homeless Programs—may be good resources. Every VA health care system has care coordinators focused on military sexual trauma, intimate partner violence, and lesbian, gay, bisexual, transgender, queer+ care. These care coordinators may be able to provide information on community resources that address social determinants of health (eg, discrimination, violence).

Reaching out to key community resources and asking for recommendations of other groups that provide assistance to veterans can also be productive. You can start by connecting with veterans service organizations (VSOs), Vet Centers, Veterans Experience Offices (VEO), and Community Veterans Engagement Boards (CVEBs). The VEO is an office designed around VA and community engagement efforts. This office utilizes the CVEBs to foster a 2-way communication feedback loop between veterans and local VA facilities regarding community engagement efforts and outreach.²² CVEBs are particularly valuable sources of information because veterans directly contribute to the conversation about community engagement by describing the difficulties and successes they’ve experienced. Veteran feedback about how a particular resource met their needs can inform which community services are prioritized for inclusion in the resource list. In addition, CVEBs may have a listing of local government, military, and/or community resources that provide services for veterans. Consider, too, organizations that are unrelated to an individual’s veteran status, but speak to their race/ethnicity, sexual orientation, gender identity, spirituality, socioeconomic status, or disability.

Step 4: Continue to Build Inventory. Use online searches to identify additional resources in the community that are known to have local relationships. These include state suicide prevention coordinators, mental health organizations, and other resources that address social determinants of health (eg, public health and human service organizations, faith-based organizations, collegial organizations). A list of links and search tips are available in the Table.

Steps 5 and 6: Create Document; Organize and Disseminate Information. A spreadsheet can be used to document organization information (Appendix). It is critical to record: (1) the name of the organization or individual; (2) the local address and a point of contact with contact information; (3) services offered to veterans; (4) services specific to suicide prevention, or that address risk factors for suicide; and (5) whether the referral organization is partnered with the VA Community Care Network, which is comprised of contracted HCPs who contract with the VA to provide care to veterans.²³

Once a document is created, it can be disseminated through VA offices and among community partners who work with veterans at risk for suicide. It should also be stored in a centralized location such as a shared folder so that it can be continuously updated.

Regularly updating the list is vital so the resource list can continue to be helpful in addressing veterans’ needs and reducing suicide risk factors. Continued collaboration with those in the community can help ensure the resource list is up to date with all available services and pertinent contact information. It can also go far in strengthening collaborative bonds.

IMPLEMENTATION

To illustrate the use of CAM for veteran suicide prevention, we offer a case example of CAM conducted by the VA Patient Safety Center of Inquiry — Suicide Prevention Collaborative (VA PSCI-SPC) team, consisting of 4 team members. A veteran was included as a team member and assisted with the CAM process.

The VA PSCI-SPC sought to identify community services for veterans in Colorado who were not enrolled in VA health care and had risk factors for suicide. Next, the team reached out to colleagues and asked about community organizations that work with individuals at risk for suicide. VA PSCI-SPC outreach resulted in a list of assets that included resources to address mental health, legal concerns, employment, homelessness/housing, finances, religion, peer support, food insecurity, exercise, intimate partner violence, sexual and gender identity needs, and peer support. VSOs and CVEBs were also added to the list.

Next, the team continued to build on the inventory and identified state suicide prevention coordinators; health care systems; regional suicide prevention commissions; Colorado Department of Health and Human Services; program coordinators for Governor’s and Mayor’s Challenges to Prevent Suicide Among Service Members, Veterans, and their Families; veterans councils; universities (eg, counseling clinics, legal clinics); and foundations devoted to general and veteran-specific suicide prevention within the region.

All the identified resources were inventoried. Details were gathered about each of the organizations, including addresses, points of contact and phone numbers, descriptions of services offered for veterans, descriptions of suicide prevention services offered, whether or not organizations were not-for-profit, the mission of the organizations, and whether or not the organizations were under contract for VA Community Care. Finally, the resource spreadsheet was created and disseminated among stakeholders to be used to enhance veteran suicide care. Stakeholders included social workers, psychologists, and nurse practitioners working with veterans. The list was circulated to VA and community partners as needed.

The VA PSCI-SPC resource document was only 1 benefit of CAM. The asset mapping also resulted in the creation of a learning collaborative comprised of VA and community partners, designed to share knowledge of best practices in suicide prevention and create an established referral network for veterans at risk for suicide.²⁴ Ultimately, the goal of the CAM and the creation of the learning collaborative was to better connect veterans to care in order to decrease suicide risk. A secondary benefit of this community connectedness is that the list of resources produced by CAM became a living document that was, and continues to be, updated as the network became aware of new resources and resources that were no longer available. The VA PSCI-SPC learning collaborative met quarterly to discuss implementation of suicide prevention best practices within their organization.

Data from the VA PSCI-SPC learning collaborative via CAM revealed that organizations felt more efficacious in implementing suicide prevention best practices, noticed increased connections and collaborations with community organizations with the goal of providing services to veterans, and resulted in staff training that improved services provided to veterans.²⁴ This is supported by other findings of a literature review of suicide prevention interventions, which indicated that programs with an established community support network were more effective at reducing suicide rates.²⁵ CAM therefore may be a process through which greater community connection and increased knowledge of resources may help prevent suicide among veterans.

It seems reasonable that the CAM processes used by the VA PSCI-SPC can be implemented within the regional Veterans Integrated Service Networks to identify assets in a specific geographical area to address challenges with social determinants of health and potentially decrease veteran suicide risk.

CONCLUSIONS

CAM can be used to identify and build relationships with community resources that address the stressors that place veterans at risk for suicide. Six proposed steps to CAM for veterans at risk for suicide include: defining community reach (the map); identifying community members and organizations with shared goals; identifying assets within the community; continuing to build inventory; creating a document; and organizing and disseminating the information (while continuing to update the resources).²¹

CAM can be used to connect veterans with resources to address needs related to adverse social determinants of health that may heighten their risk for suicide. For example, veterans facing legal challenges can connect with a legal clinic; those having difficulties paying bills can obtain financial assistance; those who need help completing their VA claims can connect with the Veterans Benefits Administration or VSOs to assist them with their claims; and those experiencing discrimination can connect with organizations where they may experience acceptance, safety, and support. Broad community support surrounding suicide risk factors can be critical for effective suicide prevention.²⁵

CAM may also be helpful for HCPs and others involved in veteran health care. For example, community mapping can be utilized by newly hired community engagement and partnership coordinators as a tool for outlining resources available for veterans in their community and as a framework to continually update their resource network. CAM develops community awareness, integrates resources, and enhances service utilization, which may assist in veteran suicide prevention by increasing care coordination.¹⁷ Finally, mapping community resources can create awareness of the many resources available to help veterans, even before suicide becomes a consideration.

Suicide prevention is the leading clinical priority for the US Department of Veterans Affairs (VA).¹ An average of 18 veterans died by suicide each day in 2021.² Numerous risk factors for veteran suicide have been identified, including mental health disorders, comorbidities, access to firearms, and potentially lethal medications.^3-5 To better understand groups of patients at risk of suicide in medical settings, the authors have previously compared demographic and clinical risk factors between patients who died by suicide by using firearms or other means with matched patients who did not die by suicide (control group) to examine the impact of lack of social support, financial stress,⁶ legal problems,⁷ homelessness,⁸ and discrimination.⁹ The number of cooccurring risk factors a veteran experiences is associated with a greater likelihood of suicide attempts over time.¹⁰ In addition, some risk factors are social and environmental risk factors known as social determinants of health (SDoH), including financial stability and access to health care, food, housing, and education. ¹¹ SDoH may influence health outcomes more broadly and are associated with greater risk of suicide.^12,13

The VA offers programming to address suicide risk factors. However, not all veterans are eligible for VA care. Further, some veterans prefer to obtain non-VA services in their communities. Providing veterans with community resources that address risk factors, particularly SDoH, may be a worthwhile strategy for reducing suicide. Such resources have demonstrated success; for example, greater use of housing services was associated with a reduced risk for suicide-related mortality among unhoused veterans.¹²

The challenges that veterans experience can go beyond the scope of services the VA provides. For example, while the VA provides some services related to homelessness, justice involvement, and assistance with home loans, these services are often limited. Other services for veterans to address SDoH may require access to community resources, including food banks, employment assistance, respite and childcare services, and transportation assistance. Some veterans also may have experienced institutional betrayal, which could be a barrier to VA care and may motivate veterans to address their needs in the community.¹⁴ Veterans therefore may need a range of services beyond those within the VA. Leveraging community resources for veterans at risk for suicide is critical, as these resources may help to mitigate suicide risk.

An emerging emphasis of the VA is improving coordination with community partners to prevent veteran suicide. In 2019, the VA launched an improved Veterans Community Care Program, which implemented portions of the VA MISSION Act of 2018 to create additional connection to community care for VA-enrolled veterans. This includes assisting veterans in gaining access to specialty services not offered at a local VA medical center (VAMC), getting access to services sooner, and receiving care if they do not live near a VAMC.¹⁵ In addition, the COMPACT Act allows veterans in acute suicidal crisis to receive emergency health care through either VA or non-VA facilities at no cost.¹⁶ The VA National Strategy for Preventing Veteran Suicide 2018-2028 is a 10-year plan to reduce veteran suicide rates that includes initiatives to increase connections between VA and community agencies.¹⁷ A suicide prevention community toolkit is available online for health care professionals (HCPs) (and others, including employers) outside of the VA who may be unfamiliar with best practices for working with veterans at risk for suicide.¹⁸

The challenge, however, is that there is often a lack of “connectedness” between VA suicide prevention coordinators and community resources to address suicide risk factors and related social determinants of health. These services include, but are not limited to suicide prevention, mental health counseling (particularly no/low-cost services), unemployment resources, financial assistance and counseling, housing assistance, and identity-related supportive spaces. A major stumbling block in connecting resources with veterans (regardless of discharge status) who need them is there is no single, national organization with a comprehensive, community-based network that can serve in this intermediary role.

Community asset mapping (CAM), also known as asset mapping or environmental scanning, is a way to bridge the gap.¹⁹ CAM provides a method for identifying and aligning community resources relative to a specific need.²⁰ CAM may be used to build community relationships in service of veteran suicide prevention. This process can help individuals learn about and make use of organizations and services within their communities. CAM also helps connect HCPs so they can network, exchange ideas, and collaborate with an eye toward increasing the availability of services and enhancing care coordination. CAM also allows community members (eg, leaders, organizations, individuals) to identify possible gaps in services that address suicide risk factors and solve these problems.

This article details CAM for suicide prevention, which can be utilized by the VA and community organizations alike. Within the VA, CAM can be used by HCPs and administrators, such as VA community engagement and partnership coordinators, to identify potential partnering organizations. For those who serve veterans outside of the VA, CAM can be used to connect at-risk individuals to resources that can enhance their care. This process can help increase the overall knowledge of, and access to, community resources.

COMMUNITY ASSET MAPPING

The University of California, Los Angeles Center for Health Policy Research provides 6 steps for the CAM process.²¹ These steps include: (1) defining the boundaries of people and places that comprise the community; (2) identifying people and organizations who share similar interests and goals; (3) determining the assets to include; (4) creating an inventory of all organizations’ assets; (5) creating an inventory of individuals’ assets; and (6) organizing the assets on a map. To address the needs of the veteran population, we’ve taken these 6 steps and adapted them to create a CAM for veterans at risk for suicide (Figure). The discussion that follows details how these steps can be implemented to identify community resources that address social determinants of health that may contribute to suicide risk. The goal is to prevent veteran suicide.

Step 1: Define Community Reach. The first step is to identify the geographical boundaries of the community. This may include all veterans within a catchment area (eg, veterans within 60 miles of a VAMC). Defining the geographical parameters of the community will provide structure to the effort so that the resource list is as comprehensive as possible.

Steps 2 and 3: Identify Community Members with Shared Goals; Identify Assets. It is important to identify community members who share similar interests and goals, including people with specific knowledge and skills, organizations with particular goals, and community partners with a broad reach. To begin building a list of referrals, reach out to colleagues within the VA system who are familiar with community resources for those with suicide risk factors. The local VA Transition and Care Management (TCM) office is a resource that connects those transitioning from military to civilian sectors with needed resources, and thus may be a helpful resource while building a CAM. Additionally, each office has a transition patient advocate, who is trained to resolve care-related concerns and may be familiar with community resources.

VA HCPs that can assist include Community Engagement and Partnership Coordinators, Suicide Prevention Coordinators, Local Recovery Coordinators, and substance abuse counselors. In addition, VA patient services, patient safety, and public affairs office staff—as well as VA Homeless Programs—may be good resources. Every VA health care system has care coordinators focused on military sexual trauma, intimate partner violence, and lesbian, gay, bisexual, transgender, queer+ care. These care coordinators may be able to provide information on community resources that address social determinants of health (eg, discrimination, violence).

Reaching out to key community resources and asking for recommendations of other groups that provide assistance to veterans can also be productive. You can start by connecting with veterans service organizations (VSOs), Vet Centers, Veterans Experience Offices (VEO), and Community Veterans Engagement Boards (CVEBs). The VEO is an office designed around VA and community engagement efforts. This office utilizes the CVEBs to foster a 2-way communication feedback loop between veterans and local VA facilities regarding community engagement efforts and outreach.²² CVEBs are particularly valuable sources of information because veterans directly contribute to the conversation about community engagement by describing the difficulties and successes they’ve experienced. Veteran feedback about how a particular resource met their needs can inform which community services are prioritized for inclusion in the resource list. In addition, CVEBs may have a listing of local government, military, and/or community resources that provide services for veterans. Consider, too, organizations that are unrelated to an individual’s veteran status, but speak to their race/ethnicity, sexual orientation, gender identity, spirituality, socioeconomic status, or disability.

Step 4: Continue to Build Inventory. Use online searches to identify additional resources in the community that are known to have local relationships. These include state suicide prevention coordinators, mental health organizations, and other resources that address social determinants of health (eg, public health and human service organizations, faith-based organizations, collegial organizations). A list of links and search tips are available in the Table.

Steps 5 and 6: Create Document; Organize and Disseminate Information. A spreadsheet can be used to document organization information (Appendix). It is critical to record: (1) the name of the organization or individual; (2) the local address and a point of contact with contact information; (3) services offered to veterans; (4) services specific to suicide prevention, or that address risk factors for suicide; and (5) whether the referral organization is partnered with the VA Community Care Network, which is comprised of contracted HCPs who contract with the VA to provide care to veterans.²³

Once a document is created, it can be disseminated through VA offices and among community partners who work with veterans at risk for suicide. It should also be stored in a centralized location such as a shared folder so that it can be continuously updated.

Regularly updating the list is vital so the resource list can continue to be helpful in addressing veterans’ needs and reducing suicide risk factors. Continued collaboration with those in the community can help ensure the resource list is up to date with all available services and pertinent contact information. It can also go far in strengthening collaborative bonds.

IMPLEMENTATION

To illustrate the use of CAM for veteran suicide prevention, we offer a case example of CAM conducted by the VA Patient Safety Center of Inquiry — Suicide Prevention Collaborative (VA PSCI-SPC) team, consisting of 4 team members. A veteran was included as a team member and assisted with the CAM process.

The VA PSCI-SPC sought to identify community services for veterans in Colorado who were not enrolled in VA health care and had risk factors for suicide. Next, the team reached out to colleagues and asked about community organizations that work with individuals at risk for suicide. VA PSCI-SPC outreach resulted in a list of assets that included resources to address mental health, legal concerns, employment, homelessness/housing, finances, religion, peer support, food insecurity, exercise, intimate partner violence, sexual and gender identity needs, and peer support. VSOs and CVEBs were also added to the list.

Next, the team continued to build on the inventory and identified state suicide prevention coordinators; health care systems; regional suicide prevention commissions; Colorado Department of Health and Human Services; program coordinators for Governor’s and Mayor’s Challenges to Prevent Suicide Among Service Members, Veterans, and their Families; veterans councils; universities (eg, counseling clinics, legal clinics); and foundations devoted to general and veteran-specific suicide prevention within the region.

All the identified resources were inventoried. Details were gathered about each of the organizations, including addresses, points of contact and phone numbers, descriptions of services offered for veterans, descriptions of suicide prevention services offered, whether or not organizations were not-for-profit, the mission of the organizations, and whether or not the organizations were under contract for VA Community Care. Finally, the resource spreadsheet was created and disseminated among stakeholders to be used to enhance veteran suicide care. Stakeholders included social workers, psychologists, and nurse practitioners working with veterans. The list was circulated to VA and community partners as needed.

The VA PSCI-SPC resource document was only 1 benefit of CAM. The asset mapping also resulted in the creation of a learning collaborative comprised of VA and community partners, designed to share knowledge of best practices in suicide prevention and create an established referral network for veterans at risk for suicide.²⁴ Ultimately, the goal of the CAM and the creation of the learning collaborative was to better connect veterans to care in order to decrease suicide risk. A secondary benefit of this community connectedness is that the list of resources produced by CAM became a living document that was, and continues to be, updated as the network became aware of new resources and resources that were no longer available. The VA PSCI-SPC learning collaborative met quarterly to discuss implementation of suicide prevention best practices within their organization.

Data from the VA PSCI-SPC learning collaborative via CAM revealed that organizations felt more efficacious in implementing suicide prevention best practices, noticed increased connections and collaborations with community organizations with the goal of providing services to veterans, and resulted in staff training that improved services provided to veterans.²⁴ This is supported by other findings of a literature review of suicide prevention interventions, which indicated that programs with an established community support network were more effective at reducing suicide rates.²⁵ CAM therefore may be a process through which greater community connection and increased knowledge of resources may help prevent suicide among veterans.

It seems reasonable that the CAM processes used by the VA PSCI-SPC can be implemented within the regional Veterans Integrated Service Networks to identify assets in a specific geographical area to address challenges with social determinants of health and potentially decrease veteran suicide risk.

CONCLUSIONS

CAM can be used to identify and build relationships with community resources that address the stressors that place veterans at risk for suicide. Six proposed steps to CAM for veterans at risk for suicide include: defining community reach (the map); identifying community members and organizations with shared goals; identifying assets within the community; continuing to build inventory; creating a document; and organizing and disseminating the information (while continuing to update the resources).²¹

CAM can be used to connect veterans with resources to address needs related to adverse social determinants of health that may heighten their risk for suicide. For example, veterans facing legal challenges can connect with a legal clinic; those having difficulties paying bills can obtain financial assistance; those who need help completing their VA claims can connect with the Veterans Benefits Administration or VSOs to assist them with their claims; and those experiencing discrimination can connect with organizations where they may experience acceptance, safety, and support. Broad community support surrounding suicide risk factors can be critical for effective suicide prevention.²⁵

CAM may also be helpful for HCPs and others involved in veteran health care. For example, community mapping can be utilized by newly hired community engagement and partnership coordinators as a tool for outlining resources available for veterans in their community and as a framework to continually update their resource network. CAM develops community awareness, integrates resources, and enhances service utilization, which may assist in veteran suicide prevention by increasing care coordination.¹⁷ Finally, mapping community resources can create awareness of the many resources available to help veterans, even before suicide becomes a consideration.

Suicide prevention is the leading clinical priority for the US Department of Veterans Affairs (VA).¹ An average of 18 veterans died by suicide each day in 2021.² Numerous risk factors for veteran suicide have been identified, including mental health disorders, comorbidities, access to firearms, and potentially lethal medications.^3-5 To better understand groups of patients at risk of suicide in medical settings, the authors have previously compared demographic and clinical risk factors between patients who died by suicide by using firearms or other means with matched patients who did not die by suicide (control group) to examine the impact of lack of social support, financial stress,⁶ legal problems,⁷ homelessness,⁸ and discrimination.⁹ The number of cooccurring risk factors a veteran experiences is associated with a greater likelihood of suicide attempts over time.¹⁰ In addition, some risk factors are social and environmental risk factors known as social determinants of health (SDoH), including financial stability and access to health care, food, housing, and education. ¹¹ SDoH may influence health outcomes more broadly and are associated with greater risk of suicide.^12,13

The VA offers programming to address suicide risk factors. However, not all veterans are eligible for VA care. Further, some veterans prefer to obtain non-VA services in their communities. Providing veterans with community resources that address risk factors, particularly SDoH, may be a worthwhile strategy for reducing suicide. Such resources have demonstrated success; for example, greater use of housing services was associated with a reduced risk for suicide-related mortality among unhoused veterans.¹²

The challenges that veterans experience can go beyond the scope of services the VA provides. For example, while the VA provides some services related to homelessness, justice involvement, and assistance with home loans, these services are often limited. Other services for veterans to address SDoH may require access to community resources, including food banks, employment assistance, respite and childcare services, and transportation assistance. Some veterans also may have experienced institutional betrayal, which could be a barrier to VA care and may motivate veterans to address their needs in the community.¹⁴ Veterans therefore may need a range of services beyond those within the VA. Leveraging community resources for veterans at risk for suicide is critical, as these resources may help to mitigate suicide risk.

An emerging emphasis of the VA is improving coordination with community partners to prevent veteran suicide. In 2019, the VA launched an improved Veterans Community Care Program, which implemented portions of the VA MISSION Act of 2018 to create additional connection to community care for VA-enrolled veterans. This includes assisting veterans in gaining access to specialty services not offered at a local VA medical center (VAMC), getting access to services sooner, and receiving care if they do not live near a VAMC.¹⁵ In addition, the COMPACT Act allows veterans in acute suicidal crisis to receive emergency health care through either VA or non-VA facilities at no cost.¹⁶ The VA National Strategy for Preventing Veteran Suicide 2018-2028 is a 10-year plan to reduce veteran suicide rates that includes initiatives to increase connections between VA and community agencies.¹⁷ A suicide prevention community toolkit is available online for health care professionals (HCPs) (and others, including employers) outside of the VA who may be unfamiliar with best practices for working with veterans at risk for suicide.¹⁸

The challenge, however, is that there is often a lack of “connectedness” between VA suicide prevention coordinators and community resources to address suicide risk factors and related social determinants of health. These services include, but are not limited to suicide prevention, mental health counseling (particularly no/low-cost services), unemployment resources, financial assistance and counseling, housing assistance, and identity-related supportive spaces. A major stumbling block in connecting resources with veterans (regardless of discharge status) who need them is there is no single, national organization with a comprehensive, community-based network that can serve in this intermediary role.

Community asset mapping (CAM), also known as asset mapping or environmental scanning, is a way to bridge the gap.¹⁹ CAM provides a method for identifying and aligning community resources relative to a specific need.²⁰ CAM may be used to build community relationships in service of veteran suicide prevention. This process can help individuals learn about and make use of organizations and services within their communities. CAM also helps connect HCPs so they can network, exchange ideas, and collaborate with an eye toward increasing the availability of services and enhancing care coordination. CAM also allows community members (eg, leaders, organizations, individuals) to identify possible gaps in services that address suicide risk factors and solve these problems.

This article details CAM for suicide prevention, which can be utilized by the VA and community organizations alike. Within the VA, CAM can be used by HCPs and administrators, such as VA community engagement and partnership coordinators, to identify potential partnering organizations. For those who serve veterans outside of the VA, CAM can be used to connect at-risk individuals to resources that can enhance their care. This process can help increase the overall knowledge of, and access to, community resources.

COMMUNITY ASSET MAPPING

The University of California, Los Angeles Center for Health Policy Research provides 6 steps for the CAM process.²¹ These steps include: (1) defining the boundaries of people and places that comprise the community; (2) identifying people and organizations who share similar interests and goals; (3) determining the assets to include; (4) creating an inventory of all organizations’ assets; (5) creating an inventory of individuals’ assets; and (6) organizing the assets on a map. To address the needs of the veteran population, we’ve taken these 6 steps and adapted them to create a CAM for veterans at risk for suicide (Figure). The discussion that follows details how these steps can be implemented to identify community resources that address social determinants of health that may contribute to suicide risk. The goal is to prevent veteran suicide.

Step 1: Define Community Reach. The first step is to identify the geographical boundaries of the community. This may include all veterans within a catchment area (eg, veterans within 60 miles of a VAMC). Defining the geographical parameters of the community will provide structure to the effort so that the resource list is as comprehensive as possible.

Steps 2 and 3: Identify Community Members with Shared Goals; Identify Assets. It is important to identify community members who share similar interests and goals, including people with specific knowledge and skills, organizations with particular goals, and community partners with a broad reach. To begin building a list of referrals, reach out to colleagues within the VA system who are familiar with community resources for those with suicide risk factors. The local VA Transition and Care Management (TCM) office is a resource that connects those transitioning from military to civilian sectors with needed resources, and thus may be a helpful resource while building a CAM. Additionally, each office has a transition patient advocate, who is trained to resolve care-related concerns and may be familiar with community resources.

VA HCPs that can assist include Community Engagement and Partnership Coordinators, Suicide Prevention Coordinators, Local Recovery Coordinators, and substance abuse counselors. In addition, VA patient services, patient safety, and public affairs office staff—as well as VA Homeless Programs—may be good resources. Every VA health care system has care coordinators focused on military sexual trauma, intimate partner violence, and lesbian, gay, bisexual, transgender, queer+ care. These care coordinators may be able to provide information on community resources that address social determinants of health (eg, discrimination, violence).

Reaching out to key community resources and asking for recommendations of other groups that provide assistance to veterans can also be productive. You can start by connecting with veterans service organizations (VSOs), Vet Centers, Veterans Experience Offices (VEO), and Community Veterans Engagement Boards (CVEBs). The VEO is an office designed around VA and community engagement efforts. This office utilizes the CVEBs to foster a 2-way communication feedback loop between veterans and local VA facilities regarding community engagement efforts and outreach.²² CVEBs are particularly valuable sources of information because veterans directly contribute to the conversation about community engagement by describing the difficulties and successes they’ve experienced. Veteran feedback about how a particular resource met their needs can inform which community services are prioritized for inclusion in the resource list. In addition, CVEBs may have a listing of local government, military, and/or community resources that provide services for veterans. Consider, too, organizations that are unrelated to an individual’s veteran status, but speak to their race/ethnicity, sexual orientation, gender identity, spirituality, socioeconomic status, or disability.

Step 4: Continue to Build Inventory. Use online searches to identify additional resources in the community that are known to have local relationships. These include state suicide prevention coordinators, mental health organizations, and other resources that address social determinants of health (eg, public health and human service organizations, faith-based organizations, collegial organizations). A list of links and search tips are available in the Table.

Steps 5 and 6: Create Document; Organize and Disseminate Information. A spreadsheet can be used to document organization information (Appendix). It is critical to record: (1) the name of the organization or individual; (2) the local address and a point of contact with contact information; (3) services offered to veterans; (4) services specific to suicide prevention, or that address risk factors for suicide; and (5) whether the referral organization is partnered with the VA Community Care Network, which is comprised of contracted HCPs who contract with the VA to provide care to veterans.²³

Once a document is created, it can be disseminated through VA offices and among community partners who work with veterans at risk for suicide. It should also be stored in a centralized location such as a shared folder so that it can be continuously updated.

Regularly updating the list is vital so the resource list can continue to be helpful in addressing veterans’ needs and reducing suicide risk factors. Continued collaboration with those in the community can help ensure the resource list is up to date with all available services and pertinent contact information. It can also go far in strengthening collaborative bonds.

IMPLEMENTATION

To illustrate the use of CAM for veteran suicide prevention, we offer a case example of CAM conducted by the VA Patient Safety Center of Inquiry — Suicide Prevention Collaborative (VA PSCI-SPC) team, consisting of 4 team members. A veteran was included as a team member and assisted with the CAM process.

The VA PSCI-SPC sought to identify community services for veterans in Colorado who were not enrolled in VA health care and had risk factors for suicide. Next, the team reached out to colleagues and asked about community organizations that work with individuals at risk for suicide. VA PSCI-SPC outreach resulted in a list of assets that included resources to address mental health, legal concerns, employment, homelessness/housing, finances, religion, peer support, food insecurity, exercise, intimate partner violence, sexual and gender identity needs, and peer support. VSOs and CVEBs were also added to the list.

Next, the team continued to build on the inventory and identified state suicide prevention coordinators; health care systems; regional suicide prevention commissions; Colorado Department of Health and Human Services; program coordinators for Governor’s and Mayor’s Challenges to Prevent Suicide Among Service Members, Veterans, and their Families; veterans councils; universities (eg, counseling clinics, legal clinics); and foundations devoted to general and veteran-specific suicide prevention within the region.

All the identified resources were inventoried. Details were gathered about each of the organizations, including addresses, points of contact and phone numbers, descriptions of services offered for veterans, descriptions of suicide prevention services offered, whether or not organizations were not-for-profit, the mission of the organizations, and whether or not the organizations were under contract for VA Community Care. Finally, the resource spreadsheet was created and disseminated among stakeholders to be used to enhance veteran suicide care. Stakeholders included social workers, psychologists, and nurse practitioners working with veterans. The list was circulated to VA and community partners as needed.

The VA PSCI-SPC resource document was only 1 benefit of CAM. The asset mapping also resulted in the creation of a learning collaborative comprised of VA and community partners, designed to share knowledge of best practices in suicide prevention and create an established referral network for veterans at risk for suicide.²⁴ Ultimately, the goal of the CAM and the creation of the learning collaborative was to better connect veterans to care in order to decrease suicide risk. A secondary benefit of this community connectedness is that the list of resources produced by CAM became a living document that was, and continues to be, updated as the network became aware of new resources and resources that were no longer available. The VA PSCI-SPC learning collaborative met quarterly to discuss implementation of suicide prevention best practices within their organization.

Data from the VA PSCI-SPC learning collaborative via CAM revealed that organizations felt more efficacious in implementing suicide prevention best practices, noticed increased connections and collaborations with community organizations with the goal of providing services to veterans, and resulted in staff training that improved services provided to veterans.²⁴ This is supported by other findings of a literature review of suicide prevention interventions, which indicated that programs with an established community support network were more effective at reducing suicide rates.²⁵ CAM therefore may be a process through which greater community connection and increased knowledge of resources may help prevent suicide among veterans.

It seems reasonable that the CAM processes used by the VA PSCI-SPC can be implemented within the regional Veterans Integrated Service Networks to identify assets in a specific geographical area to address challenges with social determinants of health and potentially decrease veteran suicide risk.

CONCLUSIONS

CAM can be used to identify and build relationships with community resources that address the stressors that place veterans at risk for suicide. Six proposed steps to CAM for veterans at risk for suicide include: defining community reach (the map); identifying community members and organizations with shared goals; identifying assets within the community; continuing to build inventory; creating a document; and organizing and disseminating the information (while continuing to update the resources).²¹

CAM can be used to connect veterans with resources to address needs related to adverse social determinants of health that may heighten their risk for suicide. For example, veterans facing legal challenges can connect with a legal clinic; those having difficulties paying bills can obtain financial assistance; those who need help completing their VA claims can connect with the Veterans Benefits Administration or VSOs to assist them with their claims; and those experiencing discrimination can connect with organizations where they may experience acceptance, safety, and support. Broad community support surrounding suicide risk factors can be critical for effective suicide prevention.²⁵

CAM may also be helpful for HCPs and others involved in veteran health care. For example, community mapping can be utilized by newly hired community engagement and partnership coordinators as a tool for outlining resources available for veterans in their community and as a framework to continually update their resource network. CAM develops community awareness, integrates resources, and enhances service utilization, which may assist in veteran suicide prevention by increasing care coordination.¹⁷ Finally, mapping community resources can create awareness of the many resources available to help veterans, even before suicide becomes a consideration.

Evidence-based psychotherapy (EBP) for posttraumatic stress disorder (PTSD), such as prolonged exposure (PE), is supported by multiple clinical practice guidelines and is expected to be available to veterans served by the Veterans Health Administration (VHA).^1-5 However, traditional models of EBP delivery with 1 or 2 sessions weekly have high dropout rates.^6,7 Few veterans who could benefit from such EBPs receive them, and those who do have low completion rates.^8,9 Over a 15-year period, VHA records review of > 265,500 veterans with PTSD showed only 9.1% completed EBP treatment that included but was not limited to PE.¹⁰

One empirically supported solution that has yet to be widely implemented is delivering EBPs for PTSD in a massed or accelerated format of ≥ 3 sessions weekly.¹¹ While these massed models of EBP delivery for PTSD are promising, their implementation is limited in federal health care settings, such as the VHA.¹² PE therapy is a first-line treatment for PTSD that has been evaluated in numerous clinical trials since the early 1990s and in a wide range of trauma populations.^13,14 Massed PE is effective and PE has been found to be effective both in-person and via telehealth.^11,15,16

Another approach to accelerated PE is the inclusion of a massed PE course within a broader treatment context that includes augmentation of the massed PE with additional services, this is referred to as an intensive outpatient model (IOP).¹⁷ PE-IOP has also been shown to be feasible, acceptable, and effective with increased completion rates in comparison to the traditional (1 or 2 sessions weekly) model of PE.^12,16,18,19 Ragsdale et al describe a 2-week IOP with multiple treatment tracks, including a PTSD track. The PTSD treatment track includes massed PE and additional standard services including case management, wellness services, family services, and a single session effective behaviors group. Additional augmentation services are available when clinically indicated (eg, repetitive transcranial magnetic stimulation, transcranial direct current stimulation treatment, psychoeducation, motivational interviewing, and/or relapse prevention).¹⁷

Rauch et al studied the first 80 patients completing an IOP program that consisted of PE (5 sessions weekly) and complementary interventions (eg, mindfulness and yoga) and reported a 96% retention rate, significant reductions of self-reported PTSD symptoms, significant reduction in self-reported co-occurring depression symptoms, and significant increase in self-reported satisfaction with social functioning. ¹⁸ In another study, Sherril et al explored patient reactions to participation in massed PE (5 sessions weekly) and found that patients reported significantly more positive than negative reactions. Sherrill et al noted that according to patients, the benefits of massed PE included a structured format that limits avoidance and distraction. The resulting fast pace of progress enhanced motivation; however, drawbacks included short-term discomfort and time demands.¹⁹ Yamokoski et al explored the feasibility of massed PE in a larger study of PTSD treatment in an intensive outpatient track (IOT) in a VHA PTSD clinic with minimal staffing. The 48 patients who completed IOT PTSD treatment in 2 or 4 weeks (including 35 patients who received massed PE) had high retention rates (85%), reported high satisfaction, and had significantly reduced PTSD and depression symptoms.¹²

The massed IOT PE model implemented by Yamokoski et al included the primary EBP intervention of massed PE with adjunctive groups. The addition of these groups increased both retention and patient-reported satisfaction. The PE-IOP model implemented by Rauch et al and Sherrill et al also included wellness and educational groups, as well as access to complementary interventions such as mindfulness and yoga.^18,19 The addition of wellness education along with a primary EBP aligned with the VHA focus on whole health well-being and wellness. The whole health approach includes understanding the factors that motivate a patient toward health and well-being, provision of health education, and providing access to complementary interventions such as mindfulness.²⁰ Dryden et al describe the whole health transformation within VHA as a proactive approach to addressing employee and patient wellness and health. Their research found that the whole health model promoted well-being in patients and staff and was sustained even during the COVID-19 pandemic.²¹ Dryden et al also noted that use of virtual technologies facilitated and promoted continued whole health implementation. The literature illustrates that: (1) massed PE can be provided with complementary education and wellness offerings, and that such offerings may increase both retention and satisfaction by enriching the massed PE treatment (eg, delivering PE-IOP); (2) whole health including wellness education and complementary interventions (eg, mindfulness, motivational enhancement) promotes well-being in both patients and mental health professionals; and (3) whole health education and complementary interventions can be delivered virtually.

Health Care Need

Prior to the implementation of a massed EBP for PTSD program at US Department of Veterans Affairs (VA) Pacific Islands Health Care System (VAPIHCS), our setting included a traditional outpatient program for treatment of PTSD and a 12- bed residential program for treatment of PTSD for male-identified (self-identified and identified as male in the electronic medical record) veterans via a cohort model with an 8- or 9-week length of stay. Both programs were located on Oahu. Thus, veterans who received care at VAPIHCS had access to PE in both outpatient and residential settings and via in-person and telehealth modalities. However, their access to PE was limited to the traditional models of PE delivery (eg, 1 or 2 session per week) and very few veterans outside of the island of Oahu had accessed PE treatment for PTSD. Moreover, when looking at PE reach within VAPIHCS, in the fiscal year prior to the implementation of the massed EBP program, only 32 of the > 5000 eligible veterans with a PTSD diagnosis had received PE. VAPIHCS serves veterans in a catchment area across the Pacific Basin which includes 3 time zones: Hawaii Standard Time (HST), Chamorro Standard Time (ChST), and Samoa Standard Time (SST). ChST is 20 hours ahead of HST, making service delivery that is inclusive for patients in Guam and Saipan especially challenging when providing care from Hawaii or other US states or territories. Given all of this, implementation of a new program offering accelerated PE virtually to any veterans with PTSD within the VAPIHCS would increase access to and reduce barriers to receiving PE.

PROGRAM DESCRIPTION

The Intensive Virtual EBP Team (iVET) for PTSD consists of an accelerated course of PE therapy and whole health education provided via VA Video Connect (VVC). iVET is a 3-week program and includes 3 parts: (1) massed individual PE therapy for PTSD; (2) group whole health and wellness classes; and (3) individual health coaching to address personal wellness goals. Programming is offered over 10-hour days to increase access across multiple time zones, especially to allow for participation in Guam and Saipan.

When a patient is referred to the iVET, their first contact is a video (or telephone) appointment with a registered nurse (RN) for a screening session. The screening session is designed to educate the patient about the program, including interventions, time commitment, and resources required for participation. In addition, following the educational discussion, the RN completes screening for safety with the patient including suicidal ideation and risk, as well as intimate partner violence risk. If urgent safety concerns are present, a licensed social worker or psychologist will join the screening to complete further assessment of risk and to address any safety concerns. Following screening, patients are scheduled for a VVC intake with a licensed therapist (social worker or psychologist) to complete the Clinician-Administered PTSD Scale (CAPS-5) for the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition), a clinical interview for PTSD assessment. Patients are also sent a secure link to complete a measurement-based care (MBC) battery of self-report measures including measures assessing demographics, PTSD symptoms, anxiety symptoms, depression symptoms, substance use, quality of life (QOL), and satisfaction with mental health care. The results of the CAPS-5 and self-report measures are discussed with the patient during the intake session when planning next steps and engaging in shared decision-making. This initial VVC intake not only allows for diagnostic goodness of fit but also provides the opportunity to troubleshoot any technical difficulties the patients might have with the virtual platforms.

There are minimal exclusion criteria for participation in iVET, which include active unmanaged psychosis or manic symptoms, recent suicidal crises (attempt within 8 weeks), active nonsuicidal self-injurious behaviors (within 8 weeks), and moderate-to-severe cognitive impairment. Following intake, patients are scheduled to begin their course of care with iVET. Upon completion of intake, patients are sent program materials for their individual and group classes, asked to obtain or request a recording device, and told they will receive email links for all VVC appointments. Patients are admitted to the iVET in a rolling admission fashion, thereby increasing access when compared to closed group and/or cohort models of care.

Patients receiving care in iVET attend 2 or 3 telehealth appointments daily with practice exercises daily between telehealth sessions. The primary EBP intervention in the iVET for PTSD program is a massed or accelerated course of PE, which includes 4 primary components: psychoeducation, in-vivo exposure, imaginal exposure, and breathing retraining. Specifically, PE is delivered in 4 90-minute individual sessions weekly allowing completion of the full PE protocol, to fidelity, in 3 weeks. In addition to receiving this primary intervention, patients also participate in four 50-minute group sessions per week of a whole health and wellness education class and have access to one 30- to 60-minute session weekly of individual health coaching should they wish to set wellness goals and receive coaching in support of attaining wellness goals. During iVET, patients are invited to complete MBC batteries of selfreport measures including measures assessing PTSD symptoms, anxiety symptoms, depression symptoms, substance use, QOL, and satisfaction with mental health care at sessions 1, 5, 9, and the final session of PE. Following discharge from the iVET, patients are offered 1-month, 3-month, and 6-month individual postdischarge check-up sessions with a therapist where they are invited to complete MBC measures and review relapse prevention and maintenance of treatment gains. Likewise, they are offered 1-month, 3-month, and 6-month postdischarge check-up sessions with an RN focused on maintaining wellness gains.

The iVET for PTSD staff includes 3 therapists (psychologists or social workers) and an RN. Additionally, the iVET for PTSD is supported by a program manager and a program support assistant. The primary cost of the program is salary for staff. Additional iVET for PTSD resources included computer equipment for staff and minimal supplies. Due to the virtual environment of care, iVET staff telework and do not require physical space within VAPIHCS.

OUTCOMES

All veterans receiving care in iVET for PTSD are invited to complete a MBC at multiple timepoints including pretreatment, during PE treatment, and posttreatment. The MBC measures included self-reported demographics, a 2-item measure of satisfaction with mental health services, the Brief Addiction Monitor-Intensive Outpatient Program questionnaire,²² the Generalized Anxiety Disorder-7 scale,^23, the Patient Health Questionnaire (PHQ-9),²⁴ the QOL Enjoyment and Satisfaction Questionnaire- Short Form,²⁵ and the PTSD Checklist for DSM-5 (PCL-5), both weekly and monthly versions. ^26,27

The retention rate has averaged 81% since the iVET for PTSD opened in 2022. To date, 132 veterans have completed the iVET for PTSD program, including a full course of massed PE (Table 1). Veterans experienced reduced PTSD (P < .005), depression (P < .005), anxiety (P < .005), and substance use risk (P < .005). Veterans experienced improved QOL (P < .005) and reported high satisfaction with mental health care in iVET for PTSD (Table 2). Veterans also experienced reduced thoughts of death or suicidal ideation (SI) based on PHQ-9 item 9 responses. When looking categorically at presence or absence of SI on PHQ-9 item 9, a significant relationship was found between the absence of suicidal ideation and completion of a course of massed PE: X² (1, N = 132) = 13.75, P < .001. In addition, veterans who completed the program showed a significant decrease in severity of SI as measured continuously (range, 0-3) on PHQ-9 item 9 (P < .005).

Another important aspect to consider when implementing massed models of EBP is the impact on employee well-being and job satisfaction. The impact of EBP on staff was assessed following the initial EBP project. To explore this further, all staff members in the iVET for PTSD were invited to engage in a small program evaluation. iVET staff were guided through a visualization meditation intended to recall a typical workday 1 month prior to starting their new position with iVET. After the visualization meditation, staff completed the Professional Quality of Life (ProQOL) scale, a 30-item, self-reported questionnaire for health care workers that evaluates compassion satisfaction, perceived support, burnout, secondary traumatic stress, and moral distress.²⁸ One week later, staff were asked to complete the ProQOL again to capture their state after the first 6 months into their tenure as iVET staff. iVET employees experienced significantly increased perceived support (P < .05), reduced burnout (P < .05), reduced secondary traumatic stress (P < .05), and reduced moral distress (P < .05). Team members also remarked on the rewarding nature of the work and care model.

Future Directions

Future research should aim to sustain these outcomes as the iVET program continues to serve more veterans. Another important line of inquiry is longer-term follow-up, as exploring if outcomes are maintained over time is an important question that has not been answered in this article. In addition, we hope to see the accelerated model of care applied to treatment of other presenting concerns in mental health treatment (eg, anxiety, depression, insomnia). Expansion of accelerated mental health treatment into other federal and non-federal health care settings is another worthy direction. Finally, while short term (6 months) assessment of staff satisfaction in iVET was promising, ongoing assessment staff satisfaction over a longer timeframe (1-5 years) is also important.

CONCLUSIONS

PE for PTSD has been demonstrated to be effective and improve functioning and is supported by multiple clinical practice guidelines.1-5 However, as federal practitioners, we must consider the reality that many of the individuals who could benefit are not engaging in PE and there is a high dropout rate for those that do. It is vital that we envision a future state where access to PE for PTSD is equitable and inclusive, retention rates are dramatically improved, and clinicians providing PE do not experience high rates of burnout.

We must continue exploring how we can better care for our patients and colleagues. We posit that the development of programs, or tracks within existing programs, that provide massed or accelerated PE for PTSD with virtual delivery options is an imperative step toward improved care. Federal health care settings treating trauma-exposed patients with PTSD, such as those within the US Department of Defense, Indian Health Services, Federal Bureau of Prisons, and VA, are well positioned to implement programs like iVET. We believe this model of care has great merit and foresee a future where all patients seeking PTSD treatment have the option to complete an accelerated or massed course of PE should they so desire. The experiences outlined in this article illustrate the feasibility, acceptability, and sustainability of such programs without requiring substantial staffing and financial resources.

Evidence-based psychotherapy (EBP) for posttraumatic stress disorder (PTSD), such as prolonged exposure (PE), is supported by multiple clinical practice guidelines and is expected to be available to veterans served by the Veterans Health Administration (VHA).^1-5 However, traditional models of EBP delivery with 1 or 2 sessions weekly have high dropout rates.^6,7 Few veterans who could benefit from such EBPs receive them, and those who do have low completion rates.^8,9 Over a 15-year period, VHA records review of > 265,500 veterans with PTSD showed only 9.1% completed EBP treatment that included but was not limited to PE.¹⁰

One empirically supported solution that has yet to be widely implemented is delivering EBPs for PTSD in a massed or accelerated format of ≥ 3 sessions weekly.¹¹ While these massed models of EBP delivery for PTSD are promising, their implementation is limited in federal health care settings, such as the VHA.¹² PE therapy is a first-line treatment for PTSD that has been evaluated in numerous clinical trials since the early 1990s and in a wide range of trauma populations.^13,14 Massed PE is effective and PE has been found to be effective both in-person and via telehealth.^11,15,16

Another approach to accelerated PE is the inclusion of a massed PE course within a broader treatment context that includes augmentation of the massed PE with additional services, this is referred to as an intensive outpatient model (IOP).¹⁷ PE-IOP has also been shown to be feasible, acceptable, and effective with increased completion rates in comparison to the traditional (1 or 2 sessions weekly) model of PE.^12,16,18,19 Ragsdale et al describe a 2-week IOP with multiple treatment tracks, including a PTSD track. The PTSD treatment track includes massed PE and additional standard services including case management, wellness services, family services, and a single session effective behaviors group. Additional augmentation services are available when clinically indicated (eg, repetitive transcranial magnetic stimulation, transcranial direct current stimulation treatment, psychoeducation, motivational interviewing, and/or relapse prevention).¹⁷

Rauch et al studied the first 80 patients completing an IOP program that consisted of PE (5 sessions weekly) and complementary interventions (eg, mindfulness and yoga) and reported a 96% retention rate, significant reductions of self-reported PTSD symptoms, significant reduction in self-reported co-occurring depression symptoms, and significant increase in self-reported satisfaction with social functioning. ¹⁸ In another study, Sherril et al explored patient reactions to participation in massed PE (5 sessions weekly) and found that patients reported significantly more positive than negative reactions. Sherrill et al noted that according to patients, the benefits of massed PE included a structured format that limits avoidance and distraction. The resulting fast pace of progress enhanced motivation; however, drawbacks included short-term discomfort and time demands.¹⁹ Yamokoski et al explored the feasibility of massed PE in a larger study of PTSD treatment in an intensive outpatient track (IOT) in a VHA PTSD clinic with minimal staffing. The 48 patients who completed IOT PTSD treatment in 2 or 4 weeks (including 35 patients who received massed PE) had high retention rates (85%), reported high satisfaction, and had significantly reduced PTSD and depression symptoms.¹²

The massed IOT PE model implemented by Yamokoski et al included the primary EBP intervention of massed PE with adjunctive groups. The addition of these groups increased both retention and patient-reported satisfaction. The PE-IOP model implemented by Rauch et al and Sherrill et al also included wellness and educational groups, as well as access to complementary interventions such as mindfulness and yoga.^18,19 The addition of wellness education along with a primary EBP aligned with the VHA focus on whole health well-being and wellness. The whole health approach includes understanding the factors that motivate a patient toward health and well-being, provision of health education, and providing access to complementary interventions such as mindfulness.²⁰ Dryden et al describe the whole health transformation within VHA as a proactive approach to addressing employee and patient wellness and health. Their research found that the whole health model promoted well-being in patients and staff and was sustained even during the COVID-19 pandemic.²¹ Dryden et al also noted that use of virtual technologies facilitated and promoted continued whole health implementation. The literature illustrates that: (1) massed PE can be provided with complementary education and wellness offerings, and that such offerings may increase both retention and satisfaction by enriching the massed PE treatment (eg, delivering PE-IOP); (2) whole health including wellness education and complementary interventions (eg, mindfulness, motivational enhancement) promotes well-being in both patients and mental health professionals; and (3) whole health education and complementary interventions can be delivered virtually.

Health Care Need

Prior to the implementation of a massed EBP for PTSD program at US Department of Veterans Affairs (VA) Pacific Islands Health Care System (VAPIHCS), our setting included a traditional outpatient program for treatment of PTSD and a 12- bed residential program for treatment of PTSD for male-identified (self-identified and identified as male in the electronic medical record) veterans via a cohort model with an 8- or 9-week length of stay. Both programs were located on Oahu. Thus, veterans who received care at VAPIHCS had access to PE in both outpatient and residential settings and via in-person and telehealth modalities. However, their access to PE was limited to the traditional models of PE delivery (eg, 1 or 2 session per week) and very few veterans outside of the island of Oahu had accessed PE treatment for PTSD. Moreover, when looking at PE reach within VAPIHCS, in the fiscal year prior to the implementation of the massed EBP program, only 32 of the > 5000 eligible veterans with a PTSD diagnosis had received PE. VAPIHCS serves veterans in a catchment area across the Pacific Basin which includes 3 time zones: Hawaii Standard Time (HST), Chamorro Standard Time (ChST), and Samoa Standard Time (SST). ChST is 20 hours ahead of HST, making service delivery that is inclusive for patients in Guam and Saipan especially challenging when providing care from Hawaii or other US states or territories. Given all of this, implementation of a new program offering accelerated PE virtually to any veterans with PTSD within the VAPIHCS would increase access to and reduce barriers to receiving PE.

PROGRAM DESCRIPTION

The Intensive Virtual EBP Team (iVET) for PTSD consists of an accelerated course of PE therapy and whole health education provided via VA Video Connect (VVC). iVET is a 3-week program and includes 3 parts: (1) massed individual PE therapy for PTSD; (2) group whole health and wellness classes; and (3) individual health coaching to address personal wellness goals. Programming is offered over 10-hour days to increase access across multiple time zones, especially to allow for participation in Guam and Saipan.

When a patient is referred to the iVET, their first contact is a video (or telephone) appointment with a registered nurse (RN) for a screening session. The screening session is designed to educate the patient about the program, including interventions, time commitment, and resources required for participation. In addition, following the educational discussion, the RN completes screening for safety with the patient including suicidal ideation and risk, as well as intimate partner violence risk. If urgent safety concerns are present, a licensed social worker or psychologist will join the screening to complete further assessment of risk and to address any safety concerns. Following screening, patients are scheduled for a VVC intake with a licensed therapist (social worker or psychologist) to complete the Clinician-Administered PTSD Scale (CAPS-5) for the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition), a clinical interview for PTSD assessment. Patients are also sent a secure link to complete a measurement-based care (MBC) battery of self-report measures including measures assessing demographics, PTSD symptoms, anxiety symptoms, depression symptoms, substance use, quality of life (QOL), and satisfaction with mental health care. The results of the CAPS-5 and self-report measures are discussed with the patient during the intake session when planning next steps and engaging in shared decision-making. This initial VVC intake not only allows for diagnostic goodness of fit but also provides the opportunity to troubleshoot any technical difficulties the patients might have with the virtual platforms.

There are minimal exclusion criteria for participation in iVET, which include active unmanaged psychosis or manic symptoms, recent suicidal crises (attempt within 8 weeks), active nonsuicidal self-injurious behaviors (within 8 weeks), and moderate-to-severe cognitive impairment. Following intake, patients are scheduled to begin their course of care with iVET. Upon completion of intake, patients are sent program materials for their individual and group classes, asked to obtain or request a recording device, and told they will receive email links for all VVC appointments. Patients are admitted to the iVET in a rolling admission fashion, thereby increasing access when compared to closed group and/or cohort models of care.

Patients receiving care in iVET attend 2 or 3 telehealth appointments daily with practice exercises daily between telehealth sessions. The primary EBP intervention in the iVET for PTSD program is a massed or accelerated course of PE, which includes 4 primary components: psychoeducation, in-vivo exposure, imaginal exposure, and breathing retraining. Specifically, PE is delivered in 4 90-minute individual sessions weekly allowing completion of the full PE protocol, to fidelity, in 3 weeks. In addition to receiving this primary intervention, patients also participate in four 50-minute group sessions per week of a whole health and wellness education class and have access to one 30- to 60-minute session weekly of individual health coaching should they wish to set wellness goals and receive coaching in support of attaining wellness goals. During iVET, patients are invited to complete MBC batteries of selfreport measures including measures assessing PTSD symptoms, anxiety symptoms, depression symptoms, substance use, QOL, and satisfaction with mental health care at sessions 1, 5, 9, and the final session of PE. Following discharge from the iVET, patients are offered 1-month, 3-month, and 6-month individual postdischarge check-up sessions with a therapist where they are invited to complete MBC measures and review relapse prevention and maintenance of treatment gains. Likewise, they are offered 1-month, 3-month, and 6-month postdischarge check-up sessions with an RN focused on maintaining wellness gains.

The iVET for PTSD staff includes 3 therapists (psychologists or social workers) and an RN. Additionally, the iVET for PTSD is supported by a program manager and a program support assistant. The primary cost of the program is salary for staff. Additional iVET for PTSD resources included computer equipment for staff and minimal supplies. Due to the virtual environment of care, iVET staff telework and do not require physical space within VAPIHCS.

OUTCOMES

All veterans receiving care in iVET for PTSD are invited to complete a MBC at multiple timepoints including pretreatment, during PE treatment, and posttreatment. The MBC measures included self-reported demographics, a 2-item measure of satisfaction with mental health services, the Brief Addiction Monitor-Intensive Outpatient Program questionnaire,²² the Generalized Anxiety Disorder-7 scale,^23, the Patient Health Questionnaire (PHQ-9),²⁴ the QOL Enjoyment and Satisfaction Questionnaire- Short Form,²⁵ and the PTSD Checklist for DSM-5 (PCL-5), both weekly and monthly versions. ^26,27

The retention rate has averaged 81% since the iVET for PTSD opened in 2022. To date, 132 veterans have completed the iVET for PTSD program, including a full course of massed PE (Table 1). Veterans experienced reduced PTSD (P < .005), depression (P < .005), anxiety (P < .005), and substance use risk (P < .005). Veterans experienced improved QOL (P < .005) and reported high satisfaction with mental health care in iVET for PTSD (Table 2). Veterans also experienced reduced thoughts of death or suicidal ideation (SI) based on PHQ-9 item 9 responses. When looking categorically at presence or absence of SI on PHQ-9 item 9, a significant relationship was found between the absence of suicidal ideation and completion of a course of massed PE: X² (1, N = 132) = 13.75, P < .001. In addition, veterans who completed the program showed a significant decrease in severity of SI as measured continuously (range, 0-3) on PHQ-9 item 9 (P < .005).

Another important aspect to consider when implementing massed models of EBP is the impact on employee well-being and job satisfaction. The impact of EBP on staff was assessed following the initial EBP project. To explore this further, all staff members in the iVET for PTSD were invited to engage in a small program evaluation. iVET staff were guided through a visualization meditation intended to recall a typical workday 1 month prior to starting their new position with iVET. After the visualization meditation, staff completed the Professional Quality of Life (ProQOL) scale, a 30-item, self-reported questionnaire for health care workers that evaluates compassion satisfaction, perceived support, burnout, secondary traumatic stress, and moral distress.²⁸ One week later, staff were asked to complete the ProQOL again to capture their state after the first 6 months into their tenure as iVET staff. iVET employees experienced significantly increased perceived support (P < .05), reduced burnout (P < .05), reduced secondary traumatic stress (P < .05), and reduced moral distress (P < .05). Team members also remarked on the rewarding nature of the work and care model.

Future Directions

Future research should aim to sustain these outcomes as the iVET program continues to serve more veterans. Another important line of inquiry is longer-term follow-up, as exploring if outcomes are maintained over time is an important question that has not been answered in this article. In addition, we hope to see the accelerated model of care applied to treatment of other presenting concerns in mental health treatment (eg, anxiety, depression, insomnia). Expansion of accelerated mental health treatment into other federal and non-federal health care settings is another worthy direction. Finally, while short term (6 months) assessment of staff satisfaction in iVET was promising, ongoing assessment staff satisfaction over a longer timeframe (1-5 years) is also important.

CONCLUSIONS

PE for PTSD has been demonstrated to be effective and improve functioning and is supported by multiple clinical practice guidelines.1-5 However, as federal practitioners, we must consider the reality that many of the individuals who could benefit are not engaging in PE and there is a high dropout rate for those that do. It is vital that we envision a future state where access to PE for PTSD is equitable and inclusive, retention rates are dramatically improved, and clinicians providing PE do not experience high rates of burnout.

We must continue exploring how we can better care for our patients and colleagues. We posit that the development of programs, or tracks within existing programs, that provide massed or accelerated PE for PTSD with virtual delivery options is an imperative step toward improved care. Federal health care settings treating trauma-exposed patients with PTSD, such as those within the US Department of Defense, Indian Health Services, Federal Bureau of Prisons, and VA, are well positioned to implement programs like iVET. We believe this model of care has great merit and foresee a future where all patients seeking PTSD treatment have the option to complete an accelerated or massed course of PE should they so desire. The experiences outlined in this article illustrate the feasibility, acceptability, and sustainability of such programs without requiring substantial staffing and financial resources.

Evidence-based psychotherapy (EBP) for posttraumatic stress disorder (PTSD), such as prolonged exposure (PE), is supported by multiple clinical practice guidelines and is expected to be available to veterans served by the Veterans Health Administration (VHA).^1-5 However, traditional models of EBP delivery with 1 or 2 sessions weekly have high dropout rates.^6,7 Few veterans who could benefit from such EBPs receive them, and those who do have low completion rates.^8,9 Over a 15-year period, VHA records review of > 265,500 veterans with PTSD showed only 9.1% completed EBP treatment that included but was not limited to PE.¹⁰

One empirically supported solution that has yet to be widely implemented is delivering EBPs for PTSD in a massed or accelerated format of ≥ 3 sessions weekly.¹¹ While these massed models of EBP delivery for PTSD are promising, their implementation is limited in federal health care settings, such as the VHA.¹² PE therapy is a first-line treatment for PTSD that has been evaluated in numerous clinical trials since the early 1990s and in a wide range of trauma populations.^13,14 Massed PE is effective and PE has been found to be effective both in-person and via telehealth.^11,15,16

Another approach to accelerated PE is the inclusion of a massed PE course within a broader treatment context that includes augmentation of the massed PE with additional services, this is referred to as an intensive outpatient model (IOP).¹⁷ PE-IOP has also been shown to be feasible, acceptable, and effective with increased completion rates in comparison to the traditional (1 or 2 sessions weekly) model of PE.^12,16,18,19 Ragsdale et al describe a 2-week IOP with multiple treatment tracks, including a PTSD track. The PTSD treatment track includes massed PE and additional standard services including case management, wellness services, family services, and a single session effective behaviors group. Additional augmentation services are available when clinically indicated (eg, repetitive transcranial magnetic stimulation, transcranial direct current stimulation treatment, psychoeducation, motivational interviewing, and/or relapse prevention).¹⁷

Rauch et al studied the first 80 patients completing an IOP program that consisted of PE (5 sessions weekly) and complementary interventions (eg, mindfulness and yoga) and reported a 96% retention rate, significant reductions of self-reported PTSD symptoms, significant reduction in self-reported co-occurring depression symptoms, and significant increase in self-reported satisfaction with social functioning. ¹⁸ In another study, Sherril et al explored patient reactions to participation in massed PE (5 sessions weekly) and found that patients reported significantly more positive than negative reactions. Sherrill et al noted that according to patients, the benefits of massed PE included a structured format that limits avoidance and distraction. The resulting fast pace of progress enhanced motivation; however, drawbacks included short-term discomfort and time demands.¹⁹ Yamokoski et al explored the feasibility of massed PE in a larger study of PTSD treatment in an intensive outpatient track (IOT) in a VHA PTSD clinic with minimal staffing. The 48 patients who completed IOT PTSD treatment in 2 or 4 weeks (including 35 patients who received massed PE) had high retention rates (85%), reported high satisfaction, and had significantly reduced PTSD and depression symptoms.¹²

The massed IOT PE model implemented by Yamokoski et al included the primary EBP intervention of massed PE with adjunctive groups. The addition of these groups increased both retention and patient-reported satisfaction. The PE-IOP model implemented by Rauch et al and Sherrill et al also included wellness and educational groups, as well as access to complementary interventions such as mindfulness and yoga.^18,19 The addition of wellness education along with a primary EBP aligned with the VHA focus on whole health well-being and wellness. The whole health approach includes understanding the factors that motivate a patient toward health and well-being, provision of health education, and providing access to complementary interventions such as mindfulness.²⁰ Dryden et al describe the whole health transformation within VHA as a proactive approach to addressing employee and patient wellness and health. Their research found that the whole health model promoted well-being in patients and staff and was sustained even during the COVID-19 pandemic.²¹ Dryden et al also noted that use of virtual technologies facilitated and promoted continued whole health implementation. The literature illustrates that: (1) massed PE can be provided with complementary education and wellness offerings, and that such offerings may increase both retention and satisfaction by enriching the massed PE treatment (eg, delivering PE-IOP); (2) whole health including wellness education and complementary interventions (eg, mindfulness, motivational enhancement) promotes well-being in both patients and mental health professionals; and (3) whole health education and complementary interventions can be delivered virtually.

Health Care Need

Prior to the implementation of a massed EBP for PTSD program at US Department of Veterans Affairs (VA) Pacific Islands Health Care System (VAPIHCS), our setting included a traditional outpatient program for treatment of PTSD and a 12- bed residential program for treatment of PTSD for male-identified (self-identified and identified as male in the electronic medical record) veterans via a cohort model with an 8- or 9-week length of stay. Both programs were located on Oahu. Thus, veterans who received care at VAPIHCS had access to PE in both outpatient and residential settings and via in-person and telehealth modalities. However, their access to PE was limited to the traditional models of PE delivery (eg, 1 or 2 session per week) and very few veterans outside of the island of Oahu had accessed PE treatment for PTSD. Moreover, when looking at PE reach within VAPIHCS, in the fiscal year prior to the implementation of the massed EBP program, only 32 of the > 5000 eligible veterans with a PTSD diagnosis had received PE. VAPIHCS serves veterans in a catchment area across the Pacific Basin which includes 3 time zones: Hawaii Standard Time (HST), Chamorro Standard Time (ChST), and Samoa Standard Time (SST). ChST is 20 hours ahead of HST, making service delivery that is inclusive for patients in Guam and Saipan especially challenging when providing care from Hawaii or other US states or territories. Given all of this, implementation of a new program offering accelerated PE virtually to any veterans with PTSD within the VAPIHCS would increase access to and reduce barriers to receiving PE.

PROGRAM DESCRIPTION

The Intensive Virtual EBP Team (iVET) for PTSD consists of an accelerated course of PE therapy and whole health education provided via VA Video Connect (VVC). iVET is a 3-week program and includes 3 parts: (1) massed individual PE therapy for PTSD; (2) group whole health and wellness classes; and (3) individual health coaching to address personal wellness goals. Programming is offered over 10-hour days to increase access across multiple time zones, especially to allow for participation in Guam and Saipan.

When a patient is referred to the iVET, their first contact is a video (or telephone) appointment with a registered nurse (RN) for a screening session. The screening session is designed to educate the patient about the program, including interventions, time commitment, and resources required for participation. In addition, following the educational discussion, the RN completes screening for safety with the patient including suicidal ideation and risk, as well as intimate partner violence risk. If urgent safety concerns are present, a licensed social worker or psychologist will join the screening to complete further assessment of risk and to address any safety concerns. Following screening, patients are scheduled for a VVC intake with a licensed therapist (social worker or psychologist) to complete the Clinician-Administered PTSD Scale (CAPS-5) for the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition), a clinical interview for PTSD assessment. Patients are also sent a secure link to complete a measurement-based care (MBC) battery of self-report measures including measures assessing demographics, PTSD symptoms, anxiety symptoms, depression symptoms, substance use, quality of life (QOL), and satisfaction with mental health care. The results of the CAPS-5 and self-report measures are discussed with the patient during the intake session when planning next steps and engaging in shared decision-making. This initial VVC intake not only allows for diagnostic goodness of fit but also provides the opportunity to troubleshoot any technical difficulties the patients might have with the virtual platforms.

There are minimal exclusion criteria for participation in iVET, which include active unmanaged psychosis or manic symptoms, recent suicidal crises (attempt within 8 weeks), active nonsuicidal self-injurious behaviors (within 8 weeks), and moderate-to-severe cognitive impairment. Following intake, patients are scheduled to begin their course of care with iVET. Upon completion of intake, patients are sent program materials for their individual and group classes, asked to obtain or request a recording device, and told they will receive email links for all VVC appointments. Patients are admitted to the iVET in a rolling admission fashion, thereby increasing access when compared to closed group and/or cohort models of care.

Patients receiving care in iVET attend 2 or 3 telehealth appointments daily with practice exercises daily between telehealth sessions. The primary EBP intervention in the iVET for PTSD program is a massed or accelerated course of PE, which includes 4 primary components: psychoeducation, in-vivo exposure, imaginal exposure, and breathing retraining. Specifically, PE is delivered in 4 90-minute individual sessions weekly allowing completion of the full PE protocol, to fidelity, in 3 weeks. In addition to receiving this primary intervention, patients also participate in four 50-minute group sessions per week of a whole health and wellness education class and have access to one 30- to 60-minute session weekly of individual health coaching should they wish to set wellness goals and receive coaching in support of attaining wellness goals. During iVET, patients are invited to complete MBC batteries of selfreport measures including measures assessing PTSD symptoms, anxiety symptoms, depression symptoms, substance use, QOL, and satisfaction with mental health care at sessions 1, 5, 9, and the final session of PE. Following discharge from the iVET, patients are offered 1-month, 3-month, and 6-month individual postdischarge check-up sessions with a therapist where they are invited to complete MBC measures and review relapse prevention and maintenance of treatment gains. Likewise, they are offered 1-month, 3-month, and 6-month postdischarge check-up sessions with an RN focused on maintaining wellness gains.

The iVET for PTSD staff includes 3 therapists (psychologists or social workers) and an RN. Additionally, the iVET for PTSD is supported by a program manager and a program support assistant. The primary cost of the program is salary for staff. Additional iVET for PTSD resources included computer equipment for staff and minimal supplies. Due to the virtual environment of care, iVET staff telework and do not require physical space within VAPIHCS.

OUTCOMES

All veterans receiving care in iVET for PTSD are invited to complete a MBC at multiple timepoints including pretreatment, during PE treatment, and posttreatment. The MBC measures included self-reported demographics, a 2-item measure of satisfaction with mental health services, the Brief Addiction Monitor-Intensive Outpatient Program questionnaire,²² the Generalized Anxiety Disorder-7 scale,^23, the Patient Health Questionnaire (PHQ-9),²⁴ the QOL Enjoyment and Satisfaction Questionnaire- Short Form,²⁵ and the PTSD Checklist for DSM-5 (PCL-5), both weekly and monthly versions. ^26,27

The retention rate has averaged 81% since the iVET for PTSD opened in 2022. To date, 132 veterans have completed the iVET for PTSD program, including a full course of massed PE (Table 1). Veterans experienced reduced PTSD (P < .005), depression (P < .005), anxiety (P < .005), and substance use risk (P < .005). Veterans experienced improved QOL (P < .005) and reported high satisfaction with mental health care in iVET for PTSD (Table 2). Veterans also experienced reduced thoughts of death or suicidal ideation (SI) based on PHQ-9 item 9 responses. When looking categorically at presence or absence of SI on PHQ-9 item 9, a significant relationship was found between the absence of suicidal ideation and completion of a course of massed PE: X² (1, N = 132) = 13.75, P < .001. In addition, veterans who completed the program showed a significant decrease in severity of SI as measured continuously (range, 0-3) on PHQ-9 item 9 (P < .005).

Another important aspect to consider when implementing massed models of EBP is the impact on employee well-being and job satisfaction. The impact of EBP on staff was assessed following the initial EBP project. To explore this further, all staff members in the iVET for PTSD were invited to engage in a small program evaluation. iVET staff were guided through a visualization meditation intended to recall a typical workday 1 month prior to starting their new position with iVET. After the visualization meditation, staff completed the Professional Quality of Life (ProQOL) scale, a 30-item, self-reported questionnaire for health care workers that evaluates compassion satisfaction, perceived support, burnout, secondary traumatic stress, and moral distress.²⁸ One week later, staff were asked to complete the ProQOL again to capture their state after the first 6 months into their tenure as iVET staff. iVET employees experienced significantly increased perceived support (P < .05), reduced burnout (P < .05), reduced secondary traumatic stress (P < .05), and reduced moral distress (P < .05). Team members also remarked on the rewarding nature of the work and care model.

Future Directions

Future research should aim to sustain these outcomes as the iVET program continues to serve more veterans. Another important line of inquiry is longer-term follow-up, as exploring if outcomes are maintained over time is an important question that has not been answered in this article. In addition, we hope to see the accelerated model of care applied to treatment of other presenting concerns in mental health treatment (eg, anxiety, depression, insomnia). Expansion of accelerated mental health treatment into other federal and non-federal health care settings is another worthy direction. Finally, while short term (6 months) assessment of staff satisfaction in iVET was promising, ongoing assessment staff satisfaction over a longer timeframe (1-5 years) is also important.

CONCLUSIONS

PE for PTSD has been demonstrated to be effective and improve functioning and is supported by multiple clinical practice guidelines.1-5 However, as federal practitioners, we must consider the reality that many of the individuals who could benefit are not engaging in PE and there is a high dropout rate for those that do. It is vital that we envision a future state where access to PE for PTSD is equitable and inclusive, retention rates are dramatically improved, and clinicians providing PE do not experience high rates of burnout.

We must continue exploring how we can better care for our patients and colleagues. We posit that the development of programs, or tracks within existing programs, that provide massed or accelerated PE for PTSD with virtual delivery options is an imperative step toward improved care. Federal health care settings treating trauma-exposed patients with PTSD, such as those within the US Department of Defense, Indian Health Services, Federal Bureau of Prisons, and VA, are well positioned to implement programs like iVET. We believe this model of care has great merit and foresee a future where all patients seeking PTSD treatment have the option to complete an accelerated or massed course of PE should they so desire. The experiences outlined in this article illustrate the feasibility, acceptability, and sustainability of such programs without requiring substantial staffing and financial resources.