Program Profile

PURPOSE

To improve the time to release of blood products for patients with severe or life-threatening bleeding.

BACKGROUND

Exsanguination, and the resultant coagulopathy, is the number one cause of trauma-related death. Massive transfusion protocols (MTP) improve mortality by shortening the time to transfusion and correcting coagulopathy. Many patients do not meet criteria for massive transfusion (> 10 units RBCs in 24 hours), yet present with clinical instability and require rapid release (RR) of uncrossmatched blood. A quality improvement initiative was performed to identify barriers to the MTP/RR protocol at a single institution.

METHODS/DATA

A multidisciplinary subcommittee was formed to evaluate the safety and efficacy of the current MTP/RR process. Timed mock-MTP/RR trials were conducted to identify areas of delay with a goal to achieve a blood to bedside (B2B) time of under 10 minutes.

RESULTS

Timed mock-MTP/RR trials were conducted, which revealed a baseline B2B time of approximately 30 minutes. We identified problems and categorized them in terms of ordering (phase 1) and processing (phase 2). We found significant delays in phase 1. Reasons for delay were varied and included difficulty logging into the computer, staff unavailable to place orders (involved in resuscitation efforts), orders entered incorrectly, etc. Once orders were received, the blood bank could process them quickly in phase 2. Using root cause analysis, we discovered a critical step was to remove the barrier of electronic ordering. For this, a new process was developed in which the blood bank could accept verbal orders to release uncrossmatched blood during a medical emergency. Over the course of one year, a new policy for MTP/RR was drafted, an education training video was recorded, informational flyers were printed, and training drills were conducted. A repeat mock-MTP/RR scenario was performed after the change showing the B2B time was reduced by 90% from pre-intervention values to under 3 minutes. Since implementation, no new safety signals have been received, and the staff have reported improved satisfaction with the MTP/RR process.

IMPLICATIONS

A critical piece of any MTP/RR is the immediate availability of blood. Allowing verbal orders for blood products reduced time to transfusion by 90%. Through multidisciplinary effort, safe and efficient release of uncrossmatched blood products for nontraumatic massive transfusion can be achieved.

PURPOSE

To improve the time to release of blood products for patients with severe or life-threatening bleeding.

BACKGROUND

Exsanguination, and the resultant coagulopathy, is the number one cause of trauma-related death. Massive transfusion protocols (MTP) improve mortality by shortening the time to transfusion and correcting coagulopathy. Many patients do not meet criteria for massive transfusion (> 10 units RBCs in 24 hours), yet present with clinical instability and require rapid release (RR) of uncrossmatched blood. A quality improvement initiative was performed to identify barriers to the MTP/RR protocol at a single institution.

METHODS/DATA

A multidisciplinary subcommittee was formed to evaluate the safety and efficacy of the current MTP/RR process. Timed mock-MTP/RR trials were conducted to identify areas of delay with a goal to achieve a blood to bedside (B2B) time of under 10 minutes.

RESULTS

Timed mock-MTP/RR trials were conducted, which revealed a baseline B2B time of approximately 30 minutes. We identified problems and categorized them in terms of ordering (phase 1) and processing (phase 2). We found significant delays in phase 1. Reasons for delay were varied and included difficulty logging into the computer, staff unavailable to place orders (involved in resuscitation efforts), orders entered incorrectly, etc. Once orders were received, the blood bank could process them quickly in phase 2. Using root cause analysis, we discovered a critical step was to remove the barrier of electronic ordering. For this, a new process was developed in which the blood bank could accept verbal orders to release uncrossmatched blood during a medical emergency. Over the course of one year, a new policy for MTP/RR was drafted, an education training video was recorded, informational flyers were printed, and training drills were conducted. A repeat mock-MTP/RR scenario was performed after the change showing the B2B time was reduced by 90% from pre-intervention values to under 3 minutes. Since implementation, no new safety signals have been received, and the staff have reported improved satisfaction with the MTP/RR process.

IMPLICATIONS

A critical piece of any MTP/RR is the immediate availability of blood. Allowing verbal orders for blood products reduced time to transfusion by 90%. Through multidisciplinary effort, safe and efficient release of uncrossmatched blood products for nontraumatic massive transfusion can be achieved.

PURPOSE

To improve the time to release of blood products for patients with severe or life-threatening bleeding.

BACKGROUND

Exsanguination, and the resultant coagulopathy, is the number one cause of trauma-related death. Massive transfusion protocols (MTP) improve mortality by shortening the time to transfusion and correcting coagulopathy. Many patients do not meet criteria for massive transfusion (> 10 units RBCs in 24 hours), yet present with clinical instability and require rapid release (RR) of uncrossmatched blood. A quality improvement initiative was performed to identify barriers to the MTP/RR protocol at a single institution.

METHODS/DATA

A multidisciplinary subcommittee was formed to evaluate the safety and efficacy of the current MTP/RR process. Timed mock-MTP/RR trials were conducted to identify areas of delay with a goal to achieve a blood to bedside (B2B) time of under 10 minutes.

RESULTS

Timed mock-MTP/RR trials were conducted, which revealed a baseline B2B time of approximately 30 minutes. We identified problems and categorized them in terms of ordering (phase 1) and processing (phase 2). We found significant delays in phase 1. Reasons for delay were varied and included difficulty logging into the computer, staff unavailable to place orders (involved in resuscitation efforts), orders entered incorrectly, etc. Once orders were received, the blood bank could process them quickly in phase 2. Using root cause analysis, we discovered a critical step was to remove the barrier of electronic ordering. For this, a new process was developed in which the blood bank could accept verbal orders to release uncrossmatched blood during a medical emergency. Over the course of one year, a new policy for MTP/RR was drafted, an education training video was recorded, informational flyers were printed, and training drills were conducted. A repeat mock-MTP/RR scenario was performed after the change showing the B2B time was reduced by 90% from pre-intervention values to under 3 minutes. Since implementation, no new safety signals have been received, and the staff have reported improved satisfaction with the MTP/RR process.

IMPLICATIONS

A critical piece of any MTP/RR is the immediate availability of blood. Allowing verbal orders for blood products reduced time to transfusion by 90%. Through multidisciplinary effort, safe and efficient release of uncrossmatched blood products for nontraumatic massive transfusion can be achieved.

BACKGROUND

Cancer risk assessment and genetic counseling are the processes to identify and counsel people at risk for familial or hereditary cancer syndromes. They serve to inform, educate and empower patients and family members to make informed decisions about testing, cancer screening, and prevention. Additionally, genetic testing can also provide therapeutic options and opportunities for research.

METHODS

Prior to this program initiative, there were no cancer genetics services available at the VA Pittsburgh Medical Center (VAPHS) and 100% of genetics consults were referred to the community. Each year over $100,000 was spent outside of VAPHS on genetic testing and counseling. Community care referral resulted in fragmented care, prolonged wait times of 3 to 5 months, communication issues, and added financial cost to the institution. Corporal Michael J. Crescenz VA Medical Center (CMCVAMC) had previously created a genetics consultation service staffed with an advanced practice nurse that increased access to genetics services and testing rates at the facility-level. VAPHS recently established an interfacility telegenetics clinic with CMCVAMC to provide virtual genetic counseling services to Veterans at VAPHS. Under this program, VAPHS providers place an interfacility consult for Veterans who need cancer genetics services. The consult is received and reviewed by the CMCVAMC team. VAPHS patients are then seen by CMCVAMC providers via VVC or CVT and provide recommendations regarding additional genetic testing and follow-up.

RESULTS

The telegenetics clinic opened in October 2022. The clinic initially focused on patients with metastatic prostate cancer but has since expanded to provide care for all patients for whom genetics testing and/ or counseling is recommended by NCCN guidelines. Since initiation, 29 consults have been placed and 26 have been completed or are in process (89.6%). In the year prior to creation of the clinic, only 31 of 67 (46%) of referred patients completed genetics evaluation.

CONCLUSIONS

Due to the success of the clinic, plans to expand services to the VISN-level and within VAPHS to include high risk breast cancer assessment are underway. Efforts to provide genetic counseling services via virtual care modalities have the potential to increase access to care and to improve outcomes for veterans with cancer.

BACKGROUND

Cancer risk assessment and genetic counseling are the processes to identify and counsel people at risk for familial or hereditary cancer syndromes. They serve to inform, educate and empower patients and family members to make informed decisions about testing, cancer screening, and prevention. Additionally, genetic testing can also provide therapeutic options and opportunities for research.

METHODS

Prior to this program initiative, there were no cancer genetics services available at the VA Pittsburgh Medical Center (VAPHS) and 100% of genetics consults were referred to the community. Each year over $100,000 was spent outside of VAPHS on genetic testing and counseling. Community care referral resulted in fragmented care, prolonged wait times of 3 to 5 months, communication issues, and added financial cost to the institution. Corporal Michael J. Crescenz VA Medical Center (CMCVAMC) had previously created a genetics consultation service staffed with an advanced practice nurse that increased access to genetics services and testing rates at the facility-level. VAPHS recently established an interfacility telegenetics clinic with CMCVAMC to provide virtual genetic counseling services to Veterans at VAPHS. Under this program, VAPHS providers place an interfacility consult for Veterans who need cancer genetics services. The consult is received and reviewed by the CMCVAMC team. VAPHS patients are then seen by CMCVAMC providers via VVC or CVT and provide recommendations regarding additional genetic testing and follow-up.

RESULTS

The telegenetics clinic opened in October 2022. The clinic initially focused on patients with metastatic prostate cancer but has since expanded to provide care for all patients for whom genetics testing and/ or counseling is recommended by NCCN guidelines. Since initiation, 29 consults have been placed and 26 have been completed or are in process (89.6%). In the year prior to creation of the clinic, only 31 of 67 (46%) of referred patients completed genetics evaluation.

CONCLUSIONS

Due to the success of the clinic, plans to expand services to the VISN-level and within VAPHS to include high risk breast cancer assessment are underway. Efforts to provide genetic counseling services via virtual care modalities have the potential to increase access to care and to improve outcomes for veterans with cancer.

BACKGROUND

Cancer risk assessment and genetic counseling are the processes to identify and counsel people at risk for familial or hereditary cancer syndromes. They serve to inform, educate and empower patients and family members to make informed decisions about testing, cancer screening, and prevention. Additionally, genetic testing can also provide therapeutic options and opportunities for research.

METHODS

Prior to this program initiative, there were no cancer genetics services available at the VA Pittsburgh Medical Center (VAPHS) and 100% of genetics consults were referred to the community. Each year over $100,000 was spent outside of VAPHS on genetic testing and counseling. Community care referral resulted in fragmented care, prolonged wait times of 3 to 5 months, communication issues, and added financial cost to the institution. Corporal Michael J. Crescenz VA Medical Center (CMCVAMC) had previously created a genetics consultation service staffed with an advanced practice nurse that increased access to genetics services and testing rates at the facility-level. VAPHS recently established an interfacility telegenetics clinic with CMCVAMC to provide virtual genetic counseling services to Veterans at VAPHS. Under this program, VAPHS providers place an interfacility consult for Veterans who need cancer genetics services. The consult is received and reviewed by the CMCVAMC team. VAPHS patients are then seen by CMCVAMC providers via VVC or CVT and provide recommendations regarding additional genetic testing and follow-up.

RESULTS

The telegenetics clinic opened in October 2022. The clinic initially focused on patients with metastatic prostate cancer but has since expanded to provide care for all patients for whom genetics testing and/ or counseling is recommended by NCCN guidelines. Since initiation, 29 consults have been placed and 26 have been completed or are in process (89.6%). In the year prior to creation of the clinic, only 31 of 67 (46%) of referred patients completed genetics evaluation.

CONCLUSIONS

Due to the success of the clinic, plans to expand services to the VISN-level and within VAPHS to include high risk breast cancer assessment are underway. Efforts to provide genetic counseling services via virtual care modalities have the potential to increase access to care and to improve outcomes for veterans with cancer.

BACKGROUND

As of May 2023, the Veterans Affairs (VA) National Precision Oncology Program (NPOP) has provided somatic molecular testing for nearly 36,000 Veterans with cancer. Automated tools to monitor test use (locally and nationally) have only been available for NGS testing in advanced stage lung and prostate cancer. To better track utilization of NPOP supported testing across all cancer indications, and to support strategies to promote wider adoption, we developed an automated data architecture to monitor program operations. Here, we describe the development of the NPOP data mart and summarize the core components of the NPOP Somatic Molecular Testing dashboards.

METHODS

SQL Server Integration Services was used to build the backend data mart, which required the ingestion of vendor-specific XML data and subsequent harmonization with data found in the VA’s Corporate Data Warehouse (CDW). The NPOP somatic testing dashboards, developed using Power BI, are securely hosted in the cloud, and accessible through SharePoint.

DATA ANALYSIS

The NPOP dashboard suite displays key measures using descriptive statistics, including counts, proportions, means, medians, and standard deviations. To support the visualization of comparisons we leveraged stacked and clustered bar charts, and violin plots.

RESULTS

The NPOP data mart refreshes nightly providing users with near real-time data. The NPOP somatic testing dashboards include an all vendor combined report and sub-reports organized by vendors: Foundation Medicine, Personalis, and Personal Genome Diagnostics and Tempus. All reports contain four views with the ability to toggle between tests ordered or completed. For current NPOP vendors, patient level data and turnaround time views were developed. Data are stratified by test category (i.e., NGS Solid, NGS Liquid, Heme, IHC) and can be viewed longitudinally (i.e., across time) and filtered by test date, VA facility, patient demographics, and cancer characteristics (diagnosis, stage). To date, over 50,000 tests have been ordered (90% through Foundation Medicine).

IMPLICATIONS

The NPOP data mart and operational dashboards synthesizes vast amounts of data into a visually consumable format that supports monitoring the uptake and variation of somatic molecular testing services being offered across the VA.

BACKGROUND

As of May 2023, the Veterans Affairs (VA) National Precision Oncology Program (NPOP) has provided somatic molecular testing for nearly 36,000 Veterans with cancer. Automated tools to monitor test use (locally and nationally) have only been available for NGS testing in advanced stage lung and prostate cancer. To better track utilization of NPOP supported testing across all cancer indications, and to support strategies to promote wider adoption, we developed an automated data architecture to monitor program operations. Here, we describe the development of the NPOP data mart and summarize the core components of the NPOP Somatic Molecular Testing dashboards.

METHODS

SQL Server Integration Services was used to build the backend data mart, which required the ingestion of vendor-specific XML data and subsequent harmonization with data found in the VA’s Corporate Data Warehouse (CDW). The NPOP somatic testing dashboards, developed using Power BI, are securely hosted in the cloud, and accessible through SharePoint.

DATA ANALYSIS

The NPOP dashboard suite displays key measures using descriptive statistics, including counts, proportions, means, medians, and standard deviations. To support the visualization of comparisons we leveraged stacked and clustered bar charts, and violin plots.

RESULTS

The NPOP data mart refreshes nightly providing users with near real-time data. The NPOP somatic testing dashboards include an all vendor combined report and sub-reports organized by vendors: Foundation Medicine, Personalis, and Personal Genome Diagnostics and Tempus. All reports contain four views with the ability to toggle between tests ordered or completed. For current NPOP vendors, patient level data and turnaround time views were developed. Data are stratified by test category (i.e., NGS Solid, NGS Liquid, Heme, IHC) and can be viewed longitudinally (i.e., across time) and filtered by test date, VA facility, patient demographics, and cancer characteristics (diagnosis, stage). To date, over 50,000 tests have been ordered (90% through Foundation Medicine).

IMPLICATIONS

The NPOP data mart and operational dashboards synthesizes vast amounts of data into a visually consumable format that supports monitoring the uptake and variation of somatic molecular testing services being offered across the VA.

BACKGROUND

As of May 2023, the Veterans Affairs (VA) National Precision Oncology Program (NPOP) has provided somatic molecular testing for nearly 36,000 Veterans with cancer. Automated tools to monitor test use (locally and nationally) have only been available for NGS testing in advanced stage lung and prostate cancer. To better track utilization of NPOP supported testing across all cancer indications, and to support strategies to promote wider adoption, we developed an automated data architecture to monitor program operations. Here, we describe the development of the NPOP data mart and summarize the core components of the NPOP Somatic Molecular Testing dashboards.

METHODS

SQL Server Integration Services was used to build the backend data mart, which required the ingestion of vendor-specific XML data and subsequent harmonization with data found in the VA’s Corporate Data Warehouse (CDW). The NPOP somatic testing dashboards, developed using Power BI, are securely hosted in the cloud, and accessible through SharePoint.

DATA ANALYSIS

The NPOP dashboard suite displays key measures using descriptive statistics, including counts, proportions, means, medians, and standard deviations. To support the visualization of comparisons we leveraged stacked and clustered bar charts, and violin plots.

RESULTS

The NPOP data mart refreshes nightly providing users with near real-time data. The NPOP somatic testing dashboards include an all vendor combined report and sub-reports organized by vendors: Foundation Medicine, Personalis, and Personal Genome Diagnostics and Tempus. All reports contain four views with the ability to toggle between tests ordered or completed. For current NPOP vendors, patient level data and turnaround time views were developed. Data are stratified by test category (i.e., NGS Solid, NGS Liquid, Heme, IHC) and can be viewed longitudinally (i.e., across time) and filtered by test date, VA facility, patient demographics, and cancer characteristics (diagnosis, stage). To date, over 50,000 tests have been ordered (90% through Foundation Medicine).

IMPLICATIONS

The NPOP data mart and operational dashboards synthesizes vast amounts of data into a visually consumable format that supports monitoring the uptake and variation of somatic molecular testing services being offered across the VA.

PURPOSE

This quality improvement project aims to enhance the rate of germline genetic testing for prostate cancer at the Stratton VA Medical Center, improving risk reduction strategies and therapeutic options for patients.

BACKGROUND

Prostate cancer is prevalent at the Stratton VA Medical Center, yet the rate of genetic evaluation for prostate cancer remains suboptimal. National guidelines recommend genetic counseling and testing in specific patient populations. To address this gap, an interdisciplinary working group conducted gap analysis and root cause analysis, identifying four significant barriers.

METHODS 

The working group comprised medical oncologists, urologists, primary care physicians, genetics counselors, data experts, and a LEAN coach. Interventions included implementing a prostate cancer pathway to educate staff on genetic testing indications and integrating genetic testing screening into clinic visits. After the interventions were implemented in January 2022, patient charts were reviewed for all genetic referrals and new prostate cancer diagnoses from January to December 2022.

DATA ANALYSIS

Descriptive analysis was conducted on referral rates, evaluation visit completion rates, and genetic testing outcomes among prostate cancer patients.

RESULTS

During the study period, 59 prostate cancer patients were referred for genetic evaluation. Notably, this was a large increase from no genetic referrals for prostate cancer in the previous year. Among them, 43 completed the evaluation visit, and 34 underwent genetic testing. Noteworthy findings were observed in 5 patients, including 3 variants of unknown significance and 2 pathogenic germline variants: HOXB13 and BRCA2 mutations.

IMPLICATIONS

This project highlights the power of a collaborative, multidisciplinary approach to overcome barriers and enhance the quality of care for prostate cancer patients. The team’s use of gap analysis and root cause analysis successfully identified barriers and proposed solutions, leading to increased referrals and the identification of significant genetic findings. Continued efforts to improve access to germline genetic testing are crucial for enhanced patient care and improved outcomes.

PURPOSE

This quality improvement project aims to enhance the rate of germline genetic testing for prostate cancer at the Stratton VA Medical Center, improving risk reduction strategies and therapeutic options for patients.

BACKGROUND

Prostate cancer is prevalent at the Stratton VA Medical Center, yet the rate of genetic evaluation for prostate cancer remains suboptimal. National guidelines recommend genetic counseling and testing in specific patient populations. To address this gap, an interdisciplinary working group conducted gap analysis and root cause analysis, identifying four significant barriers.

METHODS 

The working group comprised medical oncologists, urologists, primary care physicians, genetics counselors, data experts, and a LEAN coach. Interventions included implementing a prostate cancer pathway to educate staff on genetic testing indications and integrating genetic testing screening into clinic visits. After the interventions were implemented in January 2022, patient charts were reviewed for all genetic referrals and new prostate cancer diagnoses from January to December 2022.

DATA ANALYSIS

Descriptive analysis was conducted on referral rates, evaluation visit completion rates, and genetic testing outcomes among prostate cancer patients.

RESULTS

During the study period, 59 prostate cancer patients were referred for genetic evaluation. Notably, this was a large increase from no genetic referrals for prostate cancer in the previous year. Among them, 43 completed the evaluation visit, and 34 underwent genetic testing. Noteworthy findings were observed in 5 patients, including 3 variants of unknown significance and 2 pathogenic germline variants: HOXB13 and BRCA2 mutations.

IMPLICATIONS

This project highlights the power of a collaborative, multidisciplinary approach to overcome barriers and enhance the quality of care for prostate cancer patients. The team’s use of gap analysis and root cause analysis successfully identified barriers and proposed solutions, leading to increased referrals and the identification of significant genetic findings. Continued efforts to improve access to germline genetic testing are crucial for enhanced patient care and improved outcomes.

PURPOSE

This quality improvement project aims to enhance the rate of germline genetic testing for prostate cancer at the Stratton VA Medical Center, improving risk reduction strategies and therapeutic options for patients.

BACKGROUND

Prostate cancer is prevalent at the Stratton VA Medical Center, yet the rate of genetic evaluation for prostate cancer remains suboptimal. National guidelines recommend genetic counseling and testing in specific patient populations. To address this gap, an interdisciplinary working group conducted gap analysis and root cause analysis, identifying four significant barriers.

METHODS 

The working group comprised medical oncologists, urologists, primary care physicians, genetics counselors, data experts, and a LEAN coach. Interventions included implementing a prostate cancer pathway to educate staff on genetic testing indications and integrating genetic testing screening into clinic visits. After the interventions were implemented in January 2022, patient charts were reviewed for all genetic referrals and new prostate cancer diagnoses from January to December 2022.

DATA ANALYSIS

Descriptive analysis was conducted on referral rates, evaluation visit completion rates, and genetic testing outcomes among prostate cancer patients.

RESULTS

During the study period, 59 prostate cancer patients were referred for genetic evaluation. Notably, this was a large increase from no genetic referrals for prostate cancer in the previous year. Among them, 43 completed the evaluation visit, and 34 underwent genetic testing. Noteworthy findings were observed in 5 patients, including 3 variants of unknown significance and 2 pathogenic germline variants: HOXB13 and BRCA2 mutations.

IMPLICATIONS

This project highlights the power of a collaborative, multidisciplinary approach to overcome barriers and enhance the quality of care for prostate cancer patients. The team’s use of gap analysis and root cause analysis successfully identified barriers and proposed solutions, leading to increased referrals and the identification of significant genetic findings. Continued efforts to improve access to germline genetic testing are crucial for enhanced patient care and improved outcomes.

PURPOSE

To improve germline genetic testing among Veterans with high risk, very high risk and metastatic prostate cancer.

BACKGROUND

During our Commission on Cancer survey in 2021, it was noted that the Detroit VA’s referrals for germline genetic testing and counseling were extremely low. In 2020, only 1 Veteran was referred for prostate germline genetic testing and counseling and only 8 Veterans were referred in 2021. It was felt that the need to refer Veterans outside of the Detroit VA may have contributed to these low numbers. Our Cancer Committee chose prostate cancer as a disease to focus on. We chose a timeline of one year to implement our process.

METHODS

We made testing and counseling locally accessible to Veterans and encouraged medical oncology providers to make it part of the care of Veterans with high risk, very high risk and metastatic prostate cancer. We sought the assistance of the VA’s National Precision Oncology Program and were able to secure financial and logistical support to perform germline molecular prostate panel testing at the Detroit VA. We were also able to identify a cancer genetic specialist at the Ann Arbor VA that would perform genetic counseling among this group of patients based on their test results. Our medical oncology providers identified Veterans meeting the criteria for testing. Education regarding germline testing, its benefits and implications were conducted with Veterans, and performed after obtaining their informed consent in collaboration with our pathology department. The specimen is then sent to a VA central laboratory for processing. Detroit VA providers are alerted by the local laboratory once results are available. Veterans are then referred to the genetic counseling specialist based on the results. Some of these counseling visits are done virtually for the Veteran’s convenience.

DATA ANALYSIS

A retrospective chart analysis was used to collect the data.

RESULTS

After the implementation of our initiative, 97 Veterans with high risk, very high risk or metastatic prostate cancer were educated on the benefits of germline genetic testing, 87 of whom agreed to be tested. As of 4/2/23, 48 tests have already been performed. Pathogenic variants were recorded on 2 Veterans so far. One was for BRCA2 and KDM6A, and the other was for ATM. Data collection and recording is on-going.

IMPLICATIONS

Improving accessibility and incorporating genetic testing and counseling in cancer care can improve their utilization.

PURPOSE

To improve germline genetic testing among Veterans with high risk, very high risk and metastatic prostate cancer.

BACKGROUND

During our Commission on Cancer survey in 2021, it was noted that the Detroit VA’s referrals for germline genetic testing and counseling were extremely low. In 2020, only 1 Veteran was referred for prostate germline genetic testing and counseling and only 8 Veterans were referred in 2021. It was felt that the need to refer Veterans outside of the Detroit VA may have contributed to these low numbers. Our Cancer Committee chose prostate cancer as a disease to focus on. We chose a timeline of one year to implement our process.

METHODS

We made testing and counseling locally accessible to Veterans and encouraged medical oncology providers to make it part of the care of Veterans with high risk, very high risk and metastatic prostate cancer. We sought the assistance of the VA’s National Precision Oncology Program and were able to secure financial and logistical support to perform germline molecular prostate panel testing at the Detroit VA. We were also able to identify a cancer genetic specialist at the Ann Arbor VA that would perform genetic counseling among this group of patients based on their test results. Our medical oncology providers identified Veterans meeting the criteria for testing. Education regarding germline testing, its benefits and implications were conducted with Veterans, and performed after obtaining their informed consent in collaboration with our pathology department. The specimen is then sent to a VA central laboratory for processing. Detroit VA providers are alerted by the local laboratory once results are available. Veterans are then referred to the genetic counseling specialist based on the results. Some of these counseling visits are done virtually for the Veteran’s convenience.

DATA ANALYSIS

A retrospective chart analysis was used to collect the data.

RESULTS

After the implementation of our initiative, 97 Veterans with high risk, very high risk or metastatic prostate cancer were educated on the benefits of germline genetic testing, 87 of whom agreed to be tested. As of 4/2/23, 48 tests have already been performed. Pathogenic variants were recorded on 2 Veterans so far. One was for BRCA2 and KDM6A, and the other was for ATM. Data collection and recording is on-going.

IMPLICATIONS

Improving accessibility and incorporating genetic testing and counseling in cancer care can improve their utilization.

PURPOSE

To improve germline genetic testing among Veterans with high risk, very high risk and metastatic prostate cancer.

BACKGROUND

During our Commission on Cancer survey in 2021, it was noted that the Detroit VA’s referrals for germline genetic testing and counseling were extremely low. In 2020, only 1 Veteran was referred for prostate germline genetic testing and counseling and only 8 Veterans were referred in 2021. It was felt that the need to refer Veterans outside of the Detroit VA may have contributed to these low numbers. Our Cancer Committee chose prostate cancer as a disease to focus on. We chose a timeline of one year to implement our process.

METHODS

We made testing and counseling locally accessible to Veterans and encouraged medical oncology providers to make it part of the care of Veterans with high risk, very high risk and metastatic prostate cancer. We sought the assistance of the VA’s National Precision Oncology Program and were able to secure financial and logistical support to perform germline molecular prostate panel testing at the Detroit VA. We were also able to identify a cancer genetic specialist at the Ann Arbor VA that would perform genetic counseling among this group of patients based on their test results. Our medical oncology providers identified Veterans meeting the criteria for testing. Education regarding germline testing, its benefits and implications were conducted with Veterans, and performed after obtaining their informed consent in collaboration with our pathology department. The specimen is then sent to a VA central laboratory for processing. Detroit VA providers are alerted by the local laboratory once results are available. Veterans are then referred to the genetic counseling specialist based on the results. Some of these counseling visits are done virtually for the Veteran’s convenience.

DATA ANALYSIS

A retrospective chart analysis was used to collect the data.

RESULTS

After the implementation of our initiative, 97 Veterans with high risk, very high risk or metastatic prostate cancer were educated on the benefits of germline genetic testing, 87 of whom agreed to be tested. As of 4/2/23, 48 tests have already been performed. Pathogenic variants were recorded on 2 Veterans so far. One was for BRCA2 and KDM6A, and the other was for ATM. Data collection and recording is on-going.

IMPLICATIONS

Improving accessibility and incorporating genetic testing and counseling in cancer care can improve their utilization.

Lung cancer is the second most frequently diagnosed cancer among US veterans and the leading cause of cancer death.¹ Clinical trials have shown that annual screening of high-risk persons with low-dose computed tomography (LDCT) can reduce the risk of dying of lung cancer.² In 2011, the National Lung Screening Trial (NLST) reported that over a 3-year period, annual LDCT screening reduced the risk of dying of lung cancer by 20% compared with chest radiograph screening.³ Lung cancer screening (LCS), however, was associated with harms, including false-positive results, complications from invasive diagnostic procedures, incidental findings, overdiagnosis, and radiation exposure.

The US Preventive Services Task Force (USPSTF) began recommending annual screening of high-risk persons after publication of the NLST results.⁴ The Veterans Health Administration (VHA) recommended implementing LCS in 2017.⁵ Guidelines, however, have consistently highlighted the complexity of the decision and the importance of engaging patients in thorough discussions about the potential benefits and harms of screening (shared decision making [SDM]). The Centers for Medicare and Medicaid Services (CMS) has issued coverage determinations mandating that eligible patients undergo a counseling visit that uses a decision aid to support SDM for LCS and addresses tobacco use.^6,7 However, primary care practitioners (PCPs) face many challenges in delivering SDM, including a lack of awareness of clinical trial results and screening guidelines, competing clinical demands, being untrained in SDM, and not having educational resources.⁸ Patients in rural locations face travel burdens in attending counseling visits.⁹

We conducted a pilot study to address concerns with delivering SDM for LCS to veterans. We implemented a centralized screening model in which veterans were referred by clinicians to a trained decision coach who conducted telephone visits to discuss the initial LCS decision, addressed tobacco cessation, and placed LDCT orders. We evaluated the outcomes of this telemedicine visit by using decision quality metrics and tracking LCS uptake, referrals for tobacco cessation, and clinical outcomes. The University of Iowa Institutional Review Board considered this study to be a quality improvement project and waived informed consent and HIPAA (Health Insurance Portability and Accountability Act) authorization requirements.

Implementation

We implemented the LCS program at the Iowa City Veterans Affairs Health Care System (ICVAHCS), which has both resident and staff clinicians, and 2 community-based outpatient clinics (Coralville, Cedar Rapids) with staff clinicians. The pilot study, conducted from November 2020 through July 2022, was led by a multidisciplinary team that included a nurse, primary care physician, pulmonologist, and radiologist. The team conducted online presentations to educate PCPs about the epidemiology of lung cancer, results of screening trials, LCS guidelines, the rationale for a centralized model of SDM, and the ICVAHCS screening protocols.

Screening Referrals

When the study began in 2020, we used the 2015 USPSTF criteria for annual LCS: individuals aged 55 to 80 years with a 30 pack-year smoking history and current tobacco user or who had quit within 15 years.⁴ We lowered the starting age to 50 years and the pack-year requirement to 20 after the USPSTF issued updated guidelines in 2021.¹⁰ Clinicians were notified about potentially eligible patients through the US Department of Veterans Affairs (VA) Computerized Personal Record System (CPRS) reminders or by the nurse program coordinator (NPC) who reviewed health records of patients with upcoming appointments. If the clinician determined that screening was appropriate, they ordered an LCS consult. The NPC called the veteran to confirm eligibility, mailed a decision aid, and scheduled a telephone visit to conduct SDM. We used the VA decision aid developed for the LCS demonstration project conducted at 8 academic VA medical centers between 2013 and 2017.¹¹

Shared Decision-Making Telephone Visit

The NPC adapted a telephone script developed for a Cancer Prevention and Research Institute of Texas–funded project conducted by 2 coauthors (RJV and LML).¹² The NPC asked about receipt/review of the decision aid, described the screening process, and addressed benefits and potential harms of screening. The NPC also offered smoking cessation interventions for veterans who were currently smoking, including referrals to the VA patient aligned care team clinical pharmacist for management of tobacco cessation or to the national VA Quit Line. The encounter ended by assessing the veteran’s understanding of screening issues and eliciting the veteran’s preferences for LDCT and willingness to adhere with the LCS program.

LDCT Imaging

The NPC placed LDCT orders for veterans interested in screening and alerted the referring clinician to sign the order. Veterans who agreed to be screened were placed in an LCS dashboard developed by the Veterans Integrated Services Network (VISN) 23 LCS program that was used as a patient management tool. The dashboard allowed the NPC to track patients, ensuring that veterans were being scheduled for and completing initial and follow-up testing. Radiologists used the Lung-RADS (Lung Imaging Reporting and Data System) to categorize LDCT results (1, normal; 2, benign nodule; 3, probably benign nodule; 4, suspicious nodule).¹³ Veterans with Lung-RADS 1 or 2 results were scheduled for an annual LDCT (if they remained eligible). Veterans with Lung-RADS 3 results were scheduled for a 6-month follow-up CT. The screening program sent electronic consults to pulmonary for veterans with Lung-RADS 4 to determine whether they should undergo additional imaging or be evaluated in the pulmonary clinic.

Evaluating Shared Decision Making

We audio taped and transcribed randomly selected SDM encounters to assess fidelity with the 2016 CMS required discussion elements for counseling about lung cancer, including the benefit of reducing lung cancer mortality; the potential for harms from false alarms, incidental findings, overdiagnosis, and radiation exposure; the need for annual screening; the importance of smoking cessation; and the possibility of undergoing follow-up testing and diagnostic procedures. An investigator coded the transcripts to assess for the presence of each required element and scored the encounter from 0 to 7.

We also surveyed veterans completing SDM, using a convenience sampling strategy to evaluate knowledge, the quality of the SDM process, and decisional conflict. Initially, we sent mailed surveys to subjects to be completed 1 week after the SDM visit. To increase the response rate, we subsequently called patients to complete the surveys by telephone 1 week after the SDM visit.

We used the validated LCS-12 knowledge measure to assess awareness of lung cancer risks, screening eligibility, and the benefits and harms of screening.¹⁴ We evaluated the quality of the SDM visit by using the 3-item CollaboRATE scale (Table 1).¹⁵

Clinical Outcomes

We used the screening dashboard and CPRS to track clinical outcomes, including screening uptake, referrals for tobacco cessation, appropriate (screening or diagnostic) follow-up testing, and cancer diagnoses. We used descriptive statistics to characterize demographic data and survey responses.

Initial Findings

We conducted 105 SDM telephone visits from November 2020 through July 2022 (Table 2).

We surveyed 47 of the veterans completing SDM visits (45%) and received 37 completed surveys (79%). All respondents were male, mean age 61.9 years, 89% White, 38% married/partnered, 70% rural, 65% currently smoking, with a mean 44.8 pack-years smoking history. On average, veterans answered 6.3 (53%) of knowledge questions correctly (Table 3).

Implementing SDM

The NPC’s field notes indicated that many veterans did not perceive any need to discuss the screening decision and believed that their PCP had referred them just for screening. However, they reported having cursory discussions with their PCP, being told that only their history of heavy tobacco use meant they should be screened. For veterans who had not read the decision aid, the NPC attempted to summarize benefits and harms. However, the discussions were often inadequate because the veterans were not interested in receiving information, particularly numerical data, or indicated that they had limited time for the call.

Seventy-two (69%) of the veterans who met with the NPC were currently smoking. Tobacco cessation counseling was offered to 66; 29 were referred to the VA Quit Line, 10 were referred to the tobacco cessation pharmacist, and the NPC contacted the PCPs for 9 patients who wanted prescriptions for nicotine replacement therapy.

After the SDM visit, 91 veterans (87%) agreed to screening. By the end of the study period, 73 veterans (80%) completed testing. Most veterans had Lung-RADS 1 or 2 results, 11 (1%) had a Lung-RADS 3, and 7 (10%) had a Lung-RADS 4. All 9 veterans with Lung-RADS 3 results and at least 6 months of follow-up underwent repeat imaging within 4 to 13 months (median, 7). All veterans with a Lung-RADS 4 result were referred to pulmonary. One patient was diagnosed with an early-stage non–small cell lung cancer.

We identified several problems with LDCT coding. Radiologists did not consistently use Lung-RADS when interpreting screening LDCTs; some used the Fleischner lung nodule criteria.¹⁸ We also found discordant readings for abnormal LDCTs, where the assigned Lung-RADS score was not consistent with the nodule description in the radiology report.

Discussion

Efforts to implement LCS with a telemedicine SDM intervention were mixed. An NPC-led SDM phone call was successfully incorporated into the clinical workflow. Most veterans identified as being eligible for screening participated in the counseling visit and underwent screening. However, they were often reluctant to engage in SDM, feeling that their clinician had already recommended screening and that there was no need for further discussion. Unfortunately, many veterans had not received or reviewed the decision aid and were not interested in receiving information about benefits and harms. Because we relied on telephone calls, we could not share visual information in real time.

Overall, the surveys indicated that most veterans were very satisfied with the quality of the discussion and reported feeling no decisional conflict. However, based on the NPC’s field notes and audio recordings, we believe that the responses may have reflected earlier discussions with the PCP that reportedly emphasized only the veteran’s eligibility for screening. The fidelity assessments indicated that the NPC consistently addressed the harms and benefits of screening.

Nonetheless, the performance on knowledge measures was uneven. Veterans were generally aware of harms, including false alarms, overdiagnosis, radiation exposure, and incidental findings. They did not, however, appreciate when screening should stop. They also underestimated the risks of developing lung cancer and the portion of that risk attributable to tobacco use, and overestimated the benefits of screening. These results suggest that the veterans, at least those who completed the surveys, may not be making well-informed decisions.

Our findings echo those of other VA investigators in finding knowledge deficits among screened veterans, including being unaware that LDCT was for LCS, believing that screening could prevent cancer, receiving little information about screening harms, and feeling that negative tests meant they were among the “lucky ones” who would avoid harm from continued smoking.^19,20

The VA is currently implementing centralized screening models with the Lung Precision Oncology Program and the VA partnership to increase access to lung screening (VA-PALS).⁵ The centralized model, which readily supports the tracking, monitoring, and reporting needs of a screening program, also has advantages in delivering SDM because counselors have been trained in SDM, are more familiar with LCS evidence and processes, can better incorporate decision tools, and do not face the same time constraints as clinicians.²¹ However, studies have shown that most patients have already decided to be screened when they show up for the SDM visit.²² In contrast, about one-third of patients in primary care settings who receive decision support chose not to be screened.^23,24 We found that 13% of our patients decided against screening after a telephone discussion, suggesting that a virtually conducted SDM visit can meaningfully support decision making. Telemedicine also may reduce health inequities in centralized models arising from patients having limited access to screening centers.

Our results suggest that PCPs referring patients to a centralized program, even for virtual visits, should frame the decision to initiate LCS as SDM, where an informed patient is being supported in making a decision consistent with their values and preferences. Furthermore, engaging patients in SDM should not be construed as endorsing screening. When centralized support is less available, individual clinics may need to provide SDM, perhaps using a nonclinician decision coach if clinicians lack the time to lead the discussions. Decision coaches have been effectively used to increase patients’ knowledge about the benefits and harms of screening.¹² Regardless of the program model, PCPs will also be responsible for determining whether patients are healthy enough to undergo invasive diagnostic testing and treatment and ensuring that tobacco use is addressed.

SDM delivered in any setting will be enhanced by ensuring that patients are provided with decision aids before a counseling visit. This will help them better understand the benefits and harms of screening and the need to elicit values. The discussion can then focus on areas of concern or questions raised by reviewing the decision aid. The clinician and patient could also use a decision aid during either a face-to-face or video clinical encounter to facilitate SDM. A Cochrane review has shown that using decision aids for people facing screening decisions increases knowledge, reduces decisional conflict, and effectively elicits values and preferences.²⁵ Providing high-quality decision support is a patient-centered approach that respects a patient’s autonomy and may promote health equity and improve adherence.

We recognized the importance of having a multidisciplinary team, involving primary care, radiology, pulmonary, and nursing, with a shared understanding of the screening processes. These are essential features for a high-quality screening program where eligible veterans are readily identified and receive prompt and appropriate follow-up. Radiologists need to use Lung-RADS categories consistently and appropriately when reading LDCTs. This may require ongoing educational efforts, particularly given the new CMS guidelines accepting nonsubspecialist chest readers.⁷ Additionally, fellows and board-eligible residents may interpret images in academic settings and at VA facilities. The program needs to work closely with the pulmonary service to ensure that Lung-RADS 4 patients are promptly assessed. Radiologists and pulmonologists should calibrate the application of Lung-RADS categories to pulmonary nodules through jointly participating in meetings to review selected cases.

Challenges and Limitations

We faced some notable implementation challenges. The COVID-19 pandemic was extremely disruptive to LCS as it was to all health care. In addition, screening workflow processes were hampered by a lack of clinical reminders, which ideally would trigger for clinicians based on the tobacco history. The absence of this reminder meant that numerous patients were found to be ineligible for screening. We have a long-standing lung nodule clinic, and clinicians were confused about whether to order a surveillance imaging for an incidental nodule or a screening LDCT.

The radiology service was able to update order sets in CPRS to help guide clinicians in distinguishing indications and prerequisites for enrolling in LCS. This helped reduce the number of inappropriate orders and crossover orders between the VISN nodule tracking program and the LCS program.

Our results were preliminary and based on a small sample. We did not survey all veterans who underwent SDM, though the response rate was 79% and patient characteristics were similar to the larger cohort. Our results were potentially subject to selection bias, which could inflate the positive responses about decision quality and decisional conflict. However, the knowledge deficits are likely to be valid and suggest a need to better inform eligible veterans about the benefits and harms of screening. We did not have sufficient follow-up time to determine whether veterans were adherent to annual screenings. We showed that almost all those with abnormal imaging results completed diagnostic evaluations and/or were evaluated by pulmonary. As the program matures, we will be able to track outcomes related to cancer diagnoses and treatment.

Conclusions

A centralized LCS program was able to deliver SDM and enroll veterans in a screening program. While veterans were confident in their decision to screen and felt that they participated in decision making, knowledge testing indicated important deficits. Furthermore, we observed that many veterans did not meaningfully engage in SDM. Clinicians will need to frame the decision as patient centered at the time of referral, highlight the role of the NPC and importance of SDM, and be able to provide adequate decision support. The SDM visits can be enhanced by ensuring that veterans are able to review decision aids. Telemedicine is an acceptable and effective approach for supporting screening discussions, particularly for rural veterans.²⁶

Acknowledgments

The authors thank the following individuals for their contributions to the study: John Paul Hornbeck, program support specialist; Kelly Miell, PhD; Bradley Mecham, PhD; Christopher C. Richards, MA; Bailey Noble, NP; Rebecca Barnhart, program analyst.

Lung cancer is the second most frequently diagnosed cancer among US veterans and the leading cause of cancer death.¹ Clinical trials have shown that annual screening of high-risk persons with low-dose computed tomography (LDCT) can reduce the risk of dying of lung cancer.² In 2011, the National Lung Screening Trial (NLST) reported that over a 3-year period, annual LDCT screening reduced the risk of dying of lung cancer by 20% compared with chest radiograph screening.³ Lung cancer screening (LCS), however, was associated with harms, including false-positive results, complications from invasive diagnostic procedures, incidental findings, overdiagnosis, and radiation exposure.

The US Preventive Services Task Force (USPSTF) began recommending annual screening of high-risk persons after publication of the NLST results.⁴ The Veterans Health Administration (VHA) recommended implementing LCS in 2017.⁵ Guidelines, however, have consistently highlighted the complexity of the decision and the importance of engaging patients in thorough discussions about the potential benefits and harms of screening (shared decision making [SDM]). The Centers for Medicare and Medicaid Services (CMS) has issued coverage determinations mandating that eligible patients undergo a counseling visit that uses a decision aid to support SDM for LCS and addresses tobacco use.^6,7 However, primary care practitioners (PCPs) face many challenges in delivering SDM, including a lack of awareness of clinical trial results and screening guidelines, competing clinical demands, being untrained in SDM, and not having educational resources.⁸ Patients in rural locations face travel burdens in attending counseling visits.⁹

We conducted a pilot study to address concerns with delivering SDM for LCS to veterans. We implemented a centralized screening model in which veterans were referred by clinicians to a trained decision coach who conducted telephone visits to discuss the initial LCS decision, addressed tobacco cessation, and placed LDCT orders. We evaluated the outcomes of this telemedicine visit by using decision quality metrics and tracking LCS uptake, referrals for tobacco cessation, and clinical outcomes. The University of Iowa Institutional Review Board considered this study to be a quality improvement project and waived informed consent and HIPAA (Health Insurance Portability and Accountability Act) authorization requirements.

Implementation

We implemented the LCS program at the Iowa City Veterans Affairs Health Care System (ICVAHCS), which has both resident and staff clinicians, and 2 community-based outpatient clinics (Coralville, Cedar Rapids) with staff clinicians. The pilot study, conducted from November 2020 through July 2022, was led by a multidisciplinary team that included a nurse, primary care physician, pulmonologist, and radiologist. The team conducted online presentations to educate PCPs about the epidemiology of lung cancer, results of screening trials, LCS guidelines, the rationale for a centralized model of SDM, and the ICVAHCS screening protocols.

Screening Referrals

When the study began in 2020, we used the 2015 USPSTF criteria for annual LCS: individuals aged 55 to 80 years with a 30 pack-year smoking history and current tobacco user or who had quit within 15 years.⁴ We lowered the starting age to 50 years and the pack-year requirement to 20 after the USPSTF issued updated guidelines in 2021.¹⁰ Clinicians were notified about potentially eligible patients through the US Department of Veterans Affairs (VA) Computerized Personal Record System (CPRS) reminders or by the nurse program coordinator (NPC) who reviewed health records of patients with upcoming appointments. If the clinician determined that screening was appropriate, they ordered an LCS consult. The NPC called the veteran to confirm eligibility, mailed a decision aid, and scheduled a telephone visit to conduct SDM. We used the VA decision aid developed for the LCS demonstration project conducted at 8 academic VA medical centers between 2013 and 2017.¹¹

Shared Decision-Making Telephone Visit

The NPC adapted a telephone script developed for a Cancer Prevention and Research Institute of Texas–funded project conducted by 2 coauthors (RJV and LML).¹² The NPC asked about receipt/review of the decision aid, described the screening process, and addressed benefits and potential harms of screening. The NPC also offered smoking cessation interventions for veterans who were currently smoking, including referrals to the VA patient aligned care team clinical pharmacist for management of tobacco cessation or to the national VA Quit Line. The encounter ended by assessing the veteran’s understanding of screening issues and eliciting the veteran’s preferences for LDCT and willingness to adhere with the LCS program.

LDCT Imaging

The NPC placed LDCT orders for veterans interested in screening and alerted the referring clinician to sign the order. Veterans who agreed to be screened were placed in an LCS dashboard developed by the Veterans Integrated Services Network (VISN) 23 LCS program that was used as a patient management tool. The dashboard allowed the NPC to track patients, ensuring that veterans were being scheduled for and completing initial and follow-up testing. Radiologists used the Lung-RADS (Lung Imaging Reporting and Data System) to categorize LDCT results (1, normal; 2, benign nodule; 3, probably benign nodule; 4, suspicious nodule).¹³ Veterans with Lung-RADS 1 or 2 results were scheduled for an annual LDCT (if they remained eligible). Veterans with Lung-RADS 3 results were scheduled for a 6-month follow-up CT. The screening program sent electronic consults to pulmonary for veterans with Lung-RADS 4 to determine whether they should undergo additional imaging or be evaluated in the pulmonary clinic.

Evaluating Shared Decision Making

We audio taped and transcribed randomly selected SDM encounters to assess fidelity with the 2016 CMS required discussion elements for counseling about lung cancer, including the benefit of reducing lung cancer mortality; the potential for harms from false alarms, incidental findings, overdiagnosis, and radiation exposure; the need for annual screening; the importance of smoking cessation; and the possibility of undergoing follow-up testing and diagnostic procedures. An investigator coded the transcripts to assess for the presence of each required element and scored the encounter from 0 to 7.

We also surveyed veterans completing SDM, using a convenience sampling strategy to evaluate knowledge, the quality of the SDM process, and decisional conflict. Initially, we sent mailed surveys to subjects to be completed 1 week after the SDM visit. To increase the response rate, we subsequently called patients to complete the surveys by telephone 1 week after the SDM visit.

We used the validated LCS-12 knowledge measure to assess awareness of lung cancer risks, screening eligibility, and the benefits and harms of screening.¹⁴ We evaluated the quality of the SDM visit by using the 3-item CollaboRATE scale (Table 1).¹⁵

Clinical Outcomes

We used the screening dashboard and CPRS to track clinical outcomes, including screening uptake, referrals for tobacco cessation, appropriate (screening or diagnostic) follow-up testing, and cancer diagnoses. We used descriptive statistics to characterize demographic data and survey responses.

Initial Findings

We conducted 105 SDM telephone visits from November 2020 through July 2022 (Table 2).

We surveyed 47 of the veterans completing SDM visits (45%) and received 37 completed surveys (79%). All respondents were male, mean age 61.9 years, 89% White, 38% married/partnered, 70% rural, 65% currently smoking, with a mean 44.8 pack-years smoking history. On average, veterans answered 6.3 (53%) of knowledge questions correctly (Table 3).

Implementing SDM

The NPC’s field notes indicated that many veterans did not perceive any need to discuss the screening decision and believed that their PCP had referred them just for screening. However, they reported having cursory discussions with their PCP, being told that only their history of heavy tobacco use meant they should be screened. For veterans who had not read the decision aid, the NPC attempted to summarize benefits and harms. However, the discussions were often inadequate because the veterans were not interested in receiving information, particularly numerical data, or indicated that they had limited time for the call.

Seventy-two (69%) of the veterans who met with the NPC were currently smoking. Tobacco cessation counseling was offered to 66; 29 were referred to the VA Quit Line, 10 were referred to the tobacco cessation pharmacist, and the NPC contacted the PCPs for 9 patients who wanted prescriptions for nicotine replacement therapy.

After the SDM visit, 91 veterans (87%) agreed to screening. By the end of the study period, 73 veterans (80%) completed testing. Most veterans had Lung-RADS 1 or 2 results, 11 (1%) had a Lung-RADS 3, and 7 (10%) had a Lung-RADS 4. All 9 veterans with Lung-RADS 3 results and at least 6 months of follow-up underwent repeat imaging within 4 to 13 months (median, 7). All veterans with a Lung-RADS 4 result were referred to pulmonary. One patient was diagnosed with an early-stage non–small cell lung cancer.

We identified several problems with LDCT coding. Radiologists did not consistently use Lung-RADS when interpreting screening LDCTs; some used the Fleischner lung nodule criteria.¹⁸ We also found discordant readings for abnormal LDCTs, where the assigned Lung-RADS score was not consistent with the nodule description in the radiology report.

Discussion

Efforts to implement LCS with a telemedicine SDM intervention were mixed. An NPC-led SDM phone call was successfully incorporated into the clinical workflow. Most veterans identified as being eligible for screening participated in the counseling visit and underwent screening. However, they were often reluctant to engage in SDM, feeling that their clinician had already recommended screening and that there was no need for further discussion. Unfortunately, many veterans had not received or reviewed the decision aid and were not interested in receiving information about benefits and harms. Because we relied on telephone calls, we could not share visual information in real time.

Overall, the surveys indicated that most veterans were very satisfied with the quality of the discussion and reported feeling no decisional conflict. However, based on the NPC’s field notes and audio recordings, we believe that the responses may have reflected earlier discussions with the PCP that reportedly emphasized only the veteran’s eligibility for screening. The fidelity assessments indicated that the NPC consistently addressed the harms and benefits of screening.

Nonetheless, the performance on knowledge measures was uneven. Veterans were generally aware of harms, including false alarms, overdiagnosis, radiation exposure, and incidental findings. They did not, however, appreciate when screening should stop. They also underestimated the risks of developing lung cancer and the portion of that risk attributable to tobacco use, and overestimated the benefits of screening. These results suggest that the veterans, at least those who completed the surveys, may not be making well-informed decisions.

Our findings echo those of other VA investigators in finding knowledge deficits among screened veterans, including being unaware that LDCT was for LCS, believing that screening could prevent cancer, receiving little information about screening harms, and feeling that negative tests meant they were among the “lucky ones” who would avoid harm from continued smoking.^19,20

The VA is currently implementing centralized screening models with the Lung Precision Oncology Program and the VA partnership to increase access to lung screening (VA-PALS).⁵ The centralized model, which readily supports the tracking, monitoring, and reporting needs of a screening program, also has advantages in delivering SDM because counselors have been trained in SDM, are more familiar with LCS evidence and processes, can better incorporate decision tools, and do not face the same time constraints as clinicians.²¹ However, studies have shown that most patients have already decided to be screened when they show up for the SDM visit.²² In contrast, about one-third of patients in primary care settings who receive decision support chose not to be screened.^23,24 We found that 13% of our patients decided against screening after a telephone discussion, suggesting that a virtually conducted SDM visit can meaningfully support decision making. Telemedicine also may reduce health inequities in centralized models arising from patients having limited access to screening centers.

Our results suggest that PCPs referring patients to a centralized program, even for virtual visits, should frame the decision to initiate LCS as SDM, where an informed patient is being supported in making a decision consistent with their values and preferences. Furthermore, engaging patients in SDM should not be construed as endorsing screening. When centralized support is less available, individual clinics may need to provide SDM, perhaps using a nonclinician decision coach if clinicians lack the time to lead the discussions. Decision coaches have been effectively used to increase patients’ knowledge about the benefits and harms of screening.¹² Regardless of the program model, PCPs will also be responsible for determining whether patients are healthy enough to undergo invasive diagnostic testing and treatment and ensuring that tobacco use is addressed.

SDM delivered in any setting will be enhanced by ensuring that patients are provided with decision aids before a counseling visit. This will help them better understand the benefits and harms of screening and the need to elicit values. The discussion can then focus on areas of concern or questions raised by reviewing the decision aid. The clinician and patient could also use a decision aid during either a face-to-face or video clinical encounter to facilitate SDM. A Cochrane review has shown that using decision aids for people facing screening decisions increases knowledge, reduces decisional conflict, and effectively elicits values and preferences.²⁵ Providing high-quality decision support is a patient-centered approach that respects a patient’s autonomy and may promote health equity and improve adherence.

We recognized the importance of having a multidisciplinary team, involving primary care, radiology, pulmonary, and nursing, with a shared understanding of the screening processes. These are essential features for a high-quality screening program where eligible veterans are readily identified and receive prompt and appropriate follow-up. Radiologists need to use Lung-RADS categories consistently and appropriately when reading LDCTs. This may require ongoing educational efforts, particularly given the new CMS guidelines accepting nonsubspecialist chest readers.⁷ Additionally, fellows and board-eligible residents may interpret images in academic settings and at VA facilities. The program needs to work closely with the pulmonary service to ensure that Lung-RADS 4 patients are promptly assessed. Radiologists and pulmonologists should calibrate the application of Lung-RADS categories to pulmonary nodules through jointly participating in meetings to review selected cases.

Challenges and Limitations

We faced some notable implementation challenges. The COVID-19 pandemic was extremely disruptive to LCS as it was to all health care. In addition, screening workflow processes were hampered by a lack of clinical reminders, which ideally would trigger for clinicians based on the tobacco history. The absence of this reminder meant that numerous patients were found to be ineligible for screening. We have a long-standing lung nodule clinic, and clinicians were confused about whether to order a surveillance imaging for an incidental nodule or a screening LDCT.

The radiology service was able to update order sets in CPRS to help guide clinicians in distinguishing indications and prerequisites for enrolling in LCS. This helped reduce the number of inappropriate orders and crossover orders between the VISN nodule tracking program and the LCS program.

Our results were preliminary and based on a small sample. We did not survey all veterans who underwent SDM, though the response rate was 79% and patient characteristics were similar to the larger cohort. Our results were potentially subject to selection bias, which could inflate the positive responses about decision quality and decisional conflict. However, the knowledge deficits are likely to be valid and suggest a need to better inform eligible veterans about the benefits and harms of screening. We did not have sufficient follow-up time to determine whether veterans were adherent to annual screenings. We showed that almost all those with abnormal imaging results completed diagnostic evaluations and/or were evaluated by pulmonary. As the program matures, we will be able to track outcomes related to cancer diagnoses and treatment.

Conclusions

A centralized LCS program was able to deliver SDM and enroll veterans in a screening program. While veterans were confident in their decision to screen and felt that they participated in decision making, knowledge testing indicated important deficits. Furthermore, we observed that many veterans did not meaningfully engage in SDM. Clinicians will need to frame the decision as patient centered at the time of referral, highlight the role of the NPC and importance of SDM, and be able to provide adequate decision support. The SDM visits can be enhanced by ensuring that veterans are able to review decision aids. Telemedicine is an acceptable and effective approach for supporting screening discussions, particularly for rural veterans.²⁶

Acknowledgments

The authors thank the following individuals for their contributions to the study: John Paul Hornbeck, program support specialist; Kelly Miell, PhD; Bradley Mecham, PhD; Christopher C. Richards, MA; Bailey Noble, NP; Rebecca Barnhart, program analyst.

Lung cancer is the second most frequently diagnosed cancer among US veterans and the leading cause of cancer death.¹ Clinical trials have shown that annual screening of high-risk persons with low-dose computed tomography (LDCT) can reduce the risk of dying of lung cancer.² In 2011, the National Lung Screening Trial (NLST) reported that over a 3-year period, annual LDCT screening reduced the risk of dying of lung cancer by 20% compared with chest radiograph screening.³ Lung cancer screening (LCS), however, was associated with harms, including false-positive results, complications from invasive diagnostic procedures, incidental findings, overdiagnosis, and radiation exposure.

The US Preventive Services Task Force (USPSTF) began recommending annual screening of high-risk persons after publication of the NLST results.⁴ The Veterans Health Administration (VHA) recommended implementing LCS in 2017.⁵ Guidelines, however, have consistently highlighted the complexity of the decision and the importance of engaging patients in thorough discussions about the potential benefits and harms of screening (shared decision making [SDM]). The Centers for Medicare and Medicaid Services (CMS) has issued coverage determinations mandating that eligible patients undergo a counseling visit that uses a decision aid to support SDM for LCS and addresses tobacco use.^6,7 However, primary care practitioners (PCPs) face many challenges in delivering SDM, including a lack of awareness of clinical trial results and screening guidelines, competing clinical demands, being untrained in SDM, and not having educational resources.⁸ Patients in rural locations face travel burdens in attending counseling visits.⁹

We conducted a pilot study to address concerns with delivering SDM for LCS to veterans. We implemented a centralized screening model in which veterans were referred by clinicians to a trained decision coach who conducted telephone visits to discuss the initial LCS decision, addressed tobacco cessation, and placed LDCT orders. We evaluated the outcomes of this telemedicine visit by using decision quality metrics and tracking LCS uptake, referrals for tobacco cessation, and clinical outcomes. The University of Iowa Institutional Review Board considered this study to be a quality improvement project and waived informed consent and HIPAA (Health Insurance Portability and Accountability Act) authorization requirements.

Implementation

We implemented the LCS program at the Iowa City Veterans Affairs Health Care System (ICVAHCS), which has both resident and staff clinicians, and 2 community-based outpatient clinics (Coralville, Cedar Rapids) with staff clinicians. The pilot study, conducted from November 2020 through July 2022, was led by a multidisciplinary team that included a nurse, primary care physician, pulmonologist, and radiologist. The team conducted online presentations to educate PCPs about the epidemiology of lung cancer, results of screening trials, LCS guidelines, the rationale for a centralized model of SDM, and the ICVAHCS screening protocols.

Screening Referrals

When the study began in 2020, we used the 2015 USPSTF criteria for annual LCS: individuals aged 55 to 80 years with a 30 pack-year smoking history and current tobacco user or who had quit within 15 years.⁴ We lowered the starting age to 50 years and the pack-year requirement to 20 after the USPSTF issued updated guidelines in 2021.¹⁰ Clinicians were notified about potentially eligible patients through the US Department of Veterans Affairs (VA) Computerized Personal Record System (CPRS) reminders or by the nurse program coordinator (NPC) who reviewed health records of patients with upcoming appointments. If the clinician determined that screening was appropriate, they ordered an LCS consult. The NPC called the veteran to confirm eligibility, mailed a decision aid, and scheduled a telephone visit to conduct SDM. We used the VA decision aid developed for the LCS demonstration project conducted at 8 academic VA medical centers between 2013 and 2017.¹¹

Shared Decision-Making Telephone Visit

The NPC adapted a telephone script developed for a Cancer Prevention and Research Institute of Texas–funded project conducted by 2 coauthors (RJV and LML).¹² The NPC asked about receipt/review of the decision aid, described the screening process, and addressed benefits and potential harms of screening. The NPC also offered smoking cessation interventions for veterans who were currently smoking, including referrals to the VA patient aligned care team clinical pharmacist for management of tobacco cessation or to the national VA Quit Line. The encounter ended by assessing the veteran’s understanding of screening issues and eliciting the veteran’s preferences for LDCT and willingness to adhere with the LCS program.

LDCT Imaging

The NPC placed LDCT orders for veterans interested in screening and alerted the referring clinician to sign the order. Veterans who agreed to be screened were placed in an LCS dashboard developed by the Veterans Integrated Services Network (VISN) 23 LCS program that was used as a patient management tool. The dashboard allowed the NPC to track patients, ensuring that veterans were being scheduled for and completing initial and follow-up testing. Radiologists used the Lung-RADS (Lung Imaging Reporting and Data System) to categorize LDCT results (1, normal; 2, benign nodule; 3, probably benign nodule; 4, suspicious nodule).¹³ Veterans with Lung-RADS 1 or 2 results were scheduled for an annual LDCT (if they remained eligible). Veterans with Lung-RADS 3 results were scheduled for a 6-month follow-up CT. The screening program sent electronic consults to pulmonary for veterans with Lung-RADS 4 to determine whether they should undergo additional imaging or be evaluated in the pulmonary clinic.

Evaluating Shared Decision Making

We audio taped and transcribed randomly selected SDM encounters to assess fidelity with the 2016 CMS required discussion elements for counseling about lung cancer, including the benefit of reducing lung cancer mortality; the potential for harms from false alarms, incidental findings, overdiagnosis, and radiation exposure; the need for annual screening; the importance of smoking cessation; and the possibility of undergoing follow-up testing and diagnostic procedures. An investigator coded the transcripts to assess for the presence of each required element and scored the encounter from 0 to 7.

We also surveyed veterans completing SDM, using a convenience sampling strategy to evaluate knowledge, the quality of the SDM process, and decisional conflict. Initially, we sent mailed surveys to subjects to be completed 1 week after the SDM visit. To increase the response rate, we subsequently called patients to complete the surveys by telephone 1 week after the SDM visit.

We used the validated LCS-12 knowledge measure to assess awareness of lung cancer risks, screening eligibility, and the benefits and harms of screening.¹⁴ We evaluated the quality of the SDM visit by using the 3-item CollaboRATE scale (Table 1).¹⁵

Clinical Outcomes

We used the screening dashboard and CPRS to track clinical outcomes, including screening uptake, referrals for tobacco cessation, appropriate (screening or diagnostic) follow-up testing, and cancer diagnoses. We used descriptive statistics to characterize demographic data and survey responses.

Initial Findings

We conducted 105 SDM telephone visits from November 2020 through July 2022 (Table 2).

We surveyed 47 of the veterans completing SDM visits (45%) and received 37 completed surveys (79%). All respondents were male, mean age 61.9 years, 89% White, 38% married/partnered, 70% rural, 65% currently smoking, with a mean 44.8 pack-years smoking history. On average, veterans answered 6.3 (53%) of knowledge questions correctly (Table 3).

Implementing SDM

The NPC’s field notes indicated that many veterans did not perceive any need to discuss the screening decision and believed that their PCP had referred them just for screening. However, they reported having cursory discussions with their PCP, being told that only their history of heavy tobacco use meant they should be screened. For veterans who had not read the decision aid, the NPC attempted to summarize benefits and harms. However, the discussions were often inadequate because the veterans were not interested in receiving information, particularly numerical data, or indicated that they had limited time for the call.

Seventy-two (69%) of the veterans who met with the NPC were currently smoking. Tobacco cessation counseling was offered to 66; 29 were referred to the VA Quit Line, 10 were referred to the tobacco cessation pharmacist, and the NPC contacted the PCPs for 9 patients who wanted prescriptions for nicotine replacement therapy.

After the SDM visit, 91 veterans (87%) agreed to screening. By the end of the study period, 73 veterans (80%) completed testing. Most veterans had Lung-RADS 1 or 2 results, 11 (1%) had a Lung-RADS 3, and 7 (10%) had a Lung-RADS 4. All 9 veterans with Lung-RADS 3 results and at least 6 months of follow-up underwent repeat imaging within 4 to 13 months (median, 7). All veterans with a Lung-RADS 4 result were referred to pulmonary. One patient was diagnosed with an early-stage non–small cell lung cancer.

We identified several problems with LDCT coding. Radiologists did not consistently use Lung-RADS when interpreting screening LDCTs; some used the Fleischner lung nodule criteria.¹⁸ We also found discordant readings for abnormal LDCTs, where the assigned Lung-RADS score was not consistent with the nodule description in the radiology report.

Discussion

Efforts to implement LCS with a telemedicine SDM intervention were mixed. An NPC-led SDM phone call was successfully incorporated into the clinical workflow. Most veterans identified as being eligible for screening participated in the counseling visit and underwent screening. However, they were often reluctant to engage in SDM, feeling that their clinician had already recommended screening and that there was no need for further discussion. Unfortunately, many veterans had not received or reviewed the decision aid and were not interested in receiving information about benefits and harms. Because we relied on telephone calls, we could not share visual information in real time.

Overall, the surveys indicated that most veterans were very satisfied with the quality of the discussion and reported feeling no decisional conflict. However, based on the NPC’s field notes and audio recordings, we believe that the responses may have reflected earlier discussions with the PCP that reportedly emphasized only the veteran’s eligibility for screening. The fidelity assessments indicated that the NPC consistently addressed the harms and benefits of screening.

Nonetheless, the performance on knowledge measures was uneven. Veterans were generally aware of harms, including false alarms, overdiagnosis, radiation exposure, and incidental findings. They did not, however, appreciate when screening should stop. They also underestimated the risks of developing lung cancer and the portion of that risk attributable to tobacco use, and overestimated the benefits of screening. These results suggest that the veterans, at least those who completed the surveys, may not be making well-informed decisions.

Our findings echo those of other VA investigators in finding knowledge deficits among screened veterans, including being unaware that LDCT was for LCS, believing that screening could prevent cancer, receiving little information about screening harms, and feeling that negative tests meant they were among the “lucky ones” who would avoid harm from continued smoking.^19,20

The VA is currently implementing centralized screening models with the Lung Precision Oncology Program and the VA partnership to increase access to lung screening (VA-PALS).⁵ The centralized model, which readily supports the tracking, monitoring, and reporting needs of a screening program, also has advantages in delivering SDM because counselors have been trained in SDM, are more familiar with LCS evidence and processes, can better incorporate decision tools, and do not face the same time constraints as clinicians.²¹ However, studies have shown that most patients have already decided to be screened when they show up for the SDM visit.²² In contrast, about one-third of patients in primary care settings who receive decision support chose not to be screened.^23,24 We found that 13% of our patients decided against screening after a telephone discussion, suggesting that a virtually conducted SDM visit can meaningfully support decision making. Telemedicine also may reduce health inequities in centralized models arising from patients having limited access to screening centers.

Our results suggest that PCPs referring patients to a centralized program, even for virtual visits, should frame the decision to initiate LCS as SDM, where an informed patient is being supported in making a decision consistent with their values and preferences. Furthermore, engaging patients in SDM should not be construed as endorsing screening. When centralized support is less available, individual clinics may need to provide SDM, perhaps using a nonclinician decision coach if clinicians lack the time to lead the discussions. Decision coaches have been effectively used to increase patients’ knowledge about the benefits and harms of screening.¹² Regardless of the program model, PCPs will also be responsible for determining whether patients are healthy enough to undergo invasive diagnostic testing and treatment and ensuring that tobacco use is addressed.

SDM delivered in any setting will be enhanced by ensuring that patients are provided with decision aids before a counseling visit. This will help them better understand the benefits and harms of screening and the need to elicit values. The discussion can then focus on areas of concern or questions raised by reviewing the decision aid. The clinician and patient could also use a decision aid during either a face-to-face or video clinical encounter to facilitate SDM. A Cochrane review has shown that using decision aids for people facing screening decisions increases knowledge, reduces decisional conflict, and effectively elicits values and preferences.²⁵ Providing high-quality decision support is a patient-centered approach that respects a patient’s autonomy and may promote health equity and improve adherence.

We recognized the importance of having a multidisciplinary team, involving primary care, radiology, pulmonary, and nursing, with a shared understanding of the screening processes. These are essential features for a high-quality screening program where eligible veterans are readily identified and receive prompt and appropriate follow-up. Radiologists need to use Lung-RADS categories consistently and appropriately when reading LDCTs. This may require ongoing educational efforts, particularly given the new CMS guidelines accepting nonsubspecialist chest readers.⁷ Additionally, fellows and board-eligible residents may interpret images in academic settings and at VA facilities. The program needs to work closely with the pulmonary service to ensure that Lung-RADS 4 patients are promptly assessed. Radiologists and pulmonologists should calibrate the application of Lung-RADS categories to pulmonary nodules through jointly participating in meetings to review selected cases.

Challenges and Limitations

We faced some notable implementation challenges. The COVID-19 pandemic was extremely disruptive to LCS as it was to all health care. In addition, screening workflow processes were hampered by a lack of clinical reminders, which ideally would trigger for clinicians based on the tobacco history. The absence of this reminder meant that numerous patients were found to be ineligible for screening. We have a long-standing lung nodule clinic, and clinicians were confused about whether to order a surveillance imaging for an incidental nodule or a screening LDCT.

The radiology service was able to update order sets in CPRS to help guide clinicians in distinguishing indications and prerequisites for enrolling in LCS. This helped reduce the number of inappropriate orders and crossover orders between the VISN nodule tracking program and the LCS program.

Our results were preliminary and based on a small sample. We did not survey all veterans who underwent SDM, though the response rate was 79% and patient characteristics were similar to the larger cohort. Our results were potentially subject to selection bias, which could inflate the positive responses about decision quality and decisional conflict. However, the knowledge deficits are likely to be valid and suggest a need to better inform eligible veterans about the benefits and harms of screening. We did not have sufficient follow-up time to determine whether veterans were adherent to annual screenings. We showed that almost all those with abnormal imaging results completed diagnostic evaluations and/or were evaluated by pulmonary. As the program matures, we will be able to track outcomes related to cancer diagnoses and treatment.

Conclusions

A centralized LCS program was able to deliver SDM and enroll veterans in a screening program. While veterans were confident in their decision to screen and felt that they participated in decision making, knowledge testing indicated important deficits. Furthermore, we observed that many veterans did not meaningfully engage in SDM. Clinicians will need to frame the decision as patient centered at the time of referral, highlight the role of the NPC and importance of SDM, and be able to provide adequate decision support. The SDM visits can be enhanced by ensuring that veterans are able to review decision aids. Telemedicine is an acceptable and effective approach for supporting screening discussions, particularly for rural veterans.²⁶

Acknowledgments

The authors thank the following individuals for their contributions to the study: John Paul Hornbeck, program support specialist; Kelly Miell, PhD; Bradley Mecham, PhD; Christopher C. Richards, MA; Bailey Noble, NP; Rebecca Barnhart, program analyst.

Health care systems need practical, scalable methods to reach patients and connect them to available, evidence-based resources. Ideally, these systems need to be resource nonintensive to deploy, maintain, and use. They should also be low cost, have a relative advantage to the organization, be sensitive to patient needs, use available resources, and have rigorous evidence regarding their effect on patient-centered outcomes.^1,2 Phone service is one way to reach people that remains viable. More than 97% of Americans own a cellphone of some kind, and 40% still have a landline.^3,4 One intervention that has been increasingly used in routine care settings is an interactive voice response (IVR) system that uses phones for connecting to patients.

IVR systems are a type of telehealth that provides information or adjunct health services through use of a telecommunication platform and information technologies.⁵ These systems are automated telephone systems that use prerecorded or text-to-speech–generated messages that allow respondents to provide and access information without a live agent.⁶ Text messaging (SMS) is another modality that can be used to asynchronously engage with participants. IVR systems have been used successfully for many health conditions and services, such as improving veterans’ adherence to continuous positive airway pressure, colorectal cancer screening, and cognitive behavioral therapy.^7-10 By building on existing technology and infrastructure, IVR systems can be a cost-effective option for health care system services.

A 2016 Cochrane review of IVR systems for smoking cessation identified 7 studies.¹¹ Although none used opt-out mechanisms (where individuals are automatically enrolled in programs until they decide not to participate) to engage people without an expressed motivation to quit, these interventions seemed safe and were promisingly effective. Among patients enrolled in primary care, a trial of an IVR system led to a higher quit rate: 18% vs 8%.¹²

In one study, patients in the emergency department, particularly older ones, preferred phone-based interventions over SMS.¹³ IVR-based proactive tobacco cessation systems are cost-effective and have been successfully used in the US Department of Veterans Affairs (VA).^14,15 IVR systems using opt-out approaches are being studied, though their effectiveness in this setting has not been proven. The pros and cons of different interventions need to be explored since there is likely a tradeoff between feasibility and effectiveness. For example, intensive smoking cessation interventions are more effective but often require more resources to implement and sustain.¹⁶ Basing interventions that are not resource intensive within a reputable organizational system may amplify the effectiveness.¹⁷

This endeavor to establish an IVR system was initiated as part of our research study, a randomized trial of the Teachable Moment to Opt-Out of Tobacco (TeaM OUT) intervention at the VA Portland Health Care System in Oregon. We measured the reach and effectiveness of a novel, proactive, resource nonintensive, and pragmatic intervention to engage veterans with a recently diagnosed lung nodule who smoke cigarettes.¹⁸ Our research team extracted the contact information for patients currently smoking and found to a have a pulmonary nodule from the VA Corporate Data Warehouse.¹⁹ We then manually uploaded those data to an IVR website where the system contacted patients to connect them to smoking cessation resources on an opt-out basis. In the research study, we measured the acceptability and effectiveness of the TeaM OUT intervention using quantitative and qualitative methods.

We developed and implemented an IVR system for use at 4 facilities: VA Portland Health Care System, Minneapolis VA Health Care System, Ralph H. Johnson VA Medical Center (Charleston, NC), and the Baltimore VA Medical Center. Setting up any type of wide-scale technology within the VA can be challenging. Due to our experience in developing and implementing the IVR system in the VA, we share what we have learned about the process of finding, contracting, developing, and implementing an IVR system. We share our experiences with developing and implementing this system to provide guidance for those who may want to establish an IVR system (or similar technologies) within the VA.

Lessons Learned

During our development and implementation process, we learned several lessons about setting up an IVR system in the VA. It is important to note that VA facilities may have differing processes, and policies frequently change; thus coordination with departments (eg, contracting, finance, Office of Information and Technology [OIT], etc) to verify the following strategies is essential (Figure).

Vendor Selection

Check with the local OIT and contracting offices to see if the facility has previously used any vendors for these services and for advice on selection. We compiled a list of questions that may be helpful based on our discussions with 4 vendors, prior to selection of a vendor already VA-approved (Appendix). There are also questions to think about in parallel with choosing a vendor. Contact your OIT, contracting, and privacy (if necessary) offices before choosing a vendor.

Online Security

After selecting a vendor, if you want an online portal to view, upload, or downloaddata, then you will need to initiate the single sign-on internal (SSOI) process (www.data.va.gov/dataset/Single-Sign-On-Internal-SSOi-/cber-kxf9). Other benefits of a website are to identify call patterns (eg, no one picks up after the 10th call) and track respondents’ selections. The SSOI process can take up to 1 year. Notably, the website login at minimum needs to be created by the IVR vendor to start the process. After the SSOI is approved you can add more to the website beyond just the login capability. Note that the script needs to be finalized prior to SSOI initiation. You will need to initiate with the SSOI team, then the vendor will need to complete the process.

Contracting

Concurrent with the above steps, contact the contracting office to get a sense of the paperwork and timeline. Make sure you are comfortable with the vendor’s responses to the questions in the Appendix, and view their written proposal or scope of work (SOW) to ensure they can do what the project protocol demands.

If the vendor has previously worked with the VA, contact your local contract office (usually part of the Finance Office) for updated forms. We needed the 6500.6 Checklist, Document Checklist for Service Requests, Single Source Justification, Research & Development Order (if research-related), and Vendor File Request forms. The vendor can help complete these forms. Review the proposal/SOW and budget first, knowing that budgets have a wide range and depend on the length and complexity of the script, number of calls, number of respondents, etc. For example, our quote was $110,000 over 4 years, including development, training, hosting on a secure server, and maintenance. Our IVR system will call about 5000 patients across 4 sites. Each patient will receive up to 15 calls over 2 weeks if they do not answer. We created 2 IVR lines (1 inbound and 1 outbound). Next, contact the lead of the local OIT and contracting departments by email to justify sharing veteran information with a contracted entity via approved methods. Finally, contact the privacy officer and information security officer. Discuss where software would be installed, whether cloud storage would be used, and what information can be shared/stored. Remember that the rules may differ for research vs nonresearch projects. Also, determine whether a data-use agreement between the VA and the vendor is needed and how the institutional review board (if research) gets integrated.

If using an outside vendor who has never worked with the VA, submit form 6550.6. Note that contracting requires several months. First, contact OIT and contracting departments. Again, you will need to justify sharing veteran information with a contracted entity. Next, complete the Project Special Forces Software and Privacy Threshold Analysis process to purchase the system. Set up a meeting with OIT to determine other forms and next steps. Business need/case use form and data security categorization may be needed. If the software needs to be installed on a VA computer, you will need to submit a Technical Reference Model request if it does not have an entry.

Vendors can answer technical questions from the contracting office, especially about the SOW, but the VA team needs to write the contract and manage all documentation and communication. You will also need sole source documentation (receive from contracting office) with justification for why you want to use a specific vendor. If you do not have that justification, in cooperation with the contracts office, you must solicit bids from other companies. Importantly, understand the staff support needed for contracting and build into your timeline and budget. Not surprisingly, we found that in-person or phone meetings were invaluable compared with email correspondence. Meet with all parties involved early and often. Once the contract is clear, this begins the build process where the vendor can program and record the script. This process usually takes 1 to 2 months.

Patient Engagement, Tracking, and Long-term Support

The new Patient Engagement, Tracking, and Long-term Support (PETALS) initiative is an excellent place to start with any VA IVR-related questions. PETALS is used for research.²⁰ We hoped to use this system for our study, but its implementation was delayed until 2022. The PETALS system is designed for VA investigators who conduct research studies and need a secure platform that is compliant with VA policies for deploying SMS and IVR systems for research.²⁰ At this time, PETALS is for use only with veterans, so if research will occur outside the VA, you must use an outside vendor. Users who want to set up a new IVR system can ask their local contracting office whether any contracts have already been established for IVR development and support.

From our perspective as researchers who are not telehealth savvy, we encountered several delays from failing to ask the appropriate questions or inability to navigate complicated systems. For instance, there were several tasks that needed to be completed and were not included in the original timeline developed by the vendor and researcher. Therefore, it is important to have clear communication on both sides about who is doing what, when, and how. We tried to detail these unexpected steps to help researchers, administrators, or other VA employees in the future.

Conclusions

IVR systems, once they are developed and implemented, can be efficient, low-cost, resource-nonintensive solutions in a health care setting that can effectively connect patients with needed health care services. Our experience developing an IVR system within the VA was challenging and was a huge learning curve for our research team. We hope that our experience and lessons will help VA personnel in the future.

Acknowledgments

Thank you to everyone involved in this project and who answered questions about the process, especially Nicolle Marinec, MPH; Toan Tran, and Molly Delorit, BA. This study and Christopher Slatore, MD, are supported by an award from the US Department of Veterans Affairs (HSR&D IIR 19-425). It was also supported by resources from the Center to Improve Veteran Involvement in Care, VA Portland Health Care System, Portland, Oregon (VAPORHCS).

Health care systems need practical, scalable methods to reach patients and connect them to available, evidence-based resources. Ideally, these systems need to be resource nonintensive to deploy, maintain, and use. They should also be low cost, have a relative advantage to the organization, be sensitive to patient needs, use available resources, and have rigorous evidence regarding their effect on patient-centered outcomes.^1,2 Phone service is one way to reach people that remains viable. More than 97% of Americans own a cellphone of some kind, and 40% still have a landline.^3,4 One intervention that has been increasingly used in routine care settings is an interactive voice response (IVR) system that uses phones for connecting to patients.

IVR systems are a type of telehealth that provides information or adjunct health services through use of a telecommunication platform and information technologies.⁵ These systems are automated telephone systems that use prerecorded or text-to-speech–generated messages that allow respondents to provide and access information without a live agent.⁶ Text messaging (SMS) is another modality that can be used to asynchronously engage with participants. IVR systems have been used successfully for many health conditions and services, such as improving veterans’ adherence to continuous positive airway pressure, colorectal cancer screening, and cognitive behavioral therapy.^7-10 By building on existing technology and infrastructure, IVR systems can be a cost-effective option for health care system services.

A 2016 Cochrane review of IVR systems for smoking cessation identified 7 studies.¹¹ Although none used opt-out mechanisms (where individuals are automatically enrolled in programs until they decide not to participate) to engage people without an expressed motivation to quit, these interventions seemed safe and were promisingly effective. Among patients enrolled in primary care, a trial of an IVR system led to a higher quit rate: 18% vs 8%.¹²

In one study, patients in the emergency department, particularly older ones, preferred phone-based interventions over SMS.¹³ IVR-based proactive tobacco cessation systems are cost-effective and have been successfully used in the US Department of Veterans Affairs (VA).^14,15 IVR systems using opt-out approaches are being studied, though their effectiveness in this setting has not been proven. The pros and cons of different interventions need to be explored since there is likely a tradeoff between feasibility and effectiveness. For example, intensive smoking cessation interventions are more effective but often require more resources to implement and sustain.¹⁶ Basing interventions that are not resource intensive within a reputable organizational system may amplify the effectiveness.¹⁷

This endeavor to establish an IVR system was initiated as part of our research study, a randomized trial of the Teachable Moment to Opt-Out of Tobacco (TeaM OUT) intervention at the VA Portland Health Care System in Oregon. We measured the reach and effectiveness of a novel, proactive, resource nonintensive, and pragmatic intervention to engage veterans with a recently diagnosed lung nodule who smoke cigarettes.¹⁸ Our research team extracted the contact information for patients currently smoking and found to a have a pulmonary nodule from the VA Corporate Data Warehouse.¹⁹ We then manually uploaded those data to an IVR website where the system contacted patients to connect them to smoking cessation resources on an opt-out basis. In the research study, we measured the acceptability and effectiveness of the TeaM OUT intervention using quantitative and qualitative methods.

We developed and implemented an IVR system for use at 4 facilities: VA Portland Health Care System, Minneapolis VA Health Care System, Ralph H. Johnson VA Medical Center (Charleston, NC), and the Baltimore VA Medical Center. Setting up any type of wide-scale technology within the VA can be challenging. Due to our experience in developing and implementing the IVR system in the VA, we share what we have learned about the process of finding, contracting, developing, and implementing an IVR system. We share our experiences with developing and implementing this system to provide guidance for those who may want to establish an IVR system (or similar technologies) within the VA.

Lessons Learned

During our development and implementation process, we learned several lessons about setting up an IVR system in the VA. It is important to note that VA facilities may have differing processes, and policies frequently change; thus coordination with departments (eg, contracting, finance, Office of Information and Technology [OIT], etc) to verify the following strategies is essential (Figure).

Vendor Selection

Check with the local OIT and contracting offices to see if the facility has previously used any vendors for these services and for advice on selection. We compiled a list of questions that may be helpful based on our discussions with 4 vendors, prior to selection of a vendor already VA-approved (Appendix). There are also questions to think about in parallel with choosing a vendor. Contact your OIT, contracting, and privacy (if necessary) offices before choosing a vendor.

Online Security

After selecting a vendor, if you want an online portal to view, upload, or downloaddata, then you will need to initiate the single sign-on internal (SSOI) process (www.data.va.gov/dataset/Single-Sign-On-Internal-SSOi-/cber-kxf9). Other benefits of a website are to identify call patterns (eg, no one picks up after the 10th call) and track respondents’ selections. The SSOI process can take up to 1 year. Notably, the website login at minimum needs to be created by the IVR vendor to start the process. After the SSOI is approved you can add more to the website beyond just the login capability. Note that the script needs to be finalized prior to SSOI initiation. You will need to initiate with the SSOI team, then the vendor will need to complete the process.

Contracting

Concurrent with the above steps, contact the contracting office to get a sense of the paperwork and timeline. Make sure you are comfortable with the vendor’s responses to the questions in the Appendix, and view their written proposal or scope of work (SOW) to ensure they can do what the project protocol demands.

If the vendor has previously worked with the VA, contact your local contract office (usually part of the Finance Office) for updated forms. We needed the 6500.6 Checklist, Document Checklist for Service Requests, Single Source Justification, Research & Development Order (if research-related), and Vendor File Request forms. The vendor can help complete these forms. Review the proposal/SOW and budget first, knowing that budgets have a wide range and depend on the length and complexity of the script, number of calls, number of respondents, etc. For example, our quote was $110,000 over 4 years, including development, training, hosting on a secure server, and maintenance. Our IVR system will call about 5000 patients across 4 sites. Each patient will receive up to 15 calls over 2 weeks if they do not answer. We created 2 IVR lines (1 inbound and 1 outbound). Next, contact the lead of the local OIT and contracting departments by email to justify sharing veteran information with a contracted entity via approved methods. Finally, contact the privacy officer and information security officer. Discuss where software would be installed, whether cloud storage would be used, and what information can be shared/stored. Remember that the rules may differ for research vs nonresearch projects. Also, determine whether a data-use agreement between the VA and the vendor is needed and how the institutional review board (if research) gets integrated.

If using an outside vendor who has never worked with the VA, submit form 6550.6. Note that contracting requires several months. First, contact OIT and contracting departments. Again, you will need to justify sharing veteran information with a contracted entity. Next, complete the Project Special Forces Software and Privacy Threshold Analysis process to purchase the system. Set up a meeting with OIT to determine other forms and next steps. Business need/case use form and data security categorization may be needed. If the software needs to be installed on a VA computer, you will need to submit a Technical Reference Model request if it does not have an entry.

Vendors can answer technical questions from the contracting office, especially about the SOW, but the VA team needs to write the contract and manage all documentation and communication. You will also need sole source documentation (receive from contracting office) with justification for why you want to use a specific vendor. If you do not have that justification, in cooperation with the contracts office, you must solicit bids from other companies. Importantly, understand the staff support needed for contracting and build into your timeline and budget. Not surprisingly, we found that in-person or phone meetings were invaluable compared with email correspondence. Meet with all parties involved early and often. Once the contract is clear, this begins the build process where the vendor can program and record the script. This process usually takes 1 to 2 months.

Patient Engagement, Tracking, and Long-term Support

The new Patient Engagement, Tracking, and Long-term Support (PETALS) initiative is an excellent place to start with any VA IVR-related questions. PETALS is used for research.²⁰ We hoped to use this system for our study, but its implementation was delayed until 2022. The PETALS system is designed for VA investigators who conduct research studies and need a secure platform that is compliant with VA policies for deploying SMS and IVR systems for research.²⁰ At this time, PETALS is for use only with veterans, so if research will occur outside the VA, you must use an outside vendor. Users who want to set up a new IVR system can ask their local contracting office whether any contracts have already been established for IVR development and support.

From our perspective as researchers who are not telehealth savvy, we encountered several delays from failing to ask the appropriate questions or inability to navigate complicated systems. For instance, there were several tasks that needed to be completed and were not included in the original timeline developed by the vendor and researcher. Therefore, it is important to have clear communication on both sides about who is doing what, when, and how. We tried to detail these unexpected steps to help researchers, administrators, or other VA employees in the future.

Conclusions

IVR systems, once they are developed and implemented, can be efficient, low-cost, resource-nonintensive solutions in a health care setting that can effectively connect patients with needed health care services. Our experience developing an IVR system within the VA was challenging and was a huge learning curve for our research team. We hope that our experience and lessons will help VA personnel in the future.

Acknowledgments

Thank you to everyone involved in this project and who answered questions about the process, especially Nicolle Marinec, MPH; Toan Tran, and Molly Delorit, BA. This study and Christopher Slatore, MD, are supported by an award from the US Department of Veterans Affairs (HSR&D IIR 19-425). It was also supported by resources from the Center to Improve Veteran Involvement in Care, VA Portland Health Care System, Portland, Oregon (VAPORHCS).

Health care systems need practical, scalable methods to reach patients and connect them to available, evidence-based resources. Ideally, these systems need to be resource nonintensive to deploy, maintain, and use. They should also be low cost, have a relative advantage to the organization, be sensitive to patient needs, use available resources, and have rigorous evidence regarding their effect on patient-centered outcomes.^1,2 Phone service is one way to reach people that remains viable. More than 97% of Americans own a cellphone of some kind, and 40% still have a landline.^3,4 One intervention that has been increasingly used in routine care settings is an interactive voice response (IVR) system that uses phones for connecting to patients.

IVR systems are a type of telehealth that provides information or adjunct health services through use of a telecommunication platform and information technologies.⁵ These systems are automated telephone systems that use prerecorded or text-to-speech–generated messages that allow respondents to provide and access information without a live agent.⁶ Text messaging (SMS) is another modality that can be used to asynchronously engage with participants. IVR systems have been used successfully for many health conditions and services, such as improving veterans’ adherence to continuous positive airway pressure, colorectal cancer screening, and cognitive behavioral therapy.^7-10 By building on existing technology and infrastructure, IVR systems can be a cost-effective option for health care system services.

A 2016 Cochrane review of IVR systems for smoking cessation identified 7 studies.¹¹ Although none used opt-out mechanisms (where individuals are automatically enrolled in programs until they decide not to participate) to engage people without an expressed motivation to quit, these interventions seemed safe and were promisingly effective. Among patients enrolled in primary care, a trial of an IVR system led to a higher quit rate: 18% vs 8%.¹²

In one study, patients in the emergency department, particularly older ones, preferred phone-based interventions over SMS.¹³ IVR-based proactive tobacco cessation systems are cost-effective and have been successfully used in the US Department of Veterans Affairs (VA).^14,15 IVR systems using opt-out approaches are being studied, though their effectiveness in this setting has not been proven. The pros and cons of different interventions need to be explored since there is likely a tradeoff between feasibility and effectiveness. For example, intensive smoking cessation interventions are more effective but often require more resources to implement and sustain.¹⁶ Basing interventions that are not resource intensive within a reputable organizational system may amplify the effectiveness.¹⁷

This endeavor to establish an IVR system was initiated as part of our research study, a randomized trial of the Teachable Moment to Opt-Out of Tobacco (TeaM OUT) intervention at the VA Portland Health Care System in Oregon. We measured the reach and effectiveness of a novel, proactive, resource nonintensive, and pragmatic intervention to engage veterans with a recently diagnosed lung nodule who smoke cigarettes.¹⁸ Our research team extracted the contact information for patients currently smoking and found to a have a pulmonary nodule from the VA Corporate Data Warehouse.¹⁹ We then manually uploaded those data to an IVR website where the system contacted patients to connect them to smoking cessation resources on an opt-out basis. In the research study, we measured the acceptability and effectiveness of the TeaM OUT intervention using quantitative and qualitative methods.

We developed and implemented an IVR system for use at 4 facilities: VA Portland Health Care System, Minneapolis VA Health Care System, Ralph H. Johnson VA Medical Center (Charleston, NC), and the Baltimore VA Medical Center. Setting up any type of wide-scale technology within the VA can be challenging. Due to our experience in developing and implementing the IVR system in the VA, we share what we have learned about the process of finding, contracting, developing, and implementing an IVR system. We share our experiences with developing and implementing this system to provide guidance for those who may want to establish an IVR system (or similar technologies) within the VA.

Lessons Learned

During our development and implementation process, we learned several lessons about setting up an IVR system in the VA. It is important to note that VA facilities may have differing processes, and policies frequently change; thus coordination with departments (eg, contracting, finance, Office of Information and Technology [OIT], etc) to verify the following strategies is essential (Figure).

Vendor Selection

Check with the local OIT and contracting offices to see if the facility has previously used any vendors for these services and for advice on selection. We compiled a list of questions that may be helpful based on our discussions with 4 vendors, prior to selection of a vendor already VA-approved (Appendix). There are also questions to think about in parallel with choosing a vendor. Contact your OIT, contracting, and privacy (if necessary) offices before choosing a vendor.

Online Security

After selecting a vendor, if you want an online portal to view, upload, or downloaddata, then you will need to initiate the single sign-on internal (SSOI) process (www.data.va.gov/dataset/Single-Sign-On-Internal-SSOi-/cber-kxf9). Other benefits of a website are to identify call patterns (eg, no one picks up after the 10th call) and track respondents’ selections. The SSOI process can take up to 1 year. Notably, the website login at minimum needs to be created by the IVR vendor to start the process. After the SSOI is approved you can add more to the website beyond just the login capability. Note that the script needs to be finalized prior to SSOI initiation. You will need to initiate with the SSOI team, then the vendor will need to complete the process.

Contracting

Concurrent with the above steps, contact the contracting office to get a sense of the paperwork and timeline. Make sure you are comfortable with the vendor’s responses to the questions in the Appendix, and view their written proposal or scope of work (SOW) to ensure they can do what the project protocol demands.

If the vendor has previously worked with the VA, contact your local contract office (usually part of the Finance Office) for updated forms. We needed the 6500.6 Checklist, Document Checklist for Service Requests, Single Source Justification, Research & Development Order (if research-related), and Vendor File Request forms. The vendor can help complete these forms. Review the proposal/SOW and budget first, knowing that budgets have a wide range and depend on the length and complexity of the script, number of calls, number of respondents, etc. For example, our quote was $110,000 over 4 years, including development, training, hosting on a secure server, and maintenance. Our IVR system will call about 5000 patients across 4 sites. Each patient will receive up to 15 calls over 2 weeks if they do not answer. We created 2 IVR lines (1 inbound and 1 outbound). Next, contact the lead of the local OIT and contracting departments by email to justify sharing veteran information with a contracted entity via approved methods. Finally, contact the privacy officer and information security officer. Discuss where software would be installed, whether cloud storage would be used, and what information can be shared/stored. Remember that the rules may differ for research vs nonresearch projects. Also, determine whether a data-use agreement between the VA and the vendor is needed and how the institutional review board (if research) gets integrated.

If using an outside vendor who has never worked with the VA, submit form 6550.6. Note that contracting requires several months. First, contact OIT and contracting departments. Again, you will need to justify sharing veteran information with a contracted entity. Next, complete the Project Special Forces Software and Privacy Threshold Analysis process to purchase the system. Set up a meeting with OIT to determine other forms and next steps. Business need/case use form and data security categorization may be needed. If the software needs to be installed on a VA computer, you will need to submit a Technical Reference Model request if it does not have an entry.

Vendors can answer technical questions from the contracting office, especially about the SOW, but the VA team needs to write the contract and manage all documentation and communication. You will also need sole source documentation (receive from contracting office) with justification for why you want to use a specific vendor. If you do not have that justification, in cooperation with the contracts office, you must solicit bids from other companies. Importantly, understand the staff support needed for contracting and build into your timeline and budget. Not surprisingly, we found that in-person or phone meetings were invaluable compared with email correspondence. Meet with all parties involved early and often. Once the contract is clear, this begins the build process where the vendor can program and record the script. This process usually takes 1 to 2 months.

Patient Engagement, Tracking, and Long-term Support

The new Patient Engagement, Tracking, and Long-term Support (PETALS) initiative is an excellent place to start with any VA IVR-related questions. PETALS is used for research.²⁰ We hoped to use this system for our study, but its implementation was delayed until 2022. The PETALS system is designed for VA investigators who conduct research studies and need a secure platform that is compliant with VA policies for deploying SMS and IVR systems for research.²⁰ At this time, PETALS is for use only with veterans, so if research will occur outside the VA, you must use an outside vendor. Users who want to set up a new IVR system can ask their local contracting office whether any contracts have already been established for IVR development and support.

From our perspective as researchers who are not telehealth savvy, we encountered several delays from failing to ask the appropriate questions or inability to navigate complicated systems. For instance, there were several tasks that needed to be completed and were not included in the original timeline developed by the vendor and researcher. Therefore, it is important to have clear communication on both sides about who is doing what, when, and how. We tried to detail these unexpected steps to help researchers, administrators, or other VA employees in the future.

Conclusions

IVR systems, once they are developed and implemented, can be efficient, low-cost, resource-nonintensive solutions in a health care setting that can effectively connect patients with needed health care services. Our experience developing an IVR system within the VA was challenging and was a huge learning curve for our research team. We hope that our experience and lessons will help VA personnel in the future.

Acknowledgments

Thank you to everyone involved in this project and who answered questions about the process, especially Nicolle Marinec, MPH; Toan Tran, and Molly Delorit, BA. This study and Christopher Slatore, MD, are supported by an award from the US Department of Veterans Affairs (HSR&D IIR 19-425). It was also supported by resources from the Center to Improve Veteran Involvement in Care, VA Portland Health Care System, Portland, Oregon (VAPORHCS).

At the onset of the COVID-19 pandemic, patient encounters with the health care system plummeted.^1-3 The perceived increased risk of contracting COVID-19 while obtaining care was thought to be a contributing factor. In outpatient settings, one study noted a 63% decrease in visits to otolaryngology visits in Massachusetts, and another noted a 33% decrease in dental office visits at the onset of the pandemic in 2020 compared with the same time frame in 2019.^2,4 Along with mask mandates and stay-at-home orders, various institutions sought to mitigate the spread of COVID-19 through different protocols, including the use of social distancing, limitation of visitors, and telehealth. Despite some of these measures, nosocomial infections were not uncommon. For example, one hospital in the United Kingdom reported that 15% of COVID-19 inpatient cases in a 6-week period in 2020 were probably or definitely hospital acquired. These patients had a 36% case fatality rate.⁵

Unlike outpatient treatment centers, however, the emergency department (ED) is mandated by the Emergency Medical Treatment and Labor Act to provide a medical screening examination and to stabilize emergency medical conditions to all patients presenting to the ED. Thus, high numbers of undifferentiated and symptomatic patients are forced to congregate in EDs, increasing the risk of transmission of COVID-19. This perception of increased risk led to a 42% decrease in ED visits during March and April 2020 at the onset of the COVID-19 pandemic.¹ Correspondingly, there was a 20% decrease in code stroke activations at a hospital in Canada and a 38% decrease in ST-elevation myocardial infarction activations across 9 United States hospital systems.^6,7

Limited studies have been conducted to date to determine whether contracting COVID-19 while in the ED is a risk. One retrospective case-control study evaluating 39 EDs in the US showed that ED colocation with known patients with COVID-19 was not associated with an increased risk of COVID-19 transmission.⁵ However, this study also recognized that infection control strategies widely varied by location and date.

In this study, we report the incidence of COVID-19 infections within 21 days after the initial visit for symptoms not associated with COVID-19 infection to the Veterans Affairs Greater Los Angeles Healthcare System (VAGLAHS) ED and compared it with that of COVID-19 infections for tests performed within the VAGLAHS.

Program Description

As a quality improvement measure, the VAGLAHS ED instituted multiple protocols to mitigate COVID-19 transmission. Social distancing was instituted in the waiting room to prevent the close congregation of patients, regardless of the reason for visit. A COVID-19 testing tent was located outdoors that was adjacent to the ED and staffed by a dedicated licensed independent practitioner and nurses during business hours. During COVID-19 infection surges, hours were extended to include evenings and weekends to decrease ED exposure of stable but symptomatic patients seeking testing. If patients were felt to require more care, they were referred to the ED.

Patients with specific symptoms noted during triage, such as those associated with COVID-19 diagnosis, respiratory infections, fever, and/or myalgias, were isolated in their own patient room. Electronic tablets were used for persons under investigation and patients with COVID-19 to communicate with family and/or medical staff who did not need to enter the patient’s room. Two-hour disinfection protocols were instituted for high-risk patients who were moved during the course of their treatment (ie, transfer to another bed for admission or discharge). All staff was specifically trained in personal protective equipment (PPE) donning and doffing, and 2-physician airway teams were implemented to ensure proper PPE use and safe COVID-19 intubations.

COVID-19 Infections

Electronic health records of patients who visited the VAGLAHS ED for symptoms not related to COVID-19 were reviewed from June 1, 2020, to June 30, 2021, to determine whether these patients had an increased incidence of confirmed COVID-19 infection within 21 days of the index ED visit. Patients with upper respiratory infection symptoms, such as cough, fever, chills, sore throat, changes to taste or smell, or a confirmed COVID-19 infection on the initial visit were excluded. Patients were considered to have had an ED-acquired COVID-19 infection if they had a positive test within 21 days of visiting the ED for a symptom not related to COVID-19. We report the overall average positivity rate by month of COVID-19 infections 21 days post-ED visit for visits for symptoms not related to COVID-19. 

A total of 8708 patients who came to the ED with symptoms not associated with COVID-19 infection and had a COVID-19 test within 21 days of the ED visit met the inclusion criteria. The overall average positivity rate at the VAGLAHS ED for symptoms not associated with COVID-19 infection was 1.1% from June 1, 2020, to June 30, 2021. The positivity rate by month ranged from 0% to 6.7% for this period (Figure).

Discussion 

Implementing COVID-19 mitigation measures in the VAGLAHS ED helped minimize exposure and subsequent infection of COVID-19 for veterans who visited the VAGLAHS ED with symptoms not associated with COVID-19 infection. Contextualizing this with the overall average monthly positivity rate of veterans in the VAGLAHS catchment area (10.9%) or Los Angeles County (7.9%) between June 1, 2020, to June 30, 2021, veterans who visited the VAGLAHS ED for symptoms not associated with COVID-19 infection were less likely to test positive for COVID-19 within 21 days (1.1%), suggesting that the extensive measures taken at the VAGLAHS ED were effective.⁸

Many health care systems in the US and abroad have experimented with different transmission mitigation strategies in the ED. These tactics have included careful resource allocation when PPE shortages occur, incorporation of airway teams with appropriate safety measures to reduce nosocomial spread to health care workers, and use of a cohorting plan to separate persons under investigation and patients with COVID-19 from other patients.^9-15 Additionally, forward screening areas were incorporated similar to the COVID-19 tent that was instituted at the VAGLAHS ED to manage patients who were referred to the ED for COVID-19 testing during the beginning of the pandemic, which prevented symptomatic patients from congregating with asymptomatic patients.^14,15

Encouragingly, some of these studies reported no cases of nosocomial transmission in the ED.^11,13 In a separate study, 14 clusters of COVID-19 cases were identified at one VA health care system in which nosocomial transmission was suspected, including one in the ED.¹⁶ Using contact tracing, no patients and 9 employees were found to have contracted COVID-19 in that cluster. Overall, among all clusters examined within the health care system, either by contact tracing or by whole-genome sequencing, the authors found that transmission from health care personnel to patients was rare. Despite different methodologies, we also similarly found that ED patients in our VA facility were unlikely to become infected with COVID-19.

While the low incidence of positive COVID-19 tests cannot be attributed to any one method, our data provide a working blueprint for enhanced ED precautions in future surges of COVID-19 or other airborne diseases, including that of future pandemics.

Limitations

Notably, although the VA is the largest health care system in the US, a considerable number of veterans may present to non-VA EDs to seek care, and thus their data are not included here; these veterans may live farther from a VA facility or experience higher barriers to care than veterans who exclusively or almost exclusively seek care within the VA. As a result, we are unable to account for COVID-19 tests completed outside the VA. Moreover, the wild type SARS-CoV-2 virus was dominant during the time frame chosen for this assessment, and data may not be generalizable to other variants (eg, omicron) that are known to be more highly transmissible.¹⁷ Lastly, although our observation was performed at a single VA ED and may not apply to other facilities, especially in light of different mitigation strategies, our findings still provide support for approaches to minimizing patient and staff exposure to COVID-19 in ED settings.

Conclusions

Implementation of COVID-19 mitigation measures in the VAGLAHS ED may have minimized exposure to COVID-19 for veterans who visited the VAGLAHS ED for symptoms not associated with COVID-19 and did not put one at higher risk of contracting COVID-19. Taken together, our data suggest that patients should not avoid seeking emergency care out of fear of contracting COVID-19 if EDs have adequately instituted mitigation techniques.

At the onset of the COVID-19 pandemic, patient encounters with the health care system plummeted.^1-3 The perceived increased risk of contracting COVID-19 while obtaining care was thought to be a contributing factor. In outpatient settings, one study noted a 63% decrease in visits to otolaryngology visits in Massachusetts, and another noted a 33% decrease in dental office visits at the onset of the pandemic in 2020 compared with the same time frame in 2019.^2,4 Along with mask mandates and stay-at-home orders, various institutions sought to mitigate the spread of COVID-19 through different protocols, including the use of social distancing, limitation of visitors, and telehealth. Despite some of these measures, nosocomial infections were not uncommon. For example, one hospital in the United Kingdom reported that 15% of COVID-19 inpatient cases in a 6-week period in 2020 were probably or definitely hospital acquired. These patients had a 36% case fatality rate.⁵

Unlike outpatient treatment centers, however, the emergency department (ED) is mandated by the Emergency Medical Treatment and Labor Act to provide a medical screening examination and to stabilize emergency medical conditions to all patients presenting to the ED. Thus, high numbers of undifferentiated and symptomatic patients are forced to congregate in EDs, increasing the risk of transmission of COVID-19. This perception of increased risk led to a 42% decrease in ED visits during March and April 2020 at the onset of the COVID-19 pandemic.¹ Correspondingly, there was a 20% decrease in code stroke activations at a hospital in Canada and a 38% decrease in ST-elevation myocardial infarction activations across 9 United States hospital systems.^6,7

Limited studies have been conducted to date to determine whether contracting COVID-19 while in the ED is a risk. One retrospective case-control study evaluating 39 EDs in the US showed that ED colocation with known patients with COVID-19 was not associated with an increased risk of COVID-19 transmission.⁵ However, this study also recognized that infection control strategies widely varied by location and date.

In this study, we report the incidence of COVID-19 infections within 21 days after the initial visit for symptoms not associated with COVID-19 infection to the Veterans Affairs Greater Los Angeles Healthcare System (VAGLAHS) ED and compared it with that of COVID-19 infections for tests performed within the VAGLAHS.

Program Description

As a quality improvement measure, the VAGLAHS ED instituted multiple protocols to mitigate COVID-19 transmission. Social distancing was instituted in the waiting room to prevent the close congregation of patients, regardless of the reason for visit. A COVID-19 testing tent was located outdoors that was adjacent to the ED and staffed by a dedicated licensed independent practitioner and nurses during business hours. During COVID-19 infection surges, hours were extended to include evenings and weekends to decrease ED exposure of stable but symptomatic patients seeking testing. If patients were felt to require more care, they were referred to the ED.

Patients with specific symptoms noted during triage, such as those associated with COVID-19 diagnosis, respiratory infections, fever, and/or myalgias, were isolated in their own patient room. Electronic tablets were used for persons under investigation and patients with COVID-19 to communicate with family and/or medical staff who did not need to enter the patient’s room. Two-hour disinfection protocols were instituted for high-risk patients who were moved during the course of their treatment (ie, transfer to another bed for admission or discharge). All staff was specifically trained in personal protective equipment (PPE) donning and doffing, and 2-physician airway teams were implemented to ensure proper PPE use and safe COVID-19 intubations.

COVID-19 Infections

Electronic health records of patients who visited the VAGLAHS ED for symptoms not related to COVID-19 were reviewed from June 1, 2020, to June 30, 2021, to determine whether these patients had an increased incidence of confirmed COVID-19 infection within 21 days of the index ED visit. Patients with upper respiratory infection symptoms, such as cough, fever, chills, sore throat, changes to taste or smell, or a confirmed COVID-19 infection on the initial visit were excluded. Patients were considered to have had an ED-acquired COVID-19 infection if they had a positive test within 21 days of visiting the ED for a symptom not related to COVID-19. We report the overall average positivity rate by month of COVID-19 infections 21 days post-ED visit for visits for symptoms not related to COVID-19. 

A total of 8708 patients who came to the ED with symptoms not associated with COVID-19 infection and had a COVID-19 test within 21 days of the ED visit met the inclusion criteria. The overall average positivity rate at the VAGLAHS ED for symptoms not associated with COVID-19 infection was 1.1% from June 1, 2020, to June 30, 2021. The positivity rate by month ranged from 0% to 6.7% for this period (Figure).

Discussion 

Implementing COVID-19 mitigation measures in the VAGLAHS ED helped minimize exposure and subsequent infection of COVID-19 for veterans who visited the VAGLAHS ED with symptoms not associated with COVID-19 infection. Contextualizing this with the overall average monthly positivity rate of veterans in the VAGLAHS catchment area (10.9%) or Los Angeles County (7.9%) between June 1, 2020, to June 30, 2021, veterans who visited the VAGLAHS ED for symptoms not associated with COVID-19 infection were less likely to test positive for COVID-19 within 21 days (1.1%), suggesting that the extensive measures taken at the VAGLAHS ED were effective.⁸

Many health care systems in the US and abroad have experimented with different transmission mitigation strategies in the ED. These tactics have included careful resource allocation when PPE shortages occur, incorporation of airway teams with appropriate safety measures to reduce nosocomial spread to health care workers, and use of a cohorting plan to separate persons under investigation and patients with COVID-19 from other patients.^9-15 Additionally, forward screening areas were incorporated similar to the COVID-19 tent that was instituted at the VAGLAHS ED to manage patients who were referred to the ED for COVID-19 testing during the beginning of the pandemic, which prevented symptomatic patients from congregating with asymptomatic patients.^14,15

Encouragingly, some of these studies reported no cases of nosocomial transmission in the ED.^11,13 In a separate study, 14 clusters of COVID-19 cases were identified at one VA health care system in which nosocomial transmission was suspected, including one in the ED.¹⁶ Using contact tracing, no patients and 9 employees were found to have contracted COVID-19 in that cluster. Overall, among all clusters examined within the health care system, either by contact tracing or by whole-genome sequencing, the authors found that transmission from health care personnel to patients was rare. Despite different methodologies, we also similarly found that ED patients in our VA facility were unlikely to become infected with COVID-19.

While the low incidence of positive COVID-19 tests cannot be attributed to any one method, our data provide a working blueprint for enhanced ED precautions in future surges of COVID-19 or other airborne diseases, including that of future pandemics.

Limitations

Notably, although the VA is the largest health care system in the US, a considerable number of veterans may present to non-VA EDs to seek care, and thus their data are not included here; these veterans may live farther from a VA facility or experience higher barriers to care than veterans who exclusively or almost exclusively seek care within the VA. As a result, we are unable to account for COVID-19 tests completed outside the VA. Moreover, the wild type SARS-CoV-2 virus was dominant during the time frame chosen for this assessment, and data may not be generalizable to other variants (eg, omicron) that are known to be more highly transmissible.¹⁷ Lastly, although our observation was performed at a single VA ED and may not apply to other facilities, especially in light of different mitigation strategies, our findings still provide support for approaches to minimizing patient and staff exposure to COVID-19 in ED settings.

Conclusions

Implementation of COVID-19 mitigation measures in the VAGLAHS ED may have minimized exposure to COVID-19 for veterans who visited the VAGLAHS ED for symptoms not associated with COVID-19 and did not put one at higher risk of contracting COVID-19. Taken together, our data suggest that patients should not avoid seeking emergency care out of fear of contracting COVID-19 if EDs have adequately instituted mitigation techniques.

At the onset of the COVID-19 pandemic, patient encounters with the health care system plummeted.^1-3 The perceived increased risk of contracting COVID-19 while obtaining care was thought to be a contributing factor. In outpatient settings, one study noted a 63% decrease in visits to otolaryngology visits in Massachusetts, and another noted a 33% decrease in dental office visits at the onset of the pandemic in 2020 compared with the same time frame in 2019.^2,4 Along with mask mandates and stay-at-home orders, various institutions sought to mitigate the spread of COVID-19 through different protocols, including the use of social distancing, limitation of visitors, and telehealth. Despite some of these measures, nosocomial infections were not uncommon. For example, one hospital in the United Kingdom reported that 15% of COVID-19 inpatient cases in a 6-week period in 2020 were probably or definitely hospital acquired. These patients had a 36% case fatality rate.⁵

Unlike outpatient treatment centers, however, the emergency department (ED) is mandated by the Emergency Medical Treatment and Labor Act to provide a medical screening examination and to stabilize emergency medical conditions to all patients presenting to the ED. Thus, high numbers of undifferentiated and symptomatic patients are forced to congregate in EDs, increasing the risk of transmission of COVID-19. This perception of increased risk led to a 42% decrease in ED visits during March and April 2020 at the onset of the COVID-19 pandemic.¹ Correspondingly, there was a 20% decrease in code stroke activations at a hospital in Canada and a 38% decrease in ST-elevation myocardial infarction activations across 9 United States hospital systems.^6,7

Limited studies have been conducted to date to determine whether contracting COVID-19 while in the ED is a risk. One retrospective case-control study evaluating 39 EDs in the US showed that ED colocation with known patients with COVID-19 was not associated with an increased risk of COVID-19 transmission.⁵ However, this study also recognized that infection control strategies widely varied by location and date.

In this study, we report the incidence of COVID-19 infections within 21 days after the initial visit for symptoms not associated with COVID-19 infection to the Veterans Affairs Greater Los Angeles Healthcare System (VAGLAHS) ED and compared it with that of COVID-19 infections for tests performed within the VAGLAHS.

Program Description

As a quality improvement measure, the VAGLAHS ED instituted multiple protocols to mitigate COVID-19 transmission. Social distancing was instituted in the waiting room to prevent the close congregation of patients, regardless of the reason for visit. A COVID-19 testing tent was located outdoors that was adjacent to the ED and staffed by a dedicated licensed independent practitioner and nurses during business hours. During COVID-19 infection surges, hours were extended to include evenings and weekends to decrease ED exposure of stable but symptomatic patients seeking testing. If patients were felt to require more care, they were referred to the ED.

Patients with specific symptoms noted during triage, such as those associated with COVID-19 diagnosis, respiratory infections, fever, and/or myalgias, were isolated in their own patient room. Electronic tablets were used for persons under investigation and patients with COVID-19 to communicate with family and/or medical staff who did not need to enter the patient’s room. Two-hour disinfection protocols were instituted for high-risk patients who were moved during the course of their treatment (ie, transfer to another bed for admission or discharge). All staff was specifically trained in personal protective equipment (PPE) donning and doffing, and 2-physician airway teams were implemented to ensure proper PPE use and safe COVID-19 intubations.

COVID-19 Infections

Electronic health records of patients who visited the VAGLAHS ED for symptoms not related to COVID-19 were reviewed from June 1, 2020, to June 30, 2021, to determine whether these patients had an increased incidence of confirmed COVID-19 infection within 21 days of the index ED visit. Patients with upper respiratory infection symptoms, such as cough, fever, chills, sore throat, changes to taste or smell, or a confirmed COVID-19 infection on the initial visit were excluded. Patients were considered to have had an ED-acquired COVID-19 infection if they had a positive test within 21 days of visiting the ED for a symptom not related to COVID-19. We report the overall average positivity rate by month of COVID-19 infections 21 days post-ED visit for visits for symptoms not related to COVID-19. 

A total of 8708 patients who came to the ED with symptoms not associated with COVID-19 infection and had a COVID-19 test within 21 days of the ED visit met the inclusion criteria. The overall average positivity rate at the VAGLAHS ED for symptoms not associated with COVID-19 infection was 1.1% from June 1, 2020, to June 30, 2021. The positivity rate by month ranged from 0% to 6.7% for this period (Figure).

Discussion 

Implementing COVID-19 mitigation measures in the VAGLAHS ED helped minimize exposure and subsequent infection of COVID-19 for veterans who visited the VAGLAHS ED with symptoms not associated with COVID-19 infection. Contextualizing this with the overall average monthly positivity rate of veterans in the VAGLAHS catchment area (10.9%) or Los Angeles County (7.9%) between June 1, 2020, to June 30, 2021, veterans who visited the VAGLAHS ED for symptoms not associated with COVID-19 infection were less likely to test positive for COVID-19 within 21 days (1.1%), suggesting that the extensive measures taken at the VAGLAHS ED were effective.⁸

Many health care systems in the US and abroad have experimented with different transmission mitigation strategies in the ED. These tactics have included careful resource allocation when PPE shortages occur, incorporation of airway teams with appropriate safety measures to reduce nosocomial spread to health care workers, and use of a cohorting plan to separate persons under investigation and patients with COVID-19 from other patients.^9-15 Additionally, forward screening areas were incorporated similar to the COVID-19 tent that was instituted at the VAGLAHS ED to manage patients who were referred to the ED for COVID-19 testing during the beginning of the pandemic, which prevented symptomatic patients from congregating with asymptomatic patients.^14,15

Encouragingly, some of these studies reported no cases of nosocomial transmission in the ED.^11,13 In a separate study, 14 clusters of COVID-19 cases were identified at one VA health care system in which nosocomial transmission was suspected, including one in the ED.¹⁶ Using contact tracing, no patients and 9 employees were found to have contracted COVID-19 in that cluster. Overall, among all clusters examined within the health care system, either by contact tracing or by whole-genome sequencing, the authors found that transmission from health care personnel to patients was rare. Despite different methodologies, we also similarly found that ED patients in our VA facility were unlikely to become infected with COVID-19.

While the low incidence of positive COVID-19 tests cannot be attributed to any one method, our data provide a working blueprint for enhanced ED precautions in future surges of COVID-19 or other airborne diseases, including that of future pandemics.

Limitations

Notably, although the VA is the largest health care system in the US, a considerable number of veterans may present to non-VA EDs to seek care, and thus their data are not included here; these veterans may live farther from a VA facility or experience higher barriers to care than veterans who exclusively or almost exclusively seek care within the VA. As a result, we are unable to account for COVID-19 tests completed outside the VA. Moreover, the wild type SARS-CoV-2 virus was dominant during the time frame chosen for this assessment, and data may not be generalizable to other variants (eg, omicron) that are known to be more highly transmissible.¹⁷ Lastly, although our observation was performed at a single VA ED and may not apply to other facilities, especially in light of different mitigation strategies, our findings still provide support for approaches to minimizing patient and staff exposure to COVID-19 in ED settings.

Conclusions

Implementation of COVID-19 mitigation measures in the VAGLAHS ED may have minimized exposure to COVID-19 for veterans who visited the VAGLAHS ED for symptoms not associated with COVID-19 and did not put one at higher risk of contracting COVID-19. Taken together, our data suggest that patients should not avoid seeking emergency care out of fear of contracting COVID-19 if EDs have adequately instituted mitigation techniques.

The US Department of Health and Human Services (HHS) Ending the HIV Epidemic framework aims to decrease HIV infections in the United States by 90% before 2030.¹ Achieving this goal requires identifying persons at high risk for HIV and ensuring timely and efficient access to HIV preexposure prophylaxis (PrEP).^2-5 However, despite its commercial availability since 2012, community uptake of PrEP is low.⁶ In 2019, < 25% of Americans who could benefit from PrEP were using this preventive therapy.⁷ Poor uptake of PrEP has also been documented among veterans and US military service members. National data on men in the military and men who have sex with men (MSM) in the military suggest that about 12,000 service members are eligible for PrEP; however, only 2000 service members and their beneficiaries accessed PrEP in February 2017.⁸

A review of health records of US military service members conducted from 2014 to 2016 indicated that most patients who received PrEP did not receive recommended monitoring in accordance with the Centers for Disease Control and Prevention (CDC) guidelines. Furthermore, 16% of these individuals did not have HIV testing within 14 days of initiating PrEP, and 13% were never evaluated for hepatitis B infection.⁸

Pharmacists are highly accessible health care professionals (HCPs): More than 90% of Americans live within 5 miles of a community pharmacy.⁹ Pharmacists play an integral role within the outpatient health care team and have been responsible for improvements in health care outcomes for a variety of chronic conditions and immunization practices.^10-13 Additionally, community pharmacists have provided vital access to care during the COVID-19 pandemic.¹⁴ The clinical pharmacist practitioner (CPP) is an innovative and advanced role within the Veterans Health Administration (VHA), functioning with a scope of practice and prescribing privileges to provide direct patient care.¹⁵

CPPs are well suited to address the need for increased access, capacity, and timely provision of PrEP, especially in areas where HIV acquisition rates are high or in areas with reduced access to care. We describe a model for a pharmacist-led HIV PrEP program (Pharm-PrEP) to increase access to PrEP. A similar program could be adapted to further expand the use of PrEP in other health care systems and community settings.

Pharm-PrEP Program Description

The Veterans Affairs Greater Los Angeles Healthcare System (VAGLAHCS) provides health care services at 11 locations in southern California and serves > 86,000 veterans. The VAGLAHCS pharmacy staff includes 33 CPPs who practice in more than 9 clinical service lines. HIV PrEP services are available through the infectious diseases (ID) service for veterans wishing to begin or continue PrEP or for those identified as high risk. HIV PrEP consultations are placed by the referring HCP to the ID service for scheduling and evaluation. Prior to implementation of the pharmacist-managed PrEP clinic, 2 ID physician assistants (PAs) were responsible for PrEP evaluation, initiation, and follow-up. Each PA had 1 half-day face-to-face clinic and 1 PA had an additional half-day telehealth clinic. About 100 PrEP patients were followed by the ID group.

In July 2019, through collaboration with the ID service, a pharmacy PrEP clinic was created to increase access for veterans to initiate or continue PrEP. This clinic included 1 ID-trained CPP and 1 postgraduate-year-2 pharmacy resident. The CPP initiates and monitors veterans for HIV PrEP with prescribing privileges under a defined scope of practice.

Awareness of this novel service was raised through in-service training sessions for primary care and women’s health clinics. Referrals are generated directly from primary care practitioners (PCPs) or emergency department (ED) visits and are accepted on a continuing basis. Visits with the CPP are conducted in person or through telehealth services based on patient preference. Direct CPP patient care appointments involve a standardized assessment and discussion of patient HIV transmission risk, a review of social and sexual history, sexual practices and HIV risk, clinical evidence of acute HIV or other sexually transmitted infection (STI) symptoms, follow-up PrEP monitoring requirements, and counseling on appropriate PrEP use. CPPs can order laboratory tests, bone densitometry (DEXA scan), immunizations, PrEP, and STI treatment as required. ID service physicians are available during CPP visits for further assessment or consultation. While initially most visits are conducted in person, follow-up visits by telehealth or video have become predominant; most patients prefer these modalities, citing convenience, flexibility, and the ability to obtain laboratory tests in advance. Use of telephone and video is intended to reduce patient loss to follow-up.

All required baseline laboratory panels for PrEP monitoring are ordered and interpreted by the CPP in accordance with CDC guidelines.¹⁶ These include screening for syphilis, gonorrhea, and chlamydia; fourth-generation antibody-antigen HIV tests; renal function; viral hepatitis; and pregnancy. After reviewing screening results, the CPP will prescribe tenofovir disproxil fumarate/emtricitabine (TDF/FTC) or tenofovir alafenamide/emtricitabine (TAF/FTC) based on individual patient clinical characteristics, US Food and Drug Administration–approved labeling, and VA Pharmacy Benefits Management Criteria for Use. Initial prescriptions are for a 30-day supply with subsequent prescriptions for 90 days (no refills), providing follow-up HIV testing is completed.

Follow-up PrEP visits are scheduled about every 3 months with some overlap to avoid gaps in medication due to late laboratory testing or delayed receipt of mailed medications. The only laboratory testing strictly required each quarter before PrEP renewal is HIV and pregnancy testing. Other screenings, including STIs and renal function are completed at least every 6 months or more frequently, if indicated, based on individual risk factors. Hepatitis C antibody testing is conducted annually if the patient has ongoing risk factors. Treatment of gonorrhea/chlamydia and syphilis for patients with positive test results is also initiated by the CPP, including recommending antimicrobial regimens. Additional interventions conducted as part of the clinic include indicated vaccinations (meningococcal, human papillomavirus, hepatitis A and B), and DEXA scans. Collaboration with ID service attendings and PAs is conducted on an as-needed basis via direct consultation in the colocated clinic or through email or messaging.

Periodic surveillance of a local dashboard of veterans eligible for HIV PrEP is conducted to re-engage veterans in care who may have been lost to follow-up, along with periodic review of a local STI dashboard. These dashboards capture population-based data to identify patients who may benefit from additional STI screenings as well as potential candidates for HIV PrEP. Clinicians can review their patient panel to target individuals who may be due for specific actions. Patients are identified as needing cotesting if they screen positive for ≥ 1 STIs but have not had a concurrent or subsequent full screening panel (gonorrhea, chlamydia, syphilis, and HIV). Cotesting for bacterial STIs and HIV at the time of an encounter has been promoted to expedite STI identification and treatment and limit community transmission. These reports also identify patients who may be potential candidates for HIV PrEP, based on a history of positive screenings, frequent STI testing, recent prescriptions for postexposure prophylaxis (PEP) or encounters with specific International Classification of Diseases codes associated with high-risk practices.

Clinic Quality of Care

From July 2019 to March 2020, 53 veterans were managed by the pharm-PrEP clinic in 98 encounters. Seventy percent of encounters were in-person (Table 1).

Baseline information collected included demographics, documented patient-reported risk factors, fourth-generation HIV screening test results, STI status, viral hepatitis serologies, and renal function test results. Information collected every 3 to 6 months included STI status, fourth-generation HIV screening test results, renal function test results, adherence to therapy, changes in risk factors, and prescription refill data. Additional interventions conducted as part of clinic workflow included DEXA scans, vaccinations, and active prescriptions for condoms.

Baseline Characteristics

Pharm-PrEP clinic patients were predominantly male (94%), and a majority indicated White race with a median age of 38 years (range, 24-80 years).

Veterans referred to the clinic had up to 5 risk factors for PrEP initiation. The most common risk factors were inconsistent condom use (62%), multiple sexual partners of unknown HIV status (62%), MSM (57%), STI history (38%), bisexual partners (25%), and HIV-positive sexual partners (11%). One of the 53 individuals referred for PrEP had no risk factors and did not initiate PrEP. Two individuals declined initiation of PrEP after consultation. Twenty six of 53 veterans at baseline continued their use of PrEP following transfer to clinic CPP management; 24 of 27 veterans not currently using PrEP (89%) started or restarted lapsed PrEP use following CPP consultation.

HIV and STI Screening

No individuals tested positive for HIV at baseline (n = 52) or while on PrEP. PrEP was not renewed for 3 patients that did follow through with HIV testing. The median number of days an HIV test was completed prior to initial PrEP and PrEP renewal was 4 days and < 7 days, respectively, both of which are below the recommended maximal interval of 7 days, according to CDC PrEP guidelines. Some postinitiation HIV testing occurred using a longer interval of 14 days, in accordance with VA National Criteria for Use of PrEP. This modification allowed more flexibility as a majority of PrEP prescriptions are sent to veterans via mail. The CPP reviewing HIV test results was able to expedite the processing and mailing of PrEP prescriptions if deemed appropriate, ie, the HIV test was negative. This approach was not used if a patient had high-risk exposures without PrEP during the time between collection of the HIV test and mailing of the prescription.

STI screening is a vital component of the Pharm-PrEP clinic and helped identify 4 patients with gonorrhea/chlamydia at baseline and 1 with syphilis after initiation of PrEP. All patients were prescribed antibiotics at the screening. Los Angeles County has high rates of STI transmission;thus implementation of clinic processes allowing the CPP to screen for STIs, interpret test results, and treat patients with STIs is vital to limit spread in the community.¹⁷

Selection of PrEP Regimen

The majority of individuals in the cohort received TDF/FTC for PrEP; TAF/FTC was restricted to individuals who had documented renal dysfunction or bone loss (Table 3).

Six DEXA scans were completed by the end of the evaluation period and 2 had abnormal results. One patient discontinued TDF/FTC and reinitiated with TAF/FTC. The other was switched to TAF/FTC 1 month after initiation.

Follow-Up Visits

The median number of visits per patient was 2. The median time between visits was in accordance with recommended follow-up intervals with 35 days between visits 1 and 2, 60 days between visits 2 and 3, and 88 days thereafter. In all, 10 veterans (20%) stopped PrEP: 4 (8%) were lost to follow-up; 3 (6%) had sustained behavior changes decreasing their HIV exposure risk; 2 (4%) were concerned about ADRs; and 1 (2%) moved out of state. Even after including those patients with a decrease in HIV exposure risk who no longer required PrEP, our 20% discontinuation rate was lower than those reported in other studies that showed a wide variation in PrEP discontinuation rates ranging from 33% to 62%.^18-20

Challenges

Some challenges with the implementation of the clinic included logistic and operational barriers, such as developing clinical pathways and managing workflow to facilitate vaccinations or STI treatment for individuals using video or telehealth services, as well as encouraging referrals from PCPs. These challenges were addressed by providing periodic targeted in-service training sessions to primary care teams to increase awareness of the Pharm-PrEP clinic. Collaboration with the ID service and ED allowed implementation of a direct pathway for patients initiated on nonoccupational HIV PEP after a high-risk exposure to be evaluated for transition to HIV PrEP. This PEP-2-PrEP pathway was designed to decrease barriers to follow-up for high-risk individuals who had recently received PEP in the ED. The CPP plays an active, integral role in managing patient care in the PEP-2-PrEP pathway.

Pharmacist-Led PrEP Care

The implementation of the VAGLAHCS Pharm-PrEP clinic demonstrates how CPPs can expand access and manage HIV PrEP with high reliability. Key factors for successfully integrating CPPs as PrEP prescribers include identifying physician champions; using in-services or other training platforms to raise awareness among potential referring HCPs and stimulate referrals; and developing processes to identify high-risk veterans. Also, nontraditional modes of care, such as video or telehealth appointments, can increase access and expand the volume of patient care visits. Such modalities are useful for PrEP management when combined with a well-defined operational process for laboratory specimen collection before appointments. This system is particularly well suited to increasing access to PrEP for patients who live in rural or highly rural areas that are medically underserved or who have difficulty traveling to a clinical facility for an in-person visit.

Although community health care organizations and HCPs face pay barriers not present in the VHA system, several studies have demonstrated feasability of pharmacist-led clinics in private health care systems.^21-24 Havens and colleagues described a PrEP program affilitated with an university that assessed patient satisfaction and pharmacist acceptability with this new service.²² The results of surveys reported high patient satisfaction and pharmacist acceptability.²³ Tung and colleagues described a PrEP clinic located in a community pharmacy with the ability to bill for pharmacist and laboratory services in addition to medication costs.²⁴ These studies, along with our findings, demonstrate that CPPs are well positioned to manage HIV PrEP in the community. Leveraging the skills and experience of CPPs to address poor uptake and access to PrEP should be a central component in achieving the goals of the Ending the HIV Epidemic initiative, given that pharmacists are one of the most accessible groups of HCPs nationally.

Pharmacist prescriptive authority varies across different states and may depend on collaborative practice agreements, statewide protocols, or class-specific prescribing.²⁵ For example, California was among the first states to authorize initiation and prescription of HIV PrEP and PEP by pharmacists in specified amounts after appropriate training.²⁶ Nationwide support for similar policies in the community and within health care systems will be critical to the successful implementation and functioning of pharmacy-led PrEP clinics.

Conclusions

The success of this Pharm-PrEP clinic was largely due to a collaborative, interdisciplinary effort to implement this new clinic process and incorporate the CPP into the general ID outpatient clinic, while allowing flexibility in scheduling and use of different encounter modalities for patients. Deploying pharmacists as PrEP prescribers can help health care systems increase PrEP access and capacity and improve efforts to achieve the goals of the Ending the HIV Epidemic. This type of program can be a model for other health care organizations and systems to implement pharmacy-led PrEP clinics and expand telehealth modalities to deliver PrEP.

Acknowledgments

The infectious diseases service at the Veterans Affairs Greater Los Angeles Healthcare System and the veterans we serve.

The US Department of Health and Human Services (HHS) Ending the HIV Epidemic framework aims to decrease HIV infections in the United States by 90% before 2030.¹ Achieving this goal requires identifying persons at high risk for HIV and ensuring timely and efficient access to HIV preexposure prophylaxis (PrEP).^2-5 However, despite its commercial availability since 2012, community uptake of PrEP is low.⁶ In 2019, < 25% of Americans who could benefit from PrEP were using this preventive therapy.⁷ Poor uptake of PrEP has also been documented among veterans and US military service members. National data on men in the military and men who have sex with men (MSM) in the military suggest that about 12,000 service members are eligible for PrEP; however, only 2000 service members and their beneficiaries accessed PrEP in February 2017.⁸

A review of health records of US military service members conducted from 2014 to 2016 indicated that most patients who received PrEP did not receive recommended monitoring in accordance with the Centers for Disease Control and Prevention (CDC) guidelines. Furthermore, 16% of these individuals did not have HIV testing within 14 days of initiating PrEP, and 13% were never evaluated for hepatitis B infection.⁸

Pharmacists are highly accessible health care professionals (HCPs): More than 90% of Americans live within 5 miles of a community pharmacy.⁹ Pharmacists play an integral role within the outpatient health care team and have been responsible for improvements in health care outcomes for a variety of chronic conditions and immunization practices.^10-13 Additionally, community pharmacists have provided vital access to care during the COVID-19 pandemic.¹⁴ The clinical pharmacist practitioner (CPP) is an innovative and advanced role within the Veterans Health Administration (VHA), functioning with a scope of practice and prescribing privileges to provide direct patient care.¹⁵

CPPs are well suited to address the need for increased access, capacity, and timely provision of PrEP, especially in areas where HIV acquisition rates are high or in areas with reduced access to care. We describe a model for a pharmacist-led HIV PrEP program (Pharm-PrEP) to increase access to PrEP. A similar program could be adapted to further expand the use of PrEP in other health care systems and community settings.

Pharm-PrEP Program Description

The Veterans Affairs Greater Los Angeles Healthcare System (VAGLAHCS) provides health care services at 11 locations in southern California and serves > 86,000 veterans. The VAGLAHCS pharmacy staff includes 33 CPPs who practice in more than 9 clinical service lines. HIV PrEP services are available through the infectious diseases (ID) service for veterans wishing to begin or continue PrEP or for those identified as high risk. HIV PrEP consultations are placed by the referring HCP to the ID service for scheduling and evaluation. Prior to implementation of the pharmacist-managed PrEP clinic, 2 ID physician assistants (PAs) were responsible for PrEP evaluation, initiation, and follow-up. Each PA had 1 half-day face-to-face clinic and 1 PA had an additional half-day telehealth clinic. About 100 PrEP patients were followed by the ID group.

In July 2019, through collaboration with the ID service, a pharmacy PrEP clinic was created to increase access for veterans to initiate or continue PrEP. This clinic included 1 ID-trained CPP and 1 postgraduate-year-2 pharmacy resident. The CPP initiates and monitors veterans for HIV PrEP with prescribing privileges under a defined scope of practice.

Awareness of this novel service was raised through in-service training sessions for primary care and women’s health clinics. Referrals are generated directly from primary care practitioners (PCPs) or emergency department (ED) visits and are accepted on a continuing basis. Visits with the CPP are conducted in person or through telehealth services based on patient preference. Direct CPP patient care appointments involve a standardized assessment and discussion of patient HIV transmission risk, a review of social and sexual history, sexual practices and HIV risk, clinical evidence of acute HIV or other sexually transmitted infection (STI) symptoms, follow-up PrEP monitoring requirements, and counseling on appropriate PrEP use. CPPs can order laboratory tests, bone densitometry (DEXA scan), immunizations, PrEP, and STI treatment as required. ID service physicians are available during CPP visits for further assessment or consultation. While initially most visits are conducted in person, follow-up visits by telehealth or video have become predominant; most patients prefer these modalities, citing convenience, flexibility, and the ability to obtain laboratory tests in advance. Use of telephone and video is intended to reduce patient loss to follow-up.

All required baseline laboratory panels for PrEP monitoring are ordered and interpreted by the CPP in accordance with CDC guidelines.¹⁶ These include screening for syphilis, gonorrhea, and chlamydia; fourth-generation antibody-antigen HIV tests; renal function; viral hepatitis; and pregnancy. After reviewing screening results, the CPP will prescribe tenofovir disproxil fumarate/emtricitabine (TDF/FTC) or tenofovir alafenamide/emtricitabine (TAF/FTC) based on individual patient clinical characteristics, US Food and Drug Administration–approved labeling, and VA Pharmacy Benefits Management Criteria for Use. Initial prescriptions are for a 30-day supply with subsequent prescriptions for 90 days (no refills), providing follow-up HIV testing is completed.

Follow-up PrEP visits are scheduled about every 3 months with some overlap to avoid gaps in medication due to late laboratory testing or delayed receipt of mailed medications. The only laboratory testing strictly required each quarter before PrEP renewal is HIV and pregnancy testing. Other screenings, including STIs and renal function are completed at least every 6 months or more frequently, if indicated, based on individual risk factors. Hepatitis C antibody testing is conducted annually if the patient has ongoing risk factors. Treatment of gonorrhea/chlamydia and syphilis for patients with positive test results is also initiated by the CPP, including recommending antimicrobial regimens. Additional interventions conducted as part of the clinic include indicated vaccinations (meningococcal, human papillomavirus, hepatitis A and B), and DEXA scans. Collaboration with ID service attendings and PAs is conducted on an as-needed basis via direct consultation in the colocated clinic or through email or messaging.

Periodic surveillance of a local dashboard of veterans eligible for HIV PrEP is conducted to re-engage veterans in care who may have been lost to follow-up, along with periodic review of a local STI dashboard. These dashboards capture population-based data to identify patients who may benefit from additional STI screenings as well as potential candidates for HIV PrEP. Clinicians can review their patient panel to target individuals who may be due for specific actions. Patients are identified as needing cotesting if they screen positive for ≥ 1 STIs but have not had a concurrent or subsequent full screening panel (gonorrhea, chlamydia, syphilis, and HIV). Cotesting for bacterial STIs and HIV at the time of an encounter has been promoted to expedite STI identification and treatment and limit community transmission. These reports also identify patients who may be potential candidates for HIV PrEP, based on a history of positive screenings, frequent STI testing, recent prescriptions for postexposure prophylaxis (PEP) or encounters with specific International Classification of Diseases codes associated with high-risk practices.

Clinic Quality of Care

From July 2019 to March 2020, 53 veterans were managed by the pharm-PrEP clinic in 98 encounters. Seventy percent of encounters were in-person (Table 1).

Baseline information collected included demographics, documented patient-reported risk factors, fourth-generation HIV screening test results, STI status, viral hepatitis serologies, and renal function test results. Information collected every 3 to 6 months included STI status, fourth-generation HIV screening test results, renal function test results, adherence to therapy, changes in risk factors, and prescription refill data. Additional interventions conducted as part of clinic workflow included DEXA scans, vaccinations, and active prescriptions for condoms.

Baseline Characteristics

Pharm-PrEP clinic patients were predominantly male (94%), and a majority indicated White race with a median age of 38 years (range, 24-80 years).

Veterans referred to the clinic had up to 5 risk factors for PrEP initiation. The most common risk factors were inconsistent condom use (62%), multiple sexual partners of unknown HIV status (62%), MSM (57%), STI history (38%), bisexual partners (25%), and HIV-positive sexual partners (11%). One of the 53 individuals referred for PrEP had no risk factors and did not initiate PrEP. Two individuals declined initiation of PrEP after consultation. Twenty six of 53 veterans at baseline continued their use of PrEP following transfer to clinic CPP management; 24 of 27 veterans not currently using PrEP (89%) started or restarted lapsed PrEP use following CPP consultation.

HIV and STI Screening

No individuals tested positive for HIV at baseline (n = 52) or while on PrEP. PrEP was not renewed for 3 patients that did follow through with HIV testing. The median number of days an HIV test was completed prior to initial PrEP and PrEP renewal was 4 days and < 7 days, respectively, both of which are below the recommended maximal interval of 7 days, according to CDC PrEP guidelines. Some postinitiation HIV testing occurred using a longer interval of 14 days, in accordance with VA National Criteria for Use of PrEP. This modification allowed more flexibility as a majority of PrEP prescriptions are sent to veterans via mail. The CPP reviewing HIV test results was able to expedite the processing and mailing of PrEP prescriptions if deemed appropriate, ie, the HIV test was negative. This approach was not used if a patient had high-risk exposures without PrEP during the time between collection of the HIV test and mailing of the prescription.

STI screening is a vital component of the Pharm-PrEP clinic and helped identify 4 patients with gonorrhea/chlamydia at baseline and 1 with syphilis after initiation of PrEP. All patients were prescribed antibiotics at the screening. Los Angeles County has high rates of STI transmission;thus implementation of clinic processes allowing the CPP to screen for STIs, interpret test results, and treat patients with STIs is vital to limit spread in the community.¹⁷

Selection of PrEP Regimen

The majority of individuals in the cohort received TDF/FTC for PrEP; TAF/FTC was restricted to individuals who had documented renal dysfunction or bone loss (Table 3).

Six DEXA scans were completed by the end of the evaluation period and 2 had abnormal results. One patient discontinued TDF/FTC and reinitiated with TAF/FTC. The other was switched to TAF/FTC 1 month after initiation.

Follow-Up Visits

The median number of visits per patient was 2. The median time between visits was in accordance with recommended follow-up intervals with 35 days between visits 1 and 2, 60 days between visits 2 and 3, and 88 days thereafter. In all, 10 veterans (20%) stopped PrEP: 4 (8%) were lost to follow-up; 3 (6%) had sustained behavior changes decreasing their HIV exposure risk; 2 (4%) were concerned about ADRs; and 1 (2%) moved out of state. Even after including those patients with a decrease in HIV exposure risk who no longer required PrEP, our 20% discontinuation rate was lower than those reported in other studies that showed a wide variation in PrEP discontinuation rates ranging from 33% to 62%.^18-20

Challenges

Some challenges with the implementation of the clinic included logistic and operational barriers, such as developing clinical pathways and managing workflow to facilitate vaccinations or STI treatment for individuals using video or telehealth services, as well as encouraging referrals from PCPs. These challenges were addressed by providing periodic targeted in-service training sessions to primary care teams to increase awareness of the Pharm-PrEP clinic. Collaboration with the ID service and ED allowed implementation of a direct pathway for patients initiated on nonoccupational HIV PEP after a high-risk exposure to be evaluated for transition to HIV PrEP. This PEP-2-PrEP pathway was designed to decrease barriers to follow-up for high-risk individuals who had recently received PEP in the ED. The CPP plays an active, integral role in managing patient care in the PEP-2-PrEP pathway.

Pharmacist-Led PrEP Care

The implementation of the VAGLAHCS Pharm-PrEP clinic demonstrates how CPPs can expand access and manage HIV PrEP with high reliability. Key factors for successfully integrating CPPs as PrEP prescribers include identifying physician champions; using in-services or other training platforms to raise awareness among potential referring HCPs and stimulate referrals; and developing processes to identify high-risk veterans. Also, nontraditional modes of care, such as video or telehealth appointments, can increase access and expand the volume of patient care visits. Such modalities are useful for PrEP management when combined with a well-defined operational process for laboratory specimen collection before appointments. This system is particularly well suited to increasing access to PrEP for patients who live in rural or highly rural areas that are medically underserved or who have difficulty traveling to a clinical facility for an in-person visit.

Although community health care organizations and HCPs face pay barriers not present in the VHA system, several studies have demonstrated feasability of pharmacist-led clinics in private health care systems.^21-24 Havens and colleagues described a PrEP program affilitated with an university that assessed patient satisfaction and pharmacist acceptability with this new service.²² The results of surveys reported high patient satisfaction and pharmacist acceptability.²³ Tung and colleagues described a PrEP clinic located in a community pharmacy with the ability to bill for pharmacist and laboratory services in addition to medication costs.²⁴ These studies, along with our findings, demonstrate that CPPs are well positioned to manage HIV PrEP in the community. Leveraging the skills and experience of CPPs to address poor uptake and access to PrEP should be a central component in achieving the goals of the Ending the HIV Epidemic initiative, given that pharmacists are one of the most accessible groups of HCPs nationally.

Pharmacist prescriptive authority varies across different states and may depend on collaborative practice agreements, statewide protocols, or class-specific prescribing.²⁵ For example, California was among the first states to authorize initiation and prescription of HIV PrEP and PEP by pharmacists in specified amounts after appropriate training.²⁶ Nationwide support for similar policies in the community and within health care systems will be critical to the successful implementation and functioning of pharmacy-led PrEP clinics.

Conclusions

The success of this Pharm-PrEP clinic was largely due to a collaborative, interdisciplinary effort to implement this new clinic process and incorporate the CPP into the general ID outpatient clinic, while allowing flexibility in scheduling and use of different encounter modalities for patients. Deploying pharmacists as PrEP prescribers can help health care systems increase PrEP access and capacity and improve efforts to achieve the goals of the Ending the HIV Epidemic. This type of program can be a model for other health care organizations and systems to implement pharmacy-led PrEP clinics and expand telehealth modalities to deliver PrEP.

Acknowledgments

The infectious diseases service at the Veterans Affairs Greater Los Angeles Healthcare System and the veterans we serve.

The US Department of Health and Human Services (HHS) Ending the HIV Epidemic framework aims to decrease HIV infections in the United States by 90% before 2030.¹ Achieving this goal requires identifying persons at high risk for HIV and ensuring timely and efficient access to HIV preexposure prophylaxis (PrEP).^2-5 However, despite its commercial availability since 2012, community uptake of PrEP is low.⁶ In 2019, < 25% of Americans who could benefit from PrEP were using this preventive therapy.⁷ Poor uptake of PrEP has also been documented among veterans and US military service members. National data on men in the military and men who have sex with men (MSM) in the military suggest that about 12,000 service members are eligible for PrEP; however, only 2000 service members and their beneficiaries accessed PrEP in February 2017.⁸

A review of health records of US military service members conducted from 2014 to 2016 indicated that most patients who received PrEP did not receive recommended monitoring in accordance with the Centers for Disease Control and Prevention (CDC) guidelines. Furthermore, 16% of these individuals did not have HIV testing within 14 days of initiating PrEP, and 13% were never evaluated for hepatitis B infection.⁸

Pharmacists are highly accessible health care professionals (HCPs): More than 90% of Americans live within 5 miles of a community pharmacy.⁹ Pharmacists play an integral role within the outpatient health care team and have been responsible for improvements in health care outcomes for a variety of chronic conditions and immunization practices.^10-13 Additionally, community pharmacists have provided vital access to care during the COVID-19 pandemic.¹⁴ The clinical pharmacist practitioner (CPP) is an innovative and advanced role within the Veterans Health Administration (VHA), functioning with a scope of practice and prescribing privileges to provide direct patient care.¹⁵

CPPs are well suited to address the need for increased access, capacity, and timely provision of PrEP, especially in areas where HIV acquisition rates are high or in areas with reduced access to care. We describe a model for a pharmacist-led HIV PrEP program (Pharm-PrEP) to increase access to PrEP. A similar program could be adapted to further expand the use of PrEP in other health care systems and community settings.

Pharm-PrEP Program Description

The Veterans Affairs Greater Los Angeles Healthcare System (VAGLAHCS) provides health care services at 11 locations in southern California and serves > 86,000 veterans. The VAGLAHCS pharmacy staff includes 33 CPPs who practice in more than 9 clinical service lines. HIV PrEP services are available through the infectious diseases (ID) service for veterans wishing to begin or continue PrEP or for those identified as high risk. HIV PrEP consultations are placed by the referring HCP to the ID service for scheduling and evaluation. Prior to implementation of the pharmacist-managed PrEP clinic, 2 ID physician assistants (PAs) were responsible for PrEP evaluation, initiation, and follow-up. Each PA had 1 half-day face-to-face clinic and 1 PA had an additional half-day telehealth clinic. About 100 PrEP patients were followed by the ID group.

In July 2019, through collaboration with the ID service, a pharmacy PrEP clinic was created to increase access for veterans to initiate or continue PrEP. This clinic included 1 ID-trained CPP and 1 postgraduate-year-2 pharmacy resident. The CPP initiates and monitors veterans for HIV PrEP with prescribing privileges under a defined scope of practice.

Awareness of this novel service was raised through in-service training sessions for primary care and women’s health clinics. Referrals are generated directly from primary care practitioners (PCPs) or emergency department (ED) visits and are accepted on a continuing basis. Visits with the CPP are conducted in person or through telehealth services based on patient preference. Direct CPP patient care appointments involve a standardized assessment and discussion of patient HIV transmission risk, a review of social and sexual history, sexual practices and HIV risk, clinical evidence of acute HIV or other sexually transmitted infection (STI) symptoms, follow-up PrEP monitoring requirements, and counseling on appropriate PrEP use. CPPs can order laboratory tests, bone densitometry (DEXA scan), immunizations, PrEP, and STI treatment as required. ID service physicians are available during CPP visits for further assessment or consultation. While initially most visits are conducted in person, follow-up visits by telehealth or video have become predominant; most patients prefer these modalities, citing convenience, flexibility, and the ability to obtain laboratory tests in advance. Use of telephone and video is intended to reduce patient loss to follow-up.

All required baseline laboratory panels for PrEP monitoring are ordered and interpreted by the CPP in accordance with CDC guidelines.¹⁶ These include screening for syphilis, gonorrhea, and chlamydia; fourth-generation antibody-antigen HIV tests; renal function; viral hepatitis; and pregnancy. After reviewing screening results, the CPP will prescribe tenofovir disproxil fumarate/emtricitabine (TDF/FTC) or tenofovir alafenamide/emtricitabine (TAF/FTC) based on individual patient clinical characteristics, US Food and Drug Administration–approved labeling, and VA Pharmacy Benefits Management Criteria for Use. Initial prescriptions are for a 30-day supply with subsequent prescriptions for 90 days (no refills), providing follow-up HIV testing is completed.

Follow-up PrEP visits are scheduled about every 3 months with some overlap to avoid gaps in medication due to late laboratory testing or delayed receipt of mailed medications. The only laboratory testing strictly required each quarter before PrEP renewal is HIV and pregnancy testing. Other screenings, including STIs and renal function are completed at least every 6 months or more frequently, if indicated, based on individual risk factors. Hepatitis C antibody testing is conducted annually if the patient has ongoing risk factors. Treatment of gonorrhea/chlamydia and syphilis for patients with positive test results is also initiated by the CPP, including recommending antimicrobial regimens. Additional interventions conducted as part of the clinic include indicated vaccinations (meningococcal, human papillomavirus, hepatitis A and B), and DEXA scans. Collaboration with ID service attendings and PAs is conducted on an as-needed basis via direct consultation in the colocated clinic or through email or messaging.

Periodic surveillance of a local dashboard of veterans eligible for HIV PrEP is conducted to re-engage veterans in care who may have been lost to follow-up, along with periodic review of a local STI dashboard. These dashboards capture population-based data to identify patients who may benefit from additional STI screenings as well as potential candidates for HIV PrEP. Clinicians can review their patient panel to target individuals who may be due for specific actions. Patients are identified as needing cotesting if they screen positive for ≥ 1 STIs but have not had a concurrent or subsequent full screening panel (gonorrhea, chlamydia, syphilis, and HIV). Cotesting for bacterial STIs and HIV at the time of an encounter has been promoted to expedite STI identification and treatment and limit community transmission. These reports also identify patients who may be potential candidates for HIV PrEP, based on a history of positive screenings, frequent STI testing, recent prescriptions for postexposure prophylaxis (PEP) or encounters with specific International Classification of Diseases codes associated with high-risk practices.

Clinic Quality of Care

From July 2019 to March 2020, 53 veterans were managed by the pharm-PrEP clinic in 98 encounters. Seventy percent of encounters were in-person (Table 1).

Baseline information collected included demographics, documented patient-reported risk factors, fourth-generation HIV screening test results, STI status, viral hepatitis serologies, and renal function test results. Information collected every 3 to 6 months included STI status, fourth-generation HIV screening test results, renal function test results, adherence to therapy, changes in risk factors, and prescription refill data. Additional interventions conducted as part of clinic workflow included DEXA scans, vaccinations, and active prescriptions for condoms.

Baseline Characteristics

Pharm-PrEP clinic patients were predominantly male (94%), and a majority indicated White race with a median age of 38 years (range, 24-80 years).

Veterans referred to the clinic had up to 5 risk factors for PrEP initiation. The most common risk factors were inconsistent condom use (62%), multiple sexual partners of unknown HIV status (62%), MSM (57%), STI history (38%), bisexual partners (25%), and HIV-positive sexual partners (11%). One of the 53 individuals referred for PrEP had no risk factors and did not initiate PrEP. Two individuals declined initiation of PrEP after consultation. Twenty six of 53 veterans at baseline continued their use of PrEP following transfer to clinic CPP management; 24 of 27 veterans not currently using PrEP (89%) started or restarted lapsed PrEP use following CPP consultation.

HIV and STI Screening

No individuals tested positive for HIV at baseline (n = 52) or while on PrEP. PrEP was not renewed for 3 patients that did follow through with HIV testing. The median number of days an HIV test was completed prior to initial PrEP and PrEP renewal was 4 days and < 7 days, respectively, both of which are below the recommended maximal interval of 7 days, according to CDC PrEP guidelines. Some postinitiation HIV testing occurred using a longer interval of 14 days, in accordance with VA National Criteria for Use of PrEP. This modification allowed more flexibility as a majority of PrEP prescriptions are sent to veterans via mail. The CPP reviewing HIV test results was able to expedite the processing and mailing of PrEP prescriptions if deemed appropriate, ie, the HIV test was negative. This approach was not used if a patient had high-risk exposures without PrEP during the time between collection of the HIV test and mailing of the prescription.

STI screening is a vital component of the Pharm-PrEP clinic and helped identify 4 patients with gonorrhea/chlamydia at baseline and 1 with syphilis after initiation of PrEP. All patients were prescribed antibiotics at the screening. Los Angeles County has high rates of STI transmission;thus implementation of clinic processes allowing the CPP to screen for STIs, interpret test results, and treat patients with STIs is vital to limit spread in the community.¹⁷

Selection of PrEP Regimen

The majority of individuals in the cohort received TDF/FTC for PrEP; TAF/FTC was restricted to individuals who had documented renal dysfunction or bone loss (Table 3).

Six DEXA scans were completed by the end of the evaluation period and 2 had abnormal results. One patient discontinued TDF/FTC and reinitiated with TAF/FTC. The other was switched to TAF/FTC 1 month after initiation.

Follow-Up Visits

The median number of visits per patient was 2. The median time between visits was in accordance with recommended follow-up intervals with 35 days between visits 1 and 2, 60 days between visits 2 and 3, and 88 days thereafter. In all, 10 veterans (20%) stopped PrEP: 4 (8%) were lost to follow-up; 3 (6%) had sustained behavior changes decreasing their HIV exposure risk; 2 (4%) were concerned about ADRs; and 1 (2%) moved out of state. Even after including those patients with a decrease in HIV exposure risk who no longer required PrEP, our 20% discontinuation rate was lower than those reported in other studies that showed a wide variation in PrEP discontinuation rates ranging from 33% to 62%.^18-20

Challenges

Some challenges with the implementation of the clinic included logistic and operational barriers, such as developing clinical pathways and managing workflow to facilitate vaccinations or STI treatment for individuals using video or telehealth services, as well as encouraging referrals from PCPs. These challenges were addressed by providing periodic targeted in-service training sessions to primary care teams to increase awareness of the Pharm-PrEP clinic. Collaboration with the ID service and ED allowed implementation of a direct pathway for patients initiated on nonoccupational HIV PEP after a high-risk exposure to be evaluated for transition to HIV PrEP. This PEP-2-PrEP pathway was designed to decrease barriers to follow-up for high-risk individuals who had recently received PEP in the ED. The CPP plays an active, integral role in managing patient care in the PEP-2-PrEP pathway.

Pharmacist-Led PrEP Care

The implementation of the VAGLAHCS Pharm-PrEP clinic demonstrates how CPPs can expand access and manage HIV PrEP with high reliability. Key factors for successfully integrating CPPs as PrEP prescribers include identifying physician champions; using in-services or other training platforms to raise awareness among potential referring HCPs and stimulate referrals; and developing processes to identify high-risk veterans. Also, nontraditional modes of care, such as video or telehealth appointments, can increase access and expand the volume of patient care visits. Such modalities are useful for PrEP management when combined with a well-defined operational process for laboratory specimen collection before appointments. This system is particularly well suited to increasing access to PrEP for patients who live in rural or highly rural areas that are medically underserved or who have difficulty traveling to a clinical facility for an in-person visit.

Although community health care organizations and HCPs face pay barriers not present in the VHA system, several studies have demonstrated feasability of pharmacist-led clinics in private health care systems.^21-24 Havens and colleagues described a PrEP program affilitated with an university that assessed patient satisfaction and pharmacist acceptability with this new service.²² The results of surveys reported high patient satisfaction and pharmacist acceptability.²³ Tung and colleagues described a PrEP clinic located in a community pharmacy with the ability to bill for pharmacist and laboratory services in addition to medication costs.²⁴ These studies, along with our findings, demonstrate that CPPs are well positioned to manage HIV PrEP in the community. Leveraging the skills and experience of CPPs to address poor uptake and access to PrEP should be a central component in achieving the goals of the Ending the HIV Epidemic initiative, given that pharmacists are one of the most accessible groups of HCPs nationally.

Pharmacist prescriptive authority varies across different states and may depend on collaborative practice agreements, statewide protocols, or class-specific prescribing.²⁵ For example, California was among the first states to authorize initiation and prescription of HIV PrEP and PEP by pharmacists in specified amounts after appropriate training.²⁶ Nationwide support for similar policies in the community and within health care systems will be critical to the successful implementation and functioning of pharmacy-led PrEP clinics.

Conclusions

The success of this Pharm-PrEP clinic was largely due to a collaborative, interdisciplinary effort to implement this new clinic process and incorporate the CPP into the general ID outpatient clinic, while allowing flexibility in scheduling and use of different encounter modalities for patients. Deploying pharmacists as PrEP prescribers can help health care systems increase PrEP access and capacity and improve efforts to achieve the goals of the Ending the HIV Epidemic. This type of program can be a model for other health care organizations and systems to implement pharmacy-led PrEP clinics and expand telehealth modalities to deliver PrEP.

Acknowledgments

The infectious diseases service at the Veterans Affairs Greater Los Angeles Healthcare System and the veterans we serve.

Throughout the COVID-19 pandemic, health care professionals (HCPs), including emergency medicine physicians and hospitalists, have been continuously challenged to maintain an up-to-date clinical practice on COVID-19 therapeutics as new evidence emerged.^1,2 In the early part of the pandemic, these included not only appropriate and time-sensitive prescriptions of COVID-19 therapeutics, such as remdesivir and dexamethasone, but also judicious use of empiric antibiotics given the low prevalence for bacterial coinfection in early disease.^3-6 Alongside this, curbing the excessive laboratory testing of these patients during the pandemic was important not only to minimize costs but also to reduce potential iatrogenic harm and extended length of stay (LOS).⁷

At the beginning of the pandemic in March 2020 at the US Department of Veterans Affairs (VA) North Texas Health Care System (VANTHCS) Dallas VA Medical Center (DVAMC), we attempted to provide therapeutic guidance for physicians primarily through direct infectious disease (ID) consultation (in-person or electronic).⁸ This was secondarily supported by a pharmacist and ID physician–curated “living guidance” document on COVID-19 care accessible to all physicians through the DVAMC electronic health record (EHR) and intranet.

As the alpha variant (lineage B.1.1.7) of COVID-19 began spreading throughout North Texas in the winter of 2020, we implemented a targeted educational intervention toward the hospitalist group taking care of patients with COVID-19 with the primary goal of improving the accuracy of COVID-19 therapeutics while minimizing the consultative burden on ID clinical and pharmacy staff. This initiative consisted of (1) proactive guideline dissemination through email and text messages; (2) virtual didactics; and (3) physician reminders during the consultation process. Our ultimate aims were to improve hospitalist-led appropriate prescriptions of remdesivir and dexamethasone, reducing empiric antibiotic days of therapy in patients with COVID-19 at low risk of bacterial coinfection, and reducing laboratory orders that were not indicated for the management of these patients. Following this intervention and the resolution of the second wave, we retrospectively assessed the temporal trends of COVID-19 practices by hospitalists and associated patterns of ID consultation in the DVAMC from October 1, 2020, to March 31, 2021.

METHODS

The educational intervention was carried out at the DVAMC, a 1A high complex facility with more than 200 inpatient beds and part of the VANTHCS. During the study period, patients admitted with COVID-19 were located either on a closed floor (managed by the hospitalist team) or in a closed intensive care unit (ICU) (managed by the pulmonary/critical care team) contingent on the level of care or oxygen supplementation required. ID and other subspecialties provided consultation services as requested by hospitalists or ICU teams either electronically or in person. During the study period, 66 hospitalists were involved in the care of the patients: 59 (89.5%) permanent staff, 4 (6.0%) fee-basis physicians, and 3 (4.5%) moonlighting fellows.

Educational Initiative

We delivered educational sessions to the hospitalists, using collaboration software with video meeting capability every 1 to 2 months beginning in December 2020. An additional session focused on reducing empiric antibiotic prescriptions was also delivered to the emergency medicine department, based on feedback from the hospitalist group. The content for the educational sessions came from informal surveys of both ID trainees assigned to the consultation service and hospitalists, covering the following topics: understanding the stages of COVID-19 illness (virologic replication vs inflammatory) and rationales for therapy; assessing disease severity; indications and use of remdesivir; indications and use of dexamethasone; assessing for bacterial coinfections; when an ID consultation is required; management algorithm for COVID-19; and locating guidelines on the intranet. About 15 to 20 physicians participated in each session. In addition, slides of these didactics and updated institutional COVID-19 guidelines were disseminated to the hospitalist group via email and text messaging. We also linked the intranet institution guidelines in our communication, including a revised user-friendly flowchart (eAppendix).

Laboratory Stewardship Initiative

Laboratory stewardship initiatives were implemented by modifying suggested orders on the admission of patients with COVID-19 and directly educating hospitalist and emergency medicine physicians on evidence-based laboratory orders. At the beginning of the pandemic, a broad admission order set was established at DVAMC, based on the then limited knowledge of the course of infection with COVID-19. This order set allowed the admitting physicians to efficiently order laboratory tests for patients, especially during the demanding increase in patient volume experienced by DVAMC.

As new evidence emerged during the pandemic, many of the laboratory orders were reviewed for clinical utility during care for the patient with COVID-19 per the latest guidance. In December 2020, the admission orders for patients with COVID-19 were revised to reflect better laboratory stewardship to reduce cost and harm. The ID section revised the laboratory orders and disseminated the new order set to admitting physicians. Specifically, the admission order set removed the following laboratory tests available for selection: routine blood cultures, interleukin 6 (IL-6) level, and Legionella sputum culture. These laboratory orders were removed based on the lack of supporting evidence in persons admitted with COVID-19.⁹ In addition to modification of the admission order set, educational sessions were held with hospitalists to disseminate knowledge of the new changes and address any concerns.

Observations of Care

This study was approved by the VANTHCS Institutional Review Board (protocol code 20-047). Records were retrospectively reviewed for patients admitted to DVAMC for COVID-19 under hospitalist care (patients admitted directly to the ICU were excluded) from October 1, 2020, to March 31, 2021. Age, sex, race and ethnicity, and comorbidities were collected from the EHR. In addition clinical measures such as maximum oxygen requirement during admission (none, nasal cannula of 2-4 L/min, high flow/bilevel positive airway pressure [BiPAP] or mechanical ventilation), proven presence of coinfection (defined as the isolation of a probable pathogen in pure culture and/or clinically determined by ID specialist evaluation), and the average LOS also were collected. For laboratory stewardship data, a retrospective chart review was conducted to determine the total number of blood cultures obtained within 24 hours of admission per month during the study period. Both IL-6 levels and Legionella sputum culture data were collected as the total number of laboratory orders per month, as it was assumed that most of these orders were obtained for patients admitted with COVID-19.

Individual patient-level data were extracted to calculate monthly percentages of ID consultations for COVID-19 by the hospitalist team, adherence to institutional guidelines for dexamethasone and remdesivir prescriptions, and empiric antibiotic prescriptions for patients with COVID-19, including use of a priori adjudication criteria to determine justified vs unjustified empiric use. These criteria included asymmetric chest X-ray infiltrates concerning for bacterial pneumonia; peripheral white blood cell count > 11 K/μL; critical respiratory failure in the emergency department (ED) and being transferred to the ICU; and ID consultation recommended. Because the total number of antibiotics was not being analyzed but rather just the use of antibiotics for the justified and unjustified groups, antibiotic days were reported as the length of therapy (LOT).¹⁰ A subset analysis was performed on antibiotic prescriptions by the hospitalist group focusing on those with mild-to-moderate oxygen requirements (no high flow, noninvasive or invasive ventilatory methods) and excluding infections with a proven microbiologic entity.

Differences in demographic and clinical characteristics of patients with COVID-19 admitted from October 1, 2020, to March 31, 2021, were assessed using ANOVA, χ², and Kruskal-Wallis test. χ² was used to compare the difference in total laboratory orders for routine blood cultures, IL-6 levels, and Legionella sputum cultures between pre-intervention (October to December 2020) and postintervention (January to March 2021). These pre- and postintervention periods were determined based on the timing of revised admission orders in the EHR and initiation of focused educational sessions starting in late December 2020 and early January 2021. Linear regressions were used to examine the possible 6-month trend of the percentage of patients receiving ID consultation for appropriate dexamethasone prescriptions, appropriate remdesivir prescriptions, appropriate antibiotic coadministration, and mean number of antibiotic days per patient. Linear and logistic regression were also used to assess the trend in LOS over the 6 months while adjusting for age, race and ethnicity, sex, and coinfections. All analyses were performed using SAS 9.4. Statistical significance was defined as P < .05.

RESULTS

From October 1, 2020, to March 31, 2021, there were 565 admissions for COVID-19, which peaked in January 2021 with 163. Analysis of the patient characteristics showed no statistically significant difference for age, sex, oxygen requirements during admission, or proven presence of coinfection between the months of interest (Table 1).

The number of blood cultures obtained in the first 24 hours of admission significantly decreased from 58.1% of admissions in October 2020 to 34.8% of admissions in March 2021 (P < .01) (Table 2).

DISCUSSION

As the COVID-19 pandemic has evolved, the ability to enact up-to-date guidance is crucial to streamlining patient care, improving time to COVID-19–specific therapies, and minimizing the burden on subspecialty consultation services. At DVAMC, we initiated a targeted and deliberate educational effort directed toward hospitalist and ED groups combined with a laboratory stewardship effort over 6 months to improve the implementation of COVID-19 therapeutics, reduce empiric antibiotic use without reliance on ID consultation services, and reduce the number of unnecessary laboratory orders for admitted patients with COVID-19. During this time, we observed modest but statistically significant improvements in the accuracy of dexamethasone and remdesivir prescribing. In addition, we observed statistically significant improvement in the average LOT per patient regarding antibiotic use and overall decreased LOS. These improvements were seen in parallel with decreasing requests for ID consultation, suggesting that they were attributable in part to increasing self-confidence and efficacy in COVID-19 practices by the hospitalist group. Modification of the COVID-19 admission order set for our facility resulted in substantial decreases in orders for blood cultures, IL-6 levels, and sputum cultures for Legionella.

ID consultation, either in person or remotely, has been instrumental in assisting physicians in COVID-19 management and has been shown to reduce morbidity, mortality, and patient LOS in other infections.^11,12 However, in scenarios where ID consultation is not available or in limited supply, accessibility, familiarity, and confidence of primary practitioners to use therapeutic guidance material are integral. Frequent and accessible guidance for the management of COVID-19 has been provided by the National Institutes of Health and the Infectious Diseases Society of America.^13,14 Other mechanisms of assisting physicians in both test ordering and therapeutics include clinical decision support tools built into the EHR and the use of a smartphone digital application.¹⁵ Guidance needs to be adapted to the context of the facility, including available resources and specific restrictions and/or prohibitions on therapeutics (eg, mandatory ID consultation or approval). In our facility, while COVID-19 therapeutic living guidance documents were maintained and accessible through the intranet, proactive dissemination and redirection were important steps in enabling the use of these documents.

Limitations

We acknowledge several limitations to this study. Most important, the correlations we observed do not represent causation. Our analysis was not designed to ascertain the direct impact of any single or combined educational and laboratory stewardship intervention from this study, and we acknowledge that the improvements in part could be related to increased experience and confidence with COVID-19 management that occurred over time independent of our programs. Furthermore, we acknowledge that several areas of COVID-19 management did not improve over time (such as overall empiric antibiotic use from the ED) or had very modest improvements (hospitalist-initiated remdesivir use). These results underscore the complex dynamics and contextual barriers to rapidly implementing guideline-based care at VANTHCS. Potential factors include insufficient reach to all physicians, variable learner motivation, and therapeutic momentum of antibiotic use carried forward from the ED.^16,17 These factors should be considered as grounds for further study. Another limitation was the inability to track viewership and engagement of our COVID-19 guidance document. Without the use metrics, it is difficult to know the individual impact of the document regarding the changing trends in COVID-19 management we observed during the study period.

Conclusions

We report improvements in COVID-19 therapeutic prescriptions and the use of antibiotics and laboratory testing over 6 months at the DVAMC. This was correlated with a deliberate COVID-19 educational initiative that included antibiotic and laboratory stewardship interventions with simultaneous decreased reliance on ID consultation. These efforts lend support to the proof of the principle of combined educational and laboratory stewardship interventions to improve the care of COVID-19 patients, especially where ID support may not be available or is accessed remotely.

Throughout the COVID-19 pandemic, health care professionals (HCPs), including emergency medicine physicians and hospitalists, have been continuously challenged to maintain an up-to-date clinical practice on COVID-19 therapeutics as new evidence emerged.^1,2 In the early part of the pandemic, these included not only appropriate and time-sensitive prescriptions of COVID-19 therapeutics, such as remdesivir and dexamethasone, but also judicious use of empiric antibiotics given the low prevalence for bacterial coinfection in early disease.^3-6 Alongside this, curbing the excessive laboratory testing of these patients during the pandemic was important not only to minimize costs but also to reduce potential iatrogenic harm and extended length of stay (LOS).⁷

At the beginning of the pandemic in March 2020 at the US Department of Veterans Affairs (VA) North Texas Health Care System (VANTHCS) Dallas VA Medical Center (DVAMC), we attempted to provide therapeutic guidance for physicians primarily through direct infectious disease (ID) consultation (in-person or electronic).⁸ This was secondarily supported by a pharmacist and ID physician–curated “living guidance” document on COVID-19 care accessible to all physicians through the DVAMC electronic health record (EHR) and intranet.

As the alpha variant (lineage B.1.1.7) of COVID-19 began spreading throughout North Texas in the winter of 2020, we implemented a targeted educational intervention toward the hospitalist group taking care of patients with COVID-19 with the primary goal of improving the accuracy of COVID-19 therapeutics while minimizing the consultative burden on ID clinical and pharmacy staff. This initiative consisted of (1) proactive guideline dissemination through email and text messages; (2) virtual didactics; and (3) physician reminders during the consultation process. Our ultimate aims were to improve hospitalist-led appropriate prescriptions of remdesivir and dexamethasone, reducing empiric antibiotic days of therapy in patients with COVID-19 at low risk of bacterial coinfection, and reducing laboratory orders that were not indicated for the management of these patients. Following this intervention and the resolution of the second wave, we retrospectively assessed the temporal trends of COVID-19 practices by hospitalists and associated patterns of ID consultation in the DVAMC from October 1, 2020, to March 31, 2021.

METHODS

The educational intervention was carried out at the DVAMC, a 1A high complex facility with more than 200 inpatient beds and part of the VANTHCS. During the study period, patients admitted with COVID-19 were located either on a closed floor (managed by the hospitalist team) or in a closed intensive care unit (ICU) (managed by the pulmonary/critical care team) contingent on the level of care or oxygen supplementation required. ID and other subspecialties provided consultation services as requested by hospitalists or ICU teams either electronically or in person. During the study period, 66 hospitalists were involved in the care of the patients: 59 (89.5%) permanent staff, 4 (6.0%) fee-basis physicians, and 3 (4.5%) moonlighting fellows.

Educational Initiative

We delivered educational sessions to the hospitalists, using collaboration software with video meeting capability every 1 to 2 months beginning in December 2020. An additional session focused on reducing empiric antibiotic prescriptions was also delivered to the emergency medicine department, based on feedback from the hospitalist group. The content for the educational sessions came from informal surveys of both ID trainees assigned to the consultation service and hospitalists, covering the following topics: understanding the stages of COVID-19 illness (virologic replication vs inflammatory) and rationales for therapy; assessing disease severity; indications and use of remdesivir; indications and use of dexamethasone; assessing for bacterial coinfections; when an ID consultation is required; management algorithm for COVID-19; and locating guidelines on the intranet. About 15 to 20 physicians participated in each session. In addition, slides of these didactics and updated institutional COVID-19 guidelines were disseminated to the hospitalist group via email and text messaging. We also linked the intranet institution guidelines in our communication, including a revised user-friendly flowchart (eAppendix).

Laboratory Stewardship Initiative

Laboratory stewardship initiatives were implemented by modifying suggested orders on the admission of patients with COVID-19 and directly educating hospitalist and emergency medicine physicians on evidence-based laboratory orders. At the beginning of the pandemic, a broad admission order set was established at DVAMC, based on the then limited knowledge of the course of infection with COVID-19. This order set allowed the admitting physicians to efficiently order laboratory tests for patients, especially during the demanding increase in patient volume experienced by DVAMC.

As new evidence emerged during the pandemic, many of the laboratory orders were reviewed for clinical utility during care for the patient with COVID-19 per the latest guidance. In December 2020, the admission orders for patients with COVID-19 were revised to reflect better laboratory stewardship to reduce cost and harm. The ID section revised the laboratory orders and disseminated the new order set to admitting physicians. Specifically, the admission order set removed the following laboratory tests available for selection: routine blood cultures, interleukin 6 (IL-6) level, and Legionella sputum culture. These laboratory orders were removed based on the lack of supporting evidence in persons admitted with COVID-19.⁹ In addition to modification of the admission order set, educational sessions were held with hospitalists to disseminate knowledge of the new changes and address any concerns.

Observations of Care

This study was approved by the VANTHCS Institutional Review Board (protocol code 20-047). Records were retrospectively reviewed for patients admitted to DVAMC for COVID-19 under hospitalist care (patients admitted directly to the ICU were excluded) from October 1, 2020, to March 31, 2021. Age, sex, race and ethnicity, and comorbidities were collected from the EHR. In addition clinical measures such as maximum oxygen requirement during admission (none, nasal cannula of 2-4 L/min, high flow/bilevel positive airway pressure [BiPAP] or mechanical ventilation), proven presence of coinfection (defined as the isolation of a probable pathogen in pure culture and/or clinically determined by ID specialist evaluation), and the average LOS also were collected. For laboratory stewardship data, a retrospective chart review was conducted to determine the total number of blood cultures obtained within 24 hours of admission per month during the study period. Both IL-6 levels and Legionella sputum culture data were collected as the total number of laboratory orders per month, as it was assumed that most of these orders were obtained for patients admitted with COVID-19.

Individual patient-level data were extracted to calculate monthly percentages of ID consultations for COVID-19 by the hospitalist team, adherence to institutional guidelines for dexamethasone and remdesivir prescriptions, and empiric antibiotic prescriptions for patients with COVID-19, including use of a priori adjudication criteria to determine justified vs unjustified empiric use. These criteria included asymmetric chest X-ray infiltrates concerning for bacterial pneumonia; peripheral white blood cell count > 11 K/μL; critical respiratory failure in the emergency department (ED) and being transferred to the ICU; and ID consultation recommended. Because the total number of antibiotics was not being analyzed but rather just the use of antibiotics for the justified and unjustified groups, antibiotic days were reported as the length of therapy (LOT).¹⁰ A subset analysis was performed on antibiotic prescriptions by the hospitalist group focusing on those with mild-to-moderate oxygen requirements (no high flow, noninvasive or invasive ventilatory methods) and excluding infections with a proven microbiologic entity.

Differences in demographic and clinical characteristics of patients with COVID-19 admitted from October 1, 2020, to March 31, 2021, were assessed using ANOVA, χ², and Kruskal-Wallis test. χ² was used to compare the difference in total laboratory orders for routine blood cultures, IL-6 levels, and Legionella sputum cultures between pre-intervention (October to December 2020) and postintervention (January to March 2021). These pre- and postintervention periods were determined based on the timing of revised admission orders in the EHR and initiation of focused educational sessions starting in late December 2020 and early January 2021. Linear regressions were used to examine the possible 6-month trend of the percentage of patients receiving ID consultation for appropriate dexamethasone prescriptions, appropriate remdesivir prescriptions, appropriate antibiotic coadministration, and mean number of antibiotic days per patient. Linear and logistic regression were also used to assess the trend in LOS over the 6 months while adjusting for age, race and ethnicity, sex, and coinfections. All analyses were performed using SAS 9.4. Statistical significance was defined as P < .05.

RESULTS

From October 1, 2020, to March 31, 2021, there were 565 admissions for COVID-19, which peaked in January 2021 with 163. Analysis of the patient characteristics showed no statistically significant difference for age, sex, oxygen requirements during admission, or proven presence of coinfection between the months of interest (Table 1).

The number of blood cultures obtained in the first 24 hours of admission significantly decreased from 58.1% of admissions in October 2020 to 34.8% of admissions in March 2021 (P < .01) (Table 2).

DISCUSSION

As the COVID-19 pandemic has evolved, the ability to enact up-to-date guidance is crucial to streamlining patient care, improving time to COVID-19–specific therapies, and minimizing the burden on subspecialty consultation services. At DVAMC, we initiated a targeted and deliberate educational effort directed toward hospitalist and ED groups combined with a laboratory stewardship effort over 6 months to improve the implementation of COVID-19 therapeutics, reduce empiric antibiotic use without reliance on ID consultation services, and reduce the number of unnecessary laboratory orders for admitted patients with COVID-19. During this time, we observed modest but statistically significant improvements in the accuracy of dexamethasone and remdesivir prescribing. In addition, we observed statistically significant improvement in the average LOT per patient regarding antibiotic use and overall decreased LOS. These improvements were seen in parallel with decreasing requests for ID consultation, suggesting that they were attributable in part to increasing self-confidence and efficacy in COVID-19 practices by the hospitalist group. Modification of the COVID-19 admission order set for our facility resulted in substantial decreases in orders for blood cultures, IL-6 levels, and sputum cultures for Legionella.

ID consultation, either in person or remotely, has been instrumental in assisting physicians in COVID-19 management and has been shown to reduce morbidity, mortality, and patient LOS in other infections.^11,12 However, in scenarios where ID consultation is not available or in limited supply, accessibility, familiarity, and confidence of primary practitioners to use therapeutic guidance material are integral. Frequent and accessible guidance for the management of COVID-19 has been provided by the National Institutes of Health and the Infectious Diseases Society of America.^13,14 Other mechanisms of assisting physicians in both test ordering and therapeutics include clinical decision support tools built into the EHR and the use of a smartphone digital application.¹⁵ Guidance needs to be adapted to the context of the facility, including available resources and specific restrictions and/or prohibitions on therapeutics (eg, mandatory ID consultation or approval). In our facility, while COVID-19 therapeutic living guidance documents were maintained and accessible through the intranet, proactive dissemination and redirection were important steps in enabling the use of these documents.

Limitations

We acknowledge several limitations to this study. Most important, the correlations we observed do not represent causation. Our analysis was not designed to ascertain the direct impact of any single or combined educational and laboratory stewardship intervention from this study, and we acknowledge that the improvements in part could be related to increased experience and confidence with COVID-19 management that occurred over time independent of our programs. Furthermore, we acknowledge that several areas of COVID-19 management did not improve over time (such as overall empiric antibiotic use from the ED) or had very modest improvements (hospitalist-initiated remdesivir use). These results underscore the complex dynamics and contextual barriers to rapidly implementing guideline-based care at VANTHCS. Potential factors include insufficient reach to all physicians, variable learner motivation, and therapeutic momentum of antibiotic use carried forward from the ED.^16,17 These factors should be considered as grounds for further study. Another limitation was the inability to track viewership and engagement of our COVID-19 guidance document. Without the use metrics, it is difficult to know the individual impact of the document regarding the changing trends in COVID-19 management we observed during the study period.

Conclusions

We report improvements in COVID-19 therapeutic prescriptions and the use of antibiotics and laboratory testing over 6 months at the DVAMC. This was correlated with a deliberate COVID-19 educational initiative that included antibiotic and laboratory stewardship interventions with simultaneous decreased reliance on ID consultation. These efforts lend support to the proof of the principle of combined educational and laboratory stewardship interventions to improve the care of COVID-19 patients, especially where ID support may not be available or is accessed remotely.

Throughout the COVID-19 pandemic, health care professionals (HCPs), including emergency medicine physicians and hospitalists, have been continuously challenged to maintain an up-to-date clinical practice on COVID-19 therapeutics as new evidence emerged.^1,2 In the early part of the pandemic, these included not only appropriate and time-sensitive prescriptions of COVID-19 therapeutics, such as remdesivir and dexamethasone, but also judicious use of empiric antibiotics given the low prevalence for bacterial coinfection in early disease.^3-6 Alongside this, curbing the excessive laboratory testing of these patients during the pandemic was important not only to minimize costs but also to reduce potential iatrogenic harm and extended length of stay (LOS).⁷

At the beginning of the pandemic in March 2020 at the US Department of Veterans Affairs (VA) North Texas Health Care System (VANTHCS) Dallas VA Medical Center (DVAMC), we attempted to provide therapeutic guidance for physicians primarily through direct infectious disease (ID) consultation (in-person or electronic).⁸ This was secondarily supported by a pharmacist and ID physician–curated “living guidance” document on COVID-19 care accessible to all physicians through the DVAMC electronic health record (EHR) and intranet.

As the alpha variant (lineage B.1.1.7) of COVID-19 began spreading throughout North Texas in the winter of 2020, we implemented a targeted educational intervention toward the hospitalist group taking care of patients with COVID-19 with the primary goal of improving the accuracy of COVID-19 therapeutics while minimizing the consultative burden on ID clinical and pharmacy staff. This initiative consisted of (1) proactive guideline dissemination through email and text messages; (2) virtual didactics; and (3) physician reminders during the consultation process. Our ultimate aims were to improve hospitalist-led appropriate prescriptions of remdesivir and dexamethasone, reducing empiric antibiotic days of therapy in patients with COVID-19 at low risk of bacterial coinfection, and reducing laboratory orders that were not indicated for the management of these patients. Following this intervention and the resolution of the second wave, we retrospectively assessed the temporal trends of COVID-19 practices by hospitalists and associated patterns of ID consultation in the DVAMC from October 1, 2020, to March 31, 2021.

METHODS

The educational intervention was carried out at the DVAMC, a 1A high complex facility with more than 200 inpatient beds and part of the VANTHCS. During the study period, patients admitted with COVID-19 were located either on a closed floor (managed by the hospitalist team) or in a closed intensive care unit (ICU) (managed by the pulmonary/critical care team) contingent on the level of care or oxygen supplementation required. ID and other subspecialties provided consultation services as requested by hospitalists or ICU teams either electronically or in person. During the study period, 66 hospitalists were involved in the care of the patients: 59 (89.5%) permanent staff, 4 (6.0%) fee-basis physicians, and 3 (4.5%) moonlighting fellows.

Educational Initiative

We delivered educational sessions to the hospitalists, using collaboration software with video meeting capability every 1 to 2 months beginning in December 2020. An additional session focused on reducing empiric antibiotic prescriptions was also delivered to the emergency medicine department, based on feedback from the hospitalist group. The content for the educational sessions came from informal surveys of both ID trainees assigned to the consultation service and hospitalists, covering the following topics: understanding the stages of COVID-19 illness (virologic replication vs inflammatory) and rationales for therapy; assessing disease severity; indications and use of remdesivir; indications and use of dexamethasone; assessing for bacterial coinfections; when an ID consultation is required; management algorithm for COVID-19; and locating guidelines on the intranet. About 15 to 20 physicians participated in each session. In addition, slides of these didactics and updated institutional COVID-19 guidelines were disseminated to the hospitalist group via email and text messaging. We also linked the intranet institution guidelines in our communication, including a revised user-friendly flowchart (eAppendix).

Laboratory Stewardship Initiative

Laboratory stewardship initiatives were implemented by modifying suggested orders on the admission of patients with COVID-19 and directly educating hospitalist and emergency medicine physicians on evidence-based laboratory orders. At the beginning of the pandemic, a broad admission order set was established at DVAMC, based on the then limited knowledge of the course of infection with COVID-19. This order set allowed the admitting physicians to efficiently order laboratory tests for patients, especially during the demanding increase in patient volume experienced by DVAMC.

As new evidence emerged during the pandemic, many of the laboratory orders were reviewed for clinical utility during care for the patient with COVID-19 per the latest guidance. In December 2020, the admission orders for patients with COVID-19 were revised to reflect better laboratory stewardship to reduce cost and harm. The ID section revised the laboratory orders and disseminated the new order set to admitting physicians. Specifically, the admission order set removed the following laboratory tests available for selection: routine blood cultures, interleukin 6 (IL-6) level, and Legionella sputum culture. These laboratory orders were removed based on the lack of supporting evidence in persons admitted with COVID-19.⁹ In addition to modification of the admission order set, educational sessions were held with hospitalists to disseminate knowledge of the new changes and address any concerns.

Observations of Care

This study was approved by the VANTHCS Institutional Review Board (protocol code 20-047). Records were retrospectively reviewed for patients admitted to DVAMC for COVID-19 under hospitalist care (patients admitted directly to the ICU were excluded) from October 1, 2020, to March 31, 2021. Age, sex, race and ethnicity, and comorbidities were collected from the EHR. In addition clinical measures such as maximum oxygen requirement during admission (none, nasal cannula of 2-4 L/min, high flow/bilevel positive airway pressure [BiPAP] or mechanical ventilation), proven presence of coinfection (defined as the isolation of a probable pathogen in pure culture and/or clinically determined by ID specialist evaluation), and the average LOS also were collected. For laboratory stewardship data, a retrospective chart review was conducted to determine the total number of blood cultures obtained within 24 hours of admission per month during the study period. Both IL-6 levels and Legionella sputum culture data were collected as the total number of laboratory orders per month, as it was assumed that most of these orders were obtained for patients admitted with COVID-19.

Individual patient-level data were extracted to calculate monthly percentages of ID consultations for COVID-19 by the hospitalist team, adherence to institutional guidelines for dexamethasone and remdesivir prescriptions, and empiric antibiotic prescriptions for patients with COVID-19, including use of a priori adjudication criteria to determine justified vs unjustified empiric use. These criteria included asymmetric chest X-ray infiltrates concerning for bacterial pneumonia; peripheral white blood cell count > 11 K/μL; critical respiratory failure in the emergency department (ED) and being transferred to the ICU; and ID consultation recommended. Because the total number of antibiotics was not being analyzed but rather just the use of antibiotics for the justified and unjustified groups, antibiotic days were reported as the length of therapy (LOT).¹⁰ A subset analysis was performed on antibiotic prescriptions by the hospitalist group focusing on those with mild-to-moderate oxygen requirements (no high flow, noninvasive or invasive ventilatory methods) and excluding infections with a proven microbiologic entity.

Differences in demographic and clinical characteristics of patients with COVID-19 admitted from October 1, 2020, to March 31, 2021, were assessed using ANOVA, χ², and Kruskal-Wallis test. χ² was used to compare the difference in total laboratory orders for routine blood cultures, IL-6 levels, and Legionella sputum cultures between pre-intervention (October to December 2020) and postintervention (January to March 2021). These pre- and postintervention periods were determined based on the timing of revised admission orders in the EHR and initiation of focused educational sessions starting in late December 2020 and early January 2021. Linear regressions were used to examine the possible 6-month trend of the percentage of patients receiving ID consultation for appropriate dexamethasone prescriptions, appropriate remdesivir prescriptions, appropriate antibiotic coadministration, and mean number of antibiotic days per patient. Linear and logistic regression were also used to assess the trend in LOS over the 6 months while adjusting for age, race and ethnicity, sex, and coinfections. All analyses were performed using SAS 9.4. Statistical significance was defined as P < .05.

RESULTS

From October 1, 2020, to March 31, 2021, there were 565 admissions for COVID-19, which peaked in January 2021 with 163. Analysis of the patient characteristics showed no statistically significant difference for age, sex, oxygen requirements during admission, or proven presence of coinfection between the months of interest (Table 1).

The number of blood cultures obtained in the first 24 hours of admission significantly decreased from 58.1% of admissions in October 2020 to 34.8% of admissions in March 2021 (P < .01) (Table 2).

DISCUSSION

As the COVID-19 pandemic has evolved, the ability to enact up-to-date guidance is crucial to streamlining patient care, improving time to COVID-19–specific therapies, and minimizing the burden on subspecialty consultation services. At DVAMC, we initiated a targeted and deliberate educational effort directed toward hospitalist and ED groups combined with a laboratory stewardship effort over 6 months to improve the implementation of COVID-19 therapeutics, reduce empiric antibiotic use without reliance on ID consultation services, and reduce the number of unnecessary laboratory orders for admitted patients with COVID-19. During this time, we observed modest but statistically significant improvements in the accuracy of dexamethasone and remdesivir prescribing. In addition, we observed statistically significant improvement in the average LOT per patient regarding antibiotic use and overall decreased LOS. These improvements were seen in parallel with decreasing requests for ID consultation, suggesting that they were attributable in part to increasing self-confidence and efficacy in COVID-19 practices by the hospitalist group. Modification of the COVID-19 admission order set for our facility resulted in substantial decreases in orders for blood cultures, IL-6 levels, and sputum cultures for Legionella.

ID consultation, either in person or remotely, has been instrumental in assisting physicians in COVID-19 management and has been shown to reduce morbidity, mortality, and patient LOS in other infections.^11,12 However, in scenarios where ID consultation is not available or in limited supply, accessibility, familiarity, and confidence of primary practitioners to use therapeutic guidance material are integral. Frequent and accessible guidance for the management of COVID-19 has been provided by the National Institutes of Health and the Infectious Diseases Society of America.^13,14 Other mechanisms of assisting physicians in both test ordering and therapeutics include clinical decision support tools built into the EHR and the use of a smartphone digital application.¹⁵ Guidance needs to be adapted to the context of the facility, including available resources and specific restrictions and/or prohibitions on therapeutics (eg, mandatory ID consultation or approval). In our facility, while COVID-19 therapeutic living guidance documents were maintained and accessible through the intranet, proactive dissemination and redirection were important steps in enabling the use of these documents.

Limitations

We acknowledge several limitations to this study. Most important, the correlations we observed do not represent causation. Our analysis was not designed to ascertain the direct impact of any single or combined educational and laboratory stewardship intervention from this study, and we acknowledge that the improvements in part could be related to increased experience and confidence with COVID-19 management that occurred over time independent of our programs. Furthermore, we acknowledge that several areas of COVID-19 management did not improve over time (such as overall empiric antibiotic use from the ED) or had very modest improvements (hospitalist-initiated remdesivir use). These results underscore the complex dynamics and contextual barriers to rapidly implementing guideline-based care at VANTHCS. Potential factors include insufficient reach to all physicians, variable learner motivation, and therapeutic momentum of antibiotic use carried forward from the ED.^16,17 These factors should be considered as grounds for further study. Another limitation was the inability to track viewership and engagement of our COVID-19 guidance document. Without the use metrics, it is difficult to know the individual impact of the document regarding the changing trends in COVID-19 management we observed during the study period.

Conclusions

We report improvements in COVID-19 therapeutic prescriptions and the use of antibiotics and laboratory testing over 6 months at the DVAMC. This was correlated with a deliberate COVID-19 educational initiative that included antibiotic and laboratory stewardship interventions with simultaneous decreased reliance on ID consultation. These efforts lend support to the proof of the principle of combined educational and laboratory stewardship interventions to improve the care of COVID-19 patients, especially where ID support may not be available or is accessed remotely.