A urine drug screen (UDS) is commonly performed to evaluate illicit and prescribed drug use in patients to guide treatment decisions and ensure patient safety. Common uses include evaluating medication adherence, identifying ingested substances in cases of intoxication or overdose, ruling out substance-induced disorders, and screening for illicit drug use. There is a potential for false-positive or false-negative results due to the qualitative and nonspecific nature of UDSs.¹ These results can be verified with confirmatory testing using gas chromatography/mass spectrometry or liquid chromatography/ tandem mass spectrometry by identifying specific molecular structures and quantifying the amount of drug or substance present in the sample.¹

An April 2023 memorandum instructed all US Department of Veterans Affairs (VA) medical centers and community-based outpatient clinics (CBOC) to have fentanyl urine testing readily available.² Some facilities added fentanyl to a standard UDS, while others created a separate quick order. The memorandum led to increased fentanyl testing. As a result, unexpected positive fentanyl UDS results are more common. Some facilities have an automatic fentanyl confirmation test that is ordered after a positive fentanyl UDS. However, a positive result for fentanyl on a UDS does not automatically result in confirmation testing at all VA facilities. Without automatic confirmation testing, a clinician must decide to order a fentanyl confirmation test following the positive result. Therefore, the true rate of false-positive results for fentanyl is unknown because confirmation testing is not ordered for every positive UDS.

False-positive results can have unintended consequences, including discontinuation of prescribed medications, patient stigma, and inappropriate recommendations for substance use treatment. False-positive results may contribute to unnecessary health care costs and adversely affect patients’ lives. Previous research has reported false-positive fentanyl UDS results for patients taking risperidone, ziprasidone, and labetalol.^3-5 Studies have found that loperamide and high-concentration methamphetamine samples could cause false-positive fentanyl UDS results.^6,7 Wang et al evaluated the performance of the SEFRIA fentanyl immunoassay using the 1 ng/mL cutoff cleared by the US Food and Drug Administration (FDA). The study of 410 patients found a 38% false-positive rate; concomitant use of trazodone, labetalol, and haloperidol accounted for 230 (56%) of the false-positive results.⁸ Limited data evaluating false-positive results for the current SEFRIA fentanyl testing assay suggest the need for additional research. This study aims to add to data on false-positive results for fentanyl on UDS samples and potential causes.

Methods

A retrospective, multicenter observational cohort study was conducted that included patients at 3 VA MidSouth Healthcare Network VA medical centers located in Tennessee with their associated CBOCs from August 1, 2023, to August 1, 2024 who had positive fentanyl UDS results. The primary outcome was the rate of false-positive fentanyl UDS results when confirmation testing was performed. Secondary outcomes included the rate of confirmation testing, prescribed medications used by patients with false-positive UDS results, and the rate of follow-up in the electronic health record (EHR) on results of confirmation testing. Confirmations were primarily obtained for positive results and not all UDSs. Therefore, it was not possible in this retrospective study to obtain the true measure of false-negative or true-negative results.

A structured query language query was performed to identify patients with a UDS positive for fentanyl from August 1, 2023, to August 1, 2024. Patients were enrolled if they were aged ≥ 18 years with a UDS positive for fentanyl. Patients were excluded from the primary outcome analysis if results for the confirmatory testing were unquantifiable or could not be found.

Study Intervention

This was a descriptive study with no comparator group. The rate of confirmed false-positive results for fentanyl, rate of confirmation testing for patients with positive fentanyl UDS results, rate of follow-up on confirmation results, and prescribed medications in patients with false-positive fentanyl results were evaluated. For true-positive results, follow-up was defined as documentation in the EHR reporting fentanyl use or illicit substance use likely to be laced with fentanyl at the time of the UDS or documentation of the confirmation result. For false-positive results, follow-up was defined as documentation in the EHR of the confirmation result.

Statistical Analysis

Descriptive statistics including means and percentages were used to analyze demographic data. Continuous variables and parametric data are presented as mean (SD) and nominal data as percentages. All statistical analyses were completed using Excel. The SEFRIA fentanyl immunoassay was used at each study site. Facilities 1 and 2 were combined for the primary outcome analysis because they used the same fentanyl immunoassay cutoff level of 1 ng/mL. Facility 3 used a cutoff level of 2 ng/mL and was analyzed separately.

Results

A total of 1228 UDS tests were positive for fentanyl, including 618 at facility 1, 308 at facility 2, and 302 at facility 3 (Figure 1). Patients were predominantly male and White, with a mean age of 55 years, though age and race varied by location (Table 1). Patients may have had ≥ 1 UDS. Of 1228 UDSs recorded in the EHR, 578 were sent for confirmation testing and 546 had confirmation results available in the EHR (84 at facility 1, 271 at facility 2, and 191 at facility 3). Of 546 confirmation tests, 186 were negative for fentanyl, indicating a false-positive rate of 34.1%. Most confirmation tests (43%) were requested for patients seen in a mental health clinic.

The combined false-positive rate was 49.9% for 355 UDS confirmation results at facilities 1 and 2 (70.2% and 43.5%, respectively) and 4.7% for 191 UDS confirmation results at facility 3, which used the higher 2 ng/mL cutoff level (Figure 2). Confirmation testing was ordered for 578 tests (47.1%). There were 87 confirmation tests (14.1%) at facility 1, 277 tests (89.9%) at facility 2, and 214 (70.9%) at facility 3 (Figure 3). Follow-up after confirmation tests was completed for 406 patients (74.4%): 56 follow-ups (66.7%) at facility 1, 190 follow-ups (70.1%) at facility 2, and 160 follow-ups (83.8%) at facility 3 (Figure 4). Trazodone was the most commonly prescribed medication for patients with false-positive fentanyl UDS results. Trazodone was prescribed to 153 patients (82,3%), followed by 116 patients (62.4%) prescribed naloxone, 86 patients (46.2%) prescribed or with reported use of acetaminophen, 72 patients (38.7%) prescribed nicotine replacement products, and 64 patients (34.4%) prescribed omeprazole (Table 2).

Discussion

There are several factors to note when interpreting the study results. First, facilities 1 and 2 used the FDA-cleared 1 ng/mL cutoff for positive results on the SEFRIA fentanyl immunoassay, whereas facility 3 used a cutoff level of 2 ng/mL. Second, during the study period, facilities 1 and 3 included fentanyl as part of their standard UDS; facility 2 required a separate fentanyl UDS order. Third, facility 2 had automatic confirmation testing for positive results on individually ordered fentanyl UDS tests. Finally, confirmation tests were primarily obtained for positive fentanyl results and not all UDSs, which limited the analyses that could be performed.

This study found a high rate of false-positive fentanyl UDS results at facilities 1 and 2 and a very low rate at facility 3, likely due to the higher cutoff level. Facility 3 used the higher cutoff level due to previously observed high rates of false-positive results. While a higher cutoff level can decrease the rate of false-positive results, it also may increase the rate of false-negative results.

Studies have found false-positive rates ranging from 3% to 45% with the SEFRIA immunoassay FDA-cleared 1 ng/mL cutoff. Increasing the cutoff to 1.3 ng/mL decreased the false-positive rate from 38% to 7.5% in a study by Wang et al.^8-11 Manar et al evaluated fentanyl assays in 42 samples using a 2 ng/mL cutoff for the SEFRIA assay and reported a false-positive rate of 0 and a false-negative rate of 22.5%.¹² Given the high rate of false-positive rates demonstrated in studies using the current FDA-recommended 1 ng/mL cutoff, additional studies evaluating different cutoff levels may be beneficial to determine the best cutoff level to reduce false-positive results without significantly increasing false-negative rates. While data on the impact of using a higher cutoff level are limited, the results of our study have led to discussions at VA MidSouth Healthcare Network facilities regarding use of different cutoff levels.

There was a low rate of confirmation testing at facility 1 compared with facilities 2 and 3. Only facility 2 had automatic confirmation testing during the study period. Pharmacists at facility 3 reviewed UDS results without needing a consultation and, during the study period, could order fentanyl UDS confirmations. Another factor that may have contributed to the disparity in confirmation testing between facilities is the location of the UDS order. Most UDS samples at facilities 2 and 3 were ordered for patients seen in mental health clinics, whereas many facility 1 orders were placed in primary care or the emergency department (ED).

Given these results, education may be indicated regarding the risk of false-positive results and the importance of confirmation testing in primary care and the ED. Facility 1 and 3 did not have automatic fentanyl confirmation testing during the study; however, facility 3 implemented automatic confirmation shortly after the study period and facility 1 implemented automatic confirmation testing for a positive fentanyl UDS result after evaluation of the study data.

Although follow-up on confirmation UDS results was fairly high, it was highest at facility 3, which does not require a consultation for pharmacist UDS result evaluations. Given the high rate of false-positive results for fentanyl, confirmation testing for a positive UDS and follow-up on confirmation results is an important step to consider. The higher rate of follow-up at the facility where pharmacists had more autonomous involvement shows the benefits of having pharmacists provide comprehensive patient care. Implementing similar protocols across all facilities may improve follow-up, which may improve patient care and safety given the implications of false-positive results.

Trazodone was prescribed in 82.3% of all patients with false-positive fentanyl tests. Even at facility 3, with the higher fentanyl immunoassay cutoff level, trazodone was prescribed in 77.8% of patients with false-positive results. While this retrospective study does not show causation, it does align with the findings reported by Wang et al, adding to the data implicating trazodone as a potential cause for false-positive fentanyl UDS results. The high incidence of trazodone prescriptions in patients with false-positive UDS results at facility 3 strengthens this association, indicating that even when using a higher cutoff level, trazodone may be implicated.

While there was a high rate of confirmed false-positive results in this study, there was also a potential for undetected true-positive results. The SEFRIA fentanyl immunoassay is sensitive to multiple fentanyl analogues. Williams et al showed that the SEFRIA immunoassay detected 57 of 58 fentanyl analogues tested; norsufentanil was the only analogue it did not detect.¹³ Most of the confirmatory tests reviewed during this study did not include all fentanyl analogues, only fentanyl and norfentanyl. Given the increased prevalence of synthetic fentanyl analogues, this is an important consideration because some identified false-positive results could potentially be undetected true-positive results for a fentanyl analogue. Switching to a more comprehensive confirmation test that includes more fentanyl analogues may reduce the risk of undetected positive results and, therefore, reduce the observed rate of false-positive UDS results.

Strengths and Limitations

Patient medications were only identified if they were documented in the EHR at the time of UDS results, which could have missed over-the-counter medications or medications prescribed outside the VA; this limits identification and implication of medications as possibly contributing to false-positive results. Only samples sent for confirmation were evaluated for true- or false-positive results; therefore, the true rate of false-positive results could not be determined. UDS confirmation tests only analyzed for fentanyl and norfentanyl, which left the potential for undetected true-positive results for other fentanyl analogues. Use of EHR data for the analysis leaves the potential for documentation errors and undetected bias.

This study adds to limited data on false-positive results for fentanyl on UDS samples. It included a large sample size of patients across multiple sites. Additionally, it included results using multiple cutoff levels on the SEFRIA fentanyl immunoassay, adding to limited data in this area.

Conclusions

This retrospective study found evidence that automatic confirmation testing should be considered for positive fentanyl UDS tests due to the high rate of false-positive results. Facility 1 began automatic confirmation testing due to the findings of this study. Facilities should consider switching to a more comprehensive confirmation test that includes more fentanyl analogues to reduce the risk of undetected true-positive results. This study also adds to the data implicating trazodone in fentanyl UDS false-positive results due to high incidence of trazodone prescriptions among patients in the study with false-positive UDS results. Future considerations include investigating different cutoff levels for the SEFRIA fentanyl immunoassay to reduce false-positive results as data are currently limited.

A urine drug screen (UDS) is commonly performed to evaluate illicit and prescribed drug use in patients to guide treatment decisions and ensure patient safety. Common uses include evaluating medication adherence, identifying ingested substances in cases of intoxication or overdose, ruling out substance-induced disorders, and screening for illicit drug use. There is a potential for false-positive or false-negative results due to the qualitative and nonspecific nature of UDSs.¹ These results can be verified with confirmatory testing using gas chromatography/mass spectrometry or liquid chromatography/ tandem mass spectrometry by identifying specific molecular structures and quantifying the amount of drug or substance present in the sample.¹

An April 2023 memorandum instructed all US Department of Veterans Affairs (VA) medical centers and community-based outpatient clinics (CBOC) to have fentanyl urine testing readily available.² Some facilities added fentanyl to a standard UDS, while others created a separate quick order. The memorandum led to increased fentanyl testing. As a result, unexpected positive fentanyl UDS results are more common. Some facilities have an automatic fentanyl confirmation test that is ordered after a positive fentanyl UDS. However, a positive result for fentanyl on a UDS does not automatically result in confirmation testing at all VA facilities. Without automatic confirmation testing, a clinician must decide to order a fentanyl confirmation test following the positive result. Therefore, the true rate of false-positive results for fentanyl is unknown because confirmation testing is not ordered for every positive UDS.

False-positive results can have unintended consequences, including discontinuation of prescribed medications, patient stigma, and inappropriate recommendations for substance use treatment. False-positive results may contribute to unnecessary health care costs and adversely affect patients’ lives. Previous research has reported false-positive fentanyl UDS results for patients taking risperidone, ziprasidone, and labetalol.^3-5 Studies have found that loperamide and high-concentration methamphetamine samples could cause false-positive fentanyl UDS results.^6,7 Wang et al evaluated the performance of the SEFRIA fentanyl immunoassay using the 1 ng/mL cutoff cleared by the US Food and Drug Administration (FDA). The study of 410 patients found a 38% false-positive rate; concomitant use of trazodone, labetalol, and haloperidol accounted for 230 (56%) of the false-positive results.⁸ Limited data evaluating false-positive results for the current SEFRIA fentanyl testing assay suggest the need for additional research. This study aims to add to data on false-positive results for fentanyl on UDS samples and potential causes.

Methods

A retrospective, multicenter observational cohort study was conducted that included patients at 3 VA MidSouth Healthcare Network VA medical centers located in Tennessee with their associated CBOCs from August 1, 2023, to August 1, 2024 who had positive fentanyl UDS results. The primary outcome was the rate of false-positive fentanyl UDS results when confirmation testing was performed. Secondary outcomes included the rate of confirmation testing, prescribed medications used by patients with false-positive UDS results, and the rate of follow-up in the electronic health record (EHR) on results of confirmation testing. Confirmations were primarily obtained for positive results and not all UDSs. Therefore, it was not possible in this retrospective study to obtain the true measure of false-negative or true-negative results.

A structured query language query was performed to identify patients with a UDS positive for fentanyl from August 1, 2023, to August 1, 2024. Patients were enrolled if they were aged ≥ 18 years with a UDS positive for fentanyl. Patients were excluded from the primary outcome analysis if results for the confirmatory testing were unquantifiable or could not be found.

Study Intervention

This was a descriptive study with no comparator group. The rate of confirmed false-positive results for fentanyl, rate of confirmation testing for patients with positive fentanyl UDS results, rate of follow-up on confirmation results, and prescribed medications in patients with false-positive fentanyl results were evaluated. For true-positive results, follow-up was defined as documentation in the EHR reporting fentanyl use or illicit substance use likely to be laced with fentanyl at the time of the UDS or documentation of the confirmation result. For false-positive results, follow-up was defined as documentation in the EHR of the confirmation result.

Statistical Analysis

Descriptive statistics including means and percentages were used to analyze demographic data. Continuous variables and parametric data are presented as mean (SD) and nominal data as percentages. All statistical analyses were completed using Excel. The SEFRIA fentanyl immunoassay was used at each study site. Facilities 1 and 2 were combined for the primary outcome analysis because they used the same fentanyl immunoassay cutoff level of 1 ng/mL. Facility 3 used a cutoff level of 2 ng/mL and was analyzed separately.

Results

A total of 1228 UDS tests were positive for fentanyl, including 618 at facility 1, 308 at facility 2, and 302 at facility 3 (Figure 1). Patients were predominantly male and White, with a mean age of 55 years, though age and race varied by location (Table 1). Patients may have had ≥ 1 UDS. Of 1228 UDSs recorded in the EHR, 578 were sent for confirmation testing and 546 had confirmation results available in the EHR (84 at facility 1, 271 at facility 2, and 191 at facility 3). Of 546 confirmation tests, 186 were negative for fentanyl, indicating a false-positive rate of 34.1%. Most confirmation tests (43%) were requested for patients seen in a mental health clinic.

The combined false-positive rate was 49.9% for 355 UDS confirmation results at facilities 1 and 2 (70.2% and 43.5%, respectively) and 4.7% for 191 UDS confirmation results at facility 3, which used the higher 2 ng/mL cutoff level (Figure 2). Confirmation testing was ordered for 578 tests (47.1%). There were 87 confirmation tests (14.1%) at facility 1, 277 tests (89.9%) at facility 2, and 214 (70.9%) at facility 3 (Figure 3). Follow-up after confirmation tests was completed for 406 patients (74.4%): 56 follow-ups (66.7%) at facility 1, 190 follow-ups (70.1%) at facility 2, and 160 follow-ups (83.8%) at facility 3 (Figure 4). Trazodone was the most commonly prescribed medication for patients with false-positive fentanyl UDS results. Trazodone was prescribed to 153 patients (82,3%), followed by 116 patients (62.4%) prescribed naloxone, 86 patients (46.2%) prescribed or with reported use of acetaminophen, 72 patients (38.7%) prescribed nicotine replacement products, and 64 patients (34.4%) prescribed omeprazole (Table 2).

Discussion

There are several factors to note when interpreting the study results. First, facilities 1 and 2 used the FDA-cleared 1 ng/mL cutoff for positive results on the SEFRIA fentanyl immunoassay, whereas facility 3 used a cutoff level of 2 ng/mL. Second, during the study period, facilities 1 and 3 included fentanyl as part of their standard UDS; facility 2 required a separate fentanyl UDS order. Third, facility 2 had automatic confirmation testing for positive results on individually ordered fentanyl UDS tests. Finally, confirmation tests were primarily obtained for positive fentanyl results and not all UDSs, which limited the analyses that could be performed.

This study found a high rate of false-positive fentanyl UDS results at facilities 1 and 2 and a very low rate at facility 3, likely due to the higher cutoff level. Facility 3 used the higher cutoff level due to previously observed high rates of false-positive results. While a higher cutoff level can decrease the rate of false-positive results, it also may increase the rate of false-negative results.

Studies have found false-positive rates ranging from 3% to 45% with the SEFRIA immunoassay FDA-cleared 1 ng/mL cutoff. Increasing the cutoff to 1.3 ng/mL decreased the false-positive rate from 38% to 7.5% in a study by Wang et al.^8-11 Manar et al evaluated fentanyl assays in 42 samples using a 2 ng/mL cutoff for the SEFRIA assay and reported a false-positive rate of 0 and a false-negative rate of 22.5%.¹² Given the high rate of false-positive rates demonstrated in studies using the current FDA-recommended 1 ng/mL cutoff, additional studies evaluating different cutoff levels may be beneficial to determine the best cutoff level to reduce false-positive results without significantly increasing false-negative rates. While data on the impact of using a higher cutoff level are limited, the results of our study have led to discussions at VA MidSouth Healthcare Network facilities regarding use of different cutoff levels.

There was a low rate of confirmation testing at facility 1 compared with facilities 2 and 3. Only facility 2 had automatic confirmation testing during the study period. Pharmacists at facility 3 reviewed UDS results without needing a consultation and, during the study period, could order fentanyl UDS confirmations. Another factor that may have contributed to the disparity in confirmation testing between facilities is the location of the UDS order. Most UDS samples at facilities 2 and 3 were ordered for patients seen in mental health clinics, whereas many facility 1 orders were placed in primary care or the emergency department (ED).

Given these results, education may be indicated regarding the risk of false-positive results and the importance of confirmation testing in primary care and the ED. Facility 1 and 3 did not have automatic fentanyl confirmation testing during the study; however, facility 3 implemented automatic confirmation shortly after the study period and facility 1 implemented automatic confirmation testing for a positive fentanyl UDS result after evaluation of the study data.

Although follow-up on confirmation UDS results was fairly high, it was highest at facility 3, which does not require a consultation for pharmacist UDS result evaluations. Given the high rate of false-positive results for fentanyl, confirmation testing for a positive UDS and follow-up on confirmation results is an important step to consider. The higher rate of follow-up at the facility where pharmacists had more autonomous involvement shows the benefits of having pharmacists provide comprehensive patient care. Implementing similar protocols across all facilities may improve follow-up, which may improve patient care and safety given the implications of false-positive results.

Trazodone was prescribed in 82.3% of all patients with false-positive fentanyl tests. Even at facility 3, with the higher fentanyl immunoassay cutoff level, trazodone was prescribed in 77.8% of patients with false-positive results. While this retrospective study does not show causation, it does align with the findings reported by Wang et al, adding to the data implicating trazodone as a potential cause for false-positive fentanyl UDS results. The high incidence of trazodone prescriptions in patients with false-positive UDS results at facility 3 strengthens this association, indicating that even when using a higher cutoff level, trazodone may be implicated.

While there was a high rate of confirmed false-positive results in this study, there was also a potential for undetected true-positive results. The SEFRIA fentanyl immunoassay is sensitive to multiple fentanyl analogues. Williams et al showed that the SEFRIA immunoassay detected 57 of 58 fentanyl analogues tested; norsufentanil was the only analogue it did not detect.¹³ Most of the confirmatory tests reviewed during this study did not include all fentanyl analogues, only fentanyl and norfentanyl. Given the increased prevalence of synthetic fentanyl analogues, this is an important consideration because some identified false-positive results could potentially be undetected true-positive results for a fentanyl analogue. Switching to a more comprehensive confirmation test that includes more fentanyl analogues may reduce the risk of undetected positive results and, therefore, reduce the observed rate of false-positive UDS results.

Strengths and Limitations

Patient medications were only identified if they were documented in the EHR at the time of UDS results, which could have missed over-the-counter medications or medications prescribed outside the VA; this limits identification and implication of medications as possibly contributing to false-positive results. Only samples sent for confirmation were evaluated for true- or false-positive results; therefore, the true rate of false-positive results could not be determined. UDS confirmation tests only analyzed for fentanyl and norfentanyl, which left the potential for undetected true-positive results for other fentanyl analogues. Use of EHR data for the analysis leaves the potential for documentation errors and undetected bias.

This study adds to limited data on false-positive results for fentanyl on UDS samples. It included a large sample size of patients across multiple sites. Additionally, it included results using multiple cutoff levels on the SEFRIA fentanyl immunoassay, adding to limited data in this area.

Conclusions

This retrospective study found evidence that automatic confirmation testing should be considered for positive fentanyl UDS tests due to the high rate of false-positive results. Facility 1 began automatic confirmation testing due to the findings of this study. Facilities should consider switching to a more comprehensive confirmation test that includes more fentanyl analogues to reduce the risk of undetected true-positive results. This study also adds to the data implicating trazodone in fentanyl UDS false-positive results due to high incidence of trazodone prescriptions among patients in the study with false-positive UDS results. Future considerations include investigating different cutoff levels for the SEFRIA fentanyl immunoassay to reduce false-positive results as data are currently limited.

A urine drug screen (UDS) is commonly performed to evaluate illicit and prescribed drug use in patients to guide treatment decisions and ensure patient safety. Common uses include evaluating medication adherence, identifying ingested substances in cases of intoxication or overdose, ruling out substance-induced disorders, and screening for illicit drug use. There is a potential for false-positive or false-negative results due to the qualitative and nonspecific nature of UDSs.¹ These results can be verified with confirmatory testing using gas chromatography/mass spectrometry or liquid chromatography/ tandem mass spectrometry by identifying specific molecular structures and quantifying the amount of drug or substance present in the sample.¹

An April 2023 memorandum instructed all US Department of Veterans Affairs (VA) medical centers and community-based outpatient clinics (CBOC) to have fentanyl urine testing readily available.² Some facilities added fentanyl to a standard UDS, while others created a separate quick order. The memorandum led to increased fentanyl testing. As a result, unexpected positive fentanyl UDS results are more common. Some facilities have an automatic fentanyl confirmation test that is ordered after a positive fentanyl UDS. However, a positive result for fentanyl on a UDS does not automatically result in confirmation testing at all VA facilities. Without automatic confirmation testing, a clinician must decide to order a fentanyl confirmation test following the positive result. Therefore, the true rate of false-positive results for fentanyl is unknown because confirmation testing is not ordered for every positive UDS.

False-positive results can have unintended consequences, including discontinuation of prescribed medications, patient stigma, and inappropriate recommendations for substance use treatment. False-positive results may contribute to unnecessary health care costs and adversely affect patients’ lives. Previous research has reported false-positive fentanyl UDS results for patients taking risperidone, ziprasidone, and labetalol.^3-5 Studies have found that loperamide and high-concentration methamphetamine samples could cause false-positive fentanyl UDS results.^6,7 Wang et al evaluated the performance of the SEFRIA fentanyl immunoassay using the 1 ng/mL cutoff cleared by the US Food and Drug Administration (FDA). The study of 410 patients found a 38% false-positive rate; concomitant use of trazodone, labetalol, and haloperidol accounted for 230 (56%) of the false-positive results.⁸ Limited data evaluating false-positive results for the current SEFRIA fentanyl testing assay suggest the need for additional research. This study aims to add to data on false-positive results for fentanyl on UDS samples and potential causes.

Methods

A retrospective, multicenter observational cohort study was conducted that included patients at 3 VA MidSouth Healthcare Network VA medical centers located in Tennessee with their associated CBOCs from August 1, 2023, to August 1, 2024 who had positive fentanyl UDS results. The primary outcome was the rate of false-positive fentanyl UDS results when confirmation testing was performed. Secondary outcomes included the rate of confirmation testing, prescribed medications used by patients with false-positive UDS results, and the rate of follow-up in the electronic health record (EHR) on results of confirmation testing. Confirmations were primarily obtained for positive results and not all UDSs. Therefore, it was not possible in this retrospective study to obtain the true measure of false-negative or true-negative results.

A structured query language query was performed to identify patients with a UDS positive for fentanyl from August 1, 2023, to August 1, 2024. Patients were enrolled if they were aged ≥ 18 years with a UDS positive for fentanyl. Patients were excluded from the primary outcome analysis if results for the confirmatory testing were unquantifiable or could not be found.

Study Intervention

This was a descriptive study with no comparator group. The rate of confirmed false-positive results for fentanyl, rate of confirmation testing for patients with positive fentanyl UDS results, rate of follow-up on confirmation results, and prescribed medications in patients with false-positive fentanyl results were evaluated. For true-positive results, follow-up was defined as documentation in the EHR reporting fentanyl use or illicit substance use likely to be laced with fentanyl at the time of the UDS or documentation of the confirmation result. For false-positive results, follow-up was defined as documentation in the EHR of the confirmation result.

Statistical Analysis

Descriptive statistics including means and percentages were used to analyze demographic data. Continuous variables and parametric data are presented as mean (SD) and nominal data as percentages. All statistical analyses were completed using Excel. The SEFRIA fentanyl immunoassay was used at each study site. Facilities 1 and 2 were combined for the primary outcome analysis because they used the same fentanyl immunoassay cutoff level of 1 ng/mL. Facility 3 used a cutoff level of 2 ng/mL and was analyzed separately.

Results

A total of 1228 UDS tests were positive for fentanyl, including 618 at facility 1, 308 at facility 2, and 302 at facility 3 (Figure 1). Patients were predominantly male and White, with a mean age of 55 years, though age and race varied by location (Table 1). Patients may have had ≥ 1 UDS. Of 1228 UDSs recorded in the EHR, 578 were sent for confirmation testing and 546 had confirmation results available in the EHR (84 at facility 1, 271 at facility 2, and 191 at facility 3). Of 546 confirmation tests, 186 were negative for fentanyl, indicating a false-positive rate of 34.1%. Most confirmation tests (43%) were requested for patients seen in a mental health clinic.

The combined false-positive rate was 49.9% for 355 UDS confirmation results at facilities 1 and 2 (70.2% and 43.5%, respectively) and 4.7% for 191 UDS confirmation results at facility 3, which used the higher 2 ng/mL cutoff level (Figure 2). Confirmation testing was ordered for 578 tests (47.1%). There were 87 confirmation tests (14.1%) at facility 1, 277 tests (89.9%) at facility 2, and 214 (70.9%) at facility 3 (Figure 3). Follow-up after confirmation tests was completed for 406 patients (74.4%): 56 follow-ups (66.7%) at facility 1, 190 follow-ups (70.1%) at facility 2, and 160 follow-ups (83.8%) at facility 3 (Figure 4). Trazodone was the most commonly prescribed medication for patients with false-positive fentanyl UDS results. Trazodone was prescribed to 153 patients (82,3%), followed by 116 patients (62.4%) prescribed naloxone, 86 patients (46.2%) prescribed or with reported use of acetaminophen, 72 patients (38.7%) prescribed nicotine replacement products, and 64 patients (34.4%) prescribed omeprazole (Table 2).

Discussion

There are several factors to note when interpreting the study results. First, facilities 1 and 2 used the FDA-cleared 1 ng/mL cutoff for positive results on the SEFRIA fentanyl immunoassay, whereas facility 3 used a cutoff level of 2 ng/mL. Second, during the study period, facilities 1 and 3 included fentanyl as part of their standard UDS; facility 2 required a separate fentanyl UDS order. Third, facility 2 had automatic confirmation testing for positive results on individually ordered fentanyl UDS tests. Finally, confirmation tests were primarily obtained for positive fentanyl results and not all UDSs, which limited the analyses that could be performed.

This study found a high rate of false-positive fentanyl UDS results at facilities 1 and 2 and a very low rate at facility 3, likely due to the higher cutoff level. Facility 3 used the higher cutoff level due to previously observed high rates of false-positive results. While a higher cutoff level can decrease the rate of false-positive results, it also may increase the rate of false-negative results.

Studies have found false-positive rates ranging from 3% to 45% with the SEFRIA immunoassay FDA-cleared 1 ng/mL cutoff. Increasing the cutoff to 1.3 ng/mL decreased the false-positive rate from 38% to 7.5% in a study by Wang et al.^8-11 Manar et al evaluated fentanyl assays in 42 samples using a 2 ng/mL cutoff for the SEFRIA assay and reported a false-positive rate of 0 and a false-negative rate of 22.5%.¹² Given the high rate of false-positive rates demonstrated in studies using the current FDA-recommended 1 ng/mL cutoff, additional studies evaluating different cutoff levels may be beneficial to determine the best cutoff level to reduce false-positive results without significantly increasing false-negative rates. While data on the impact of using a higher cutoff level are limited, the results of our study have led to discussions at VA MidSouth Healthcare Network facilities regarding use of different cutoff levels.

There was a low rate of confirmation testing at facility 1 compared with facilities 2 and 3. Only facility 2 had automatic confirmation testing during the study period. Pharmacists at facility 3 reviewed UDS results without needing a consultation and, during the study period, could order fentanyl UDS confirmations. Another factor that may have contributed to the disparity in confirmation testing between facilities is the location of the UDS order. Most UDS samples at facilities 2 and 3 were ordered for patients seen in mental health clinics, whereas many facility 1 orders were placed in primary care or the emergency department (ED).

Given these results, education may be indicated regarding the risk of false-positive results and the importance of confirmation testing in primary care and the ED. Facility 1 and 3 did not have automatic fentanyl confirmation testing during the study; however, facility 3 implemented automatic confirmation shortly after the study period and facility 1 implemented automatic confirmation testing for a positive fentanyl UDS result after evaluation of the study data.

Although follow-up on confirmation UDS results was fairly high, it was highest at facility 3, which does not require a consultation for pharmacist UDS result evaluations. Given the high rate of false-positive results for fentanyl, confirmation testing for a positive UDS and follow-up on confirmation results is an important step to consider. The higher rate of follow-up at the facility where pharmacists had more autonomous involvement shows the benefits of having pharmacists provide comprehensive patient care. Implementing similar protocols across all facilities may improve follow-up, which may improve patient care and safety given the implications of false-positive results.

Trazodone was prescribed in 82.3% of all patients with false-positive fentanyl tests. Even at facility 3, with the higher fentanyl immunoassay cutoff level, trazodone was prescribed in 77.8% of patients with false-positive results. While this retrospective study does not show causation, it does align with the findings reported by Wang et al, adding to the data implicating trazodone as a potential cause for false-positive fentanyl UDS results. The high incidence of trazodone prescriptions in patients with false-positive UDS results at facility 3 strengthens this association, indicating that even when using a higher cutoff level, trazodone may be implicated.

While there was a high rate of confirmed false-positive results in this study, there was also a potential for undetected true-positive results. The SEFRIA fentanyl immunoassay is sensitive to multiple fentanyl analogues. Williams et al showed that the SEFRIA immunoassay detected 57 of 58 fentanyl analogues tested; norsufentanil was the only analogue it did not detect.¹³ Most of the confirmatory tests reviewed during this study did not include all fentanyl analogues, only fentanyl and norfentanyl. Given the increased prevalence of synthetic fentanyl analogues, this is an important consideration because some identified false-positive results could potentially be undetected true-positive results for a fentanyl analogue. Switching to a more comprehensive confirmation test that includes more fentanyl analogues may reduce the risk of undetected positive results and, therefore, reduce the observed rate of false-positive UDS results.

Strengths and Limitations

Patient medications were only identified if they were documented in the EHR at the time of UDS results, which could have missed over-the-counter medications or medications prescribed outside the VA; this limits identification and implication of medications as possibly contributing to false-positive results. Only samples sent for confirmation were evaluated for true- or false-positive results; therefore, the true rate of false-positive results could not be determined. UDS confirmation tests only analyzed for fentanyl and norfentanyl, which left the potential for undetected true-positive results for other fentanyl analogues. Use of EHR data for the analysis leaves the potential for documentation errors and undetected bias.

This study adds to limited data on false-positive results for fentanyl on UDS samples. It included a large sample size of patients across multiple sites. Additionally, it included results using multiple cutoff levels on the SEFRIA fentanyl immunoassay, adding to limited data in this area.

Conclusions

This retrospective study found evidence that automatic confirmation testing should be considered for positive fentanyl UDS tests due to the high rate of false-positive results. Facility 1 began automatic confirmation testing due to the findings of this study. Facilities should consider switching to a more comprehensive confirmation test that includes more fentanyl analogues to reduce the risk of undetected true-positive results. This study also adds to the data implicating trazodone in fentanyl UDS false-positive results due to high incidence of trazodone prescriptions among patients in the study with false-positive UDS results. Future considerations include investigating different cutoff levels for the SEFRIA fentanyl immunoassay to reduce false-positive results as data are currently limited.

The US Department of Veterans Affairs (VA) mission realizes President Abraham Lincoln’s promise to “to care for him who shall have borne the battle, and for his widow, and his orphan.”¹ Evidence-based care fulfills this promise and is the backbone of Veterans Health Administration (VHA) mental health care.^2,3 To ensure veterans receive state-of-the-art clinical care, a skilled workforce and investment in data-driven approaches are necessary to identify best treatments and strategies to implement them in practice.

Through scientific and clinical training tailored to VA, the 23 VA Advanced Fellowships have secured a steady flow of highly trained PhD professionals (ie, psychologists and other allied health professionals), and medical doctors (ie, psychiatrists and neurologists) into the VA workforce.⁴ The VA Advanced Fellows are funded by the Office of Academic Affiliations (OAA) and offer 2-year training opportunities for postresidency MDs and postdoctoral PhDs. This article describes a VA Advanced Fellowship in mental health as an example of how these programs can have a broad and positive impact on the VA health care system.

Advanced Fellows Program

The VA Advanced Fellowship in Mental Illness Research and Treatment (AF MIRT), formerly known as the VA Special Fellowship Program in Advanced Psychiatry and Psychology, educates and trains clinician and nonclinician researchers to meet VA priority mental health care needs.⁵ Clinical AF MIRT fellows dedicate 75% of their time to training and research activities and 25% to direct clinical services. Data science fellows complete projects that inform veteran clinical care through qualitative data collection, program evaluation, and analysis of large datasets. The full translational pathway to evidence-based clinical care is represented by fellow research spanning basic animal models, genetics, and neuroimaging to implementation science and applied clinical care for veterans.

In 2025, AF MIRT marked its 25th year of training postdoctoral-level mental health scientific practitioners and scholars. This investment in clinical research training has had profound benefits for innovation and retention of clinicians and scientists within the VA system. As of April 1, 2026, AF MIRT trained 700 fellows, including 152 MD or MD/PhD fellows, 544 PhD or PsyD fellows, 3 PharmDs fellows, and 1 doctor of nursing practice fellow.

Fellowship Structure

The AF MIRT coordinating center provides key administrative support to fellowship site directors and topical didactic training to Advanced Fellows, ensuring consistent standard of quality training across locations in 15 states and 4 times zones. The training provided by the AF MIRT coordinating center deepens the nationally-mandated focus of local translational clinical centers (eg, Mental Illness Research Education and Clinical Centers, Centers of Excellence) on posttraumatic stress disorder (PTSD), serious mental illness, dementia, and other areas.

The AF MIRT coordinating center also promotes VA workforce sustainability. Advanced Fellows in programs with a coordinating center are much more likely to be retained in VA for postfellowship employment compared with fellows in programs without such a coordinating center (60% vs 38%) according to unpublished Office of Academic Affiliations data (Joel Schmidt, oral communication, May 15, 2025). The AF MIRT coordinating center provides central standardization and uses evidence-based approaches to ensure fellows receive consistent support, resources, and training. More specifically, the coordinating center develops and delivers a standardized, core curriculum to the program’s 28 sites. The program pioneered video delivery of integrated didactics that enlist national experts, many of them VA researchers and clinicians themselves. Didactics include high priority veteran mental health topics, such as suicide prevention, new and emerging evidence-based treatments (eg, neurostimulation for treatment resistant PTSD, psychotherapeutic approaches for traumatic brain injury), and VA health system considerations for mental health treatment delivery.

This curated didactic series also covers professional and technical issues, such as statistical and methodological considerations for clinical trials, scientific writing, and grant-writing skill development. These offerings support the career pathways of advanced fellows to pursue careers as researchers, scientifically-informed clinicians, or data scientists at VA or academic medical centers. The coordinating center prepares fellows to apply for mentored career award funding or independent investigator awards through the VA, National Institutes of Health (NIH), US Department of Defense, and other organizations by offering an annual mock grant review session and monthly reviews and discussions of fellows’ grant applications.

AF MIRT continuously fine tunes the didactic series curriculum based on feedback from fellows on how the program meets their training needs. For example, learning about the strategies Advanced Fellows used to remain productive during COVID-19 pandemic lockdowns revealed a strong trend toward use of secondary data (eg, publicly available data or VA electronic health record data). This fueled curriculum adjustments to include more topics relevant to fellow interests and needs for accessing secondary data resources for high priority veteran mental health topics.⁶

VA Advanced Fellowships Successes

From July 2020 to June 2025, MIRT advanced fellows published 906 peer-reviewed articles in psychiatry, psychology, and other disciplines. Each year, about 20 to 25 articles are published in high-impact journals. In this 5-year period, fellows have received 153 grants (114 VA grants) as principal investigators– many examining new innovations to improve the quality of care of veterans. Of the 165 fellows who graduated since 2020, 63% continued working in veteran health care: 38% transitioned to full-time VA employment and 25% moved to VA employment with an academic-affiliated role. Nineteen percent transitioned to academic positions, 12% transitioned to the private sector, and 5% transitioned to other government, industry, or nonprofit employment where these professionals contribute to scientific and clinical innovation benefiting the US public; 1% did not provide postfellowship employment information. The Figure displays geographic locations of graduated fellows’ postfellowship employment from July 2020 to June 2025.

The accomplishments of fellows are wide-ranging and aligned with VA’s mission. Each year, roughly 15 fellows receive new investigator awards, travel awards, and poster or presentation awards from prominent professional societies. Fellows have obtained VA Career Development Awards in diverse topics, including suicide prevention through clinician resources and training programs, firearm safety discussions, digital phenotyping and neuroimaging to enhance social integration in veterans with schizophrenia, rapid transcranial magnetic stimulation to treat nicotine use and PTSD, and evidence-based psychotherapy techniques for female veterans experiencing issues in menopause.

Several recent MIRT fellows have also received highly competitive NIH K Career Development Awards. One notable example is a fellow who studied pharmacologic approaches for treatment-resistant depression informed by novel brain circuit findings, first testing these approaches in community samples through a NIH K grant and translating findings to veterans. Fellows have gone on to become directors of important national research centers and studies, chairs of academic departments, and presidents of national medical organizations. Importantly, many MIRT fellows have become local directors and mentors to a new generation of VA fellows and researchers.

Conclusions

The AF MIRT coordinating center supports the VA’s mission of fulfilling President Lincoln’s promise to care for veterans. There are multiple benefits to evidence-based work that helps veterans and fosters a highly skilled VA workforce. Veterans are at the center of the MIRT data-driven approach, which is critical given their complex needs. Approaches to building the AF MIRT’s evidence base include randomized controlled trials open to veteran participants; program evaluation of current local, regional, or national VHA clinical services through measurement-based care and evaluation of national clinician training programs; and even smaller quality improvement projects in local VA clinics. These efforts support effective, efficient, and accessible provision of treatments that benefit veterans.

The US Department of Veterans Affairs (VA) mission realizes President Abraham Lincoln’s promise to “to care for him who shall have borne the battle, and for his widow, and his orphan.”¹ Evidence-based care fulfills this promise and is the backbone of Veterans Health Administration (VHA) mental health care.^2,3 To ensure veterans receive state-of-the-art clinical care, a skilled workforce and investment in data-driven approaches are necessary to identify best treatments and strategies to implement them in practice.

Through scientific and clinical training tailored to VA, the 23 VA Advanced Fellowships have secured a steady flow of highly trained PhD professionals (ie, psychologists and other allied health professionals), and medical doctors (ie, psychiatrists and neurologists) into the VA workforce.⁴ The VA Advanced Fellows are funded by the Office of Academic Affiliations (OAA) and offer 2-year training opportunities for postresidency MDs and postdoctoral PhDs. This article describes a VA Advanced Fellowship in mental health as an example of how these programs can have a broad and positive impact on the VA health care system.

Advanced Fellows Program

The VA Advanced Fellowship in Mental Illness Research and Treatment (AF MIRT), formerly known as the VA Special Fellowship Program in Advanced Psychiatry and Psychology, educates and trains clinician and nonclinician researchers to meet VA priority mental health care needs.⁵ Clinical AF MIRT fellows dedicate 75% of their time to training and research activities and 25% to direct clinical services. Data science fellows complete projects that inform veteran clinical care through qualitative data collection, program evaluation, and analysis of large datasets. The full translational pathway to evidence-based clinical care is represented by fellow research spanning basic animal models, genetics, and neuroimaging to implementation science and applied clinical care for veterans.

In 2025, AF MIRT marked its 25th year of training postdoctoral-level mental health scientific practitioners and scholars. This investment in clinical research training has had profound benefits for innovation and retention of clinicians and scientists within the VA system. As of April 1, 2026, AF MIRT trained 700 fellows, including 152 MD or MD/PhD fellows, 544 PhD or PsyD fellows, 3 PharmDs fellows, and 1 doctor of nursing practice fellow.

Fellowship Structure

The AF MIRT coordinating center provides key administrative support to fellowship site directors and topical didactic training to Advanced Fellows, ensuring consistent standard of quality training across locations in 15 states and 4 times zones. The training provided by the AF MIRT coordinating center deepens the nationally-mandated focus of local translational clinical centers (eg, Mental Illness Research Education and Clinical Centers, Centers of Excellence) on posttraumatic stress disorder (PTSD), serious mental illness, dementia, and other areas.

The AF MIRT coordinating center also promotes VA workforce sustainability. Advanced Fellows in programs with a coordinating center are much more likely to be retained in VA for postfellowship employment compared with fellows in programs without such a coordinating center (60% vs 38%) according to unpublished Office of Academic Affiliations data (Joel Schmidt, oral communication, May 15, 2025). The AF MIRT coordinating center provides central standardization and uses evidence-based approaches to ensure fellows receive consistent support, resources, and training. More specifically, the coordinating center develops and delivers a standardized, core curriculum to the program’s 28 sites. The program pioneered video delivery of integrated didactics that enlist national experts, many of them VA researchers and clinicians themselves. Didactics include high priority veteran mental health topics, such as suicide prevention, new and emerging evidence-based treatments (eg, neurostimulation for treatment resistant PTSD, psychotherapeutic approaches for traumatic brain injury), and VA health system considerations for mental health treatment delivery.

This curated didactic series also covers professional and technical issues, such as statistical and methodological considerations for clinical trials, scientific writing, and grant-writing skill development. These offerings support the career pathways of advanced fellows to pursue careers as researchers, scientifically-informed clinicians, or data scientists at VA or academic medical centers. The coordinating center prepares fellows to apply for mentored career award funding or independent investigator awards through the VA, National Institutes of Health (NIH), US Department of Defense, and other organizations by offering an annual mock grant review session and monthly reviews and discussions of fellows’ grant applications.

AF MIRT continuously fine tunes the didactic series curriculum based on feedback from fellows on how the program meets their training needs. For example, learning about the strategies Advanced Fellows used to remain productive during COVID-19 pandemic lockdowns revealed a strong trend toward use of secondary data (eg, publicly available data or VA electronic health record data). This fueled curriculum adjustments to include more topics relevant to fellow interests and needs for accessing secondary data resources for high priority veteran mental health topics.⁶

VA Advanced Fellowships Successes

From July 2020 to June 2025, MIRT advanced fellows published 906 peer-reviewed articles in psychiatry, psychology, and other disciplines. Each year, about 20 to 25 articles are published in high-impact journals. In this 5-year period, fellows have received 153 grants (114 VA grants) as principal investigators– many examining new innovations to improve the quality of care of veterans. Of the 165 fellows who graduated since 2020, 63% continued working in veteran health care: 38% transitioned to full-time VA employment and 25% moved to VA employment with an academic-affiliated role. Nineteen percent transitioned to academic positions, 12% transitioned to the private sector, and 5% transitioned to other government, industry, or nonprofit employment where these professionals contribute to scientific and clinical innovation benefiting the US public; 1% did not provide postfellowship employment information. The Figure displays geographic locations of graduated fellows’ postfellowship employment from July 2020 to June 2025.

The accomplishments of fellows are wide-ranging and aligned with VA’s mission. Each year, roughly 15 fellows receive new investigator awards, travel awards, and poster or presentation awards from prominent professional societies. Fellows have obtained VA Career Development Awards in diverse topics, including suicide prevention through clinician resources and training programs, firearm safety discussions, digital phenotyping and neuroimaging to enhance social integration in veterans with schizophrenia, rapid transcranial magnetic stimulation to treat nicotine use and PTSD, and evidence-based psychotherapy techniques for female veterans experiencing issues in menopause.

Several recent MIRT fellows have also received highly competitive NIH K Career Development Awards. One notable example is a fellow who studied pharmacologic approaches for treatment-resistant depression informed by novel brain circuit findings, first testing these approaches in community samples through a NIH K grant and translating findings to veterans. Fellows have gone on to become directors of important national research centers and studies, chairs of academic departments, and presidents of national medical organizations. Importantly, many MIRT fellows have become local directors and mentors to a new generation of VA fellows and researchers.

Conclusions

The AF MIRT coordinating center supports the VA’s mission of fulfilling President Lincoln’s promise to care for veterans. There are multiple benefits to evidence-based work that helps veterans and fosters a highly skilled VA workforce. Veterans are at the center of the MIRT data-driven approach, which is critical given their complex needs. Approaches to building the AF MIRT’s evidence base include randomized controlled trials open to veteran participants; program evaluation of current local, regional, or national VHA clinical services through measurement-based care and evaluation of national clinician training programs; and even smaller quality improvement projects in local VA clinics. These efforts support effective, efficient, and accessible provision of treatments that benefit veterans.

The US Department of Veterans Affairs (VA) mission realizes President Abraham Lincoln’s promise to “to care for him who shall have borne the battle, and for his widow, and his orphan.”¹ Evidence-based care fulfills this promise and is the backbone of Veterans Health Administration (VHA) mental health care.^2,3 To ensure veterans receive state-of-the-art clinical care, a skilled workforce and investment in data-driven approaches are necessary to identify best treatments and strategies to implement them in practice.

Through scientific and clinical training tailored to VA, the 23 VA Advanced Fellowships have secured a steady flow of highly trained PhD professionals (ie, psychologists and other allied health professionals), and medical doctors (ie, psychiatrists and neurologists) into the VA workforce.⁴ The VA Advanced Fellows are funded by the Office of Academic Affiliations (OAA) and offer 2-year training opportunities for postresidency MDs and postdoctoral PhDs. This article describes a VA Advanced Fellowship in mental health as an example of how these programs can have a broad and positive impact on the VA health care system.

Advanced Fellows Program

The VA Advanced Fellowship in Mental Illness Research and Treatment (AF MIRT), formerly known as the VA Special Fellowship Program in Advanced Psychiatry and Psychology, educates and trains clinician and nonclinician researchers to meet VA priority mental health care needs.⁵ Clinical AF MIRT fellows dedicate 75% of their time to training and research activities and 25% to direct clinical services. Data science fellows complete projects that inform veteran clinical care through qualitative data collection, program evaluation, and analysis of large datasets. The full translational pathway to evidence-based clinical care is represented by fellow research spanning basic animal models, genetics, and neuroimaging to implementation science and applied clinical care for veterans.

In 2025, AF MIRT marked its 25th year of training postdoctoral-level mental health scientific practitioners and scholars. This investment in clinical research training has had profound benefits for innovation and retention of clinicians and scientists within the VA system. As of April 1, 2026, AF MIRT trained 700 fellows, including 152 MD or MD/PhD fellows, 544 PhD or PsyD fellows, 3 PharmDs fellows, and 1 doctor of nursing practice fellow.

Fellowship Structure

The AF MIRT coordinating center provides key administrative support to fellowship site directors and topical didactic training to Advanced Fellows, ensuring consistent standard of quality training across locations in 15 states and 4 times zones. The training provided by the AF MIRT coordinating center deepens the nationally-mandated focus of local translational clinical centers (eg, Mental Illness Research Education and Clinical Centers, Centers of Excellence) on posttraumatic stress disorder (PTSD), serious mental illness, dementia, and other areas.

The AF MIRT coordinating center also promotes VA workforce sustainability. Advanced Fellows in programs with a coordinating center are much more likely to be retained in VA for postfellowship employment compared with fellows in programs without such a coordinating center (60% vs 38%) according to unpublished Office of Academic Affiliations data (Joel Schmidt, oral communication, May 15, 2025). The AF MIRT coordinating center provides central standardization and uses evidence-based approaches to ensure fellows receive consistent support, resources, and training. More specifically, the coordinating center develops and delivers a standardized, core curriculum to the program’s 28 sites. The program pioneered video delivery of integrated didactics that enlist national experts, many of them VA researchers and clinicians themselves. Didactics include high priority veteran mental health topics, such as suicide prevention, new and emerging evidence-based treatments (eg, neurostimulation for treatment resistant PTSD, psychotherapeutic approaches for traumatic brain injury), and VA health system considerations for mental health treatment delivery.

This curated didactic series also covers professional and technical issues, such as statistical and methodological considerations for clinical trials, scientific writing, and grant-writing skill development. These offerings support the career pathways of advanced fellows to pursue careers as researchers, scientifically-informed clinicians, or data scientists at VA or academic medical centers. The coordinating center prepares fellows to apply for mentored career award funding or independent investigator awards through the VA, National Institutes of Health (NIH), US Department of Defense, and other organizations by offering an annual mock grant review session and monthly reviews and discussions of fellows’ grant applications.

AF MIRT continuously fine tunes the didactic series curriculum based on feedback from fellows on how the program meets their training needs. For example, learning about the strategies Advanced Fellows used to remain productive during COVID-19 pandemic lockdowns revealed a strong trend toward use of secondary data (eg, publicly available data or VA electronic health record data). This fueled curriculum adjustments to include more topics relevant to fellow interests and needs for accessing secondary data resources for high priority veteran mental health topics.⁶

VA Advanced Fellowships Successes

From July 2020 to June 2025, MIRT advanced fellows published 906 peer-reviewed articles in psychiatry, psychology, and other disciplines. Each year, about 20 to 25 articles are published in high-impact journals. In this 5-year period, fellows have received 153 grants (114 VA grants) as principal investigators– many examining new innovations to improve the quality of care of veterans. Of the 165 fellows who graduated since 2020, 63% continued working in veteran health care: 38% transitioned to full-time VA employment and 25% moved to VA employment with an academic-affiliated role. Nineteen percent transitioned to academic positions, 12% transitioned to the private sector, and 5% transitioned to other government, industry, or nonprofit employment where these professionals contribute to scientific and clinical innovation benefiting the US public; 1% did not provide postfellowship employment information. The Figure displays geographic locations of graduated fellows’ postfellowship employment from July 2020 to June 2025.

The accomplishments of fellows are wide-ranging and aligned with VA’s mission. Each year, roughly 15 fellows receive new investigator awards, travel awards, and poster or presentation awards from prominent professional societies. Fellows have obtained VA Career Development Awards in diverse topics, including suicide prevention through clinician resources and training programs, firearm safety discussions, digital phenotyping and neuroimaging to enhance social integration in veterans with schizophrenia, rapid transcranial magnetic stimulation to treat nicotine use and PTSD, and evidence-based psychotherapy techniques for female veterans experiencing issues in menopause.

Several recent MIRT fellows have also received highly competitive NIH K Career Development Awards. One notable example is a fellow who studied pharmacologic approaches for treatment-resistant depression informed by novel brain circuit findings, first testing these approaches in community samples through a NIH K grant and translating findings to veterans. Fellows have gone on to become directors of important national research centers and studies, chairs of academic departments, and presidents of national medical organizations. Importantly, many MIRT fellows have become local directors and mentors to a new generation of VA fellows and researchers.

Conclusions

The AF MIRT coordinating center supports the VA’s mission of fulfilling President Lincoln’s promise to care for veterans. There are multiple benefits to evidence-based work that helps veterans and fosters a highly skilled VA workforce. Veterans are at the center of the MIRT data-driven approach, which is critical given their complex needs. Approaches to building the AF MIRT’s evidence base include randomized controlled trials open to veteran participants; program evaluation of current local, regional, or national VHA clinical services through measurement-based care and evaluation of national clinician training programs; and even smaller quality improvement projects in local VA clinics. These efforts support effective, efficient, and accessible provision of treatments that benefit veterans.

The Veterans Health Administration (VHA) Home Improvements and Structural Alterations (HISA) program is a primary means through which veterans can obtain home modifications necessary to continue safe and independent living in their home, including fall risk reduction and accessibility to essential parts of the home. However, not all eligible veterans who may benefit from this program participate, for a variety of reasons.^1-6 Historically, the HISA program has been administered in a decentralized and nonstandardized fashion dictated by the organizational structure of each US Department of Veterans Affairs (VA) medical center (VAMC) within a certain region or Veterans Integrated Service Network (VISN). Previous research found differential access to the HISA program by younger veterans, women, minorities, veterans with certain disability types, and veterans living in rural vs urban settings. These disparities in access and use of benefits conferred by the HISA program suggests an area of unmet need, which may improve veterans’ health care outcomes and reduce costs associated with their care.^2-8

The purpose of this article is to provide information to improve equitable provision and effective eligible use of resources available through the HISA program in a more generalizable manner by providing insight to highlight common program process deficiencies and care provision gaps relevant to VAMCs nationwide. This information can be used to inform the VA Physical Medicine and Rehabilitation (PM&R) and Prosthetic and Sensory Aid Service (PSAS) national policy initiatives, as well as hiring practices, clinic organization, specific care provision, and administrative goals and metrics at each VISN and at the VA Healthcare System level.

Methods

Veterans who participated in the HISA program, VHA administrators, and VHA clinicians from select VAMCs were identified and interviewed to better understand what helps increase access to the program, barriers to access, and how existing program components and processes impact use of the service. These interviews were taken from a directed convenience sample of selected VAMCs. To obtain this directed convenience sample, 167 VAMCs that participated in the HISA program were categorized as facilities that provided either a high or low number of HISA program prescriptions based on data from 2010 to 2018. Ten facilities from the top quartiles and 10 from the bottom quartiles of prescribing locations were selected. This facility selection was driven by the proportion of rural veterans served by each facility, favoring those serving a greater proportion of rural veterans, as well geographic location, with the aim of avoiding overrepresentation of any specific region. The convenience sample included 45 individuals (20 VHA employees and 25 veterans) across 22 states from the Northeast, West, South, and Midwest US Census regions.

Interview Process

Interviews underwent a coding process. The development of topical themes followed a systematic, 2-phase approach. Initially, researchers analyzed responses to semistructured interview questions addressing specific aspects of the HISA program, such as program awareness and accessibility. These responses naturally clustered into preliminary categories based on the interview guide structure. For example, responses related to program discovery formed a marketing-related category, while recommendations about program implementation contributed to a training and development category.

Following this initial categorization, the research team conducted a more rigorous coding process. A team of 3 researchers systematically reviewed assigned interview transcripts to extract practical recommendations for the guide. The researchers first identified relevant responses individually and then convened during group meetings to discuss and finalize selections. This second phase refined the preliminary categorization while maintaining alignment with the original interview structure.

This approach allowed the team to preserve the practical utility of participant feedback while ensuring methodological rigor in the analysis process. Resulting themes reflect both the structured nature of the original inquiry and the practical recommendations identified for improving the HISA program. Information on the following areas were collected: education about the HISA program, the contracting process, use of telehealth, interaction between VHA clinical care and the PSAS, marketing of the program, program funding, and revising the application process.

Results

Interview respondents provided several recommendations for improving the HISA program (Table). Regarding training and education, respondents noted deficiencies in VHA employee communication about the HISA program to veterans. Some employees did not know details or were unaware the HISA program existed. Additionally, a lack of knowledge about HISA program alternatives, including other available programs for obtaining home modifications or other durable medical equipment alternatives (eg, provision of a portable ramp rather than construction of a permanent one), was apparent. It was strongly recommended to provide additional education to effectively disseminate knowledge about the HISA program. Specifically, VHA employees, especially those in Primary Care, Geriatrics, Home Based Primary Care, the Caregiver Support Program, and Blind Rehabilitation Services, require greater awareness of the program and its processes.

PSAS and PM&R professionals, including physicians, nurse practitioners, physician assistants, and physical and occupational therapists, would be expected to have some knowledge of the HISA program, and therefore be more likely to connect a veteran with it. However, they may lack specific details about the program such as correct contact persons in the other service (PSAS or PM&R, respectively), facility- specific processes, such as how to enter a HISA consultation within the veteran’s electronic health record, how the entered consultation would progress through the system and avoid cancellation, and what should routinely be done to avoid HISA consultation cancellation, such as referral to Occupational Therapy for a functional assessment so appropriate durable medical equipment can be trialed with the veteran prior to proceeding with more costly and time-consuming home modifications.

In addition, there is no routine standard work process to ensure that PM&R staff are aware of updates in HISA program regulations and policy. Further recommendations in this area include having supervisory employees in PSAS and PM&R work both individually and together to develop effective information dissemination methods for key stakeholders. These include targeted in-services (ie, educational trainings often scheduled and conducted during recurring meetings), whether faceto- face or virtually in real time, or recorded, that occur on an ongoing and regular basis with sister services such as Primary Care, Geriatrics, Home Based Primary Care, the Caregiver Support Program, and Blind Rehabilitation Services (eg, the facility Vision Impairment Services Team coordinator). Regularly updated educational materials should be provided to veterans and VHA adjacent stakeholders such as Veteran Service Organizations and Veteran County Service Officers, via a variety of platforms.

Successfully navigating the provision of home modifications via the HISA program involves identifying a contractor to perform the home modification and obtaining service and construction plan pricing. A key barrier in this area is that veterans and VHA clinicians perceive the funds available through HISA as insufficient, regardless of whether they have serviceconnected status or not. Service connection refers to designation of ≥ 1 medical conditions determined to be related to military service and thus eligible to receive VHA care.⁹ Service-connected veterans receive a lifetime maximum award of $6800 from HISA while veterans without service connection receive a lifetime maximum award of $2000.^1,2

Rural veterans face a greater challenge than urban veterans, as there are fewer contractors located nearby. Thus, providing higher funding for rural veterans, or specific funding such as for travel expenses, would be especially helpful to find a willing contractor to perform home medications.¹ The current requirement of working with a licensed contractor was also a barrier, especially for smaller jobs, and could result in VHA employees (including clinicians) feeling pressured to become overly involved to assist veterans to move through the process.

To that point, respondents requested resources such as a regularly updated list of licensed contractors in the area, especially those familiar with working with the HISA program, be provided to veterans and their assisting groups. In addition, respondents asked that VHA take on greater responsibility and liability with regard to contractors accessing HISA funding, such as not releasing final payment until VHA approved the completed home modification. On the other hand, respondents also expressed concerns about the length of time associated with HISA program payment and noted it should be sped up to allow contractors who participate to receive payment sooner, which many believed would increase the number of contractors willing to take on this work.

The role of telehealth was noted as a great facilitator of increased access to care, especially following the COVID-19 pandemic. Telehealth modalities adapted for the HISA program could help increase access to the program and improve processing speed. Barriers include lack of appropriate veteran telehealth equipment and poor understanding of information needed to move the process forward. Recommendations included providing veterans tablets to connect to virtual services, and developing information on home measurements needed, assistance in obtaining and sending photographs, and detailed information on successfully using telehealth for the HISA application process. Of note, some clinicians, representing home-based primary care, prosthetics services, geriatrics, rehabilitation therapy, mobile clinic, and the telehealth division, and including both clinical staff (eg, occupational therapists) and nonclinical staff (eg, prosthetics representatives and administrative personnel), have found patients expressed comparable satisfaction with the process whether faceto- face or via telehealth.

The essential relationship between PSAS and PM&R regarding the HISA program was a key finding. Both services are integral to helping veterans successfully obtain home modifications via the HISA program.^1,2 Barriers include insufficient communication and a lack of clearly defined points of contact for each service, poorly defined roles, and inefficiencies because 2 services are involved in navigating the process. Recommendations therefore include addressing these issues, such as adopting a case management or liaison model between the services to better manage the process.

Respondents indicated that insufficient program funding was a concern. Veterans living in poorer quality housing, such as older homes, often require more expensive home modifications, necessitating greater out-of-pocket expenses. Veterans and VHA employees advocated for the creation of an exception to the lower funding cap for veterans without service connection in cases of financial hardship. Overall, the funding limits for both service-connected veterans and those without service connection were thought to be insufficient, especially as the COVID-19 pandemic increased the cost of construction materials.

Respondents also noted that veterans would benefit from clear messaging that receiving HISA funds does not impact eligibility for other VA benefits and services. Veterans must understand that home modifications work must be approved by VHA before being started and should be aware that if their disability rating increases so that they become eligible for the higher level service-connected benefits, they would then become eligible for the higher maximum benefit. Respondents recommended veterans should receive assistance in understanding the full costs of the home modification and ongoing maintenance, and the HISA research team recommended that the National Program develop a fact sheet that can be used to advise veterans.

Respondents consistently indicated that information about the HISA program was not disseminated effectively to key internal and external stakeholders, and opportunities to highlight the program on VHA websites, brochures throughout VHA facilities, and other outlets such as direct mailing should be used. Veterans who have used the program are overwhelmingly older (mean age 71 years), White, and male, suggesting missed opportunities and unmet need for underrepresented groups. Therefore, targeted marketing interventions would especially benefit these groups.

Respondents also noted inefficiencies throughout the HISA program application process and advocated for changes such as national standard operating procedures (SOPs) to guide navigation through the HISA process. The national SOPs could include home evaluation prior to HISA application submission, clearly identified points of contact for the HISA program in PSAS and PM&R, and standardized documentation.

Future Directions

Information from respondents provided several avenues for future studies. Recommendations were obtained from each of the 7 broad topical areas: training and educational needs, potential, contracting challenges and opportunities, telehealth as a conduit to facilitate the availability of the HISA program, PSAS, and clinical services collaboration, marketing, need for increased funding, and revision of the application process. Input from stakeholders can help direct efficient use of resources to guide future studies for the greatest impact and highlight current and future priorities. Easy areas of intervention indicated by respondents include creating a national standard work process regarding the HISA program with standardized educational materials for key stakeholders, revised at regular intervals, and readily available on national websites. A pre- and postimplementation survey could help provide quantifiable information about the benefits of such an intervention.

Conclusions

A qualitative analysis of interviews with veterans and VHA clinicians provides evidence of potential barriers for the HISA program. Addressing these barriers could allow HISA to better meet the VHA goal of providing home modifications that allow veterans to live safely and independently in their homes. There is a need for ongoing review and assessment of the program to ensure optimization and efficient use of resources across the spectrum of veteran needs.

The Veterans Health Administration (VHA) Home Improvements and Structural Alterations (HISA) program is a primary means through which veterans can obtain home modifications necessary to continue safe and independent living in their home, including fall risk reduction and accessibility to essential parts of the home. However, not all eligible veterans who may benefit from this program participate, for a variety of reasons.^1-6 Historically, the HISA program has been administered in a decentralized and nonstandardized fashion dictated by the organizational structure of each US Department of Veterans Affairs (VA) medical center (VAMC) within a certain region or Veterans Integrated Service Network (VISN). Previous research found differential access to the HISA program by younger veterans, women, minorities, veterans with certain disability types, and veterans living in rural vs urban settings. These disparities in access and use of benefits conferred by the HISA program suggests an area of unmet need, which may improve veterans’ health care outcomes and reduce costs associated with their care.^2-8

The purpose of this article is to provide information to improve equitable provision and effective eligible use of resources available through the HISA program in a more generalizable manner by providing insight to highlight common program process deficiencies and care provision gaps relevant to VAMCs nationwide. This information can be used to inform the VA Physical Medicine and Rehabilitation (PM&R) and Prosthetic and Sensory Aid Service (PSAS) national policy initiatives, as well as hiring practices, clinic organization, specific care provision, and administrative goals and metrics at each VISN and at the VA Healthcare System level.

Methods

Veterans who participated in the HISA program, VHA administrators, and VHA clinicians from select VAMCs were identified and interviewed to better understand what helps increase access to the program, barriers to access, and how existing program components and processes impact use of the service. These interviews were taken from a directed convenience sample of selected VAMCs. To obtain this directed convenience sample, 167 VAMCs that participated in the HISA program were categorized as facilities that provided either a high or low number of HISA program prescriptions based on data from 2010 to 2018. Ten facilities from the top quartiles and 10 from the bottom quartiles of prescribing locations were selected. This facility selection was driven by the proportion of rural veterans served by each facility, favoring those serving a greater proportion of rural veterans, as well geographic location, with the aim of avoiding overrepresentation of any specific region. The convenience sample included 45 individuals (20 VHA employees and 25 veterans) across 22 states from the Northeast, West, South, and Midwest US Census regions.

Interview Process

Interviews underwent a coding process. The development of topical themes followed a systematic, 2-phase approach. Initially, researchers analyzed responses to semistructured interview questions addressing specific aspects of the HISA program, such as program awareness and accessibility. These responses naturally clustered into preliminary categories based on the interview guide structure. For example, responses related to program discovery formed a marketing-related category, while recommendations about program implementation contributed to a training and development category.

Following this initial categorization, the research team conducted a more rigorous coding process. A team of 3 researchers systematically reviewed assigned interview transcripts to extract practical recommendations for the guide. The researchers first identified relevant responses individually and then convened during group meetings to discuss and finalize selections. This second phase refined the preliminary categorization while maintaining alignment with the original interview structure.

This approach allowed the team to preserve the practical utility of participant feedback while ensuring methodological rigor in the analysis process. Resulting themes reflect both the structured nature of the original inquiry and the practical recommendations identified for improving the HISA program. Information on the following areas were collected: education about the HISA program, the contracting process, use of telehealth, interaction between VHA clinical care and the PSAS, marketing of the program, program funding, and revising the application process.

Results

Interview respondents provided several recommendations for improving the HISA program (Table). Regarding training and education, respondents noted deficiencies in VHA employee communication about the HISA program to veterans. Some employees did not know details or were unaware the HISA program existed. Additionally, a lack of knowledge about HISA program alternatives, including other available programs for obtaining home modifications or other durable medical equipment alternatives (eg, provision of a portable ramp rather than construction of a permanent one), was apparent. It was strongly recommended to provide additional education to effectively disseminate knowledge about the HISA program. Specifically, VHA employees, especially those in Primary Care, Geriatrics, Home Based Primary Care, the Caregiver Support Program, and Blind Rehabilitation Services, require greater awareness of the program and its processes.

PSAS and PM&R professionals, including physicians, nurse practitioners, physician assistants, and physical and occupational therapists, would be expected to have some knowledge of the HISA program, and therefore be more likely to connect a veteran with it. However, they may lack specific details about the program such as correct contact persons in the other service (PSAS or PM&R, respectively), facility- specific processes, such as how to enter a HISA consultation within the veteran’s electronic health record, how the entered consultation would progress through the system and avoid cancellation, and what should routinely be done to avoid HISA consultation cancellation, such as referral to Occupational Therapy for a functional assessment so appropriate durable medical equipment can be trialed with the veteran prior to proceeding with more costly and time-consuming home modifications.

In addition, there is no routine standard work process to ensure that PM&R staff are aware of updates in HISA program regulations and policy. Further recommendations in this area include having supervisory employees in PSAS and PM&R work both individually and together to develop effective information dissemination methods for key stakeholders. These include targeted in-services (ie, educational trainings often scheduled and conducted during recurring meetings), whether faceto- face or virtually in real time, or recorded, that occur on an ongoing and regular basis with sister services such as Primary Care, Geriatrics, Home Based Primary Care, the Caregiver Support Program, and Blind Rehabilitation Services (eg, the facility Vision Impairment Services Team coordinator). Regularly updated educational materials should be provided to veterans and VHA adjacent stakeholders such as Veteran Service Organizations and Veteran County Service Officers, via a variety of platforms.

Successfully navigating the provision of home modifications via the HISA program involves identifying a contractor to perform the home modification and obtaining service and construction plan pricing. A key barrier in this area is that veterans and VHA clinicians perceive the funds available through HISA as insufficient, regardless of whether they have serviceconnected status or not. Service connection refers to designation of ≥ 1 medical conditions determined to be related to military service and thus eligible to receive VHA care.⁹ Service-connected veterans receive a lifetime maximum award of $6800 from HISA while veterans without service connection receive a lifetime maximum award of $2000.^1,2

Rural veterans face a greater challenge than urban veterans, as there are fewer contractors located nearby. Thus, providing higher funding for rural veterans, or specific funding such as for travel expenses, would be especially helpful to find a willing contractor to perform home medications.¹ The current requirement of working with a licensed contractor was also a barrier, especially for smaller jobs, and could result in VHA employees (including clinicians) feeling pressured to become overly involved to assist veterans to move through the process.

To that point, respondents requested resources such as a regularly updated list of licensed contractors in the area, especially those familiar with working with the HISA program, be provided to veterans and their assisting groups. In addition, respondents asked that VHA take on greater responsibility and liability with regard to contractors accessing HISA funding, such as not releasing final payment until VHA approved the completed home modification. On the other hand, respondents also expressed concerns about the length of time associated with HISA program payment and noted it should be sped up to allow contractors who participate to receive payment sooner, which many believed would increase the number of contractors willing to take on this work.

The role of telehealth was noted as a great facilitator of increased access to care, especially following the COVID-19 pandemic. Telehealth modalities adapted for the HISA program could help increase access to the program and improve processing speed. Barriers include lack of appropriate veteran telehealth equipment and poor understanding of information needed to move the process forward. Recommendations included providing veterans tablets to connect to virtual services, and developing information on home measurements needed, assistance in obtaining and sending photographs, and detailed information on successfully using telehealth for the HISA application process. Of note, some clinicians, representing home-based primary care, prosthetics services, geriatrics, rehabilitation therapy, mobile clinic, and the telehealth division, and including both clinical staff (eg, occupational therapists) and nonclinical staff (eg, prosthetics representatives and administrative personnel), have found patients expressed comparable satisfaction with the process whether faceto- face or via telehealth.

The essential relationship between PSAS and PM&R regarding the HISA program was a key finding. Both services are integral to helping veterans successfully obtain home modifications via the HISA program.^1,2 Barriers include insufficient communication and a lack of clearly defined points of contact for each service, poorly defined roles, and inefficiencies because 2 services are involved in navigating the process. Recommendations therefore include addressing these issues, such as adopting a case management or liaison model between the services to better manage the process.

Respondents indicated that insufficient program funding was a concern. Veterans living in poorer quality housing, such as older homes, often require more expensive home modifications, necessitating greater out-of-pocket expenses. Veterans and VHA employees advocated for the creation of an exception to the lower funding cap for veterans without service connection in cases of financial hardship. Overall, the funding limits for both service-connected veterans and those without service connection were thought to be insufficient, especially as the COVID-19 pandemic increased the cost of construction materials.

Respondents also noted that veterans would benefit from clear messaging that receiving HISA funds does not impact eligibility for other VA benefits and services. Veterans must understand that home modifications work must be approved by VHA before being started and should be aware that if their disability rating increases so that they become eligible for the higher level service-connected benefits, they would then become eligible for the higher maximum benefit. Respondents recommended veterans should receive assistance in understanding the full costs of the home modification and ongoing maintenance, and the HISA research team recommended that the National Program develop a fact sheet that can be used to advise veterans.

Respondents consistently indicated that information about the HISA program was not disseminated effectively to key internal and external stakeholders, and opportunities to highlight the program on VHA websites, brochures throughout VHA facilities, and other outlets such as direct mailing should be used. Veterans who have used the program are overwhelmingly older (mean age 71 years), White, and male, suggesting missed opportunities and unmet need for underrepresented groups. Therefore, targeted marketing interventions would especially benefit these groups.

Respondents also noted inefficiencies throughout the HISA program application process and advocated for changes such as national standard operating procedures (SOPs) to guide navigation through the HISA process. The national SOPs could include home evaluation prior to HISA application submission, clearly identified points of contact for the HISA program in PSAS and PM&R, and standardized documentation.

Future Directions

Information from respondents provided several avenues for future studies. Recommendations were obtained from each of the 7 broad topical areas: training and educational needs, potential, contracting challenges and opportunities, telehealth as a conduit to facilitate the availability of the HISA program, PSAS, and clinical services collaboration, marketing, need for increased funding, and revision of the application process. Input from stakeholders can help direct efficient use of resources to guide future studies for the greatest impact and highlight current and future priorities. Easy areas of intervention indicated by respondents include creating a national standard work process regarding the HISA program with standardized educational materials for key stakeholders, revised at regular intervals, and readily available on national websites. A pre- and postimplementation survey could help provide quantifiable information about the benefits of such an intervention.

Conclusions

A qualitative analysis of interviews with veterans and VHA clinicians provides evidence of potential barriers for the HISA program. Addressing these barriers could allow HISA to better meet the VHA goal of providing home modifications that allow veterans to live safely and independently in their homes. There is a need for ongoing review and assessment of the program to ensure optimization and efficient use of resources across the spectrum of veteran needs.

The Veterans Health Administration (VHA) Home Improvements and Structural Alterations (HISA) program is a primary means through which veterans can obtain home modifications necessary to continue safe and independent living in their home, including fall risk reduction and accessibility to essential parts of the home. However, not all eligible veterans who may benefit from this program participate, for a variety of reasons.^1-6 Historically, the HISA program has been administered in a decentralized and nonstandardized fashion dictated by the organizational structure of each US Department of Veterans Affairs (VA) medical center (VAMC) within a certain region or Veterans Integrated Service Network (VISN). Previous research found differential access to the HISA program by younger veterans, women, minorities, veterans with certain disability types, and veterans living in rural vs urban settings. These disparities in access and use of benefits conferred by the HISA program suggests an area of unmet need, which may improve veterans’ health care outcomes and reduce costs associated with their care.^2-8

The purpose of this article is to provide information to improve equitable provision and effective eligible use of resources available through the HISA program in a more generalizable manner by providing insight to highlight common program process deficiencies and care provision gaps relevant to VAMCs nationwide. This information can be used to inform the VA Physical Medicine and Rehabilitation (PM&R) and Prosthetic and Sensory Aid Service (PSAS) national policy initiatives, as well as hiring practices, clinic organization, specific care provision, and administrative goals and metrics at each VISN and at the VA Healthcare System level.

Methods

Veterans who participated in the HISA program, VHA administrators, and VHA clinicians from select VAMCs were identified and interviewed to better understand what helps increase access to the program, barriers to access, and how existing program components and processes impact use of the service. These interviews were taken from a directed convenience sample of selected VAMCs. To obtain this directed convenience sample, 167 VAMCs that participated in the HISA program were categorized as facilities that provided either a high or low number of HISA program prescriptions based on data from 2010 to 2018. Ten facilities from the top quartiles and 10 from the bottom quartiles of prescribing locations were selected. This facility selection was driven by the proportion of rural veterans served by each facility, favoring those serving a greater proportion of rural veterans, as well geographic location, with the aim of avoiding overrepresentation of any specific region. The convenience sample included 45 individuals (20 VHA employees and 25 veterans) across 22 states from the Northeast, West, South, and Midwest US Census regions.

Interview Process

Interviews underwent a coding process. The development of topical themes followed a systematic, 2-phase approach. Initially, researchers analyzed responses to semistructured interview questions addressing specific aspects of the HISA program, such as program awareness and accessibility. These responses naturally clustered into preliminary categories based on the interview guide structure. For example, responses related to program discovery formed a marketing-related category, while recommendations about program implementation contributed to a training and development category.

Following this initial categorization, the research team conducted a more rigorous coding process. A team of 3 researchers systematically reviewed assigned interview transcripts to extract practical recommendations for the guide. The researchers first identified relevant responses individually and then convened during group meetings to discuss and finalize selections. This second phase refined the preliminary categorization while maintaining alignment with the original interview structure.

This approach allowed the team to preserve the practical utility of participant feedback while ensuring methodological rigor in the analysis process. Resulting themes reflect both the structured nature of the original inquiry and the practical recommendations identified for improving the HISA program. Information on the following areas were collected: education about the HISA program, the contracting process, use of telehealth, interaction between VHA clinical care and the PSAS, marketing of the program, program funding, and revising the application process.

Results

Interview respondents provided several recommendations for improving the HISA program (Table). Regarding training and education, respondents noted deficiencies in VHA employee communication about the HISA program to veterans. Some employees did not know details or were unaware the HISA program existed. Additionally, a lack of knowledge about HISA program alternatives, including other available programs for obtaining home modifications or other durable medical equipment alternatives (eg, provision of a portable ramp rather than construction of a permanent one), was apparent. It was strongly recommended to provide additional education to effectively disseminate knowledge about the HISA program. Specifically, VHA employees, especially those in Primary Care, Geriatrics, Home Based Primary Care, the Caregiver Support Program, and Blind Rehabilitation Services, require greater awareness of the program and its processes.

PSAS and PM&R professionals, including physicians, nurse practitioners, physician assistants, and physical and occupational therapists, would be expected to have some knowledge of the HISA program, and therefore be more likely to connect a veteran with it. However, they may lack specific details about the program such as correct contact persons in the other service (PSAS or PM&R, respectively), facility- specific processes, such as how to enter a HISA consultation within the veteran’s electronic health record, how the entered consultation would progress through the system and avoid cancellation, and what should routinely be done to avoid HISA consultation cancellation, such as referral to Occupational Therapy for a functional assessment so appropriate durable medical equipment can be trialed with the veteran prior to proceeding with more costly and time-consuming home modifications.

In addition, there is no routine standard work process to ensure that PM&R staff are aware of updates in HISA program regulations and policy. Further recommendations in this area include having supervisory employees in PSAS and PM&R work both individually and together to develop effective information dissemination methods for key stakeholders. These include targeted in-services (ie, educational trainings often scheduled and conducted during recurring meetings), whether faceto- face or virtually in real time, or recorded, that occur on an ongoing and regular basis with sister services such as Primary Care, Geriatrics, Home Based Primary Care, the Caregiver Support Program, and Blind Rehabilitation Services (eg, the facility Vision Impairment Services Team coordinator). Regularly updated educational materials should be provided to veterans and VHA adjacent stakeholders such as Veteran Service Organizations and Veteran County Service Officers, via a variety of platforms.

Successfully navigating the provision of home modifications via the HISA program involves identifying a contractor to perform the home modification and obtaining service and construction plan pricing. A key barrier in this area is that veterans and VHA clinicians perceive the funds available through HISA as insufficient, regardless of whether they have serviceconnected status or not. Service connection refers to designation of ≥ 1 medical conditions determined to be related to military service and thus eligible to receive VHA care.⁹ Service-connected veterans receive a lifetime maximum award of $6800 from HISA while veterans without service connection receive a lifetime maximum award of $2000.^1,2

Rural veterans face a greater challenge than urban veterans, as there are fewer contractors located nearby. Thus, providing higher funding for rural veterans, or specific funding such as for travel expenses, would be especially helpful to find a willing contractor to perform home medications.¹ The current requirement of working with a licensed contractor was also a barrier, especially for smaller jobs, and could result in VHA employees (including clinicians) feeling pressured to become overly involved to assist veterans to move through the process.

To that point, respondents requested resources such as a regularly updated list of licensed contractors in the area, especially those familiar with working with the HISA program, be provided to veterans and their assisting groups. In addition, respondents asked that VHA take on greater responsibility and liability with regard to contractors accessing HISA funding, such as not releasing final payment until VHA approved the completed home modification. On the other hand, respondents also expressed concerns about the length of time associated with HISA program payment and noted it should be sped up to allow contractors who participate to receive payment sooner, which many believed would increase the number of contractors willing to take on this work.

The role of telehealth was noted as a great facilitator of increased access to care, especially following the COVID-19 pandemic. Telehealth modalities adapted for the HISA program could help increase access to the program and improve processing speed. Barriers include lack of appropriate veteran telehealth equipment and poor understanding of information needed to move the process forward. Recommendations included providing veterans tablets to connect to virtual services, and developing information on home measurements needed, assistance in obtaining and sending photographs, and detailed information on successfully using telehealth for the HISA application process. Of note, some clinicians, representing home-based primary care, prosthetics services, geriatrics, rehabilitation therapy, mobile clinic, and the telehealth division, and including both clinical staff (eg, occupational therapists) and nonclinical staff (eg, prosthetics representatives and administrative personnel), have found patients expressed comparable satisfaction with the process whether faceto- face or via telehealth.

The essential relationship between PSAS and PM&R regarding the HISA program was a key finding. Both services are integral to helping veterans successfully obtain home modifications via the HISA program.^1,2 Barriers include insufficient communication and a lack of clearly defined points of contact for each service, poorly defined roles, and inefficiencies because 2 services are involved in navigating the process. Recommendations therefore include addressing these issues, such as adopting a case management or liaison model between the services to better manage the process.

Respondents indicated that insufficient program funding was a concern. Veterans living in poorer quality housing, such as older homes, often require more expensive home modifications, necessitating greater out-of-pocket expenses. Veterans and VHA employees advocated for the creation of an exception to the lower funding cap for veterans without service connection in cases of financial hardship. Overall, the funding limits for both service-connected veterans and those without service connection were thought to be insufficient, especially as the COVID-19 pandemic increased the cost of construction materials.

Respondents also noted that veterans would benefit from clear messaging that receiving HISA funds does not impact eligibility for other VA benefits and services. Veterans must understand that home modifications work must be approved by VHA before being started and should be aware that if their disability rating increases so that they become eligible for the higher level service-connected benefits, they would then become eligible for the higher maximum benefit. Respondents recommended veterans should receive assistance in understanding the full costs of the home modification and ongoing maintenance, and the HISA research team recommended that the National Program develop a fact sheet that can be used to advise veterans.

Respondents consistently indicated that information about the HISA program was not disseminated effectively to key internal and external stakeholders, and opportunities to highlight the program on VHA websites, brochures throughout VHA facilities, and other outlets such as direct mailing should be used. Veterans who have used the program are overwhelmingly older (mean age 71 years), White, and male, suggesting missed opportunities and unmet need for underrepresented groups. Therefore, targeted marketing interventions would especially benefit these groups.

Respondents also noted inefficiencies throughout the HISA program application process and advocated for changes such as national standard operating procedures (SOPs) to guide navigation through the HISA process. The national SOPs could include home evaluation prior to HISA application submission, clearly identified points of contact for the HISA program in PSAS and PM&R, and standardized documentation.

Future Directions

Information from respondents provided several avenues for future studies. Recommendations were obtained from each of the 7 broad topical areas: training and educational needs, potential, contracting challenges and opportunities, telehealth as a conduit to facilitate the availability of the HISA program, PSAS, and clinical services collaboration, marketing, need for increased funding, and revision of the application process. Input from stakeholders can help direct efficient use of resources to guide future studies for the greatest impact and highlight current and future priorities. Easy areas of intervention indicated by respondents include creating a national standard work process regarding the HISA program with standardized educational materials for key stakeholders, revised at regular intervals, and readily available on national websites. A pre- and postimplementation survey could help provide quantifiable information about the benefits of such an intervention.

Conclusions

A qualitative analysis of interviews with veterans and VHA clinicians provides evidence of potential barriers for the HISA program. Addressing these barriers could allow HISA to better meet the VHA goal of providing home modifications that allow veterans to live safely and independently in their homes. There is a need for ongoing review and assessment of the program to ensure optimization and efficient use of resources across the spectrum of veteran needs.

Often disguised as comorbid conditions, nonhealing and chronic wounds have emerged as a silent epidemic that affects about 6.5 million Americans.^1-3 In 2023, estimated US wound care costs were $126.86 billion.⁴ About 1% to 2% of individuals worldwide will experience a chronic wound in their lifetime. The Veterans Health Administration reported 277,000 inpatient and outpatient encounters for ulcers in 2011, including chronic ulcers of the lower extremity due to diabetes, venous disease, or arterial disease.⁵ Associated costs of chronic wounds are expected to increase as the populations of developed countries age.⁶ Effective treatment of chronic wounds requires a nuanced understanding of complex wound pathophysiology, best practices in interdisciplinary and multidisciplinary wound care, and advanced wound care technologies.^7,8

The typical 4-year medical school curriculum, followed by residency, offers little in the way of formal didactic training in wound care.^9,10 Without specialized and advanced fellowship training dedicated to wound care, health care will lack specialists prepared to manage complex wounds. As a result, wound care-related difficulties may be exacerbated by prolonged recovery time, increased costs, productivity loss, and increased mortality risk.⁸ Wound care is a growing field of study and practice, and there is a critical need for rigorous training, research, and quality improvement efforts to enhance outcomes for patients with nonhealing wounds.⁵

One of the most direct ways to address the need for more physicians with specialty training in wound medicine is to implement a comprehensive training curriculum for advanced wound care practice. Although specialized advanced wound care fellowships are available, the curricula primarily detail rotation names and areas for practice without accompanying competencies, milestones, or entrustable professional activities.¹¹ Furthermore, wound care is not recognized as a subspecialty by the Accreditation Council for Graduate Medical Education (ACGME).

This article synthesized the literature and integrated innovative, evidence-based practices into a curriculum for a formal advanced fellowship training program. To our knowledge, no comprehensive wound care curriculum is publicly available that includes rotations, competencies, milestones, entrustable professional activities, and 360-degree evaluation forms.

Program Development

The advanced wound care fellowship program started in January 2014 at the Michael E. DeBakey Veterans Affairs Medical Center in affiliation with the Baylor College of Medicine. The fellowship program was originally designed for geriatrics fellows to extend the 1-year fellowship for an additional year to learn wound care. It has been adjusted to address formal program goals and objectives, competencies, milestones, entrustable professional activities, and evaluations, with the goal of developing an example curriculum for wound care fellowships across specialties. Although the ACGME does not recognize a wound care subspecialty, this curriculum complies with the ACGME 1-year fellowship common program requirements.^12,13

Scoping Review

A scoping literature review of Google Scholar and PubMed was performed using the medical subject heading terms “wound care + curriculum” and “wound + care + curriculum” to find advanced wound care medical training, fellowship programs, boards, and related ACGME-accredited specialty curricula. The local wound care fellowship program was initially implemented based on an informal literature review by faculty and their respective contributions to curriculum (ie, process establishing wound care-specific competency domains in accordance with ACGME accreditation competency requirements of 1-year fellowships). ^12,13 Standing program practice-based competencies and activities were examined and determined to align with best practices. This scoping review considered additional competencies, competency domains, and entrustable professional activities of reputable wound care fellowship training programs (eg, University of Chicago at Illinois and Wake Forest School of Medicine),^8,11,14 a specialty wound care board (American Board of Wound Medicine and Surgery),¹⁵ an international wound specialist professional society (European Union of Medical Specialists), ¹⁶ and recommended curriculum guidelines for wound care residency programs.¹⁷ ACGME-accredited specialty and subspecialty milestones professional activities were examined, including vascular surgery,¹⁸ plastic surgery,¹⁹ dermatology, ²⁰ foot and ankle,²¹ orthopedic surgery,²² spinal cord injury,²³ and geriatric medicine.²⁴

The competencies, milestones, and entrustable professional activities were compiled and redundancies were eliminated. Wound care specialists from geriatrics, family medicine, internal medicine, undersea and hyperbaric medicine, general surgery, podiatry, and physical therapy examined the findings and suggested eliminating redundancies, irrelevant content, and content that fell below the minimal expected level of competence for an advanced medical specialist in wound care. An expert consensus meeting further refined items presented to the panel before unanimous consensus resulted in the final set of curriculum competencies, milestones, and entrustable professional activities.

Training Program Feedback

We developed a comprehensive wound care curriculum for an advanced physician fellowship training program based on the streamlined competencies, milestones, and entrustable professional activities (Appendix). Multiple wound care experts from various interdisciplinary backgrounds reached consensus to establish this fellowship curriculum as adaptable for use across training settings. The training program is 12 core rotations and 2 elective rotations (Table 1). Additionally, we developed wound care evaluation forms for faculty-, peer-, and self-assessment of trainees which were adapted from an evidence-based 360-degree evaluation template.²⁵ Suggestions for structured, advanced didactics are in Table 2.

Seventeen fellows have successfully matriculated through the wound care training program. Although wound care certification is not required to work as a wound care specialist, after completion of this fellowship, graduates are able to sit for a wound care certification examination. The American Board of Wound Medicine and Surgery (ABWMS) and the American Board of Wound Management (ABWM) allow physicians to take a certification examination after 1 year of a dedicated wound fellowship program, instead of the typical wound care practice experience ≥ 3 years.

The Clinical Wound Care Fellowship Program collected data for program improvement, and 15 alumni responded (response rate, 88%) to a survey using a 5-point Likert scale. Respondents indicated high mean scores for overall satisfaction (4.7), instructional methods (4.7), program enjoyment (4.7), teaching materials (4.6), and relevance (4.6). All respondents indicated that the fellowship prepared them for a career in wound care as well as their current employment, and 13 of 15 (87%) reported they obtained immediate relevant postfellowship wound care positions and stated that the fellowship prepared them for their current roles. Nine respondents (69%) reported that they were engaged in wound care ≥ 26% of work time. Six respondents (46%) worked in private practice, 3 (23%) at academic medical centers, and 2 (15%) at government- funded hospitals. Four respondents indicated they were board certified in wound care. Program alumni are currently involved in scholarly activities, including 8 in quality improvement and 3 in research.

Discussion

An easily accessible, comprehensive wound care fellowship curriculum has not been previously developed or published. This limited the sources that informed this curriculum. However, the developmental process for this curriculum was robust, as the authors reviewed previously published materials related to wound care, including: 1) descriptive overviews of wound care fellowships; 2) details of month-long rotations for medical students and residents; and 3) practices of the specific environment in which this curriculum was created. Confidence in the practical nature of the curriculum can be assumed, as the experts involved in the development process represented diverse physician specializations, including geriatrics, family medicine, internal medicine, undersea and hyperbaric medicine, general surgery, podiatry, and physical therapy.

Most wound care clinicians have not completed a formal comprehensive fellowship program. Instead, due to the lack of a comprehensive training curriculum, clinicians have had to use various continuing medical education programs and practice in a wound care setting for ≥ 3 years to be eligible for certification in the specialty. This curriculum will help academic medical centers develop their own fellowship programs, enabling new wound care clinicians to attain certifications more efficiently. As more fellowship programs develop, the goal would be to obtain recognition as an ACGME specialty and standardize the training and competencies for graduates of wound care fellowships.

Conclusions

As new wound care fellowships develop, wound care may become formally acknowledged as its own specialty within medicine and surgery. This will provide wound care with a voice at the national level, particularly in an era of value-based care. Wound care clinicians will be able to advocate for specialty-specific quality metrics and avoid potential penalization for not meeting quality metrics that are irrelevant to wound care.

Often disguised as comorbid conditions, nonhealing and chronic wounds have emerged as a silent epidemic that affects about 6.5 million Americans.^1-3 In 2023, estimated US wound care costs were $126.86 billion.⁴ About 1% to 2% of individuals worldwide will experience a chronic wound in their lifetime. The Veterans Health Administration reported 277,000 inpatient and outpatient encounters for ulcers in 2011, including chronic ulcers of the lower extremity due to diabetes, venous disease, or arterial disease.⁵ Associated costs of chronic wounds are expected to increase as the populations of developed countries age.⁶ Effective treatment of chronic wounds requires a nuanced understanding of complex wound pathophysiology, best practices in interdisciplinary and multidisciplinary wound care, and advanced wound care technologies.^7,8

The typical 4-year medical school curriculum, followed by residency, offers little in the way of formal didactic training in wound care.^9,10 Without specialized and advanced fellowship training dedicated to wound care, health care will lack specialists prepared to manage complex wounds. As a result, wound care-related difficulties may be exacerbated by prolonged recovery time, increased costs, productivity loss, and increased mortality risk.⁸ Wound care is a growing field of study and practice, and there is a critical need for rigorous training, research, and quality improvement efforts to enhance outcomes for patients with nonhealing wounds.⁵

One of the most direct ways to address the need for more physicians with specialty training in wound medicine is to implement a comprehensive training curriculum for advanced wound care practice. Although specialized advanced wound care fellowships are available, the curricula primarily detail rotation names and areas for practice without accompanying competencies, milestones, or entrustable professional activities.¹¹ Furthermore, wound care is not recognized as a subspecialty by the Accreditation Council for Graduate Medical Education (ACGME).

This article synthesized the literature and integrated innovative, evidence-based practices into a curriculum for a formal advanced fellowship training program. To our knowledge, no comprehensive wound care curriculum is publicly available that includes rotations, competencies, milestones, entrustable professional activities, and 360-degree evaluation forms.

Program Development

The advanced wound care fellowship program started in January 2014 at the Michael E. DeBakey Veterans Affairs Medical Center in affiliation with the Baylor College of Medicine. The fellowship program was originally designed for geriatrics fellows to extend the 1-year fellowship for an additional year to learn wound care. It has been adjusted to address formal program goals and objectives, competencies, milestones, entrustable professional activities, and evaluations, with the goal of developing an example curriculum for wound care fellowships across specialties. Although the ACGME does not recognize a wound care subspecialty, this curriculum complies with the ACGME 1-year fellowship common program requirements.^12,13

Scoping Review

A scoping literature review of Google Scholar and PubMed was performed using the medical subject heading terms “wound care + curriculum” and “wound + care + curriculum” to find advanced wound care medical training, fellowship programs, boards, and related ACGME-accredited specialty curricula. The local wound care fellowship program was initially implemented based on an informal literature review by faculty and their respective contributions to curriculum (ie, process establishing wound care-specific competency domains in accordance with ACGME accreditation competency requirements of 1-year fellowships). ^12,13 Standing program practice-based competencies and activities were examined and determined to align with best practices. This scoping review considered additional competencies, competency domains, and entrustable professional activities of reputable wound care fellowship training programs (eg, University of Chicago at Illinois and Wake Forest School of Medicine),^8,11,14 a specialty wound care board (American Board of Wound Medicine and Surgery),¹⁵ an international wound specialist professional society (European Union of Medical Specialists), ¹⁶ and recommended curriculum guidelines for wound care residency programs.¹⁷ ACGME-accredited specialty and subspecialty milestones professional activities were examined, including vascular surgery,¹⁸ plastic surgery,¹⁹ dermatology, ²⁰ foot and ankle,²¹ orthopedic surgery,²² spinal cord injury,²³ and geriatric medicine.²⁴

The competencies, milestones, and entrustable professional activities were compiled and redundancies were eliminated. Wound care specialists from geriatrics, family medicine, internal medicine, undersea and hyperbaric medicine, general surgery, podiatry, and physical therapy examined the findings and suggested eliminating redundancies, irrelevant content, and content that fell below the minimal expected level of competence for an advanced medical specialist in wound care. An expert consensus meeting further refined items presented to the panel before unanimous consensus resulted in the final set of curriculum competencies, milestones, and entrustable professional activities.

Training Program Feedback

We developed a comprehensive wound care curriculum for an advanced physician fellowship training program based on the streamlined competencies, milestones, and entrustable professional activities (Appendix). Multiple wound care experts from various interdisciplinary backgrounds reached consensus to establish this fellowship curriculum as adaptable for use across training settings. The training program is 12 core rotations and 2 elective rotations (Table 1). Additionally, we developed wound care evaluation forms for faculty-, peer-, and self-assessment of trainees which were adapted from an evidence-based 360-degree evaluation template.²⁵ Suggestions for structured, advanced didactics are in Table 2.

Seventeen fellows have successfully matriculated through the wound care training program. Although wound care certification is not required to work as a wound care specialist, after completion of this fellowship, graduates are able to sit for a wound care certification examination. The American Board of Wound Medicine and Surgery (ABWMS) and the American Board of Wound Management (ABWM) allow physicians to take a certification examination after 1 year of a dedicated wound fellowship program, instead of the typical wound care practice experience ≥ 3 years.

The Clinical Wound Care Fellowship Program collected data for program improvement, and 15 alumni responded (response rate, 88%) to a survey using a 5-point Likert scale. Respondents indicated high mean scores for overall satisfaction (4.7), instructional methods (4.7), program enjoyment (4.7), teaching materials (4.6), and relevance (4.6). All respondents indicated that the fellowship prepared them for a career in wound care as well as their current employment, and 13 of 15 (87%) reported they obtained immediate relevant postfellowship wound care positions and stated that the fellowship prepared them for their current roles. Nine respondents (69%) reported that they were engaged in wound care ≥ 26% of work time. Six respondents (46%) worked in private practice, 3 (23%) at academic medical centers, and 2 (15%) at government- funded hospitals. Four respondents indicated they were board certified in wound care. Program alumni are currently involved in scholarly activities, including 8 in quality improvement and 3 in research.

Discussion

An easily accessible, comprehensive wound care fellowship curriculum has not been previously developed or published. This limited the sources that informed this curriculum. However, the developmental process for this curriculum was robust, as the authors reviewed previously published materials related to wound care, including: 1) descriptive overviews of wound care fellowships; 2) details of month-long rotations for medical students and residents; and 3) practices of the specific environment in which this curriculum was created. Confidence in the practical nature of the curriculum can be assumed, as the experts involved in the development process represented diverse physician specializations, including geriatrics, family medicine, internal medicine, undersea and hyperbaric medicine, general surgery, podiatry, and physical therapy.

Most wound care clinicians have not completed a formal comprehensive fellowship program. Instead, due to the lack of a comprehensive training curriculum, clinicians have had to use various continuing medical education programs and practice in a wound care setting for ≥ 3 years to be eligible for certification in the specialty. This curriculum will help academic medical centers develop their own fellowship programs, enabling new wound care clinicians to attain certifications more efficiently. As more fellowship programs develop, the goal would be to obtain recognition as an ACGME specialty and standardize the training and competencies for graduates of wound care fellowships.

Conclusions

As new wound care fellowships develop, wound care may become formally acknowledged as its own specialty within medicine and surgery. This will provide wound care with a voice at the national level, particularly in an era of value-based care. Wound care clinicians will be able to advocate for specialty-specific quality metrics and avoid potential penalization for not meeting quality metrics that are irrelevant to wound care.

Often disguised as comorbid conditions, nonhealing and chronic wounds have emerged as a silent epidemic that affects about 6.5 million Americans.^1-3 In 2023, estimated US wound care costs were $126.86 billion.⁴ About 1% to 2% of individuals worldwide will experience a chronic wound in their lifetime. The Veterans Health Administration reported 277,000 inpatient and outpatient encounters for ulcers in 2011, including chronic ulcers of the lower extremity due to diabetes, venous disease, or arterial disease.⁵ Associated costs of chronic wounds are expected to increase as the populations of developed countries age.⁶ Effective treatment of chronic wounds requires a nuanced understanding of complex wound pathophysiology, best practices in interdisciplinary and multidisciplinary wound care, and advanced wound care technologies.^7,8

The typical 4-year medical school curriculum, followed by residency, offers little in the way of formal didactic training in wound care.^9,10 Without specialized and advanced fellowship training dedicated to wound care, health care will lack specialists prepared to manage complex wounds. As a result, wound care-related difficulties may be exacerbated by prolonged recovery time, increased costs, productivity loss, and increased mortality risk.⁸ Wound care is a growing field of study and practice, and there is a critical need for rigorous training, research, and quality improvement efforts to enhance outcomes for patients with nonhealing wounds.⁵

One of the most direct ways to address the need for more physicians with specialty training in wound medicine is to implement a comprehensive training curriculum for advanced wound care practice. Although specialized advanced wound care fellowships are available, the curricula primarily detail rotation names and areas for practice without accompanying competencies, milestones, or entrustable professional activities.¹¹ Furthermore, wound care is not recognized as a subspecialty by the Accreditation Council for Graduate Medical Education (ACGME).

This article synthesized the literature and integrated innovative, evidence-based practices into a curriculum for a formal advanced fellowship training program. To our knowledge, no comprehensive wound care curriculum is publicly available that includes rotations, competencies, milestones, entrustable professional activities, and 360-degree evaluation forms.

Program Development

The advanced wound care fellowship program started in January 2014 at the Michael E. DeBakey Veterans Affairs Medical Center in affiliation with the Baylor College of Medicine. The fellowship program was originally designed for geriatrics fellows to extend the 1-year fellowship for an additional year to learn wound care. It has been adjusted to address formal program goals and objectives, competencies, milestones, entrustable professional activities, and evaluations, with the goal of developing an example curriculum for wound care fellowships across specialties. Although the ACGME does not recognize a wound care subspecialty, this curriculum complies with the ACGME 1-year fellowship common program requirements.^12,13

Scoping Review

A scoping literature review of Google Scholar and PubMed was performed using the medical subject heading terms “wound care + curriculum” and “wound + care + curriculum” to find advanced wound care medical training, fellowship programs, boards, and related ACGME-accredited specialty curricula. The local wound care fellowship program was initially implemented based on an informal literature review by faculty and their respective contributions to curriculum (ie, process establishing wound care-specific competency domains in accordance with ACGME accreditation competency requirements of 1-year fellowships). ^12,13 Standing program practice-based competencies and activities were examined and determined to align with best practices. This scoping review considered additional competencies, competency domains, and entrustable professional activities of reputable wound care fellowship training programs (eg, University of Chicago at Illinois and Wake Forest School of Medicine),^8,11,14 a specialty wound care board (American Board of Wound Medicine and Surgery),¹⁵ an international wound specialist professional society (European Union of Medical Specialists), ¹⁶ and recommended curriculum guidelines for wound care residency programs.¹⁷ ACGME-accredited specialty and subspecialty milestones professional activities were examined, including vascular surgery,¹⁸ plastic surgery,¹⁹ dermatology, ²⁰ foot and ankle,²¹ orthopedic surgery,²² spinal cord injury,²³ and geriatric medicine.²⁴

The competencies, milestones, and entrustable professional activities were compiled and redundancies were eliminated. Wound care specialists from geriatrics, family medicine, internal medicine, undersea and hyperbaric medicine, general surgery, podiatry, and physical therapy examined the findings and suggested eliminating redundancies, irrelevant content, and content that fell below the minimal expected level of competence for an advanced medical specialist in wound care. An expert consensus meeting further refined items presented to the panel before unanimous consensus resulted in the final set of curriculum competencies, milestones, and entrustable professional activities.

Training Program Feedback

We developed a comprehensive wound care curriculum for an advanced physician fellowship training program based on the streamlined competencies, milestones, and entrustable professional activities (Appendix). Multiple wound care experts from various interdisciplinary backgrounds reached consensus to establish this fellowship curriculum as adaptable for use across training settings. The training program is 12 core rotations and 2 elective rotations (Table 1). Additionally, we developed wound care evaluation forms for faculty-, peer-, and self-assessment of trainees which were adapted from an evidence-based 360-degree evaluation template.²⁵ Suggestions for structured, advanced didactics are in Table 2.

Seventeen fellows have successfully matriculated through the wound care training program. Although wound care certification is not required to work as a wound care specialist, after completion of this fellowship, graduates are able to sit for a wound care certification examination. The American Board of Wound Medicine and Surgery (ABWMS) and the American Board of Wound Management (ABWM) allow physicians to take a certification examination after 1 year of a dedicated wound fellowship program, instead of the typical wound care practice experience ≥ 3 years.

The Clinical Wound Care Fellowship Program collected data for program improvement, and 15 alumni responded (response rate, 88%) to a survey using a 5-point Likert scale. Respondents indicated high mean scores for overall satisfaction (4.7), instructional methods (4.7), program enjoyment (4.7), teaching materials (4.6), and relevance (4.6). All respondents indicated that the fellowship prepared them for a career in wound care as well as their current employment, and 13 of 15 (87%) reported they obtained immediate relevant postfellowship wound care positions and stated that the fellowship prepared them for their current roles. Nine respondents (69%) reported that they were engaged in wound care ≥ 26% of work time. Six respondents (46%) worked in private practice, 3 (23%) at academic medical centers, and 2 (15%) at government- funded hospitals. Four respondents indicated they were board certified in wound care. Program alumni are currently involved in scholarly activities, including 8 in quality improvement and 3 in research.

Discussion

An easily accessible, comprehensive wound care fellowship curriculum has not been previously developed or published. This limited the sources that informed this curriculum. However, the developmental process for this curriculum was robust, as the authors reviewed previously published materials related to wound care, including: 1) descriptive overviews of wound care fellowships; 2) details of month-long rotations for medical students and residents; and 3) practices of the specific environment in which this curriculum was created. Confidence in the practical nature of the curriculum can be assumed, as the experts involved in the development process represented diverse physician specializations, including geriatrics, family medicine, internal medicine, undersea and hyperbaric medicine, general surgery, podiatry, and physical therapy.

Most wound care clinicians have not completed a formal comprehensive fellowship program. Instead, due to the lack of a comprehensive training curriculum, clinicians have had to use various continuing medical education programs and practice in a wound care setting for ≥ 3 years to be eligible for certification in the specialty. This curriculum will help academic medical centers develop their own fellowship programs, enabling new wound care clinicians to attain certifications more efficiently. As more fellowship programs develop, the goal would be to obtain recognition as an ACGME specialty and standardize the training and competencies for graduates of wound care fellowships.

Conclusions

As new wound care fellowships develop, wound care may become formally acknowledged as its own specialty within medicine and surgery. This will provide wound care with a voice at the national level, particularly in an era of value-based care. Wound care clinicians will be able to advocate for specialty-specific quality metrics and avoid potential penalization for not meeting quality metrics that are irrelevant to wound care.

The US Department of Veterans Affairs (VA) Home Loan Program, administered by the Veterans Benefits Administration (VBA), is a unique benefit for veterans, active-duty service members, National Guard and Reserve members, and eligible surviving spouses. Established in 1944, the program aims to help these individuals achieve homeownership by leveraging a third-party guarantee, typically from a government agency, to enhance access to credit and improve loan terms for borrowers who may not meet conventional loan qualifications.¹ Since its inception, the VA has guaranteed > 28.5 million loans, enabling millions of veterans to buy, build, repair, retain, or adapt homes for personal occupancy.² The program is designed to support veterans and eligible individuals to become homeowners, recognizing homeownership as a pathway to financial stability and community integration. VA home loans are provided by private lenders (eg, banks, mortgage companies) with a portion guaranteed by the VA, which reduces the risk for lenders and enables them to offer competitive terms, such as no down payment and lower interest rates, making homeownership more accessible to veterans.²

Eligibility criteria for the VA Home Loan Program include military service criteria such as active-duty service members with ≥ 90 continuous days of service; veterans with an honorable discharge meeting minimum service requirements; individuals who served in the National Guard/Reserve for ≥ 90 days of active service or 6 years of service with an honorable discharge; and surviving spouses of veterans who died in service or from a service-connected disability, were designated as missing in action/ prisoner of war, and the spouse is receiving Dependency and Indemnity Compensation. Financial criteria also apply: borrowers must meet lender requirements for credit and income (although VA loans are more flexible than conventional loans) and the home must be for personal occupancy rather than an investment property.³

A June 2025 PubMed literature search did not reveal any prior research on the VA Home Loan Program, although a limited number of studies tackled a wide range of issues related to federal and private home loans.^4-12 To our knowledge, there is no prior published examination of the VA Home Loan Program. Understanding VA Home Loan Program usage among Veterans Health Administration (VHA) users can inform the future direction of the program. The VHA operates the largest integrated US health care system, serving > 9 million enrolled veterans annually at 1321 facilities, including 172 medical centers and 1138 outpatient clinics, providing primary and specialized health care, and related medical and social support services for enrolled veterans, including those who are experiencing housing instability or homelessness.¹³ Specialized VHA programs for homeless veterans include housing, employment, health care, justice, and re-entryrelated services in collaboration with federal and community partners.¹⁴ Housing instability has been defined as the state of being at risk of losing housing due to challenges such as difficulties paying rent, overcrowding, frequent relocation, and a substantial proportion of income spent on housing.^15,16 Homelessness is a severe manifestation of housing instability that has been defined as the lack of stable, safe, and functioning housing.^17,18

Health care and social services, including those that address housing instability and homelessness, are major priorities for the VHA and VBA.¹⁹ The VA Home Loan Program may represent an important resource to help veterans achieve long-term housing stability through home ownership. There has been wide public concern about housing affordability and the ability of many Americans, including veterans, to achieve home ownership.²⁰ Homeownership is considered an important part of developing financial assets and achieving financial stability. Lowincome veterans, in particular, may benefit from this program as a national study found that 8.0% of low-income veterans and 13.9% of veterans with a history of homelessness have previously experienced a home foreclosure. ²¹ A greater understanding of who applies for and receives assistance from the VA Home Loan Program would inform homelessness prevention services and future planning for this program.

We conducted a quality improvement (QI) project on behalf of the VHA Homeless Programs Office and in partnership with the VBA. Our goals were to: (1) describe the annual number of applicants and recipients of the VA Home Loan Program by age group, sex, race/ethnicity, presence of any diagnosed substance use and/or mental health disorder, and history of homelessness; and (2) compare demographic, clinical, and homelessness characteristics among individuals who apply and are granted a loan through this program, individuals who apply and are denied a loan through this program, and individuals who do not apply for a loan through this program.

Methods

This project involved linked VA administrative national databases and was undertaken by the VHA Homeless Programs Office in partnership with the VBA. Specifically, VHA and VBA databases were linked together using veteran identifiers and all data were managed and analyzed on secure VA servers. The project followed VA’s Program Guide 1200.21 for nonresearch activities and institutional review board approval was waived through sponsorship by the VA Homeless Programs Office. The VHA Corporate Data Warehouse (CDW) was accessed to obtain data from the Homeless Operations Management and Evaluation System (HOMES) and other clinical data systems used by VHA clinicians and administrators that capture diagnoses, workload, and other health care data.^22,23 HOMES collects intake, progress, and outcome data on homeless veterans within its care system that enables the VA to assess the effectiveness of programs and strategically allocate resources to prevent homelessness.^24,25

A list of veterans who filed disability compensation and pension claims was obtained from the VBA Office of Performance Analysis and Integrity, including Social Security number, name, city and state, date of claim submission, grant or increase in benefits, homeless status, VA home loan approval, and homeless aid for dependent children from fiscal year (FY) 2022 through FY 2024. VBA data were linked to VHA CDW electronic health record data from veterans who sought VA health care services and HOMES data on veteran participation in homeless programs who were also experiencing homelessness. VHA data included demographic characteristics (eg, sex, age, race, marital status, combat service) at an index date (earliest visit to the VHA between October 1, 2021, and September 30, 2024); military sexual trauma; clinical characteristics within 12 months prior to the index date (VHA disability rating, substance use disorder [SUD] diagnosis, mental health disorder diagnosis, Charlson Comorbidity Index [CCI] score), and homelessness experience ≤ 5 years prior to the index date.

History of homelessness ≤ 5 years prior to the index date was determined using an operational definition of homelessness based on multiple indicators, including International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) diagnostic code Z59.0; clinic stop codes or HOMES records indicating VA homeless programs clinical encounters; or a positive screen on an annual homelessness screener.¹⁶ US Department of Housing and Urban Development-VA Supportive Housing enrollees were excluded because they are considered to no longer be experiencing homelessness, and Veterans Justice Program enrollees were excluded because the program primarily focuses on serving criminal justice-involved veterans. The CCI predicts the risk of death ≤ 1 year by assessing the number and severity of a patient’s coexisting health conditions and is a valuable tool for understanding a patient’s overall health burden, aiding in clinical decision-making and evaluation research studies.^26-29 Diagnoses based on ICD-10-CM codes were used to determine SUDs, mental health disorders, and CCI score, using methods that have been described in other publications.³⁰

Population

The VBA cohort of veterans requesting benefits was further restricted to those who met the following eligibility criteria: (1) requested VA benefits FYs 2022 to 2024; (2) sought VHA services ≥ 1 time between FY 2022 and 2024; (3) had matching VBA/VHA records; (4) had no missing data on claim status and/ or demographic, clinical, and homelessness characteristics; and (5) had known home loan status FYs 2022 to 2024. The original VBA dataset consisted of 4,219,755 records and the original VHA dataset consisted of 7,170,199 records (Figure 1). The final linked VBA/VHA dataset after excluding 29 records with missing data on sex, 7 with missing data on age, 6 with missing data on marital status, and an additional 143,444 with unknown VBA claim status, consisted of 3,089,295 records corresponding to 2,260,851 unique veterans. Specifically, 251,796 records corresponded to veterans who had applied and received a loan, 84,751 to veterans who had applied and were nonrecipients of a loan, and 2,752,748 to veterans who did not apply for a loan.

Statistical Analysis

All statistical analyses were performed using SAS Enterprise Guide, an application that provides a point-and-click interface for data access, analysis, and management, accommodating both code-based and visual programming. ³¹ First, we relied on the final analytic sample to calculate the annual proportions of veterans who applied for and/or received a loan through the VA Home Loan Program. We also generated descriptive statistics stratified by age group, sex, race/ethnicity, SUD, mental health disorder, and homelessness, overall and within each FY. Pearson χ² and Cochran-Armitage trend tests were applied to examine differences in application and receipt of a home loan by baseline characteristics and FY, respectively. Second, we conducted bivariate and multivariable analyses to compare demographic, clinical, and homelessness characteristics between 3 groups of veterans as they pertain to the VA Home Loan Program. Veterans who applied and were nonrecipients of a loan (group 1), veterans who applied and were recipients of a loan (group 2), and veterans who did not apply for a loan (group 3). Similar analyses compared VA Home Loan Program applicants who were recipients of a home loan vs VA Home Loan Program applicants who were nonrecipients of a home loan. Multinomial and binary logistic regression models were constructed to estimate the relative risk ratio (RR) and odds ratio (OR) with 95% CIs for comparisons between these distinct groups on demographic, clinical, and homelessness characteristics. Two-sided statistical tests were evaluated at α = 0.05.

Results

Tables 1 and 2 present the number of VBA applicants, including those who applied for and received benefits through the VA Home Loan Program, by age group, sex, race/ethnicity, as well as histories of SUDs, mental health disorders, and homelessness, overall, and by FY. As shown in Figure 2, 336,547 of 3,089,295 VBA applications (10.9%) pertained to the VA Home Loan Program, with a statistically significant decline in application rates, from 12.2% in FY 2022 to 9.9% in FY 2024 (P < .001 for trend). Among 336,547 veterans who applied for the VA Home Loan Program, 251,796 (74.8%) received a home loan during FYs 2022 to 2024, ranging between 73.8% for FY 2024 and 75.5% for FY 2023 (P < .001 for trend).

Multinomial logistic regression models for demographic, clinical, and homelessness characteristics as predictors of VA Home Loan Program status are provided in Appendix 1. Based on the fully adjusted model, compared with veterans who did not apply to the VA Home Loan Program, those who applied for a home loan were less likely to be aged ≥ 50 years, unmarried, Hispanic ethnicity, mixed race, or other race, diagnosed with a SUD, or history of homelessness. Veterans with higher VA service-connected disability ratings were more frequently recipients of VA home loans, whereas those who self-identified as non-Hispanic Black and those with higher CCI scores were less frequently recipients of VA home loans. Finally, those with mental health disorders were more likely than their counterparts to be applicants (recipients or nonrecipients) of VA home loans.

Binary logistic regression models for demographic, clinical, and homelessness characteristics as predictors of receipt status among applicants to the VA Home Loan Program are provided in Appendix 2. Among applicants, those who were granted a VA home loan were less likely to be aged ≥ 50 years; have a CCI score > 0; have experienced combat service and/or military sexual trauma; be diagnosed with a SUD and/or mental health disorder; or to have a history of homelessness compared with those denied a VA home loan. Applicants granted a VA home loan were also more likely to be female, non-Hispanic White, single or never married, and/or have a VA service-connected disability ratings > 0%.

Discussion

The VA Home Loan Program is a unique benefit and resource for eligible veterans that may be increasingly important in a time of growing concern about the affordability of housing for many Americans. Research on other federally-supported home loan programs as well as private home mortgage programs has been mostly conducted in the economic realm, and studies focused on understanding these programs from a health care system perspective have been sparse.^32,33 However, there is a large body of literature documenting the importance of stable, safe, and secure housing on health and well-being.^34-37 This study did not focus on evaluating the effects of the VA Home Loan Program, because we wanted to first examine the characteristics of veterans who benefited from the program and how they differed from veterans who did not apply or did apply but had a denied application.

Our findings suggest that several thousands of veterans benefit from the VA Home Loan Program each year. For historical context, the time period examined was one of economic downturn with rising costs of living, including housing, and steady increases in homelessness as reported in the annual point-in-time count of sheltered and unsheltered people experiencing homelessness on a single night as mandated by the US Department of Housing and Urban Development.^38-40 The Sergeant First Class Heath Robinson Honoring Our Promise to Address Comprehensive Toxics (PACT) Act of 2022 expanded health care and benefits for veterans exposed to burn pits, Agent Orange, and other toxic substances, resulting in more VA disability benefit claims, including large retroactive payments.^41-43 Anecdotally, the VBA has noted that the PACT Act helped some homeless veterans with funds and stability to exit homelessness and enroll in the VA Home Loan Program.

Our analysis suggests that beneficiaries of the VA Home Loan Program were frequently aged < 50 years, female, of non-Hispanic White race, and did not have histories of psychiatric disorders or homelessness. Most of these demographic and clinical characteristics were not surprising given the composition of the veteran population, although in-depth analyses are needed to examine sex differences that may have led to more females than males benefiting from the VA Home Loan Program. In addition, it was notable that many younger and non-Hispanic Black veterans had applied. While relatively few veterans with SUDs benefited from the VA Home Loan Program, few had applied. Research is warranted into why veterans with SUDs are less likely to apply for home loans. Quite surprisingly, a sizable proportion of veterans with histories of homelessness reported they had applied to the VA Home Loan Program, although they were less likely than veterans who had not experienced homelessness to be granted a loan.

The examination of differences between veterans who did not apply, were granted, and denied a loan through the VA Home Loan Program revealed several key predictors of application outcomes in multivariable models. Specifically, veterans who applied for home loans were less likely to be aged ≥ 50 years, unmarried, of Hispanic, mixed, or other race/ethnicity, diagnosed with an SUD, or have a history of homelessness. Veterans with higher disability ratings were less frequently denied and more frequently approved, while non-Hispanic Black veterans and those with higher CCI scores were more frequently denied and less frequently approved. VBA applicants with mental health disorders were also more likely to apply for a home loan. Conversely, those granted a home loan were more likely than those denied a home loan to be female, non-Hispanic White, single/unmarried, or to have > 0% VA service-connected disability rating, but less likely to be aged ≥ 50 years, have CCI score > 0, be diagnosed with psychiatric disorders, or have a history of homelessness.

Limitations

This analysis was restricted to a subset of FY 2022 to FY 2024 linked VBA/VHA databases (ie, to veterans who had both VBA and VHA records and met prespecified eligibility criteria). Despite the large number of linked records, a small percentage of these records corresponded to veterans who were applicants or recipients of the VA Home Loan Program. Future studies should expand the time frame to examine variations in application outcomes over time and by background characteristics of veterans enrolled in VHA care who applied for VBA benefits. In addition, we relied on data and ICD-10-CM diagnostic codes from existing electronic health records and claims data to define histories of homelessness, comorbidities, SUDs, and mental health disorders. Given the time-varying nature of these conditions, the temporal sequence of events was difficult to ascertain. Third, it is worth noting that these findings can only be generalized to veterans who applied for VBA benefits and met eligibility criteria, and that these veterans may differ in terms of their demographic and clinical characteristics from those who did not apply for these benefits.

Conclusions

This study analyzed data from 251,796 individuals who applied for and received a VA home loan, 84,751 who were denied a VA home loan, and 2,752,748 veterans who did not apply for a VA home loan from FY 2022 to FY 2024. Accordingly, 11% of applications pertained to the VA Home Loan Program, and 75% of VA Home Loan Program applicants received a home loan. Distinct demographic and clinical characteristics were observed for applicants and recipients of the VA Home Loan Program, which can set the stage for future planning and evaluation of the program. Despite the broad accessibility of veterans to the VA Home Loan Program, there were differences in approval rates among applicants based on sociodemographic and clinical characteristics. Further evaluation, perhaps using qualitative methods, is needed to better understand opportunities and challenges to achieving a VA home loan, especially among underserved veteran populations. Investigation and research can guide future recommendations for any development or corrective actions that can help increase access to veterans who can benefit from the program. Future analyses are also needed to compare veterans enrolled and not enrolled in the VA Home Loan Program on health care-related outcomes.

The US Department of Veterans Affairs (VA) Home Loan Program, administered by the Veterans Benefits Administration (VBA), is a unique benefit for veterans, active-duty service members, National Guard and Reserve members, and eligible surviving spouses. Established in 1944, the program aims to help these individuals achieve homeownership by leveraging a third-party guarantee, typically from a government agency, to enhance access to credit and improve loan terms for borrowers who may not meet conventional loan qualifications.¹ Since its inception, the VA has guaranteed > 28.5 million loans, enabling millions of veterans to buy, build, repair, retain, or adapt homes for personal occupancy.² The program is designed to support veterans and eligible individuals to become homeowners, recognizing homeownership as a pathway to financial stability and community integration. VA home loans are provided by private lenders (eg, banks, mortgage companies) with a portion guaranteed by the VA, which reduces the risk for lenders and enables them to offer competitive terms, such as no down payment and lower interest rates, making homeownership more accessible to veterans.²

Eligibility criteria for the VA Home Loan Program include military service criteria such as active-duty service members with ≥ 90 continuous days of service; veterans with an honorable discharge meeting minimum service requirements; individuals who served in the National Guard/Reserve for ≥ 90 days of active service or 6 years of service with an honorable discharge; and surviving spouses of veterans who died in service or from a service-connected disability, were designated as missing in action/ prisoner of war, and the spouse is receiving Dependency and Indemnity Compensation. Financial criteria also apply: borrowers must meet lender requirements for credit and income (although VA loans are more flexible than conventional loans) and the home must be for personal occupancy rather than an investment property.³

A June 2025 PubMed literature search did not reveal any prior research on the VA Home Loan Program, although a limited number of studies tackled a wide range of issues related to federal and private home loans.^4-12 To our knowledge, there is no prior published examination of the VA Home Loan Program. Understanding VA Home Loan Program usage among Veterans Health Administration (VHA) users can inform the future direction of the program. The VHA operates the largest integrated US health care system, serving > 9 million enrolled veterans annually at 1321 facilities, including 172 medical centers and 1138 outpatient clinics, providing primary and specialized health care, and related medical and social support services for enrolled veterans, including those who are experiencing housing instability or homelessness.¹³ Specialized VHA programs for homeless veterans include housing, employment, health care, justice, and re-entryrelated services in collaboration with federal and community partners.¹⁴ Housing instability has been defined as the state of being at risk of losing housing due to challenges such as difficulties paying rent, overcrowding, frequent relocation, and a substantial proportion of income spent on housing.^15,16 Homelessness is a severe manifestation of housing instability that has been defined as the lack of stable, safe, and functioning housing.^17,18

Health care and social services, including those that address housing instability and homelessness, are major priorities for the VHA and VBA.¹⁹ The VA Home Loan Program may represent an important resource to help veterans achieve long-term housing stability through home ownership. There has been wide public concern about housing affordability and the ability of many Americans, including veterans, to achieve home ownership.²⁰ Homeownership is considered an important part of developing financial assets and achieving financial stability. Lowincome veterans, in particular, may benefit from this program as a national study found that 8.0% of low-income veterans and 13.9% of veterans with a history of homelessness have previously experienced a home foreclosure. ²¹ A greater understanding of who applies for and receives assistance from the VA Home Loan Program would inform homelessness prevention services and future planning for this program.

We conducted a quality improvement (QI) project on behalf of the VHA Homeless Programs Office and in partnership with the VBA. Our goals were to: (1) describe the annual number of applicants and recipients of the VA Home Loan Program by age group, sex, race/ethnicity, presence of any diagnosed substance use and/or mental health disorder, and history of homelessness; and (2) compare demographic, clinical, and homelessness characteristics among individuals who apply and are granted a loan through this program, individuals who apply and are denied a loan through this program, and individuals who do not apply for a loan through this program.

Methods

This project involved linked VA administrative national databases and was undertaken by the VHA Homeless Programs Office in partnership with the VBA. Specifically, VHA and VBA databases were linked together using veteran identifiers and all data were managed and analyzed on secure VA servers. The project followed VA’s Program Guide 1200.21 for nonresearch activities and institutional review board approval was waived through sponsorship by the VA Homeless Programs Office. The VHA Corporate Data Warehouse (CDW) was accessed to obtain data from the Homeless Operations Management and Evaluation System (HOMES) and other clinical data systems used by VHA clinicians and administrators that capture diagnoses, workload, and other health care data.^22,23 HOMES collects intake, progress, and outcome data on homeless veterans within its care system that enables the VA to assess the effectiveness of programs and strategically allocate resources to prevent homelessness.^24,25

A list of veterans who filed disability compensation and pension claims was obtained from the VBA Office of Performance Analysis and Integrity, including Social Security number, name, city and state, date of claim submission, grant or increase in benefits, homeless status, VA home loan approval, and homeless aid for dependent children from fiscal year (FY) 2022 through FY 2024. VBA data were linked to VHA CDW electronic health record data from veterans who sought VA health care services and HOMES data on veteran participation in homeless programs who were also experiencing homelessness. VHA data included demographic characteristics (eg, sex, age, race, marital status, combat service) at an index date (earliest visit to the VHA between October 1, 2021, and September 30, 2024); military sexual trauma; clinical characteristics within 12 months prior to the index date (VHA disability rating, substance use disorder [SUD] diagnosis, mental health disorder diagnosis, Charlson Comorbidity Index [CCI] score), and homelessness experience ≤ 5 years prior to the index date.

History of homelessness ≤ 5 years prior to the index date was determined using an operational definition of homelessness based on multiple indicators, including International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) diagnostic code Z59.0; clinic stop codes or HOMES records indicating VA homeless programs clinical encounters; or a positive screen on an annual homelessness screener.¹⁶ US Department of Housing and Urban Development-VA Supportive Housing enrollees were excluded because they are considered to no longer be experiencing homelessness, and Veterans Justice Program enrollees were excluded because the program primarily focuses on serving criminal justice-involved veterans. The CCI predicts the risk of death ≤ 1 year by assessing the number and severity of a patient’s coexisting health conditions and is a valuable tool for understanding a patient’s overall health burden, aiding in clinical decision-making and evaluation research studies.^26-29 Diagnoses based on ICD-10-CM codes were used to determine SUDs, mental health disorders, and CCI score, using methods that have been described in other publications.³⁰

Population

The VBA cohort of veterans requesting benefits was further restricted to those who met the following eligibility criteria: (1) requested VA benefits FYs 2022 to 2024; (2) sought VHA services ≥ 1 time between FY 2022 and 2024; (3) had matching VBA/VHA records; (4) had no missing data on claim status and/ or demographic, clinical, and homelessness characteristics; and (5) had known home loan status FYs 2022 to 2024. The original VBA dataset consisted of 4,219,755 records and the original VHA dataset consisted of 7,170,199 records (Figure 1). The final linked VBA/VHA dataset after excluding 29 records with missing data on sex, 7 with missing data on age, 6 with missing data on marital status, and an additional 143,444 with unknown VBA claim status, consisted of 3,089,295 records corresponding to 2,260,851 unique veterans. Specifically, 251,796 records corresponded to veterans who had applied and received a loan, 84,751 to veterans who had applied and were nonrecipients of a loan, and 2,752,748 to veterans who did not apply for a loan.

Statistical Analysis

All statistical analyses were performed using SAS Enterprise Guide, an application that provides a point-and-click interface for data access, analysis, and management, accommodating both code-based and visual programming. ³¹ First, we relied on the final analytic sample to calculate the annual proportions of veterans who applied for and/or received a loan through the VA Home Loan Program. We also generated descriptive statistics stratified by age group, sex, race/ethnicity, SUD, mental health disorder, and homelessness, overall and within each FY. Pearson χ² and Cochran-Armitage trend tests were applied to examine differences in application and receipt of a home loan by baseline characteristics and FY, respectively. Second, we conducted bivariate and multivariable analyses to compare demographic, clinical, and homelessness characteristics between 3 groups of veterans as they pertain to the VA Home Loan Program. Veterans who applied and were nonrecipients of a loan (group 1), veterans who applied and were recipients of a loan (group 2), and veterans who did not apply for a loan (group 3). Similar analyses compared VA Home Loan Program applicants who were recipients of a home loan vs VA Home Loan Program applicants who were nonrecipients of a home loan. Multinomial and binary logistic regression models were constructed to estimate the relative risk ratio (RR) and odds ratio (OR) with 95% CIs for comparisons between these distinct groups on demographic, clinical, and homelessness characteristics. Two-sided statistical tests were evaluated at α = 0.05.

Results

Tables 1 and 2 present the number of VBA applicants, including those who applied for and received benefits through the VA Home Loan Program, by age group, sex, race/ethnicity, as well as histories of SUDs, mental health disorders, and homelessness, overall, and by FY. As shown in Figure 2, 336,547 of 3,089,295 VBA applications (10.9%) pertained to the VA Home Loan Program, with a statistically significant decline in application rates, from 12.2% in FY 2022 to 9.9% in FY 2024 (P < .001 for trend). Among 336,547 veterans who applied for the VA Home Loan Program, 251,796 (74.8%) received a home loan during FYs 2022 to 2024, ranging between 73.8% for FY 2024 and 75.5% for FY 2023 (P < .001 for trend).

Multinomial logistic regression models for demographic, clinical, and homelessness characteristics as predictors of VA Home Loan Program status are provided in Appendix 1. Based on the fully adjusted model, compared with veterans who did not apply to the VA Home Loan Program, those who applied for a home loan were less likely to be aged ≥ 50 years, unmarried, Hispanic ethnicity, mixed race, or other race, diagnosed with a SUD, or history of homelessness. Veterans with higher VA service-connected disability ratings were more frequently recipients of VA home loans, whereas those who self-identified as non-Hispanic Black and those with higher CCI scores were less frequently recipients of VA home loans. Finally, those with mental health disorders were more likely than their counterparts to be applicants (recipients or nonrecipients) of VA home loans.

Binary logistic regression models for demographic, clinical, and homelessness characteristics as predictors of receipt status among applicants to the VA Home Loan Program are provided in Appendix 2. Among applicants, those who were granted a VA home loan were less likely to be aged ≥ 50 years; have a CCI score > 0; have experienced combat service and/or military sexual trauma; be diagnosed with a SUD and/or mental health disorder; or to have a history of homelessness compared with those denied a VA home loan. Applicants granted a VA home loan were also more likely to be female, non-Hispanic White, single or never married, and/or have a VA service-connected disability ratings > 0%.

Discussion

The VA Home Loan Program is a unique benefit and resource for eligible veterans that may be increasingly important in a time of growing concern about the affordability of housing for many Americans. Research on other federally-supported home loan programs as well as private home mortgage programs has been mostly conducted in the economic realm, and studies focused on understanding these programs from a health care system perspective have been sparse.^32,33 However, there is a large body of literature documenting the importance of stable, safe, and secure housing on health and well-being.^34-37 This study did not focus on evaluating the effects of the VA Home Loan Program, because we wanted to first examine the characteristics of veterans who benefited from the program and how they differed from veterans who did not apply or did apply but had a denied application.

Our findings suggest that several thousands of veterans benefit from the VA Home Loan Program each year. For historical context, the time period examined was one of economic downturn with rising costs of living, including housing, and steady increases in homelessness as reported in the annual point-in-time count of sheltered and unsheltered people experiencing homelessness on a single night as mandated by the US Department of Housing and Urban Development.^38-40 The Sergeant First Class Heath Robinson Honoring Our Promise to Address Comprehensive Toxics (PACT) Act of 2022 expanded health care and benefits for veterans exposed to burn pits, Agent Orange, and other toxic substances, resulting in more VA disability benefit claims, including large retroactive payments.^41-43 Anecdotally, the VBA has noted that the PACT Act helped some homeless veterans with funds and stability to exit homelessness and enroll in the VA Home Loan Program.

Our analysis suggests that beneficiaries of the VA Home Loan Program were frequently aged < 50 years, female, of non-Hispanic White race, and did not have histories of psychiatric disorders or homelessness. Most of these demographic and clinical characteristics were not surprising given the composition of the veteran population, although in-depth analyses are needed to examine sex differences that may have led to more females than males benefiting from the VA Home Loan Program. In addition, it was notable that many younger and non-Hispanic Black veterans had applied. While relatively few veterans with SUDs benefited from the VA Home Loan Program, few had applied. Research is warranted into why veterans with SUDs are less likely to apply for home loans. Quite surprisingly, a sizable proportion of veterans with histories of homelessness reported they had applied to the VA Home Loan Program, although they were less likely than veterans who had not experienced homelessness to be granted a loan.

The examination of differences between veterans who did not apply, were granted, and denied a loan through the VA Home Loan Program revealed several key predictors of application outcomes in multivariable models. Specifically, veterans who applied for home loans were less likely to be aged ≥ 50 years, unmarried, of Hispanic, mixed, or other race/ethnicity, diagnosed with an SUD, or have a history of homelessness. Veterans with higher disability ratings were less frequently denied and more frequently approved, while non-Hispanic Black veterans and those with higher CCI scores were more frequently denied and less frequently approved. VBA applicants with mental health disorders were also more likely to apply for a home loan. Conversely, those granted a home loan were more likely than those denied a home loan to be female, non-Hispanic White, single/unmarried, or to have > 0% VA service-connected disability rating, but less likely to be aged ≥ 50 years, have CCI score > 0, be diagnosed with psychiatric disorders, or have a history of homelessness.

Limitations

This analysis was restricted to a subset of FY 2022 to FY 2024 linked VBA/VHA databases (ie, to veterans who had both VBA and VHA records and met prespecified eligibility criteria). Despite the large number of linked records, a small percentage of these records corresponded to veterans who were applicants or recipients of the VA Home Loan Program. Future studies should expand the time frame to examine variations in application outcomes over time and by background characteristics of veterans enrolled in VHA care who applied for VBA benefits. In addition, we relied on data and ICD-10-CM diagnostic codes from existing electronic health records and claims data to define histories of homelessness, comorbidities, SUDs, and mental health disorders. Given the time-varying nature of these conditions, the temporal sequence of events was difficult to ascertain. Third, it is worth noting that these findings can only be generalized to veterans who applied for VBA benefits and met eligibility criteria, and that these veterans may differ in terms of their demographic and clinical characteristics from those who did not apply for these benefits.

Conclusions

This study analyzed data from 251,796 individuals who applied for and received a VA home loan, 84,751 who were denied a VA home loan, and 2,752,748 veterans who did not apply for a VA home loan from FY 2022 to FY 2024. Accordingly, 11% of applications pertained to the VA Home Loan Program, and 75% of VA Home Loan Program applicants received a home loan. Distinct demographic and clinical characteristics were observed for applicants and recipients of the VA Home Loan Program, which can set the stage for future planning and evaluation of the program. Despite the broad accessibility of veterans to the VA Home Loan Program, there were differences in approval rates among applicants based on sociodemographic and clinical characteristics. Further evaluation, perhaps using qualitative methods, is needed to better understand opportunities and challenges to achieving a VA home loan, especially among underserved veteran populations. Investigation and research can guide future recommendations for any development or corrective actions that can help increase access to veterans who can benefit from the program. Future analyses are also needed to compare veterans enrolled and not enrolled in the VA Home Loan Program on health care-related outcomes.

The US Department of Veterans Affairs (VA) Home Loan Program, administered by the Veterans Benefits Administration (VBA), is a unique benefit for veterans, active-duty service members, National Guard and Reserve members, and eligible surviving spouses. Established in 1944, the program aims to help these individuals achieve homeownership by leveraging a third-party guarantee, typically from a government agency, to enhance access to credit and improve loan terms for borrowers who may not meet conventional loan qualifications.¹ Since its inception, the VA has guaranteed > 28.5 million loans, enabling millions of veterans to buy, build, repair, retain, or adapt homes for personal occupancy.² The program is designed to support veterans and eligible individuals to become homeowners, recognizing homeownership as a pathway to financial stability and community integration. VA home loans are provided by private lenders (eg, banks, mortgage companies) with a portion guaranteed by the VA, which reduces the risk for lenders and enables them to offer competitive terms, such as no down payment and lower interest rates, making homeownership more accessible to veterans.²

Eligibility criteria for the VA Home Loan Program include military service criteria such as active-duty service members with ≥ 90 continuous days of service; veterans with an honorable discharge meeting minimum service requirements; individuals who served in the National Guard/Reserve for ≥ 90 days of active service or 6 years of service with an honorable discharge; and surviving spouses of veterans who died in service or from a service-connected disability, were designated as missing in action/ prisoner of war, and the spouse is receiving Dependency and Indemnity Compensation. Financial criteria also apply: borrowers must meet lender requirements for credit and income (although VA loans are more flexible than conventional loans) and the home must be for personal occupancy rather than an investment property.³

A June 2025 PubMed literature search did not reveal any prior research on the VA Home Loan Program, although a limited number of studies tackled a wide range of issues related to federal and private home loans.^4-12 To our knowledge, there is no prior published examination of the VA Home Loan Program. Understanding VA Home Loan Program usage among Veterans Health Administration (VHA) users can inform the future direction of the program. The VHA operates the largest integrated US health care system, serving > 9 million enrolled veterans annually at 1321 facilities, including 172 medical centers and 1138 outpatient clinics, providing primary and specialized health care, and related medical and social support services for enrolled veterans, including those who are experiencing housing instability or homelessness.¹³ Specialized VHA programs for homeless veterans include housing, employment, health care, justice, and re-entryrelated services in collaboration with federal and community partners.¹⁴ Housing instability has been defined as the state of being at risk of losing housing due to challenges such as difficulties paying rent, overcrowding, frequent relocation, and a substantial proportion of income spent on housing.^15,16 Homelessness is a severe manifestation of housing instability that has been defined as the lack of stable, safe, and functioning housing.^17,18

Health care and social services, including those that address housing instability and homelessness, are major priorities for the VHA and VBA.¹⁹ The VA Home Loan Program may represent an important resource to help veterans achieve long-term housing stability through home ownership. There has been wide public concern about housing affordability and the ability of many Americans, including veterans, to achieve home ownership.²⁰ Homeownership is considered an important part of developing financial assets and achieving financial stability. Lowincome veterans, in particular, may benefit from this program as a national study found that 8.0% of low-income veterans and 13.9% of veterans with a history of homelessness have previously experienced a home foreclosure. ²¹ A greater understanding of who applies for and receives assistance from the VA Home Loan Program would inform homelessness prevention services and future planning for this program.

We conducted a quality improvement (QI) project on behalf of the VHA Homeless Programs Office and in partnership with the VBA. Our goals were to: (1) describe the annual number of applicants and recipients of the VA Home Loan Program by age group, sex, race/ethnicity, presence of any diagnosed substance use and/or mental health disorder, and history of homelessness; and (2) compare demographic, clinical, and homelessness characteristics among individuals who apply and are granted a loan through this program, individuals who apply and are denied a loan through this program, and individuals who do not apply for a loan through this program.

Methods

This project involved linked VA administrative national databases and was undertaken by the VHA Homeless Programs Office in partnership with the VBA. Specifically, VHA and VBA databases were linked together using veteran identifiers and all data were managed and analyzed on secure VA servers. The project followed VA’s Program Guide 1200.21 for nonresearch activities and institutional review board approval was waived through sponsorship by the VA Homeless Programs Office. The VHA Corporate Data Warehouse (CDW) was accessed to obtain data from the Homeless Operations Management and Evaluation System (HOMES) and other clinical data systems used by VHA clinicians and administrators that capture diagnoses, workload, and other health care data.^22,23 HOMES collects intake, progress, and outcome data on homeless veterans within its care system that enables the VA to assess the effectiveness of programs and strategically allocate resources to prevent homelessness.^24,25

A list of veterans who filed disability compensation and pension claims was obtained from the VBA Office of Performance Analysis and Integrity, including Social Security number, name, city and state, date of claim submission, grant or increase in benefits, homeless status, VA home loan approval, and homeless aid for dependent children from fiscal year (FY) 2022 through FY 2024. VBA data were linked to VHA CDW electronic health record data from veterans who sought VA health care services and HOMES data on veteran participation in homeless programs who were also experiencing homelessness. VHA data included demographic characteristics (eg, sex, age, race, marital status, combat service) at an index date (earliest visit to the VHA between October 1, 2021, and September 30, 2024); military sexual trauma; clinical characteristics within 12 months prior to the index date (VHA disability rating, substance use disorder [SUD] diagnosis, mental health disorder diagnosis, Charlson Comorbidity Index [CCI] score), and homelessness experience ≤ 5 years prior to the index date.

History of homelessness ≤ 5 years prior to the index date was determined using an operational definition of homelessness based on multiple indicators, including International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) diagnostic code Z59.0; clinic stop codes or HOMES records indicating VA homeless programs clinical encounters; or a positive screen on an annual homelessness screener.¹⁶ US Department of Housing and Urban Development-VA Supportive Housing enrollees were excluded because they are considered to no longer be experiencing homelessness, and Veterans Justice Program enrollees were excluded because the program primarily focuses on serving criminal justice-involved veterans. The CCI predicts the risk of death ≤ 1 year by assessing the number and severity of a patient’s coexisting health conditions and is a valuable tool for understanding a patient’s overall health burden, aiding in clinical decision-making and evaluation research studies.^26-29 Diagnoses based on ICD-10-CM codes were used to determine SUDs, mental health disorders, and CCI score, using methods that have been described in other publications.³⁰

Population

The VBA cohort of veterans requesting benefits was further restricted to those who met the following eligibility criteria: (1) requested VA benefits FYs 2022 to 2024; (2) sought VHA services ≥ 1 time between FY 2022 and 2024; (3) had matching VBA/VHA records; (4) had no missing data on claim status and/ or demographic, clinical, and homelessness characteristics; and (5) had known home loan status FYs 2022 to 2024. The original VBA dataset consisted of 4,219,755 records and the original VHA dataset consisted of 7,170,199 records (Figure 1). The final linked VBA/VHA dataset after excluding 29 records with missing data on sex, 7 with missing data on age, 6 with missing data on marital status, and an additional 143,444 with unknown VBA claim status, consisted of 3,089,295 records corresponding to 2,260,851 unique veterans. Specifically, 251,796 records corresponded to veterans who had applied and received a loan, 84,751 to veterans who had applied and were nonrecipients of a loan, and 2,752,748 to veterans who did not apply for a loan.

Statistical Analysis

All statistical analyses were performed using SAS Enterprise Guide, an application that provides a point-and-click interface for data access, analysis, and management, accommodating both code-based and visual programming. ³¹ First, we relied on the final analytic sample to calculate the annual proportions of veterans who applied for and/or received a loan through the VA Home Loan Program. We also generated descriptive statistics stratified by age group, sex, race/ethnicity, SUD, mental health disorder, and homelessness, overall and within each FY. Pearson χ² and Cochran-Armitage trend tests were applied to examine differences in application and receipt of a home loan by baseline characteristics and FY, respectively. Second, we conducted bivariate and multivariable analyses to compare demographic, clinical, and homelessness characteristics between 3 groups of veterans as they pertain to the VA Home Loan Program. Veterans who applied and were nonrecipients of a loan (group 1), veterans who applied and were recipients of a loan (group 2), and veterans who did not apply for a loan (group 3). Similar analyses compared VA Home Loan Program applicants who were recipients of a home loan vs VA Home Loan Program applicants who were nonrecipients of a home loan. Multinomial and binary logistic regression models were constructed to estimate the relative risk ratio (RR) and odds ratio (OR) with 95% CIs for comparisons between these distinct groups on demographic, clinical, and homelessness characteristics. Two-sided statistical tests were evaluated at α = 0.05.

Results

Tables 1 and 2 present the number of VBA applicants, including those who applied for and received benefits through the VA Home Loan Program, by age group, sex, race/ethnicity, as well as histories of SUDs, mental health disorders, and homelessness, overall, and by FY. As shown in Figure 2, 336,547 of 3,089,295 VBA applications (10.9%) pertained to the VA Home Loan Program, with a statistically significant decline in application rates, from 12.2% in FY 2022 to 9.9% in FY 2024 (P < .001 for trend). Among 336,547 veterans who applied for the VA Home Loan Program, 251,796 (74.8%) received a home loan during FYs 2022 to 2024, ranging between 73.8% for FY 2024 and 75.5% for FY 2023 (P < .001 for trend).

Multinomial logistic regression models for demographic, clinical, and homelessness characteristics as predictors of VA Home Loan Program status are provided in Appendix 1. Based on the fully adjusted model, compared with veterans who did not apply to the VA Home Loan Program, those who applied for a home loan were less likely to be aged ≥ 50 years, unmarried, Hispanic ethnicity, mixed race, or other race, diagnosed with a SUD, or history of homelessness. Veterans with higher VA service-connected disability ratings were more frequently recipients of VA home loans, whereas those who self-identified as non-Hispanic Black and those with higher CCI scores were less frequently recipients of VA home loans. Finally, those with mental health disorders were more likely than their counterparts to be applicants (recipients or nonrecipients) of VA home loans.

Binary logistic regression models for demographic, clinical, and homelessness characteristics as predictors of receipt status among applicants to the VA Home Loan Program are provided in Appendix 2. Among applicants, those who were granted a VA home loan were less likely to be aged ≥ 50 years; have a CCI score > 0; have experienced combat service and/or military sexual trauma; be diagnosed with a SUD and/or mental health disorder; or to have a history of homelessness compared with those denied a VA home loan. Applicants granted a VA home loan were also more likely to be female, non-Hispanic White, single or never married, and/or have a VA service-connected disability ratings > 0%.

Discussion

The VA Home Loan Program is a unique benefit and resource for eligible veterans that may be increasingly important in a time of growing concern about the affordability of housing for many Americans. Research on other federally-supported home loan programs as well as private home mortgage programs has been mostly conducted in the economic realm, and studies focused on understanding these programs from a health care system perspective have been sparse.^32,33 However, there is a large body of literature documenting the importance of stable, safe, and secure housing on health and well-being.^34-37 This study did not focus on evaluating the effects of the VA Home Loan Program, because we wanted to first examine the characteristics of veterans who benefited from the program and how they differed from veterans who did not apply or did apply but had a denied application.

Our findings suggest that several thousands of veterans benefit from the VA Home Loan Program each year. For historical context, the time period examined was one of economic downturn with rising costs of living, including housing, and steady increases in homelessness as reported in the annual point-in-time count of sheltered and unsheltered people experiencing homelessness on a single night as mandated by the US Department of Housing and Urban Development.^38-40 The Sergeant First Class Heath Robinson Honoring Our Promise to Address Comprehensive Toxics (PACT) Act of 2022 expanded health care and benefits for veterans exposed to burn pits, Agent Orange, and other toxic substances, resulting in more VA disability benefit claims, including large retroactive payments.^41-43 Anecdotally, the VBA has noted that the PACT Act helped some homeless veterans with funds and stability to exit homelessness and enroll in the VA Home Loan Program.

Our analysis suggests that beneficiaries of the VA Home Loan Program were frequently aged < 50 years, female, of non-Hispanic White race, and did not have histories of psychiatric disorders or homelessness. Most of these demographic and clinical characteristics were not surprising given the composition of the veteran population, although in-depth analyses are needed to examine sex differences that may have led to more females than males benefiting from the VA Home Loan Program. In addition, it was notable that many younger and non-Hispanic Black veterans had applied. While relatively few veterans with SUDs benefited from the VA Home Loan Program, few had applied. Research is warranted into why veterans with SUDs are less likely to apply for home loans. Quite surprisingly, a sizable proportion of veterans with histories of homelessness reported they had applied to the VA Home Loan Program, although they were less likely than veterans who had not experienced homelessness to be granted a loan.

The examination of differences between veterans who did not apply, were granted, and denied a loan through the VA Home Loan Program revealed several key predictors of application outcomes in multivariable models. Specifically, veterans who applied for home loans were less likely to be aged ≥ 50 years, unmarried, of Hispanic, mixed, or other race/ethnicity, diagnosed with an SUD, or have a history of homelessness. Veterans with higher disability ratings were less frequently denied and more frequently approved, while non-Hispanic Black veterans and those with higher CCI scores were more frequently denied and less frequently approved. VBA applicants with mental health disorders were also more likely to apply for a home loan. Conversely, those granted a home loan were more likely than those denied a home loan to be female, non-Hispanic White, single/unmarried, or to have > 0% VA service-connected disability rating, but less likely to be aged ≥ 50 years, have CCI score > 0, be diagnosed with psychiatric disorders, or have a history of homelessness.

Limitations

This analysis was restricted to a subset of FY 2022 to FY 2024 linked VBA/VHA databases (ie, to veterans who had both VBA and VHA records and met prespecified eligibility criteria). Despite the large number of linked records, a small percentage of these records corresponded to veterans who were applicants or recipients of the VA Home Loan Program. Future studies should expand the time frame to examine variations in application outcomes over time and by background characteristics of veterans enrolled in VHA care who applied for VBA benefits. In addition, we relied on data and ICD-10-CM diagnostic codes from existing electronic health records and claims data to define histories of homelessness, comorbidities, SUDs, and mental health disorders. Given the time-varying nature of these conditions, the temporal sequence of events was difficult to ascertain. Third, it is worth noting that these findings can only be generalized to veterans who applied for VBA benefits and met eligibility criteria, and that these veterans may differ in terms of their demographic and clinical characteristics from those who did not apply for these benefits.

Conclusions

This study analyzed data from 251,796 individuals who applied for and received a VA home loan, 84,751 who were denied a VA home loan, and 2,752,748 veterans who did not apply for a VA home loan from FY 2022 to FY 2024. Accordingly, 11% of applications pertained to the VA Home Loan Program, and 75% of VA Home Loan Program applicants received a home loan. Distinct demographic and clinical characteristics were observed for applicants and recipients of the VA Home Loan Program, which can set the stage for future planning and evaluation of the program. Despite the broad accessibility of veterans to the VA Home Loan Program, there were differences in approval rates among applicants based on sociodemographic and clinical characteristics. Further evaluation, perhaps using qualitative methods, is needed to better understand opportunities and challenges to achieving a VA home loan, especially among underserved veteran populations. Investigation and research can guide future recommendations for any development or corrective actions that can help increase access to veterans who can benefit from the program. Future analyses are also needed to compare veterans enrolled and not enrolled in the VA Home Loan Program on health care-related outcomes.

Traumatic brain injury (TBI) is the signature injury of post-9/11 military operations, impacting > 441,000 combat veterans from 2001 to 2021 and 87% diagnosed with mild TBI (mTBI).^1,2 The most common cause of mTBI during these operations was blast exposures stemming from improvised explosive devices, rocket-propelled grenades, or land mines. mTBI was once thought to be self-limiting, lasting hours or days postinjury, but is now recognized as a complex focal and diffuse injury causing a cascade of molecular and biochemical responses with significant physiologic effects lasting for a longer duration. A significant number of combat veterans with mTBI (23%-48%) experience long-standing postconcussive symptoms (PCSs) for many years postinjury.^3-5

Developing and implementing strategies to reduce persistent symptoms associated with mTBI is of critical importance. Veterans diagnosed with mTBI and experiencing PCSs present ongoing treatment challenges to the health care system due to limited or suboptimal treatment options.^6,7 According to the 2021 US Department of Veterans Affairs (VA) and US Department of Defense (DoD) clinical guidelines for postacute mTBI, treatment for PCSs should be symptom focused. ^8,9 For instance, veterans with migraine headaches associated with mTBIs are often treated with abortive agents (eg, triptans) and preventive medications (eg, anticonvulsants and tricyclics).¹⁰ Cognitive dysfunction and insomnia are treated with cognitive rehabilitation programs, cognitive behavioral therapy, occupational therapy, and medications (eg, hypnotics for insomnia).^11,12 The 2021 VA/DoD guidelines note that veteran and military focus groups described greater success with nonpharmacologic treatments than with pharmacologic treatments.⁸ The VA launched an enterprise-wide Whole Health Service program with the requirement that complementary and integrative health approaches must be available to veterans.¹³ As a nonpharmacologic, integrative, and noninvasive modality, neurofeedback (NFB) supports the VA Whole Health initiative and veterans’ preferences for integrative treatments.¹⁴

Neurofeedback

Rather than a symptom management approach, Defina et al described the possibilities of brain repair in TBI by treatments to enhance neuroplasticity, thereby establishing a more normalized or stable brain environment and enabling the brain to reorganize itself and function more normally.¹⁵ NFB has been shown to influence neuroplasticity,¹⁶ as evident in microstructural changes in white and gray matter¹⁷ and its ability to contribute to functional rehabilitation by restoring connectivity in specific areas of the brain that may have been impaired.¹⁸ The benefits of neuroenhancement strategies include potentially reduced pain for patients with mTBI and improved quality of life (QOL).¹⁹

NFB assists individuals by helping them become more aware of and self-regulate their physiology.^20,21 Because there are several types of NFB (eg, quantitative electroencephalography, Z-scored, α-θ) that differ in terms of equipment, mechanism of action, focus, and patient and clinician procedures, it is important to note that this study used a novel technologically advanced form of NFB, referred to as infra-low frequency (ILF) NFB. It works by reflecting a person’s brain wave activity via conventional electroencephalography back to the person through the visual cortex, thus providing relevant information to which the brain responds to improve core state regulation.²²

In 2006, ILF NFB developers sought to extend NFB capability into the slow cortical potential domain (< 0.1 Hz) and then gradually extended to lower frequencies on the basis of favorable clinical responses.^22,23 In 2017, the technology reached an ILF capacity that appeared to be helpful for several clinical issues. These developments depended on instrumentation capable of low noise signal detection down to the lowest frequency of interest. Instrumentation was developed for the purpose (eg, Bee Medic Cygnet NFB).

Although mTBI has been a clinical focus in NFB since the 1980s, there are few published studies demonstrating the efficacy of ILF NFB relating to the PCSs of interest in this study, and 2 suggested ILF NFB positively affected change in PCS severity.^24,25 Other studies found that ILF NFB decreased incidence of migraines and tension type headaches.^26,27 However, the findings of these studies had limited generalizability due to methodologic limitations, such as selection bias and small sample sizes.^24-27 Of importance to this article, there are also several publications on the efficacy of ILF NFB in clinical settings.^28-33

This article presents the second analysis of data from veterans who completed ILF NFB intervention and control group procedures during a 5-year randomized controlled trial (RCT). The RCT included veterans who experienced an mTBI while participating in post-9/11 military operations to evaluate the impact of ILF NFB on chronic PCSs, including headache, insomnia, and attention dysfunction. Initial results of this trial demonstrated significant differences between the intervention and control groups with strong effect sizes on all outcome measures at the end of treatment.³⁴

Methods

Participants included male and nonpregnant female veterans with a diagnosed mTBI during post-9/11 military operations; aged 18 to 65 years; reports of persistent (ie, > 3 months in duration) headaches, insomnia, and attention difficulties; and able to read and write English, comprehend what is read, and follow directions. mTBI diagnosis was verified for each veteran via the electronic health record. Patients were excluded if they had a severe TBI diagnosis or impaired decision-making capacity; were unable to comply with study visit schedule; or endorsed active suicidal intent on the Columbia-Suicide Severity Rating Scale.³⁵

Recruitment efforts included: (1) letters sent to eligible veterans with mTBI who were identified by clinical informatics data after waiver of Health Insurance Portability and Accountability Act was obtained; veterans could contact the research team directly or the research team would call the veteran 2 weeks after the letter was sent; (2) veterans could be referred by a clinician; and (3) veterans could self-refer based on flyers and other study marketing materials.

The study was conducted from 2019 to 2024 at Spark M. Matsunaga VA Medical Center, in Honolulu, Hawaii. Four private research spaces in compliance with human research standards were used for consent, treatment, and assessment.

Consenting Procedure and Randomization

The privacy rights of potential participants were observed, and interested veterans who met the eligibility criteria underwent an informed consent procedure and were administered the Columbia-Suicide Severity Rating Scale.³⁵ Those veterans not indicating active suicidal intent were randomized into the intervention or control group. Once randomized, the participant was enrolled and scheduled for baseline assessment.

All procedures of this study were performed in adherence with relevant laws and institutional guidelines. The study was reviewed and approved by the VA Pacific Islands Health Care System Institutional Review Board (#2019-06-JC/Promise 0003).

Outcome Measures

The outcome measures were administered at baseline, midpoint (3-7 weeks), end of treatment (6-12 weeks), and at a 2-month follow-up appointment with the research assistant or project coordinator.

The primary outcome measures included the Headache Impact Test (HIT-6), TBIQOL Headache Pain item short form, Insomnia Severity Index (ISI), Quality of Life in Neurological Disorders (Neuro-QOL) Sleep Disturbance short form, and attention measure: QIKtest Continuous Performance Test (QIKtest) (Table 1).^36-44

Secondary outcome measures included QOL After Brain Injury (QOLIBRI), Neuro- QOL Satisfaction With Roles/Activities short form (Neuro-QOL Satisfaction), Neuro-QOL Ability to Participate in Roles/Activities short form (Neuro-QOL Participate), Depression Anxiety Stress Scales (DASS-21), Patient Health Questionnaire-9 (PHQ-9), Posttraumatic Stress Disorder (PTSD) Checklist for DSM-5 (PCL-5), and the General Symptom Inventory (eAppendix 1).^39,42,45-52

Sample

Seventy-two participants (36 in each group) were needed to have adequate statistical power for the analysis. Presuming attrition, the goal was to recruit 100 veterans. Literature on NFB studies of patients with mTBI have reported dropout rates ranging from 10% to 30%.^53,54 Assuming a dropout rate of 28% and a moderate autocorrelation of 0.6 among repeated measures, this sample size ensured the detection of an average difference of at least 0.49 SDs with a power of 80% in the NFB intervention group compared with the control group using a 2-tailed significance level of 0.05.

Control Group

Following baseline assessment, control group participants received 8 phone calls (1 call/wk) from 1 of 4 clinical investigators over 8 to 10 weeks. During each 15-minute call, 1 of the following health topics was discussed: sleep hygiene, basic nutritional concepts, beverage choices, positive thinking, thought reframing, fitness, daily calming activity, and enhancement of focus strategies. A script for each topic was used to guide each call.

Intervention Group

Following baseline assessment, intervention group participants completed 20 half-hour ILF NFB sessions, typically receiving 3 sessions per week over an 8- to 10-week period. ILF NFB treatments were administered by 1 of 4 licensed health care employees who had received substantial ILF NFB training and achieved a skill reliability index score of 0.95, ensuring the skill level of the ILF NFB providers was equal. A script was used by the ILF NFB providers during the ILF NFB sessions to keep the interaction approach consistent with all participants.

All procedures were explained in advance to participants and voluntary participation affirmed. At the first session, participants filled out a clinical symptom checklist of 5 symptoms (eAppendix 1).^39,42,45-49 The initial rating on the symptom checklist was reflective of their experience over the past month, while in each subsequent session, participants indicated their experience of those symptoms that day. ILF NFB providers were never privy to participants’ primary or secondary outcome measures data during the study, so these recurring clinical symptom checklist ratings, as well as other feedback provided by participants on their experience within and between sessions, were the clinical data used to make decisions about ILF NFB treatment protocol.

The Othmer Optimal Response Frequency (ORF) protocol was used for participants in this study.⁵⁵ Through an iterative process, ORF protocol establishes the specific frequency point along the 0.000001 mHz to 0.1 Hz continuum, which is optimal to diminish symptoms experienced in real-time during the session (eg, tension or pain in shoulders; racing thoughts).

During each ILF NFB session, participants were seated comfortably and encouraged to look at the feedback screen. The moving images on the game screen provided almost instantaneous feedback (within 500 ms) to participants about their brain functioning, as ascertained by electrodes placed on the scalp as dictated by study protocol.⁵⁶ A standardized protocol for site placement was used beginning with T3-T4, followed by the weekly addition of a site as tolerated in the following sequence: T4-P4, FP2-T4, and FP1-T4. More information about the ILF NFB procedures are outlined in the report of the pilot study and RCT initial results.^22,34

Statistical Analysis

Eighty-seven participants were randomized, with 43 assigned to the intervention group and 44 to the control group to achieve the enrollment goal of ≥ 36 participants in each group. This report is the second analysis of data from this RCT that employed a per-protocol approach, analyzing a subset of participants who fully adhered to the study protocol and completed all study procedures. Outcome scores at baseline, midpoint, end of treatment, and 2-month follow-up were summarized as means with corresponding 95% CIs. Group comparisons at the end of treatment and 2-month follow-up time points were conducted using 2-sample t tests. All statistical tests were 2-sided with a significance level of .05 (Type I error rate). SAS software version 9.4 Maintenance 8 was used for statistical analysis. Cohen d analyses were used for effect sizes.

Results

Seventy-four participants fully adhered to the study protocol and were included in the present analyses, with 38 in the control group and 36 in the intervention group. eAppendix 2 depicts the flow of participants through this study. There were no adverse events related to treatment, and the 13 participants who withdrew typically reported difficulty with scheduling or transportation as the primary reason. This study also took place during the COVID-19 pandemic, which likely had some impact on enrollment; participants were differentially impacted by changes in employment and moves to the continental US.

Participants were aged 30 to 60 years (mean [SD], 45.4 [8.0]). Most participants (90.5%) were male, and multiracial and White were the most common racial identities (Table 2). Participant characteristics were largely balanced across randomized groups. Similarly, test scores on the primary variables of interest in this study and secondary clinical variables assessed were comparable across participants (Table 3).

Primary Variables of Interest Analyses

This study’s hypothesis was that those who completed ILF NFB treatment per protocol would demonstrate statistically significant improvement in symptoms related to headaches, sleep disturbance, and difficulty with attention when compared with veterans in the control group. This hypothesis was partially supported. A 2-sample t test showed that veterans in the intervention group demonstrated significant improvement in headache symptoms compared with veterans in the control group on the HIT-6 at the end-of-treatment (P < .001, d = 1.53) and 2-month follow-up assessment (P < .001, d = 1.14). This pattern also was consistent with the TBI-QOL Headache Pain item short form, with veterans in the intervention group showing improvement beyond those in the control group at the end-of-treatment (P < .001, d = 0.89) and 2-month follow-up assessment (P < .001, d = 0.83). Two-sample t tests also demonstrated significant improvement in subjective reports of sleep; those in the intervention group had significantly lower scores on the ISI at the end-of-study (P < .001, d = 1.53) and 2-month follow-up assessment (P < .001, d = 0.97). This pattern also held true for the Neuro-QOL Sleep Disturbance short form subtest, which demonstrated significantly more improvement in the intervention group compared with the control group at the end-of-study (P < .001, d = 0.97) and 2-month follow- up assessment (P < .001, d = 0.92). improvement in attention was not supported by the present results. A 2-sample t test found no significant difference between performance on the QIKtest for veterans in the intervention group vs the control group at the end-of-study (P = .40, d = 0.19) or the 2-month follow-up (P = .43, d = 0.20) (eAppendix 3).

Secondary Variables of Interest Analysis

Secondary variables examined differences in QOL, PTSD, depressive symptoms, and general symptoms reported between veterans in the intervention and control groups. Results demonstrated that veterans in the intervention group showed improvement above and beyond those in the control group on all measures. In regard to QOL, veterans in the intervention group had significantly higher scores on the Neuro-QOL Participate subtest than those in the control group at the end-of-study (P = .01, d = 0.89) and 2-month follow-up assessment (P < .001, d = 0.62). A similar pattern was found for the Neuro-QOL Satisfaction subtest, with veterans in the intervention group showing significantly higher scores than those in the control group at the end-of-study (P = .001, d = 0.95) and 2-month follow-up assessment (P < .001, d = 0.62). This also held true on the QOLIBRI, with veterans in the intervention group demonstrating significantly higher scores than those in the control group at the end-of-study (P = .001, d = 0.92) and 2-month follow-up assessment (P < .001, d = 0.66).

Veterans in the intervention group had significantly lower scores on the PCL-5 than those in the control group at the end-of- study (P = .003, d = 0.78) and 2-month follow-up assessment (P = .001, d = 0.72). Veterans in the intervention group also had significantly lower scores on the PHQ-9 than those in the control group at the end-of-study (P < .001, d = 0.98) and 2-month follow-up assessment (P < .001, d = 0.83). Veterans in the intervention group had significantly lower scores on the DASS- 21 than those in the control group at the end-of-study (P = .002, d = 0.80) and 2-month follow-up assessment (P = .001, d = 0.77). They also had significantly lower scores on the General Symptom Inventory than those in the control group at the end-of-study (P = .02, d = 0.75) and 2-month follow-up assessment (P = .002, d = 0.57). A clinically significant shift of score occurred for each of the measures except DASS-21 (eAppendix 3). eAppendix 4 depicts the change in scores for the intervention group at the end of treatment and the clinically significant shift score of each measure.

Discussion

The results of this RCT revealed a promising impact of ILF NFB on the commonly experienced persistent PCSs of headaches and disrupted sleep. Veterans in the intervention group demonstrated statistically significant improvement in headache symptoms compared with veterans in the control group when assessed at the end of treatment and during a 2-month follow-up. The statistical significance of these improvements was also supported by large or very large effect sizes. In addition to these primary variables of interest, veterans in the intervention group notably demonstrated significant improvement compared with those in the control group in a number of secondary clinical measures, including QOL, traumatic stress-related symptoms, depressive symptoms, and general symptom report. The clinical impact was further supported by the clinically relevant shift in scores in the intervention group.

The data did not support the hypothesis that attention concerns would show significant improvement following ILF NFB. Performance on an attention measure did not differ significantly between groups at either the end-of-treatment or 2-month follow up assessment. The QIKtest, a continuous performance test used to measure attention, was a go/no-go task and calculated based on a combination of various types of errors and outlier responses. The stimulus for this task is a series of computerized, blinking lights, for which participants are tasked with discriminating targets and nontargets under time pressure. However, the order of the stimuli are consistent across administrations, rather than being randomized, introducing a potential confound of practice effects on this task since patients were administered the QIKtest 3 times in a 2-month period and again 2 months later. Veterans in the control group notably improved in their average performance of this task from baseline to the endpoint of their treatment participation and demonstrated further improvement at the 2-month follow-up assessment; this pattern would be consistent with potential practice effects and warrants caution in its interpretation for both groups.

Previously published ILF NFB clinical studies that used the QIKtest and found positive results were mostly conducted among children and teen populations across longer treatment periods. This research may indicate the QIKtest is not an appropriate measure to assess adults who have specialized training in responding to stimuli (ie, trained military personnel). This suggests the concept of attention dysfunction experienced by veterans and the best method to measure it may need to be explored further. This construct may not be related to the focus and skill in prolonged attention needed in selecting go/ no-go tasks, but rather related to a broader conceptual basis involving memory, recall, clarity of rational thought, and decision making impacted by the mTBI. For instance, a study among combat veterans with mTBI and PTSD found that performance on objective cognitive measures did not significantly correlate with their subjective reports of cognitive difficulties.⁵⁷ This reflects the pattern of the present study, in which subjective reports of attention improved over time on the clinical symptom checklist filled out by participants at each session, but the objective measure did not. The mean attention dysfunction score was 6 at session 1 and 1 to 2 at session 20 (lower scores are better on a 10-point scale).

Strengths and Limitations

This study presents results stemming from the first RCT examining clinical effectiveness of ILF NFB in a VA setting for veterans with diagnoses of mTBI. The study design shows promising external validity. Veterans were able to participate in a treatment consisting of 20 sessions over a period of typically 8 to 10 weeks, entailing 2 to 3 sessions per week, with an attrition of only 18% over the course of the study. Notably, attrition rates may have been impacted by the time course of the study, which was recruiting and running participants throughout the COVID-19 pandemic (March 2020 to May 2023). No attrition was due to the intervention itself, and no adverse reactions to ILF NFB were reported during the course of the study. Other strengths of the study include the ethnically and racially diverse participants, representative of the population of veterans in Hawaii. Additionally, all ILF NFB providers underwent supervised ILF NFB training and achieved a skill reliability index score of 0.95 prior to providing ILF NFB to the intervention group.

This study was not blinded. Neither veterans nor ILF NFB clinicians were blinded and were therefore aware of the randomly assigned groups. Research assistants administering the periodic assessments were meant to be blinded to condition by design; however, as the study progressed, a research assistant became unintentionally aware of each study participant's condition based on required documentation in the veteran’s health records; more notes were present for those in the intervention group (20 specialist notes) than the control group (8 notes). While the presence of a control group represents a strength relative to much of the existing ILF NFB literature, the control group in this case did not account for the total time spent with the researchers. Participants in the intervention group met with researchers for 20 total sessions as opposed to 8 telephone calls. Therefore, the study design cannot fully rule out the differential impact of demand characteristics between the 2 groups, nor can it fully address or rule out the impact of differential motivation and expectations between groups. There is also evidence that technological innovation can influence the expectations of research participants, meaning that the intervention group may have been unduly influenced by the novelty of the ILF NFB technology, to which the control group did not have exposure.⁵⁸

A second attention measure for this study would have been beneficial, perhaps in identifying true change in attention ability or providing more insight into finding better methods to assess attention among veterans with mTBI. ILF NFB demonstrated significant impact across multiple outcome measures of clinical relevance for veterans diagnosed with mTBI, including the primary outcome variables of headache and sleep. The strength of the improvements seen in these areas, supported by large practical effects as well as veterans’ subjective reports, indicates much promise. Follow-up studies may also focus on the potential effectiveness of ILF NFB as a treatment of the secondary concerns measured in this study, including traumatic stress-related and depressive symptoms, and may explore the added benefit, if any, of ILF NFB alongside other evidence-based treatments for traumatic stress-related and mood disorders (eg, cognitive behavioral therapy). Using functional magnetic resonance imaging before and after assessments to determine actual brain enhancement with ILF NFB for certain disorders in which a brain signature exists (ie, migraine) should be explored. Further examination of ILF NFB as an intervention for attention may also be warranted, using more effective measures of attention in the population of veterans with mTBI, given the concerns noted earlier. Future research on this topic will need to clearly define attention in relation to the veteran experience and use relevant measures.

Conclusions

This study supports ILF NFB as a safe, noninvasive, nonpharmacologic treatment that may be effective in addressing the complex clinical concerns of veterans diagnosed with mTBI, a population for whom effective treatments have been difficult to identify. This intervention can provide veterans with a desirable and effective nonpharmacologic alternative in their care.

Traumatic brain injury (TBI) is the signature injury of post-9/11 military operations, impacting > 441,000 combat veterans from 2001 to 2021 and 87% diagnosed with mild TBI (mTBI).^1,2 The most common cause of mTBI during these operations was blast exposures stemming from improvised explosive devices, rocket-propelled grenades, or land mines. mTBI was once thought to be self-limiting, lasting hours or days postinjury, but is now recognized as a complex focal and diffuse injury causing a cascade of molecular and biochemical responses with significant physiologic effects lasting for a longer duration. A significant number of combat veterans with mTBI (23%-48%) experience long-standing postconcussive symptoms (PCSs) for many years postinjury.^3-5

Developing and implementing strategies to reduce persistent symptoms associated with mTBI is of critical importance. Veterans diagnosed with mTBI and experiencing PCSs present ongoing treatment challenges to the health care system due to limited or suboptimal treatment options.^6,7 According to the 2021 US Department of Veterans Affairs (VA) and US Department of Defense (DoD) clinical guidelines for postacute mTBI, treatment for PCSs should be symptom focused. ^8,9 For instance, veterans with migraine headaches associated with mTBIs are often treated with abortive agents (eg, triptans) and preventive medications (eg, anticonvulsants and tricyclics).¹⁰ Cognitive dysfunction and insomnia are treated with cognitive rehabilitation programs, cognitive behavioral therapy, occupational therapy, and medications (eg, hypnotics for insomnia).^11,12 The 2021 VA/DoD guidelines note that veteran and military focus groups described greater success with nonpharmacologic treatments than with pharmacologic treatments.⁸ The VA launched an enterprise-wide Whole Health Service program with the requirement that complementary and integrative health approaches must be available to veterans.¹³ As a nonpharmacologic, integrative, and noninvasive modality, neurofeedback (NFB) supports the VA Whole Health initiative and veterans’ preferences for integrative treatments.¹⁴

Neurofeedback

Rather than a symptom management approach, Defina et al described the possibilities of brain repair in TBI by treatments to enhance neuroplasticity, thereby establishing a more normalized or stable brain environment and enabling the brain to reorganize itself and function more normally.¹⁵ NFB has been shown to influence neuroplasticity,¹⁶ as evident in microstructural changes in white and gray matter¹⁷ and its ability to contribute to functional rehabilitation by restoring connectivity in specific areas of the brain that may have been impaired.¹⁸ The benefits of neuroenhancement strategies include potentially reduced pain for patients with mTBI and improved quality of life (QOL).¹⁹

NFB assists individuals by helping them become more aware of and self-regulate their physiology.^20,21 Because there are several types of NFB (eg, quantitative electroencephalography, Z-scored, α-θ) that differ in terms of equipment, mechanism of action, focus, and patient and clinician procedures, it is important to note that this study used a novel technologically advanced form of NFB, referred to as infra-low frequency (ILF) NFB. It works by reflecting a person’s brain wave activity via conventional electroencephalography back to the person through the visual cortex, thus providing relevant information to which the brain responds to improve core state regulation.²²

In 2006, ILF NFB developers sought to extend NFB capability into the slow cortical potential domain (< 0.1 Hz) and then gradually extended to lower frequencies on the basis of favorable clinical responses.^22,23 In 2017, the technology reached an ILF capacity that appeared to be helpful for several clinical issues. These developments depended on instrumentation capable of low noise signal detection down to the lowest frequency of interest. Instrumentation was developed for the purpose (eg, Bee Medic Cygnet NFB).

Although mTBI has been a clinical focus in NFB since the 1980s, there are few published studies demonstrating the efficacy of ILF NFB relating to the PCSs of interest in this study, and 2 suggested ILF NFB positively affected change in PCS severity.^24,25 Other studies found that ILF NFB decreased incidence of migraines and tension type headaches.^26,27 However, the findings of these studies had limited generalizability due to methodologic limitations, such as selection bias and small sample sizes.^24-27 Of importance to this article, there are also several publications on the efficacy of ILF NFB in clinical settings.^28-33

This article presents the second analysis of data from veterans who completed ILF NFB intervention and control group procedures during a 5-year randomized controlled trial (RCT). The RCT included veterans who experienced an mTBI while participating in post-9/11 military operations to evaluate the impact of ILF NFB on chronic PCSs, including headache, insomnia, and attention dysfunction. Initial results of this trial demonstrated significant differences between the intervention and control groups with strong effect sizes on all outcome measures at the end of treatment.³⁴

Methods

Participants included male and nonpregnant female veterans with a diagnosed mTBI during post-9/11 military operations; aged 18 to 65 years; reports of persistent (ie, > 3 months in duration) headaches, insomnia, and attention difficulties; and able to read and write English, comprehend what is read, and follow directions. mTBI diagnosis was verified for each veteran via the electronic health record. Patients were excluded if they had a severe TBI diagnosis or impaired decision-making capacity; were unable to comply with study visit schedule; or endorsed active suicidal intent on the Columbia-Suicide Severity Rating Scale.³⁵

Recruitment efforts included: (1) letters sent to eligible veterans with mTBI who were identified by clinical informatics data after waiver of Health Insurance Portability and Accountability Act was obtained; veterans could contact the research team directly or the research team would call the veteran 2 weeks after the letter was sent; (2) veterans could be referred by a clinician; and (3) veterans could self-refer based on flyers and other study marketing materials.

The study was conducted from 2019 to 2024 at Spark M. Matsunaga VA Medical Center, in Honolulu, Hawaii. Four private research spaces in compliance with human research standards were used for consent, treatment, and assessment.

Consenting Procedure and Randomization

The privacy rights of potential participants were observed, and interested veterans who met the eligibility criteria underwent an informed consent procedure and were administered the Columbia-Suicide Severity Rating Scale.³⁵ Those veterans not indicating active suicidal intent were randomized into the intervention or control group. Once randomized, the participant was enrolled and scheduled for baseline assessment.

All procedures of this study were performed in adherence with relevant laws and institutional guidelines. The study was reviewed and approved by the VA Pacific Islands Health Care System Institutional Review Board (#2019-06-JC/Promise 0003).

Outcome Measures

The outcome measures were administered at baseline, midpoint (3-7 weeks), end of treatment (6-12 weeks), and at a 2-month follow-up appointment with the research assistant or project coordinator.

The primary outcome measures included the Headache Impact Test (HIT-6), TBIQOL Headache Pain item short form, Insomnia Severity Index (ISI), Quality of Life in Neurological Disorders (Neuro-QOL) Sleep Disturbance short form, and attention measure: QIKtest Continuous Performance Test (QIKtest) (Table 1).^36-44

Secondary outcome measures included QOL After Brain Injury (QOLIBRI), Neuro- QOL Satisfaction With Roles/Activities short form (Neuro-QOL Satisfaction), Neuro-QOL Ability to Participate in Roles/Activities short form (Neuro-QOL Participate), Depression Anxiety Stress Scales (DASS-21), Patient Health Questionnaire-9 (PHQ-9), Posttraumatic Stress Disorder (PTSD) Checklist for DSM-5 (PCL-5), and the General Symptom Inventory (eAppendix 1).^39,42,45-52

Sample

Seventy-two participants (36 in each group) were needed to have adequate statistical power for the analysis. Presuming attrition, the goal was to recruit 100 veterans. Literature on NFB studies of patients with mTBI have reported dropout rates ranging from 10% to 30%.^53,54 Assuming a dropout rate of 28% and a moderate autocorrelation of 0.6 among repeated measures, this sample size ensured the detection of an average difference of at least 0.49 SDs with a power of 80% in the NFB intervention group compared with the control group using a 2-tailed significance level of 0.05.

Control Group

Following baseline assessment, control group participants received 8 phone calls (1 call/wk) from 1 of 4 clinical investigators over 8 to 10 weeks. During each 15-minute call, 1 of the following health topics was discussed: sleep hygiene, basic nutritional concepts, beverage choices, positive thinking, thought reframing, fitness, daily calming activity, and enhancement of focus strategies. A script for each topic was used to guide each call.

Intervention Group

Following baseline assessment, intervention group participants completed 20 half-hour ILF NFB sessions, typically receiving 3 sessions per week over an 8- to 10-week period. ILF NFB treatments were administered by 1 of 4 licensed health care employees who had received substantial ILF NFB training and achieved a skill reliability index score of 0.95, ensuring the skill level of the ILF NFB providers was equal. A script was used by the ILF NFB providers during the ILF NFB sessions to keep the interaction approach consistent with all participants.

All procedures were explained in advance to participants and voluntary participation affirmed. At the first session, participants filled out a clinical symptom checklist of 5 symptoms (eAppendix 1).^39,42,45-49 The initial rating on the symptom checklist was reflective of their experience over the past month, while in each subsequent session, participants indicated their experience of those symptoms that day. ILF NFB providers were never privy to participants’ primary or secondary outcome measures data during the study, so these recurring clinical symptom checklist ratings, as well as other feedback provided by participants on their experience within and between sessions, were the clinical data used to make decisions about ILF NFB treatment protocol.

The Othmer Optimal Response Frequency (ORF) protocol was used for participants in this study.⁵⁵ Through an iterative process, ORF protocol establishes the specific frequency point along the 0.000001 mHz to 0.1 Hz continuum, which is optimal to diminish symptoms experienced in real-time during the session (eg, tension or pain in shoulders; racing thoughts).

During each ILF NFB session, participants were seated comfortably and encouraged to look at the feedback screen. The moving images on the game screen provided almost instantaneous feedback (within 500 ms) to participants about their brain functioning, as ascertained by electrodes placed on the scalp as dictated by study protocol.⁵⁶ A standardized protocol for site placement was used beginning with T3-T4, followed by the weekly addition of a site as tolerated in the following sequence: T4-P4, FP2-T4, and FP1-T4. More information about the ILF NFB procedures are outlined in the report of the pilot study and RCT initial results.^22,34

Statistical Analysis

Eighty-seven participants were randomized, with 43 assigned to the intervention group and 44 to the control group to achieve the enrollment goal of ≥ 36 participants in each group. This report is the second analysis of data from this RCT that employed a per-protocol approach, analyzing a subset of participants who fully adhered to the study protocol and completed all study procedures. Outcome scores at baseline, midpoint, end of treatment, and 2-month follow-up were summarized as means with corresponding 95% CIs. Group comparisons at the end of treatment and 2-month follow-up time points were conducted using 2-sample t tests. All statistical tests were 2-sided with a significance level of .05 (Type I error rate). SAS software version 9.4 Maintenance 8 was used for statistical analysis. Cohen d analyses were used for effect sizes.

Results

Seventy-four participants fully adhered to the study protocol and were included in the present analyses, with 38 in the control group and 36 in the intervention group. eAppendix 2 depicts the flow of participants through this study. There were no adverse events related to treatment, and the 13 participants who withdrew typically reported difficulty with scheduling or transportation as the primary reason. This study also took place during the COVID-19 pandemic, which likely had some impact on enrollment; participants were differentially impacted by changes in employment and moves to the continental US.

Participants were aged 30 to 60 years (mean [SD], 45.4 [8.0]). Most participants (90.5%) were male, and multiracial and White were the most common racial identities (Table 2). Participant characteristics were largely balanced across randomized groups. Similarly, test scores on the primary variables of interest in this study and secondary clinical variables assessed were comparable across participants (Table 3).

Primary Variables of Interest Analyses

This study’s hypothesis was that those who completed ILF NFB treatment per protocol would demonstrate statistically significant improvement in symptoms related to headaches, sleep disturbance, and difficulty with attention when compared with veterans in the control group. This hypothesis was partially supported. A 2-sample t test showed that veterans in the intervention group demonstrated significant improvement in headache symptoms compared with veterans in the control group on the HIT-6 at the end-of-treatment (P < .001, d = 1.53) and 2-month follow-up assessment (P < .001, d = 1.14). This pattern also was consistent with the TBI-QOL Headache Pain item short form, with veterans in the intervention group showing improvement beyond those in the control group at the end-of-treatment (P < .001, d = 0.89) and 2-month follow-up assessment (P < .001, d = 0.83). Two-sample t tests also demonstrated significant improvement in subjective reports of sleep; those in the intervention group had significantly lower scores on the ISI at the end-of-study (P < .001, d = 1.53) and 2-month follow-up assessment (P < .001, d = 0.97). This pattern also held true for the Neuro-QOL Sleep Disturbance short form subtest, which demonstrated significantly more improvement in the intervention group compared with the control group at the end-of-study (P < .001, d = 0.97) and 2-month follow- up assessment (P < .001, d = 0.92). improvement in attention was not supported by the present results. A 2-sample t test found no significant difference between performance on the QIKtest for veterans in the intervention group vs the control group at the end-of-study (P = .40, d = 0.19) or the 2-month follow-up (P = .43, d = 0.20) (eAppendix 3).

Secondary Variables of Interest Analysis

Secondary variables examined differences in QOL, PTSD, depressive symptoms, and general symptoms reported between veterans in the intervention and control groups. Results demonstrated that veterans in the intervention group showed improvement above and beyond those in the control group on all measures. In regard to QOL, veterans in the intervention group had significantly higher scores on the Neuro-QOL Participate subtest than those in the control group at the end-of-study (P = .01, d = 0.89) and 2-month follow-up assessment (P < .001, d = 0.62). A similar pattern was found for the Neuro-QOL Satisfaction subtest, with veterans in the intervention group showing significantly higher scores than those in the control group at the end-of-study (P = .001, d = 0.95) and 2-month follow-up assessment (P < .001, d = 0.62). This also held true on the QOLIBRI, with veterans in the intervention group demonstrating significantly higher scores than those in the control group at the end-of-study (P = .001, d = 0.92) and 2-month follow-up assessment (P < .001, d = 0.66).

Veterans in the intervention group had significantly lower scores on the PCL-5 than those in the control group at the end-of- study (P = .003, d = 0.78) and 2-month follow-up assessment (P = .001, d = 0.72). Veterans in the intervention group also had significantly lower scores on the PHQ-9 than those in the control group at the end-of-study (P < .001, d = 0.98) and 2-month follow-up assessment (P < .001, d = 0.83). Veterans in the intervention group had significantly lower scores on the DASS- 21 than those in the control group at the end-of-study (P = .002, d = 0.80) and 2-month follow-up assessment (P = .001, d = 0.77). They also had significantly lower scores on the General Symptom Inventory than those in the control group at the end-of-study (P = .02, d = 0.75) and 2-month follow-up assessment (P = .002, d = 0.57). A clinically significant shift of score occurred for each of the measures except DASS-21 (eAppendix 3). eAppendix 4 depicts the change in scores for the intervention group at the end of treatment and the clinically significant shift score of each measure.

Discussion

The results of this RCT revealed a promising impact of ILF NFB on the commonly experienced persistent PCSs of headaches and disrupted sleep. Veterans in the intervention group demonstrated statistically significant improvement in headache symptoms compared with veterans in the control group when assessed at the end of treatment and during a 2-month follow-up. The statistical significance of these improvements was also supported by large or very large effect sizes. In addition to these primary variables of interest, veterans in the intervention group notably demonstrated significant improvement compared with those in the control group in a number of secondary clinical measures, including QOL, traumatic stress-related symptoms, depressive symptoms, and general symptom report. The clinical impact was further supported by the clinically relevant shift in scores in the intervention group.

The data did not support the hypothesis that attention concerns would show significant improvement following ILF NFB. Performance on an attention measure did not differ significantly between groups at either the end-of-treatment or 2-month follow up assessment. The QIKtest, a continuous performance test used to measure attention, was a go/no-go task and calculated based on a combination of various types of errors and outlier responses. The stimulus for this task is a series of computerized, blinking lights, for which participants are tasked with discriminating targets and nontargets under time pressure. However, the order of the stimuli are consistent across administrations, rather than being randomized, introducing a potential confound of practice effects on this task since patients were administered the QIKtest 3 times in a 2-month period and again 2 months later. Veterans in the control group notably improved in their average performance of this task from baseline to the endpoint of their treatment participation and demonstrated further improvement at the 2-month follow-up assessment; this pattern would be consistent with potential practice effects and warrants caution in its interpretation for both groups.

Previously published ILF NFB clinical studies that used the QIKtest and found positive results were mostly conducted among children and teen populations across longer treatment periods. This research may indicate the QIKtest is not an appropriate measure to assess adults who have specialized training in responding to stimuli (ie, trained military personnel). This suggests the concept of attention dysfunction experienced by veterans and the best method to measure it may need to be explored further. This construct may not be related to the focus and skill in prolonged attention needed in selecting go/ no-go tasks, but rather related to a broader conceptual basis involving memory, recall, clarity of rational thought, and decision making impacted by the mTBI. For instance, a study among combat veterans with mTBI and PTSD found that performance on objective cognitive measures did not significantly correlate with their subjective reports of cognitive difficulties.⁵⁷ This reflects the pattern of the present study, in which subjective reports of attention improved over time on the clinical symptom checklist filled out by participants at each session, but the objective measure did not. The mean attention dysfunction score was 6 at session 1 and 1 to 2 at session 20 (lower scores are better on a 10-point scale).

Strengths and Limitations

This study presents results stemming from the first RCT examining clinical effectiveness of ILF NFB in a VA setting for veterans with diagnoses of mTBI. The study design shows promising external validity. Veterans were able to participate in a treatment consisting of 20 sessions over a period of typically 8 to 10 weeks, entailing 2 to 3 sessions per week, with an attrition of only 18% over the course of the study. Notably, attrition rates may have been impacted by the time course of the study, which was recruiting and running participants throughout the COVID-19 pandemic (March 2020 to May 2023). No attrition was due to the intervention itself, and no adverse reactions to ILF NFB were reported during the course of the study. Other strengths of the study include the ethnically and racially diverse participants, representative of the population of veterans in Hawaii. Additionally, all ILF NFB providers underwent supervised ILF NFB training and achieved a skill reliability index score of 0.95 prior to providing ILF NFB to the intervention group.

This study was not blinded. Neither veterans nor ILF NFB clinicians were blinded and were therefore aware of the randomly assigned groups. Research assistants administering the periodic assessments were meant to be blinded to condition by design; however, as the study progressed, a research assistant became unintentionally aware of each study participant's condition based on required documentation in the veteran’s health records; more notes were present for those in the intervention group (20 specialist notes) than the control group (8 notes). While the presence of a control group represents a strength relative to much of the existing ILF NFB literature, the control group in this case did not account for the total time spent with the researchers. Participants in the intervention group met with researchers for 20 total sessions as opposed to 8 telephone calls. Therefore, the study design cannot fully rule out the differential impact of demand characteristics between the 2 groups, nor can it fully address or rule out the impact of differential motivation and expectations between groups. There is also evidence that technological innovation can influence the expectations of research participants, meaning that the intervention group may have been unduly influenced by the novelty of the ILF NFB technology, to which the control group did not have exposure.⁵⁸

A second attention measure for this study would have been beneficial, perhaps in identifying true change in attention ability or providing more insight into finding better methods to assess attention among veterans with mTBI. ILF NFB demonstrated significant impact across multiple outcome measures of clinical relevance for veterans diagnosed with mTBI, including the primary outcome variables of headache and sleep. The strength of the improvements seen in these areas, supported by large practical effects as well as veterans’ subjective reports, indicates much promise. Follow-up studies may also focus on the potential effectiveness of ILF NFB as a treatment of the secondary concerns measured in this study, including traumatic stress-related and depressive symptoms, and may explore the added benefit, if any, of ILF NFB alongside other evidence-based treatments for traumatic stress-related and mood disorders (eg, cognitive behavioral therapy). Using functional magnetic resonance imaging before and after assessments to determine actual brain enhancement with ILF NFB for certain disorders in which a brain signature exists (ie, migraine) should be explored. Further examination of ILF NFB as an intervention for attention may also be warranted, using more effective measures of attention in the population of veterans with mTBI, given the concerns noted earlier. Future research on this topic will need to clearly define attention in relation to the veteran experience and use relevant measures.

Conclusions

This study supports ILF NFB as a safe, noninvasive, nonpharmacologic treatment that may be effective in addressing the complex clinical concerns of veterans diagnosed with mTBI, a population for whom effective treatments have been difficult to identify. This intervention can provide veterans with a desirable and effective nonpharmacologic alternative in their care.

Traumatic brain injury (TBI) is the signature injury of post-9/11 military operations, impacting > 441,000 combat veterans from 2001 to 2021 and 87% diagnosed with mild TBI (mTBI).^1,2 The most common cause of mTBI during these operations was blast exposures stemming from improvised explosive devices, rocket-propelled grenades, or land mines. mTBI was once thought to be self-limiting, lasting hours or days postinjury, but is now recognized as a complex focal and diffuse injury causing a cascade of molecular and biochemical responses with significant physiologic effects lasting for a longer duration. A significant number of combat veterans with mTBI (23%-48%) experience long-standing postconcussive symptoms (PCSs) for many years postinjury.^3-5

Developing and implementing strategies to reduce persistent symptoms associated with mTBI is of critical importance. Veterans diagnosed with mTBI and experiencing PCSs present ongoing treatment challenges to the health care system due to limited or suboptimal treatment options.^6,7 According to the 2021 US Department of Veterans Affairs (VA) and US Department of Defense (DoD) clinical guidelines for postacute mTBI, treatment for PCSs should be symptom focused. ^8,9 For instance, veterans with migraine headaches associated with mTBIs are often treated with abortive agents (eg, triptans) and preventive medications (eg, anticonvulsants and tricyclics).¹⁰ Cognitive dysfunction and insomnia are treated with cognitive rehabilitation programs, cognitive behavioral therapy, occupational therapy, and medications (eg, hypnotics for insomnia).^11,12 The 2021 VA/DoD guidelines note that veteran and military focus groups described greater success with nonpharmacologic treatments than with pharmacologic treatments.⁸ The VA launched an enterprise-wide Whole Health Service program with the requirement that complementary and integrative health approaches must be available to veterans.¹³ As a nonpharmacologic, integrative, and noninvasive modality, neurofeedback (NFB) supports the VA Whole Health initiative and veterans’ preferences for integrative treatments.¹⁴

Neurofeedback

Rather than a symptom management approach, Defina et al described the possibilities of brain repair in TBI by treatments to enhance neuroplasticity, thereby establishing a more normalized or stable brain environment and enabling the brain to reorganize itself and function more normally.¹⁵ NFB has been shown to influence neuroplasticity,¹⁶ as evident in microstructural changes in white and gray matter¹⁷ and its ability to contribute to functional rehabilitation by restoring connectivity in specific areas of the brain that may have been impaired.¹⁸ The benefits of neuroenhancement strategies include potentially reduced pain for patients with mTBI and improved quality of life (QOL).¹⁹

NFB assists individuals by helping them become more aware of and self-regulate their physiology.^20,21 Because there are several types of NFB (eg, quantitative electroencephalography, Z-scored, α-θ) that differ in terms of equipment, mechanism of action, focus, and patient and clinician procedures, it is important to note that this study used a novel technologically advanced form of NFB, referred to as infra-low frequency (ILF) NFB. It works by reflecting a person’s brain wave activity via conventional electroencephalography back to the person through the visual cortex, thus providing relevant information to which the brain responds to improve core state regulation.²²

In 2006, ILF NFB developers sought to extend NFB capability into the slow cortical potential domain (< 0.1 Hz) and then gradually extended to lower frequencies on the basis of favorable clinical responses.^22,23 In 2017, the technology reached an ILF capacity that appeared to be helpful for several clinical issues. These developments depended on instrumentation capable of low noise signal detection down to the lowest frequency of interest. Instrumentation was developed for the purpose (eg, Bee Medic Cygnet NFB).

Although mTBI has been a clinical focus in NFB since the 1980s, there are few published studies demonstrating the efficacy of ILF NFB relating to the PCSs of interest in this study, and 2 suggested ILF NFB positively affected change in PCS severity.^24,25 Other studies found that ILF NFB decreased incidence of migraines and tension type headaches.^26,27 However, the findings of these studies had limited generalizability due to methodologic limitations, such as selection bias and small sample sizes.^24-27 Of importance to this article, there are also several publications on the efficacy of ILF NFB in clinical settings.^28-33

This article presents the second analysis of data from veterans who completed ILF NFB intervention and control group procedures during a 5-year randomized controlled trial (RCT). The RCT included veterans who experienced an mTBI while participating in post-9/11 military operations to evaluate the impact of ILF NFB on chronic PCSs, including headache, insomnia, and attention dysfunction. Initial results of this trial demonstrated significant differences between the intervention and control groups with strong effect sizes on all outcome measures at the end of treatment.³⁴

Methods

Participants included male and nonpregnant female veterans with a diagnosed mTBI during post-9/11 military operations; aged 18 to 65 years; reports of persistent (ie, > 3 months in duration) headaches, insomnia, and attention difficulties; and able to read and write English, comprehend what is read, and follow directions. mTBI diagnosis was verified for each veteran via the electronic health record. Patients were excluded if they had a severe TBI diagnosis or impaired decision-making capacity; were unable to comply with study visit schedule; or endorsed active suicidal intent on the Columbia-Suicide Severity Rating Scale.³⁵

Recruitment efforts included: (1) letters sent to eligible veterans with mTBI who were identified by clinical informatics data after waiver of Health Insurance Portability and Accountability Act was obtained; veterans could contact the research team directly or the research team would call the veteran 2 weeks after the letter was sent; (2) veterans could be referred by a clinician; and (3) veterans could self-refer based on flyers and other study marketing materials.

The study was conducted from 2019 to 2024 at Spark M. Matsunaga VA Medical Center, in Honolulu, Hawaii. Four private research spaces in compliance with human research standards were used for consent, treatment, and assessment.

Consenting Procedure and Randomization

The privacy rights of potential participants were observed, and interested veterans who met the eligibility criteria underwent an informed consent procedure and were administered the Columbia-Suicide Severity Rating Scale.³⁵ Those veterans not indicating active suicidal intent were randomized into the intervention or control group. Once randomized, the participant was enrolled and scheduled for baseline assessment.

All procedures of this study were performed in adherence with relevant laws and institutional guidelines. The study was reviewed and approved by the VA Pacific Islands Health Care System Institutional Review Board (#2019-06-JC/Promise 0003).

Outcome Measures

The outcome measures were administered at baseline, midpoint (3-7 weeks), end of treatment (6-12 weeks), and at a 2-month follow-up appointment with the research assistant or project coordinator.

The primary outcome measures included the Headache Impact Test (HIT-6), TBIQOL Headache Pain item short form, Insomnia Severity Index (ISI), Quality of Life in Neurological Disorders (Neuro-QOL) Sleep Disturbance short form, and attention measure: QIKtest Continuous Performance Test (QIKtest) (Table 1).^36-44

Secondary outcome measures included QOL After Brain Injury (QOLIBRI), Neuro- QOL Satisfaction With Roles/Activities short form (Neuro-QOL Satisfaction), Neuro-QOL Ability to Participate in Roles/Activities short form (Neuro-QOL Participate), Depression Anxiety Stress Scales (DASS-21), Patient Health Questionnaire-9 (PHQ-9), Posttraumatic Stress Disorder (PTSD) Checklist for DSM-5 (PCL-5), and the General Symptom Inventory (eAppendix 1).^39,42,45-52

Sample

Seventy-two participants (36 in each group) were needed to have adequate statistical power for the analysis. Presuming attrition, the goal was to recruit 100 veterans. Literature on NFB studies of patients with mTBI have reported dropout rates ranging from 10% to 30%.^53,54 Assuming a dropout rate of 28% and a moderate autocorrelation of 0.6 among repeated measures, this sample size ensured the detection of an average difference of at least 0.49 SDs with a power of 80% in the NFB intervention group compared with the control group using a 2-tailed significance level of 0.05.

Control Group

Following baseline assessment, control group participants received 8 phone calls (1 call/wk) from 1 of 4 clinical investigators over 8 to 10 weeks. During each 15-minute call, 1 of the following health topics was discussed: sleep hygiene, basic nutritional concepts, beverage choices, positive thinking, thought reframing, fitness, daily calming activity, and enhancement of focus strategies. A script for each topic was used to guide each call.

Intervention Group

Following baseline assessment, intervention group participants completed 20 half-hour ILF NFB sessions, typically receiving 3 sessions per week over an 8- to 10-week period. ILF NFB treatments were administered by 1 of 4 licensed health care employees who had received substantial ILF NFB training and achieved a skill reliability index score of 0.95, ensuring the skill level of the ILF NFB providers was equal. A script was used by the ILF NFB providers during the ILF NFB sessions to keep the interaction approach consistent with all participants.

All procedures were explained in advance to participants and voluntary participation affirmed. At the first session, participants filled out a clinical symptom checklist of 5 symptoms (eAppendix 1).^39,42,45-49 The initial rating on the symptom checklist was reflective of their experience over the past month, while in each subsequent session, participants indicated their experience of those symptoms that day. ILF NFB providers were never privy to participants’ primary or secondary outcome measures data during the study, so these recurring clinical symptom checklist ratings, as well as other feedback provided by participants on their experience within and between sessions, were the clinical data used to make decisions about ILF NFB treatment protocol.

The Othmer Optimal Response Frequency (ORF) protocol was used for participants in this study.⁵⁵ Through an iterative process, ORF protocol establishes the specific frequency point along the 0.000001 mHz to 0.1 Hz continuum, which is optimal to diminish symptoms experienced in real-time during the session (eg, tension or pain in shoulders; racing thoughts).

During each ILF NFB session, participants were seated comfortably and encouraged to look at the feedback screen. The moving images on the game screen provided almost instantaneous feedback (within 500 ms) to participants about their brain functioning, as ascertained by electrodes placed on the scalp as dictated by study protocol.⁵⁶ A standardized protocol for site placement was used beginning with T3-T4, followed by the weekly addition of a site as tolerated in the following sequence: T4-P4, FP2-T4, and FP1-T4. More information about the ILF NFB procedures are outlined in the report of the pilot study and RCT initial results.^22,34

Statistical Analysis

Eighty-seven participants were randomized, with 43 assigned to the intervention group and 44 to the control group to achieve the enrollment goal of ≥ 36 participants in each group. This report is the second analysis of data from this RCT that employed a per-protocol approach, analyzing a subset of participants who fully adhered to the study protocol and completed all study procedures. Outcome scores at baseline, midpoint, end of treatment, and 2-month follow-up were summarized as means with corresponding 95% CIs. Group comparisons at the end of treatment and 2-month follow-up time points were conducted using 2-sample t tests. All statistical tests were 2-sided with a significance level of .05 (Type I error rate). SAS software version 9.4 Maintenance 8 was used for statistical analysis. Cohen d analyses were used for effect sizes.

Results

Seventy-four participants fully adhered to the study protocol and were included in the present analyses, with 38 in the control group and 36 in the intervention group. eAppendix 2 depicts the flow of participants through this study. There were no adverse events related to treatment, and the 13 participants who withdrew typically reported difficulty with scheduling or transportation as the primary reason. This study also took place during the COVID-19 pandemic, which likely had some impact on enrollment; participants were differentially impacted by changes in employment and moves to the continental US.

Participants were aged 30 to 60 years (mean [SD], 45.4 [8.0]). Most participants (90.5%) were male, and multiracial and White were the most common racial identities (Table 2). Participant characteristics were largely balanced across randomized groups. Similarly, test scores on the primary variables of interest in this study and secondary clinical variables assessed were comparable across participants (Table 3).

Primary Variables of Interest Analyses

This study’s hypothesis was that those who completed ILF NFB treatment per protocol would demonstrate statistically significant improvement in symptoms related to headaches, sleep disturbance, and difficulty with attention when compared with veterans in the control group. This hypothesis was partially supported. A 2-sample t test showed that veterans in the intervention group demonstrated significant improvement in headache symptoms compared with veterans in the control group on the HIT-6 at the end-of-treatment (P < .001, d = 1.53) and 2-month follow-up assessment (P < .001, d = 1.14). This pattern also was consistent with the TBI-QOL Headache Pain item short form, with veterans in the intervention group showing improvement beyond those in the control group at the end-of-treatment (P < .001, d = 0.89) and 2-month follow-up assessment (P < .001, d = 0.83). Two-sample t tests also demonstrated significant improvement in subjective reports of sleep; those in the intervention group had significantly lower scores on the ISI at the end-of-study (P < .001, d = 1.53) and 2-month follow-up assessment (P < .001, d = 0.97). This pattern also held true for the Neuro-QOL Sleep Disturbance short form subtest, which demonstrated significantly more improvement in the intervention group compared with the control group at the end-of-study (P < .001, d = 0.97) and 2-month follow- up assessment (P < .001, d = 0.92). improvement in attention was not supported by the present results. A 2-sample t test found no significant difference between performance on the QIKtest for veterans in the intervention group vs the control group at the end-of-study (P = .40, d = 0.19) or the 2-month follow-up (P = .43, d = 0.20) (eAppendix 3).

Secondary Variables of Interest Analysis

Secondary variables examined differences in QOL, PTSD, depressive symptoms, and general symptoms reported between veterans in the intervention and control groups. Results demonstrated that veterans in the intervention group showed improvement above and beyond those in the control group on all measures. In regard to QOL, veterans in the intervention group had significantly higher scores on the Neuro-QOL Participate subtest than those in the control group at the end-of-study (P = .01, d = 0.89) and 2-month follow-up assessment (P < .001, d = 0.62). A similar pattern was found for the Neuro-QOL Satisfaction subtest, with veterans in the intervention group showing significantly higher scores than those in the control group at the end-of-study (P = .001, d = 0.95) and 2-month follow-up assessment (P < .001, d = 0.62). This also held true on the QOLIBRI, with veterans in the intervention group demonstrating significantly higher scores than those in the control group at the end-of-study (P = .001, d = 0.92) and 2-month follow-up assessment (P < .001, d = 0.66).

Veterans in the intervention group had significantly lower scores on the PCL-5 than those in the control group at the end-of- study (P = .003, d = 0.78) and 2-month follow-up assessment (P = .001, d = 0.72). Veterans in the intervention group also had significantly lower scores on the PHQ-9 than those in the control group at the end-of-study (P < .001, d = 0.98) and 2-month follow-up assessment (P < .001, d = 0.83). Veterans in the intervention group had significantly lower scores on the DASS- 21 than those in the control group at the end-of-study (P = .002, d = 0.80) and 2-month follow-up assessment (P = .001, d = 0.77). They also had significantly lower scores on the General Symptom Inventory than those in the control group at the end-of-study (P = .02, d = 0.75) and 2-month follow-up assessment (P = .002, d = 0.57). A clinically significant shift of score occurred for each of the measures except DASS-21 (eAppendix 3). eAppendix 4 depicts the change in scores for the intervention group at the end of treatment and the clinically significant shift score of each measure.

Discussion

The results of this RCT revealed a promising impact of ILF NFB on the commonly experienced persistent PCSs of headaches and disrupted sleep. Veterans in the intervention group demonstrated statistically significant improvement in headache symptoms compared with veterans in the control group when assessed at the end of treatment and during a 2-month follow-up. The statistical significance of these improvements was also supported by large or very large effect sizes. In addition to these primary variables of interest, veterans in the intervention group notably demonstrated significant improvement compared with those in the control group in a number of secondary clinical measures, including QOL, traumatic stress-related symptoms, depressive symptoms, and general symptom report. The clinical impact was further supported by the clinically relevant shift in scores in the intervention group.

The data did not support the hypothesis that attention concerns would show significant improvement following ILF NFB. Performance on an attention measure did not differ significantly between groups at either the end-of-treatment or 2-month follow up assessment. The QIKtest, a continuous performance test used to measure attention, was a go/no-go task and calculated based on a combination of various types of errors and outlier responses. The stimulus for this task is a series of computerized, blinking lights, for which participants are tasked with discriminating targets and nontargets under time pressure. However, the order of the stimuli are consistent across administrations, rather than being randomized, introducing a potential confound of practice effects on this task since patients were administered the QIKtest 3 times in a 2-month period and again 2 months later. Veterans in the control group notably improved in their average performance of this task from baseline to the endpoint of their treatment participation and demonstrated further improvement at the 2-month follow-up assessment; this pattern would be consistent with potential practice effects and warrants caution in its interpretation for both groups.

Previously published ILF NFB clinical studies that used the QIKtest and found positive results were mostly conducted among children and teen populations across longer treatment periods. This research may indicate the QIKtest is not an appropriate measure to assess adults who have specialized training in responding to stimuli (ie, trained military personnel). This suggests the concept of attention dysfunction experienced by veterans and the best method to measure it may need to be explored further. This construct may not be related to the focus and skill in prolonged attention needed in selecting go/ no-go tasks, but rather related to a broader conceptual basis involving memory, recall, clarity of rational thought, and decision making impacted by the mTBI. For instance, a study among combat veterans with mTBI and PTSD found that performance on objective cognitive measures did not significantly correlate with their subjective reports of cognitive difficulties.⁵⁷ This reflects the pattern of the present study, in which subjective reports of attention improved over time on the clinical symptom checklist filled out by participants at each session, but the objective measure did not. The mean attention dysfunction score was 6 at session 1 and 1 to 2 at session 20 (lower scores are better on a 10-point scale).

Strengths and Limitations

This study presents results stemming from the first RCT examining clinical effectiveness of ILF NFB in a VA setting for veterans with diagnoses of mTBI. The study design shows promising external validity. Veterans were able to participate in a treatment consisting of 20 sessions over a period of typically 8 to 10 weeks, entailing 2 to 3 sessions per week, with an attrition of only 18% over the course of the study. Notably, attrition rates may have been impacted by the time course of the study, which was recruiting and running participants throughout the COVID-19 pandemic (March 2020 to May 2023). No attrition was due to the intervention itself, and no adverse reactions to ILF NFB were reported during the course of the study. Other strengths of the study include the ethnically and racially diverse participants, representative of the population of veterans in Hawaii. Additionally, all ILF NFB providers underwent supervised ILF NFB training and achieved a skill reliability index score of 0.95 prior to providing ILF NFB to the intervention group.

This study was not blinded. Neither veterans nor ILF NFB clinicians were blinded and were therefore aware of the randomly assigned groups. Research assistants administering the periodic assessments were meant to be blinded to condition by design; however, as the study progressed, a research assistant became unintentionally aware of each study participant's condition based on required documentation in the veteran’s health records; more notes were present for those in the intervention group (20 specialist notes) than the control group (8 notes). While the presence of a control group represents a strength relative to much of the existing ILF NFB literature, the control group in this case did not account for the total time spent with the researchers. Participants in the intervention group met with researchers for 20 total sessions as opposed to 8 telephone calls. Therefore, the study design cannot fully rule out the differential impact of demand characteristics between the 2 groups, nor can it fully address or rule out the impact of differential motivation and expectations between groups. There is also evidence that technological innovation can influence the expectations of research participants, meaning that the intervention group may have been unduly influenced by the novelty of the ILF NFB technology, to which the control group did not have exposure.⁵⁸

A second attention measure for this study would have been beneficial, perhaps in identifying true change in attention ability or providing more insight into finding better methods to assess attention among veterans with mTBI. ILF NFB demonstrated significant impact across multiple outcome measures of clinical relevance for veterans diagnosed with mTBI, including the primary outcome variables of headache and sleep. The strength of the improvements seen in these areas, supported by large practical effects as well as veterans’ subjective reports, indicates much promise. Follow-up studies may also focus on the potential effectiveness of ILF NFB as a treatment of the secondary concerns measured in this study, including traumatic stress-related and depressive symptoms, and may explore the added benefit, if any, of ILF NFB alongside other evidence-based treatments for traumatic stress-related and mood disorders (eg, cognitive behavioral therapy). Using functional magnetic resonance imaging before and after assessments to determine actual brain enhancement with ILF NFB for certain disorders in which a brain signature exists (ie, migraine) should be explored. Further examination of ILF NFB as an intervention for attention may also be warranted, using more effective measures of attention in the population of veterans with mTBI, given the concerns noted earlier. Future research on this topic will need to clearly define attention in relation to the veteran experience and use relevant measures.

Conclusions

This study supports ILF NFB as a safe, noninvasive, nonpharmacologic treatment that may be effective in addressing the complex clinical concerns of veterans diagnosed with mTBI, a population for whom effective treatments have been difficult to identify. This intervention can provide veterans with a desirable and effective nonpharmacologic alternative in their care.

Medication regimens may require adjustment in acute care settings due to dysphagia and/or enteral feeding tubes. When a patient has dysphagia and/or a feeding tube, the health care team must review the pharmacotherapy regimen to assess the appropriateness of medication formulations. Patient anatomy, the type of feeding tube in place, pharmacokinetic and pharmacodynamic properties of medications, risk of feeding tube obstruction, and potential for interactions between enteral nutrition and medications should be considered when clinicians administer medications through feeding tubes. The risk of feeding tube obstruction and clogging rises with increasing tube length and decreasing tube lumen. Incidence of obstructed percutaneous endoscopic gastrotomy tubes is reported to be 23% to 35%.¹

A coordinated effort by all members of the health care team is essential to provide safe and effective care to patients with dysphagia and/or enteral feeding tubes. To decrease the risk of feeding tube obstruction, medications should be dissolved in water or administered in liquid form, saline fluids should be avoided, and the tube should be flushed with water before and after administering medications.

The pharmacokinetics of medications can be altered when tablets are crushed or capsules are opened. The bioavailability of dabigatran, for example, increases by 75% when the capsules are opened and pellets are taken orally.² Medications may become intolerable after manipulation due to taste.³ Others may also increase the risk of feeding tube obstruction, such as omeprazole granules that increase the risk of small-bore feeding tube obstruction.⁴

Prior assessments of drug administration for patients with dysphagia and/or enteral feeding tubes has shown medication errors are prevalent.^5-7 The Institute for Safe Medication Practices (ISMP) issued a Medication Safety Alert that provides a framework for preventing medication errors when preparing and administering medications via enteral feeding tubes.⁸ Other resources, such as monographs, are also available to guide pharmacotherapy decisions when oral medications require manipulation for administration to patients with dysphagia and/or enteral feeding tubes.^9-11

In 2021, the Kansas City Veterans Affairs Medical Center (KCVAMC) was recognized as a Veterans Health Administration (VHA) Shark Tank finalist for improving the safety of medication administration for patients with enteral feeding tubes.¹² This involved the addition of a Computerized Patient Record System (CPRS), clinical reminder order check (CROC), and a comprehensive medication review by a pharmacist. After implementing the CROC alert and pharmacy e-consultation workflow, the KCVAMC team reported that the number of inappropriate medications (ie, drugs on the ISMP do not crush list) was reduced from 41 to 6 in 1 year, resulting in an 85.4% reduction in potential medication errors.¹³

In 2014, the Richard L. Roudebush VAMC (RLRVAMC) created a pharmacy consultation process for patients with dysphagia and/or enteral feeding tubes. Any clinician could place a pharmacy consultation in CPRS. A pharmacist then reviewed patient charts, medication information resources, the VA formulary, and RLRVAMC pharmacy inventory. The pharmacist conferred with the patient’s care team to adjust pharmacotherapy, completed a consultation note, and updated medication order comments in Veterans Health Information Systems and Technology Architecture (VistA). These comments interfaced with the barcode medication administration software for the health care professional administering medications.

Despite the 2014 quality improvement (QI) process, medication errors involving the inappropriate ordering, preparation, and administration of medications for patients with dysphagia and/or enteral feeding tubes continued to be reported. Additionally, anonymous feedback revealed that only 3 of 10 responding pharmacists were satisfied with the existing medication use process for patients with dysphagia and/or enteral feeding tubes. Pharmacists expressed concerns that (1) clinicians were inappropriately crushing and/or manipulating new medications that were ordered after pharmacy consultations; (2) there was a lack of comprehensive documentation in CPRS; and (3) there were too many manual steps in the process. In response, RLRVAMC initiated a new QI initiative to improve the medication use process for patients with dysphagia and/or enteral feeding tubes in the acute care setting.

Quality Improvement Project

This multidisciplinary RLRVAMC QI project began November 2024 to improve pharmacotherapy care for patients with dysphagia and/or enteral feeding tubes in acute care. It was approved by the RLRVAMC Pharmacy Service. This intervention addressed the pharmacy consultation template, standardization of equipment, standardization of language, creation of clinical alerts, and sustainment (Table 1).

RLRVAMC has about 8600 annual inpatient admissions and 159 acute care beds.¹⁴ The project charter was drafted, and local stakeholders were identified including pharmacy technicians, pharmacists, nurses, speech language pathologists, and acute care clinicians. Pharmacy consultation workload was retrospectively reviewed to describe the scope of the existing state.

A workshop with 12 QI project stakeholders in December 2024 used A3 methodology to define the current process and the target state, barriers and solutions, prioritize interventions on an impact-effort matrix, perform a gap analysis, identify rapid plan-do-study-act (PDSA) experiments, and develop a completion plan (Figure). Five postworkshop PDSA experiments engaged additional stakeholders, clinical application coordinators, and medical supply representatives to ascertain the feasibility of the tools implemented.

About 3% of RLRVAMC admissions involve a pharmacy consultation to review medications for dysphagia and/or enteral feeding tubes. Clinicians reviewed 30 preimplementation inpatient pharmacy consultations involving 200 oral medications. Pharmacists were more frequently consulted for inpatients with dysphagia (19 [63%]) than for patients with enteral feeding tubes (11 [37%]) (Table 2).

Pharmacy Consultation Template

The pharmacy consultation was updated in CPRS. Prior to this QI project, the ordering clinician was prompted to select 1 option for the indication: dysphagia or enteral feeding tube. The type of enteral feeding tube was not prompted by the consultation text nor required to be specified in the consultation. The ordering clinician could provide free-text comments. Of 11 preimplementation consultations, the type of enteral feeding tube was specified in 5 (45%). The consultation template entry was updated to include an option to check a box for the consultation indication from 3 options: dysphagia, enteral feeding, or other patient- specific condition/request. If enteral feeding tube is selected, then the clinician is prompted to select the type of enteral feeding tube. Since the completion of the project, there have been no patient safety reports concerning an erroneous or incomplete consultation entry (Supplemental Material).

The note template was updated to import the list of active inpatient medications and provide sections for the adjudicating pharmacist to document which medications can be crushed (or opened), which require adjustment, and which are hazardous and require special handling. Additionally, the revised template added a statement clarifying that the documented recommendations apply only to the medication regimen at the time of the consultation (Supplemental Material).

Standardizations

There are multiple pill-crushing devices used at RLRVAMC that vary in crushing mechanism, corresponding medication pouches, and degree of protection when manipulating hazardous medications. Prior to this QI project, RLRVAMC used 3 pill-crushing devices (about 30 total devices in inpatient care areas). Only 1 device with corresponding closed pouches for preparation of hazardous medications was available, which was stored in the RLRVAMC inpatient pharmacy. This workflow resulted in waste and posed potential risks for delays in care. This project incorporated a standard pill-crushing system with the corresponding medication pouches in all inpatient care areas, which provided safeguards for clinicians to prepare and administer hazardous medications (Supplemental Material).

Patients requiring medications to be crushed or opened on discharge should receive education, written instruction, and have care plans documented in CPRS. RLRVAMC patients receive education and a printed medication list. Prior to this QI project, the instructions for crushing or opening medications could only be entered by free text in the electronic medication reconciliation tool, allowing for the potential for inconsistent language or omissions.

This QI project included an update to the electronic medication reconciliation tool. An optional checkbox selection was added for patients requiring medications to be manipulated. When checked, a radial selection for individual medications is displayed, prompting the clinician and pharmacist to indicate either do not crush tablet or OK to crush tablet. These selections appear in clinical care notes and on the printed medication list provided to the patient (Supplemental Material).

Clinical Alerts

As part of the RLRVAMC QI initiative, a CROC alert was implemented, based on the KCVAMC intervention for patients with enteral feeding tubes.¹³ The RLRVAMC CROC alert also included patients with dysphagia. A nursing text order was made available in CPRS for patients requiring medications and remains active throughout the duration of the patient’s admission or until discontinued. It generates CROC alerts in CPRS and VistA when new medication orders are entered and reviewed by pharmacists.

Clinicians used clinical decision support systems to create daily lists of patients receiving medications by feeding tube and patients receiving crushed/opened medications due to dysphagia. This allows pharmacists to perform a census review of all inpatients to confirm appropriateness of medication orders. Clinical alerts for patients with enteral feeding tubes are advised by the ISMP and have data demonstrating a reduction in medication errors (Supplemental Material).^14,15

Sustainment

During the sustainment phase, process owners were identified and a Pharmacy Service standard operating procedure (SOP) was written. The development of an institutional do not crush medication list was discussed; however, it was determined to be difficult to develop and maintain. An institutional tertiary resource list was selected in favor of a locally developed resource. These resources include the Handbook of Drug Administration via Enteral Feeding Tubes, Third Edition, the Pharmacist’s Letter list, “Meds that Should Not be Crushed,” and the Up- ToDate Lexidrug list, “Oral Medications That Should Not Be Crushed or Altered.”^9-11 Links to the resources were added to the RLRVAMC pharmacy service SharePoint. In addition to defining the preferred tertiary resources, the SOP defined the process for reviewing inventory and the process for reviewing medication orders for hazard risk.

Discussion

Continued patient safety reports and low satisfaction rates among pharmacists prompted this QI project to improve safety for patients with dysphagia and/or enteral feeding tubes at RLRVAMC. The project engaged stakeholders and also identified and addressed gaps with potential for patient harm.

The tools implemented by this initiative drew from previous work by the KCVAMC and from framework provided by the ISMP.^8,13 We expanded the QI intervention to include acute care patients with dysphagia.

RLRVAMC did not take steps to track the impact of the interventions on medication errors. However, no patient safety reports concerning an erroneous or incomplete pharmacy consultation entry have been reported. We also think that it is reasonable to assume that the adoption of the safety tools described here will have a positive impact on patient safety. RLRVAMC pharmacists have noted an increased appreciation for medication safety when processing medication orders for patients with dysphagia and/or enteral feeding tubes. While the workflow took time to adopt and integrate, clinical pharmacists perceived it as an improvement in patient safety. Our future focus is aimed at translating the process improvement into the Oracle/Cerner electronic health record, which is scheduled to be deployed at the RLRVAMC in August 2026.

Limitations

This QI project did not aim to quantify or compare medication errors before and after the intervention. An accurate number of unreported errors in the medication use process for patients with dysphagia and/or enteral feeding tubes would be challenging to quantify without direct observation. Multiple clinicians are engaged in the medication use process and individual steps may not be documented at all, or documented properly. In addition, medication errors are often underreported and may not reflect the total number of errors and/or potential for errors. That said, reported medication errors in the medication use process for patients with dysphagia and/or enteral feeding tubes are reviewed on a monthly basis by the RLRVAMC Multidisciplinary Medication Safety committee to continuously improve patient safety.

Another potential limitation is the extent to which the project can be adapted at other VHA sites. For example, RLRVAMC uses CPRS; the framework and tools to improve medication safety may not translate to sites using the Oracle/Cerner electronic health record. Furthermore, this QI project included a pharmacy consultation workflow that relied on pharmacists who are available at any hour. Other facilities may not have continuous consultation coverage to review medications for patients with dysphagia and/or enteral feeding tubes.

Conclusions

This QI project drew from ISMP recommendations, previous work within the VHA, local practice, and insight from multiple disciplines on the health care team to revise and create tools to improve medication safety for patients with dysphagia and/or enteral feeding tubes in the acute care setting. These tools included a revised pharmacy consultation workflow with improvements to the pharmacy consultation template, standardization of the pill-crushing devices and language used for patient medication lists, implementation of CROC alerts within the EHR, and development of an SOP.

The RLRVAMC Pharmacy Service intends to continue reviewing patient safety reports, assessing staff perspectives, and refining (and potentially adding) tools for medication safety. Future QI initiatives may focus on improving medication safety for outpatients with dysphagia and/or enteral feeding tubes. We also hope that these tools can be adapted at other VAMCs to promote medication safety for patients with dysphagia and/or enteral feeding tubes.

Medication regimens may require adjustment in acute care settings due to dysphagia and/or enteral feeding tubes. When a patient has dysphagia and/or a feeding tube, the health care team must review the pharmacotherapy regimen to assess the appropriateness of medication formulations. Patient anatomy, the type of feeding tube in place, pharmacokinetic and pharmacodynamic properties of medications, risk of feeding tube obstruction, and potential for interactions between enteral nutrition and medications should be considered when clinicians administer medications through feeding tubes. The risk of feeding tube obstruction and clogging rises with increasing tube length and decreasing tube lumen. Incidence of obstructed percutaneous endoscopic gastrotomy tubes is reported to be 23% to 35%.¹

A coordinated effort by all members of the health care team is essential to provide safe and effective care to patients with dysphagia and/or enteral feeding tubes. To decrease the risk of feeding tube obstruction, medications should be dissolved in water or administered in liquid form, saline fluids should be avoided, and the tube should be flushed with water before and after administering medications.

The pharmacokinetics of medications can be altered when tablets are crushed or capsules are opened. The bioavailability of dabigatran, for example, increases by 75% when the capsules are opened and pellets are taken orally.² Medications may become intolerable after manipulation due to taste.³ Others may also increase the risk of feeding tube obstruction, such as omeprazole granules that increase the risk of small-bore feeding tube obstruction.⁴

Prior assessments of drug administration for patients with dysphagia and/or enteral feeding tubes has shown medication errors are prevalent.^5-7 The Institute for Safe Medication Practices (ISMP) issued a Medication Safety Alert that provides a framework for preventing medication errors when preparing and administering medications via enteral feeding tubes.⁸ Other resources, such as monographs, are also available to guide pharmacotherapy decisions when oral medications require manipulation for administration to patients with dysphagia and/or enteral feeding tubes.^9-11

In 2021, the Kansas City Veterans Affairs Medical Center (KCVAMC) was recognized as a Veterans Health Administration (VHA) Shark Tank finalist for improving the safety of medication administration for patients with enteral feeding tubes.¹² This involved the addition of a Computerized Patient Record System (CPRS), clinical reminder order check (CROC), and a comprehensive medication review by a pharmacist. After implementing the CROC alert and pharmacy e-consultation workflow, the KCVAMC team reported that the number of inappropriate medications (ie, drugs on the ISMP do not crush list) was reduced from 41 to 6 in 1 year, resulting in an 85.4% reduction in potential medication errors.¹³

In 2014, the Richard L. Roudebush VAMC (RLRVAMC) created a pharmacy consultation process for patients with dysphagia and/or enteral feeding tubes. Any clinician could place a pharmacy consultation in CPRS. A pharmacist then reviewed patient charts, medication information resources, the VA formulary, and RLRVAMC pharmacy inventory. The pharmacist conferred with the patient’s care team to adjust pharmacotherapy, completed a consultation note, and updated medication order comments in Veterans Health Information Systems and Technology Architecture (VistA). These comments interfaced with the barcode medication administration software for the health care professional administering medications.

Despite the 2014 quality improvement (QI) process, medication errors involving the inappropriate ordering, preparation, and administration of medications for patients with dysphagia and/or enteral feeding tubes continued to be reported. Additionally, anonymous feedback revealed that only 3 of 10 responding pharmacists were satisfied with the existing medication use process for patients with dysphagia and/or enteral feeding tubes. Pharmacists expressed concerns that (1) clinicians were inappropriately crushing and/or manipulating new medications that were ordered after pharmacy consultations; (2) there was a lack of comprehensive documentation in CPRS; and (3) there were too many manual steps in the process. In response, RLRVAMC initiated a new QI initiative to improve the medication use process for patients with dysphagia and/or enteral feeding tubes in the acute care setting.

Quality Improvement Project

This multidisciplinary RLRVAMC QI project began November 2024 to improve pharmacotherapy care for patients with dysphagia and/or enteral feeding tubes in acute care. It was approved by the RLRVAMC Pharmacy Service. This intervention addressed the pharmacy consultation template, standardization of equipment, standardization of language, creation of clinical alerts, and sustainment (Table 1).

RLRVAMC has about 8600 annual inpatient admissions and 159 acute care beds.¹⁴ The project charter was drafted, and local stakeholders were identified including pharmacy technicians, pharmacists, nurses, speech language pathologists, and acute care clinicians. Pharmacy consultation workload was retrospectively reviewed to describe the scope of the existing state.

A workshop with 12 QI project stakeholders in December 2024 used A3 methodology to define the current process and the target state, barriers and solutions, prioritize interventions on an impact-effort matrix, perform a gap analysis, identify rapid plan-do-study-act (PDSA) experiments, and develop a completion plan (Figure). Five postworkshop PDSA experiments engaged additional stakeholders, clinical application coordinators, and medical supply representatives to ascertain the feasibility of the tools implemented.

About 3% of RLRVAMC admissions involve a pharmacy consultation to review medications for dysphagia and/or enteral feeding tubes. Clinicians reviewed 30 preimplementation inpatient pharmacy consultations involving 200 oral medications. Pharmacists were more frequently consulted for inpatients with dysphagia (19 [63%]) than for patients with enteral feeding tubes (11 [37%]) (Table 2).

Pharmacy Consultation Template

The pharmacy consultation was updated in CPRS. Prior to this QI project, the ordering clinician was prompted to select 1 option for the indication: dysphagia or enteral feeding tube. The type of enteral feeding tube was not prompted by the consultation text nor required to be specified in the consultation. The ordering clinician could provide free-text comments. Of 11 preimplementation consultations, the type of enteral feeding tube was specified in 5 (45%). The consultation template entry was updated to include an option to check a box for the consultation indication from 3 options: dysphagia, enteral feeding, or other patient- specific condition/request. If enteral feeding tube is selected, then the clinician is prompted to select the type of enteral feeding tube. Since the completion of the project, there have been no patient safety reports concerning an erroneous or incomplete consultation entry (Supplemental Material).

The note template was updated to import the list of active inpatient medications and provide sections for the adjudicating pharmacist to document which medications can be crushed (or opened), which require adjustment, and which are hazardous and require special handling. Additionally, the revised template added a statement clarifying that the documented recommendations apply only to the medication regimen at the time of the consultation (Supplemental Material).

Standardizations

There are multiple pill-crushing devices used at RLRVAMC that vary in crushing mechanism, corresponding medication pouches, and degree of protection when manipulating hazardous medications. Prior to this QI project, RLRVAMC used 3 pill-crushing devices (about 30 total devices in inpatient care areas). Only 1 device with corresponding closed pouches for preparation of hazardous medications was available, which was stored in the RLRVAMC inpatient pharmacy. This workflow resulted in waste and posed potential risks for delays in care. This project incorporated a standard pill-crushing system with the corresponding medication pouches in all inpatient care areas, which provided safeguards for clinicians to prepare and administer hazardous medications (Supplemental Material).

Patients requiring medications to be crushed or opened on discharge should receive education, written instruction, and have care plans documented in CPRS. RLRVAMC patients receive education and a printed medication list. Prior to this QI project, the instructions for crushing or opening medications could only be entered by free text in the electronic medication reconciliation tool, allowing for the potential for inconsistent language or omissions.

This QI project included an update to the electronic medication reconciliation tool. An optional checkbox selection was added for patients requiring medications to be manipulated. When checked, a radial selection for individual medications is displayed, prompting the clinician and pharmacist to indicate either do not crush tablet or OK to crush tablet. These selections appear in clinical care notes and on the printed medication list provided to the patient (Supplemental Material).

Clinical Alerts

As part of the RLRVAMC QI initiative, a CROC alert was implemented, based on the KCVAMC intervention for patients with enteral feeding tubes.¹³ The RLRVAMC CROC alert also included patients with dysphagia. A nursing text order was made available in CPRS for patients requiring medications and remains active throughout the duration of the patient’s admission or until discontinued. It generates CROC alerts in CPRS and VistA when new medication orders are entered and reviewed by pharmacists.

Clinicians used clinical decision support systems to create daily lists of patients receiving medications by feeding tube and patients receiving crushed/opened medications due to dysphagia. This allows pharmacists to perform a census review of all inpatients to confirm appropriateness of medication orders. Clinical alerts for patients with enteral feeding tubes are advised by the ISMP and have data demonstrating a reduction in medication errors (Supplemental Material).^14,15

Sustainment

During the sustainment phase, process owners were identified and a Pharmacy Service standard operating procedure (SOP) was written. The development of an institutional do not crush medication list was discussed; however, it was determined to be difficult to develop and maintain. An institutional tertiary resource list was selected in favor of a locally developed resource. These resources include the Handbook of Drug Administration via Enteral Feeding Tubes, Third Edition, the Pharmacist’s Letter list, “Meds that Should Not be Crushed,” and the Up- ToDate Lexidrug list, “Oral Medications That Should Not Be Crushed or Altered.”^9-11 Links to the resources were added to the RLRVAMC pharmacy service SharePoint. In addition to defining the preferred tertiary resources, the SOP defined the process for reviewing inventory and the process for reviewing medication orders for hazard risk.

Discussion

Continued patient safety reports and low satisfaction rates among pharmacists prompted this QI project to improve safety for patients with dysphagia and/or enteral feeding tubes at RLRVAMC. The project engaged stakeholders and also identified and addressed gaps with potential for patient harm.

The tools implemented by this initiative drew from previous work by the KCVAMC and from framework provided by the ISMP.^8,13 We expanded the QI intervention to include acute care patients with dysphagia.

RLRVAMC did not take steps to track the impact of the interventions on medication errors. However, no patient safety reports concerning an erroneous or incomplete pharmacy consultation entry have been reported. We also think that it is reasonable to assume that the adoption of the safety tools described here will have a positive impact on patient safety. RLRVAMC pharmacists have noted an increased appreciation for medication safety when processing medication orders for patients with dysphagia and/or enteral feeding tubes. While the workflow took time to adopt and integrate, clinical pharmacists perceived it as an improvement in patient safety. Our future focus is aimed at translating the process improvement into the Oracle/Cerner electronic health record, which is scheduled to be deployed at the RLRVAMC in August 2026.

Limitations

This QI project did not aim to quantify or compare medication errors before and after the intervention. An accurate number of unreported errors in the medication use process for patients with dysphagia and/or enteral feeding tubes would be challenging to quantify without direct observation. Multiple clinicians are engaged in the medication use process and individual steps may not be documented at all, or documented properly. In addition, medication errors are often underreported and may not reflect the total number of errors and/or potential for errors. That said, reported medication errors in the medication use process for patients with dysphagia and/or enteral feeding tubes are reviewed on a monthly basis by the RLRVAMC Multidisciplinary Medication Safety committee to continuously improve patient safety.

Another potential limitation is the extent to which the project can be adapted at other VHA sites. For example, RLRVAMC uses CPRS; the framework and tools to improve medication safety may not translate to sites using the Oracle/Cerner electronic health record. Furthermore, this QI project included a pharmacy consultation workflow that relied on pharmacists who are available at any hour. Other facilities may not have continuous consultation coverage to review medications for patients with dysphagia and/or enteral feeding tubes.

Conclusions

This QI project drew from ISMP recommendations, previous work within the VHA, local practice, and insight from multiple disciplines on the health care team to revise and create tools to improve medication safety for patients with dysphagia and/or enteral feeding tubes in the acute care setting. These tools included a revised pharmacy consultation workflow with improvements to the pharmacy consultation template, standardization of the pill-crushing devices and language used for patient medication lists, implementation of CROC alerts within the EHR, and development of an SOP.

The RLRVAMC Pharmacy Service intends to continue reviewing patient safety reports, assessing staff perspectives, and refining (and potentially adding) tools for medication safety. Future QI initiatives may focus on improving medication safety for outpatients with dysphagia and/or enteral feeding tubes. We also hope that these tools can be adapted at other VAMCs to promote medication safety for patients with dysphagia and/or enteral feeding tubes.

Medication regimens may require adjustment in acute care settings due to dysphagia and/or enteral feeding tubes. When a patient has dysphagia and/or a feeding tube, the health care team must review the pharmacotherapy regimen to assess the appropriateness of medication formulations. Patient anatomy, the type of feeding tube in place, pharmacokinetic and pharmacodynamic properties of medications, risk of feeding tube obstruction, and potential for interactions between enteral nutrition and medications should be considered when clinicians administer medications through feeding tubes. The risk of feeding tube obstruction and clogging rises with increasing tube length and decreasing tube lumen. Incidence of obstructed percutaneous endoscopic gastrotomy tubes is reported to be 23% to 35%.¹

A coordinated effort by all members of the health care team is essential to provide safe and effective care to patients with dysphagia and/or enteral feeding tubes. To decrease the risk of feeding tube obstruction, medications should be dissolved in water or administered in liquid form, saline fluids should be avoided, and the tube should be flushed with water before and after administering medications.

The pharmacokinetics of medications can be altered when tablets are crushed or capsules are opened. The bioavailability of dabigatran, for example, increases by 75% when the capsules are opened and pellets are taken orally.² Medications may become intolerable after manipulation due to taste.³ Others may also increase the risk of feeding tube obstruction, such as omeprazole granules that increase the risk of small-bore feeding tube obstruction.⁴

Prior assessments of drug administration for patients with dysphagia and/or enteral feeding tubes has shown medication errors are prevalent.^5-7 The Institute for Safe Medication Practices (ISMP) issued a Medication Safety Alert that provides a framework for preventing medication errors when preparing and administering medications via enteral feeding tubes.⁸ Other resources, such as monographs, are also available to guide pharmacotherapy decisions when oral medications require manipulation for administration to patients with dysphagia and/or enteral feeding tubes.^9-11

In 2021, the Kansas City Veterans Affairs Medical Center (KCVAMC) was recognized as a Veterans Health Administration (VHA) Shark Tank finalist for improving the safety of medication administration for patients with enteral feeding tubes.¹² This involved the addition of a Computerized Patient Record System (CPRS), clinical reminder order check (CROC), and a comprehensive medication review by a pharmacist. After implementing the CROC alert and pharmacy e-consultation workflow, the KCVAMC team reported that the number of inappropriate medications (ie, drugs on the ISMP do not crush list) was reduced from 41 to 6 in 1 year, resulting in an 85.4% reduction in potential medication errors.¹³

In 2014, the Richard L. Roudebush VAMC (RLRVAMC) created a pharmacy consultation process for patients with dysphagia and/or enteral feeding tubes. Any clinician could place a pharmacy consultation in CPRS. A pharmacist then reviewed patient charts, medication information resources, the VA formulary, and RLRVAMC pharmacy inventory. The pharmacist conferred with the patient’s care team to adjust pharmacotherapy, completed a consultation note, and updated medication order comments in Veterans Health Information Systems and Technology Architecture (VistA). These comments interfaced with the barcode medication administration software for the health care professional administering medications.

Despite the 2014 quality improvement (QI) process, medication errors involving the inappropriate ordering, preparation, and administration of medications for patients with dysphagia and/or enteral feeding tubes continued to be reported. Additionally, anonymous feedback revealed that only 3 of 10 responding pharmacists were satisfied with the existing medication use process for patients with dysphagia and/or enteral feeding tubes. Pharmacists expressed concerns that (1) clinicians were inappropriately crushing and/or manipulating new medications that were ordered after pharmacy consultations; (2) there was a lack of comprehensive documentation in CPRS; and (3) there were too many manual steps in the process. In response, RLRVAMC initiated a new QI initiative to improve the medication use process for patients with dysphagia and/or enteral feeding tubes in the acute care setting.

Quality Improvement Project

This multidisciplinary RLRVAMC QI project began November 2024 to improve pharmacotherapy care for patients with dysphagia and/or enteral feeding tubes in acute care. It was approved by the RLRVAMC Pharmacy Service. This intervention addressed the pharmacy consultation template, standardization of equipment, standardization of language, creation of clinical alerts, and sustainment (Table 1).

RLRVAMC has about 8600 annual inpatient admissions and 159 acute care beds.¹⁴ The project charter was drafted, and local stakeholders were identified including pharmacy technicians, pharmacists, nurses, speech language pathologists, and acute care clinicians. Pharmacy consultation workload was retrospectively reviewed to describe the scope of the existing state.

A workshop with 12 QI project stakeholders in December 2024 used A3 methodology to define the current process and the target state, barriers and solutions, prioritize interventions on an impact-effort matrix, perform a gap analysis, identify rapid plan-do-study-act (PDSA) experiments, and develop a completion plan (Figure). Five postworkshop PDSA experiments engaged additional stakeholders, clinical application coordinators, and medical supply representatives to ascertain the feasibility of the tools implemented.

About 3% of RLRVAMC admissions involve a pharmacy consultation to review medications for dysphagia and/or enteral feeding tubes. Clinicians reviewed 30 preimplementation inpatient pharmacy consultations involving 200 oral medications. Pharmacists were more frequently consulted for inpatients with dysphagia (19 [63%]) than for patients with enteral feeding tubes (11 [37%]) (Table 2).

Pharmacy Consultation Template

The pharmacy consultation was updated in CPRS. Prior to this QI project, the ordering clinician was prompted to select 1 option for the indication: dysphagia or enteral feeding tube. The type of enteral feeding tube was not prompted by the consultation text nor required to be specified in the consultation. The ordering clinician could provide free-text comments. Of 11 preimplementation consultations, the type of enteral feeding tube was specified in 5 (45%). The consultation template entry was updated to include an option to check a box for the consultation indication from 3 options: dysphagia, enteral feeding, or other patient- specific condition/request. If enteral feeding tube is selected, then the clinician is prompted to select the type of enteral feeding tube. Since the completion of the project, there have been no patient safety reports concerning an erroneous or incomplete consultation entry (Supplemental Material).

The note template was updated to import the list of active inpatient medications and provide sections for the adjudicating pharmacist to document which medications can be crushed (or opened), which require adjustment, and which are hazardous and require special handling. Additionally, the revised template added a statement clarifying that the documented recommendations apply only to the medication regimen at the time of the consultation (Supplemental Material).

Standardizations

There are multiple pill-crushing devices used at RLRVAMC that vary in crushing mechanism, corresponding medication pouches, and degree of protection when manipulating hazardous medications. Prior to this QI project, RLRVAMC used 3 pill-crushing devices (about 30 total devices in inpatient care areas). Only 1 device with corresponding closed pouches for preparation of hazardous medications was available, which was stored in the RLRVAMC inpatient pharmacy. This workflow resulted in waste and posed potential risks for delays in care. This project incorporated a standard pill-crushing system with the corresponding medication pouches in all inpatient care areas, which provided safeguards for clinicians to prepare and administer hazardous medications (Supplemental Material).

Patients requiring medications to be crushed or opened on discharge should receive education, written instruction, and have care plans documented in CPRS. RLRVAMC patients receive education and a printed medication list. Prior to this QI project, the instructions for crushing or opening medications could only be entered by free text in the electronic medication reconciliation tool, allowing for the potential for inconsistent language or omissions.

This QI project included an update to the electronic medication reconciliation tool. An optional checkbox selection was added for patients requiring medications to be manipulated. When checked, a radial selection for individual medications is displayed, prompting the clinician and pharmacist to indicate either do not crush tablet or OK to crush tablet. These selections appear in clinical care notes and on the printed medication list provided to the patient (Supplemental Material).

Clinical Alerts

As part of the RLRVAMC QI initiative, a CROC alert was implemented, based on the KCVAMC intervention for patients with enteral feeding tubes.¹³ The RLRVAMC CROC alert also included patients with dysphagia. A nursing text order was made available in CPRS for patients requiring medications and remains active throughout the duration of the patient’s admission or until discontinued. It generates CROC alerts in CPRS and VistA when new medication orders are entered and reviewed by pharmacists.

Clinicians used clinical decision support systems to create daily lists of patients receiving medications by feeding tube and patients receiving crushed/opened medications due to dysphagia. This allows pharmacists to perform a census review of all inpatients to confirm appropriateness of medication orders. Clinical alerts for patients with enteral feeding tubes are advised by the ISMP and have data demonstrating a reduction in medication errors (Supplemental Material).^14,15

Sustainment

During the sustainment phase, process owners were identified and a Pharmacy Service standard operating procedure (SOP) was written. The development of an institutional do not crush medication list was discussed; however, it was determined to be difficult to develop and maintain. An institutional tertiary resource list was selected in favor of a locally developed resource. These resources include the Handbook of Drug Administration via Enteral Feeding Tubes, Third Edition, the Pharmacist’s Letter list, “Meds that Should Not be Crushed,” and the Up- ToDate Lexidrug list, “Oral Medications That Should Not Be Crushed or Altered.”^9-11 Links to the resources were added to the RLRVAMC pharmacy service SharePoint. In addition to defining the preferred tertiary resources, the SOP defined the process for reviewing inventory and the process for reviewing medication orders for hazard risk.

Discussion

Continued patient safety reports and low satisfaction rates among pharmacists prompted this QI project to improve safety for patients with dysphagia and/or enteral feeding tubes at RLRVAMC. The project engaged stakeholders and also identified and addressed gaps with potential for patient harm.

The tools implemented by this initiative drew from previous work by the KCVAMC and from framework provided by the ISMP.^8,13 We expanded the QI intervention to include acute care patients with dysphagia.

RLRVAMC did not take steps to track the impact of the interventions on medication errors. However, no patient safety reports concerning an erroneous or incomplete pharmacy consultation entry have been reported. We also think that it is reasonable to assume that the adoption of the safety tools described here will have a positive impact on patient safety. RLRVAMC pharmacists have noted an increased appreciation for medication safety when processing medication orders for patients with dysphagia and/or enteral feeding tubes. While the workflow took time to adopt and integrate, clinical pharmacists perceived it as an improvement in patient safety. Our future focus is aimed at translating the process improvement into the Oracle/Cerner electronic health record, which is scheduled to be deployed at the RLRVAMC in August 2026.

Limitations

This QI project did not aim to quantify or compare medication errors before and after the intervention. An accurate number of unreported errors in the medication use process for patients with dysphagia and/or enteral feeding tubes would be challenging to quantify without direct observation. Multiple clinicians are engaged in the medication use process and individual steps may not be documented at all, or documented properly. In addition, medication errors are often underreported and may not reflect the total number of errors and/or potential for errors. That said, reported medication errors in the medication use process for patients with dysphagia and/or enteral feeding tubes are reviewed on a monthly basis by the RLRVAMC Multidisciplinary Medication Safety committee to continuously improve patient safety.

Another potential limitation is the extent to which the project can be adapted at other VHA sites. For example, RLRVAMC uses CPRS; the framework and tools to improve medication safety may not translate to sites using the Oracle/Cerner electronic health record. Furthermore, this QI project included a pharmacy consultation workflow that relied on pharmacists who are available at any hour. Other facilities may not have continuous consultation coverage to review medications for patients with dysphagia and/or enteral feeding tubes.

Conclusions

This QI project drew from ISMP recommendations, previous work within the VHA, local practice, and insight from multiple disciplines on the health care team to revise and create tools to improve medication safety for patients with dysphagia and/or enteral feeding tubes in the acute care setting. These tools included a revised pharmacy consultation workflow with improvements to the pharmacy consultation template, standardization of the pill-crushing devices and language used for patient medication lists, implementation of CROC alerts within the EHR, and development of an SOP.

The RLRVAMC Pharmacy Service intends to continue reviewing patient safety reports, assessing staff perspectives, and refining (and potentially adding) tools for medication safety. Future QI initiatives may focus on improving medication safety for outpatients with dysphagia and/or enteral feeding tubes. We also hope that these tools can be adapted at other VAMCs to promote medication safety for patients with dysphagia and/or enteral feeding tubes.

The Veterans Health Administration (VHA) is now in the sixth year of its enterprise-wide transformation into a high reliability organization (HRO). This effort began with a 2016 pilot project and is now implemented in 170 VHA medical centers.^1-4 This transformation reflects a commitment to implementing standardized and reliable health care practices.

The VHA HRO implementation strategy includes a multifaceted approach to engage leadership through education, training, leader coaching, and change management initiatives.² Despite the diversity of facilities in terms of cultures, geographies, and complexities, US Department of Veterans Affairs (VA) medical centers (VAMCs) have increasingly embraced standardized HRO practices. These changes are evident in improvements in VHA All Employee Survey scores, which assess 4 key patient safety culture dimensions: risk identification and just culture, error transparency and mitigation, supervisor communication and trust, and team cohesion and engagement.⁵ Positive trends in these dimensions highlight a cultural shift toward greater reliability, even amid challenges introduced by the COVID-19 pandemic.

However, this progress has encountered some challenges. Leadership turnover, budgetary constraints, and extensive educational demands for implementing and sustaining HRO practices have created obstacles, particularly for frontline health care practitioners.⁶ Additionally, there are pockets of resistance similar to what the airline industry faced when implementing crew resource management (CRM). Specifically, senior pilots and legacy leaders were reluctant to abandon their high-status, autocratic management styles and embrace CRM, despite its proven benefits for enhancing commercial airline safety.⁷ Similarly, some VHA staff have expressed resistance to foundational HRO practices, which include safety huddles, safety forums, leader rounding, and visual management systems.^6,8

The training requirements for HRO practices range from a 25-minute introductory course (HRO 101) to a 7.5-hour team training session facilitated by the VHA National Center for Patient Safety (NCPS).⁹ While some supervisors view these requirements as burdensome, others have demonstrated strong enthusiasm for the process.⁶ Understanding the perspectives of unit and departmental managers regarding factors that enhance or hinder the adoption of HRO practices is critical for continuous improvement.^10-12 Research has suggested that fostering psychological safety can create an environment where new ideas are shared openly, helping organizations navigate resistance to change.^13-16

A 2024 quality improvement study, drawing on the perceptions of HRO leads, identified key facilitators, including training, coaching, leader approachability, and psychological safety, as well as barriers such as inadequate training and lack of accountability among managers.¹⁷ Building on this work, the current study focused on frontline supervisors, who are directly involved in integrating HRO practices into patient care activities. By addressing both barriers and facilitators, this expanded approach aims to provide a more comprehensive understanding of the challenges influencing HRO implementation in day-to-day operations.

Methods

This quality improvement initiative examined facilitators and barriers to establishing just culture and implementing high reliability practices, focusing on frontline supervisors overseeing clinical care teams (eg, emergency department, critical care) or patient-support functions (eg, dietary services). A questionnaire was sent to a randomized sample of VHA facility supervisors.

A qualitative grounded theory approach was employed to provide a deeper understanding of nuanced phenomena that cannot be captured through numerical data alone. This method enables systematic analysis using open, axial, and thematic coding, ensuring that emerging themes achieve saturation.^18,19 It is particularly suited for this study, given the limited prior data on frontline supervisors. Additionally, qualitative methods help mitigate biases common in Likert-style scales, where respondents may lean toward agreement, potentially skewing results.²⁰

Inclusion Criteria

Participants were required to have served as a frontline supervisor for ≥ 6 months. Frontline supervisors are assigned responsibility for supporting staff who deliver services to VHA patients, including clinical care, dietary support, and other functions. These staff must complete baseline HRO cultural training as well as NCPS team training and are responsible for supporting quality, safety, and patient experience. Potential participants were identified from a list of frontline supervisors provided by VHA management. A subset was chosen through random sampling across geographically distributed VHA hospital facilities that vary in size and complexity. Invitations to participate in completing the questionnaire were sent via email, explaining the quality improvement initiative’s purpose, and encouraging voluntary participation. Of 2000 frontline supervisors invited to participate in the initiative, 97 completed the questionnaire. Participants represented a mix of VHA sites in terms of geography, size, and complexity.

Procedures

The authors used a qualitative approach and administered a confidential online survey. Demographic data were collected within the survey to understand characteristics of the participant population, including length of time as a frontline supervisor, facility complexity level, and professional background (clinical vs nonclinical). Survey questions were developed to elicit responses to specific areas of interest based on existing literature related to HRO and just culture.

Facilitators were defined as factors that increase the likelihood of establishing or sustaining high reliability practices and/or culture. Barriers were defined as factors that decrease or inhibit the likelihood of establishing or sustaining high reliability practices and/or culture. The questionnaire consisted of open-ended questions asking frontline supervisors to describe HRO practices and just culture at their individual facility and within their role. Participants also were asked to identify facilitators and barriers that helped or hindered their efforts to establish and maintain high reliability practices and just culture. The questionnaire solicited recommendations for additional support, training, resources, or leadership interventions to strengthen high reliability practices and just culture from each participant.

Analysis

Participant characteristics were analyzed using descriptive statistics. Responses to the 7 open-ended questions were coded and analyzed using ATLAS.ti v.24 qualitative data analysis software by an experienced researcher and coauthor. Grounded theory methodology allowed themes to emerge from the data and although the response rate was limited, the themes reached a saturation point.^18,19

Ethical Considerations

Institutional review board (IRB) review and approval were not required for this quality improvement initiative. Formal IRB review and approval of a quality improvement initiative are not required by VHA. Participation was confidential and voluntary, and participants could withdraw at any time without consequences. Completion of the survey indicated consent, and facility names and participant identifiers were not used. Unique numbers were assigned to each participant and all responses were kept confidential and nonattributional. Frequency coding was used to identify the facilitators and barriers to high reliability practices implementation and just culture among frontline supervisors until thematic saturation was obtained.

Results

A total of 2000 frontline supervisors were invited to participate, of whom 97 completed the questionnaire (response rate, 4.9%). Participants were first asked to describe just culture and high reliability practices in their own words. The consensus was that a just culture emphasizes a nonpunitive environment where employees can report errors or incidents without fear of retaliation. It encourages accountability at the systems level, focusing on learning from mistakes to improve processes. In response to a question asking respondents to describe HRO practices and just culture in their own words, participants noted that organizations with a just culture promote open communication, allowing staff to discuss safety issues and concerns without fear of personal blame. Additionally, participants agreed that HRO practices were defined as a set of principles and practices aimed at minimizing errors and promoting safety, especially within complex and high-risk environments. Participants responded that key characteristics include a preoccupation with failure, sensitivity to operations, reluctance to simplify, and a commitment to resilience. HRO practices entail proactively identifying and mitigating risks through open communication and collaboration among team members, they added.

Overall, participants were aligned with their view of the role a frontline supervisor plays in supporting just culture and HRO principles at their facility by fostering open communication and psychological safety, encouraging continuous learning and improvement, and promoting team collaboration and shared accountability. Among frontline supervisors, 93 (96%) identified their role as being critical to creating a safe space and reinforcing just culture and HRO principles at their facility, while 4 (4%) failed to identify a single duty.

Identified Themes

Table 1 summarizes 6 key themes identified from participants’ responses, highlighting the most frequently cited facilitators and barriers to implementing and sustaining high reliability practices and a just culture. Table 2 shows the classification of several themes in relation to facility complexity, emphasizing leadership commitment and support as a pivotal facilitator, while listing resistance to change and entrenched attitudes as a prominent barrier.

Role of Leadership

Facilitators. Leadership commitment and support were the most frequently identified facilitator, accounting for 44 mentions (45%). This aligns with participants’ descriptions of leadership involvement as crucial, particularly in setting standards and fostering accountability throughout the organization. For example, a frontline supervisor with < 5 years of experience from a nonclinical background at a 1B facility remarked, “Facility leadership are involved, which trickles down to lower-level leads and supervisors, which keeps everyone accountable and holds everyone to the same standards.” Participants frequently identified that leaders setting the standard and communicating expectations as paramount facilitators for strengthening high reliability practices and just culture at their facility.

Barriers. A lack of leadership commitment and support was a significant barrier, cited in 17 responses (18%). Participants described this barrier as a deficiency in follow-through, transparency, and presence, which undermines efforts to sustain just culture and high reliability principles. Notably, the lack of leadership commitment and support stood out as a distinct and recurring theme, underscoring its critical role as an independent challenge to achieving organizational goals. “Many leaders are not yet fully bought in,” a respondent explained. “They take the training and pass it off and go right back to their units and focus on blaming or chastis[ing] people for speaking up.” This theme frequently intersected with mentions of insufficient resources and entrenched attitudes, amplifying other challenges.

Open Communication and Transparency

Facilitators. Open communication and transparency were identified as facilitators in 12 responses (12%). Participants emphasized the importance of mechanisms such as HRO meetings and the sharing of “real” examples of positive outcomes from applying HRO principles. Transparent communication fosters psychological safety, allowing staff to report concerns without fear of reprisal. One participant with < 5 years of experience from a clinical background at a 1A facility encapsulated this theme by saying, “Quarterly ‘fireside chats’ are helpful, [this] creates open dialogue about where the next safety issue may occur, what staff need to do their job safely, while also imparting more of the philosophy of HRO that staff may not be aware of.”

Barriers. While communication serves as a facilitator, participants also highlighted barriers such as siloed communication and fear of reprisal. These reflect challenges in creating open and transparent feedback loops essential to high reliability. For example, a participant concluded, “Leadership does not communicate problem-solving efforts and resolution down the chain, they do not see the problems.” Another participant added, “[HRO principles] are not discussed that much.” While this theme presented as a barrier, it was noted less frequently.

Education and Training

Facilitators. Education and training were noted as facilitators in 10 responses (10%), underscoring their role in establishing high reliability practices. Participants suggested tailored training, simulation-based exercises, and mentorship to enhance practical application. However, they noted the importance of linking training to real change and ensuring leadership enforcement of learned behaviors. This theme is best represented by a participant who concluded, “Trainings have helped, but I think as a supervisor, being involved and interacting with your staff, observing, doing the work they do to help identify potential problems areas, especially when new systems are introduced are key. Being hands-on is the only way to successfully manage your team.”

Barriers. Insufficient resources, including time and staffing constraints, were identified as barriers to education and training, accounting for 24 responses (25%). Participants observed that mandatory training without mentorship or application diminishes its effectiveness.

Insufficient Resources and Funding

Barriers. Resource constraints, including low staffing levels and budget cuts, accounted for 24 responses (25%). Participants reported these limitations prevented staff from attending training and affected the overall implementation of just culture and HRO principles. “Low staffing in supporting services as well as in my own service line have created barriers,” a participant reported. Another participant responded that barriers to HRO were primarily “…financial, as the focus is how to curb costs and bring in more funding rather than taking the time to review and apply the concepts of high reliability.”

Resistance to Change and Entrenched Attitudes

Barriers. Resistance to change was the most frequently identified barrier, with 31 responses (32%). One participant described a persistent “gotcha” culture, where blame and punishment hinder progress toward just culture. This entrenched mindset creates significant obstacles to adopting HRO practices and requires active leadership and supervisor intervention to overcome. This theme is best captured by a respondent who noted that “culture change is difficult, especially among staff with such long tenure. It’s a long game.”

Synthesis and Integration of Findings

The data in Table 1 and Table 2 reinforce the themes identified in the qualitative analysis. Leadership commitment and support are pivotal, both as a facilitator and barrier. Open communication and education and training, while recognized as facilitators, were less frequently mentioned, but still critical. Resistance to change and insufficient resources were the most prominent barriers, indicating where organizational efforts should focus to further foster a culture of high reliability.

By addressing these barriers, particularly resistance to change and resource constraints, and leveraging facilitators like leadership engagement and transparent communication, organizations can enhance their implementation of just culture and high reliability practices. These efforts require deliberate strategies, including effective training, mentorship, and the active presence of leadership.

Discussion

This quality improvement initiative builds on prior research by examining the implementation of HRO practices from the perspective of frontline supervisors. Unlike earlier research focused on HRO leads, this study explores the critical role of supervisors who integrate HRO principles into clinical and administrative operations.¹⁷ By analyzing their experiences, this study offers practical insights into facilitating HRO implementation across organizational levels.

The findings highlight broad agreement on the value of just culture and HRO principles in fostering safe, accountable health care environments. Participants described just culture as promoting system—level accountability rather than individual blame, encouraging error reporting and learning for continuous improvement. Similarly, HRO practices—emphasizing a preoccupation with failure, operational sensitivity, and resilience— were seen as vital for patient safety in complex settings.

Frontline supervisors play a pivotal role, with 96% of respondents identifying their influence on fostering open communication, psychological safety, and shared accountability. Key facilitators included leadership commitment, open communication, and mentorship. Active leadership involvement was particularly valued, as it trickles down to reinforce standards across all organizational levels. HRO meetings using real-world examples were seen as instrumental in demonstrating the tangible benefits of these principles, helping embed them into daily practices.

Despite these facilitators, several barriers to implementation were noted. Resistance to change and entrenched attitudes, and a persistent gotcha culture undermined efforts to establish just culture. Resource constraints, including staffing shortages and budget limitations, further hindered the adoption of HRO practices. The lack of consistent leadership engagement, marked by limited visibility, follow-through, and transparency, exacerbated these challenges.

HRO leads are important for promoting education and embedding HRO principles into daily operations. These individuals provide vital support to frontline supervisors, translating HRO concepts into actionable practices. However, organizational challenges such as staff turnover and redirected funding have weakened the infrastructure supporting HRO initiatives. The elimination of HRO lead roles due to budgetary pressures at several facilities reflects a short-term focus on operational demands at the expense of long-term cultural transformation.

Additional barriers included siloed communication, fear of reprisal, bureaucratic obstacles, and outdated technology. These challenges limit progress toward high reliability and diminish the effectiveness of HRO principles.

Participants proposed strategies focused on education, training, and leadership engagement. Simulation-based training tailored to specific roles was identified as an effective tool for preparing staff to apply HRO principles in real-world scenarios. Enhanced communication, such as regular leadership rounding and transparent updates on safety concerns, was also emphasized. Participants stressed the importance of showing staff how their feedback influences organizational decisions to build trust and accountability. Finally, standardizing procedures and protocols across facilities was seen as critical for aligning practices and reducing variability in safety processes.

This study underscores the need for sustained leadership commitment and infrastructure to ensure the long-term success of HRO implementation. Addressing the identified barriers and leveraging the proposed mitigation strategies can foster a culture of safety and reliability across the organization.

Limitations

This quality improvement initiative used qualitative grounded theory methods and sampled a relatively small group of experienced leaders specifically involved in implementing HRO within the VHA. In addition, while saturation of themes was reached, the number of responses represents a small sample of VHA frontline supervisors. As such, the findings may not be fully representative of the perspectives of all unit and departmental leaders across the VHA or other health care systems. A previous qualitative quality improvement initiative focused on the perceptions of HRO leads regarding facilitators and barriers to just culture.¹⁷ This quality improvement initiative broadened that focus by examining the perspectives of frontline supervisors in the operational environment, who may not be HRO experts but work to implement HRO principles with the guidance of HRO leads (HRO subject matter experts).

There remains an opportunity to address a critical gap by assessing facilitators and barriers beyond the facility level, incorporating both the Veterans Integrated Service Networks (VISN) and VHA Central Office (VHACO). While qualitative methods, such as those used in this study, provide deep insights and detailed understanding, they are limited in their ability to identify system-wide trends and variations at a more strategic VISN and VHACO level. Addressing this could enhance the broader applicability of HRO principles across the VHA.

Conclusions

Successful implementation of the recommendations reported in this study will require sustained focus and continued commitment from all stakeholders across the VHA. As the VHA enters its seventh year on the HRO journey, the risk of organizational drift remains an ongoing concern. Progress has been made, as evidenced by incremental improvements in All Employee Survey scores and increased reporting of adverse events and near misses, but the challenge will be to maintain focus and continue to build upon progress amid the current climate of budgetary constraints.

This study builds on previous quality improvement efforts and provides valuable insights into the barriers and facilitators that can either hinder or support the VHA’s ongoing pursuit of high reliability. The findings offer a model for understanding the complexities of this journey—one that requires continuous effort and adaptation, as there is no definitive endpoint in the quest for high reliability.

Since completion of this study in 2024, the VHA has entered a period of organizational transition and restructuring. Such transitions are often accompanied by increased operational demands and organizational strain. These include realignments, personnel changes, staffing adjustments, workforce reductions, and continued implementation of a new electronic health record system. In this context, maintaining attention to culture, communication, frontline engagement, and mechanisms that provide visibility into organizational climate is essential to sustain momentum in high-reliability efforts.

The Veterans Health Administration (VHA) is now in the sixth year of its enterprise-wide transformation into a high reliability organization (HRO). This effort began with a 2016 pilot project and is now implemented in 170 VHA medical centers.^1-4 This transformation reflects a commitment to implementing standardized and reliable health care practices.

The VHA HRO implementation strategy includes a multifaceted approach to engage leadership through education, training, leader coaching, and change management initiatives.² Despite the diversity of facilities in terms of cultures, geographies, and complexities, US Department of Veterans Affairs (VA) medical centers (VAMCs) have increasingly embraced standardized HRO practices. These changes are evident in improvements in VHA All Employee Survey scores, which assess 4 key patient safety culture dimensions: risk identification and just culture, error transparency and mitigation, supervisor communication and trust, and team cohesion and engagement.⁵ Positive trends in these dimensions highlight a cultural shift toward greater reliability, even amid challenges introduced by the COVID-19 pandemic.

However, this progress has encountered some challenges. Leadership turnover, budgetary constraints, and extensive educational demands for implementing and sustaining HRO practices have created obstacles, particularly for frontline health care practitioners.⁶ Additionally, there are pockets of resistance similar to what the airline industry faced when implementing crew resource management (CRM). Specifically, senior pilots and legacy leaders were reluctant to abandon their high-status, autocratic management styles and embrace CRM, despite its proven benefits for enhancing commercial airline safety.⁷ Similarly, some VHA staff have expressed resistance to foundational HRO practices, which include safety huddles, safety forums, leader rounding, and visual management systems.^6,8

The training requirements for HRO practices range from a 25-minute introductory course (HRO 101) to a 7.5-hour team training session facilitated by the VHA National Center for Patient Safety (NCPS).⁹ While some supervisors view these requirements as burdensome, others have demonstrated strong enthusiasm for the process.⁶ Understanding the perspectives of unit and departmental managers regarding factors that enhance or hinder the adoption of HRO practices is critical for continuous improvement.^10-12 Research has suggested that fostering psychological safety can create an environment where new ideas are shared openly, helping organizations navigate resistance to change.^13-16

A 2024 quality improvement study, drawing on the perceptions of HRO leads, identified key facilitators, including training, coaching, leader approachability, and psychological safety, as well as barriers such as inadequate training and lack of accountability among managers.¹⁷ Building on this work, the current study focused on frontline supervisors, who are directly involved in integrating HRO practices into patient care activities. By addressing both barriers and facilitators, this expanded approach aims to provide a more comprehensive understanding of the challenges influencing HRO implementation in day-to-day operations.

Methods

This quality improvement initiative examined facilitators and barriers to establishing just culture and implementing high reliability practices, focusing on frontline supervisors overseeing clinical care teams (eg, emergency department, critical care) or patient-support functions (eg, dietary services). A questionnaire was sent to a randomized sample of VHA facility supervisors.

A qualitative grounded theory approach was employed to provide a deeper understanding of nuanced phenomena that cannot be captured through numerical data alone. This method enables systematic analysis using open, axial, and thematic coding, ensuring that emerging themes achieve saturation.^18,19 It is particularly suited for this study, given the limited prior data on frontline supervisors. Additionally, qualitative methods help mitigate biases common in Likert-style scales, where respondents may lean toward agreement, potentially skewing results.²⁰

Inclusion Criteria

Participants were required to have served as a frontline supervisor for ≥ 6 months. Frontline supervisors are assigned responsibility for supporting staff who deliver services to VHA patients, including clinical care, dietary support, and other functions. These staff must complete baseline HRO cultural training as well as NCPS team training and are responsible for supporting quality, safety, and patient experience. Potential participants were identified from a list of frontline supervisors provided by VHA management. A subset was chosen through random sampling across geographically distributed VHA hospital facilities that vary in size and complexity. Invitations to participate in completing the questionnaire were sent via email, explaining the quality improvement initiative’s purpose, and encouraging voluntary participation. Of 2000 frontline supervisors invited to participate in the initiative, 97 completed the questionnaire. Participants represented a mix of VHA sites in terms of geography, size, and complexity.

Procedures

The authors used a qualitative approach and administered a confidential online survey. Demographic data were collected within the survey to understand characteristics of the participant population, including length of time as a frontline supervisor, facility complexity level, and professional background (clinical vs nonclinical). Survey questions were developed to elicit responses to specific areas of interest based on existing literature related to HRO and just culture.

Facilitators were defined as factors that increase the likelihood of establishing or sustaining high reliability practices and/or culture. Barriers were defined as factors that decrease or inhibit the likelihood of establishing or sustaining high reliability practices and/or culture. The questionnaire consisted of open-ended questions asking frontline supervisors to describe HRO practices and just culture at their individual facility and within their role. Participants also were asked to identify facilitators and barriers that helped or hindered their efforts to establish and maintain high reliability practices and just culture. The questionnaire solicited recommendations for additional support, training, resources, or leadership interventions to strengthen high reliability practices and just culture from each participant.

Analysis

Participant characteristics were analyzed using descriptive statistics. Responses to the 7 open-ended questions were coded and analyzed using ATLAS.ti v.24 qualitative data analysis software by an experienced researcher and coauthor. Grounded theory methodology allowed themes to emerge from the data and although the response rate was limited, the themes reached a saturation point.^18,19

Ethical Considerations

Institutional review board (IRB) review and approval were not required for this quality improvement initiative. Formal IRB review and approval of a quality improvement initiative are not required by VHA. Participation was confidential and voluntary, and participants could withdraw at any time without consequences. Completion of the survey indicated consent, and facility names and participant identifiers were not used. Unique numbers were assigned to each participant and all responses were kept confidential and nonattributional. Frequency coding was used to identify the facilitators and barriers to high reliability practices implementation and just culture among frontline supervisors until thematic saturation was obtained.

Results

A total of 2000 frontline supervisors were invited to participate, of whom 97 completed the questionnaire (response rate, 4.9%). Participants were first asked to describe just culture and high reliability practices in their own words. The consensus was that a just culture emphasizes a nonpunitive environment where employees can report errors or incidents without fear of retaliation. It encourages accountability at the systems level, focusing on learning from mistakes to improve processes. In response to a question asking respondents to describe HRO practices and just culture in their own words, participants noted that organizations with a just culture promote open communication, allowing staff to discuss safety issues and concerns without fear of personal blame. Additionally, participants agreed that HRO practices were defined as a set of principles and practices aimed at minimizing errors and promoting safety, especially within complex and high-risk environments. Participants responded that key characteristics include a preoccupation with failure, sensitivity to operations, reluctance to simplify, and a commitment to resilience. HRO practices entail proactively identifying and mitigating risks through open communication and collaboration among team members, they added.

Overall, participants were aligned with their view of the role a frontline supervisor plays in supporting just culture and HRO principles at their facility by fostering open communication and psychological safety, encouraging continuous learning and improvement, and promoting team collaboration and shared accountability. Among frontline supervisors, 93 (96%) identified their role as being critical to creating a safe space and reinforcing just culture and HRO principles at their facility, while 4 (4%) failed to identify a single duty.

Identified Themes

Table 1 summarizes 6 key themes identified from participants’ responses, highlighting the most frequently cited facilitators and barriers to implementing and sustaining high reliability practices and a just culture. Table 2 shows the classification of several themes in relation to facility complexity, emphasizing leadership commitment and support as a pivotal facilitator, while listing resistance to change and entrenched attitudes as a prominent barrier.

Role of Leadership

Facilitators. Leadership commitment and support were the most frequently identified facilitator, accounting for 44 mentions (45%). This aligns with participants’ descriptions of leadership involvement as crucial, particularly in setting standards and fostering accountability throughout the organization. For example, a frontline supervisor with < 5 years of experience from a nonclinical background at a 1B facility remarked, “Facility leadership are involved, which trickles down to lower-level leads and supervisors, which keeps everyone accountable and holds everyone to the same standards.” Participants frequently identified that leaders setting the standard and communicating expectations as paramount facilitators for strengthening high reliability practices and just culture at their facility.

Barriers. A lack of leadership commitment and support was a significant barrier, cited in 17 responses (18%). Participants described this barrier as a deficiency in follow-through, transparency, and presence, which undermines efforts to sustain just culture and high reliability principles. Notably, the lack of leadership commitment and support stood out as a distinct and recurring theme, underscoring its critical role as an independent challenge to achieving organizational goals. “Many leaders are not yet fully bought in,” a respondent explained. “They take the training and pass it off and go right back to their units and focus on blaming or chastis[ing] people for speaking up.” This theme frequently intersected with mentions of insufficient resources and entrenched attitudes, amplifying other challenges.

Open Communication and Transparency

Facilitators. Open communication and transparency were identified as facilitators in 12 responses (12%). Participants emphasized the importance of mechanisms such as HRO meetings and the sharing of “real” examples of positive outcomes from applying HRO principles. Transparent communication fosters psychological safety, allowing staff to report concerns without fear of reprisal. One participant with < 5 years of experience from a clinical background at a 1A facility encapsulated this theme by saying, “Quarterly ‘fireside chats’ are helpful, [this] creates open dialogue about where the next safety issue may occur, what staff need to do their job safely, while also imparting more of the philosophy of HRO that staff may not be aware of.”

Barriers. While communication serves as a facilitator, participants also highlighted barriers such as siloed communication and fear of reprisal. These reflect challenges in creating open and transparent feedback loops essential to high reliability. For example, a participant concluded, “Leadership does not communicate problem-solving efforts and resolution down the chain, they do not see the problems.” Another participant added, “[HRO principles] are not discussed that much.” While this theme presented as a barrier, it was noted less frequently.

Education and Training

Facilitators. Education and training were noted as facilitators in 10 responses (10%), underscoring their role in establishing high reliability practices. Participants suggested tailored training, simulation-based exercises, and mentorship to enhance practical application. However, they noted the importance of linking training to real change and ensuring leadership enforcement of learned behaviors. This theme is best represented by a participant who concluded, “Trainings have helped, but I think as a supervisor, being involved and interacting with your staff, observing, doing the work they do to help identify potential problems areas, especially when new systems are introduced are key. Being hands-on is the only way to successfully manage your team.”

Barriers. Insufficient resources, including time and staffing constraints, were identified as barriers to education and training, accounting for 24 responses (25%). Participants observed that mandatory training without mentorship or application diminishes its effectiveness.

Insufficient Resources and Funding

Barriers. Resource constraints, including low staffing levels and budget cuts, accounted for 24 responses (25%). Participants reported these limitations prevented staff from attending training and affected the overall implementation of just culture and HRO principles. “Low staffing in supporting services as well as in my own service line have created barriers,” a participant reported. Another participant responded that barriers to HRO were primarily “…financial, as the focus is how to curb costs and bring in more funding rather than taking the time to review and apply the concepts of high reliability.”

Resistance to Change and Entrenched Attitudes

Barriers. Resistance to change was the most frequently identified barrier, with 31 responses (32%). One participant described a persistent “gotcha” culture, where blame and punishment hinder progress toward just culture. This entrenched mindset creates significant obstacles to adopting HRO practices and requires active leadership and supervisor intervention to overcome. This theme is best captured by a respondent who noted that “culture change is difficult, especially among staff with such long tenure. It’s a long game.”

Synthesis and Integration of Findings

The data in Table 1 and Table 2 reinforce the themes identified in the qualitative analysis. Leadership commitment and support are pivotal, both as a facilitator and barrier. Open communication and education and training, while recognized as facilitators, were less frequently mentioned, but still critical. Resistance to change and insufficient resources were the most prominent barriers, indicating where organizational efforts should focus to further foster a culture of high reliability.

By addressing these barriers, particularly resistance to change and resource constraints, and leveraging facilitators like leadership engagement and transparent communication, organizations can enhance their implementation of just culture and high reliability practices. These efforts require deliberate strategies, including effective training, mentorship, and the active presence of leadership.

Discussion

This quality improvement initiative builds on prior research by examining the implementation of HRO practices from the perspective of frontline supervisors. Unlike earlier research focused on HRO leads, this study explores the critical role of supervisors who integrate HRO principles into clinical and administrative operations.¹⁷ By analyzing their experiences, this study offers practical insights into facilitating HRO implementation across organizational levels.

The findings highlight broad agreement on the value of just culture and HRO principles in fostering safe, accountable health care environments. Participants described just culture as promoting system—level accountability rather than individual blame, encouraging error reporting and learning for continuous improvement. Similarly, HRO practices—emphasizing a preoccupation with failure, operational sensitivity, and resilience— were seen as vital for patient safety in complex settings.

Frontline supervisors play a pivotal role, with 96% of respondents identifying their influence on fostering open communication, psychological safety, and shared accountability. Key facilitators included leadership commitment, open communication, and mentorship. Active leadership involvement was particularly valued, as it trickles down to reinforce standards across all organizational levels. HRO meetings using real-world examples were seen as instrumental in demonstrating the tangible benefits of these principles, helping embed them into daily practices.

Despite these facilitators, several barriers to implementation were noted. Resistance to change and entrenched attitudes, and a persistent gotcha culture undermined efforts to establish just culture. Resource constraints, including staffing shortages and budget limitations, further hindered the adoption of HRO practices. The lack of consistent leadership engagement, marked by limited visibility, follow-through, and transparency, exacerbated these challenges.

HRO leads are important for promoting education and embedding HRO principles into daily operations. These individuals provide vital support to frontline supervisors, translating HRO concepts into actionable practices. However, organizational challenges such as staff turnover and redirected funding have weakened the infrastructure supporting HRO initiatives. The elimination of HRO lead roles due to budgetary pressures at several facilities reflects a short-term focus on operational demands at the expense of long-term cultural transformation.

Additional barriers included siloed communication, fear of reprisal, bureaucratic obstacles, and outdated technology. These challenges limit progress toward high reliability and diminish the effectiveness of HRO principles.

Participants proposed strategies focused on education, training, and leadership engagement. Simulation-based training tailored to specific roles was identified as an effective tool for preparing staff to apply HRO principles in real-world scenarios. Enhanced communication, such as regular leadership rounding and transparent updates on safety concerns, was also emphasized. Participants stressed the importance of showing staff how their feedback influences organizational decisions to build trust and accountability. Finally, standardizing procedures and protocols across facilities was seen as critical for aligning practices and reducing variability in safety processes.

This study underscores the need for sustained leadership commitment and infrastructure to ensure the long-term success of HRO implementation. Addressing the identified barriers and leveraging the proposed mitigation strategies can foster a culture of safety and reliability across the organization.

Limitations

This quality improvement initiative used qualitative grounded theory methods and sampled a relatively small group of experienced leaders specifically involved in implementing HRO within the VHA. In addition, while saturation of themes was reached, the number of responses represents a small sample of VHA frontline supervisors. As such, the findings may not be fully representative of the perspectives of all unit and departmental leaders across the VHA or other health care systems. A previous qualitative quality improvement initiative focused on the perceptions of HRO leads regarding facilitators and barriers to just culture.¹⁷ This quality improvement initiative broadened that focus by examining the perspectives of frontline supervisors in the operational environment, who may not be HRO experts but work to implement HRO principles with the guidance of HRO leads (HRO subject matter experts).

There remains an opportunity to address a critical gap by assessing facilitators and barriers beyond the facility level, incorporating both the Veterans Integrated Service Networks (VISN) and VHA Central Office (VHACO). While qualitative methods, such as those used in this study, provide deep insights and detailed understanding, they are limited in their ability to identify system-wide trends and variations at a more strategic VISN and VHACO level. Addressing this could enhance the broader applicability of HRO principles across the VHA.

Conclusions

Successful implementation of the recommendations reported in this study will require sustained focus and continued commitment from all stakeholders across the VHA. As the VHA enters its seventh year on the HRO journey, the risk of organizational drift remains an ongoing concern. Progress has been made, as evidenced by incremental improvements in All Employee Survey scores and increased reporting of adverse events and near misses, but the challenge will be to maintain focus and continue to build upon progress amid the current climate of budgetary constraints.

This study builds on previous quality improvement efforts and provides valuable insights into the barriers and facilitators that can either hinder or support the VHA’s ongoing pursuit of high reliability. The findings offer a model for understanding the complexities of this journey—one that requires continuous effort and adaptation, as there is no definitive endpoint in the quest for high reliability.

Since completion of this study in 2024, the VHA has entered a period of organizational transition and restructuring. Such transitions are often accompanied by increased operational demands and organizational strain. These include realignments, personnel changes, staffing adjustments, workforce reductions, and continued implementation of a new electronic health record system. In this context, maintaining attention to culture, communication, frontline engagement, and mechanisms that provide visibility into organizational climate is essential to sustain momentum in high-reliability efforts.

The Veterans Health Administration (VHA) is now in the sixth year of its enterprise-wide transformation into a high reliability organization (HRO). This effort began with a 2016 pilot project and is now implemented in 170 VHA medical centers.^1-4 This transformation reflects a commitment to implementing standardized and reliable health care practices.

The VHA HRO implementation strategy includes a multifaceted approach to engage leadership through education, training, leader coaching, and change management initiatives.² Despite the diversity of facilities in terms of cultures, geographies, and complexities, US Department of Veterans Affairs (VA) medical centers (VAMCs) have increasingly embraced standardized HRO practices. These changes are evident in improvements in VHA All Employee Survey scores, which assess 4 key patient safety culture dimensions: risk identification and just culture, error transparency and mitigation, supervisor communication and trust, and team cohesion and engagement.⁵ Positive trends in these dimensions highlight a cultural shift toward greater reliability, even amid challenges introduced by the COVID-19 pandemic.

However, this progress has encountered some challenges. Leadership turnover, budgetary constraints, and extensive educational demands for implementing and sustaining HRO practices have created obstacles, particularly for frontline health care practitioners.⁶ Additionally, there are pockets of resistance similar to what the airline industry faced when implementing crew resource management (CRM). Specifically, senior pilots and legacy leaders were reluctant to abandon their high-status, autocratic management styles and embrace CRM, despite its proven benefits for enhancing commercial airline safety.⁷ Similarly, some VHA staff have expressed resistance to foundational HRO practices, which include safety huddles, safety forums, leader rounding, and visual management systems.^6,8

The training requirements for HRO practices range from a 25-minute introductory course (HRO 101) to a 7.5-hour team training session facilitated by the VHA National Center for Patient Safety (NCPS).⁹ While some supervisors view these requirements as burdensome, others have demonstrated strong enthusiasm for the process.⁶ Understanding the perspectives of unit and departmental managers regarding factors that enhance or hinder the adoption of HRO practices is critical for continuous improvement.^10-12 Research has suggested that fostering psychological safety can create an environment where new ideas are shared openly, helping organizations navigate resistance to change.^13-16

A 2024 quality improvement study, drawing on the perceptions of HRO leads, identified key facilitators, including training, coaching, leader approachability, and psychological safety, as well as barriers such as inadequate training and lack of accountability among managers.¹⁷ Building on this work, the current study focused on frontline supervisors, who are directly involved in integrating HRO practices into patient care activities. By addressing both barriers and facilitators, this expanded approach aims to provide a more comprehensive understanding of the challenges influencing HRO implementation in day-to-day operations.

Methods

This quality improvement initiative examined facilitators and barriers to establishing just culture and implementing high reliability practices, focusing on frontline supervisors overseeing clinical care teams (eg, emergency department, critical care) or patient-support functions (eg, dietary services). A questionnaire was sent to a randomized sample of VHA facility supervisors.

A qualitative grounded theory approach was employed to provide a deeper understanding of nuanced phenomena that cannot be captured through numerical data alone. This method enables systematic analysis using open, axial, and thematic coding, ensuring that emerging themes achieve saturation.^18,19 It is particularly suited for this study, given the limited prior data on frontline supervisors. Additionally, qualitative methods help mitigate biases common in Likert-style scales, where respondents may lean toward agreement, potentially skewing results.²⁰

Inclusion Criteria

Participants were required to have served as a frontline supervisor for ≥ 6 months. Frontline supervisors are assigned responsibility for supporting staff who deliver services to VHA patients, including clinical care, dietary support, and other functions. These staff must complete baseline HRO cultural training as well as NCPS team training and are responsible for supporting quality, safety, and patient experience. Potential participants were identified from a list of frontline supervisors provided by VHA management. A subset was chosen through random sampling across geographically distributed VHA hospital facilities that vary in size and complexity. Invitations to participate in completing the questionnaire were sent via email, explaining the quality improvement initiative’s purpose, and encouraging voluntary participation. Of 2000 frontline supervisors invited to participate in the initiative, 97 completed the questionnaire. Participants represented a mix of VHA sites in terms of geography, size, and complexity.

Procedures

The authors used a qualitative approach and administered a confidential online survey. Demographic data were collected within the survey to understand characteristics of the participant population, including length of time as a frontline supervisor, facility complexity level, and professional background (clinical vs nonclinical). Survey questions were developed to elicit responses to specific areas of interest based on existing literature related to HRO and just culture.

Facilitators were defined as factors that increase the likelihood of establishing or sustaining high reliability practices and/or culture. Barriers were defined as factors that decrease or inhibit the likelihood of establishing or sustaining high reliability practices and/or culture. The questionnaire consisted of open-ended questions asking frontline supervisors to describe HRO practices and just culture at their individual facility and within their role. Participants also were asked to identify facilitators and barriers that helped or hindered their efforts to establish and maintain high reliability practices and just culture. The questionnaire solicited recommendations for additional support, training, resources, or leadership interventions to strengthen high reliability practices and just culture from each participant.

Analysis

Participant characteristics were analyzed using descriptive statistics. Responses to the 7 open-ended questions were coded and analyzed using ATLAS.ti v.24 qualitative data analysis software by an experienced researcher and coauthor. Grounded theory methodology allowed themes to emerge from the data and although the response rate was limited, the themes reached a saturation point.^18,19

Ethical Considerations

Institutional review board (IRB) review and approval were not required for this quality improvement initiative. Formal IRB review and approval of a quality improvement initiative are not required by VHA. Participation was confidential and voluntary, and participants could withdraw at any time without consequences. Completion of the survey indicated consent, and facility names and participant identifiers were not used. Unique numbers were assigned to each participant and all responses were kept confidential and nonattributional. Frequency coding was used to identify the facilitators and barriers to high reliability practices implementation and just culture among frontline supervisors until thematic saturation was obtained.

Results

A total of 2000 frontline supervisors were invited to participate, of whom 97 completed the questionnaire (response rate, 4.9%). Participants were first asked to describe just culture and high reliability practices in their own words. The consensus was that a just culture emphasizes a nonpunitive environment where employees can report errors or incidents without fear of retaliation. It encourages accountability at the systems level, focusing on learning from mistakes to improve processes. In response to a question asking respondents to describe HRO practices and just culture in their own words, participants noted that organizations with a just culture promote open communication, allowing staff to discuss safety issues and concerns without fear of personal blame. Additionally, participants agreed that HRO practices were defined as a set of principles and practices aimed at minimizing errors and promoting safety, especially within complex and high-risk environments. Participants responded that key characteristics include a preoccupation with failure, sensitivity to operations, reluctance to simplify, and a commitment to resilience. HRO practices entail proactively identifying and mitigating risks through open communication and collaboration among team members, they added.

Overall, participants were aligned with their view of the role a frontline supervisor plays in supporting just culture and HRO principles at their facility by fostering open communication and psychological safety, encouraging continuous learning and improvement, and promoting team collaboration and shared accountability. Among frontline supervisors, 93 (96%) identified their role as being critical to creating a safe space and reinforcing just culture and HRO principles at their facility, while 4 (4%) failed to identify a single duty.

Identified Themes

Table 1 summarizes 6 key themes identified from participants’ responses, highlighting the most frequently cited facilitators and barriers to implementing and sustaining high reliability practices and a just culture. Table 2 shows the classification of several themes in relation to facility complexity, emphasizing leadership commitment and support as a pivotal facilitator, while listing resistance to change and entrenched attitudes as a prominent barrier.

Role of Leadership

Facilitators. Leadership commitment and support were the most frequently identified facilitator, accounting for 44 mentions (45%). This aligns with participants’ descriptions of leadership involvement as crucial, particularly in setting standards and fostering accountability throughout the organization. For example, a frontline supervisor with < 5 years of experience from a nonclinical background at a 1B facility remarked, “Facility leadership are involved, which trickles down to lower-level leads and supervisors, which keeps everyone accountable and holds everyone to the same standards.” Participants frequently identified that leaders setting the standard and communicating expectations as paramount facilitators for strengthening high reliability practices and just culture at their facility.

Barriers. A lack of leadership commitment and support was a significant barrier, cited in 17 responses (18%). Participants described this barrier as a deficiency in follow-through, transparency, and presence, which undermines efforts to sustain just culture and high reliability principles. Notably, the lack of leadership commitment and support stood out as a distinct and recurring theme, underscoring its critical role as an independent challenge to achieving organizational goals. “Many leaders are not yet fully bought in,” a respondent explained. “They take the training and pass it off and go right back to their units and focus on blaming or chastis[ing] people for speaking up.” This theme frequently intersected with mentions of insufficient resources and entrenched attitudes, amplifying other challenges.

Open Communication and Transparency

Facilitators. Open communication and transparency were identified as facilitators in 12 responses (12%). Participants emphasized the importance of mechanisms such as HRO meetings and the sharing of “real” examples of positive outcomes from applying HRO principles. Transparent communication fosters psychological safety, allowing staff to report concerns without fear of reprisal. One participant with < 5 years of experience from a clinical background at a 1A facility encapsulated this theme by saying, “Quarterly ‘fireside chats’ are helpful, [this] creates open dialogue about where the next safety issue may occur, what staff need to do their job safely, while also imparting more of the philosophy of HRO that staff may not be aware of.”

Barriers. While communication serves as a facilitator, participants also highlighted barriers such as siloed communication and fear of reprisal. These reflect challenges in creating open and transparent feedback loops essential to high reliability. For example, a participant concluded, “Leadership does not communicate problem-solving efforts and resolution down the chain, they do not see the problems.” Another participant added, “[HRO principles] are not discussed that much.” While this theme presented as a barrier, it was noted less frequently.

Education and Training

Facilitators. Education and training were noted as facilitators in 10 responses (10%), underscoring their role in establishing high reliability practices. Participants suggested tailored training, simulation-based exercises, and mentorship to enhance practical application. However, they noted the importance of linking training to real change and ensuring leadership enforcement of learned behaviors. This theme is best represented by a participant who concluded, “Trainings have helped, but I think as a supervisor, being involved and interacting with your staff, observing, doing the work they do to help identify potential problems areas, especially when new systems are introduced are key. Being hands-on is the only way to successfully manage your team.”

Barriers. Insufficient resources, including time and staffing constraints, were identified as barriers to education and training, accounting for 24 responses (25%). Participants observed that mandatory training without mentorship or application diminishes its effectiveness.

Insufficient Resources and Funding

Barriers. Resource constraints, including low staffing levels and budget cuts, accounted for 24 responses (25%). Participants reported these limitations prevented staff from attending training and affected the overall implementation of just culture and HRO principles. “Low staffing in supporting services as well as in my own service line have created barriers,” a participant reported. Another participant responded that barriers to HRO were primarily “…financial, as the focus is how to curb costs and bring in more funding rather than taking the time to review and apply the concepts of high reliability.”

Resistance to Change and Entrenched Attitudes

Barriers. Resistance to change was the most frequently identified barrier, with 31 responses (32%). One participant described a persistent “gotcha” culture, where blame and punishment hinder progress toward just culture. This entrenched mindset creates significant obstacles to adopting HRO practices and requires active leadership and supervisor intervention to overcome. This theme is best captured by a respondent who noted that “culture change is difficult, especially among staff with such long tenure. It’s a long game.”

Synthesis and Integration of Findings

The data in Table 1 and Table 2 reinforce the themes identified in the qualitative analysis. Leadership commitment and support are pivotal, both as a facilitator and barrier. Open communication and education and training, while recognized as facilitators, were less frequently mentioned, but still critical. Resistance to change and insufficient resources were the most prominent barriers, indicating where organizational efforts should focus to further foster a culture of high reliability.

By addressing these barriers, particularly resistance to change and resource constraints, and leveraging facilitators like leadership engagement and transparent communication, organizations can enhance their implementation of just culture and high reliability practices. These efforts require deliberate strategies, including effective training, mentorship, and the active presence of leadership.

Discussion

This quality improvement initiative builds on prior research by examining the implementation of HRO practices from the perspective of frontline supervisors. Unlike earlier research focused on HRO leads, this study explores the critical role of supervisors who integrate HRO principles into clinical and administrative operations.¹⁷ By analyzing their experiences, this study offers practical insights into facilitating HRO implementation across organizational levels.

The findings highlight broad agreement on the value of just culture and HRO principles in fostering safe, accountable health care environments. Participants described just culture as promoting system—level accountability rather than individual blame, encouraging error reporting and learning for continuous improvement. Similarly, HRO practices—emphasizing a preoccupation with failure, operational sensitivity, and resilience— were seen as vital for patient safety in complex settings.

Frontline supervisors play a pivotal role, with 96% of respondents identifying their influence on fostering open communication, psychological safety, and shared accountability. Key facilitators included leadership commitment, open communication, and mentorship. Active leadership involvement was particularly valued, as it trickles down to reinforce standards across all organizational levels. HRO meetings using real-world examples were seen as instrumental in demonstrating the tangible benefits of these principles, helping embed them into daily practices.

Despite these facilitators, several barriers to implementation were noted. Resistance to change and entrenched attitudes, and a persistent gotcha culture undermined efforts to establish just culture. Resource constraints, including staffing shortages and budget limitations, further hindered the adoption of HRO practices. The lack of consistent leadership engagement, marked by limited visibility, follow-through, and transparency, exacerbated these challenges.

HRO leads are important for promoting education and embedding HRO principles into daily operations. These individuals provide vital support to frontline supervisors, translating HRO concepts into actionable practices. However, organizational challenges such as staff turnover and redirected funding have weakened the infrastructure supporting HRO initiatives. The elimination of HRO lead roles due to budgetary pressures at several facilities reflects a short-term focus on operational demands at the expense of long-term cultural transformation.

Additional barriers included siloed communication, fear of reprisal, bureaucratic obstacles, and outdated technology. These challenges limit progress toward high reliability and diminish the effectiveness of HRO principles.

Participants proposed strategies focused on education, training, and leadership engagement. Simulation-based training tailored to specific roles was identified as an effective tool for preparing staff to apply HRO principles in real-world scenarios. Enhanced communication, such as regular leadership rounding and transparent updates on safety concerns, was also emphasized. Participants stressed the importance of showing staff how their feedback influences organizational decisions to build trust and accountability. Finally, standardizing procedures and protocols across facilities was seen as critical for aligning practices and reducing variability in safety processes.

This study underscores the need for sustained leadership commitment and infrastructure to ensure the long-term success of HRO implementation. Addressing the identified barriers and leveraging the proposed mitigation strategies can foster a culture of safety and reliability across the organization.

Limitations

This quality improvement initiative used qualitative grounded theory methods and sampled a relatively small group of experienced leaders specifically involved in implementing HRO within the VHA. In addition, while saturation of themes was reached, the number of responses represents a small sample of VHA frontline supervisors. As such, the findings may not be fully representative of the perspectives of all unit and departmental leaders across the VHA or other health care systems. A previous qualitative quality improvement initiative focused on the perceptions of HRO leads regarding facilitators and barriers to just culture.¹⁷ This quality improvement initiative broadened that focus by examining the perspectives of frontline supervisors in the operational environment, who may not be HRO experts but work to implement HRO principles with the guidance of HRO leads (HRO subject matter experts).

There remains an opportunity to address a critical gap by assessing facilitators and barriers beyond the facility level, incorporating both the Veterans Integrated Service Networks (VISN) and VHA Central Office (VHACO). While qualitative methods, such as those used in this study, provide deep insights and detailed understanding, they are limited in their ability to identify system-wide trends and variations at a more strategic VISN and VHACO level. Addressing this could enhance the broader applicability of HRO principles across the VHA.

Conclusions

Successful implementation of the recommendations reported in this study will require sustained focus and continued commitment from all stakeholders across the VHA. As the VHA enters its seventh year on the HRO journey, the risk of organizational drift remains an ongoing concern. Progress has been made, as evidenced by incremental improvements in All Employee Survey scores and increased reporting of adverse events and near misses, but the challenge will be to maintain focus and continue to build upon progress amid the current climate of budgetary constraints.

This study builds on previous quality improvement efforts and provides valuable insights into the barriers and facilitators that can either hinder or support the VHA’s ongoing pursuit of high reliability. The findings offer a model for understanding the complexities of this journey—one that requires continuous effort and adaptation, as there is no definitive endpoint in the quest for high reliability.

Since completion of this study in 2024, the VHA has entered a period of organizational transition and restructuring. Such transitions are often accompanied by increased operational demands and organizational strain. These include realignments, personnel changes, staffing adjustments, workforce reductions, and continued implementation of a new electronic health record system. In this context, maintaining attention to culture, communication, frontline engagement, and mechanisms that provide visibility into organizational climate is essential to sustain momentum in high-reliability efforts.