Department Of Veterans Affairs Research Articles

Abstract 4140167: Lipid Management among US Veterans with Prevalent Atherosclerotic Cardiovascular Disease (ASCVD) * Veteran Affairs Lipid Optimization Reimagined Quality Improvement Program (VALOR-QI)

ASCVD is the most prevalent form of cardiovascular disease and the main cause of morbidity and mortality for Veterans in the VA healthcare system. Management of cholesterol is one of the most effective approaches for reducing CV disease, however, over two-thirds of Veterans with ASCVD are not optimally managed. Veterans with ASCVD are at high risk for recurrent CV events and can benefit greatly from more effective management of their low-density lipoprotein (LDL-C) cholesterol. The reasons for the current undertreatment of dyslipidemia in Veterans with ASCVD are multifaceted, including factors such as low disease awareness among the patients, patient’s preference, statin intolerance, and poor adherence to medications. Purpose: VALOR-QI is a collaborative effort between the U.S. Department of Veterans Affairs (VA) and the American Heart Association (AHA) with the goal of positively impacting Veterans’ cardiovascular health. Method: This project targets at risk veterans over 18 years of age, with ASCVD and LDL-C ≥70 mg/dl or non-HDL-C ≥100 mg/dl identified across 50 VA medical centers nationwide. As part of the program, VA sites work with an AHA QI Consultant to develop and deploy a local quality improvement plan to help overcome site specific barriers preventing Veterans from achieving optimal cholesterol levels. Health coaches at these centers aid in lipid optimization through patient counseling, medication adherence support, appointment reminders, and referrals to a nutritionist or clinical pharmacist as required. The plan’s effectiveness will be assessed by tracking LDL-C goal achievement rates, LDL-C changes with therapy use, and veteran demographics. Our primary endpoints are for over 30% of veterans to reach the LDL-C target and a significant drop (around 10%) from baseline in veterans with ASCVD and LDL-C not at target. Best practices are shared among sites using the PDSA implementation science model. Results: As of May 2024, 182 patients at the Hines VA are engaged in the project. Among them, 84.8% are on lipid-lowering therapy, 83.1% are on statins (with 57.9% on a high intensity dose), and 11.3% are on dual therapy with a statin plus an additional medication (PCSK9 inhibitor or ezetimibe). So far, 59.5% of enrolled patients reached their LDL-C cholesterol target of <70 mg/dl. Conclusion: Lipid lowering strategies with collaboration of patients, network providers, dieticians and health coaches improved lipid control in veterans with ASCVD.

Abstract 4136978: Six-month Changes in Lipid Management in the Veterans Affairs Lipid Optimization Reimagined Quality Improvement (VALOR-QI) Program

Background: US Veterans have a high burden of cardiovascular disease (CVD). While cholesterol management is one of the most effective approaches for reducing CVD burden, over two-thirds of Veterans with atherosclerotic cardiovascular disease (ASCVD) are not optimally managed. Aims: To evaluate LDL-C monitoring, lipid lowering therapy (LLT) use, and LDL-C levels at baseline and six-months for Veterans in the Veterans Affairs Lipid Optimization Reimagined Quality Improvement (VALOR-QI) Program. Methods: VALOR-QI is a national quality improvement collaboration between the US Department of Veterans Affairs and the American Heart Association (AHA) with the goal of improving lipid management among Veterans with ASCVD. To assess and address barriers to achieving optimal lipid levels, Clinical Champions, Health Care Coaches, and participating providers from 50 VA sites work with AHA QI Consultants. Eligible Veterans (those with an ASCVD diagnosis at two outpatient or one inpatient visit or one ASCVD procedure) were considered engaged in VALOR-QI if they had a qualifying appointment with a participating provider during the program. We examined rates of LDL-C monitoring and LLT use at baseline (start of site monitoring) and 6 months after. Among Veterans who were in the program ≥6 months and had >1 LDL-C measure, we investigated percent meeting an LDL-C goal of <70 mg/dL at their first LDL-C (closest to their first visit with priority given to labs within 365 days before their first visit) and follow-up LDL-C (closest to 6 months after entering the program) and mean LDL-C change (paired t-test). Results: Six months after starting VALOR-QI, sites had a 41% increase in LDL-C monitoring and a 6% increase in LLT use. Among 29,610 Veterans engaged in the program ≥6 months with at least two lipid labs [mean (SD) age 71.0 (9.3) years, 95% men, 72% white race], the proportion who met the LDL-C goal <70 mg/dL increased from 44% at their first measure to 51% at 6-month follow-up. Among these Veterans, we observed a mean LDL-C decrease of 5.1 mg/dL (95% CI: -5.50, -4.78). Conclusion: We observed an increase in lipid monitoring and LLT use and improved LDL-C at 6-month follow-up among US Veterans engaged in VALOR-QI.

Abstract 4136995: Veterans Affairs (VA) Lipid Optimization Reimagined Quality Improvement Program (VALOR-QI) in Veterans with Atherosclerotic Cardiovascular Disease (ASCVD) at the San Juan VA

ASCVD is the principal cause of morbidity and mortality for Veterans in the VA Healthcare System. San Juan VA is one of 50 VA sites participating in a national quality improvement initiative called the VALOR QI: VA Lipid Optimization Reimagined Quality Improvement Project. Is a collaborative project between the U.S. Department of Veterans Affairs (VA) and the American Heart Association (AHA) with the goal of positively impacting Veterans’ cardiovascular (CV) health. VA sites work with an AHA QI consultant to develop and deploy a local quality improvement plan to help overcome site specific barriers preventing Veterans from achieving optimal cholesterol levels. The program’s objectives include improving clinical pathways and processes to impact ASCVD management through a Learning Healthcare System model of quality improvement designed to improve the management of dyslipidemia among those with high-risk ASCVD. The hypothesis is that patients who are part of the VALOR QI program will be more successful in reaching LDL-C target. This will help to reduce the risk of ASCVD and mortality for the patients, promoting better management of lipid levels through medications, diet and regular monitoring. As part of the methodology, the patients are enrolled to the program using the criteria of Veterans > 18 years of age with diagnosis of ASCVD and LDL-C > 70 mg/dl or non-HDL > 100 mg/dl. The Healthcare Coach has a full track of their lipid medications, assists the patients with refills, provides educational materials, follows up with their clinical appointments, and emphasizes the importance of having a good compliance with therapy, appointments and diets to maintain the target of LDL-C. Once the patient starts with a new lipid medication, they are followed in 3 months with labs. After reaching the target the patient is followed up closely in 6 months with labs to prevent relapse. The VALOR QI Program started at VA San Juan in June 2023 and, as of May 30, 2024, had directly engaged 282 Hispanic patients. 111 (39.4%) achieved target LDL-C; 268 (95%) have any statin use; 117 (41.5%) are on any non-statin lipid-lowering therapy (LLT); 116 (41%) are on statin plus LLT; 25 (8.9%) are on PCSK9, and 133 (47.2%) received educational materials. In conclusion, this initiative led to target LDL levels in 39% of patients which represents a significant population. As this program is further implemented in our institution, we expect improvement in patient outcomes and prognosis.

Abstract 4142792: VA Lipid Optimization Reimagined Quality Improvement Project (VALOR-QI) at the Dallas VA

The Dallas VA is one of the 50 VA sites participating in a national quality improvement initiative called VALOR-QI: VA Lipid Optimization Reimagined Quality Improvement Project. VALOR-QI is a collaborative project between the U.S. Department of Veterans Affairs (VA) and the American Heart Association (AHA) with the goal of positively impacting veterans’ cardiovascular (CV) health. As part of the program, VA sites work with an AHA QI Consultant to develop and deploy a local quality improvement plan to help overcome site specific barriers preventing veterans from achieving optimal cholesterol levels. We hypothesize that the QI strategies implemented will positively impact lipid levels and ultimately CV outcomes among high-risk patients. We aim to assess potential barriers to achieving LDL-C <70 mg/dL and develop efficient ways to maintain LDL-C goal. Our approach to the VALOR-QI program at Dallas VA is by enrolling patients with established ASCVD and LDL-C > 70 mg/dL from cardiology, vascular, diabetes, lipid, and independent PharmD clinics. These patients are followed by a health coach every 2- 6 months. Medical adherence is enforced by the health coach ensuring timely refills and reminders. Lifestyle modifications are encouraged via educational materials, referral to dieticians, recreation classes, and tobacco cessation. Patients are also encouraged to sign up for patient portal (my HealtheVet) to access electronic medical records and expedite communication with their healthcare team. The health coach provides individualized counseling regarding lipid lowering treatment and acts as liaison between patients and their providers. VALOR-QI was launched at Dallas VA in Jan 2023. As of May 17 th , 2024, an interim analysis showed that out of 132 veterans engaged, 49 (37.1%) achieved target LDL-C, 66 (50%) received educational material, 4 (3.03%) were referred to dieticians, 10 (7.58%) were referred to recreation programs, and 4 (17.4% of active smokers) were interested in quitting. In conclusion, our VALOR-QI strategy at Dallas VA showed encouraging results, but it is premature to make final conclusions. The support of a health coach showed improved medication adherence, health literacy, and lifestyle modification, thus achieving LDL-C target. Major barriers to achieving target LDL-C were health literacy about high cholesterol, challenges in navigating the health care system, and treatment inertia among patients and providers.

Examining the impact of the veterans affairs community care program on mental healthcare in rural veterans: A qualitative study.

To investigate provider and administrators' perspectives about the impact of the Department of Veterans Affairs' (VA) Community Care program on acute and residential mental health treatment of rural Veterans. Primary data were collected from participants via interviews. Participants were employees of VA Healthcare Systems located in Northern New England, or employees of non-VA mental health treatment settings affiliated with VA in Northern New England. This study was informed by the Consolidated Framework for Implementation Research (CFIR), with Community Care as the implemented program. Individual, semi-structured interviews were conducted. Individual interviews were transcribed, coded deductively using the CFIR, and inductively coded by locating themes. Twenty-one people completed interviews. Commonly reported challenges included community programs not focused on Veterans' needs, poor coordination of care, communication challenges, and problems tracking Veteran care. Facilitators included increased access to care and strengthening coordination of care. The VA's Community Care program can address the acute or residential mental health needs of Veterans in rural settings in some circumstances, however there are challenges to successful implementation.

Adherence to Synoptic Cancer Pathology Reporting Among Pathologists in the National Department of Veterans Affairs Health Care System.

Quality communication between clinicians and pathologists is required for optimal cancer care. The College of American Pathologists provides anatomic site-specific cancer protocols that facilitate synoptic reporting for efficient communication, contributing to accuracy and completeness of cancer staging. To evaluate synoptic cancer pathology reporting across the Department of Veterans Affairs (VA), the largest integrated health system in the United States, for 4 common cancers: melanoma and colon, bladder, and kidney cancer. For each cancer type, we investigated at least 200 biopsy and 200 resection reports from 2019 to 2021. In each report, we determined whether a synoptic format was used. The reports were selected using random sampling across all VA health care facilities. We also identified a set of core elements that were underdocumented. Among 1618 pathology reports, 778 (48%; 95% CI, 46%-50%) were synoptic reports. Synoptic reporting was much more common among resections (621 of 811; 77%; 95% CI, 74%-79%) than among biopsies (157 of 807; 19%; 95% CI, 17%-22%). It was most common in colorectal resections (200 of 206; 97%; 95% CI, 94%-99%) and least common in colon biopsy reports (1 of 200; 0.5%; 95% CI, 0%-3%). Core elements that were underdocumented included procedure and regional lymph nodes for resections of bladder and kidney cancer and of melanoma. Synoptic reporting was used about three-quarters of the time for resections and about 1 in 5 times for biopsies. Future work should develop implementation strategies to improve synoptic reporting, especially for biopsy specimens and core elements that were relatively underdocumented.

Risk Score for Hepatocellular Cancer in Adults Without Viral Hepatitis or Cirrhosis

Hepatocellular carcinoma (HCC) is typically detected only at advanced stages when treatment options are limited. Most of the current HCC risk models focus on patients with viral hepatitis or diagnosed cirrhosis or require variables not routinely available in clinical care. To identify modifiable HCC risk factors in the general population and to develop a risk score to inform HCC screening and risk-factor modification interventions for high-risk individuals without viral hepatitis or decompensated cirrhosis. This cohort study analyzed demographic, clinical, laboratory, and diagnostic data from the US Department of Veterans Affairs (VA) electronic health records. Data were divided into development and validation samples. Veterans aged 30 to 95 years were included, and those with hepatitis B or C virus infection, hepatic decompensation, or prevalent HCC were excluded. Patients were followed up until the occurrence of HCC diagnosis, death, or December 31, 2021. A Cox proportional hazards regression model for 10-year risk of HCC was developed and used to create an HCC risk score, and performance in development and validation samples and in patient subgroups was evaluated. One outpatient visit date per person at least 18 months after VA entry, between October 1, 2007, and March 31, 2020, was randomly selected and used as the index date for the start of follow-up. Analyses were performed from March 2023 to May 2024. Age, sex, race and ethnicity, body mass index, liver fibrosis (detected with Fibrosis-4 Index [FIB-4]), diabetes status, smoking status, and alcohol use. First HCC diagnosis during follow-up. This information was ascertained from VA national cancer registry topography and histology codes and from International Classification of Diseases, Ninth Revision and International Statistical Classification of Diseases, Tenth Revision, Clinical Modification diagnosis codes for the inpatient or outpatient visits. This study of 6 509 288 veterans included 6 048 917 males (92.9%), with a median (IQR) age of 65 (54-74) years, who identified as being of Hispanic (5.3%), non-Hispanic Black (15.0%), non-Hispanic White (68.9%), or other (4.6%) race and ethnicity. Overall, 15 142 patients (0.2%) developed HCC, 69.5% of whom had FIB-4 of 3.25 or lower at baseline. While FIB-4 was the most important variable, age, sex, race and ethnicity, body mass index, diabetes, smoking, and alcohol use were also informative. Discrimination in the development sample was better than FIB-4 alone (C statistic, 0.83 [95% CI, 0.82-0.85] vs 0.79 [95% CI, 0.77-0.80]). The HCC risk score performed consistently well in the validation sample and in all subgroups. A FIB-4 threshold of 3.25 would screen 5.0% of the cohort at a cost of 28 false-positives for every true-positive; a model risk score of 58 would screen 4.7% of the cohort at a cost of 23 false-positives for every true-positive. Results of this study suggest that a multivariable risk score that uses routinely available clinical data outperforms FIB-4 alone in identifying patients at risk of HCC who do not have viral hepatitis or hepatic decompensation at baseline.

Remote Foot Temperature Monitoring Among Veterans: Large Observational Study of Noncompliance and Its Correlates.

In-home remote foot temperature monitoring (RTM) holds promise as a method to reduce foot ulceration in high-risk patients with diabetes. Few studies have evaluated adherence to this method or evaluated the factors associated with noncompliance. The aims of this study were to estimate noncompliance in patients who were enrolled in RTM nationwide across Department of Veterans Affairs (VA) and to evaluate characteristics associated with noncompliance. We conducted an observational study including 1137 patients in the VA who were enrolled in RTM between January 2019 and June 2021, with follow-up through October 2021. Patient information was obtained from the VA's electronic health record and RTM use was obtained from the company. Noncompliance was defined as using the mat <2 days per week for ≥4 of the 12 months of follow-up. Using a multivariable model, we calculated odds ratios (ORs) and 95% CIs for associations between various factors and noncompliance and compared using Akaike information criterion statistics, a measure of model fit. The sample was predominantly male (n=1125, 98.94%) ; 21.1% (n=230) were Black and 75.7% (n=825) were White. Overall, 37.6% (428/1137) of patients were classified as noncompliant. In the multivariable model, an intermediate area deprivation index was statistically significantly and inversely associated with noncompliance (area deprivation index 50-74 vs 1-24; OR 0.56, 95% CI 0.35-0.89); factors significantly and positively associated with noncompliance included recent history of osteomyelitis (OR 1.44, 95% CI 1.06-1.97), Gagne comorbidity index score ≥4 (vs ≤0; OR 1.81, 95% CI 1.15-2.83), telehealth encounters (28+ vs <6; OR 1.70, 95% CI 1.02-2.84), hemoglobin A1c≥10 (vs <5.7; OR 2.67, 95% CI 1.27-5.58), and current smoking (OR 2.06, 95% CI 1.32-3.20). Based on Akaike information criterion differences, the strongest factors associated with noncompliance were behavioral factors (poor glucose control [as measured by hemoglobin A1c] and smoking), and to a lesser extent, factors such as a recent history of osteomyelitis and an elevated Gagne comorbidity index, indicating a high comorbidity burden. To reduce the risk of ulcer recurrence and amputation, proactively providing additional support for self-monitoring to patients with characteristics identified in this study (poor glucose control, current smoking, high comorbidity burden) may be helpful. Furthermore, research is needed to better understand barriers to use, and whether the addition of design features, reminders, or incentives may reduce noncompliance and the risk of foot ulcers.

Cost-Effectiveness of Temporary Financial Assistance for Veterans Experiencing Housing Instability

The US Department of Veterans Affairs (VA) partners with community organizations (grantees) across the US to provide temporary financial assistance (TFA) to vulnerable veterans through the Supportive Services for Veteran Families (SSVF) program. The goal of TFA for housing-related expenses is to prevent homelessness or to quickly house those who have become homeless. To assess the cost-effectiveness of the SSVF program with TFA vs without TFA as an intervention for veterans who are experiencing housing insecurity. This study used a Markov simulation model to compare cost and housing outcomes in a hypothetical cohort of veterans enrolled in the SSVF program. Enrollees who are homeless receive rapid rehousing services, while those who are at risk of becoming homeless receive homelessness prevention services. The SSVF program with TFA for veterans who are experiencing housing insecurity. The effectiveness measure was the incremental cost-effectiveness ratio (ICER) with quality-adjusted life-years (QALYs). The model was parameterized using a combination of inputs taken from published literature and internal VA data. The model had a 2-year time horizon and a 1-day cycle length. In addition, probabilistic sensitivity analyses were conducted using 10 000 Monte Carlo simulations. The base case analyses found that the SSVF program with TFA was more costly ($35 814 vs $32 562) and yielded more QALYs (1.541 vs 1.398) than the SSVF program without TFA. The resulting ICER was $22 676 per QALY, indicating that TFA is the preferred strategy at a willingness-to-pay threshold of $150 000 per QALY. This ICER was $19 114 per QALY for veterans in the rapid rehousing component of the SSVF program and $29 751 per QALY for those in the homelessness prevention component of the SSVF program. At a willingness-to-pay threshold of $150 000 per QALY, probabilistic sensitivity analyses showed that TFA was cost-effective in 8972 of the 10 000 Monte Carlo simulations (89.7%) for rapid rehousing and in 8796 of the 10 000 Monte Carlo simulations (88.0%) for homelessness prevention only. This economic evaluation suggests that TFA is a cost-effective approach (ie, yields improved health benefits at a reasonable cost) for addressing housing insecurity for veterans enrolling in the SSVF program. Future research could examine the cost effectiveness of large, nationwide housing interventions such as this one among subpopulations of veterans such as those with certain comorbidities including severe mental illness or substance use disorders, those with chronic diseases, or those experiencing long-term housing instability vs acute loss of housing.

Sociodemographic and Clinical Characteristics Associated With Veterans' Digital Needs.

Telehealth can expand access to care, but digital needs present barriers for some patients. To investigate sociodemographic and clinical associations of digital needs among veterans. This quality improvement study used data collected between July 2021 and September 2023 from Assessing Circumstances and Offering Resources for Needs (ACORN), a Department of Veterans Affairs (VA) initiative to systematically screen for, comprehensively assess, and address social risks and social needs. Eligible participants were veterans screened for social risks and social needs during routine care at 12 outpatient clinics, 3 emergency departments, and 1 inpatient unit across 14 VA medical centers. Data analysis occurred between October 2023 and January 2024. The ACORN screening tool was administered by clinical staff. Veterans were considered positive for a digital need if they reported no smartphone or computer, no access to affordable and reliable internet, running out of minutes and/or data before the end of the month, and/or requested help setting up a video telehealth visit. Among 6419 veterans screened (mean [SD] age, 67.6 [15.9] years; 716 female [11.2%]; 1740 Black or African American [27.1%]; 202 Hispanic or Latino [3.1%]; 4125 White [64.3%]), 2740 (42.7%) reported 1 or more digital needs. Adjusting for sociodemographic and clinical characteristics, the adjusted prevalence (AP) of lacking a device among veterans aged 80 years or older was 30.8% (95% CI, 27.9%-33.7%), 17.9% (95% CI, 16.5%-19.2%) among veterans aged 65 to 79 years, 9.9% (95% CI, 8.2%-11.6%) among veterans aged 50 to 64 years, 3.4% (95% CI, 2.1%-4.6%) among veterans aged 18 to 49 years, 17.6% (95% CI, 16.7%-18.6%) for males, and 7.9% (95% CI, 5.5%-10.3%) for females. AP of lacking affordable or reliable internet was 25.3% (95% CI, 22.6%-27.9%) among veterans aged 80 years or older, 15.0% (95% CI, 12.1%-18.0%) among veterans aged 18 to 49 years, 31.1% (95% CI, 28.9%-33.4%) for Black or African American veterans, 32.1% (95% CI, 25.2%-39.0%) for veterans belonging to other racial groups (ie, American Indian or Alaska Native, Asian, Native Hawaiian or Other Pacific Islander, as well as those with more than 1 race captured in their medical record), and 19.4% (95% CI, 18.2%-20.6%) for White veterans. Veterans with dementia were at higher risk of lacking a device (adjusted relative risk [aRR], 1.21; 95% CI, 1.00-1.48). Veterans with high medical complexity were at higher risk of lacking internet (aRR, 1.26; 95% CI, 1.11-1.42). Veterans with dementia (aRR, 1.58; 95% CI, 1.24-2.01) or substance use disorder (aRR, 1.22; 95% CI, 1.00-1.49) were more likely to want help scheduling a telehealth visit than those without. In this quality improvement study of veterans screened for social risks and social needs, there were substantial disparities in digital needs. These findings suggest that routine screening is important to understand patients' digital access barriers and connect patients with telehealth resources to address inequities in health care.

Multiple Sclerosis Disease-Modifying Therapy Use in the Department of Veteran Affairs and Medicare: A Comparative Analysis

BackgroundHigh-cost disease-modifying therapies (DMT) for multiple sclerosis (MS) have created affordability challenges for people with MS (PwMS) and payers. The Department of Veterans Affairs (VA) is the largest integrated healthcare system in the US and uses a variety of approaches to manage utilization and cost of MS DMT. The objective of this paper is to compare national utilization trends in the VA to the US Medicare program, another large federal public healthcare program. MethodsCounts of PwMS prescribed DMT from 2012 to 2021 in the VA and Medicare programs were used to estimate changes utilization over this period. For each DMT, we estimated the proportion of all DMT users treated in each year. Trends in utilization were compared to identify differences in how these systems manage DMT use. We compared demographics and DMT use between PwMS in the VA to previously published estimates from a Medicare cohort of PwMS. ResultsDMT use in PwMS was comparable in VA and Medicare programs (65.9% vs 69.7%). In younger (<50 years) PwMS, DMT use was more prevalent in the VA compared to Medicare (85.8% vs 76.9%). Between 2012 and 2021, the proportion of patients on DMT using a lower-efficacy agent (interferon beta and glatiramer) declined in both the VA (90% to 32%) and Medicare (81% to 38%). Oral DMT use (primarily fumarates and sphingosine 1-phosphate [S1P] modulators) increased to a similar degree such that by 2021, 39% of patients in both systems were receiving oral DMT. Use of high-efficacy B cell depleting DMT (ocrelizumab, ofatumumab, and rituximab) was consistently higher in the VA than in Medicare. Despite the approval of generic glatiramer and dimethyl fumarate in 2015 and 2020 respectively, 49% of glatiramer and 58% of fumarate utilization in the Medicare program continued to be for a branded product in 2021. ConclusionsGreater DMT use among younger PwMS along with more frequent use of high-efficacy B cell depleting DMT in VA has the potential to reduce disability and attendant healthcare system costs. Generic DMT adoption in the Medicare program was lower than might be expected. Future studies should evaluate the relationship between DMT utilization, costs, and health outcomes in these populations.

The implementation of a pain navigator program in the department of Veterans Affairs' (VA) health care systems: a cluster randomized pragmatic clinical trial.

This manuscript describes the uptake of the AIM-Back Pain Navigator Pathway (PNP) designed to encourage use of non-pharmacologic care options within the Veterans Health Administration (VHA). This manuscript describes the implementation of a telehealth intervention from one arm of a multisite, embedded, cluster-randomized pragmatic trial comparing the effectiveness of two novel clinical care pathways that provide access to non-pharmacologic care for Veterans with low back pain (LBP). Ten VHA clinics. 19 pain navigators, >200 primary care physicians, and over 1000 Veterans were involved in the PNP implementation. Data were generated within the VHA electronic health record (EHR) for the ongoing AIM-Back trial to describe PNP implementation for system-level findings in terms of number of visits, and type of care received. Over a 3-year period, 9 of 10 clinics implemented the PNP within the context of the AIM-Back trial. The most frequent care recommended in the PNP included physical therapy, chiropractic, acupuncture, and yoga/tai chi. During follow-up at six-weeks, ∼50% of Veterans elected to receive a different care choice than what was initially prescribed. Notable variation across clinics was documented for PNP based on time to initiation of care and follow-up rates. Implementation of the telehealth delivered PNP provides a nuanced understanding of the introduction of novel care programs within diverse clinical settings. These findings are most applicable to care programs that are delivered remotely and involve facilitation of existing care options.

Impact of the COVID-19 pandemic on participants in pragmatic clinical trials for chronic pain: implications for trial outcomes and beyond.

The COVID-19 pandemic had profound effects on society, including those living with chronic pain. This study sought to examine pandemic impacts on individuals enrolled in pragmatic clinical trials focused on nonpharmacological treatments for chronic pain. We evaluated responses to a questionnaire on COVID-19 impacts that had been administered to participants (n=2024) during study enrollment in 3 pragmatic clinical trials for chronic pain treatment. All trials were part of the National Institutes of Health (NIH)-Department of Veterans Affairs (VA)-Department of Defense (DOD) Pain Management Collaboratory. COVID-19-related impacts on access to health care, mental health, finances, ability to meet basic needs, and social support were assessed. Pandemic impacts were found in all domains assessed, including access to health care, mental and emotional health, ability to meet basic needs, finances, and social support. Impacts varied by demographic and clinical characteristics. The participants most negatively impacted by the pandemic were younger, Black or Latino, female, more educated, and unemployed and had screened positive for depression. No impact differences were found with regard to alcohol use disorder screenings or a prior history of COVID-19. Higher levels of pain were associated with worse pandemic impacts, and negative impacts declined over time. Negative impacts of the pandemic on individuals living with chronic pain cut across aspects of life that are also central to effective pain management, including access to health care, social support, and mental and emotional health, with differential impacts found across key demographic and clinical factors. These findings should yield consideration of pandemic impacts in clinical practice and as moderating effects of treatment outcomes in clinical trials conducted during the pandemic.

Screening, brief intervention, and referral to treatment for pain management for veterans separating from military service: study protocol of a hybrid type 2 study testing implementation facilitation versus training-as-usual.

Veterans transitioning to civilian life often have chronic pain from service-related musculoskeletal disorders (MSD) with higher risk for substance misuse. Many seek VA (Department of Veterans Affairs) compensation for MSD. Use of Screening, Brief Intervention, and Referral to Treatment for Pain Management (SBIRT-PM) by VA Post-9/11 Military2VA (M2VA) case managers presents an opportunity to engage these veterans in VA pain care and address substance misuse. Implementation facilitation might help case managers use SBIRT-PM and engage veterans in services to improve outcomes. This study is a 2-cohort multisite cluster-randomized hybrid type 2 effectiveness-implementation trial. Within 2 separate cohorts of 14 VA sites each, sites will be allocated to receive an implementation strategy through the use of a constrained randomization procedure: virtual implementation facilitation or training-as-usual. Sites and M2VA case managers will receive the assigned implementation strategy to support use of SBIRT-PM. Recently discharged veterans (n = 1848) claiming service-connected MSD will be recruited, with case managers blind to veterans' study enrollment. The proportion of participants who receive any SBIRT-PM will be the primary implementation outcome. Veteran participants will complete baseline, 12-week, and 36-week assessments, irrespective of whether case managers conduct SBIRT-PM with them (intent-to-treat). Pain intensity and interference will be the primary clinical outcomes. The study emphasizes pragmatic over explanatory methodological features. This pragmatic trial will examine implementation facilitation versus training-as-usual in implementing SBIRT-PM to promote veteran engagement in nonpharmacological pain services. Using innovative methods to train and support VA case managers in SBIRT-PM, study outcomes could have broad implications for case management systems of care across the VA.

Optimizing diversity, equity and inclusion in pragmatic clinical trials: Findings from the Pain Management Collaboratory

The National Institutes of Health, U.S. Department of Defense, and U.S. Department of Veterans Affairs established a Pain Management Collaboratory (PMC) in 2017, with the purpose of implementing and evaluating nonpharmacological approaches for management of pain and co-occurring conditions in military and veteran healthcare systems through the execution of pragmatic clinical trials. The purpose of the current study is to detail and critically examine recruitment and retention procedures across the PMC’s large-scale multi-site pragmatic clinical trials, with attention to efforts made by trialists to diversify their study samples. Team members from 11 pragmatic clinical trials completed semi-structured interviews that focused on the meaning of diversity to the trial teams when planning the composition of their samples, methods used to recruit and retain diverse samples of patients, and planned analyses that take into consideration diverse subgroups of patients. Nearly 18,000 patients have been enrolled across trials, 22 % of whom were assigned female sex at birth and 34 % of whom identify with a marginalized race or ethnicity. Respondents highlighted study site selection, formation of partnerships with patient groups, and leveraging of data informatics as strategies that aided in the recruitment of patients diverse in terms of birth sex, race, and ethnicity. Notably, trialists adopted a narrow definition of diversity that did not take into consideration multiple intersecting identities of trial participants. Based on experiences of the PMC, we provide 14 recommendations on ways to diversify patient samples in clinical pain research. PerspectiveThis article describes challenges posed, and opportunities provided, with pain pragmatic clinical trial designs, emphasizing approaches that optimize the inclusion of social identity groups that have historically been under-represented in pain research.

Successful pilot implementation of mailing lethal means safety devices to veterans calling the Veterans Crisis Line.

Veterans are at greater risk for suicide than non-veterans; veterans who call the Veterans Crisis Line are at even higher risk. Firearms and poisoning are among the most common methods by which people die by suicide in the United States and access to those lethal means are risk factors for suicide. The United States Department of Veterans Affairs' Veterans Crisis Line conducted a six-month pilot to enhance lethal means safety counseling conversations by mailing lethal means safety devices (cable gun locks and/or medication takeback envelopes) to veteran callers. Veterans Crisis Line responders were selected based on quality assurance ratings, received training, and passed a knowledge check prior to participating. Veterans were eligible if they were calling for themselves and had access to firearms and/or surplus medications. The pilot was assessed using operational data and qualitative interviews with responders to assess their experience, barriers and facilitators, and suggestions for improvement. Responders documented 8,323 calls from 7,005 unique phone numbers; 10.8% were eligible for cable gun locks and 8.7% were eligible for medication takeback envelopes. Responders offered cable gun locks to 652 veterans and medication takeback envelopes to 522 veterans. A total of 465 cable gun locks and 567 medication takeback envelopes were mailed to 307 veterans. Operationally, there was little impact of the pilot on call handle time. Five responders participated in qualitative interviews. They reported feeling comfortable incorporating mailing devices into their work and reported that response from veterans was positive. Their most frequent suggestion for improvement was additional training. Results demonstrate that mailing these devices to veterans was feasible and acceptable. Call handle time results show that the Veterans Crisis Line would not need additional personnel to manage changes in call handle time associated with offering devices to all veteran callers. Full implementation of this program will require updates to procedures and policies, training, documentation system changes, additional logistical support for mailing, and a plan for ongoing evaluation.

A Virtual Breakthrough Series Collaborative for Missed Test Results

Missed test results, defined as test results not followed up within an appropriate time frame, are common and lead to delays in diagnosis and treatment. To evaluate the effect of a quality improvement collaborative, the Virtual Breakthrough Series (VBTS), on the follow-up rate of 2 types of test results prone to being missed: chest imaging suspicious for lung cancer and laboratory findings suggestive of colorectal cancer. This stepped-wedge cluster-randomized clinical trial was conducted between February 2020 and March 2022 at 12 Department of Veterans Affairs (VA) medical centers, with a predefined 3-cohort roll-out. Each cohort was exposed to 3 phases: preintervention, action, and continuous improvement. Follow-up ranged from 0 to 12 months, depending on cohort. Teams at each site were led by a project leader and included diverse interdisciplinary representation, with a mix of clinical and technical experts, senior leaders, nursing champions, and other interdisciplinary team members. Analysis was conducted per protocol, and data were analyzed from April 2022 to March 2024. All teams participated in a VBTS, which included instruction on reducing rates of missed test results at their site. The primary outcome was changes in the percentage of abnormal test result follow-up, comparing the preintervention phase with the action phase. Secondary outcomes were effects across cohorts and the intervention's effect on sites with the highest and lowest preintervention follow-up rates. Previously validated electronic algorithms measured abnormal imaging and laboratory test result follow-up rates. A total of 11 teams completed the VBTS and implemented 47 (mean, 4 per team; range, 3-8 per team; mode, 3 per team) unique interventions to improve missed test results. A total of 40 027 colorectal cancer-related tests were performed, with 5130 abnormal results, of which 1286 results were flagged by the electronic trigger (e-trigger) algorithm as being missed. For lung cancer-related studies, 376 765 tests were performed, with 7314 abnormal results and 2436 flagged by the e-trigger as being missed. There was no significant difference in the percentage of abnormal test results followed up by study phase, consistent across all 3 cohorts. The estimated mean difference between the preintervention and action phases was -0.78 (95% CI, -6.88 to 5.31) percentage points for the colorectal e-trigger and 0.36 (95% CI, -5.19 to 5.9) percentage points for the lung e-trigger. However, there was a significant effect of the intervention by site, with the site with the lowest follow-up rate at baseline increasing its follow-up rate from 27.8% in the preintervention phase to 55.6% in the action phase. In this cluster-randomized clinical trial of the VBTS intervention, there was no improvement in the percentage of test results receiving follow-up. However, the VBTS may offer benefits for sites with low baseline performance. ClinicalTrials.gov Identifier: NCT04166240.

2023 U.S. Department of Veterans Affairs and U.S. Department of Defense Clinical Practice Guideline for the Management of Headache

2023 U.S. Department of Veterans Affairs and U.S. Department of Defense Clinical Practice Guideline for the Management of Headache

A machine learning framework to adjust for learning effects in medical device safety evaluation.

Traditional methods for medical device post-market surveillance often fail to accurately account for operator learning effects, leading to biased assessments of device safety. These methods struggle with non-linearity, complex learning curves, and time-varying covariates, such as physician experience. To address these limitations, we sought to develop a machine learning (ML) framework to detect and adjust for operator learning effects. A gradient-boosted decision tree ML method was used to analyze synthetic datasets that replicate the complexity of clinical scenarios involving high-risk medical devices. We designed this process to detect learning effects using a risk-adjusted cumulative sum method, quantify the excess adverse event rate attributable to operator inexperience, and adjust for these alongside patient factors in evaluating device safety signals. To maintain integrity, we employed blinding between data generation and analysis teams. Synthetic data used underlying distributions and patient feature correlations based on clinical data from the Department of Veterans Affairs between 2005 and 2012. We generated 2494 synthetic datasets with widely varying characteristics including number of patient features, operators and institutions, and the operator learning form. Each dataset contained a hypothetical study device, Device B, and a reference device, Device A. We evaluated accuracy in identifying learning effects and identifying and estimating the strength of the device safety signal. Our approach also evaluated different clinically relevant thresholds for safety signal detection. Our framework accurately identified the presence or absence of learning effects in 93.6% of datasets and correctly determined device safety signals in 93.4% of cases. The estimated device odds ratios' 95% confidence intervals were accurately aligned with the specified ratios in 94.7% of datasets. In contrast, a comparative model excluding operator learning effects significantly underperformed in detecting device signals and in accuracy. Notably, our framework achieved 100% specificity for clinically relevant safety signal thresholds, although sensitivity varied with the threshold applied. A machine learning framework, tailored for the complexities of post-market device evaluation, may provide superior performance compared to standard parametric techniques when operator learning is present. Demonstrating the capacity of ML to overcome complex evaluative challenges, our framework addresses the limitations of traditional statistical methods in current post-market surveillance processes. By offering a reliable means to detect and adjust for learning effects, it may significantly improve medical device safety evaluation.

Provider Perspectives on Healthcare System Barriers to Engaging Caregivers of Rural US Veterans in Firearm Suicide Prevention.

Firearms account for the majority of US Veteran suicides. Studies demonstrate that secure firearm storage can decrease risk of suicide. Veterans prefer to have discussions about secure firearm storage with familiar individuals, such as their caregivers. Providers in the Department of Veterans Affairs (VA) are well-positioned to engage caregivers of Veterans in firearm suicide prevention; however, challenges remain. Elucidate healthcare system barriers to caregiver engagement in firearm suicide prevention, as seen by Suicide Prevention and Caregiver Support Program staff, to inform development of an intervention to increase involvement of caregivers in efforts to reduce Veteran firearm suicides. An Advisory Board consisting of key stakeholders provided input regarding study methods and interpretation of findings. Participants included 16 Caregiver Support Program and 14 Suicide Prevention staff recruited from 8 geographically diverse rural VA medical centers. Interview topics and data analyses were guided by the Consolidated Framework for Implementation Research (CFIR). Rapid analysis and a team-based approach were employed to identify key barriers; emergent themes were mapped onto relevant constructs of the CFIR inner setting domain. Healthcare system barriers included structural characteristics (e.g., understaffing and heavy workloads), relational connections and communications (e.g., poor channels of communication between Caregiver Support Program and Suicide Prevention staff), culture (e.g., lack of recipient-centered care), and access to knowledge and information (e.g., lack of training in how to incorporate caregivers in Veteran care). The present study provides much needed perspective from VA staff in Suicide Prevention and Caregiver Support programs regarding barriers to involving caregivers in firearm suicide prevention efforts within the VA healthcare setting. Identifying these barriers and potential solutions is a critical step towards increasing engagement of caregivers in reducing firearm suicide among Veterans.