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The coronavirus disease (COVID-19) pandemic disrupted healthcare and clinical research, including a suite of 11 pragmatic clinical trials (PCTs), across clinics within the Department of Veterans Affairs (VA) and the Department of Defense (DOD). These PCTs were designed to evaluate an array of nonpharmacological treatments and models of care for treatment of patients with pain and co-occurring conditions. The aims of the study are to (a) describe modifications to PCTs and interventions to address the evolving pandemic and (b) describe the application of implementation science methods for evaluation of those PCT modifications. The project used a two-phase, sequential, mixed-methods design. In Phase I, we captured PCT disruptions and modifications via a Research Electronic Data Capture questionnaire, using Periodic Reflections methods as a guide. In Phase II, we utilized the Framework for Reporting Adaptations and Modifications-Expanded (FRAME) taxonomy to develop a focus group interview guide and checklist that would provide more in-depth data than Phase I. Data were analyzed using directed content analysis. Phase I revealed that all PCTs made between two and six trial modifications. Phase II, FRAME-guided analyses showed that the key goals for modifying interventions were increasing treatment feasibility and decreasing patient exposure to COVID-19, while preserving intervention core elements. Context (format) modifications led eight PCTs to modify parts of the interventions for virtual delivery. Content modifications added elements to enhance patient safety; tailored interventions for virtual delivery (counseling, exercise, mindfulness); and modified interventions involving manual therapies. Implementation science methods identified near-real-time disruptions and modifications to PCTs focused on pain management in veteran and military healthcare settings., (Published by Oxford University Press on behalf of the Society of Behavioral Medicine 2023.)

Purpose: As the largest integrated health care system in the United States, the Veterans Health Administration (VA) is a leader in telehealth-delivered care. All 10 million Veterans cared for within the VA are eligible for telehealth. The VA cares for approximately 46,000 Veteran patients with newly diagnosed cancer and an estimated 400,000 prevalent cases annually. With nearly 38% of VA health care system users residing in rural areas and only 44% of rural counties having an oncologist, many Veterans lack local access to specialized cancer services., Methods: We describe the VA's National TeleOncology (NTO) Service. NTO was established to provide Veterans with the opportunity for specialized treatment regardless of geographical location. Designed as a hub-and-spoke model, VA oncologists from across the country can provide care to patients at spoke sites. Spoke sites are smaller and rural VA medical centers that are less able to independently provide the full range of services available at larger facilities. In addition to smaller rural spoke sites, NTO also provides subspecialized oncology care to Veterans located in larger VA medical facilities that do not have subspecialties available or that have limited capacity., Results: As of fiscal year 2021, 23 clinics are served by or engaged in planning for delivery of NTO and there are 24 physicians providing care through the NTO virtual hub. Most NTO physicians continue to provide patient care in separate traditional in-person clinics. Approximately 4,300 unique Veterans have used NTO services. Approximately half (52%) of Veterans using NTO lived in rural areas. Most of these Veterans had more than one remote visit through NTO., Conclusion: NTO is a state-of-the-art model that has the potential to revolutionize the way cancer care is delivered, which should improve the experience of Veterans receiving cancer care.

Purpose: To improve patient access to skin care, the Department of Veterans Affairs (VA) developed a patient-facing asynchronous mobile teledermatology application (app), which allows patients to follow up remotely with dermatologists. To understand how the app would be received in VA, we examined Organizational Readiness for Change (ORC), an important prelude to effective implementation, which includes the shared resolve and collective ability of organizational members to implement a change. Methods: We used a mixed-methods multiple case study approach to assess ORC at three VA facilities. Data derived from a site process call, surveys, and semistructured telephone interviews of VA staff, field notes, and administrative data. Results: Participants at all three facilities supported the intervention and recognized the value of using the app to increase patients' access to dermatologists, but expressed concerns largely related to disruption of the pre-existing clinical workflow. Participants at the facility most actively using the app had the highest overall ORC score and reported the most facilitators. Facility leadership support when guided by a clinical champion minimized barriers by recognizing the complexities of health care provision at specialty clinics. Discussion: While provider buy-in remained a barrier, leadership, guided by the clinical champion, played a critical role instituting implementation strategies. The strong association between the ORC survey score and the presence of facilitators and barriers suggests that the ORC survey may be a rapid, convenient, and effective tool for health care systems to identify favorable sites for wider implementation of mobile telehealth care. Clinical Trials Identifier: NCT03241589.

Objectives: The Helping Invested Families Improve Veterans' Experiences Study (HI-FIVES) evaluated a skills training program to support family caregivers of cognitively or functionally impaired persons. HI-FIVES demonstrated sustained improvements in caregivers' and patients' experiences of VA care. The aim of this distinct, secondary qualitative study was to explore the potential processes related to the individual tailored skills-based telephone training underpinning HI-FIVES intervention effects. We explored topics caregivers selected, characteristics of action items created, patterns of action or inaction, and barriers to action item completion across topics., Methods: Qualitative data was analysed from 118 dyads randomized into the HI-FIVES intervention which included three weekly facilitated training calls covering five education topics and action items developed by caregivers for each topic. Qualitative analysis of text responses to questions from the training calls was used., Results: Three of the top four most selected topics were caregiver-oriented and caregivers created an action item most often for self-care topics. Caregiver-oriented topics also had the highest action item completion rates. The majority of action items created met SMART guidelines for goal setting and simple structure. With regard to barriers to action item completion, caregivers commonly reported still contemplating/pending., Conclusion: Our findings identify motivational interviewing as an effective technique to identify critical intervention content and address barriers to achieving caregiving goals. We suggest that caregivers felt more empowered to create and complete an action item when they had more control over completing the action item, such as in topics related to their own self-care.

The psychospiritual nature of moral injury invites consideration regarding how chaplains understand the construct and provide care. To identify how chaplains in the VA Healthcare System conceptualize moral injury, we conducted an anonymous online survey ( N  = 361; 45% response rate). Chaplains responded to a battery of items and provided free-text definitions of moral injury that generally aligned with key elements in the existing literature, though with different emphases. Over 90% of chaplain respondents indicated that they encounter moral injury in their chaplaincy care, and a similar proportion agreed that chaplains and mental health professionals should collaborate in providing care for moral injury. Over one-third of chaplain respondents reported offering or planning to offer a moral injury group. Separately, nearly one-quarter indicated present or planned collaboration with mental health to provide groups that in some manner address moral injury. Previous training in evidence-based and collaborative care approaches appears to contribute to the likelihood of providing integrated psychosocial-spiritual care. Results and future directions are discussed, including a description of moral injury that may be helpful to understand present areas of emphasis in VA chaplains' care for moral injury.

Purpose: The purpose of this project was to identify additional facets of diabetes distress (DD) in veterans that may be present due to the veteran's military-related experience., Methods: The study team completed cognitive interviews with veterans with type 2 diabetes mellitus (T2DM) to examine how they answered the Diabetes Distress Scale (DD Scale), a tool that assesses DD. The DD Scale was used because of its strong associations with self-management challenges, physician-related distress, and clinical outcomes., Results: The veterans sample (n= 15) was 73% male, mean age of 61 (SD = 8.6), 53% Black, 53% with glycosylated hemoglobin level <9%, and 67% with prescribed insulin. The DD Scale is readily understood by veterans and interpreted. Thematic analysis indicated additional domains affecting DD and T2DM self-management, including access to care, comorbidities, disruptions in routine, fluctuations in emotions and behaviors, interactions with providers, lifelong nature of diabetes, mental health concerns, military as culture, personal characteristics, physical limitations, physical pain, sources of information and support, spirituality, and stigma., Conclusions: This study describes how a veteran's military experience may contribute to DD in the context of T2DM self-management. Findings indicate clinicians and researchers should account for additional domains when developing self-management interventions and discussing self-management behaviors with individuals with T2DM.

Moral injury merits further study to clarify its identification, prevalence, assessment and intersection with psychosocial and psychiatric problems. The present study investigated the screening potential of the Brief Moral Injury Screen (BMIS) in a sample of post-9/11 veterans (N = 315) and comparatively evaluated how this tool, the Moral Injury Events Scale (MIES), and the Moral Injury Questionnaire-Military Version (MIQ-M) relate to psychiatric diagnoses and mental illness symptom severity. Those who endorsed failing to prevent or doing something morally wrong had the highest symptomatology scores on measures of posttraumatic stress disorder, depression, suicidality, alcohol abuse and drug abuse, followed by those who reported solely witnessing a moral injury event. Posttraumatic stress disorder and depressive symptoms correlated most strongly with scores on the MIQ-M; suicidality, alcohol abuse and drug abuse scores correlated most strongly with scores on the BMIS and MIQ-M. Moral injury, as measured by three scales, was robustly correlated with worse outcomes on various symptom measures. The three scales appear to differentially predict mental illness symptomatology and diagnoses, with the BMIS predicting suicidality and alcohol and drug abuse as well as better than other measures., (Published 2020. This article is a U.S. Government work and is in the public domain in the USA.)

Objective: To evaluate the effectiveness of Helping Invested Families Improve Veterans' Experiences Study (HI-FIVES), a skills training program for caregivers of persons with functional or cognitive impairments., Design: A two-arm RCT., Setting: Single Veterans Affairs Medical Center., Participants: Patients and their primary caregivers referred in the past 6 months to home and community-based services or geriatrics clinic., Intervention: All caregivers received usual care. Caregivers in HI-FIVES also received five training calls and four group training sessions., Main Measures: Cumulative patient days at home 12 months post-randomization, defined as days not in an emergency department, inpatient hospital, or post-acute facility. Secondary outcomes included patients' total VA health care costs, caregiver and patient rating of the patient's experience of VA health care, and caregiver depressive symptoms., Results: Of 241 dyads, caregivers' (patients') mean age was 61 (73) years, 54% (53%) Black and 89% (4%) female. HI-FIVES was associated with a not statistically significant 9% increase in the rate of days at home (95% CI 0.72, 1.65; mean difference 1 day over 12 months). No significant differences were observed in health care costs or caregiver depressive symptoms. Model-estimated mean baseline patient experience of VA care (scale of 0-10) was 8.43 (95% CI 8.16, 8.70); the modeled mean difference between HI-FIVES and controls at 3 months was 0.29 (p = .27), 0.31 (p = 0.26) at 6 months, and 0.48 (p = 0.03) at 12 months. For caregivers, it was 8.34 (95% CI 8.10, 8.57); the modeled mean difference at 3 months was 0.28 (p = .18), 0.53 (p < .01) at 6 months, and 0.46 (p = 0.054) at 12 months., Conclusions: HI-FIVES did not increase patients' days at home; it showed sustained improvements in caregivers' and patients' experience of VA care at clinically significant levels, nearly 0.5 points. The training holds promise in increasing an important metric of care quality-reported experience with care.

Introduction: Teledermatology has emerged as an important strategy to enhance access to high-quality skin care. VA Telederm is a provider-facing, web-based mobile app designed to integrate into the existing teledermatology workflow in the US Veterans Health Administration (VHA). In this study, we will conduct a systematic evaluation of VA Telederm on access outcomes in VHA facilities using a pragmatic trial guided by clinical and operational leaders., Methods and Analysis: The study is a prospective, stepped-wedge cluster randomised trial with cross-sectional exposure and outcome measurement via retrospective database analysis of administrative records. Each cluster is a VHA facility deemed eligible for the trial. We assign the intervention using a cluster-level balanced randomisation scheme based on facility size, baseline teledermatology uptake and geographic location. The trial will test whether patients receiving dermatological care at participating facilities will have better access compared with patients receiving care through the current standard process. The primary outcomes proxy for patient-level access to dermatology services, including (1) consult completion time for teledermatology consults; (2) appointment completion time for new dermatology consults; and (3) travel distance for dermatology services. As secondary outcomes, we will assess facility-level adoption outcomes, that is, the number of dermatology encounters and the proportion of teledermatology consults out of all dermatology encounters. To account for secular trends in outcomes and for correlation across individuals within clusters, we will assess the impact of the intervention using generalised linear mixed regression models., Discussion: Streamlining the current practice for store-and-forward teledermatology in the VHA can improve access to expert dermatological care for US veterans. The lessons learnt in this trial could validate the use of mobile technology for consultative store-and-forward dermatology in a large healthcare organisation. The results may also be of interest to other medical specialties assessing the merits of implementing mobile telehealth., Protocol Version: Version 3; 7 November 2018., Trial Registration Number: NCT03241589; Pre-results., Competing Interests: Competing interests: JDW declares that he receives royalties based on sales as coeditor of ’Teledermatology: a User’s Guide', Cambridge University Press 2008. No other authors declare any conflict of interest., (© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

The coronavirus disease (COVID-19) pandemic disrupted healthcare and clinical research, including a suite of 11 pragmatic clinical trials (PCTs), across clinics within the Department of Veterans Affairs (VA) and the Department of Defense (DOD). These PCTs were designed to evaluate an array of nonpharmacological treatments and models of care for treatment of patients with pain and co-occurring conditions. The aims of the study are to (a) describe modifications to PCTs and interventions to address the evolving pandemic and (b) describe the application of implementation science methods for evaluation of those PCT modifications. The project used a two-phase, sequential, mixed-methods design. In Phase I, we captured PCT disruptions and modifications via a Research Electronic Data Capture questionnaire, using Periodic Reflections methods as a guide. In Phase II, we utilized the Framework for Reporting Adaptations and Modifications-Expanded (FRAME) taxonomy to develop a focus group interview guide and checklist that would provide more in-depth data than Phase I. Data were analyzed using directed content analysis. Phase I revealed that all PCTs made between two and six trial modifications. Phase II, FRAME-guided analyses showed that the key goals for modifying interventions were increasing treatment feasibility and decreasing patient exposure to COVID-19, while preserving intervention core elements. Context (format) modifications led eight PCTs to modify parts of the interventions for virtual delivery. Content modifications added elements to enhance patient safety; tailored interventions for virtual delivery (counseling, exercise, mindfulness); and modified interventions involving manual therapies. Implementation science methods identified near-real-time disruptions and modifications to PCTs focused on pain management in veteran and military healthcare settings.

Introduction: The Veterans Health Administration (VHA) Diffusion of Excellence (DoE) program provides a system to identify, replicate, and spread promising practices across the largest integrated healthcare system in the United States. DoE identifies innovations that have been successfully implemented in the VHA through a Shark Tank style competition. VHA facility and regional directors bid resources needed to replicate promising practices. Winning facilities/regions receive external facilitation to aid in replication/implementation over the course of a year. DoE staff then support diffusion of successful practices across the nationwide VHA. Methods: Organized around the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) Framework, we summarize results of an ongoing longterm mixed-methods implementation evaluation of DoE. Data sources include: Shark Tank application and bid details, tracking practice adoptions through a Diffusion Marketplace, characteristics of VHA facilities, focus groups with Shark Tank bidders, structured observations of DoE events, surveys of DoE program participants, and semi-structured interviews of national VHA program office leaders, VHA healthcare system/facility executives, practice developers, implementation teams and facilitators. Results: In the first eight Shark Tanks (2016-2022), 3,280 Shark Tank applications were submitted; 88 were designated DoE Promising Practices (i.e., practices receive facilitated replication). DoE has effectively spread practices across the VHA, with 1,440 documented instances of adoption/replication of practices across the VHA. This includes 180 adoptions/replications in facilities located in rural areas. Leadership decisions to adopt innovations are often based on big picture considerations such as constituency support and linkage to organizational goals. DoE Promising Practices that have the greatest national spread have been successfully replicated at new sites during the facilitated replication process, have close partnerships with VHA national program offices, and tend to be less expensive to implement. Two indicators of sustainment indicate that 56 of the 88 Promising Practices are still being diffused across the VHA; 56% of facilities originally replicating the practices have sustained them, even up to 6 years after the first Shark Tank. Conclusion: DoE has developed a sustainable process for the identification, replication, and spread of promising practices as part of a learning health system committed to providing equitable access to high quality care. [ABSTRACT FROM AUTHOR]

Background: Innovative technology can enhance patient access to healthcare but must be successfully implemented to be effective. Objective: We evaluated Department of Veterans Affairs' (VA's) implementation of My VA Images, a direct-to-patient asynchronous teledermatology mobile application enabling established dermatology patients to receive follow-up care remotely instead of in-person. Design /Participants/Approach: Following pilot testing at 3 facilities, the app was introduced to 28 facilities (4 groups of 7) every 3 months using a stepped-wedge cluster-randomized design. Using the Organizational Theory of Implementation Effectiveness, we examined the app's implementation using qualitative and quantitative data consisting of encounter data from VA's corporate data warehouse; app usage from VA's Mobile Health database; bi-monthly reports from facility representatives; phone interviews with clinicians; and documented communications between the operational partner and facility staff. Key Results: Implementation policies and practices included VA's vision to expand home telehealth and marketing/communication strategies. The COVID-19 pandemic dominated the implementation climate by stressing staffing, introducing competing demands, and influencing stakeholder attitudes to the app, including its fit to their values. These factors were associated with mixed implementation effectiveness, defined as high quality consistent use. Nineteen of 31 exposed facilities prepared to use the app; 10 facilities used it for actual patient care, 7 as originally intended. Residents, nurse practitioners, and physician assistants were more likely than attendings to use the app. Facilities exposed to the app pre-pandemic were more likely to use and sustain the new process. Conclusions: Considerable heterogeneity existed in implementing mobile teledermatology, despite VA's common mission, integrated healthcare system, and stakeholders' broad interest. Identifying opportunities to target favorable facilities and user groups (such as teaching facilities and physician extenders, respectively) while addressing internal implementation barriers including incomplete integration with the electronic health record as well as inadequate staffing may help optimize the initial impact of direct-to-patient telehealth. The COVID pandemic was a notable extrinsic barrier. Clinical Trials Registration: NCT03241589 [ABSTRACT FROM AUTHOR]

Purpose: To improve patient access to skin care, the Department of Veterans Affairs (VA) developed a patient-facing asynchronous mobile teledermatology application (app), which allows patients to follow up remotely with dermatologists. To understand how the app would be received in VA, we examined Organizational Readiness for Change (ORC), an important prelude to effective implementation, which includes the shared resolve and collective ability of organizational members to implement a change. Methods: We used a mixed-methods multiple case study approach to assess ORC at three VA facilities. Data derived from a site process call, surveys, and semistructured telephone interviews of VA staff, field notes, and administrative data. Results: Participants at all three facilities supported the intervention and recognized the value of using the app to increase patients' access to dermatologists, but expressed concerns largely related to disruption of the pre-existing clinical workflow. Participants at the facility most actively using the app had the highest overall ORC score and reported the most facilitators. Facility leadership support when guided by a clinical champion minimized barriers by recognizing the complexities of health care provision at specialty clinics. Discussion: While provider buy-in remained a barrier, leadership, guided by the clinical champion, played a critical role instituting implementation strategies. The strong association between the ORC survey score and the presence of facilitators and barriers suggests that the ORC survey may be a rapid, convenient, and effective tool for health care systems to identify favorable sites for wider implementation of mobile telehealth care. Clinical Trials Identifier: NCT03241589 [ABSTRACT FROM AUTHOR]