A Partner-Engaged Approach to Developing an Implementation Research Logic Model for a Traumatic Brain Injury-Intensive Evaluation and Treatment Program.

BACKGROUND: A partnered evaluation project with Veterans Health Administration Physical Medicine and Rehabilitation program office uses a partner-engaged approach to characterize and evaluate the national implementation of traumatic brain injury (TBI)Intensive Evaluation and Treatment Program (IETP). OBJECTIVE: This paper illustrates a partner-engaged approach to contextualizing the IETP within an implementation research logic model (IRLM) to inform program sustainment and spread. SETTING: The project was conducted at five IETP sites: Tampa, Richmond, San Antonio, Palo Alto, and Minneapolis. PARTICIPANTS: Partners included national and site program leaders, clinicians, Department of Defense Referral Representatives, and researchers. Participants included program staff (n = 46) and Service Members/Veterans (n = 48). DESIGN: This paper represents a component of a larger participatory-based concurrent mixed methods quality improvement project. MAIN MEASURES: Participant scripts and demographic surveys. METHODS: Datasets were analyzed using rapid iterative content analysis; IETP model was iteratively revised with partner feedback. Each site had an IETP clinical team member participate. The IRLM was contextualized within the Consolidated Framework for Implementation Research (CFIR); systematic consensus building expert reviewed implementation strategies; RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance); and Implementation Outcomes Framework (IOF). RESULTS: Analyses and partner feedback identified key characteristics, determinants, implementation strategies, mechanisms, and outcomes. CONCLUSIONS: This partner-engaged IRLM informs implementation and sustainment of a rehabilitation program for individuals with TBI. Findings will be leveraged to examine implementation, standardize core outcome measurements, and inform knowledge translation.

Benchmark findings from a veteran electronic patient-reported outcomes evaluation from a chronic pain management telehealth program.

BACKGROUND: Chronic pain is a leading cause of disability and negatively impacts biological/physical, psychological, and social aspects of life resulting in significant pain interference or disability. This project was part of a longitudinal mixed-methods implementation evaluation of the TelePain-Empower Veterans Program (EVP), a non-pharmacological chronic pain intervention. The purpose of this quality management project was to examine electronic patient-reported outcome measures (ePROs) including primary pain-related (intensity, interference, catastrophizing, kinesiophobia) and secondary outcomes (physical, psychological, acceptance, social) to determine TelePain-EVP effectiveness. Secondary purpose was to examine dosing effects to better understand potential dose relationships between EVP use and ePROs. METHODS: Standardized ePRO measures were examined at week 1 (baseline), week 10 (post-EVP), and week 26 (follow-up). Qualtrics, a cloud-based platform was used to collect ePRO data at each time point. Veterans that completed at-least one survey at any specified time point were categorized as responders (n = 221). Linear-mixed models (LMMs) were fit to assess changes for each primary and secondary ePRO. RESULTS: Participants ranged from 24 to 81 years old; veterans were typically male (65.16%), black or African American (76.47%), married or partnered (41.63%), attended at-least some college or vocational school (67.87%), and reported low back as their primary pain location (29.41%). There was a significant decrease in pain catastrophizing from baseline to post-TelePain-EVP (p < .001). However, pain catastrophizing improvement from baseline was not present at week 26 (p = .116). Pain interference also decreased from baseline to post-treatment (p = .05), but this improvement did not exceed the adjusted significance threshold. Additional pre-post improvements were also observed for certain secondary ePROs: psychological (anxiety, depression), acceptance (activities engagement). Only the activities engagement effect remained 26 weeks from baseline. Mixed results were observed for EVP dose across primary and secondary outcomes. CONCLUSIONS: Evidence from this evaluation indicate that TelePain-EVP has positive outcomes for certain pain (catastrophizing), psychological (anxiety, depression), and acceptance (activities engagement) for veterans with chronic pain. More TelePain related studies and enterprise-wide evaluations are needed along with comparative and cost effectiveness methods to determine patient benefits and the economic value gained of treatment options such as TelePain-EVP.

Outcomes of a Remotely Delivered Complementary and Integrative Health Partnered Intervention to Improve Chronic Pain and Posttraumatic Stress Disorder Symptoms: Randomized Controlled Trial.

BACKGROUND: Nonpharmacological interventions for veterans are needed to help them manage chronic pain and posttraumatic stress disorder (PTSD) symptoms. Complementary and integrative health (CIH) interventions such as Mission Reconnect (MR) seek to provide veterans with the option of a partnered, self-directed intervention that teaches CIH skills remotely to support symptom management. OBJECTIVE: The purpose of this study was to describe the physical, psychological, and social outcomes of a self-directed mobile- and web-based CIH intervention for veterans with comorbid chronic pain and PTSD and their partners and qualitatively examine their MR user experience. METHODS: A sample of veteran-partner dyads (n=364) were recruited to participate in a mixed methods multisite waitlist control randomized controlled trial to measure physical, psychological, and social outcomes, with pain as the primary outcome and PTSD, depression, stress, sleep, quality of life, and relationships as secondary outcomes. Linear mixed models were constructed for primary and secondary patient-reported outcomes. The quantitative analysis was triangulated using qualitative interviews from a subsample of dyads (n=35) to examine participants' perceptions of their program experience. RESULTS: Dyads were randomized to 2 groups: intervention (MR; 140/364, 38.5%) and waitlist control (136/364, 37.4%). No significant change was observed in overall pain, sleep, PTSD, quality of life, relationship satisfaction, overall self-compassion, or compassion for others. A significant reduction in pain interference in mood (P=.008) and sleep (P=.008) was observed among the veteran MR group that was not observed in the waitlist control group. We also observed a positive effect of the MR intervention on a reduction in negative affect associated with pain (P=.049), but this effect did not exceed the adjusted significance threshold (P=.01). Significant improvements were also observed for partners in the affection (P=.007) and conflict (P=.001) subdomains of the consensus and satisfaction domains. In contrast to quantitative results, qualitative data indicated that intervention impacts included improved sleep and reduced pain, anxiety, and stress and, in contrast to the survey data, overall improvement in PTSD symptoms and social relationships. Participants' overall impressions of MR highlight usability and navigation, perceptions on packaging and content, and barriers to and facilitators of MR use. CONCLUSIONS: Adjunctive CIH-based modalities can be delivered using web and mobile apps but should be developed and tailored using established best practices. MR may be beneficial for veterans with pain and PTSD and their partners. Further pragmatic trials and implementation efforts are warranted. TRIAL REGISTRATION: ClinicalTrials.gov NCT03593772; https://clinicaltrials.gov/study/NCT03593772. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/13666.

Empower Veterans Program (EVP): a chronic pain management program demonstrates positive outcomes among veterans.

BACKGROUND: Chronic pain is a highly prevalent health condition among veterans. Traditional pharmacological interventions present unique challenges for chronic pain management including prescription opioid addiction and overdose. In alignment with the 2016 Comprehensive Addiction and Recovery Act and VA's Stepped Care Model to meet veterans' pain management needs, the Offices of Rural Health and Pain Management, Opioid Safety, and Prescription Drug Monitoring Program (PMOP) funded an enterprise-wide initiative to implement a Step 3 integrated tele-pain program: Empower Veterans Program (EVP). EVP provides veterans with chronic pain self-care skills using a whole health driven approach to pain management. OBJECTIVES: The Comprehensive Addiction and Recovery Act prompted the strategic approach to offer non-pharmacological options to meet veterans' pain management needs. EVP, a 10-week interdisciplinary group medical appointment, leverages Acceptance and Commitment Therapy, Mindful Movement, and Whole Health to provide veterans with chronic pain self-care skills. This evaluation was conducted to describe participant characteristics, graduation, and satisfaction rates; and assess pre-post patient-reported outcomes (PRO) associated with EVP participation. METHODS: A sample of 639 veterans enrolled in EVP between May, 2015 and December, 2017 provided data to conduct descriptive analyses to assess participant demographics, graduation, and satisfaction rates. PRO data were analyzed using a within-participants pre-post design, and linear mixed-effects models were used to examine pre-post changes in PRO. RESULTS: Of 639 participants, 444 (69.48%) graduated EVP. Participant median program satisfaction rating was 8.41 (Interquartile Range: 8.20-9.20). Results indicate pre-post EVP improvements (Bonferroni-adjusted p < .003) in the three primary pain outcomes (intensity, interference, catastrophizing), and 12 of 17 secondary outcomes, including physical, psychological, health-related quality of life (HRQoL), acceptance, and mindfulness measures. DISCUSSION: Data suggest that EVP has significant positive outcomes in pain, psychological, physical, HRQoL, acceptance, and mindfulness measures for veterans with chronic pain through non-pharmacological means. Future evaluations of intervention dosing effect and long-term effectiveness of the program is needed.

User Testing of the Veteran Delegation Tool: Qualitative Inquiry.

BACKGROUND: Informal caregivers, or care partners, provide critical support to care recipients when managing health care. Veterans Health Administration (VHA) priorities identify care partners as vital in supporting veterans' care management. The Veteran Delegation Tool (VDT) is VHA's Health Insurance Portability and Accountability Act-compliant solution for care partners to comanage veterans' care through VHA's electronic health portal. Human-centered design approaches in VDT development are needed to inform enhancements aimed at promoting uptake and sustained use. OBJECTIVE: The objective of this prospective descriptive quality improvement project was to use a human-centered design approach to examine VDT use perceptions and practical experiences. METHODS: This project was conducted using a 4-phase approach: frame, discover, design, and deliver. The frame phase designed the protocol and prepared the VDT system for testing. This paper reports on the discover phase, which used semistructured and follow-up interviews and user testing to examine VDT's benefits, facilitators, and barriers. The discover phase data informed the design and deliver phases, which are underway. RESULTS: Veterans (24/54, 44%), care partners (21/54, 39%), and individuals who represented dual roles (9/54, 17%)-namely veteran care partner (4/54, 7%), veteran clinical provider (2/54, 4%), and care partner provider (3/54, 6%)-participated in semistructured interviews in the discover phase. A subsample of these participants (3/54, 6%) participated in the follow-up interviews and user testing. Analysis of the semistructured interviews indicated convergence on the respondents' perceptions of VDT's benefits, facilitators, and barriers and recommendations for improving VDT. The perceived benefits were authorized access, comanagement of care needs on the web, communication with the clinical team, access to resources, and ease of burden. Perceived barriers were nonrecognition of the benefits of VDT, technical literacy access issues, increased stress in or burden on care partners, and personal health information security. Participant experiences across 4 VDT activity domains were upgrade to My HealtheVet Premium account, registration, sign-in, and use. User testing demonstrated users' challenges to register, navigate, and use VDT. Findings informed VDT development enhancements and recommendations. CONCLUSIONS: Care partners need Health Insurance Portability and Accountability Act-compliant access to electronic health portals to assist with care management. VDT is VHA's solution, allowing communication among delegates, veterans, and clinical care teams. Users value VDT's potential use and benefits, while access and navigation improvements to ensure uptake and sustained use are needed. Future efforts need to iteratively evaluate the human-centered phases, design and deliver, of VDT to target audiences. Continued efforts to understand and respond to care partners' needs are warranted.

Mobile and Web-Based Partnered Intervention to Improve Remote Access to Pain and Posttraumatic Stress Disorder Symptom Management: Recruitment and Attrition in a Randomized Controlled Trial.

BACKGROUND: Increasing access to nonpharmacological interventions to manage pain and posttraumatic stress disorder (PTSD) is essential for veterans. Complementary and integrative health (CIH) interventions can help individuals manage symptom burden with enhanced accessibility via remotely delivered health care. Mission Reconnect (MR) is a partnered, self-directed intervention that remotely teaches CIH skills. OBJECTIVE: The purpose of this paper is to describe the recruitment, onboarding phase, and attrition of a fully remote randomized controlled trial (RCT) assessing the efficacy of a self-directed mobile and web-based intervention for veterans with comorbid chronic pain and PTSD and their partners. METHODS: A total of 364 veteran-partner dyads were recruited to participate in a mixed methods multisite waitlist control RCT. Qualitative attrition interviews were conducted with 10 veterans with chronic pain and PTSD, and their self-elected partners (eg, spouse) who consented but did not begin the program. RESULTS: At the point of completing onboarding and being randomized to the 2 treatment arms, of the 364 recruited dyads, 97 (26.6%) failed to complete onboarding activities. Reported reasons for failure to complete onboarding include loss of self-elected partner buy-in (n=8, 8%), difficulties with using remote data collection methods and interventions (n=30, 31%), and adverse health experiences unrelated to study activities (n=23, 24%). Enrolled veterans presented at baseline with significant PTSD symptom burden and moderate-to-severe pain severity, and represented a geographically and demographically diverse population. Attrition interviews (n=10) indicated that misunderstanding MR including the intent of the intervention or mistaking the surveys as the actual intervention was a reason for not completing the MR registration process. Another barrier to MR registration was that interviewees described the mailed study information and registration packets as too confusing and excessive. Competing personal circumstances including health concerns that required attention interfered with MR registration. Common reasons for attrition following successful MR registration included partner withdrawal, adverse health issues, and technological challenges relating to the MR and electronic data collection platform (Qualtrics). Participant recommendations for reducing attrition included switching to digital forms to reduce participant burden and increasing human interaction throughout the registration and baseline data collection processes. CONCLUSIONS: Challenges, solutions, and lessons learned for study recruitment and intervention delivery inform best practices of delivering remote self-directed CIH interventions when addressing the unique needs of this medically complex population. Successful recruitment and enrollment of veterans with chronic pain and PTSD, and their partners, to remote CIH programs and research studies requires future examination of demographic and symptom-associated access barriers. Accommodating the unique needs of this medically complex population is essential for improving the effectiveness of CIH programs. Disseminating lessons learned and improving access to remotely delivered research studies and CIH programs is paramount in the post-COVID-19 climate. TRIAL REGISTRATION: ClinicalTrials.gov NCT03593772; https://clinicaltrials.gov/ct2/show/NCT03593772.

Veterans' lived experiences with the VA's Whole Health system and perceived impact on dimensions of wellness.

RESEARCH QUESTION: What are the lived experiences and wellness related outcomes of veterans engaged in the Department of Veterans' Affairs (VA) Whole Health (WH) system of care? THEORETICAL FRAMEWORK: This qualitative work was conducted with a pragmatic phenomenological approach to understand patients' lived experience within the WH system of care. Data were contextualized within a multi-dimensional wellness model. METHODOLOGY: This descriptive quality improvement project used semi-structured telephone interviews. Interview script elicited veterans' WH participation experiences and perceived wellness related outcomes. CONTEXT: Data were collected within a WH Service, at a large Veterans Health Administration Hospital in the Southeast United States. SAMPLE SELECTION: Data were collected with a purposive sample of veterans that participated in at least 2 WH activities. DATA COLLECTION: Patients were recruited by WH clinical team collaborators to participate in qualitative data collection. ANALYSIS AND INTERPRETATION: Rapid content analysis and interpretation of results were conducted in alignment with dimensions of wellness constructs. MAIN RESULTS: WH offers veterans' non-pharmacological tools to improve mental, physical, and social wellness. Participants (n = 50) represented the larger veteran population. Most veterans perceived a positive WH experience with improvement of three primary dimensions including mental and emotional, physical, and social wellness - impacts on other dimensions gleaned less perceived impact. Veterans reported adopting mindfulness and coping strategies, better mobility, pain management, and sleep quality, and enhanced social engagement. Even those who did benefit personally from all aspects of WH, felt the services are needed to support the larger veteran population. Reduced suicidal ideation and pain medication use emerged as a WH effect among approximately 10% of the sample.

Qualitative Evaluation Informs the Implementation of a Telehealth Program to Manage Chronic Pain.

In response to the opioid epidemic and high rates of chronic pain among the veteran population, the U.S. Department of Veterans Affairs implemented the TelePain-Empower Veterans Program (EVP), a nonpharmacological pain management program for veterans. Delivered virtually, TelePain-EVP incorporates integrated health components (Whole Health, Acceptance and Commitment Therapy, and Mindful Movement) through interdisciplinary personalized coaching. The objective of this quality improvement project was to evaluate the implementation of TelePain-EVP to identify determinants to implementation, benefits and challenges to participation, and recommendations for future direction. We used a qualitative descriptive design to conduct semistructured telephone interviews with TelePain-EVP leaders (n = 3), staff (n = 10), and veterans (n = 22). The interview guides aligned with the Consolidated Framework for Implementation Research (CFIR). Thematic content analysis organized and characterized findings. Several CFIR domains emerged as determinants relevant to program implementation, including innovation (eg, design); individuals (eg, deliverers, recipients); inner (eg, communications) and outer settings (eg, local conditions); and implementation process (eg, reflecting and evaluating). Identified determinants included facilitators (eg, virtual delivery) and barriers (eg, staff shortages). Participants reported improvements in pain management coping skills, interpersonal relationships, and sense of community, but no self-reported reductions in pain or medication use. Program improvement recommendations included using centralized staff to address vacancies, collecting electronic data, offering structured training, and providing course materials to veteran participants. Qualitative data can inform the sustained implementation of TelePain-EVP and other similar telehealth pain management programs. These descriptive data should be triangulated with quantitative data to objectively assess participant TelePain-EVP outcomes and associated participant characteristics. PERSPECTIVE: A qualitative evaluation of a telehealth program to manage chronic pain, guided by the CFIR framework, identified determinants of program implementation. Additionally, participants reported improvements in pain management coping skills, interpersonal relationships, and sense of community, but no self-reported reductions in pain or medication use.

Developing Evidence to Support Policy: Protocol for the StrAtegic PoLicy EvIdence-Based Evaluation CeNTer (SALIENT).

BACKGROUND: All federal agencies are required to support appropriation requests with evidence and evaluation (US Public Law 115-435; the Evidence Act). The StrAtegic PoLicy EvIdence-Based Evaluation CeNTer (SALIENT) is 1 of 6 centers that help the Department of Veterans Affairs (VA) meet this requirement. OBJECTIVE: Working with the existing VA evaluation structure, SALIENT evaluations will contribute to (1) optimize policies and programs for veteran populations; (2) improve outcomes regarding health, equity, cost, and provider well-being; (3) advance the science of dissemination and knowledge translation; and (4) expand the implementation and dissemination science workforce. METHODS: We leverage the Lean Sprint methodology (iterative, incremental, rule-governed approach to clearly defined, and time-boxed work) and 3 cores to develop our evaluation plans collaboratively with operational partners and key stakeholders including veterans, policy experts, and clinicians. The Operations Core will work with evaluation teams to develop timelines, facilitate work, monitor progress, and guide quality improvement within SALIENT. The Methods Core will work with evaluation teams to identify the most appropriate qualitative, quantitative, and mixed methods approaches to address each evaluation, ensure that the analyses are conducted appropriately, and troubleshoot when problems with data acquisition and analysis arise. The Knowledge Translation (KT) Core will target key partners and decision makers using a needs-based market segmentation approach to ensure that needs are incorporated in the dissemination of knowledge. The KT Core will create communications briefs, playbooks, and other materials targeted at these market segments to facilitate implementation of evidence-based practices and maximize the impact of evaluation results. RESULTS: The SALIENT team has developed a center infrastructure to support high-priority evaluations, often to be responsive to shifting operational needs and priorities. Our team has engaged in our core missions and operations to rapidly evaluate a high-priority areas, develop a comprehensive Lean Sprint systems redesign approach to training, and accelerate rapid knowledge translation. CONCLUSIONS: With an array of interdisciplinary expertise, operational partnerships, and integrated resources, SALIENT has an established and evolving infrastructure to rapidly develop and implement high-impact evaluations. Projects are developed with sustained efficiency approaches that can pivot to new priorities as needed and effectively translate knowledge for key stakeholders and policy makers, while creating a learning health system infrastructure to foster the next generation of evaluation and implementation scientists. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/59830.

Traumatic Brain Injury Intensive Evaluation and Treatment Program: Protocol for a Partnered Evaluation Initiative Mixed Methods Study.

BACKGROUND: The traumatic brain injury (TBI) Intensive Evaluation and Treatment Program (IETP) is an innovative modality for delivering evidence-based treatments in a residential, inpatient format to special operational forces service members and veterans with mild TBI. IETPs provide bundled evidence-based assessment, treatment, referral, and case management in concordance with the existing guidelines for mild TBI and commonly co-occurring comorbidities. To date, there has been no formal characterization or evaluation of the IETP to understand the determinants of implementation across the system of care. The goal of our partnered evaluation initiative (PEI) with an operational partner, the Physical Medicine and Rehabilitation National Program Office, is to facilitate the full implementation of the IETP across all 5 Veterans Health Administration TBI-Centers of Excellence (TBI-COE) and to inform minimum standards while supporting the unique characteristics of each site. OBJECTIVE: This IETP partnered evaluation will describe each of the 5 TBI-COE IETP services and state of implementation to identify opportunities for adaptation and scale, characterize the relationship between patient characteristics and clinical services received, evaluate the outcomes for participants in the IETP, and inform ongoing implementation and knowledge translation efforts to support IETP expansion. In alignment with the goals of the protocol, ineffective treatment components will be targeted for deimplementation. METHODS: A 3-year concurrent mixed methods evaluation using a participatory approach in collaboration with the operational partner and TBI-COE site leadership will be conducted. Qualitative observations, semistructured focus groups, and interviewing methods will be used to describe IETP, stakeholder experiences and needs, and suggestions for IETP implementation. Quantitative methods will include primary data collection from patients in the IETP at each site to characterize long-term outcomes and patient satisfaction with treatment and secondary data collection to quantitatively characterize patient-level and care system-level data. Finally, data sets will be triangulated to share data findings with partners to inform ongoing implementation efforts. RESULTS: Data collection began in December 2021 and is currently ongoing. The results and deliverables will inform IETP characterization, evaluation, implementation, and knowledge translation. CONCLUSIONS: The results of this evaluation seek to provide an understanding of the determinants affecting the implementation of IETPs. Service member, staff, and stakeholder insights will inform the state of implementation at each site, and quantitative measures will provide options for standardized outcome measures. This evaluation is expected to inform national Physical Medicine and Rehabilitation Office policies and processes and knowledge translation efforts to improve and expand the IETP. Future work may include cost evaluations and rigorous research, such as randomized controlled trials. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/44776.