Using brief reflections to capture and evaluate end-user engagement: a case example using the COMPASS study.

BACKGROUND: Use of participatory research methods is increasing in research trials. Once partnerships are established with end-users, there is less guidance about processes research teams can use to successfully incorporate end-user feedback. The current study describes the use of a brief reflections process to systematically examine and evaluate the impact of end-user feedback on study conduct. METHODS: The Comparative Effectiveness of Trauma-Focused and Non-Trauma- Focused Treatment Strategies for PTSD among those with Co-Occurring SUD (COMPASS) study was a randomized controlled trial to determine the effectiveness of trauma-focused psychotherapy versus non-trauma-focused psychotherapy for Veterans with co-occurring posttraumatic stress disorder and substance use disorder who were entering substance use treatment within the Department of Veterans Affairs. We developed and paired a process of "brief reflections" with our end-user engagement methods as part of a supplemental evaluation of the COMPASS study engagement plan. Brief reflections were 30-minute semi-structured discussions with the COMPASS Team following meetings with three study engagement panels about feedback received regarding study issues. To evaluate the impact of panel feedback, 16 reflections were audio-recorded, transcribed, rapidly analyzed, and integrated with other study data sources. RESULTS: Brief reflections revealed that the engagement panels made recommended changes in eight areas: enhancing recruitment; study assessment completion; creating uniformity across Study Coordinators; building Study Coordinator connection to Veteran participants; mismatch between study procedures and clinical practice; therapist skill with patients with active substance use; therapist burnout; and dissemination of study findings. Some recommendations positively impact study conduct while others had mixed impact. Reflections were iterative and led to emergent processes that included revisiting previously discussed topics, cross-pollination of ideas across panels, and sparking solutions amongst the Team when the panels did not make any recommendations or recommendations were not feasible. CONCLUSIONS: When paired with end-user engagement methods, brief reflections can facilitate systematic examination of end-user input, particularly when the engagement strategy is robust. Reflections offer a forum of accountability for researchers to give careful thought to end-user recommendations and make timely improvements to the study conduct. Reflections can also facilitate evaluation of these recommendations and reveal end-user-driven strategies that can effectively improve study conduct. TRIAL REGISTRATION: ClinicalTrials.gov (NCT04581434) on October 9, 2020; https://clinicaltrials.gov/ct2/show/study/NCT04581434?term=NCT04581434&draw=2&rank=1 .

What Contributes to Sustainability? Examining Access to Medications for Opioid Use Disorder in Low-Adopting VHA Facilities.

BACKGROUND: Successful implementation can increase the availability of evidence-based treatments but continued patient access can be threatened if there is not deliberate focus on sustainment. Real-world examples are needed to elucidate contributors to sustainability. OBJECTIVE: We examined sustainability of outcomes of a study which tested a 12-month external facilitation intervention. The study evaluated change in access to medications for opioid use disorder (MOUD) in Veterans Health Administration (VHA) facilities in the lowest quartile of MOUD prescribing. DESIGN: Convergent mixed-methods design. PARTICIPANTS: Thirty-nine providers and leaders from eight VHA facilities. APPROACH: Thirty-minute post-implementation telephone interviews explored whether barriers identified pre-implementation were successfully addressed, the presence of any new challenges, helpfulness of external facilitation, and plans for sustaining MOUD access. Interviews were analyzed using a rapid turn-around approach. VHA administrative data were used to characterize the facilities and assess their ratio of patients with an OUD diagnosis receiving MOUD (MOUD/OUD ratio) at the end of a 9-month sustainability period. KEY RESULTS: Commonly reported contributors to sustained MOUD access included national attention on the opioid epidemic, accountability created by study participation, culture shift in MOUD acceptability, leadership support, and plans to build on initial progress. Frequently reported barriers included staffing issues and lack of MOUD-devoted time; the need to overhaul existing policies, practices, and/or processes; and fear and anxiety about MOUD prescribing. All facilities either maintained MOUD/OUD ratio improvement (n = 2) or further improved (n = 6) at the end of sustainability. Facilities with the highest and lowest ratio at the end of sustainability used a team-based approach to MOUD delivery; however, organizational setting differences may have impacted overall MOUD access. CONCLUSIONS: Ensuring stable and consistent staff, and sufficient time dedicated to MOUD are critical to sustaining access to evidence-based treatment in low-adopting facilities. This study highlights the importance of investing in local, system-level changes to improve and sustain access to effective treatments.

Advancing Pharmacological Treatments for Opioid Use Disorder (ADaPT-OUD): an Implementation Trial in Eight Veterans Health Administration Facilities.

BACKGROUND: Identifying effective strategies to improve access to medication treatments for opioid use disorder (MOUD) is imperative. Within the Veterans Health Administration (VHA), provision of MOUD varies significantly, requiring development and testing of implementation strategies that target facilities with low provision of MOUD. OBJECTIVE: Determine the effectiveness of external facilitation in increasing the provision of MOUD among VHA facilities with low baseline provision of MOUD compared to matched controls. DESIGN: Pre-post, block randomized study designed to compare facility-level outcomes in a stratified sample of eligible facilities. Four blocks (two intervention facilities in each) were defined by median splits of both the ratio of patients with OUD receiving MOUD and number of patients with OUD not currently receiving MOUD (i.e., number of actionable patients). Intervention facilities participated in a 12-month implementation intervention. PARTICIPANTS: VHA facilities in the lowest quartile of MOUD provision (35 facilities), eight of which were randomly assigned to participate in the intervention (two per block) with twenty-seven serving as matched controls by block. INTERVENTION: External facilitation included assessment of local barriers/facilitators, formation of a local implementation team, a site visit for action planning and training/education, cross-facility quarterly calls, monthly coaching calls, and consultation. MAIN MEASURES: Pre- to post-change in the facility-level ratio of patients with an OUD diagnosis receiving MOUD compared to control facilities. KEY RESULTS: Intervention facilities significantly increased the ratio of patients with OUD receiving MOUD from an average of 18% at baseline to 30% 1 year later, with an absolute difference of 12% (95% confidence interval [CI]: 6.6%, 17.0%). The difference in differences between intervention and control facilities was 3.0% (95% CI: - 0.2%. 6.7%). The impact of the intervention varied by block, with smaller, less complex facilities more likely to outperform matched controls. CONCLUSIONS: Intensive external facilitation improved the adoption of MOUD in most low-performing facilities and may enhance adoption beyond other interventions less tailored to individual facility contexts.

Fluctuations in barriers to medication treatment for opioid use disorder prescribing over the course of a one-year external facilitation intervention.

BACKGROUND: The Veterans Health Administration (VHA) is invested in expanding access to medication treatment for opioid use disorder (MOUD) to save lives. Access varies across VHA facilities and, thus, requires implementation strategies to promote system-wide adoption of MOUD. We conducted a 12-month study employing external facilitation that targeted MOUD treatment among low-adopting VHA facilities. In this study, we sought to evaluate the patterns of perceived barriers over 1 year of external implementation facilitation using the integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework. METHODS: We randomly selected eight VHA facilities from the bottom quartile of the proportion of Veterans with an OUD diagnosis receiving MOUD (< 21%). The 1-year external implementation intervention included developmental evaluation to tailor the facilitation, an on-site visit, and monthly facilitation calls. Facilitators recorded detailed notes for each call on a structured template. Qualitative data was analyzed by coding and mapping barriers to the constructs in the i-PARIHS framework (Innovation, Recipients, Context). We identified emerging themes within each construct by month. RESULTS: Barriers related to the Innovation, such as provider perception of the need for MOUD in their setting, were minimal throughout the 12-month study. Barriers related to Recipients were predominant and fluctuated over time. Recipient barriers were common during the initial months when providers did not have the training and waivers necessary to prescribe MOUD. Once additional providers (Recipients) were trained and waivered to prescribe MOUD, Recipient barriers dropped and then resurfaced as the facilities worked to expand MOUD prescribing to other clinics. Context barriers, such as restrictions on which clinics could prescribe MOUD and fragmented communication across clinics regarding the management of patients receiving MOUD, emerged more prominently in the middle of the study. CONCLUSIONS: VHA facilities participating in 12-month external facilitation interventions experienced fluctuations in barriers to MOUD prescribing with contextual barriers emerging after a facilitated reduction in recipient- level barriers. Adoption of MOUD prescribing in low-adopting VHA facilities requires continual reassessment, monitoring, and readjustment of implementation strategies over time to meet challenges. Although i-PARIHS was useful in categorizing most barriers, the lack of conceptual clarity was a concern for some constructs.

Early impacts of a multi-faceted implementation strategy to increase use of medication treatments for opioid use disorder in the Veterans Health Administration.

BACKGROUND: Despite the risk of negative sequelae from opioid use disorder (OUD) and clinical guidelines for the use of effective medication treatment for OUD (M-OUD), many Veterans Health Administration (VHA) providers and facilities lag in providing M-OUD. An intensive external facilitation intervention may enhance uptake in low-adopting VHA facilities by engaging stakeholders from multiple clinical settings within a facility (e.g., mental health, primary care, pain specialty clinic, substance use disorder clinics). Our study identified pre-intervention determinants of implementation through qualitative interviews, described strategies employed during the first 6 months of intensive external facilitation, and explored patterns of implementation determinants in relation to early outcomes. METHODS: Guided by the integrated-Promoting Action on Research Implementation in Health Services (i-PARIHS) framework, we interviewed stakeholders at low-adopting VHA facilities prior to external facilitation, employed a rapid qualitative analytic process, presented findings during facility visits, and collaboratively created facilitation action plans to achieve goals set by the facilities that would increase M-OUD uptake. The primary outcome was the Substance Use Disorder (SUD)-16, which is a VHA facility-level performance metric consisting of the percent of patients receiving M-OUD among those with an OUD diagnosis. We examined the relationship between pre-implementation factors and 6-month SUD-16 outcomes. RESULTS: Across eight VHA facilities, we interviewed 68 participants. Implementation determinants included barriers and facilitators across innovation, context, and recipients constructs of i-PARIHS. Each facility selected goals based on the qualitative results. At 6 months, two facilities achieved most goals and two facilities demonstrated progress. The SUD-16 from baseline to 6 months significantly improved in two facilities (8.4% increase (95 % confidence interval [CI] 4.4-12.4) and 9.9% increase (95% CI 3.6-16.2), respectively). Six-month implementation outcomes showed that the extent to which M-OUD aligns with existing clinical practices and values was a primary factor at all facilities, with six of eight facilities perceiving it as both a barrier and facilitator. External health system barriers were most challenging for facilities with the smallest change in SUD-16. CONCLUSIONS: Early impacts of a multi-faceted implementation approach demonstrated a strong signal for positively impacting M-OUD prescribing in low-adopting VHA facilities. This signal indicates that external facilitation can influence adoption of M-OUD at the facility level in the early implementation phase. These short-term wins experienced by stakeholders may encourage continued adoption and long-term sustainability M-OUD.