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 .

Feasibility of a family-involved intervention to increase engagement in evidenced-based psychotherapies for posttraumatic stress disorder: A pilot study.

OBJECTIVE: To assess the feasibility of a family-involved intervention, family support in mental health recovery (FAMILIAR), for veterans with posttraumatic stress disorder (PTSD) seeking psychotherapy at a single Veterans Administration Health System. METHOD: This mixed-methods study reports qualitative and quantitative findings from a single-group pilot of 24 veterans and their support partners (SPs) about experiences with the intervention and interviews with eight VA mental health clinicians and leaders and the study interventionist to explore intervention feasibility. Findings across data sources were merged within domains of Bowen and colleagues' pilot study feasibility framework. RESULTS: Out of 24 dyads, 16 veterans and 15 associated SPs completed the intervention. Participants viewed the intervention to be valuable and feasible. Veterans and SPs reported that they enrolled in the study to develop a shared understanding of PTSD and treatment. While participants identified few logistical barriers, finding a time for conjoint sessions could be a challenge. Veterans, SPs, and providers discussed benefits of the intervention, including that it facilitated conversation between the veteran and SP about PTSD and mental health care and helped to prepare the dyad for treatment. Providers noted potential challenges integrating family-involved interventions into clinical workflow in VA and suggested the need for additional training and standardized procedures for family-centered care. CONCLUSIONS: Our study identified potential implementation facilitators (e.g., standard operating procedures about session documentation, confidentiality, and family ethics) and challenges (e.g., clinical workflow integration) that require further study to bring FAMILIAR into routine clinical care. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Treatment-related beliefs and reactions among trauma-focused therapy completers and discontinuers: A qualitative examination.

Prolonged exposure (PE) and cognitive processing therapy (CPT) for posttraumatic stress disorder (PTSD) are effective, but some patients do not respond adequately, and dropout rates are high. Patients' beliefs about treatment and perceptions of treatment components influence treatment outcomes and may be amenable to change through intervention. The present study sought to identify beliefs and reactions to PE and CPT that differentiated completers who screened negative for a PTSD diagnosis after treatment (PTSD-), completers who screened positive for a PTSD diagnosis after treatment (PTSD+), and discontinuers who attended six or fewer sessions. Thematic analysis was used to identify themes in qualitative data collected via retrospective semistructured interviews with 51 completers (19 PTSD- after treatment, 32 PTSD+ after treatment) and 66 discontinuers of PE/CPT. Participants were demographically diverse veterans across service eras. Treatment-related beliefs and reactions differentiating these groups included perceived helpfulness of treatment, self-efficacy in engaging in treatment, anticipatory anxiety and concerns, interpretations of ongoing symptoms, and perceived consequences of treatment on functioning. Further, some patterns seemed to differ in early treatment sessions compared to during the active components of treatment. Findings point to potentially malleable targets that could be intervened upon to improve trauma-focused treatment outcomes. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Co-occurring implementation strategies: The effects of academic detailing for opioid use disorder campaign on the advancing pharmacological treatments for opioid use disorder (ADaPT-OUD) study.

Background: Barriers at the system, clinician, and patient level limit access to medications for opioid use disorder (MOUD). The Advancing Pharmacological Treatments for Opioid Use Disorder (ADaPT-OUD) study implemented an external facilitation strategy within the Veterans Health Administration (VHA) aimed at facility-level barriers to improve uptake of MOUD. During ADaPT-OUD, an independent Academic Detailing Services Opioid Agonist Treatment of OUD Campaign was co-occurring and aimed to increase evidence-based practice for OUD at the clinician level. While both these initiatives aim to increase MOUD reach, they address different barriers and did not intentionally collaborate. Thus, understanding the interaction between these two independent implementation initiatives and their effect on MOUD reach will further inform and mold future implementation efforts of MOUD. Methods: This was a secondary analysis of the ADaPT-OUD study that included 35 VHA facilities in the lowest quartile of MOUD reach; eight received the ADaPT-OUD external facilitation and 27 matched sites received implementation as usual. The number of academic detailing (AD) visits during ADaPT-OUD was used as a proxy for the intensity of Academic Detailing for OUD Campaign activity. The interaction between external facilitation status and AD intensity was evaluated by comparing the change in facility-level MOUD reach. Results: There was a general increase in the number of AD visits, in both external facilitation and implementation as usual sites, over the course of ADaPT-OUD's implementation period. A non-statistically significant, positively sloped, linear relationship was observed between average number of AD visits per quarter and change in MOUD reach in facilities also receiving ADaPT-OUD external facilitation that was not observed in the implementation as usual sites. Conclusion: Co-occurring initiatives focusing on different barriers to MOUD access have the potential to further increase MOUD in low-performing facilities, but further research into timing, quality, and collaboration between initiatives are warranted.

Medication treatment of opioid use disorder (MOUD) is a key element in addressing the opioid epidemic. The development, approval, and effectiveness of buprenorphine and naltrexone have expanded access to MOUD from specialty opioid treatment programs to office-based treatment. However, uptake of these evidence-based treatments across the Veterans Health Administration (VHA) is variable. To address this gap in care within the VHA, The Advancing Pharmacological Treatment for Opioid Use Disorder (ADaPT-OUD) study implemented an external facilitation strategy aimed at facility-level barriers at low-adopting VHA facilities while the VHA Pharmacy Benefits Management Academic Detailing Services Opioid Agonist Treatment of OUD Campaign implemented academic detailing with the goal to address clinician-level barriers. This article evaluates the effect these two co-occurring and independent initiatives had on each other and MOUD reach. The results suggest a trend toward a positive synergistic relationship between the two initiatives, that warrants further study and evaluation to inform further implementation efforts.

Costs of implementing a multi-site facilitation intervention to increase access to medication treatment for opioid use disorder.

BACKGROUND: The United States has been grappling with the opioid epidemic, which has resulted in over 75,000 opioid-related deaths between April 2020 and 2021. Evidence-based pharmaceutical interventions (buprenorphine, methadone, and naltrexone) are available to reduce opioid-related overdoses and deaths. However, adoption of these medications for opioid use disorder has been stifled due to individual- and system-level barriers. External facilitation is an evidence-based implementation intervention that has been used to increase access to medication for opioid use disorder (MOUD), but the implementation costs of external facilitation have not been assessed. We sought to measure the facility-level direct costs of implementing an external facilitation intervention for MOUD to provide decision makers with estimates of the resources needed to implement this evidence-based program. METHODS: We performed a cost analysis of the pre-implementation and implementation phases, including an itemization of external facilitation team and local site labor costs. We used labor estimates from the Bureau of Labor and Statistics, and sensitivity analyses were performed using labor estimates from the Veterans Health Administration (VHA) Financial Management System general ledger data. RESULTS: The average total costs for implementing an external facilitation intervention for MOUD per site was $18,847 (SD 6717) and ranged between $11,320 and $31,592. This translates to approximately $48 per patient with OUD. Sites with more encounters and participants with higher salaries in attendance had higher costs. This was driven mostly by the labor involved in planning and implementation activities. The average total cost of the pre-implementation and implementation activities were $1031 and $17,816 per site, respectively. In the sensitivity analysis, costs for VHA were higher than BLS estimates likely due to higher wages. CONCLUSIONS: Implementing external facilitation to increase MOUD prescribing may be affordable depending on the payer's budget constraints. Our study reported that there were variations in the time invested at each phase of implementation and the number and type of participants involved with implementing an external facilitation intervention. Participant composition played an important role in total implementation costs, and decision makers will need to identify the most efficient and optimal number of stakeholders to involve in their implementation plans.

Implementation of Evidence-Based Psychotherapies for Posttraumatic Stress Disorder: A Systematic Review.

Guidelines strongly recommend trauma-focused therapies to treat posttraumatic stress disorder. Implementation of cognitive processing therapy (CPT) and prolonged exposure (PE) in Veterans Health Administration (VHA) and non-VHA settings began in 2006. We conducted a systematic review of implementation facilitators and challenges and strategies to address barriers. We searched MEDLINE, Embase, PsycINFO, and CINAHL from inception until March 2021 for English-language articles. Two individuals reviewed eligibility and rated quality. Quantitative results were abstracted by one reviewer and verified by a second. Qualitative results were independently coded by two reviewers and finalized through consensus. We used RE-AIM and CFIR frameworks to synthesize findings. 29 eligible studies addressed CPT/PE, mostly conducted in VHA. Training/education with audit/feedback was the primary implementation strategy and was linked to improved provider CPT/PE perceptions and self-efficacy. Use was not widespread. Only six studies tested other implementation strategies with mixed impact. Following VHA implementation, strong support for training, perceived effectiveness for patients and benefits for clinics, and positive patient experiences and relationships with providers were reported. However, barriers persisted including perceived protocol inflexibility, complex referral processes and patient complexity and competing needs. In non-VHA settings, providers perceived fewer barriers, but few were CPT/PE trained. Across both settings, fewer studies targeted patient factors. Training/education with audit/feedback improved perceptions and the availability of CPT/PE, but not consistent use. Studies testing implementation strategies to address post-training challenges, including patient-level factors, are needed. A few studies are underway in VHA to test patient-focused and other implementation strategies. Research assessing actual vs perceived barriers in non-VHA settings is needed to elucidate unique challenges experienced.

Exploring the importance of predisposing, enabling, and need factors for promoting Veteran engagement in mental health therapy for post-traumatic stress: a multiple methods study.

PURPOSE: This study explored Veteran and family member perspectives on factors that drive post-traumatic stress disorder (PTSD) therapy engagement within constructs of the Andersen model of behavioral health service utilization. Despite efforts by the Department of Veterans Affairs (VA) to increase mental health care access, the proportion of Veterans with PTSD who engage in PTSD therapy remains low. Support for therapy from family members and friends could improve Veteran therapy use. METHODS: We applied a multiple methods approach using data from VA administrative data and semi-structured individual interviews with Veterans and their support partners who applied to the VA Caregiver Support Program. We integrated findings from a machine learning analysis of quantitative data with findings from a qualitative analysis of the semi-structured interviews. RESULTS: In quantitative models, Veteran medical need for health care use most influenced treatment initiation and retention. However, qualitative data suggested mental health symptoms combined with positive Veteran and support partner treatment attitudes motivated treatment engagement. Veterans indicated their motivation to seek treatment increased when family members perceived treatment to be of high value. Veterans who experienced poor continuity of VA care, group, and virtual treatment modalities expressed less care satisfaction. Prior marital therapy use emerged as a potentially new facilitator of PTSD treatment engagement that warrants more exploration. CONCLUSIONS: Our multiple methods findings represent Veteran and support partner perspectives and show that amid Veteran and organizational barriers to care, attitudes and support of family members and friends still matter. Family-oriented services and intervention could be a gateway to increase Veteran PTSD therapy engagement.

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.

Evaluation of Implementation Strategies for Cognitive Behavioral Therapy (CBT), Acceptance and Commitment Therapy (ACT), and Mindfulness-Based Stress Reduction (MBSR): a Systematic Review.

BACKGROUND: Improving access to evidence-based psychotherapies (EBPs) is a Veterans Health Administration (VHA) priority. Cognitive behavioral therapy (CBT), acceptance and commitment therapy (ACT), and mindfulness-based stress reduction (MBSR) are effective for chronic pain and several mental health conditions. We synthesized evidence on implementation strategies to increase EBP access and use. METHODS: We searched MEDLINE, Embase, PsycINFO, and CINAHL from inception until March 2021 for articles on EBP implementation within integrated health systems to treat chronic pain or chronic mental health conditions. Reviewers independently screened articles, extracted results, coded qualitative findings, and rated quality using modified criteria from Newcastle-Ottawa (quantitative results) or Critical Appraisal Skills Programme (qualitative results). We categorized implementation strategies using the Expert Recommendations for Implementing Change (ERIC) framework and classified outcomes using RE-AIM domains (Reach, Effectiveness, Adoption, Implementation, Maintenance). RESULTS: Twelve articles (reporting results from 10 studies) evaluated CBT (k = 11) and ACT (k = 1) implementation strategies in large integrated healthcare systems. No studies evaluated MBSR implementation. Eight articles evaluated strategies within VHA. Six articles reported on national VHA EBP implementation programs; all involved training/education, facilitation, and audit/feedback. CBT and ACT implementation demonstrated moderate to large improvements in patient symptoms and quality of life. Trainings increased mental health provider self-efficacy in delivering EBPs, improved provider EBP perceptions, and increased provider EBP use during programs, but had unclear impacts on Reach. It was unclear whether external facilitation added benefit. Provider EBP maintenance was modest; barriers included competing professional time demands and patient barriers. DISCUSSION: Multi-faceted CBT and ACT implementation programs increased provider EBP Adoption but had unclear impacts on Reach. Future implementation efforts should further evaluate Reach, Adoption, and Maintenance; assess the added value of external facilitation; and consider strategies targeting patient barriers. Future work should use implementation frameworks to guide evaluations of barriers and facilitators, processes of change, and outcomes. REGISTRATION: PROSPERO registration number CRD42021252038.

Barriers and Facilitators of Evidence-Based Psychotherapies for Chronic Pain in Adults: A Systematic Review.

Cognitive behavioral therapy (CBT), acceptance and commitment therapy (ACT), and mindfulness-based stress reduction (MBSR) have demonstrated effectiveness for improving outcomes in chronic pain. These evidence-based psychotherapies (EBPs) remain underutilized in clinical practice, however. To identify research gaps and next steps for improving uptake of EBPs, we conducted a systematic review of patient-, provider-, and system-level barriers and facilitators of their use for chronic pain. We searched MEDLINE, Embase, PsycINFO, and CINAHL databases from inception through September 2022. Prespecified eligibility criteria included outpatient treatment of adults with chronic pain; examination of barriers and facilitators and/or evaluation of implementation strategies; conducted in the United States (US), United Kingdom (UK), Ireland, Canada or Australia; and publication in English. Two reviewers independently assessed eligibility and rated quality. We conducted a qualitative synthesis of results using a best-fit framework approach building upon domains of the Consolidated Framework for Implementation Research (CFIR). We identified 34 eligible studies (33 moderate or high quality), most (n = 28) of which addressed patient-level factors. Shared barriers across EBPs included variable patient buy-in to therapy rationale and competing responsibilities for patients; shared facilitators included positive group or patient-therapist dynamics. Most studies examining ACT and all examining MBSR assessed only group formats. No studies compared barriers, facilitators, or implementation strategies of group CBT to individual CBT, or of telehealth to in-person EBPs. Conceptual mismatches of patient knowledge and beliefs with therapy principles were largely analyzed qualitatively, and studies did not explore how these mismatches were addressed to support engagement. Future research on EBPs for chronic pain in real-world practice settings is needed to explore provider and system-level barriers and facilitators, heterogeneity of effects and uptake, and both effects and uptake of EBPs delivered in various formats, including group vs individual therapy and telehealth or asynchronous digital approaches. PERSPECTIVE: This systematic review synthesizes evidence on barriers and facilitators to uptake of cognitive behavioral therapy, acceptance and commitment therapy, and mindfulness-based stress reduction for chronic pain. Findings can guide future implementation work to increase availability and use of evidence-based psychotherapies for treatment of chronic pain. REGISTRATION: PROSPERO number CRD42021252038.

Mental health therapy for veterans with PTSD as a family affair: A qualitative inquiry into how family support and social norms influence veteran engagement in care.

Social support is important for posttraumatic stress disorder (PTSD) recovery and emerging literature indicate that social support could increase engagement in PTSD therapy. However, there is a need to understand how and why family involvement can increase treatment engagement to inform strategies used in clinical practice. This study explores how individuals with PTSD and family members of individuals with PTSD experience therapy and how social interactions help or hinder therapy engagement. We interviewed 18 U.S. military veterans who had been referred for psychotherapy for PTSD in the Veterans Health Administration and 13 family members and used rapid content analysis to identify themes. We found that engaging in therapy was a family-level decision that participants expected to improve family life. Veterans were motivated to seek treatment to protect their relationships with loved ones. Family members generally encouraged veterans to seek treatment. Specifically, family members who viewed PTSD as a treatable illness versus a static aspect of the veteran's personality expressed positive attitudes about the effectiveness of therapy for reducing symptoms. Veterans whose social networks included individuals with prior military or trauma-related experiences reported that their loved ones possessed more understanding of PTSD and described positive subjective norms around therapy. Family members are often embedded in the therapy process because PTSD has a profound impact on the family. Positive subjective norms for therapy are created by family encouragement and may influence veteran perceptions about the value of treatment. Family members should be engaged early in mental health therapy and to the extent desired by the patient and family member. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Provider perceptions of their patients' dropout from trauma-focused therapy for PTSD in the U.S. Veterans Health Administration.

OBJECTIVE: Many patients who initiate prolonged exposure (PE) and cognitive processing therapy (CPT) do not complete a full course, although little is known about how providers view PE and CPT dropout among their own patients. METHOD: Semistructured interviews were conducted with providers (n = 29) in the Veterans Health Administration to understand each provider's experience of dropout by a specific patient whom they treated using PE or CPT. Content analysis was used to categorize perceptions of dropout as negative, somewhat negative, or not negative. Themes associated with somewhat or not negative views of dropout were identified via inductive coding. RESULTS: Fourteen percent of providers viewed their patient's dropout from PE or CPT as wholly negative, 38% as somewhat negative, and 48% as not a negative outcome. Themes associated with viewing dropout as something other than wholly negative included belief that the patient would not benefit from treatment if they were not ready, the importance of maintaining the therapeutic relationship, the view that trauma-focused therapy was not what the patient needed or that the patient could benefit from other approaches, the impression that the patient had made some gains, and that patients are responsible for treatment engagement and have the right to disengage. CONCLUSIONS: Providers' perceptions of dropout from PE or CPT for individual patients were rarely viewed as entirely negative. Research is needed to help providers determine when patient dropout is an undesirable outcome and when efforts to reengage patients in trauma-focused treatment are warranted. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Healthcare quality measures in implementation research: advantages, risks and lessons learned.

Implementation studies evaluate strategies to move evidence-based practices into routine clinical practice. Often, implementation scientists use healthcare quality measures to evaluate the integration of an evidence-based clinical practice into real-world healthcare settings. Healthcare quality measures have standardized definitions and are a method to operationalize and monitor guideline-congruent care. Implementation scientists can access existing data on healthcare quality measures through various sources (e.g. operations-calculated), or they can calculate the measures directly from healthcare claims and administrative data (i.e. researcher-calculated). Implementation scientists need a better understanding of the advantages and disadvantages of these methods of obtaining healthcare quality data for designing, planning and executing an implementation study. The purpose of this paper is to describe the advantages, risks and lessons learned when using operations- versus researcher-calculated healthcare quality measures in site selection, implementation monitoring and implementation outcome evaluation. A key lesson learned was that relying solely on operations-calculated healthcare quality measures during an implementation study poses risks to site selection, accurate feedback on implementation progress to stakeholders, and the integrity of study results. A possible solution is using operations-calculated quality measures for monitoring of evidence-based practice uptake and researcher-calculated measures for site section and outcomes evaluation. This approach provides researchers greater control over the data and consistency of the measurement from site selection to outcomes evaluation while still retaining measures that are familiar and understood by key stakeholders whom implementation scientists need to engage in practice change efforts.

Adapting a family-involved intervention to increase initiation and completion of evidenced-based psychotherapy for posttraumatic stress disorder.

Posttraumatic stress disorder (PTSD) is disabling condition among United States Veterans. Training programs for evidenced-based therapies have been rolled out nationally in the Veterans Health Administration (VHA), but provider adoption of these treatments is limited and rates of Veteran dropout are high. Increasing support for mental health therapy within the Veteran's social network would improve treatment engagement. We discuss the adaptation of Recovery-Oriented Decisions for Relatives' Support (REORDER)-a family-based intervention for individuals with serious mental illness- to create Family Support in Mental Health Recovery (FAMILIAR), an intervention that seeks to strengthen support partners' abilities to help Veterans engage in therapy. Our goal was to apply modifications to meet the needs of Veterans with PTSD and their support partners. We used input from Veterans, support partners, clinicians and VA system leaders to inform the modifications. Then, a multi-disciplinary intervention development team met to determine which modifications would be applied and how. We used the domains from the Framework for Adaptations and Modification (FRAME) to systematically track and describe modifications. Adaptations made to REORDER included changes in content, structure, and delivery format. The resulting intervention, FAMILIAR, was a 3-4 session intervention beginning prior to EBP initiation and continuing through sessions 3, 4 or 5 of the EBP. Sessions were designed for maximum flexibility and could be offered either in-person or virtually, and sessions involve interactions between the interventionist with the Veteran and support partner alone and together. We learned the importance of including diverse stakeholder perspectives to develop a comprehensive understanding of the needs of the target population and the health system. While feasibility and effectiveness testing is needed, we applied a proactive adaptation approach that we anticipate will make FAMILIAR successful in addressing patient, clinical, and system considerations of a family approach to increase Veteran engagement in PTSD treatment.

Comparative effectiveness of trauma-focused and non-trauma-focused psychotherapy for PTSD among veterans with comorbid substance use disorders: Protocol & rationale for a randomized clinical trial.

BACKGROUND: Co-occurrence of posttraumatic stress disorder (PTSD) and substance use disorders (SUDs) is common and concurrent treatment is recommended. Relatively little is known about which evidence-based psychotherapies for PTSD are most effective for patients with varying substance use profiles. We aim to examine the comparative effectiveness of trauma-focused therapy (TFT) and non-trauma-focused therapy (NTFT) among Veterans with PTSD and SUD. TFT has been found to be effective among those with PTSD/SUD, though effects are smaller and rates of treatment non-completion are higher than in those without SUD. NTFTs suggested for the treatment of PTSD, such as Present Centered Therapy, (PCT) have not been examined among those with co-occurring SUD, despite lower rates of treatment dropout. We will also examine the comparative effectiveness of TFT and NTFT for patients with varying SUD severity, type of substances used, and patient treatment preference. METHOD: 420 Veterans with PTSD and SUD will be randomized in a prospective, pragmatic comparative effectiveness trial at 14 Veterans Health Administration facilities. Participants will receive either TFT (Prolonged Exposure or Cognitive Processing Therapy) or NTFT (PCT) after enrolling in concurrent SUD treatment-as-usual. Assessments will occur at baseline, posttreatment, 3- and 6 -months posttreatment. Main outcomes are PTSD symptom severity and PTSD treatment dropout. Clinician, patient, and leadership stakeholder panels advise study activities, and a process evaluation will identify strategies to enhance the implementation of evidence-based PTSD treatments in SUD care settings. CONCLUSIONS: Results will provide critical information to guide clinicians when recommending PTSD treatments to patients with comorbid SUD. CLINICALTRIALS: gov Identifier: NCT04581434.

Divergent experiences of U.S. veterans who did and did not complete trauma-focused therapies for PTSD: A national qualitative study of treatment dropout.

Prolonged Exposure (PE) and Cognitive Processing Therapy (CPT) are first-line treatments for posttraumatic stress disorder (PTSD) and have been disseminated throughout the U.S. Veterans Health Administration. Treatment non-completion is common and lessens clinical effectiveness; however, prior work has failed to identify factors consistently associated with non-completion. Semi-structured interviews were conducted with a national sample of veterans who recently completed (n = 60) or did not complete (n = 66) PE or CPT. Non-completer interviews focused on factors that contributed to veterans' decisions to drop out and efforts undertaken to complete PE/CPT. Completer interviews focused on challenges faced in completing treatment and facilitators of completion. Transcripts were coded using a mixed deductive/inductive approach; constant comparison was used to identify differences between completers and non-completers. Completers and non-completers differed in the extent of treatment-specific therapist support received, therapists' flexibility in treatment delivery, the type of encouragement offered by the care team and social supports, their interpretation of symptom worsening, the perceived impact of treatment on functioning, and the impact of stressors on their treatment engagement. Treatment-specific therapist support, more patient-centered and flexible treatment delivery, leveraging the full care team, and addressing functional concerns are potential targets for PE and CPT engagement interventions.

Can families help veterans get more from PTSD treatment? A randomized clinical trial examining Prolonged Exposure with and without family involvement.

BACKGROUND: Posttraumatic stress disorder occurs in as many as one in five combat veterans and is associated with a host of negative, long-term consequences to the individual, their families, and society at large. Trauma-focused treatments, such as Prolonged Exposure, result in clinically significant symptom relief for many. Adherence to these treatments (i.e., session attendance and homework compliance) is vital to ensuring recovery but can be challenging for patients. Engaging families in veterans' treatment could prove to be an effective strategy for promoting treatment adherence while also addressing long-standing calls for better family inclusion in treatment for posttraumatic stress disorder. This paper describes the methods of a pragmatic randomized controlled trial designed to evaluate if family inclusion in Prolonged Exposure can improve treatment adherence. METHODS: One hundred fifty-six veterans, with clinically significant symptoms of posttraumatic stress disorder, will be randomized to receive either standard Prolonged Exposure or Prolonged Exposure enhanced through family inclusion (Family-Supported Prolonged Exposure) across three different VA facilities. Our primary outcomes are session attendance and homework compliance. Secondary outcomes include posttraumatic stress disorder symptom severity, depression, quality of life, and relationship functioning. The study includes a concurrent process evaluation to identify potential implementation facilitators and barriers to family involvement in Prolonged Exposure within VA. DISCUSSION: While the importance of family involvement in posttraumatic stress disorder treatment is non-controversial, there is no evidence base supporting best practices on how to integrate families into PE or any other individually focused trauma-focused treatments for posttraumatic stress disorder. This study is an important step in addressing this gap, contributing to the literature for both retention and family involvement in trauma-focused treatments. TRIAL REGISTRATION: ClinicalTrials.gov NCT03256227 . Registered on August 21, 2017.

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.