Adapting an Alcohol Care Linkage Intervention to US Military Veterans Presenting to Primary Care with Hazardous Drinking and PTSD and/or Depression Symptoms: A Qualitative Study.

There is a critical need to improve linkage to alcohol care for veterans in primary care with hazardous drinking and PTSD and/or depression symptoms (A-MH). We adapted an alcohol care linkage intervention, "Connect to Care" (C2C), for this population. We conducted separate focus groups with veterans with A-MH, providers, and policy leaders. Feedback centered on how psychologists and other providers can optimally inform veterans about their care options and alcohol use, and how to ensure C2C is accessible. Participants reported that veterans with A-MH may not view alcohol use as their primary concern but rather as a symptom of a potential co-occurring mental health condition. Veterans have difficulty identifying and accessing existing alcohol care options within the Veterans Health Administration. C2C was modified to facilitate alcohol care linkage for this population specific to their locality, provide concrete support and education, and offer care options to preserve privacy.

Connect To Care (C2C): protocol for two-site randomized controlled pilot trial to improve outcomes for patients with hazardous drinking and PTSD and/or depression symptoms.

BACKGROUND: In studies of the general population and of military veterans, many primary care patients with hazardous drinking and PTSD and/or depression (abbreviated here as HD +) do not initiate or engage with alcohol-related care. To address this gap in care, we identified and will pilot test a promising evidence-based intervention, Connect To Care (C2C). C2C is a strengths-based approach, delivered by a Care Coach by telephone and/or video, with four components: (1) identifying and leveraging patient strengths to facilitate care initiation, (2) collaborative decision-making around a menu of care options, (3) identifying and resolving barriers to care, and (4) monitoring and facilitating progress toward care initiation by, for example, checking on barriers, identifying solutions, and revisiting care options. METHODS/DESIGN: Aim 1 will involve adapting C2C for use in Veterans Affairs' (VA) primary care. We will use an iterative process that includes focus groups and semi-structured interviews with key stakeholders (patients, primary care providers, and VA national policy leaders). In Aim 2, we will conduct a two-site, pilot randomized controlled trial to determine the feasibility of conducting a larger scale trial to test C2C's effectiveness, ascertain the acceptability of C2C among primary care patients with HD + , and explore the efficacy of C2C to improve veteran patients' initiation of and engagement in alcohol care, and their alcohol and mental health (PTSD, depression) outcomes, at 3-month follow-up. We will explore explanatory mechanisms by which C2C is effective. DISCUSSION: Study findings are likely to have implications for clinical practice to enhance current approaches to linking patients with HD + to alcohol care by applying a practical intervention such as C2C. The results may improve treatment outcomes for people with HD + by drawing on patients' strengths to problem-solve barriers to care following a process of shared decision-making with a coach. In addition to possibly accelerating the translation of C2C into practice, study findings will also support additional research in terms of a planned effectiveness-implementation hybrid trial, adding to this study's potential for high impact. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05023317.

Promoting benzodiazepine cessation through an electronically-delivered patient self-management intervention (EMPOWER-ED): Randomized controlled trial protocol.

Background: Long-term benzodiazepine dependence carries significant health risks which might be reduced with low-cost patient self-management interventions. A booklet version of one such intervention (Eliminating Medications Through Patient Ownership of End Results; EMPOWER) proved effective in a Canadian clinical trial with older adults. Digitizing such an intervention for electronic delivery and tailoring it to different populations could expand its reach. Accordingly, this article describes the protocol for a randomized controlled trial to test the effectiveness of an electronically-delivered, direct-to-patient benzodiazepine cessation intervention tailored to U.S. military veterans. Methods: Design: Two-arm individually randomized controlled trial. Setting: US Veterans Health Administration primary care clinics. Participants: Primary care patients taking benzodiazepines for three or more months and having access to a smartphone, tablet or desktop computer. Intervention and comparator: Participants will be randomized to receive either the electronically-delivered EMPOWER (EMPOWER-ED) protocol or asked to continue to follow provider recommendations regarding their benzodiazepine use (treatment-as-usual). Measurements: The primary outcomes are complete benzodiazepine cessation and 25% dose reduction, assessed using administrative and self-report data, between baseline and six-month follow-up. Secondary outcomes are self-reported anxiety symptoms, sleep quality, and overall health and quality of life, measured at baseline and 6-month follow-up, and benzodiazepine cessation at 12-month follow-up. Comments: This randomized controlled trial will evaluate whether the accessibility and effectiveness of a promising intervention for benzodiazepine cessation can be improved through digitization and population tailoring.

Adapting the Eliminating Medications Through Patient Ownership of End Results Protocol to Promote Benzodiazepine Cessation Among US Military Veterans: Focus Group Study With US Military Veterans and National Veterans Health Administration Leaders.

BACKGROUND: Long-term dependence on prescribed benzodiazepines is a public health problem. Eliminating Medications Through Patient Ownership of End Results (EMPOWER) is a promising self-management intervention, delivered directly to patients as a printed booklet, that is effective in promoting benzodiazepine reduction and cessation in older adults. EMPOWER has high potential to benefit large health care systems such as the US Veterans Health Administration (VHA), which cares for many veterans who use benzodiazepines for extended periods. OBJECTIVE: We aimed to adapt the original EMPOWER booklet materials for electronic delivery and for use among US military veterans receiving VHA care who were long-term benzodiazepine users. METHODS: We used elements of Analysis, Design, Development, Implementation, and Evaluation, a framework commonly used in the field of instructional design, to guide a qualitative approach to iteratively adapting EMPOWER Electronic Delivery (EMPOWER-ED). We conducted 3 waves of focus groups with the same 2 groups of VHA stakeholders. Stakeholders were VHA-enrolled veterans (n=16) with medical chart evidence of long-term benzodiazepine use and national VHA leaders (n=7) with expertise in setting VHA policy for prescription benzodiazepine use and developing electronically delivered educational tools for veterans. Qualitative data collected from each wave of focus groups were analyzed using template analysis. RESULTS: Themes that emerged from the initial focus groups included veterans' anxiety about self-tapering from benzodiazepines and prior negative experiences attempting to self-taper without support. Participants also provided feedback on the protocol's look and feel, educational content, the tapering protocol, and website functionality; for example, feedback from policy leaders included listing, on the cover page, the most commonly prescribed benzodiazepines to ensure that veterans were aware of medications that qualify for self-taper using the EMPOWER-ED protocol. Both groups of stakeholders identified the importance of having access to supportive resources to help veterans manage sleep and anxiety in the absence of taking benzodiazepines. Both groups also emphasized the importance of ensuring that the self-taper could be personalized and that the taper instructions were clear. The policy leaders emphasized the importance of encouraging veterans to notify their provider of their decision to self-taper to help facilitate provider assistance, if needed, with the taper process and to help prevent medication stockpiling. CONCLUSIONS: EMPOWER-ED is the first direct-to-patient electronically delivered protocol designed to help US military veterans self-taper from long-term benzodiazepine use. We used the Analysis, Design, Development, Implementation, and Evaluation framework to guide the successful adaption of the original EMPOWER booklet for use with this population and for electronic delivery. The next step in this line of research is to evaluate EMPOWER-ED in a randomized controlled trial.

A randomized controlled trial comparing a manual and computer version of CALM in VA community-based outpatient clinics.

BACKGROUND: This study compared a computer and manual version of a tailored Coordinated Anxiety Learning and Management (VA CALM) protocol on provider fidelity to CBT and patient outcomes. METHODS: This study was a cluster randomized controlled trial. Providers (N = 32) were randomized to deliver VA CALM by computer or manual. Veteran patients (N = 135), treated by study providers, were recruited. The primary outcome was CBT fidelity, measured by rating audiotaped sessions. Secondary outcomes were Veterans' general (BSI-18 GSI, SF-12) and disorder-specific (GAD-7, PCL-5, PHQ-9) outcomes assessed at baseline, three and six month follow-up. RESULTS: We found a large (d = 0.88) but not statistically significant difference in mean fidelity rating scores between conditions. Compared with the manual, participants with generalized anxiety disorder receiving VA CALM by computer reported lower GAD-7 scores at three (-5.88; 95% CI=-11.37, -0.39) and six month (-5.25; 95% CI=-10.29, -0.22) follow-ups (d = 0.37 to 0.55). Participants in the computer and manual conditions reported lower PHQ-9 (-3.11; 95% CI=-5.51, -0.71; -4.06; 95% CI=-7.22, -0.90, respectively) and BSI-18 GSI (0.78; 95% CI=0.68,0.90; 0.71; 95% CI=0.58, 0.87, respectively) scores from baseline to six month follow-up. We did not find statistically significant differences over time or between conditions on SF-12 or PCL-5 scores. LIMITATIONS: This study was underpowered to test the primary outcome. Small samples sizes in the disorder-specific subgroup analysis may limit the generalizability of findings. CONCLUSIONS: Neither modality proved to be superior on VA CALM fidelity. The computer version of VA CALM, compared to the manual, may provide modest benefit to Veterans with GAD.

An Evidence-Based Model for Disseminating-Implementing Coordinated Anxiety Learning and Management in Department of Veterans Affairs' Community-Based Outpatient Clinics.

PURPOSE: To explore the feasibility and utility of using a workshop, and supervision-consultation plus external facilitation to disseminate and implement cognitive-behavioral therapy in Veterans Affairs (VA) community-based outpatient clinics (CBOCs). METHODS: This study occurred in the context of a randomized controlled trial aimed at comparing 2 methods for implementing Coordinated Anxiety Learning Management (CALM) in VA CBOCs. A 3-phase (workshop, supervision-consultation, external facilitation) model was used to support 32 VA CBOC mental health providers in learning and adopting CALM in their clinical practice. Qualitative data describe training activities and the feasibility and utility of each training phase in addressing challenges to adopting CALM. FINDINGS: All 3 phases of the model were feasible to use with our sample of CBOC mental health providers. Providers reported challenges learning CALM during the workshop and concerns about not having enough training post-workshop to use CALM in practice. Providers primarily utilized supervision-consultation to tailor CALM to their practice, including learning how to prioritize a target disorder, "switch" the focus of treatment to a different disorder when comorbidities were present, and modify CALM sessions to fit shorter treatment visits. Providers primarily utilized external facilitation to further tailor CALM to their practice through implementation (eg, concrete help) and support-oriented help. Key lessons for implementing CALM in CBOCs are presented and discussed. CONCLUSIONS: Findings provide initial evidence for the feasibility and utility of using each component of a facilitation-enhanced training model to promote CBOC VA providers' implementation of a computer and manual version of CALM in their practice.

Monitoring and managing metabolic effects of antipsychotics: a cluster randomized trial of an intervention combining evidence-based quality improvement and external facilitation.

BACKGROUND: Treatment of psychotic disorders consists primarily of second generation antipsychotics, which are associated with metabolic side effects such as overweight/obesity, diabetes, and dyslipidemia. Evidence-based clinical practice guidelines recommend timely assessment and management of these conditions; however, research studies show deficits and delays in metabolic monitoring and management for these patients. This protocol article describes the project 'Monitoring and Management for Metabolic Side Effects of Antipsychotics,' which is testing an approach to implement recommendations for these practices. METHODS/DESIGN: This project employs a cluster randomized clinical trial design to test effectiveness of an evidence-based quality improvement plus facilitation intervention. Eligible study sites were VA Medical Centers with ≥300 patients started on a new antipsychotic prescription in a six-month period. A total of 12 sites, matched in pairs based on scores on an organizational practice survey, were then randomized within pairs to intervention or control conditions.Study participants include VA employees involved in metabolic monitoring and management of patients treated with antipsychotics at participating sites. The intervention involves researchers partnering with clinical stakeholders to facilitate tailoring of local implementation strategies to address barriers to metabolic side-effect monitoring and management. The intervention includes a Design Phase (initial site visit and subsequent development of a local implementation plan); Implementation Phase (guided by an experienced external facilitator); and a Sustainability Phase. Evaluation includes developmental, implementation-focused, progress-focused and interpretative formative evaluation components, as well as summative evaluation. Evaluation methods include surveys, qualitative data collection from provider participants, and quantitative data analysis of data for all patients prescribed a new antipsychotic medication at a study site who are due for monitoring or management of metabolic side effects during the study phases. Changes in rates of recommended monitoring and management actions at intervention and control sites will be compared using time series analyses. DISCUSSION: Improving monitoring for metabolic side effects of antipsychotics, as well as promoting timely evidence-based management when these effects emerge, will lead to improved patient safety and long-term outcomes. This article discusses key strengths and challenges of the study. TRIAL REGISTRATION: NCT01875861.