Collaborative Care for Women Veterans

Study Overview
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Brief Summary
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Implementation of Tailored Collaborative Care for Women Veterans (CCWV) is designed to enhance primary care-mental health integration for women Veterans, by tailoring services to women Veterans' and providers' needs and providing an evidence-based intervention, Coordinated Anxiety Learning and Management, to address anxiety and depression in a patient-centered approach. CCWV will be implemented in four of the Women's Health Practice-Based Research Network sites, with careful attention to local tailoring and adaptation to enhance the fit of the care model in varied local contexts.

Detailed Description
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Background: Women Veterans are the fastest growing segment of Veterans Health Administration (VHA) users. This dramatic growth has created challenges for VHA. Gender disparities persist in cardiovascular (CV) and diabetes risk factor control, and rates of depression, anxiety, and mental health comorbidity are disproportionately high among women Veterans. Furthermore, a high rate of women Veterans' attrition from VA care, along with organizational barriers to care, substantiate that organizational changes are needed in order to engage and retain women Veteran VHA users in evidence-based, patient-centered care. Objectives: The Enhancing Mental and Physical health of Women through Engagement and Retention (EMPOWER) QUERI addresses VHA Blueprint for Excellence Strategy 6, by advancing personalized, proactive, patient-centered care models, and Transformational Strategy 7.2.g by implementation of innovative care models in women Veterans' health care. The EMPOWER QUERI Program is designed to improve women Veterans' engagement and retention in evidence-based care for three high priority health conditions, i.e., prediabetes, cardiovascular, and mental health. To achieve this impact goal, the investigators propose a cohesive portfolio of projects with the following aims: (1) To use an evidence-based implementation strategy that emphasizes local tailoring of care models, multilevel stakeholder engagement, and systematic evaluation of complex implementation processes in order to enrich organizational capacity for innovations in women Veterans' VHA health care; (2) To implement personalized, proactive, patient-centered innovations in VHA women's health that are acceptable, feasible, satisfactory, relevant, and effective for both providers and patients, thereby encouraging women Veterans' engagement and retention and sustainability of the innovations; and, (3) To generate implementation playbooks for the investigators' partners that are scalable and serve as guidance for future implementation of a broader array of evidence-based women's health programs and policy. Methods: Three projects will be conducted by an experienced multidisciplinary team. This trial pertains to Implementation of Tailored Collaborative Care for Women Veterans, which will evaluate implementation of an evidence-based collaborative care model tailored to enhance provider- and system-level capabilities to address women Veterans' anxiety and depression treatment needs, thereby improving organizational primary care-mental health integration (PC-MHI) effectiveness and women Veterans' engagement and retention in PC-MHI. This implementation research study will use a nonrandomized stepped wedge design and will apply the evidence-based Replicating Effective Programs (REP) implementation strategy. Mixed methods implementation evaluation will focus on investigating primary implementation outcomes of adoption, acceptability, feasibility, and reach. Multilevel stakeholder engagement will be prioritized. Program-wide organizational-, provider-, and patient-level measures and tools will be utilized to enhance synergy, productivity, and impact. As a coherent program of women's health implementation research and quality improvement, the proposed EMPOWER QUERI will constitute a major milestone in achieving Blueprint for Excellence (BPE) strategies and realizing women Veterans' engagement and, ultimately, empowerment in the VHA system.

Official Title
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Implementation of Tailored Collaborative Care For Women Veterans (CCWV) (QUE 15-272)

Conditions
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Anxiety, Depression, Stress Disorders, Post Traumatic

Intervention / Treatment
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* Behavioral: Collaborative Care for Women Veterans


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women VA patients with possible or confirmed anxiety and/or depression and/or PTSD Exclusion Criteria: Male gender Cognitive impairment that would preclude completion of informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm 1: nonrandomized stepped wedge<br>The investigators will use a nonrandomized stepped wedge design to evaluate the implementation in four VA Women's Practice Based Research Network (PBRN) sites. In the context of the nonrandomized stepped wedge design, the intervention is turned on when a primary care provider (PCP) at a site makes her/his first referral to the CCWV care manager. This design relies on sequential roll-out to participating sites over time, while using other sites as controls until they begin implementation. The investigators will use nonrandomized stepped wedges (rather than randomized) given their suitability for studying implementation. The design explicitly considers the timing of implementation spread and addresses the statistical issues introduced by lack of randomization in implementation starts and processes. The investigators will analytically compensate for the design by collecting patient-, provider-, and site-level data that may be associated with timing of the adoption of each intervention. | Behavioral: Collaborative Care for Women Veterans<br>* This is a collaborative care model that focuses on identifying need for depression and/or anxiety care. Patients with possible anxiety and/or depression are referred to a care manager in primary care-mental health integration. The care manager then conducts a thorough assessment, offers the patient a variety of appropriate treatment options, and works with the patient to determine a care plan. One of the key options the investigators will be offering in this study is the Calm Tools for Living (CALM) intervention, which is focused on anxiety and which is rooted in patient preferences. Patients can choose web-based cognitive behavioral therapy (CBT) and/or pharmacologic treatment. In this study the investigators will be training appropriate MH providers in CALM and studying the ways in which the intervention needs to be tailored to women Veterans. The investigators will also examine the relative importance of patient preference with regard to engagement and retention in care.<br>* Other names: Gender-Tailored Primary Care-Mental Health Integration;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Referrals | Using the nonrandomized stepped wedge design, we will compare referrals to PC-MHI at baseline at each site, and compare to referrals throughout the 18-month implementation phase. | baseline, 18 months (implementation phase) | 
| Adoption of care models | This implementation outcome will be captured through qualitative methods which evaluate the extent to which the care model is being used (also informed by referral information), and plans for continuing to use the care model after active implementation. | 18 months | 
| Acceptability of care model | This implementation outcome will be captured through qualitative methods which evaluate the acceptability of the care model for provider and patients, both in theory (at baseline), and practice (mid- and post-implementation). | 18 months | 
| Feasibility of care model | This implementation outcome will be captured through qualitative methods which evaluate the feasibility of the care model for providers and patients, both in theory (at baseline) and in practice (mid- and post-implementation). | 18 months | 
| Satisfaction with care model | This implementation outcome will be captured through qualitative methods which evaluate satisfaction with the care model among providers and patients, assessed at mid- and post-implementation. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-Reported Outcomes Measurement Information System (PROMIS) | brief measure of global health | 6 months | 
| Overall Anxiety Severity and Impairment Scale (OASIS) | brief measure of anxiety | 6 months | 
| Patient Health Questionnaire for Depression and Anxiety (PHQ-4) | brief measure of depression | 6 months | 
| WHO Disability Assessment Schedule (WHODAS) Out Of Role Days items | brief measure of impact of disability on role functioning | 6 months | 
| Global rating of satisfaction/quality of care | brief measure of satisfaction and quality that we have used in several surveys of women Veteran VA patients | 6 months | 
| Altarum Consumer Engagement | brief measure of patient engagement in care | 6 months | 
| Health literacy (Chew et al. 2004) | brief measure of health literacy | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety [F01.470.132], Depression [F01.145.126.350], Stress Disorders, Post-Traumatic [F03.950.750.500], Primary Health Care [N04.590.233.727], Mental Health [F02.418], Patient Participation [N05.300.150.600.620], Patient Satisfaction [N05.300.150.600.630], Patient Preference [N05.300.150.600.630.500], Physicians, Primary Care [M01.526.485.810.800], Physicians, Women [M01.526.485.810.820], Health Behavior [F01.145.488]