Collaborative Care for Women Veterans (CCWV)
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|ClinicalTrials.gov Identifier: NCT02950961|
Recruitment Status : Recruiting
First Posted : November 1, 2016
Last Update Posted : July 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Anxiety Depression Stress Disorders, Post Traumatic||Behavioral: Collaborative Care for Women Veterans||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Implementation of Tailored Collaborative Care For Women Veterans (CCWV) (QUE 15-272)|
|Actual Study Start Date :||June 30, 2017|
|Estimated Primary Completion Date :||March 31, 2020|
|Estimated Study Completion Date :||September 30, 2020|
Arm 1: nonrandomized stepped wedge
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
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.
Other Name: Gender-Tailored Primary Care-Mental Health Integration
- Change in Referrals [ Time Frame: baseline, 18 months (implementation phase) ]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.
- Adoption of care models [ Time Frame: 18 months ]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.
- Acceptability of care model [ Time Frame: 18 months ]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).
- Feasibility of care model [ Time Frame: 18 months ]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).
- Satisfaction with care model [ Time Frame: 18 months ]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.
- Patient-Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: 6 months ]brief measure of global health
- Overall Anxiety Severity and Impairment Scale (OASIS) [ Time Frame: 6 months ]brief measure of anxiety
- Patient Health Questionnaire for Depression and Anxiety (PHQ-4) [ Time Frame: 6 months ]brief measure of depression
- WHO Disability Assessment Schedule (WHODAS) Out Of Role Days items [ Time Frame: 6 months ]brief measure of impact of disability on role functioning
- Global rating of satisfaction/quality of care [ Time Frame: 6 months ]brief measure of satisfaction and quality that we have used in several surveys of women Veteran VA patients
- Altarum Consumer Engagement [ Time Frame: 6 months ]brief measure of patient engagement in care
- Health literacy (Chew et al. 2004) [ Time Frame: 6 months ]brief measure of health literacy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02950961
|Contact: Alison B Hamilton, PhD MPH||(310) 478-3711 ext 44157||Alison.Hamilton@va.gov|
|Contact: Ariel J Lang, PhD||(619) 400-5173||Ariel.Lang@va.gov|
|United States, California|
|VA San Diego Healthcare System, San Diego, CA||Recruiting|
|San Diego, California, United States, 92161|
|Contact: Ariel J Lang, PhD 619-400-5173 Ariel.Lang@va.gov|
|Principal Investigator: Ariel J. Lang, PhD|
|VA Greater Los Angeles Healthcare System, West Los Angeles, CA||Active, not recruiting|
|West Los Angeles, California, United States, 90073|
|United States, Oregon|
|VA Portland Health Care System, Portland, OR||Active, not recruiting|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Alison B Hamilton, PhD MPH||VA Greater Los Angeles Healthcare System, West Los Angeles, CA|
|Principal Investigator:||Ariel J. Lang, PhD||VA San Diego Healthcare System, San Diego, CA|