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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
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE October 21, 2016
First Posted Date  ICMJE November 1, 2016
Last Update Posted Date July 22, 2019
Actual Study Start Date  ICMJE June 30, 2017
Estimated Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2016)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02950961 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2016)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Collaborative Care for Women Veterans
Official Title  ICMJE Implementation of Tailored Collaborative Care For Women Veterans (CCWV) (QUE 15-272)
Brief Summary 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

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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Anxiety
  • Depression
  • Stress Disorders, Post Traumatic
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Behavioral: Collaborative Care for Women Veterans
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 27, 2016)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2020
Estimated Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Women VA patients with possible or confirmed anxiety and/or depression and/or PTSD
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02950961
Other Study ID Numbers  ICMJE QUX 16-008
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account VA Office of Research and Development
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP