Clinical trial NCT02950961: Collaborative Care for Women Veterans
Official title: Implementation of Tailored Collaborative Care For Women Veterans (CCWV) (QUE 15-272)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Stress Disorders, Post Traumatic
Keywords: 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 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]
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2016-11-01
Enrollment: 153
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Implementation of Tailored Collaborative Care for Women Veterans (CCWV) was 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 was implemented in two 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 was 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 proposed 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 were conducted by an experienced multidisciplinary team. This trial pertains to "Implementation of Tailored Collaborative Care for Women Veterans," which evaluated 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 used mixed methods implementation evaluation to investigate primary implementation outcomes of adoption, acceptability, feasibility, and reach. Multilevel stakeholder engagement was prioritized. Program-wide organizational-, provider-, and patient-level data was utilized to enhance synergy, productivity, and impact. Several implementation outcomes were assessed using qualitative methods and will be reported elsewhere (e.g. final report, manuscripts).These include Adoption of Care Model, Acceptability of Care Model, Feasibility of Care Model, and Satisfaction With Care Model.

As a coherent program of women's health implementation research and quality improvement, the EMPOWER QUERI constituted a major milestone in achieving Blueprint for Excellence (BPE) strategies and realizing women Veterans' engagement and, ultimately, empowerment in the VHA system.

Eligibility criteria: Inclusion Criteria

Patient Participants:

* Women VA patients with possible or confirmed anxiety and/or depression and/or PTSD

Provider Participants:

* VA staff in a primary care and/or mental health clinic

  * Note: gender based inclusion criteria did not apply to provider participants

Exclusion Criteria

Patient Participants:

* Male gender
* Cognitive impairment that would preclude completion of informed consent

Provider Participants:

* None

Primary outcomes:
measure: Change in Utilization of Services (30 Days)
timeFrame: 30 days
measure: Change in Utilization of Services (60 Days)
timeFrame: 60 days
measure: Change in Utilization of Services (180 Days)
timeFrame: 180 days
measure: Change in Utilization of Services (365 Days)
timeFrame: 365 days
measure: Change in Referrals
timeFrame: baseline, 18 months (implementation phase)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS)
timeFrame: 6 months
measure: Overall Anxiety Severity and Impairment Scale (OASIS)
timeFrame: 6 months
measure: Patient Health Questionnaire for Depression and Anxiety (PHQ-4)
timeFrame: 6 months
measure: WHO Disability Assessment Schedule (WHODAS) Out Of Role Days Items
timeFrame: 6 months
measure: Global Rating of Satisfaction/Quality of Care
timeFrame: 6 months
measure: Altarum Consumer Engagement
timeFrame: 6 months
measure: Health Literacy (Chew et al. 2004)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego, CA
state: California
city: West Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
state: California
city: Portland
country: United States
facility: VA Portland Health Care System, Portland, OR
state: Oregon
Study officials:
affiliation: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
name: Alison B Hamilton, PhD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: VA San Diego Healthcare System, San Diego, CA
name: Ariel J. Lang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Finley EP, Huynh AK, Farmer MM, Bean-Mayberry B, Moin T, Oishi SM, Moreau JL, Dyer KE, Lanham HJ, Leykum L, Hamilton AB. Periodic reflections: a method of guided discussions for documenting implementation phenomena. BMC Med Res Methodol. 2018 Nov 27;18(1):153. doi: 10.1186/s12874-018-0610-y.
citation: Hamilton AB, Farmer MM, Moin T, Finley EP, Lang AJ, Oishi SM, Huynh AK, Zuchowski J, Haskell SG, Bean-Mayberry B. Enhancing Mental and Physical Health of Women through Engagement and Retention (EMPOWER): a protocol for a program of research. Implement Sci. 2017 Nov 7;12(1):127. doi: 10.1186/s13012-017-0658-9.