Collaborative Care for Women Veterans (CCWV)

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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Anxiety; Stress Disorders, Post Traumatic
• Intervention / Treatment: Behavioral: Collaborative Care for Women Veterans

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.

• Study Type: Interventional
• Enrollment (Actual): 153
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92161
      • VA San Diego Healthcare System, San Diego, CA
    • West Los Angeles, California, United States, 90073
      • VA Greater Los Angeles Healthcare System, West Los Angeles, CA
  • Oregon
    • Portland, Oregon, United States, 97239
      • VA Portland Health Care System, Portland, OR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Arm 1: Mixed Methods Implementation Evaluation; The investigators used mixed methods to evaluate the implementation in two VA Women's Practice Based Research Network (PBRN) sites, describing services and patterns of care utilized by patients prior to seeing a care manager, and then 30, 60, 180, and 365 days post initiation of care with the care manager. Investigators also evaluated facilitators and barriers to implementation of this collaborative care model.

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 offered 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 trained appropriate MH providers in CALM and studied the ways in which the intervention needs to be tailored to women Veterans.; Other Names: Gender-Tailored Primary Care-Mental Health Integration

What is the study measuring?

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)
Altarum Consumer Engagement	brief measure of patient engagement in care	6 months
Change in Utilization of Services (30 Days)	Change in utilization of services comparing utilization 30 days prior to 30 days post initiation of care with the care manager.	30 days
Change in Utilization of Services (60 Days)	Change in utilization of services comparing utilization 60 days prior to 60 days post initiation of care with the care manager.	60 days
Change in Utilization of Services (180 Days)	Change in utilization of services 180 days prior to 180 days post initiation of care with the care manager.	180 days
Change in Utilization of Services (365 Days)	Change in utilization of services comparing utilization 365 days prior to 365 days post initiation of care with the care manager.	365 days
Patient-Reported Outcomes Measurement Information System (PROMIS)	brief measure of global health: Patient-Reported Outcomes Measurement Information System (PROMIS)	6 months
Overall Anxiety Severity and Impairment Scale (OASIS)	brief measure of anxiety: Overall Anxiety Severity and Impairment Scale (OASIS)	6 months
Patient Health Questionnaire for Depression and Anxiety (PHQ-4)	brief measure of depression: Patient Health Questionnaire for Depression and Anxiety (PHQ-4)	6 months
WHO Disability Assessment Schedule (WHODAS) Out Of Role Days Items	brief measure of impact of disability on role functioning: WHO Disability Assessment Schedule (WHODAS) Out Of Role Days items	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
Health Literacy (Chew et al. 2004)	brief measure of health literacy: (Chew et al. 2004)	6 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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: 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

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2017
• Primary Completion (Actual): March 8, 2021
• Study Completion (Actual): March 8, 2021

Study Registration Dates

• First Submitted: October 21, 2016
• First Submitted That Met QC Criteria: October 27, 2016
• First Posted (Estimated): November 1, 2016

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• 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]
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Trauma and Stressor Related Disorders; Depression; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: QUX 16-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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