Collaborative Care for Women Veterans

Depression Clinical Trial

— CCWV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02950961
• Other study ID #: QUX 16-008
• Status: Completed
• Phase: N/A
• Start date: June 30, 2017
• Est. completion date: March 8, 2021

Study information

• Verified date: August 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: March 8, 2021
• Est. primary completion date: March 8, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Stress Disorders, Post Traumatic
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

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 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.

Locations

Country	Name	City	State
United States	VA Portland Health Care System, Portland, OR	Portland	Oregon
United States	VA San Diego Healthcare System, San Diego, CA	San Diego	California
United States	VA Greater Los Angeles Healthcare System, West Los Angeles, CA	West Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	Patient-Reported Outcomes Measurement Information System (PROMIS)	brief measure of global health: Patient-Reported Outcomes Measurement Information System (PROMIS)	6 months
Primary	Overall Anxiety Severity and Impairment Scale (OASIS)	brief measure of anxiety: Overall Anxiety Severity and Impairment Scale (OASIS)	6 months
Primary	Patient Health Questionnaire for Depression and Anxiety (PHQ-4)	brief measure of depression: Patient Health Questionnaire for Depression and Anxiety (PHQ-4)	6 months
Primary	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
Primary	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
Primary	Altarum Consumer Engagement	brief measure of patient engagement in care	6 months
Primary	Health Literacy (Chew et al. 2004)	brief measure of health literacy: (Chew et al. 2004)	6 months