Collaborative Care for Women Veterans

NCT02950961 | Completed Results

• 1 other identifier: QUX 16-008
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 3

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.

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]

Outcome Measures

Primary Outcomes (12)

• 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

• 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)

• 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

• Altarum Consumer Engagement

  brief measure of patient engagement in care

  6 months

• Health Literacy (Chew et al. 2004)

  brief measure of health literacy: (Chew et al. 2004)

  6 months

Study Arms (1)

Arm 1: Mixed Methods Implementation Evaluation

OTHER

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

Interventions

Collaborative Care for Women Veterans BEHAVIORAL

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.

Also known as: Gender-Tailored Primary Care-Mental Health Integration

Arm 1: Mixed Methods Implementation Evaluation

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women VA patients with possible or confirmed anxiety and/or depression and/or PTSD. Participant eligibility is based on self-representation of gender identity.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient Participants:
• Male gender
• Cognitive impairment that would preclude completion of informed consent
• Provider Participants:
• None

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (3)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161, United States

Location

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, 90073, United States

Location

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97239, United States

Location

Related Publications (2)

• 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.

  PMID: 30482159 DERIVED

• 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.

  PMID: 29116022 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depression; Combat Disorders; Stress Disorders, Traumatic

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Trauma and Stressor Related Disorders

Limitations and Caveats

Our implementation outcomes were assessed using qualitative methods

Results Point of Contact

• Title: Alison B Hamilton, PhD MPH
• Organization: VA Greater Los Angeles Healthcare System, West Los Angeles, CA

alison.hamilton@va.gov

(310) 478-3711

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2016
• First Posted: November 1, 2016
• Study Start: June 30, 2017
• Primary Completion: March 8, 2021
• Study Completion: March 8, 2021
• Last Updated: March 18, 2024
• Results First Posted: March 18, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)