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Collaborative Care for Women Veterans (CCWV)

Primary Purpose

Anxiety, Depression, Stress Disorders, Post Traumatic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Collaborative Care for Women Veterans
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Anxiety focused on measuring 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 Participation [N05.300.150.600.620], 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]

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • VA San Diego Healthcare System, San Diego, CA
  • VA Greater Los Angeles Healthcare System, West Los Angeles, CA
  • VA Portland Health Care System, Portland, OR

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Arm 1: nonrandomized stepped wedge

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
Adoption of care models
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
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
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
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.

Secondary Outcome Measures

Patient-Reported Outcomes Measurement Information System (PROMIS)
brief measure of global health
Overall Anxiety Severity and Impairment Scale (OASIS)
brief measure of anxiety
Patient Health Questionnaire for Depression and Anxiety (PHQ-4)
brief measure of depression
WHO Disability Assessment Schedule (WHODAS) Out Of Role Days items
brief measure of impact of disability on role functioning
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
Altarum Consumer Engagement
brief measure of patient engagement in care
Health literacy (Chew et al. 2004)
brief measure of health literacy

Full Information

First Posted
October 21, 2016
Last Updated
December 23, 2021
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT02950961
Brief Title
Collaborative Care for Women Veterans
Acronym
CCWV
Official Title
Implementation of Tailored Collaborative Care For Women Veterans (CCWV) (QUE 15-272)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
June 30, 2017 (Actual)
Primary Completion Date
March 8, 2021 (Actual)
Study Completion Date
March 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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 Participation [N05.300.150.600.620], 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]

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: nonrandomized stepped wedge
Arm Type
Other
Arm Description
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 Type
Behavioral
Intervention Name(s)
Collaborative Care for Women Veterans
Other Intervention Name(s)
Gender-Tailored Primary Care-Mental Health Integration
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Referrals
Description
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.
Time Frame
baseline, 18 months (implementation phase)
Title
Adoption of care models
Description
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.
Time Frame
18 months
Title
Acceptability of care model
Description
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).
Time Frame
18 months
Title
Feasibility of care model
Description
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).
Time Frame
18 months
Title
Satisfaction with care model
Description
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.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Patient-Reported Outcomes Measurement Information System (PROMIS)
Description
brief measure of global health
Time Frame
6 months
Title
Overall Anxiety Severity and Impairment Scale (OASIS)
Description
brief measure of anxiety
Time Frame
6 months
Title
Patient Health Questionnaire for Depression and Anxiety (PHQ-4)
Description
brief measure of depression
Time Frame
6 months
Title
WHO Disability Assessment Schedule (WHODAS) Out Of Role Days items
Description
brief measure of impact of disability on role functioning
Time Frame
6 months
Title
Global rating of satisfaction/quality of care
Description
brief measure of satisfaction and quality that we have used in several surveys of women Veteran VA patients
Time Frame
6 months
Title
Altarum Consumer Engagement
Description
brief measure of patient engagement in care
Time Frame
6 months
Title
Health literacy (Chew et al. 2004)
Description
brief measure of health literacy
Time Frame
6 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women VA patients with possible or confirmed anxiety and/or depression and/or PTSD
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alison B Hamilton, PhD MPH
Organizational Affiliation
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ariel J. Lang, PhD
Organizational Affiliation
VA San Diego Healthcare System, San Diego, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System, San Diego, CA
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
City
West Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
VA Portland Health Care System, Portland, OR
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30482159
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.
Results Reference
derived
PubMed Identifier
29116022
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.
Results Reference
derived
Links:
URL
http://www.queri.research.va.gov/programs/womens_health.cfm
Description
Related Info

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