AnxietyCCWVNCT02950961
Collaborative Care for Women Veterans
A study testing Collaborative Care for Women Veterans in people with Anxiety and Depression, run by VA Office of Research and Development at 3 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anxiety, Depression, Stress Disorders, Post Traumatic
- What is being tested?
- Collaborative Care for Women Veterans
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Jun 2017to 8 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient Participants:
- Male gender
- Cognitive impairment that would preclude completion of informed consent
- Provider Participants:
- None
Trial locations and contacts
3 sites in 1 country.
United States3 sites
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97239
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073
About this study
Official title: 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.
Read the 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.
- Conditions
- Anxiety, Depression, Stress Disorders, Post Traumatic
- Being tested
- Collaborative Care for Women Veterans
- 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]
- Medical subject headings
- Anxiety Disorders, Depression, Combat Disorders, Stress Disorders, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative Care for Women VeteransBehavioural
Also called Gender-Tailored Primary Care-Mental Health Integration
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Collaborative Care for Women Veterans |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, 18 months (implementation phase)
Patient-Reported Outcomes Measurement Information System (PROMIS)
brief measure of global health: Patient-Reported Outcomes Measurement Information System (PROMIS)
Measured: 6 months
Overall Anxiety Severity and Impairment Scale (OASIS)
brief measure of anxiety: Overall Anxiety Severity and Impairment Scale (OASIS)
Measured: 6 months
Patient Health Questionnaire for Depression and Anxiety (PHQ-4)
brief measure of depression: Patient Health Questionnaire for Depression and Anxiety (PHQ-4)
Measured: 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
Measured: 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
Measured: 6 months
Altarum Consumer Engagement
brief measure of patient engagement in care
Measured: 6 months
Health Literacy (Chew et al. 2004)
brief measure of health literacy: (Chew et al. 2004)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study start30 Jun 2017
- Primary completion8 Mar 2021
- Study completion8 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Alison B Hamilton, PhD MPH, Principal investigator, VA Greater Los Angeles Healthcare System, West Los Angeles, CAAriel J. Lang, PhD, Principal investigator, VA San Diego Healthcare System, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02950961
- Sponsor's protocol ID
- QUX 16-008
- Acronym
- CCWV
- Status last verified
- Aug 2023
- First submitted
- 21 Oct 2016
- Last updated
- 18 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30482159Hamilton 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.
PubMed 29116022
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Tailored Collaborative Care For Women Veterans (CCWV) (QUE 15-272)
- ClinicalTrials.gov ID
- NCT02950961
- Acronym / sponsor ID
- CCWV / QUX 16-008
- 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]
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 30 Jun 2017 (actual)
- Primary completion
- 8 Mar 2021 (actual)
- Study completion
- 8 Mar 2021 (actual)
- First posted
- 1 Nov 2016 (estimated)
- Results
- Posted 18 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Mixed Methods Implementation Evaluation | Other | Behavioral: Collaborative Care for Women VeteransThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women VA patients with possible or confirmed anxiety and/or depression and/or PTSD
- VA staff in a primary care and/or mental health clinic
Key exclusion criteria (5 listed)
- Male gender
- Cognitive impairment that would preclude completion of informed consent
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collaborative Care for Women VeteransAlso: Gender-Tailored Primary Care-Mental Health IntegrationThis 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. | Behavioural | Arm 1: Mixed Methods Implementation Evaluation |
Primary outcome
Change in Utilization of Services (30 Days)
Time frame: 30 days
Change in utilization of services comparing utilization 30 days prior to 30 days post initiation of care with the care manager.
Change in Utilization of Services (60 Days)
Time frame: 60 days
Change in utilization of services comparing utilization 60 days prior to 60 days post initiation of care with the care manager.
Change in Utilization of Services (180 Days)
Time frame: 180 days
Change in utilization of services 180 days prior to 180 days post initiation of care with the care manager.
Change in Utilization of Services (365 Days)
Time frame: 365 days
Change in utilization of services comparing utilization 365 days prior to 365 days post initiation of care with the care manager.
Change in Referrals
Time frame: baseline, 18 months (implementation phase)
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.
Patient-Reported Outcomes Measurement Information System (PROMIS)
Time frame: 6 months
brief measure of global health: Patient-Reported Outcomes Measurement Information System (PROMIS)
Overall Anxiety Severity and Impairment Scale (OASIS)
Time frame: 6 months
brief measure of anxiety: Overall Anxiety Severity and Impairment Scale (OASIS)
Patient Health Questionnaire for Depression and Anxiety (PHQ-4)
Time frame: 6 months
brief measure of depression: Patient Health Questionnaire for Depression and Anxiety (PHQ-4)
WHO Disability Assessment Schedule (WHODAS) Out Of Role Days Items
Time frame: 6 months
brief measure of impact of disability on role functioning: WHO Disability Assessment Schedule (WHODAS) Out Of Role Days items
Global Rating of Satisfaction/Quality of Care
Time frame: 6 months
brief measure of satisfaction and quality that we have used in several surveys of women Veteran VA patients
Altarum Consumer Engagement
Time frame: 6 months
brief measure of patient engagement in care
Health Literacy (Chew et al. 2004)
Time frame: 6 months
brief measure of health literacy: (Chew et al. 2004)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30482159Finley 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.
- Derived from this study: PubMed 29116022Hamilton 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison B Hamilton, PhD MPH principal investigator
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Ariel J. Lang, PhD principal investigator
VA San Diego Healthcare System, San Diego, CA
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collaborative Care for Women Veterans in people with Anxiety and Depression, run by VA Office of Research and Development at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Utilization of Services (30 Days) (time frame: 30 days). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02950961, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.