- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02991534
Cardiovascular Risk Screening and Risk Reduction in Women Vets
Facilitating Cardiovascular Risk Screening and Risk Reduction in Women Veterans (QUE 15-272)
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, we 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 our 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. "Tailoring VA's Diabetes Prevention Program to Women Veterans' Needs" is a one-year QI project to be conducted in VA Greater Los Angeles women's health clinics. Women Veterans with prediabetes will select an in-person, peer-led or online gender-specific, evidence-based diabetes prevention program to address their risk behaviors and health conditions. "Facilitating Cardiovascular Risk Screening and Risk Reduction in Women Veterans" will increase identification of CV risk among women Veterans, enhance patient/provider communication and shared decision-making about CV risk, and provide a supportive, coordinated health coaching intervention to facilitate women Veterans' engagement and retention in appropriate health services. "Implementation of Tailored Collaborative Care for Women Veterans" 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. Both implementation research studies will use a modified stepped wedge design and will apply the evidence-based Replicating Effective Programs (REP) implementation strategy. Mixed methods implementation evaluations 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 BPE strategies and realizing women Veterans' engagement and, ultimately, empowerment in our VHA system.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
California
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Sepulveda, California, United States, 91343
- VA Greater Los Angeles Healthcare System, Sepulveda, CA
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West Los Angeles, California, United States, 90073
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA
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Connecticut
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West Haven, Connecticut, United States, 06516
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT
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-
Texas
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San Antonio, Texas, United States, 78229
- South Texas Health Care System, San Antonio, TX
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- For Patient Activities: Women VA patients with any cardiovascular risk factors
- For Key Stakeholder Activities: VA staff affiliated with the Women's Health Clinic
Exclusion Criteria:
- For Patient Activities: Men & Patients with cognitive impairment precluding informed consent
- For Key Stakeholder Activities: non- VA staff
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Arm 1
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 this nonrandomized stepped wedge design, the intervention is "turned on" when a primary care provider (PCP) uses a CV screening template which maps to the patient CV self-screener.
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.
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Referrals to Health Promotion and Disease Prevention Services
Time Frame: 6 months
|
Examples include smoking cessation, dietitian, MOVE program or other weight loss/physical activity programs, pharmacy services, facilitated groups, Health Coaching services, specialty services, and other programs.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Altarum Consumer Engagement (ACE)
Time Frame: 6 months
|
Brief measure of patient engagement in care
|
6 months
|
PROMIS Global Health
Time Frame: 6 months
|
Brief measure of global health
|
6 months
|
Patient Satisfaction
Time Frame: 6 months
|
Global rating of patient satisfaction/quality of care
|
6 months
|
Overall Anxiety Severity and Impairment Scale (OASIS)
Time Frame: 6 months
|
Brief measure of anxiety
|
6 months
|
Depression screen (PHQ-4)
Time Frame: 6 months
|
Brief measure of depression symptoms
|
6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Bevanne A Bean-Mayberry, MD MHS, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
- Principal Investigator: Melissa M Farmer Coste, PhD MS, VA Greater Los Angeles Healthcare System, Sepulveda, 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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Obesity [C18.654.726.500]
- Women [M01.975]
- Patient Participation [N05.300.150.600.620]
- Physicians, Primary Care [M01.526.485.810.800]
- Physicians, Women [M01.526.485.810.820]
- Health Behavior [F01.145.488]
- Patient Satisfaction [N05.715.360.600]
- Health Educators [M01.526.485.410]
- Cardiovascular Diseases [C14]
- Hypertension [C14.907.489]
- Hyperlipidemias [C18.452.584.500.500]
- Dyslipidemias [C18.452.584.500]
- Diabetes Mellitus [C18.452.394.750]
- Tobacco Use Disorder [C25.775.912]
- Overweight [C23.888.144.699]
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Vascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Substance-Related Disorders
- Endocrine System Diseases
- Body Weight
- Lipid Metabolism Disorders
- Hypertension
- Cardiovascular Diseases
- Diabetes Mellitus
- Dyslipidemias
- Tobacco Use Disorder
- Overweight
- Hyperlipidemias
- Hyperlipoproteinemias
Other Study ID Numbers
- QUX 16-007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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