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Cardiovascular Risk Screening and Risk Reduction in Women Vets

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ClinicalTrials.gov Identifier: NCT02991534
Recruitment Status : Recruiting
First Posted : December 13, 2016
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Hypertension Hyperlipidemias Dyslipidemias Obesity Diabetes Mellitus Tobacco Use Disorder Overweight Behavioral: CV Toolkit Components Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Facilitating Cardiovascular Risk Screening and Risk Reduction in Women Veterans (QUE 15-272)
Actual Study Start Date : November 15, 2016
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : September 30, 2020

Arm Intervention/treatment
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.
Behavioral: CV Toolkit Components
  • Patient completes a CV self screener.
  • Patient discusses CV risks factors with primary care providers and CV risks are documented and discussed for action steps and referrals.
  • Patient will be recommended to attend a gender tailored facilitated workgroup - Gateways to Healthy Living to make specific SMART goals and commit to patient preferred services or program




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Altarum Consumer Engagement (ACE) [ Time Frame: 6 months ]
    Brief measure of patient engagement in care

  2. PROMIS Global Health [ Time Frame: 6 months ]
    Brief measure of global health

  3. Patient Satisfaction [ Time Frame: 6 months ]
    Global rating of patient satisfaction/quality of care

  4. Overall Anxiety Severity and Impairment Scale (OASIS) [ Time Frame: 6 months ]
    Brief measure of anxiety

  5. Depression screen (PHQ-4) [ Time Frame: 6 months ]
    Brief measure of depression symptoms



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02991534


Contacts
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Contact: Bevanne A Bean-Mayberry, MD MHS (818) 891-7711 ext 36009 bevanne.bean-mayberry@va.gov
Contact: Melissa M Farmer Coste, PhD MS (818) 891-7711 ext 36046 Melissa.Farmer@va.gov

Locations
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United States, California
VA Greater Los Angeles Healthcare System, Sepulveda, CA Recruiting
Sepulveda, California, United States, 91343
Contact: Bevanne A Bean-Mayberry, MD MHS    818-891-7711 ext 36009    bevanne.bean-mayberry@va.gov   
Contact: Melissa M Farmer Coste, PhD MS    (818) 891-7711 ext 36046    Melissa.Farmer@va.gov   
Principal Investigator: Melissa M Farmer Coste, PhD MS         
VA Greater Los Angeles Healthcare System, West Los Angeles, CA Recruiting
West Los Angeles, California, United States, 90073
Contact: Hemen N Saifu, MPH    310-478-3711 ext 40782    Hemen.Saifu@va.gov   
Contact: Ismelda A Canelo, MPA    (818) 891-7711 ext 36069    Ismelda.Canelo@va.gov   
Principal Investigator: Bevanne A Bean-Mayberry, MD MHS         
United States, Connecticut
VA Connecticut Healthcare System West Haven Campus, West Haven, CT Recruiting
West Haven, Connecticut, United States, 06516
Contact: Mary Driscoll, PhD       Mary.Driscoll3@va.gov   
United States, Texas
South Texas Health Care System, San Antonio, TX Recruiting
San Antonio, Texas, United States, 78229
Contact: Erin Finley, PhD       Erin.Finley@va.gov   
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02991534     History of Changes
Other Study ID Numbers: QUX 16-007
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by VA Office of Research and Development:
Patient Participation [N05.300.150.600.620]
Health Behavior [F01.145.488]
Women [M01.975]
Patient Satisfaction [N05.715.360.600]
Physicians, Primary Care [M01.526.485.810.800]
Physicians, Women [M01.526.485.810.820]
Health Educators [M01.526.485.410]
Cardiovascular Diseases [C14]
Hypertension [C14.907.489]
Hyperlipidemias [C18.452.584.500.500]
Dyslipidemias [C18.452.584.500]
Obesity [C18.654.726.500]
Diabetes Mellitus [C18.452.394.750]
Tobacco Use Disorder [C25.775.912]
Overweight [C23.888.144.699]

Additional relevant MeSH terms:
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Diabetes Mellitus
Hypertension
Cardiovascular Diseases
Overweight
Dyslipidemias
Hyperlipidemias
Hyperlipoproteinemias
Tobacco Use Disorder
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Body Weight
Signs and Symptoms
Lipid Metabolism Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders