Clinical trial NCT02991534: Cardiovascular Risk Screening and Risk Reduction in Women Vets
Official title: Facilitating Cardiovascular Risk Screening and Risk Reduction in Women Veterans (QUE 15-272)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Hypertension
Hyperlipidemias
Dyslipidemias
Obesity
Diabetes Mellitus
Tobacco Use Disorder
Overweight
Keywords: 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]
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2016-12-13
Enrollment: 6009
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: The implementation of the CV Toolkit will be evaluated using a non-randomized stepped wedge design
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Cardiovascular (CV) disease is the number one cause of death in American women, and all adult women are potentially at risk for CV disease. There are clear gender differences in the control of CV risk factors such as lipids, blood pressure, and intermediate diabetes outcomes nationally and within the VA, with women Veterans often at higher CV risk than their male counterparts. The combination of disparities and gender-specific CV risk factors suggest an urgent need for CV risk factor management in women Veterans. As one project in the Enhancing Mental and Physical health of Women through Engagement and Retention (EMPOWER) QUERI, the objectives of "Facilitating Cardiovascular Risk Screening and Risk Reduction in Women Veterans" are to implement and evaluate a CV risk reduction toolkit (CV toolkit) designed to increase identification of CV risk among Women Veterans, enhance patient/provider communication about their risk, and increase Women Veterans' engagement and retention in relevant health services including referrals to key health programs (e.g., MOVE!, dieticians, health coaches, and CV specialists as needed). The initial CV Toolkit includes four components: (1) Patient education/activation tools including educational materials and a patient CV self-screener to help make CV risk discussion a priority for women before they enter the exam room; (2) A CV risk assessment computerized template to systematically capture CV disease risk factor history and data from the medical record and then facilitate referrals to Gateway to Healthy Living program and other CV risk reduction services/programs; (3) Provider information and education programs as well as referral tools to internal services; and (4) The Gateway to Healthy Living, a facilitated goal-setting group tailored for women Veterans. The goal is to implement the CV Toolkit at four VA facilities with comprehensive women's health clinics. The implementation of the CV Toolkit will be evaluated using a non-randomized stepped wedge design and will apply the evidence-based Replicating Effective Programs (REP) implementation strategy. For the nonrandomized stepped wedge design, each phase represents when one site moved from inactive to active implementation. It was pre-specified for the non-randomized design to evaluate the outcomes as the odds ratio of active intervention versus inactive for the overall study period and not by individual site/phase. This is a function of the use of the non-randomized design. Since the order of sites being introduced into the active intervention is not random, probabilistically the individual site results are not as meaningful here as they would be in a randomized stepped wedge design. Also, 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, impact and facilitate spread.

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, 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 non-randomized stepped wedge design and will apply the evidence-based Replicating Effective Programs (REP) implementation strategy. For the nonrandomized stepped wedge design, each phase represents when one site moved from inactive to active implementation. It was pre-specified for the non-randomized design to evaluate the outcomes as the odds ratio of active intervention versus inactive for the overall study period and not by individual site/phase. This is a function of the use of the non-randomized design. Since the order of sites being introduced into the active intervention is not random, probabilistically the individual site results are not as meaningful here as they would be in a randomized stepped wedge design. 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. The original protocol proposes the administration of a follow-up survey that includes four secondary outcome measures (PROMIS Global Health; Patient Satisfaction; Overall Anxiety Severity and Impairment Scale (OASIS); and Depression Screen (PHQ-4)). However, the follow-up survey was not administered (data not collected) due to patient burden and COVID-19. 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.

Eligibility 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

Primary outcomes:
measure: New Participation in MOVE! (Among Women Aged 65 and Older)
timeFrame: 46 months
measure: New Participation in MOVE! (Among Women Less Than 65 Years Old)
timeFrame: 46 months
measure: Participation in HPDP/CIH Programs (Among Women Aged 65 and Older)
timeFrame: 46 months
measure: Participation in HPDP/CIH Programs (Among Women Less Than 65 Years Old)
timeFrame: 46 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sepulveda
country: United States
facility: VA Greater Los Angeles Healthcare System, Sepulveda, CA
state: California
city: West Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
state: California
city: West Haven
country: United States
facility: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
state: Connecticut
city: San Antonio
country: United States
facility: South Texas Health Care System, San Antonio, TX
state: Texas
Study officials:
affiliation: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
name: Bevanne A Bean-Mayberry, MD MHS
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Greater Los Angeles Healthcare System, Sepulveda, CA
name: Melissa M Farmer Coste, PhD MS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.