Cardiovascular Risk Screening and Risk Reduction in Women Vets

Obesity Clinical Trial

Official title:

Facilitating Cardiovascular Risk Screening and Risk Reduction in Women Veterans (QUE 15-272)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02991534
• Other study ID #: QUX 16-007
• Status: Completed
• Phase: N/A
• Start date: November 15, 2016
• Est. completion date: September 30, 2020

Study information

• Verified date: October 2020
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus
• Dyslipidemias
• Hyperlipidemias
• Hyperlipoproteinemias
• Hypertension
• Obesity
• Overweight
• Tobacco Use Disorder

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

Locations

Country	Name	City	State
United States	South Texas Health Care System, San Antonio, TX	San Antonio	Texas
United States	VA Greater Los Angeles Healthcare System, Sepulveda, CA	Sepulveda	California
United States	VA Connecticut Healthcare System West Haven Campus, West Haven, CT	West Haven	Connecticut
United States	VA Greater Los Angeles Healthcare System, West Los Angeles, CA	West Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Referrals to Health Promotion and Disease Prevention Services	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	Altarum Consumer Engagement (ACE)	Brief measure of patient engagement in care	6 months
Secondary	PROMIS Global Health	Brief measure of global health	6 months
Secondary	Patient Satisfaction	Global rating of patient satisfaction/quality of care	6 months
Secondary	Overall Anxiety Severity and Impairment Scale (OASIS)	Brief measure of anxiety	6 months
Secondary	Depression screen (PHQ-4)	Brief measure of depression symptoms	6 months

External Links

•   Related Info