Cardiovascular Risk Screening and Risk Reduction in Women Vets

Sponsor

VA Office of Research and Development (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT02991534

Collaborator

(none)

254

Enrollment

Locations

Arm

46.5

Actual Duration (Months)

63.5

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

254 participants

Allocation:

N/A

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 :

Nov 15, 2016

Actual Primary Completion Date :

Sep 30, 2020

Actual Study Completion Date :

Sep 30, 2020

Arms and Interventions

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.	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

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.

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

Outcome Measures

Primary Outcome Measures

Referrals to Health Promotion and Disease Prevention Services [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

Altarum Consumer Engagement (ACE) [6 months]
Brief measure of patient engagement in care
PROMIS Global Health [6 months]
Brief measure of global health
Patient Satisfaction [6 months]
Global rating of patient satisfaction/quality of care
Overall Anxiety Severity and Impairment Scale (OASIS) [6 months]
Brief measure of anxiety
Depression screen (PHQ-4) [6 months]
Brief measure of depression symptoms

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Greater Los Angeles Healthcare System, Sepulveda, CA	Sepulveda	California	United States	91343
2	VA Greater Los Angeles Healthcare System, West Los Angeles, CA	West Los Angeles	California	United States	90073
3	VA Connecticut Healthcare System West Haven Campus, West Haven, CT	West Haven	Connecticut	United States	06516
4	South Texas Health Care System, San Antonio, TX	San Antonio	Texas	United States	78229

Sponsors and Collaborators

VA Office of Research and Development

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