Cardiovascular Risk Screening and Risk Reduction in Women Vets

NCT02991534 | Completed Results

• 1 other identifier: QUX 16-007
• Study Type: interventional
• Target: 6,009
• Locations: 1 country
• Sites: 4

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.

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]

Outcome Measures

Primary Outcomes (4)

• New Participation in MOVE! (Among Women Aged 65 and Older)

  The study utilized a non-randomized stepped wedge design, and in this design, there are two arms: the not-active CV Toolkit arm and the active ("turned on") CV Toolkit arm. All five sites were in both arms at some point in the study period. The determination of when a study was in a particular arm was determined using the non-randomized step wedge design. In this design, all sites begin in the not-active arm and then cross-over to the active arm at a time when they are organized to do so (not a random event). In the non-randomized stepped wedge design (which is very similar to the crossover clinical trial) results are not analyzed separately by arm as is done for standard randomized controlled trials. The analysis also considered stratification of the women by age (\< and ≥ 65 years of age). The main outcomes examined participation in MOVE! and HPDP and/or CIH services for each age strata.

  46 months

• New Participation in MOVE! (Among Women Less Than 65 Years Old)

  The study utilized a non-randomized stepped wedge design, and in this design, there are two arms: the not-active CV Toolkit arm and the active ("turned on") CV Toolkit arm. All five sites were in both arms at some point in the study period. The determination of when a study was in a particular arm was determined using the non-randomized step wedge design. In this design, all sites begin in the not-active arm and then cross-over to the active arm at a time when they are organized to do so (not a random event). In the non-randomized stepped wedge design (which is very similar to the crossover clinical trial) results are not analyzed separately by arm as is done for standard randomized controlled trials. The analysis also considered stratification of the women by age (\< and ≥ 65 years of age). The main outcomes examined participation in MOVE! and HPDP and/or CIH services for each age strata.

  46 months

• Participation in HPDP/CIH Programs (Among Women Aged 65 and Older)

  The study utilized a non-randomized stepped wedge design, and in this design, there are two arms: the not-active CV Toolkit arm and the active ("turned on") CV Toolkit arm. All five sites were in both arms at some point in the study period. The determination of when a study was in a particular arm was determined using the non-randomized step wedge design. In this design, all sites begin in the not-active arm and then cross-over to the active arm at a time when they are organized to do so (not a random event). In the non-randomized stepped wedge design (which is very similar to the crossover clinical trial) results are not analyzed separately by arm as is done for standard randomized controlled trials. The analysis also considered stratification of the women by age (\< and ≥ 65 years of age). The main outcomes examined participation in MOVE! and HPDP and/or CIH services for each age strata.

  46 months

• Participation in HPDP/CIH Programs (Among Women Less Than 65 Years Old)

  The study utilized a non-randomized stepped wedge design, and in this design, there are two arms: the not-active CV Toolkit arm and the active ("turned on") CV Toolkit arm. All five sites were in both arms at some point in the study period. The determination of when a study was in a particular arm was determined using the non-randomized step wedge design. In this design, all sites begin in the not-active arm and then cross-over to the active arm at a time when they are organized to do so (not a random event). In the non-randomized stepped wedge design (which is very similar to the crossover clinical trial) results are not analyzed separately by arm as is done for standard randomized controlled trials. The analysis also considered stratification of the women by age (\< and ≥ 65 years of age). The main outcomes examined participation in MOVE! and HPDP and/or CIH services for each age strata.

  46 months

Study Arms (1)

Active implementation of the CV Toolkit

EXPERIMENTAL

The investigators will use a non-randomized stepped wedge design to evaluate the implementation in four VA Women's Practice Based Research Network sites. In this design, the intervention is "turned on" when a primary care provider at the site first engages in the Cardiovascular (CV) Toolkit (i.e. 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 non-randomized 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

Interventions

CV Toolkit Components BEHAVIORAL

* 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

Active implementation of the CV Toolkit

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For Patient Activities: Women VA patients with any cardiovascular risk factors
• For Key Stakeholder Activities: VA staff affiliated with the Women's Health Clinic

You may not qualify if:

• For Patient Activities: Men \& Patients with cognitive impairment precluding informed consent
• For Key Stakeholder Activities: non- VA staff

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (4)

VA Greater Los Angeles Healthcare System, Sepulveda, CA

Sepulveda, California, 91343, United States

Location

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, 90073, United States

Location

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, 06516, United States

Location

South Texas Health Care System, San Antonio, TX

San Antonio, Texas, 78229, United States

Location

Related Publications (5)

• Farmer MM, Hamilton AB, Finley EP, Lee ML, Chanfreau C, Than C, Brunner J, Schweizer CA, Moin T, Bean-Mayberry B. Implementation of a cardiovascular toolkit in primary care increased women Veterans' engagement in behavior change programs: results from a non-randomized stepped wedge trial. BMC Prim Care. 2026 Jan 8. doi: 10.1186/s12875-025-03158-5. Online ahead of print.

  PMID: 41507799 DERIVED

• Farmer MM, Hamilton AB, Finley EP, Lee M, Chanfreau C, Than C, Brunner J, Schweizer CA, Huynh AK, Moin T, Bean-Mayberry B. Implementation of a cardiovascular toolkit in primary care increased women Veterans' engagement in behavior change programs: results from a non-randomized stepped wedge trial. Res Sq [Preprint]. 2024 Nov 26:rs.3.rs-5347756. doi: 10.21203/rs.3.rs-5347756/v1.

  PMID: 39649163 DERIVED

• Clair KS, Bean-Mayberry B, Schweizer CA, Chanfreau C, Jackson L, Than CT, Finley EP, Hamilton A, Farmer MM. Factors Associated with Delayed Care Among Women Veterans Actively Engaged in Primary Care. J Womens Health (Larchmt). 2024 May;33(5):604-612. doi: 10.1089/jwh.2023.0227. Epub 2024 Feb 21.

  PMID: 38386795 DERIVED

• 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.

  PMID: 30482159 DERIVED

• 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.

  PMID: 29116022 DERIVED

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Vascular Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Endocrine System Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Limitations and Caveats

Additional implementation outcomes (e.g. provider level) were assessed using qualitative methods and will be reported elsewhere (e.g. final report, manuscripts).

Results Point of Contact

• Title: Dr. Bevanne Bean-Mayberry
• Organization: VA Greater Los Angeles Healthcare System

bevanne.bean-mayberry@va.gov

818-891-7711

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: The implementation of the CV Toolkit will be evaluated using a non-randomized stepped wedge design

Study Record Dates

• First Submitted: December 9, 2016
• First Posted: December 13, 2016
• Study Start: November 15, 2016
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: March 3, 2025
• Results First Posted: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)