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Cardiovascular Risk Screening and Risk Reduction in Women Vets

Primary Purpose

Cardiovascular Diseases, Hypertension, Hyperlipidemias

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CV Toolkit Components
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cardiovascular Diseases focused on measuring 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]

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • VA Greater Los Angeles Healthcare System, Sepulveda, CA
  • VA Greater Los Angeles Healthcare System, West Los Angeles, CA
  • VA Connecticut Healthcare System West Haven Campus, West Haven, CT
  • South Texas Health Care System, San Antonio, TX

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Arm 1

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
December 9, 2016
Last Updated
October 6, 2020
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT02991534
Brief Title
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

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
November 15, 2016 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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]

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
254 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CV Toolkit Components
Intervention Description
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 Measure Information:
Title
Referrals to Health Promotion and Disease Prevention Services
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Altarum Consumer Engagement (ACE)
Description
Brief measure of patient engagement in care
Time Frame
6 months
Title
PROMIS Global Health
Description
Brief measure of global health
Time Frame
6 months
Title
Patient Satisfaction
Description
Global rating of patient satisfaction/quality of care
Time Frame
6 months
Title
Overall Anxiety Severity and Impairment Scale (OASIS)
Description
Brief measure of anxiety
Time Frame
6 months
Title
Depression screen (PHQ-4)
Description
Brief measure of depression symptoms
Time Frame
6 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bevanne A Bean-Mayberry, MD MHS
Organizational Affiliation
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Melissa M Farmer Coste, PhD MS
Organizational Affiliation
VA Greater Los Angeles Healthcare System, Sepulveda, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Greater Los Angeles Healthcare System, Sepulveda, CA
City
Sepulveda
State/Province
California
ZIP/Postal Code
91343
Country
United States
Facility Name
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
City
West Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
Facility Name
South Texas Health Care System, San Antonio, TX
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30482159
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.
Results Reference
derived
PubMed Identifier
29116022
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.
Results Reference
derived
Links:
URL
http://www.queri.research.va.gov/programs/womens_health.cfm
Description
Related Info

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Cardiovascular Risk Screening and Risk Reduction in Women Vets

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