Cardiovascular DiseasesNCT02991534
Cardiovascular Risk Screening and Risk Reduction in Women Vets
A study testing CV Toolkit Components in people with Cardiovascular Diseases and Hypertension, run by VA Office of Research and Development at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cardiovascular Diseases, Hypertension, Hyperlipidemias
- What is being tested?
- CV Toolkit Components
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,009 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Nov 2016to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For Patient Activities: Women VA patients with any cardiovascular risk factors
- For Key Stakeholder Activities: VA staff affiliated with the Women's Health Clinic
Who cannot join
- For Patient Activities: Men \& Patients with cognitive impairment precluding informed consent
- For Key Stakeholder Activities: non- VA staff
Trial locations and contacts
4 sites in 1 country.
United States4 sites
South Texas Health Care System, San Antonio, TX
San Antonio, Texas, 78229
VA Greater Los Angeles Healthcare System, Sepulveda, CA
Sepulveda, California, 91343
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073
About this study
Official title: Facilitating Cardiovascular Risk Screening and Risk Reduction in Women Veterans (QUE 15-272)
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.
Read the 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.
- Conditions
- Cardiovascular Diseases, Hypertension, Hyperlipidemias, Dyslipidemias, Obesity, Diabetes Mellitus
- Being tested
- CV Toolkit Components
- 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]
- Medical subject headings
- Cardiovascular Diseases, Hypertension, Hyperlipidemias, Dyslipidemias, Obesity, Diabetes Mellitus, Tobacco Use Disorder, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CV Toolkit ComponentsBehavioural
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: CV Toolkit Components |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 46 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study start15 Nov 2016
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- The implementation of the CV Toolkit will be evaluated using a non-randomized stepped wedge design
- Masking
- None (open label)
- Enrolment
- 6,009 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Bevanne A Bean-Mayberry, MD MHS, Principal investigator, VA Greater Los Angeles Healthcare System, West Los Angeles, CAMelissa M Farmer Coste, PhD MS, Principal investigator, VA Greater Los Angeles Healthcare System, Sepulveda, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02991534
- Sponsor's protocol ID
- QUX 16-007
- Status last verified
- Feb 2025
- First submitted
- 9 Dec 2016
- Last updated
- 3 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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;27(1):95. doi: 10.1186/s12875-025-03158-5.
PubMed 41507799Farmer 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.
PubMed 39649163Clair 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.
PubMed 38386795Finley 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.
PubMed 30482159Hamilton 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.
PubMed 29116022
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating Cardiovascular Risk Screening and Risk Reduction in Women Veterans (QUE 15-272)
- ClinicalTrials.gov ID
- NCT02991534
- Acronym / sponsor ID
- QUX 16-007
- Conditions
- Cardiovascular Diseases, Hypertension, Hyperlipidemias, Dyslipidemias, Obesity, Diabetes Mellitus
- 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]
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,009 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 15 Nov 2016 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 13 Dec 2016 (estimated)
- Results
- Posted 3 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The implementation of the CV Toolkit will be evaluated using a non-randomized stepped wedge design
| Arm | Type | Receives |
|---|---|---|
| Active implementation of the CV Toolkit | Experimental | Behavioral: CV Toolkit ComponentsThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- For Patient Activities: Women VA patients with any cardiovascular risk factors
- For Key Stakeholder Activities: VA staff affiliated with the Women's Health Clinic
Key exclusion criteria (2 listed)
- For Patient Activities: Men \& Patients with cognitive impairment precluding informed consent
- For Key Stakeholder Activities: non- VA staff
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Active implementation of the CV Toolkit |
Primary outcome
New Participation in MOVE! (Among Women Aged 65 and Older)
Time frame: 46 months
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.
New Participation in MOVE! (Among Women Less Than 65 Years Old)
Time frame: 46 months
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.
Participation in HPDP/CIH Programs (Among Women Aged 65 and Older)
Time frame: 46 months
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.
Participation in HPDP/CIH Programs (Among Women Less Than 65 Years Old)
Time frame: 46 months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41507799Farmer 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;27(1):95. doi: 10.1186/s12875-025-03158-5.
- Derived from this study: PubMed 39649163Farmer 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.
- Derived from this study: PubMed 38386795Clair 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.
- Derived from this study: PubMed 30482159Finley 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.
- Derived from this study: PubMed 29116022Hamilton 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bevanne A Bean-Mayberry, MD MHS principal investigator
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Melissa M Farmer Coste, PhD MS principal investigator
VA Greater Los Angeles Healthcare System, Sepulveda, CA
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CV Toolkit Components in people with Cardiovascular Diseases and Hypertension, run by VA Office of Research and Development at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New Participation in MOVE! (Among Women Aged 65 and Older) (time frame: 46 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02991534, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.