Trial Outcomes & Findings for Cardiovascular Risk Screening and Risk Reduction in Women Vets (NCT NCT02991534)
NCT ID: NCT02991534
Last Updated: 2025-03-03
Results Overview
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.
COMPLETED
NA
6009 participants
46 months
2025-03-03
Participant Flow
All women with at least one primary care visit at one of the five participating VA clinic sites during the study period (December 2016 - March 2020).
Non-randomized stepped wedge trial; All women with at least one primary care visit at one of the five participating VA clinic sites during the study period were eligible to receive components of the CV Toolkit when the toolkit was active. Note: one more site implemented the toolkit than the originally proposed four sites.
Unit of analysis: Sites
Participant milestones
| Measure |
Active Implementation of the CV Toolkit
All women with at least one primary care visit at one of the five participating VA clinic sites during the study period were eligible to receive components of the CV Toolkit when the toolkit was active at their site.
|
|---|---|
|
Non-randomized Stepped Wedge Baseline
STARTED
|
6009 5
|
|
Non-randomized Stepped Wedge Baseline
Intervention
|
0 0
|
|
Non-randomized Stepped Wedge Baseline
Control
|
6009 5
|
|
Non-randomized Stepped Wedge Baseline
COMPLETED
|
6009 5
|
|
Non-randomized Stepped Wedge Baseline
NOT COMPLETED
|
0 0
|
|
Trial Step One
STARTED
|
6009 5
|
|
Trial Step One
Intervention
|
1461 1
|
|
Trial Step One
Control
|
4548 4
|
|
Trial Step One
COMPLETED
|
6009 5
|
|
Trial Step One
NOT COMPLETED
|
0 0
|
|
Trial Step Two
STARTED
|
6009 5
|
|
Trial Step Two
Intervention
|
2704 2
|
|
Trial Step Two
Control
|
3305 3
|
|
Trial Step Two
COMPLETED
|
6009 5
|
|
Trial Step Two
NOT COMPLETED
|
0 0
|
|
Trial Step Three
STARTED
|
6009 5
|
|
Trial Step Three
Intervention
|
4909 3
|
|
Trial Step Three
Control
|
1100 2
|
|
Trial Step Three
COMPLETED
|
6009 5
|
|
Trial Step Three
NOT COMPLETED
|
0 0
|
|
Trial Step Four
STARTED
|
6009 5
|
|
Trial Step Four
Intervention
|
5539 4
|
|
Trial Step Four
Control
|
470 1
|
|
Trial Step Four
COMPLETED
|
6009 5
|
|
Trial Step Four
NOT COMPLETED
|
0 0
|
|
Trial Step Five
STARTED
|
6009 5
|
|
Trial Step Five
Intervention
|
6009 5
|
|
Trial Step Five
Control
|
0 0
|
|
Trial Step Five
COMPLETED
|
6009 5
|
|
Trial Step Five
NOT COMPLETED
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
For the non-randomized stepped wedge analysis, the total population of 6,009 was stratified by age (65+ and less than age 65)
Baseline characteristics by cohort
| Measure |
Active Implementation of the CV Toolkit
n=6009 Participants
Women with at least one primary care visit at one of the five participating VA clinic sites during the study period were eligible to receive components of the CV Toolkit when the toolkit was active at their site.
|
|---|---|
|
Age, Categorical
Stratification: Women Age 65 and Older · <=18 years
|
0 Participants
n=618 Participants • For the non-randomized stepped wedge analysis, the total population of 6,009 was stratified by age (65+ and less than age 65)
|
|
Age, Categorical
Stratification: Women Age 65 and Older · Between 18 and 65 years
|
0 Participants
n=618 Participants • For the non-randomized stepped wedge analysis, the total population of 6,009 was stratified by age (65+ and less than age 65)
|
|
Age, Categorical
Stratification: Women Age 65 and Older · >=65 years
|
618 Participants
n=618 Participants • For the non-randomized stepped wedge analysis, the total population of 6,009 was stratified by age (65+ and less than age 65)
|
|
Age, Categorical
Stratification: Women Less Than Age 65 · <=18 years
|
0 Participants
n=5391 Participants • For the non-randomized stepped wedge analysis, the total population of 6,009 was stratified by age (65+ and less than age 65)
|
|
Age, Categorical
Stratification: Women Less Than Age 65 · Between 18 and 65 years
|
5391 Participants
n=5391 Participants • For the non-randomized stepped wedge analysis, the total population of 6,009 was stratified by age (65+ and less than age 65)
|
|
Age, Categorical
Stratification: Women Less Than Age 65 · >=65 years
|
0 Participants
n=5391 Participants • For the non-randomized stepped wedge analysis, the total population of 6,009 was stratified by age (65+ and less than age 65)
|
|
Sex/Gender, Customized
Stratification: Women Age 65 and Older
|
618 Participants
n=618 Participants • For the non-randomized stepped wedge analysis, the total population of 6,009 was stratified by age (65+ and less than age 65)
|
|
Sex/Gender, Customized
Stratification: Women Less Than Age 65
|
5391 Participants
n=5391 Participants • For the non-randomized stepped wedge analysis, the total population of 6,009 was stratified by age (65+ and less than age 65)
|
|
Ethnicity (NIH/OMB)
Stratification: Women Age 65 and Older · Hispanic or Latino
|
43 Participants
n=618 Participants • For the non-randomized stepped wedge analysis, the total population of 6,009 was stratified by age (65+ and less than age 65)
|
|
Ethnicity (NIH/OMB)
Stratification: Women Age 65 and Older · Not Hispanic or Latino
|
549 Participants
n=618 Participants • For the non-randomized stepped wedge analysis, the total population of 6,009 was stratified by age (65+ and less than age 65)
|
|
Ethnicity (NIH/OMB)
Stratification: Women Age 65 and Older · Unknown or Not Reported
|
26 Participants
n=618 Participants • For the non-randomized stepped wedge analysis, the total population of 6,009 was stratified by age (65+ and less than age 65)
|
|
Ethnicity (NIH/OMB)
Stratification: Women Less Than Age 65 · Hispanic or Latino
|
968 Participants
n=5391 Participants • For the non-randomized stepped wedge analysis, the total population of 6,009 was stratified by age (65+ and less than age 65)
|
|
Ethnicity (NIH/OMB)
Stratification: Women Less Than Age 65 · Not Hispanic or Latino
|
4193 Participants
n=5391 Participants • For the non-randomized stepped wedge analysis, the total population of 6,009 was stratified by age (65+ and less than age 65)
|
|
Ethnicity (NIH/OMB)
Stratification: Women Less Than Age 65 · Unknown or Not Reported
|
230 Participants
n=5391 Participants • For the non-randomized stepped wedge analysis, the total population of 6,009 was stratified by age (65+ and less than age 65)
|
|
Race/Ethnicity, Customized
Race (Stratification: Women Age 65 and Older) · American Indian, Alaska Native, Asian, Native Hawaiian, or Other Pacific Islander
|
21 Participants
n=618 Participants • For the non-randomized stepped wedge analysis, the total population of 6,009 was stratified by age (65+ and less than age 65)
|
|
Race/Ethnicity, Customized
Race (Stratification: Women Age 65 and Older) · Black or African American
|
162 Participants
n=618 Participants • For the non-randomized stepped wedge analysis, the total population of 6,009 was stratified by age (65+ and less than age 65)
|
|
Race/Ethnicity, Customized
Race (Stratification: Women Age 65 and Older) · White
|
371 Participants
n=618 Participants • For the non-randomized stepped wedge analysis, the total population of 6,009 was stratified by age (65+ and less than age 65)
|
|
Race/Ethnicity, Customized
Race (Stratification: Women Age 65 and Older) · Unknown or Not Reported
|
64 Participants
n=618 Participants • For the non-randomized stepped wedge analysis, the total population of 6,009 was stratified by age (65+ and less than age 65)
|
|
Race/Ethnicity, Customized
Race (Stratification: Women Less Than Age 65) · American Indian, Alaska Native, Asian, Native Hawaiian, or Other Pacific Islander
|
355 Participants
n=5391 Participants • For the non-randomized stepped wedge analysis, the total population of 6,009 was stratified by age (65+ and less than age 65)
|
|
Race/Ethnicity, Customized
Race (Stratification: Women Less Than Age 65) · Black or African American
|
1743 Participants
n=5391 Participants • For the non-randomized stepped wedge analysis, the total population of 6,009 was stratified by age (65+ and less than age 65)
|
|
Race/Ethnicity, Customized
Race (Stratification: Women Less Than Age 65) · White
|
2583 Participants
n=5391 Participants • For the non-randomized stepped wedge analysis, the total population of 6,009 was stratified by age (65+ and less than age 65)
|
|
Race/Ethnicity, Customized
Race (Stratification: Women Less Than Age 65) · Unknown or Not Reported
|
710 Participants
n=5391 Participants • For the non-randomized stepped wedge analysis, the total population of 6,009 was stratified by age (65+ and less than age 65)
|
|
Region of Enrollment
United States · Northeast
|
1243 Participants
n=6009 Participants
|
|
Region of Enrollment
United States · West
|
3666 Participants
n=6009 Participants
|
|
Region of Enrollment
United States · South
|
1100 Participants
n=6009 Participants
|
|
Region of Enrollment
United States · Midwest
|
0 Participants
n=6009 Participants
|
|
Clinic Type
Stratification: Women Age 65 and Older · Women's Clinic
|
469 Participants
n=618 Participants • For the non-randomized stepped wedge analysis, the total population of 6,009 was stratified by age (65+ and less than age 65)
|
|
Clinic Type
Stratification: Women Age 65 and Older · Primary Care
|
149 Participants
n=618 Participants • For the non-randomized stepped wedge analysis, the total population of 6,009 was stratified by age (65+ and less than age 65)
|
|
Clinic Type
Stratification: Women Less Than Age 65 · Women's Clinic
|
4440 Participants
n=5391 Participants • For the non-randomized stepped wedge analysis, the total population of 6,009 was stratified by age (65+ and less than age 65)
|
|
Clinic Type
Stratification: Women Less Than Age 65 · Primary Care
|
951 Participants
n=5391 Participants • For the non-randomized stepped wedge analysis, the total population of 6,009 was stratified by age (65+ and less than age 65)
|
PRIMARY outcome
Timeframe: 46 monthsPopulation: Comparing participation in MOVE at all 5 sites when CV Toolkit was active (turned one) versus not active (model stratified to include women aged 65 and older only) It was pre-specified in the non-randomized design analysis plan to evaluate the primary outcome measures as the odds ratio between the active and inactive intervention for the overall study period and not by individual site/phase.
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.
Outcome measures
| Measure |
Active Implementation of the CV Toolkit
n=618 Participants
Women with at least one primary care visit at one of the five participating VA clinic sites during the study period were eligible to receive components of the CV Toolkit when the toolkit was active at their site.
|
|---|---|
|
New Participation in MOVE! (Among Women Aged 65 and Older)
|
1.09 Odds Ratio
Interval 1.03 to 1.152
|
PRIMARY outcome
Timeframe: 46 monthsPopulation: Comparing participation in MOVE at all 5 sites when CV Toolkit was active (turned one) versus not active (model stratified to include women less than age 65 only) It was pre-specified in the non-randomized design analysis plan to evaluate the primary outcome measures as the odds ratio between the active and inactive intervention for the overall study period and not by individual site/phase.
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.
Outcome measures
| Measure |
Active Implementation of the CV Toolkit
n=5391 Participants
Women with at least one primary care visit at one of the five participating VA clinic sites during the study period were eligible to receive components of the CV Toolkit when the toolkit was active at their site.
|
|---|---|
|
New Participation in MOVE! (Among Women Less Than 65 Years Old)
|
1.00 Odds Ratio
Interval 0.976 to 1.022
|
PRIMARY outcome
Timeframe: 46 monthsPopulation: Comparing participation in HPDP and CIH services at all 5 sites when CV Toolkit was active (turned one) versus not active (model stratified to include women aged 65 and older only) It was pre-specified in the non-randomized design analysis plan to evaluate the primary outcome measures as the odds ratio between the active and inactive intervention for the overall study period and not by individual site/phase.
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.
Outcome measures
| Measure |
Active Implementation of the CV Toolkit
n=618 Participants
Women with at least one primary care visit at one of the five participating VA clinic sites during the study period were eligible to receive components of the CV Toolkit when the toolkit was active at their site.
|
|---|---|
|
Participation in HPDP/CIH Programs (Among Women Aged 65 and Older)
|
1.06 Odds Ratio
Interval 0.959 to 1.165
|
PRIMARY outcome
Timeframe: 46 monthsPopulation: Comparing participation in HPDP and CIH services at all 5 sites when CV Toolkit was active (turned one) versus not active (model stratified to include women less than age 65 only) It was pre-specified in the non-randomized design analysis plan to evaluate the primary outcome measures as the odds ratio between the active and inactive intervention for the overall study period and not by individual site/phase.
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.
Outcome measures
| Measure |
Active Implementation of the CV Toolkit
n=5391 Participants
Women with at least one primary care visit at one of the five participating VA clinic sites during the study period were eligible to receive components of the CV Toolkit when the toolkit was active at their site.
|
|---|---|
|
Participation in HPDP/CIH Programs (Among Women Less Than 65 Years Old)
|
1.01 Odds Ratio
Interval 1.002 to 1.022
|
Adverse Events
Active Implementation of the CV Toolkit
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Bevanne Bean-Mayberry
VA Greater Los Angeles Healthcare System
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place