Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-02-24 @ 3:52 AM
Study NCT ID:
NCT02991534
Status:
COMPLETED
Last Update Posted:
2025-03-03
First Post:
2016-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cardiovascular Risk Screening and Risk Reduction in Women Vets
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bevanne.bean-mayberry@va.gov', 'phone': '818-891-7711', 'title': 'Dr. Bevanne Bean-Mayberry', 'phoneExt': '36009', 'organization': 'VA Greater Los Angeles Healthcare System'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Additional implementation outcomes (e.g. provider level) were assessed using qualitative methods and will be reported elsewhere (e.g. final report, manuscripts).'}}, 'adverseEventsModule': {'description': 'Given the nature of this study, adverse advents were not monitored. CV Toolkit was a clinic based intervention and was deemed low/minimal risk by the IRB.', 'eventGroups': [{'id': 'EG000', 'title': 'Active Implementation of the CV Toolkit', 'description': "All women who had a VA visit to a primary care or women's clinic at any of the 5 VA sites while the CV toolkit was being implemented across sites", 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'New Participation in MOVE! 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The main outcomes examined participation in MOVE! and HPDP and/or CIH services for each age strata.', 'unitOfMeasure': 'Odds Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Participation in HPDP/CIH Programs (Among Women Aged 65 and Older)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '618', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Implementation of the CV Toolkit', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.06', 'groupId': 'OG000', 'lowerLimit': '0.959', 'upperLimit': '1.165'}]}]}], 'analyses': [{'pValue': '.265', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '.959', 'ciUpperLimit': '1.165', 'statisticalMethod': 'Non-linear model with Logit', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Non-linear model with Logit Link Function with Robust Standard Errors'}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': '46 months', 'description': '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.', 'unitOfMeasure': 'Odds Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Participation in HPDP/CIH Programs (Among Women Less Than 65 Years Old)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5391', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Implementation of the CV Toolkit', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.01', 'groupId': 'OG000', 'lowerLimit': '1.002', 'upperLimit': '1.022'}]}]}], 'analyses': [{'pValue': '0.015', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '1.002', 'ciUpperLimit': '1.022', 'statisticalMethod': 'Non-linear model with Logit', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Non-linear model with Logit Link Function with Robust Standard Errors'}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': '46 months', 'description': '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). 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Each site had a separate time interval for when the CV Toolkit was active.', 'groupId': 'FG000', 'numUnits': '5', 'numSubjects': '6009'}]}, {'type': 'Intervention', 'comment': 'Non-active implementation period (control): no sites were actively implementing the CV Toolkit.', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}]}, {'type': 'Control', 'achievements': [{'groupId': 'FG000', 'numUnits': '5', 'numSubjects': '6009'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '5', 'numSubjects': '6009'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}]}]}, {'title': 'Trial Step One', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '5', 'numSubjects': '6009'}]}, {'type': 'Intervention', 'comment': 'First site began active implementation of the CV Toolkit.', 'achievements': [{'groupId': 'FG000', 'numUnits': '1', 'numSubjects': '1461'}]}, {'type': 'Control', 'achievements': [{'groupId': 'FG000', 'numUnits': '4', 'numSubjects': '4548'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '5', 'numSubjects': '6009'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}]}]}, {'title': 'Trial Step Two', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '5', 'numSubjects': '6009'}]}, {'type': 'Intervention', 'comment': 'Second site began active implementation of the CV Toolkit.', 'achievements': [{'groupId': 'FG000', 'numUnits': '2', 'numSubjects': '2704'}]}, {'type': 'Control', 'achievements': [{'groupId': 'FG000', 'numUnits': '3', 'numSubjects': '3305'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '5', 'numSubjects': '6009'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}]}]}, {'title': 'Trial Step Three', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '5', 'numSubjects': '6009'}]}, {'type': 'Intervention', 'comment': 'Third site began active implementation of the CV Toolkit.', 'achievements': [{'groupId': 'FG000', 'numUnits': '3', 'numSubjects': '4909'}]}, {'type': 'Control', 'achievements': [{'groupId': 'FG000', 'numUnits': '2', 'numSubjects': '1100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '5', 'numSubjects': '6009'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}]}]}, {'title': 'Trial Step Four', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '5', 'numSubjects': '6009'}]}, {'type': 'Intervention', 'comment': 'Fourth site began active implementation of the CV Toolkit.', 'achievements': [{'groupId': 'FG000', 'numUnits': '4', 'numSubjects': '5539'}]}, {'type': 'Control', 'achievements': [{'groupId': 'FG000', 'numUnits': '1', 'numSubjects': '470'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '5', 'numSubjects': '6009'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}]}]}, {'title': 'Trial Step Five', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '5', 'numSubjects': '6009'}]}, {'type': 'Intervention', 'comment': 'Fifth (and final) site began active implementation of the CV Toolkit.', 'achievements': [{'groupId': 'FG000', 'numUnits': '5', 'numSubjects': '6009'}]}, {'type': 'Control', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '5', 'numSubjects': '6009'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'Sites', 'recruitmentDetails': '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).', 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6009', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Active Implementation of the CV Toolkit', 'description': '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.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'title': 'Stratification: Women Age 65 and Older', 'denoms': [{'units': 'Participants', 'counts': [{'value': '618', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '618', 'groupId': 'BG000'}]}]}, {'title': 'Stratification: Women Less Than Age 65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5391', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5391', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'For the non-randomized stepped wedge analysis, the total population of 6,009 was stratified by age (65+ and less than age 65)'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Stratification: Women Age 65 and Older', 'denoms': [{'units': 'Participants', 'counts': [{'value': '618', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '618', 'groupId': 'BG000'}]}]}, {'title': 'Stratification: Women Less Than Age 65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5391', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5391', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'All persons identifying as women', 'unitOfMeasure': 'Participants', 'populationDescription': 'For the non-randomized stepped wedge analysis, the total population of 6,009 was stratified by age (65+ and less than age 65)'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'title': 'Stratification: Women Age 65 and Older', 'denoms': [{'units': 'Participants', 'counts': [{'value': '618', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '43', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '549', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}, {'title': 'Stratification: Women Less Than Age 65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5391', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '968', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4193', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '230', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'For the non-randomized stepped wedge analysis, the total population of 6,009 was stratified by age (65+ and less than age 65)'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race (Stratification: Women Age 65 and Older)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '618', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian, Alaska Native, Asian, Native Hawaiian, or Other Pacific Islander', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '162', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '371', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '64', 'groupId': 'BG000'}]}]}, {'title': 'Race (Stratification: Women Less Than Age 65)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5391', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian, Alaska Native, Asian, Native Hawaiian, or Other Pacific Islander', 'measurements': [{'value': '355', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1743', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '2583', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '710', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Due to small numbers, American Indian, Alaska Native, Asian, Native Hawaiian, or Other Pacific Islander were collapsed into one group here to protect confidentiality.', 'unitOfMeasure': 'Participants', 'populationDescription': 'For the non-randomized stepped wedge analysis, the total population of 6,009 was stratified by age (65+ and less than age 65)'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6009', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Northeast', 'measurements': [{'value': '1243', 'groupId': 'BG000'}]}, {'title': 'West', 'measurements': [{'value': '3666', 'groupId': 'BG000'}]}, {'title': 'South', 'measurements': [{'value': '1100', 'groupId': 'BG000'}]}, {'title': 'Midwest', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Clinic Type', 'classes': [{'title': 'Stratification: Women Age 65 and Older', 'denoms': [{'units': 'Participants', 'counts': [{'value': '618', 'groupId': 'BG000'}]}], 'categories': [{'title': "Women's Clinic", 'measurements': [{'value': '469', 'groupId': 'BG000'}]}, {'title': 'Primary Care', 'measurements': [{'value': '149', 'groupId': 'BG000'}]}]}, {'title': 'Stratification: Women Less Than Age 65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5391', 'groupId': 'BG000'}]}], 'categories': [{'title': "Women's Clinic", 'measurements': [{'value': '4440', 'groupId': 'BG000'}]}, {'title': 'Primary Care', 'measurements': [{'value': '951', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'For the non-randomized stepped wedge analysis, the total population of 6,009 was stratified by age (65+ and less than age 65)'}], 'populationDescription': 'For the non-randomized stepped wedge analysis, the total population of 6,009 was stratified by age (65+ and less than age 65)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-06-15', 'size': 906449, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-10-25T15:48', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'The implementation of the CV Toolkit will be evaluated using a non-randomized stepped wedge design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6009}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-11', 'studyFirstSubmitDate': '2016-12-09', 'resultsFirstSubmitDate': '2022-08-16', 'studyFirstSubmitQcDate': '2016-12-09', 'lastUpdatePostDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-11', 'studyFirstPostDateStruct': {'date': '2016-12-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'New Participation in MOVE! (Among Women Aged 65 and Older)', 'timeFrame': '46 months', 'description': '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.'}, {'measure': 'New Participation in MOVE! (Among Women Less Than 65 Years Old)', 'timeFrame': '46 months', 'description': '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.'}, {'measure': 'Participation in HPDP/CIH Programs (Among Women Aged 65 and Older)', 'timeFrame': '46 months', 'description': '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.'}, {'measure': 'Participation in HPDP/CIH Programs (Among Women Less Than 65 Years Old)', 'timeFrame': '46 months', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'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]'], 'conditions': ['Cardiovascular Diseases', 'Hypertension', 'Hyperlipidemias', 'Dyslipidemias', 'Obesity', 'Diabetes Mellitus', 'Tobacco Use Disorder', 'Overweight']}, 'referencesModule': {'references': [{'pmid': '39649163', 'type': 'DERIVED', 'citation': "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': '38386795', 'type': 'DERIVED', 'citation': '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': '30482159', 'type': 'DERIVED', '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.'}, {'pmid': '29116022', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nObjectives: 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.\n\nMethods: 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* For Patient Activities: Women VA patients with any cardiovascular risk factors\n* For Key Stakeholder Activities: VA staff affiliated with the Women's Health Clinic\n\nExclusion Criteria:\n\n* For Patient Activities: Men \\& Patients with cognitive impairment precluding informed consent\n* For Key Stakeholder Activities: non- VA staff"}, 'identificationModule': {'nctId': 'NCT02991534', 'briefTitle': 'Cardiovascular Risk Screening and Risk Reduction in Women Vets', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Facilitating Cardiovascular Risk Screening and Risk Reduction in Women Veterans (QUE 15-272)', 'orgStudyIdInfo': {'id': 'QUX 16-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active implementation of the CV Toolkit', 'description': '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.', 'interventionNames': ['Behavioral: CV Toolkit Components']}], 'interventions': [{'name': 'CV Toolkit Components', 'type': 'BEHAVIORAL', 'description': '* Patient completes a CV self screener.\n* Patient discusses CV risks factors with primary care providers and CV risks are documented and discussed for action steps and referrals.\n* 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', 'armGroupLabels': ['Active implementation of the CV Toolkit']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91343', 'city': 'Sepulveda', 'state': 'California', 'country': 'United States', 'facility': 'VA Greater Los Angeles Healthcare System, Sepulveda, CA', 'geoPoint': {'lat': 34.16167, 'lon': -118.28285}}, {'zip': '90073', 'city': 'West Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'VA Greater Los Angeles Healthcare System, West Los Angeles, CA', 'geoPoint': {'lat': 34.0462, 'lon': -118.43068}}, {'zip': '06516', 'city': 'West Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'VA Connecticut Healthcare System West Haven Campus, West Haven, CT', 'geoPoint': {'lat': 41.27065, 'lon': -72.94705}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'South Texas Health Care System, San Antonio, TX', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Bevanne A Bean-Mayberry, MD MHS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Greater Los Angeles Healthcare System, West Los Angeles, CA'}, {'name': 'Melissa M Farmer Coste, PhD MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Greater Los Angeles Healthcare System, Sepulveda, CA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}