Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-02-23 @ 4:54 AM
Study NCT ID:
NCT04106193
Status:
COMPLETED
Last Update Posted:
2023-10-05
First Post:
2019-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Addressing Intimate Partner Violence Among Women Veterans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-09-13', 'releaseDate': '2024-08-15'}, {'resetDate': '2025-06-24', 'releaseDate': '2025-06-04'}], 'estimatedResultsFirstSubmitDate': '2024-08-15'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Hybrid type II implementation-effectiveness design; stepped wedge'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7421}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-04', 'studyFirstSubmitDate': '2019-09-23', 'studyFirstSubmitQcDate': '2019-09-25', 'lastUpdatePostDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Reach (primary implementation outcome)', 'timeFrame': 'For each site, the proportion calculated at baseline (months 1-3) will be compared to the proportion calculated for the latter half of the facilitation period (months 7-9).', 'description': 'Change in proportion of WVs seen in Model 1 and 2 clinics during the last three months of each study phase who receive IPV screening'}, {'measure': 'Change in Disclosure Rate (primary clinical effectiveness outcome)', 'timeFrame': 'For each site, the proportion calculated at baseline (months 1-3) will be compared to the proportion calculated for the latter half of the facilitation period (months 7-9).', 'description': 'Change in proportion of eligible WVs who screen positive for IPV'}], 'secondaryOutcomes': [{'measure': 'Change in Psychosocial Service Use (secondary clinical effectiveness outcome)', 'timeFrame': 'For each site, the proportion calculated at baseline (months 1-3) will be compared to the proportion calculated for the latter half of the facilitation period (months 7-9).', 'description': 'Change in proportion of WVs accepting psychosocial service referrals following a positive IPV screen who use such services within two months'}, {'measure': 'Adoption of Screening (secondary implementation outcome)', 'timeFrame': 'For each site, the proportion calculated at baseline (months 1-3) will be compared to the proportion calculated for the latter half of the facilitation period (months 7-9).', 'description': 'Change in proportion of PC clinics completing IPV screening with eligible WVs during evaluation periods'}, {'measure': 'Change in Adoption of Referrals / Resource Provision (secondary implementation outcome)', 'timeFrame': 'For each site, the proportion calculated at baseline (months 1-3) will be compared to the proportion calculated for the latter half of the facilitation period (months 7-9).', 'description': 'Change in proportion of PC clinics delivering IPV screening program to eligible WVs during evaluation periods, including evidence of resource provision and referral offered for those with positive screens'}, {'measure': 'Change in Implementation Fidelity (secondary implementation outcome)', 'timeFrame': 'For each site, the proportion calculated at baseline (months 1-3) will be compared to the proportion calculated for the latter half of the facilitation period (months 7-9).', 'description': 'Change in proportion of clinics for whom WVs accept referrals attend psychosocial services within two months of positive screen'}, {'measure': 'Maintenance (secondary implementation outcome)', 'timeFrame': 'For each site, the proportion calculated in the latter half of the facilitation phase (months 7-9) will be compared to the proportion calculated for the last three months of the maintenance phase (months 19-21)', 'description': 'Change in proportion of WVs seen in Model 1 and 2 clinics during the last three months of the facilitation and maintenance phases who receive IPV screening'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intimate partner violence', 'women Veterans', 'screening', 'primary care'], 'conditions': ['Intimate Partner Violence']}, 'referencesModule': {'references': [{'pmid': '32381013', 'type': 'RESULT', 'citation': "Iverson KM, Dichter ME, Stolzmann K, Adjognon OL, Lew RA, Bruce LE, Gerber MR, Portnoy GA, Miller CJ. Assessing the Veterans Health Administration's response to intimate partner violence among women: protocol for a randomized hybrid type 2 implementation-effectiveness trial. Implement Sci. 2020 May 7;15(1):29. doi: 10.1186/s13012-020-0969-0."}, {'pmid': '34933089', 'type': 'RESULT', 'citation': 'Ogden SN, Dichter ME, Bazzi AR. Intimate partner violence as a predictor of substance use outcomes among women: A systematic review. Addict Behav. 2022 Apr;127:107214. doi: 10.1016/j.addbeh.2021.107214. Epub 2021 Dec 18.'}, {'pmid': '37990345', 'type': 'DERIVED', 'citation': 'Adjognon OL, Brady JE, Iverson KM, Stolzmann K, Dichter ME, Lew RA, Gerber MR, Portnoy GA, Iqbal S, Haskell SG, Bruce LAE, Miller CJ. Using the Matrixed Multiple Case Study approach to identify factors affecting the uptake of IPV screening programs following the use of implementation facilitation. Implement Sci Commun. 2023 Nov 21;4(1):145. doi: 10.1186/s43058-023-00528-x.'}, {'pmid': '37031032', 'type': 'DERIVED', 'citation': 'Iverson KM, Stolzmann KL, Brady JE, Adjognon OL, Dichter ME, Lew RA, Gerber MR, Portnoy GA, Iqbal S, Haskell SG, Bruce LE, Miller CJ. Integrating Intimate Partner Violence Screening Programs in Primary Care: Results from a Hybrid-II Implementation-Effectiveness RCT. Am J Prev Med. 2023 Aug;65(2):251-260. doi: 10.1016/j.amepre.2023.02.013. Epub 2023 Apr 7.'}]}, 'descriptionModule': {'briefSummary': "Up to 20% of women Veterans (WV) using VHA primary care experience past-year intimate partner violence (IPV), which contributes to numerous physical and mental health conditions, including suicidality. Despite national recommendations to screen WVs for IPV, there is low adoption of IPV screening programs in primary care. In response, VHA is spreading IPV screening programs in Women's Health Model 1 and Model 2 primary care clinics, where the majority of WV VHA primary care patients receive care. The systematic and effective implementation of IPV screening programs within primary care clinics is expected to enhance care for WVs as well as improve access to, and timeliness of, IPV-related care. Given the high prevalence of IPV among WVs and its significant negative health effects, successful implementation of IPV screening programs is expected to reduce morbidity among WV VHA patients. This stepped wedge hybrid II implementation/effectiveness study will assess efforts to implement routine IPV screening for WV VHA patients.", 'detailedDescription': 'Background: Intimate partner violence (IPV) is common among women Veterans (WVs), with nearly 20% of WVs treated in Veterans Health Administration (VHA) primary care clinics experiencing past-year IPV. VHA\'s Women\'s Health Services (WHS), the IPV Assistance Program, and the Offices of Primary Care and Mental Health and Suicide Prevention developed recommendations for implementing IPV screening programs in primary care. More than two-thirds of WV primary care patients receive care in "Model 1" (i.e., mixed-gender primary care) and "Model 2" (i.e., separate but shared space) clinics, but uptake of screening is low in these clinics. WHS therefore plans to use Blended Facilitation (BF) to roll out IPV screening programs in Model 1 and Model 2 primary care clinics. Given the high number of these clinics throughout VHA, it is unclear whether resource-intensive BF is feasible and whether a less intensive strategy (i.e., toolkit + Implementation as Usual \\[IAU\\]) can be effective. Research is also needed on the clinical effectiveness of IPV screening programs.\n\nSignificance/Impact: Given the high prevalence of IPV among WVs and its significant health effects, successful implementation of IPV screening programs is expected to improve healthcare services and reduce morbidity among WV VHA patients, an HSR\\&D priority area.\n\nInnovation: This study will be the most comprehensive evaluation of both the implementation impact and clinical effectiveness of IPV screening programs globally. It is innovative in its inclusion of four strong VHA operations partners dedicated to successful implementation of IPV screening programs. This project capitalizes on a time-sensitive opportunity to advance IPV screening programs and implementation science.\n\nSpecific Aims: This objective of this proposal is to comprehensively evaluate two strategies for implementing IPV screening programs through achieving three specific aims.\n\n1. Evaluate the degree of reach, adoption, implementation fidelity, and maintenance achieved using two implementation strategies for IPV screening programs.\n2. Evaluate the clinical effectiveness of IPV screening programs, as evidenced by disclosure rates and post-screening psychosocial service use.\n3. Identify multi-level barriers to and facilitators of IPV screening program implementation and sustainment.\n\nMethodology: The investigators propose a cluster randomized, stepped wedge, Hybrid Type II program evaluation design to compare the impact of two implementation strategies (BF + toolkit vs. toolkit + IAU) and the clinical effectiveness of IPV screening programs. This study will use a mixed methods approach to collect quantitative (clinical records data) and qualitative (key informant interviews) implementation outcomes (Aims 1 and 3), as well as quantitative (clinical records data) clinical effectiveness outcomes (Aim 2). The investigators will supplement these data collection methods with surveys to assess implementation strategies survey to be completed pre-BF, post-BF, and in the maintenance phase. The integrated-Promoting Action on Research Implementation in Health Services (i-PARIHS) framework will guide the qualitative data collection and analysis. Summative data will be analyzed using the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) Framework.\n\nNext Steps/Implementation: This study\'s four VHA operations partners are eager to use the study results to inform future implementation strategies and clinical practices to spread IPV screening programs to all VHA primary care clinics and other clinical settings so that this vital intervention is accessible to all WV VHA patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Patient population is limited to Women Veterans (WVs) eligible for screening for intimate partner violence (IPV) in primary care.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women Veterans age 18+\n* Presenting for care at participating VA-based primary care clinics.\n* Due to be screened for intimate partner violence (IPV)\n\nExclusion Criteria:\n\n* IPV screen completed in past year.'}, 'identificationModule': {'nctId': 'NCT04106193', 'briefTitle': 'Addressing Intimate Partner Violence Among Women Veterans', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': "Addressing Intimate Partner Violence Among Women Veterans: Evaluating the Impact and Effectiveness of VHA's Response", 'orgStudyIdInfo': {'id': 'SDR 18-150'}, 'secondaryIdInfos': [{'id': 'Iverson Miller SDR', 'type': 'OTHER', 'domain': 'VA Boston Healthcare System'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Toolkit + Implementation as Usual', 'description': 'Participating clinics assigned to this arm will receive a guiding toolkit and implementation as usual regarding IPV screening practices.', 'interventionNames': ['Other: Implementation as usual', 'Other: Toolkit']}, {'type': 'EXPERIMENTAL', 'label': 'Toolkit + Blended Facilitation', 'description': 'Participating clinics assigned to this arm will receive a guiding toolkit and blended facilitation to support IPV screening practices.', 'interventionNames': ['Other: Blended Facilitation', 'Other: Toolkit']}], 'interventions': [{'name': 'Blended Facilitation', 'type': 'OTHER', 'description': 'Blended facilitation consists of an External Facilitator and Internal Facilitator to support adoption of intimate partner violence screening practices for WVs treated in primary care.', 'armGroupLabels': ['Toolkit + Blended Facilitation']}, {'name': 'Implementation as usual', 'type': 'OTHER', 'description': 'Implementation as usual refers to traditional, site-initiated support for screening practices to detect intimate partner violence among WVs treated in primary care.', 'armGroupLabels': ['Toolkit + Implementation as Usual']}, {'name': 'Toolkit', 'type': 'OTHER', 'description': "All study arms will feature a toolkit meant to guide sites' adoption of intimate partner violence screening among WVs treated in primary care.", 'armGroupLabels': ['Toolkit + Blended Facilitation', 'Toolkit + Implementation as Usual']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85723', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Southern Arizona VA Health Care System, Tucson, AZ', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90822', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'VA Long Beach Healthcare System, Long Beach, CA', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '95655', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'VA Northern California Health Care System, Mather, CA', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92161', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'VA San Diego Healthcare System, San Diego, CA', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'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': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando VA Medical Center, Orlando, FL', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '02130-4817', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '39531', 'city': 'Biloxi', 'state': 'Mississippi', 'country': 'United States', 'facility': 'VA Gulf Coast Veterans Health Care System, Biloxi, MS', 'geoPoint': {'lat': 30.39603, 'lon': -88.88531}}, {'zip': '23249', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Hunter Holmes McGuire VA Medical Center, Richmond, VA', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '99362', 'city': 'Walla Walla', 'state': 'Washington', 'country': 'United States', 'facility': 'Jonathan M. Wainwright Memorial VA Medical Center, Walla Walla, WA', 'geoPoint': {'lat': 46.06458, 'lon': -118.34302}}], 'overallOfficials': [{'name': 'Katherine M. Iverson, PhD MA BA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'collaborators': [{'name': 'VA Boston Healthcare System', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-08-15', 'type': 'RELEASE'}, {'date': '2024-09-13', 'type': 'RESET'}, {'date': '2025-06-04', 'type': 'RELEASE'}, {'date': '2025-06-24', 'type': 'RESET'}], 'unpostedResponsibleParty': 'VA Office of Research and Development'}}}}