Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:32 PM
Study NCT ID:
NCT04106193
Status:
COMPLETED
Last Update Posted:
2023-10-05
First Post:
2019-09-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Addressing Intimate Partner Violence Among Women Veterans
Sponsor:
VA Office of Research and Development
Organization:
Study Overview
Official Title:
Addressing Intimate Partner Violence Among Women Veterans: Evaluating the Impact and Effectiveness of VHA's Response
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
Significance/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.
Innovation: 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.
Specific Aims: This objective of this proposal is to comprehensively evaluate two strategies for implementing IPV screening programs through achieving three specific aims.
1. Evaluate the degree of reach, adoption, implementation fidelity, and maintenance achieved using two implementation strategies for IPV screening programs.
2. Evaluate the clinical effectiveness of IPV screening programs, as evidenced by disclosure rates and post-screening psychosocial service use.
3. Identify multi-level barriers to and facilitators of IPV screening program implementation and sustainment.
Methodology: 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.
Next 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.
Significance/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.
Innovation: 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.
Specific Aims: This objective of this proposal is to comprehensively evaluate two strategies for implementing IPV screening programs through achieving three specific aims.
1. Evaluate the degree of reach, adoption, implementation fidelity, and maintenance achieved using two implementation strategies for IPV screening programs.
2. Evaluate the clinical effectiveness of IPV screening programs, as evidenced by disclosure rates and post-screening psychosocial service use.
3. Identify multi-level barriers to and facilitators of IPV screening program implementation and sustainment.
Methodology: 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.
Next 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| Iverson Miller SDR | OTHER | VA Boston Healthcare System | View |