Addressing Intimate Partner Violence Among Women Veterans

NCT ID: NCT04106193

Last Updated: 2023-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7421 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2023-09-30

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.

Conditions

Intimate Partner Violence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Toolkit + Implementation as Usual

Participating clinics assigned to this arm will receive a guiding toolkit and implementation as usual regarding IPV screening practices.

Group Type: EXPERIMENTAL

Implementation as usual

Intervention Type: OTHER

Implementation as usual refers to traditional, site-initiated support for screening practices to detect intimate partner violence among WVs treated in primary care.

Toolkit

Intervention Type: OTHER

All study arms will feature a toolkit meant to guide sites' adoption of intimate partner violence screening among WVs treated in primary care.

Toolkit + Blended Facilitation

Participating clinics assigned to this arm will receive a guiding toolkit and blended facilitation to support IPV screening practices.

Group Type: EXPERIMENTAL

Blended Facilitation

Intervention Type: OTHER

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.

Toolkit

Intervention Type: OTHER

All study arms will feature a toolkit meant to guide sites' adoption of intimate partner violence screening among WVs treated in primary care.

Interventions

Blended Facilitation

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.

Intervention Type: OTHER

Implementation as usual

Implementation as usual refers to traditional, site-initiated support for screening practices to detect intimate partner violence among WVs treated in primary care.

Intervention Type: OTHER

Toolkit

All study arms will feature a toolkit meant to guide sites' adoption of intimate partner violence screening among WVs treated in primary care.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Women Veterans age 18+
• Presenting for care at participating VA-based primary care clinics.
• Due to be screened for intimate partner violence (IPV)

Exclusion Criteria

• IPV screen completed in past year.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

VA Boston Healthcare System

FED

Sponsor Role: collaborator

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katherine M. Iverson, PhD MA BA

Role: PRINCIPAL_INVESTIGATOR

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Locations

Southern Arizona VA Health Care System, Tucson, AZ

Tucson, Arizona, United States

VA Long Beach Healthcare System, Long Beach, CA

Long Beach, California, United States

VA Northern California Health Care System, Mather, CA

Sacramento, California, United States

VA San Diego Healthcare System, San Diego, CA

San Diego, California, United States

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, United States

Orlando VA Medical Center, Orlando, FL

Orlando, Florida, United States

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, United States

VA Gulf Coast Veterans Health Care System, Biloxi, MS

Biloxi, Mississippi, United States

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Richmond, Virginia, United States

Jonathan M. Wainwright Memorial VA Medical Center, Walla Walla, WA

Walla Walla, Washington, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 32381013 (View on PubMed)

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.

Reference Type: RESULT

PMID: 34933089 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37990345 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37031032 (View on PubMed)

Other Identifiers

Iverson Miller SDR

Identifier Type: OTHER

Identifier Source: secondary_id

SDR 18-150

Identifier Type: -

Identifier Source: org_study_id