Addressing Intimate Partner Violence Among Women Veterans

October 4, 2023 updated by: VA Office of Research and Development

Addressing Intimate Partner Violence Among Women Veterans: Evaluating the Impact and Effectiveness of VHA's Response

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

7421

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arizona
      • Tucson, Arizona, United States, 85723
        • Southern Arizona VA Health Care System, Tucson, AZ
    • California
      • Long Beach, California, United States, 90822
        • VA Long Beach Healthcare System, Long Beach, CA
      • Sacramento, California, United States, 95655
        • VA Northern California Health Care System, Mather, CA
      • San Diego, California, United States, 92161
        • VA San Diego Healthcare System, San Diego, CA
      • West Los Angeles, California, United States, 90073
        • VA Greater Los Angeles Healthcare System, West Los Angeles, CA
    • Florida
      • Orlando, Florida, United States, 32803
        • Orlando VA Medical Center, Orlando, FL
    • Massachusetts
      • Boston, Massachusetts, United States, 02130-4817
        • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
    • Mississippi
      • Biloxi, Mississippi, United States, 39531
        • VA Gulf Coast Veterans Health Care System, Biloxi, MS
    • Virginia
      • Richmond, Virginia, United States, 23249
        • Hunter Holmes McGuire VA Medical Center, Richmond, VA
    • Washington
      • Walla Walla, Washington, United States, 99362
        • Jonathan M. Wainwright Memorial VA Medical Center, Walla Walla, WA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Toolkit + Implementation as Usual
Participating clinics assigned to this arm will receive a guiding toolkit and implementation as usual regarding IPV screening practices.
Implementation as usual refers to traditional, site-initiated support for screening practices to detect intimate partner violence among WVs treated in primary care.
All study arms will feature a toolkit meant to guide sites' adoption of intimate partner violence screening among WVs treated in primary care.
Experimental: Toolkit + Blended Facilitation
Participating clinics assigned to this arm will receive a guiding toolkit and blended facilitation to support IPV screening practices.
All study arms will feature a toolkit meant to guide sites' adoption of intimate partner violence screening among WVs treated in primary care.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Reach (primary implementation outcome)
Time Frame: 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).
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
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).
Change in Disclosure Rate (primary clinical effectiveness outcome)
Time Frame: 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).
Change in proportion of eligible WVs who screen positive for IPV
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).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Psychosocial Service Use (secondary clinical effectiveness outcome)
Time Frame: 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).
Change in proportion of WVs accepting psychosocial service referrals following a positive IPV screen who use such services within two months
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).
Adoption of Screening (secondary implementation outcome)
Time Frame: 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).
Change in proportion of PC clinics completing IPV screening with eligible WVs during evaluation periods
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).
Change in Adoption of Referrals / Resource Provision (secondary implementation outcome)
Time Frame: 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).
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
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).
Change in Implementation Fidelity (secondary implementation outcome)
Time Frame: 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).
Change in proportion of clinics for whom WVs accept referrals attend psychosocial services within two months of positive screen
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).
Maintenance (secondary implementation outcome)
Time Frame: 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)
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
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Katherine M. Iverson, PhD MA BA, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2020

Primary Completion (Actual)

September 30, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

September 23, 2019

First Submitted That Met QC Criteria

September 25, 2019

First Posted (Actual)

September 26, 2019

Study Record Updates

Last Update Posted (Actual)

October 5, 2023

Last Update Submitted That Met QC Criteria

October 4, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • SDR 18-150
  • Iverson Miller SDR (Other Identifier: VA Boston Healthcare System)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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