Clinical trial NCT04106193: Addressing Intimate Partner Violence Among Women Veterans
Official title: Addressing Intimate Partner Violence Among Women Veterans: Evaluating the Impact and Effectiveness of VHA's Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intimate Partner Violence
Keywords: intimate partner violence
women Veterans
screening
primary care
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: VA Boston Healthcare System
First posted: 2019-09-26
Enrollment: 7421
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Hybrid type II implementation-effectiveness design; stepped wedge
Primary purpose: SCREENING

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.

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.

Primary outcomes:
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).
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).
Secondary outcomes:
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).
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).
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).
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).
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)
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Southern Arizona VA Health Care System, Tucson, AZ
state: Arizona
city: Long Beach
country: United States
facility: VA Long Beach Healthcare System, Long Beach, CA
state: California
city: Sacramento
country: United States
facility: VA Northern California Health Care System, Mather, CA
state: California
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego, CA
state: California
city: West Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
state: California
city: Orlando
country: United States
facility: Orlando VA Medical Center, Orlando, FL
state: Florida
city: Boston
country: United States
facility: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
state: Massachusetts
city: Biloxi
country: United States
facility: VA Gulf Coast Veterans Health Care System, Biloxi, MS
state: Mississippi
city: Richmond
country: United States
facility: Hunter Holmes McGuire VA Medical Center, Richmond, VA
state: Virginia
city: Walla Walla
country: United States
facility: Jonathan M. Wainwright Memorial VA Medical Center, Walla Walla, WA
state: Washington
Study officials:
affiliation: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
name: Katherine M. Iverson, PhD MA BA
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.