NCT04106193

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,421

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 26, 2019

Completed
1.1 years until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

October 5, 2023

Status Verified

October 1, 2023

Enrollment Period

2.9 years

First QC Date

September 23, 2019

Last Update Submit

October 4, 2023

Conditions

Keywords

intimate partner violencewomen Veteransscreeningprimary care

Outcome Measures

Primary Outcomes (2)

  • Change in Reach (primary implementation outcome)

    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)

    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 Outcomes (5)

  • Change in Psychosocial Service Use (secondary clinical effectiveness outcome)

    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)

    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)

    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)

    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)

    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)

Study Arms (2)

Toolkit + Implementation as Usual

EXPERIMENTAL

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

Other: Implementation as usualOther: Toolkit

Toolkit + Blended Facilitation

EXPERIMENTAL

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

Other: Blended FacilitationOther: Toolkit

Interventions

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 + Blended Facilitation

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

Toolkit + Implementation as Usual
ToolkitOTHER

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 FacilitationToolkit + Implementation as Usual

Eligibility Criteria

Age18 Years - 100 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPatient population is limited to Women Veterans (WVs) eligible for screening for intimate partner violence (IPV) in primary care.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • IPV screen completed in past year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Southern Arizona VA Health Care System, Tucson, AZ

Tucson, Arizona, 85723, United States

Location

VA Long Beach Healthcare System, Long Beach, CA

Long Beach, California, 90822, United States

Location

VA Northern California Health Care System, Mather, CA

Sacramento, California, 95655, United States

Location

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161, United States

Location

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

West Los Angeles, California, 90073, United States

Location

Orlando VA Medical Center, Orlando, FL

Orlando, Florida, 32803, United States

Location

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

Boston, Massachusetts, 02130-4817, United States

Location

VA Gulf Coast Veterans Health Care System, Biloxi, MS

Biloxi, Mississippi, 39531, United States

Location

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Richmond, Virginia, 23249, United States

Location

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

Walla Walla, Washington, 99362, United States

Location

Related Publications (4)

  • 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.

  • 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.

  • 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.

  • 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.

Study Officials

  • Katherine M. Iverson, PhD MA BA

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
CROSSOVER
Model Details: Hybrid type II implementation-effectiveness design; stepped wedge
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2019

First Posted

September 26, 2019

Study Start

November 1, 2020

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

October 5, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations