NCT06284148

Brief Summary

Intimate partner violence (IPV) against women in the US is a serious public health problem and a human rights issue. Our research team has developed confidential screening tools using exam-room computer for intimate partner violence to be used in primary care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19,655

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

October 6, 2010

Completed
12.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

12.8 years

First QC Date

February 9, 2024

Last Update Submit

February 21, 2024

Conditions

Keywords

Intimate Partner Violence

Outcome Measures

Primary Outcomes (2)

  • IPV positive (Yes/No)

    Depending on patient's answers to screening questions, they are flagged as either IPV positive or negative

    29 months

  • Screening completed (Yes/No)

    Whether the assigned screening was completed during patient visit

    29 months

Secondary Outcomes (2)

  • Severity of risk

    29 months

  • Physician compliance with IPV management tools

    29 months

Study Arms (3)

Sequence 1

OTHER

5 clinics. In stepped wedge design study, this was the sequence with shortest control (run-in) period. All sequences have a run-in period and intervention period. In control period participants were screened using existing nurse-led oral screening, in intervention period both - nurse-led and our new confidential screen were used at the same time.

Diagnostic Test: Screening for intimate partner violenceOther: Assessment and referral

Sequence 2

OTHER

5 clinics.

Diagnostic Test: Screening for intimate partner violenceOther: Assessment and referral

Sequence 3

OTHER

5 clinics. This was the sequence with longest control (run-in) period.

Diagnostic Test: Screening for intimate partner violenceOther: Assessment and referral

Interventions

confidential screening using exam computer

Sequence 1Sequence 2Sequence 3

confidential assessment and referral of high-risk patients using decision-support templates

Sequence 1Sequence 2Sequence 3

Eligibility Criteria

Age18 Years - 49 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsAll patients who identified as women were eligible
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Being an Medical University of South Carolina patient at primary care clinics (family medicine)
  • Women 18-49 years of age inclusive
  • Reported yes to wanting to be contacted for a follow-up research study
  • English-speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biomedical Informatics Center

Charleston, South Carolina, 29403, United States

Location

Related Publications (1)

  • Lenert L, Rheingold AA, Simpson KN, Scherbakov D, Aiken M, Hahn C, McCauley JL, Ennis N, Diaz VA. Electronic Health Record-Based Screening for Intimate Partner Violence: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2024 Aug 1;7(8):e2425070. doi: 10.1001/jamanetworkopen.2024.25070.

MeSH Terms

Interventions

Mass ScreeningRestraint, PhysicalReferral and Consultation

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health PracticeBehavior ControlTherapeuticsImmobilizationProfessional PracticeOrganization and AdministrationHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
SEQUENTIAL
Model Details: This is a stepped wedge cluster randomized trial which has 3 sequences starting intervention in randomized order.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor-Faculty

Study Record Dates

First Submitted

February 9, 2024

First Posted

February 28, 2024

Study Start

October 6, 2010

Primary Completion

July 31, 2023

Study Completion

July 31, 2023

Last Updated

February 28, 2024

Record last verified: 2024-02

Locations