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Clinical Trials/NCT06284148
NCT06284148CompletedNot Applicable

EHR-based Screening and Intervention for Intimate Partner Violence

Medical University of South Carolina2 sites in 1 country19,655 target enrollmentStarted: October 6, 2010Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
19,655
Locations
2
Primary Endpoint
Screening completed (Yes/No)

Study Overview

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.

Detailed Description

The objective of this study was to develop and evaluate an integrated suite of electronic health record (EHR) tools that automates "best practices" from Northern California Kaiser Permanente for screening and intervention for IPV identified within clinical settings. The goal of the intervention goes beyond mere screening of patients for IPV and includes tools for assessment of IPV risk, for documentation of IPV care, and support for a warm hand-off during the primary care visit to a national IPV hotline resource. Importantly, the study includes work to keep notes documenting IPV and billing for IPV care confidential, segmenting this care in a secure segment of the electronic health record.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential
Primary Purpose
Screening
Masking
None

Eligibility Criteria

Ages
18 Years to 49 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • No exclusion criteria

Arms & Interventions

Sequence 2

Other

5 clinics.

Intervention: Assessment and referral (Other)

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.

Intervention: Screening for intimate partner violence (Diagnostic Test)

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.

Intervention: Assessment and referral (Other)

Sequence 2

Other

5 clinics.

Intervention: Screening for intimate partner violence (Diagnostic Test)

Sequence 3

Other

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

Intervention: Screening for intimate partner violence (Diagnostic Test)

Sequence 3

Other

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

Intervention: Assessment and referral (Other)

Outcomes

Primary Outcomes

Screening completed (Yes/No)

Time Frame: 29 months

Whether the assigned screening was completed during patient visit

IPV positive (Yes/No)

Time Frame: 29 months

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

Secondary Outcomes

  • Severity of risk(29 months)
  • Physician compliance with IPV management tools(29 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Leslie Lenert

Professor-Faculty

Medical University of South Carolina

Study Sites (2)

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