Confidential IPV Screening Tool

NCT ID: NCT06284148

Last Updated: 2024-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19655 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-06

Study Completion Date

2023-07-31

Brief Summary

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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

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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.

Conditions

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Violence, Domestic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

This is a stepped wedge cluster randomized trial which has 3 sequences starting intervention in randomized order.
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Sequence 1

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.

Group Type OTHER

Screening for intimate partner violence

Intervention Type DIAGNOSTIC_TEST

confidential screening using exam computer

Assessment and referral

Intervention Type OTHER

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

Sequence 2

5 clinics.

Group Type OTHER

Screening for intimate partner violence

Intervention Type DIAGNOSTIC_TEST

confidential screening using exam computer

Assessment and referral

Intervention Type OTHER

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

Sequence 3

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

Group Type OTHER

Screening for intimate partner violence

Intervention Type DIAGNOSTIC_TEST

confidential screening using exam computer

Assessment and referral

Intervention Type OTHER

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

Interventions

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Screening for intimate partner violence

confidential screening using exam computer

Intervention Type DIAGNOSTIC_TEST

Assessment and referral

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role collaborator

Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Leslie Lenert

Professor-Faculty

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Biomedical Informatics Center

Charleston, South Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 39088215 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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5R18HS025654-03

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

Pro00093964

Identifier Type: -

Identifier Source: org_study_id

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