Confidential IPV Screening Tool

February 21, 2024 updated by: Leslie Lenert, Medical University of South Carolina

EHR-based Screening and Intervention for Intimate Partner Violence

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

19655

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • Biomedical Informatics Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.

confidential screening using exam computer
confidential assessment and referral of high-risk patients using decision-support templates
Other: Sequence 2
5 clinics.
confidential screening using exam computer
confidential assessment and referral of high-risk patients using decision-support templates
Other: Sequence 3
5 clinics. This was the sequence with longest control (run-in) period.
confidential screening using exam computer
confidential assessment and referral of high-risk patients using decision-support templates

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
29 months
Screening completed (Yes/No)
Time Frame: 29 months
Whether the assigned screening was completed during patient visit
29 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of risk
Time Frame: 29 months
using Danger 5 risk assessment, ranging from 0 to 5
29 months
Physician compliance with IPV management tools
Time Frame: 29 months
Measured as the rate of completion of follow-up decision templates, and the rate of referrals for post-visit counseling to a national hotline (a share from screened positive patients
29 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2010

Primary Completion (Actual)

July 31, 2023

Study Completion (Actual)

July 31, 2023

Study Registration Dates

First Submitted

February 9, 2024

First Submitted That Met QC Criteria

February 21, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • Pro00093964
  • 5R18HS025654-03 (U.S. AHRQ Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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