- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06284148
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
Status
Completed
Conditions
Intervention / Treatment
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.
Collaborators
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
Keywords
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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