Violence, DomesticNCT06284148
Confidential IPV Screening Tool
A study testing Screening for intimate partner violence and Assessment and referral in people with Violence, Domestic, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years
- Conditions the study is for
- Violence, Domestic
- What is being tested?
- Screening for intimate partner violence and Assessment and referral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19,655 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2010to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- No exclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Biomedical Informatics Center
Charleston, South Carolina, 29403
About this study
Official title: 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.
Read the 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.
- Conditions
- Violence, Domestic
- Being tested
- Screening for intimate partner violence, Assessment and referral
- Keywords
- Intimate Partner Violence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening for intimate partner violenceDiagnostic test
confidential screening using exam computer
Assessment and referralOther
confidential assessment and referral of high-risk patients using decision-support templates
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Screening for intimate partner violence; Other: Assessment and referral |
| Sequence 2 | Other | 5 clinics. Receives: Diagnostic Test: Screening for intimate partner violence; Other: Assessment and referral |
| Sequence 3 | Other | 5 clinics. This was the sequence with longest control (run-in) period. Receives: Diagnostic Test: Screening for intimate partner violence; Other: Assessment and referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
IPV positive (Yes/No)
Depending on patient's answers to screening questions, they are flagged as either IPV positive or negative
Measured: 29 months
Screening completed (Yes/No)
Whether the assigned screening was completed during patient visit
Measured: 29 months
Secondary outcomes (2)
Severity of risk
using Danger 5 risk assessment, ranging from 0 to 5
Measured: 29 months
Physician compliance with IPV management tools
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
Measured: 29 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start6 Oct 2010
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Violence, DomesticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This is a stepped wedge cluster randomized trial which has 3 sequences starting intervention in randomized order.
- Masking
- None (open label)
- Enrolment
- 19,655 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Leslie Lenert, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284148
- Sponsor's protocol ID
- Pro00093964
- Other IDs
- 5R18HS025654-03
- Status last verified
- Feb 2024
- First submitted
- 9 Feb 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39088215
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EHR-based Screening and Intervention for Intimate Partner Violence
- ClinicalTrials.gov ID
- NCT06284148
- Acronym / sponsor ID
- Pro00093964
- Conditions
- Violence, Domestic
- Keywords
- Intimate Partner Violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19,655 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 6 Oct 2010 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a stepped wedge cluster randomized trial which has 3 sequences starting intervention in randomized order.
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Other | Diagnostic Test: Screening for intimate partner violence, Other: Assessment and referral5 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. |
| Sequence 2 | Other | Diagnostic Test: Screening for intimate partner violence, Other: Assessment and referral5 clinics. |
| Sequence 3 | Other | Diagnostic Test: Screening for intimate partner violence, Other: Assessment and referral5 clinics. This was the sequence with longest control (run-in) period. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- No exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening for intimate partner violenceconfidential screening using exam computer | Diagnostic test | Sequence 1, Sequence 2, Sequence 3 |
| Assessment and referralconfidential assessment and referral of high-risk patients using decision-support templates | Other | Sequence 1, Sequence 2, Sequence 3 |
Primary outcome
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
Screening completed (Yes/No)
Time frame: 29 months
Whether the assigned screening was completed during patient visit
2 secondary outcomes
Severity of risk
Time frame: 29 months
Physician compliance with IPV management tools
Time frame: 29 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Derived from this study: PubMed 39088215Lenert 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening for intimate partner violence and Assessment and referral in people with Violence, Domestic, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IPV positive (Yes/No) (time frame: 29 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06284148, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.