NCT06322251

Brief Summary

The goal of this study is to increase primary care professional's ability to identify individuals exposed to intimate partner violence (IPV) in primary health care settings. The main questions it aims to answer are

  1. 1.To what extent do the following three interventions contribute to identify potential victims of IPV: (1) the use of a standardized questionnaire that screens exposure to IPV, (2) staff using tailored virtual patients for clinical training on IPV and (3) a combination of interventions 1 and 2?
  2. 2.Which intervention do primary care professionals experience as most effective in increasing the ability to identify and respond to victims of IPV?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
26mo left

Started Apr 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress49%
Apr 2024Jun 2028

First Submitted

Initial submission to the registry

March 8, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 21, 2024

Completed
11 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

April 29, 2024

Status Verified

January 1, 2024

Enrollment Period

3.2 years

First QC Date

March 8, 2024

Last Update Submit

April 26, 2024

Conditions

Keywords

YouthPregnancyPrimary careVirtual patientInterpersonal violence

Outcome Measures

Primary Outcomes (1)

  • Number of identified persons seeking healthcare who have been exposed to violence

    Comparison between before and after intervention - Effectiveness within intervention

    Baseline

Secondary Outcomes (1)

  • Number of identified persons seeking healthcae who have been exposed to violence

    After the intervention during a period of 2 months

Other Outcomes (1)

  • Experiences of health care staff

    Three months after the intervention

Study Arms (3)

Use of questionnaire

OTHER

Intervention I: Over a period of two months, healthcare professionals will ask standardized questions about exposure to violence using a questionnaire that measures exposure to physical, psychological, and sexual violence over the past 12 months. These questions will be verbally asked to all patients visiting the care units, regardless of the reason for their visit.

Behavioral: Use of instrument to identify exposure to violence in close relationships

Use of virtual patient

OTHER

Intervention II: Healthcare professionals will undergo training to ask questions about violence in close relationships and practice how to utilize the answers, determine necessary care and interventions, and refer patients further. This training will utilize a "virtual patient" scenario where users interact with a realistic simulated patient through recorded video sequences. The training with the virtual patient will be conducted individually. On the digital platform, users will have access to the patient's medical background and other relevant information. Users can choose questions from a question bank, and based on their choices, they will receive feedback from both the patient and experts on their questions and treatment in the final part of the platform.

Behavioral: Use of instrument to identify exposure to violence in close relationships

Combined use of questionnaire and virtual patient

OTHER

Intervention III: This intervention combines Intervention I and II methods. Participants will investigate the identification of intimate partner violence over a two-month period after training with the virtual patient and in parallel with administering the violence questionnaire.

Behavioral: Use of instrument to identify exposure to violence in close relationships

Interventions

Use of instrument to identify exposure to violence in close relationships

Also known as: Use of Questionnaire, Use of Virtual patient, Use of a combination of questionnaire and virtual patient
Combined use of questionnaire and virtual patientUse of questionnaireUse of virtual patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All health care staff who meet patients at the included study sites are elegible for the study
  • Midwives, MDs, psychologists, social workers, nurses etc.

You may not qualify if:

  • \- Health care staff who does not want to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Linköping University

Linköping, 581 83, Sweden

RECRUITING

Study Officials

  • Mia M Barimani, Professor

    Linkoeping University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mia Barimani, Professor

CONTACT

Wibke Jonas, Ass Prof

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Baseline measure - Number of patients that are identified fo being exposed to violence. Intervention: There are three settings: 1. Primary Care Health Centers 2. Youth Clinics 3. Maternity Clinics At each type of clinic, the following interventions will be applied: Identification of domestic violence through 1. Use of Virtual patient 2. use of screening questionnaire 3. a combination of a and b above. The clinics will randomised to either condition a, b or c.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2024

First Posted

March 21, 2024

Study Start

April 1, 2024

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2028

Last Updated

April 29, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations