Identification of Interpesonal Violence

Pregnancy Clinical Trial

— ViP  

Official title:

Identifying Intimate Partner Violence: an Intervention Study in Health Care Using a Standardised Questionnaire and Virtual Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06322251
• Other study ID #: 2023-03399-01
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: June 30, 2028

Study information

• Verified date: January 2024
• Source: Region Stockholm
• Contact: Mia Barimani, Professor
• Phone: 0046-73-7083163
• Email: mia.barimani[@]liu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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. Which intervention do primary care professionals experience as most effective in increasing the ability to identify and respond to victims of IPV?

Participants will be divided to apply one of the three interventions in their health care setting: 1) a standardized questionnaire to patients, 2) virtual patients tailored to health professionals, and 3) a combination of 1 and 2.

Pre-and post-measurement of the health professionals identification of patients exposed to IPV will will be used to explore the effect of the interventions.

Focus group interviews with the participating health professionals will be a qualitative complement. The participants will be asked about what intervention they experience as the most effective in increasing the ability to identify victims of IPV.

Description:

The project is expected to last for three years and is based on a quasi-experimental design. The outcome is the registration of the number of individuals exposed to intimate partner violence, which will be investigated before and after intervention. Qualitative focus group interviews with participating healthcare professionals will also be included to investigate which intervention they perceive as most effective in increasing the ability to identify people exposed to intimate partner violence. The project will be carried out at different care units in primary care (health centers, midwifery clinics, youth clinics), and healthcare professionals will be randomized based on the following three interventions:

1. Use of a standardized questionnaire.

2. Training in asking questions about intimate partner violence via training with tailored virtual patients.

3. A combination of interventions 1 and 2.

To measure the outcome of the project, the research group will use registry data (health centers/youth clinics) and a protocol (midwifery clinics) to record the number of patients exposed to intimate partner violence.

The research subjects in this project are primarily participating healthcare professionals involved in the interventions. The nature of data from the research subjects primarily consists of background information such as demographic data (e.g., age, level of education, occupational category, gender, professional experience), and whether healthcare professionals have undergone any training on IPV. This data should not be used in any analyses but only constitutes a descriptive description of the research subjects when data will be presented in scientific papers. Qualitative focus group interviews with participating healthcare professionals will also be included to investigate which intervention they experience as most effective in increasing the ability to identify people exposed to intimate partner violence.

Registry data for patients who have visited health centers and youth clinics will be collected retrospectively from the Center for Health Data in Region Stockholm. Sociodemographic information about visitors to health centers and youth clinics is obtained from Statistics Sweden's population register; however, names and social security numbers are not conveyed to the research group. Pseudonymization is carried out, and the code key is stored at the Centre for Health Data. In the protocols, midwifery clinics will note the number of patients who state exposure to violence in close relationships, reasons for seeking treatment, support measures taken by healthcare staff, and whether the patient is exposed to violence.

Data will be measured at the group level within participating activities. Validity may become uncertain if healthcare professionals forget to document information in medical records or protocols, or if there are healthcare professionals who do not want to participate in the intervention. To counteract this, each participating unit will have a contact person who will be available and in regular contact with the unit. Before the intervention starts, members of the research team will also provide information about the study and approach.

Regarding the qualitative design, reliability is of paramount importance. Therefore, we will thoroughly describe data collection and the process of data analysis.

The analysis will primarily involve pre- and post-measurements of the interventions. Additionally, the reseachers will employ statistical analyses to compare the identification of cases of intimate partner violence among the three different interventions (comparisons between intervention groups). The researches will investigate whether the number of patients registered as victims of intimate partner violence has increased at each care unit after participants have undergone the study's interventions. Measurements will be conducted at the group level based on the participating care units, with the analysis focusing primarily on pre- and post-measurements.

Furthermore, the researchers will compare whether the number of registered cases of intimate partner violence differs between the three different interventions (comparison between intervention groups). This will be analyzed through regression analyses, where pre- and post-measurement is included as an interaction variable (time-after) x group (intervention).

The focus group interviews will be recorded, transcribed, and analyzed using inductive thematic analysis. Inductive analysis involves encoding data without attempting to fit it into a pre-existing coding template or the researcher's analytical starting points. This approach ensures that the thematic analysis remains data-driven.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 30, 2028
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• All health care staff who meet patients at the included study sites are elegible for the study

• Midwives, MDs, psychologists, social workers, nurses etc.

Exclusion criteria:

• Health care staff who does not want to participate

Related Conditions & MeSH terms

• Interpersonal Violence
• Pregnancy
• Primary Health Care
• Youth

Intervention

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

Locations

Country	Name	City	State
Sweden	Linköping University	Linköping

Sponsors (4)

Lead Sponsor	Collaborator
Region Stockholm	Karolinska Institutet, Linkoeping University, Stockholm University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Experiences of health care staff	Experiences of health care staff to use questionnaire / virtual patient will be obtained in interviews.	Three months after the intervention
Primary	Number of identified persons seeking healthcare who have been exposed to violence	Comparison between before and after intervention - Effectiveness within intervention	Baseline
Secondary	Number of identified persons seeking healthcae who have been exposed to violence	Comparison between different interventions (Effectiveness between interventions)	After the intervention during a period of 2 months