Primary Health CareViPNCT06322251
Identification of Interpesonal Violence
A study testing Use of instrument to identify exposure to violence in close relationships in people with Primary Health Care and Interpersonal Violence, run by Region Stockholm at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Health Care, Interpersonal Violence, Youth
- What is being tested?
- Use of instrument to identify exposure to violence in close relationships
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 1 Apr 2024to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All health care staff who meet patients at the included study sites are elegible for the study
- Midwives, MDs, psychologists, social workers, nurses etc.
Who cannot join
- Health care staff who does not want to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Linköping University
Linköping, 581 83
Mia Barimani, Professor, +46737083163, mia.barimani@liu.se
Wibke Jonas, Ass prof, +46707482518, wibke.jonas@ki.se
About this study
Official title: Identifying Intimate Partner Violence: an Intervention Study in Health Care Using a Standardised Questionnaire and Virtual Patients
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
Read more
- 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?
- 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.
Read the detailed 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:
- Use of a standardized questionnaire.
- Training in asking questions about intimate partner violence via training with tailored virtual patients.
- 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.
- Conditions
- Primary Health Care, Interpersonal Violence, Youth, Pregnancy
- Being tested
- Use of instrument to identify exposure to violence in close relationships
- Keywords
- Youth, Pregnancy, Primary care, Virtual patient, Interpersonal violence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of instrument to identify exposure to violence in close relationshipsBehavioural
Also called Use of Questionnaire, Use of Virtual patient, Use of a combination of questionnaire and virtual patient
Use of instrument to identify exposure to violence in close relationships
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Use of instrument to identify exposure to violence in close relationships |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of identified persons seeking healthcare who have been exposed to violence
Comparison between before and after intervention - Effectiveness within intervention
Measured: Baseline
Secondary outcomes (1)
Number of identified persons seeking healthcae who have been exposed to violence
Comparison between different interventions (Effectiveness between interventions)
Measured: After the intervention during a period of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start1 Apr 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
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 Primary Health CareStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- Linkoeping University, Karolinska Institutet, Stockholm University
- Responsible party
- Sponsor
- Investigators
- Mia M Barimani, Professor, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06322251
- Sponsor's protocol ID
- 2023-03399-01
- Other IDs
- 2023
- Acronym
- ViP
- Status last verified
- Jan 2024
- First submitted
- 8 Mar 2024
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jonas W, Dahlstrom K, Eikemo R, Elvin Nowak Y, Fors U, Hurtig C, Lindberg L, Rhen M, Stenfors T, Sorman K, Zamora Hernandez M, Barimani M. Intimate partner violence: protocol of a quasi-experimental study to increase primary care professionals' ability to identify exposed individuals. BMJ Open. 2026 May 24;16(5):e095421. doi: 10.1136/bmjopen-2024-095421.
PubMed 42192620
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Intimate Partner Violence: an Intervention Study in Health Care Using a Standardised Questionnaire and Virtual Patients
- ClinicalTrials.gov ID
- NCT06322251
- Acronym / sponsor ID
- ViP / 2023-03399-01
- Conditions
- Primary Health Care, Interpersonal Violence, Youth, Pregnancy
- Keywords
- Youth, Pregnancy, Primary care, Virtual patient, Interpersonal violence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- Linkoeping University, Karolinska Institutet, Stockholm University
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 21 Mar 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.
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
- 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?
- 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.
Detailed 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:
- Use of a standardized questionnaire.
- Training in asking questions about intimate partner violence via training with tailored virtual patients.
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Use of questionnaire | Other | Behavioral: Use of instrument to identify exposure to violence in close relationshipsIntervention 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. |
| Use of virtual patient | Other | Behavioral: Use of instrument to identify exposure to violence in close relationshipsIntervention 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. |
| Combined use of questionnaire and virtual patient | Other | Behavioral: Use of instrument to identify exposure to violence in close relationshipsIntervention 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All health care staff who meet patients at the included study sites are elegible for the study
- Midwives, MDs, psychologists, social workers, nurses etc.
Key exclusion criteria (1 listed)
- Health care staff who does not want to participate
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 |
|---|---|---|
| Use of instrument to identify exposure to violence in close relationshipsAlso: Use of Questionnaire, Use of Virtual patient, Use of a combination of questionnaire and virtual patientUse of instrument to identify exposure to violence in close relationships | Behavioural | Combined use of questionnaire and virtual patient, Use of questionnaire, Use of virtual patient |
Primary outcome
Number of identified persons seeking healthcare who have been exposed to violence
Time frame: Baseline
Comparison between before and after intervention - Effectiveness within intervention
1 secondary outcome
Number of identified persons seeking healthcae who have been exposed to violence
Time frame: After the intervention during a period of 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- Derived from this study: PubMed 42192620Jonas W, Dahlstrom K, Eikemo R, Elvin Nowak Y, Fors U, Hurtig C, Lindberg L, Rhen M, Stenfors T, Sorman K, Zamora Hernandez M, Barimani M. Intimate partner violence: protocol of a quasi-experimental study to increase primary care professionals' ability to identify exposed individuals. BMJ Open. 2026 May 24;16(5):e095421. doi: 10.1136/bmjopen-2024-095421.
- Individual participant dataSharing planned: No
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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.
Mia M Barimani, Professor principal investigator
Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of instrument to identify exposure to violence in close relationships in people with Primary Health Care and Interpersonal Violence, run by Region Stockholm at 1 site in Sweden.
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 2 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: looking for participants now, as of the sponsor's last update on 29 Apr 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mia Barimani, Professor (0046-73-7083163, mia.barimani@liu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of identified persons seeking healthcare who have been exposed to violence (time frame: Baseline). 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 NCT06322251, 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 29 Apr 2024.