Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06322251
Status:
RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-03-08
Brief Title:
Identification of Interpesonal Violence
Sponsor:
Region Stockholm
Organization:
Region Stockholm
Study Overview
Official Title:
Identifying Intimate Partner Violence an Intervention Study in Health Care Using a Standardised Questionnaire and Virtual Patients
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ViP
Brief Summary:
The goal of this study is to increase primary care professionals 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
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
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
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 centersyouth 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 eg 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 Swedens 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 studys 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 researchers analytical starting points This approach ensures that the thematic analysis remains data-driven
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 centersyouth 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 eg 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 Swedens 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 studys 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 researchers analytical starting points This approach ensures that the thematic analysis remains data-driven
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None