Domestic ViolenceNCT05543395
The Reporting of Domestic Violence by Patients in the Emergency Department of the Reims University Hospital Center
An observational study of Domestic Violence, run by CHU de Reims at 1 site in France.
Trial summary
Domestic violence is defined as violence carried out by one of the partners in a relationship of domination. This can be verbal, psychological, physical or sexual. Domestic violence is a real public health problem for which emergencies are at the forefront. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Domestic Violence
- What is being tested?
- Domestic Violence Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 47 participants
- Where
- 1 siteFrance
- Study dates
- 8 Feb 2021to 3 Aug 2021
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patient, who consults in the emergency department of the Reims University Hospital Center, for whom domestic violence is known or suspected, accepting or not to report to the public prosecutor. Patient is able to agree of their own accord to participate in the study.
Who may be able to join
- Adults over 18 years old
- Accepting participation in the study
- For whom domestic violence is known or suspected during the interview with the emergency doctor
Who cannot join
- Minors under the age of 18
- Unable to agree to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Domestic violence is defined as violence carried out by one of the partners in a relationship of domination. This can be verbal, psychological, physical or sexual.
Domestic violence is a real public health problem for which emergencies are at the forefront.
Read more
In this context, the emergency department of the Reims University Hospital Center, the Public Prosecutor and the association LE MARS France Victim 51 decided to set up a report on July 01, 2020.
The report consists of retrieving the identity and information relating to the violence suffered through a survey, or report card . The report card, as well as an initial certificate without the total incapacity for work written by the doctor during the consultation, will be sent immediately by secure email to the public prosecutor and the police. The emails will be processed in real time by the prosecutor on duty. The contact details with the family name, first name and telephone number will be sent to the association LE MARS France Victime 51. Reporting therefore allows the prosecutor to decide whether or not to open a criminal investigation., At the same time, this will allow us to provide support through the association providing assistance to victims of domestic violence.
The objective of this study is to describe the proportion of patients accepting to report to the public prosecutor among the patients consulting the emergency department of the Reims University Hospital Center and for whom domestic violence is known or suspected. The secondary objectives will be to describe the number of patients who are victims of proven or suspected domestic violence consulting the emergency department, as well as to describe the factors associated with the acceptance of the report.
Participation in the study will consist of completing a questionnaire specific to the study. The estimated time to complete this questionnaire is 5 minutes.
This study will allow us to know the prevalence of acceptance of the report card in the emergency department of the Reims University Hospital Center. This information will tell us if this new procedure could be beneficial for the management of domestic violence and if the majority of patients are in favor of it.
Read the detailed description
- Medical background :
Domestic violence is defined as violence carried out by one of the partners in a relationship of domination. This can be verbal, psychological, physical or sexual.
This type of violence is a real public health problem. According to a study carried out by the French government in 2018, 213 000 women aged 18 to 75 were victims of physical and / or sexual violence committed by their spouse or ex-spouse in 2018. According to this same study, 121 women and 28 men were killed by their partner or ex-partner. These figures are increasing every year, and the screening of these patients is a major issue.
A doctor is on the front line in screening for this violence. In fact, 3 to 4 women out of 10 in doctors' waiting rooms are victims of domestic violence; and one in five victims first saw a doctor after an incident. A French study carried out in 2002 also showed that 35% of consultations in an emergency department with a woman patient were related to domestic violence.
The High Authority of Health systematically recommends asking each patient and each suspicion of violence within the couple the question "are you a victim of domestic violence?". However, this recommendation remains largely insufficient as well as the assistance provided to the victims. Furthermore, only 19% of these victims say they have filed a complaint with an authority according to the High Authority of Health. Screening remains the first step in the care and identification of victims, but more measures are needed to be put in place to help these patients take legal action and get out of this vicious circle of domestic violence.
The emergencies are therefore one of the first recourse for patients who are victims of domestic violence and it is the role of the emergency physician to take all possible means to detect, help and support these victims.
In this context, the emergency department of the Reims University Hospital Center, the Public Prosecutor and the association LE MARS France Victim 51 decided to set up a report on July 01, 2020.
The report consists of retrieving the identity and information relating to the violence suffered through a survey, or report card . The report card, as well as an initial certificate without the total incapacity for work written by the doctor during the consultation, will be sent immediately by secure email to the public prosecutor and the police. The emails will be processed in real time by the prosecutor on duty. The contact details with the family name, first name and telephone number will be sent to the association LE MARS France Victime 51. Reporting therefore allows the prosecutor to decide whether or not to open a criminal investigation., At the same time, this will allow us to provide support through the association providing assistance to victims of domestic violence.
II. Goals:
The objective of this study is to describe the proportion of patients accepting to report to the public prosecutor among the patients consulting the emergency department of the Reims university hospital center and for whom domestic violence is known or suspected. The secondary objectives will be to describe the number of patients who are victims of proven or suspected domestic violence consulting the emergency department, as well as to describe the factors associated with the acceptance of the report card.
III. Investigation plan:
- Evaluation criteria: A questionnaire composed of two parts was drawn up as part of this study. The first part will be completed by the patients thmselves and will collect information about them relating to their current circumstances and history. The second part is completed by the doctor specifying whether or not the patient has accepted to complete the report, the examinations carried out in the emergency room as well as the entry and exit diagnoses.
The main endpoint is acceptance of direct reporting to the public prosecutor. Secondary endpoints are the factors potentially associated with whether or not patients accept direct reporting to the public prosecutor.
IV. Methodology:
- Experimental design: This is a cross-sectional, observational, prospective inclusion, single-center (Reims University Hospital Center) study over a period of 6 months.
- Investigation plan: Participation in the study will be offered to all patients consulting the emergency reception service of the Reims University Hospital Center during the inclusion phase of the study and for whom domestic violence is proven or suspected during the interview. Information on the objectives and methods of the study will be given to them with the help of the information note. If the patient agrees to participate in the study, they will be included in the study. Participation in the study will not affect the patient's medical management. Participation in the study will lead to:
- Completion of a questionnaire by the patient (on proven or suspected domestic violence)
- A collection of data concerning the patient and their consultation at the emergency reception service.
- Estimated recruitment time The recruitment period will be 6 months.
- Duration of participation by subject The duration of patient participation is ad hoc, the time to complete the questionnaire, the duration of which is estimated to be 5 minutes.
- Statistical analysis:
The data will be described using means ± standard deviation for quantitative and numerical variables and percentages for qualitative variables.
The factors associated with the acceptance of direct reporting to the public prosecutor will be sought by univariate analysis (Student's, Wilcoxon, Chi2 or Fisher's exact tests, depending on the conditions of application) and then multivariate (logistic regression).
The significance level adopted is 0.05. The data will be entered in an Epi info database (version 3.5.4). The statistical analyzes will be carried out using Epi info (version 3.5.4) and SAS (version 9.4) software, with the help of the Methodological Aid Unit of the Reims University Hospital Center.
- Conditions
- Domestic Violence
- Being tested
- Domestic Violence Questionnaire
- Keywords
- Domestic violence, Report of domestic violence, Reims University Hospital Center, emergency department
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Domestic Violence QuestionnaireBehavioural
Domestic Violence Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| The group accepting to report | Not described Receives: Behavioral: Domestic Violence Questionnaire | |
| The group refusing to report | Not described Receives: Behavioral: Domestic Violence Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
acceptance of direct reporting to the public prosecutor
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start8 Feb 2021
- Primary completion3 Aug 2021
- Study completion3 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Domestic ViolenceStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05543395
- Sponsor's protocol ID
- PO21001
- Status last verified
- Sep 2022
- First submitted
- 3 Aug 2021
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reporting of Domestic Violence by Patients in the Emergency Department of the Reims University Hospital Center
- ClinicalTrials.gov ID
- NCT05543395
- Acronym / sponsor ID
- PO21001
- Conditions
- Domestic Violence
- Keywords
- Domestic violence, Report of domestic violence, Reims University Hospital Center, emergency department
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 3 Aug 2021 (actual)
- Study completion
- 3 Aug 2021 (actual)
- First posted
- 16 Sep 2022 (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.
Domestic violence is defined as violence carried out by one of the partners in a relationship of domination. This can be verbal, psychological, physical or sexual.
Domestic violence is a real public health problem for which emergencies are at the forefront.
In this context, the emergency department of the Reims University Hospital Center, the Public Prosecutor and the association LE MARS France Victim 51 decided to set up a report on July 01, 2020.
The report consists of retrieving the identity and information relating to the violence suffered through a survey, or report card . The report card, as well as an initial certificate without the total incapacity for work written by the doctor during the consultation, will be sent immediately by secure email to the public prosecutor and the police. The emails will be processed in real time by the prosecutor on duty. The contact details with the family name, first name and telephone number will be sent to the association LE MARS France Victime 51. Reporting therefore allows the prosecutor to decide whether or not to open a criminal investigation., At the same time, this will allow us to provide support through the association providing assistance to victims of domestic violence.
The objective of this study is to describe the proportion of patients accepting to report to the public prosecutor among the patients consulting the emergency department of the Reims University Hospital Center and for whom domestic violence is known or suspected. The secondary objectives will be to describe the number of patients who are victims of proven or suspected domestic violence consulting the emergency department, as well as to describe the factors associated with the acceptance of the report.
Participation in the study will consist of completing a questionnaire specific to the study. The estimated time to complete this questionnaire is 5 minutes.
This study will allow us to know the prevalence of acceptance of the report card in the emergency department of the Reims University Hospital Center. This information will tell us if this new procedure could be beneficial for the management of domestic violence and if the majority of patients are in favor of it.
Detailed description
- Medical background :
Domestic violence is defined as violence carried out by one of the partners in a relationship of domination. This can be verbal, psychological, physical or sexual.
This type of violence is a real public health problem. According to a study carried out by the French government in 2018, 213 000 women aged 18 to 75 were victims of physical and / or sexual violence committed by their spouse or ex-spouse in 2018. According to this same study, 121 women and 28 men were killed by their partner or ex-partner. These figures are increasing every year, and the screening of these patients is a major issue.
A doctor is on the front line in screening for this violence. In fact, 3 to 4 women out of 10 in doctors' waiting rooms are victims of domestic violence; and one in five victims first saw a doctor after an incident. A French study carried out in 2002 also showed that 35% of consultations in an emergency department with a woman patient were related to domestic violence.
The High Authority of Health systematically recommends asking each patient and each suspicion of violence within the couple the question "are you a victim of domestic violence?". However, this recommendation remains largely insufficient as well as the assistance provided to the victims. Furthermore, only 19% of these victims say they have filed a complaint with an authority according to the High Authority of Health. Screening remains the first step in the care and identification of victims, but more measures are needed to be put in place to help these patients take legal action and get out of this vicious circle of domestic violence.
The emergencies are therefore one of the first recourse for patients who are victims of domestic violence and it is the role of the emergency physician to take all possible means to detect, help and support these victims.
In this context, the emergency department of the Reims University Hospital Center, the Public Prosecutor and the association LE MARS France Victim 51 decided to set up a report on July 01, 2020.
The report consists of retrieving the identity and information relating to the violence suffered through a survey, or report card . The report card, as well as an initial certificate without the total incapacity for work written by the doctor during the consultation, will be sent immediately by secure email to the public prosecutor and the police. The emails will be processed in real time by the prosecutor on duty. The contact details with the family name, first name and telephone number will be sent to the association LE MARS France Victime 51. Reporting therefore allows the prosecutor to decide whether or not to open a criminal investigation., At the same time, this will allow us to provide support through the association providing assistance to victims of domestic violence.
II. Goals:
The objective of this study is to describe the proportion of patients accepting to report to the public prosecutor among the patients consulting the emergency department of the Reims university hospital center and for whom domestic violence is known or suspected. The secondary objectives will be to describe the number of patients who are victims of proven or suspected domestic violence consulting the emergency department, as well as to describe the factors associated with the acceptance of the report card.
III. Investigation plan:
- Evaluation criteria: A questionnaire composed of two parts was drawn up as part of this study. The first part will be completed by the patients thmselves and will collect information about them relating to their current circumstances and history. The second part is completed by the doctor specifying whether or not the patient has accepted to complete the report, the examinations carried out in the emergency room as well as the entry and exit diagnoses.
The main endpoint is acceptance of direct reporting to the public prosecutor. Secondary endpoints are the factors potentially associated with whether or not patients accept direct reporting to the public prosecutor.
IV. Methodology:
- Experimental design: This is a cross-sectional, observational, prospective inclusion, single-center (Reims University Hospital Center) study over a period of 6 months.
- Investigation plan: Participation in the study will be offered to all patients consulting the emergency reception service of the Reims University Hospital Center during the inclusion phase of the study and for whom domestic violence is proven or suspected during the interview. Information on the objectives and methods of the study will be given to them with the help of the information note. If the patient agrees to participate in the study, they will be included in the study. Participation in the study will not affect the patient's medical management. Participation in the study will lead to:
- Completion of a questionnaire by the patient (on proven or suspected domestic violence)
- A collection of data concerning the patient and their consultation at the emergency reception service.
- Estimated recruitment time The recruitment period will be 6 months.
- Duration of participation by subject The duration of patient participation is ad hoc, the time to complete the questionnaire, the duration of which is estimated to be 5 minutes.
- Statistical analysis:
The data will be described using means ± standard deviation for quantitative and numerical variables and percentages for qualitative variables.
The factors associated with the acceptance of direct reporting to the public prosecutor will be sought by univariate analysis (Student's, Wilcoxon, Chi2 or Fisher's exact tests, depending on the conditions of application) and then multivariate (logistic regression).
The significance level adopted is 0.05. The data will be entered in an Epi info database (version 3.5.4). The statistical analyzes will be carried out using Epi info (version 3.5.4) and SAS (version 9.4) software, with the help of the Methodological Aid Unit of the Reims University Hospital Center.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The group accepting to report | – | Behavioral: Domestic Violence Questionnaire |
| The group refusing to report | – | Behavioral: Domestic Violence Questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient, who consults in the emergency department of the Reims University Hospital Center, for whom domestic violence is known or suspected, accepting or not to report to the public prosecutor. Patient is able to agree of their own accord to participate in the study.
Key inclusion criteria (3 listed)
- Adults over 18 years old
- Accepting participation in the study
- For whom domestic violence is known or suspected during the interview with the emergency doctor
Key exclusion criteria (2 listed)
- Minors under the age of 18
- Unable to agree to participate in the study
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 |
|---|---|---|
| Domestic Violence QuestionnaireDomestic Violence Questionnaire | Behavioural | The group accepting to report, The group refusing to report |
Primary outcome
acceptance of direct reporting to the public prosecutor
Time frame: Day 0
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 16 Sep 2022.
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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?
An observational study of Domestic Violence, run by CHU de Reims at 1 site in France.
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 3 inclusion and 2 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 16 Sep 2022. 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 France. 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?
acceptance of direct reporting to the public prosecutor (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Sep 2022.