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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

France1 site
  • Damien JOLLY

    Reims

Other trials in France

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
  1. 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:

  1. 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:

  1. Experimental design: This is a cross-sectional, observational, prospective inclusion, single-center (Reims University Hospital Center) study over a period of 6 months.
  2. 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.
  1. Estimated recruitment time The recruitment period will be 6 months.
  2. 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.
  3. 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.

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 groups in NCT05543395
Study groupRoleWhat they receive
The group accepting to reportNot described
Receives: Behavioral: Domestic Violence Questionnaire
The group refusing to reportNot described
Receives: Behavioral: Domestic Violence Questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted16 Sep 2022
  2. Study start8 Feb 2021
  3. Primary completion3 Aug 2021
  4. Study completion3 Aug 2021

Resources

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)
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

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.

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