Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05543395 |
| Other study ID # |
PO21001 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 8, 2021 |
| Est. completion date |
August 3, 2021 |
Study information
| Verified date |
September 2022 |
| Source |
CHU de Reims |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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.
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.
Description:
I. 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:
a. 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.
3. Estimated recruitment time The recruitment period will be 6 months.
4. 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.
V. 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.
