Clinical trial NCT04953273: A Case Management Algorithm for Women Victims of Violence
Official title: Effectiveness of a Case Management Algorithm on Clinical Outcome After Consultations Requested in a Clinical Forensic Medicine Unit by Female Victims of Violence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-Traumatic Stress Disorder
Violence-Related Symptom
Keywords: Post-Traumatic Stress Disorder
Women Health
Physical Abuse
Forensic Medicine
Case-Management Algorithm
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2021-07-07
Enrollment: 756
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A considerable body of research has demonstrated that women who are victims of interpersonal violence are at substantially elevated risk for the development of post-traumatic stress disorder (PTSD). In France, victims can request a medico-legal examination in a clinical forensic medicine unit. Although these units are also a place for initial psychological examination, women often don't attend future scheduled appointments. Decision-making algorithm using phone contact are effective in suicide prevention. Our aim is to assess the effectiveness of case management algorithm using early phone contact compared to a control group treated as usual on clinical outcome after consultation requested in a clinical forensic medicine unit by female victims of violence.

Method: Prospective, multicenter, open-label, randomized controlled clinical trial, for women victims of violence. Victims randomized in VIGITRAUMA group will be contacted by phone at 3 weeks after the consultation in a clinical forensic medicine unit, and a second phone call can be done. If the subject is not contacted after the second phone call, he will receive a postcard.

Control group will benefit from usual follow-up.

All the subjects included will be then evaluated at 3 months, 6 months and 1 year during a phone call.


Eligibility criteria: Inclusion Criteria:

* Women
* 18 years and older
* Consultation requested in a clinical forensic medicine unit after being victim of violence
* The person was exposed to: death, threatened death, actual or threatened serious injury, or actual or threatened sexual violence (PTSD criterion A - DSM -5)
* With social insurance
* Consent to participate to the study

Exclusion Criteria:

* Do no consent to participate to the study
* Intrafamilial or intimate partner violence
* Do not speak french

Primary outcomes:
measure: Clinical Outcome
timeFrame: 3 months
measure: Clinical Outcome
timeFrame: 6 months
measure: Clinical Outcome
timeFrame: 12 months
Secondary outcomes:
measure: Severity of post-traumatic stress disorder symptoms
timeFrame: 3 months, 6 months and 12 months
measure: General psychopathology
timeFrame: 3 months, 6 months and 12 months
measure: Severity of somatic symptoms
timeFrame: 3 months, 6 months and 12 months
measure: Medical cost
timeFrame: 12 months
measure: Judicial outcome
timeFrame: 12 months
measure: Suicidal ideation intensity
timeFrame: 12 months
measure: Number of suicide attempters
timeFrame: 12 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: University Hospital, Amiens
city: Boulogne-sur-Mer
country: France
facility: General Hospital, Boulogne sur Mer
city: Caen
country: France
facility: University Hospital, Caen
city: Creil
country: France
facility: General Hospital, Creil
city: Lille
country: France
facility: University Hospital, Lille
city: Rouen
country: France
facility: University Hospital, Rouen
city: Saint-Quentin
country: France
facility: General Hospital, Saint-Quentin
city: Valenciennes
country: France
facility: General Hospital, Valenciennes
Study officials:
affiliation: University Hospital, Lille
name: Arnaud Leroy, MD
role: PRINCIPAL_INVESTIGATOR
References: