A Case Management Algorithm for Women Victims of Violence

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of a Case Management Algorithm on Clinical Outcome After Consultations Requested in a Clinical Forensic Medicine Unit by Female Victims of Violence

Conditions
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Post-Traumatic Stress Disorder, Violence-Related Symptom

Intervention / Treatment
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* Other: Vigitrauma


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vigitrauma<br>Contact by phone at 3 weeks after the consultation in a clinical forensic medicine unit, and a second phone call if necessary. If the subject is not contacted after the second phone call, he will receive a postcard. | Other: Vigitrauma<br>* Case management algorithm using early phone contact<br>|
| No Intervention: Control group<br>Usual follow-up. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Outcome | Rate of patients with a Clinical Global Impression (CGI) severity scale < 4 | 3 months | 
| Clinical Outcome | Rate of patients with a Clinical Global Impression (CGI) severity scale < 4 | 6 months | 
| Clinical Outcome | Rate of patients with a Clinical Global Impression (CGI) severity scale < 4 | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of post-traumatic stress disorder symptoms | Post-traumatic stress disorder Checklist Scale-5 | 3 months, 6 months and 12 months | 
| General psychopathology | French version of Mini International Neuropsychiatric Interview (DSM 5) | 3 months, 6 months and 12 months | 
| Severity of somatic symptoms | Physical Health Questionnaire (PHQ-15) | 3 months, 6 months and 12 months | 
| Medical cost | Nnumber of hospitalizations, consultations, and drugs consummation | 12 months | 
| Judicial outcome | Number of days of temporary inability to work | 12 months | 
| Suicidal ideation intensity | The Beck Scale for Suicide Ideation (SSI) The Scale for Suicide Ideation (SSI; Beck, et al., 1979) is a brief 21-item scale that assesses the person's current intensity of attitudes, plans, and behaviors to commit suicide. | 12 months | 
| Number of suicide attempters | Suicide risk | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-Traumatic Stress Disorder, Women Health, Physical Abuse, Forensic Medicine, Case-Management Algorithm