A Case Management Algorithm for Women Victims of Violence

Официальное название

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

Обзор

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.

Вмешательства

• Другое Vigitrauma
  Case management algorithm using early phone contact

Первичные конечные точки

• Clinical Outcome [Срок оценки: 3 months]
• Clinical Outcome [Срок оценки: 6 months]
• Clinical Outcome [Срок оценки: 12 months]

Вторичные конечные точки (7)

• Severity of post-traumatic stress disorder symptoms [Срок оценки: 3 months, 6 months and 12 months]
• General psychopathology [Срок оценки: 3 months, 6 months and 12 months]
• Severity of somatic symptoms [Срок оценки: 3 months, 6 months and 12 months]
• Medical cost [Срок оценки: 12 months]
• Judicial outcome [Срок оценки: 12 months]
• Suicidal ideation intensity [Срок оценки: 12 months]
• Number of suicide attempters [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Франция · 8 центров

• University Hospital, Amiens — Amiens
• General Hospital, Boulogne sur Mer — Boulogne-sur-Mer
• University Hospital, Caen — Caen
• General Hospital, Creil — Creil
• University Hospital, Lille — Lille
• University Hospital, Rouen — Rouen
• General Hospital, Saint-Quentin — Saint-Quentin
• General Hospital, Valenciennes — Valenciennes

Идентификаторы

NCT: NCT04953273 · 2020_ 01 · 2020-A02591-38

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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