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临床试验/NCT03512925
NCT03512925已完成不适用

Effects of a Standardized Post-coercion Review Session on Objective and Perceived Coercion

Charite University, Berlin, Germany12 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2017年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
109
试验地点
12
主要终点
Objective coercive measures

研究概览

简要总结

The present study aims at exploring the impact of a standardized post-coercion review session of coercive measures that took place in the psychiatric inpatient setting in reducing the use of coercive measures and the subjective perception of coercion. It is well known that coercive measures have a major negative impact on the health, well-being and the course of treatment of patients suffering from mental health issues. Many interventions have been implemented in the last years to reduce the use of coercion and limit its consequences.

The investigators developed a standardized post-coercion review intervention. This session takes place as soon as possible after the concerned coercive measure and is moderated by a member of staff who has not been involved in the use of coercion. Other persons involved are the patient, a staff member who took the decision leading to the use of the coercive measure, and a one of the patient's relatives.

Hypothesis is that the use of this standardized intervention can reduce the use of subsequent coercive measures and level of perceived coercion, prevent the development of post-traumatic symptoms, help preserving a trustful therapeutic relationship and positively change the attitude of staff regarding the use of coercion. This intervention has been proven to be well accepted by patients and staff members in a previous pilot study.

The present study is designed as a randomised-controlled study investigating the effect of post-coercion review.

详细描述

The present study aims at exploring the impact of a standardized post-coercion review session of coercive measures that took place in the psychiatric inpatient setting in reducing the use of coercive measures and the subjective perception of coercion. It is well known that coercive measures have a major negative impact on the health, well-being and the course of treatment of patients suffering from mental health issues. Many interventions have been implemented in the last years to reduce the use of coercion and limit its consequences.

The investigators developed a standardized post-coercion review intervention. This session takes place as soon as possible after the concerned coercive measure and is moderated by a member of staff who has not been involved in the use of coercion. Other persons involved are the patient, a staff member who took the decision leading to the use of the coercive measure, and a one of the patient's relatives. The guidelines define important themes and questions that should be addressed during the review session. These guidelines have been developed with the help of psychiatrists, nurses and a peer worker.

Hypothesis is that the use of this standardized intervention can reduce the use of subsequent coercive measures and level of perceived coercion, prevent the development of post-traumatic symptoms, help preserving a trustful therapeutic relationship and positively change the attitude of staff regarding the use of coercion. This intervention has been proven to be well accepted by patients and staff members in a previous pilot study. The methods combine quantitative and qualitative evaluations.

The present study is designed as a randomised-controlled study investigating the effect of post-coercion review.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inpatient
  • Subject to coercive measure (seclusion, restraint, forced medication)
  • Diagnosis of a psychotic disorder (ICD-10: F1x.5, F2x, F31.x).
  • Written and informed consent.

排除标准

  • Inability to provide informed consent
  • Hospital stay < 24h

结局指标

主要结局

Objective coercive measures

时间窗: At the time of discharge from the hospital by every included patient, up to 6 months

Number of coercive measures (seclusion, restraint, forced medication)

次要结局

  • Subjective experience of coercion (3)(At the time of discharge from the hospital by every included patient, up to 6 months)
  • Quality of the therapeutic relationship(At the time of discharge from the hospital by every included patient, up to 6 months)
  • Subjective experience of coercion (1)(At the time of discharge from the hospital by every included patient, up to 6 months)
  • Subjective experience of coercion (2)(At the time of discharge from the hospital by every included patient, up to 6 months)
  • Post-traumatic symptoms (1)(At the time of discharge from the hospital by every included patient, up to 6 months)
  • Post-traumatic symptoms (2)(At the time of discharge from the hospital by every included patient, up to 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexandre Wullschleger

Principal Investigator

Charite University, Berlin, Germany

研究点 (12)

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