跳至主要内容
临床试验/NCT03630822
NCT03630822已完成不适用

Experimentation of a Protocol of Psychiatric Advance Directives: Randomized Controlled Multi-site Trial

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 399 人开始时间: 2019年1月2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
399
试验地点
2
主要终点
Rate of patients with compulsory admission

研究概览

简要总结

Severe mental illness is accompanied by cognitive fluctuations that can alter decision-making skills and lead to coerced care. Taking into account, on the one hand, the health, social and economic impact of forced hospitalization, on the other hand the importance of self-determination, the reinforcement of the power to act in the evolution of these disorders, new strategies to better reflect the views of people have been developed.

Among these, the drafting of Advanced Directives in Psychiatric (ADP), allows people with mental disorders to write while their decision-making skills are restored care instructions in case of decompensation.

It is a tool of "advanced therapeutic education" and early prevention of relapses.

It is hypothesized that the implementation of drafting accompanied by advance directives to people with severe psychiatric disorders decreases in the short term the number of forced hospitalization care pathway of these people, compared to the subjects having not benefited from this device.

This research will take the form of a randomized controlled trial on 3 sites. The "quantitative" evaluation component of results and processes will be completed with a qualitative anthropological and socio-political evaluation component documenting the trajectories of individuals and the implementation of the program, as well as a "participatory research" component aimed at a dialogue between users, researchers and professionals.

The patient who is a beneficiary of the "Advanced Directives in Psychiatric" program will be encouraged to complete the " Advanced Directives in Psychiatric" document and will receive support in drafting them. The non-beneficiary patient of the program will follow up with his psychiatrist unchanged.

The experimental design of the quantitative component is based on an experimental, randomized, prospective, controlled, parallel study, comparing two groups of subjects with severe psychiatric disorders.

This research will assess the effectiveness, efficiency and impact of the " Advanced Directives in Psychiatric" program compared to conventional psychiatric care alone.

Ultimately, the objective of describing the effects of the program on health organizations and on the representations and practices of professionals, caregivers and users is at the service of a better understanding of the conditions of possibility of the generalization of this experimentation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

  • over 18 years old;
  • diagnosed with schizophrenia, bipolar I disorder, or schizoaffective disorder
  • receiving ambulatory care by a treating psychiatrist, investigator
  • having been hospitalized under duress at least once during the year preceding the inclusion
  • being in decision-making jurisdiction
  • can be under curator
  • agreeing to participate in the study and with informed consent signed by the subject, as well as by the legal representative in the case of a person under guardianship.

排除标准

  • less than 18 years old;
  • participating in another study simultaneously
  • in situations of decision-making incompetence
  • not able to read and write
  • refusing to participate in the study, or the legal representative refusing to participate in the study in the case of a person under guardianship.

结局指标

主要结局

Rate of patients with compulsory admission

时间窗: 12 months

Evaluation of the hospitalization rate by comparing the two groups

次要结局

  • Evaluation of the therapeutic alliance between the patient and his psychiatrist(12 months)
  • Evaluation of the severity of the psychiatric disorder by the psychiatrist(12 months)
  • Measuring mental health symptoms of patients(12 months)
  • Evaluation of the empowerment rate(12 months)
  • Measuring the health-related quality of life of patients(12 months)
  • Evaluation of patient recovery rates(12 months)
  • Measuring Disease Awareness(12 months)
  • Medico-economic analysis (cost-utility)(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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