NCT03630822

Multicenter, Randomized, Comparative and Prospective Study Evaluating the Impact on the Care Path of an Editorial Program Accompanied by Advance Directives in Psychiatry (DAP) for People Suffering From Schizophrenia, Bipolar I Disorder or Schizoaffective Disorder

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 399 (actual)
• Sponsor: Assistance Publique Hopitaux De Marseille · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Schizophrenia
• Bipolar I Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Psychiatric Advanced Directive	The patient completes a questionnaire to express in advance his wishes regarding his future care in psychiatry.
BEHAVIORAL	Standard care	standardized maintenance with the patient

Timeline

• Start date: 2019-01-02
• Primary completion: 2021-05-10
• Completion: 2022-01-02
• First posted: 2018-08-15
• Last updated: 2022-03-31

Locations

1 site across 1 country: France