Clinical trial 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
Official title: Experimentation of a Protocol of Psychiatric Advance Directives: Randomized Controlled Multi-site Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Bipolar I Disorder
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 399
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Rate of patients with compulsory admission
timeFrame: 12 months
Secondary outcomes:
measure: Evaluation of patient recovery rates
timeFrame: 12 months
measure: Evaluation of the empowerment rate
timeFrame: 12 months
measure: Measuring the health-related quality of life of patients
timeFrame: 12 months
measure: Measuring mental health symptoms of patients
timeFrame: 12 months
measure: Evaluation of the therapeutic alliance between the patient and his psychiatrist
timeFrame: 12 months
measure: Measuring Disease Awareness
timeFrame: 12 months
measure: Evaluation of the severity of the psychiatric disorder by the psychiatrist
timeFrame: 12 months
measure: Medico-economic analysis (cost-utility)
timeFrame: 12 months
measure: Medico-economic analysis (cost-utility)
timeFrame: 12 months
measure: Medico-economic analysis (cost-utility)
timeFrame: 12 months
measure: Medico-economic analysis (cost-utility)
timeFrame: 12 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Jean-Olivier ARNAUD, Director
role: STUDY_DIRECTOR
References:
citation: Tinland A, Loubiere S, Mougeot F, Jouet E, Pontier M, Baumstarck K, Loundou A, Franck N, Lancon C, Auquier P; DAiP Group. Effect of Psychiatric Advance Directives Facilitated by Peer Workers on Compulsory Admission Among People With Mental Illness: A Randomized Clinical Trial. JAMA Psychiatry. 2022 Aug 1;79(8):752-759. doi: 10.1001/jamapsychiatry.2022.1627.
citation: Tinland A, Leclerc L, Loubiere S, Mougeot F, Greacen T, Pontier M, Franck N, Lancon C, Boucekine M, Auquier P. Psychiatric advance directives for people living with schizophrenia, bipolar I disorders, or schizoaffective disorders: Study protocol for a randomized controlled trial - DAiP study. BMC Psychiatry. 2019 Dec 27;19(1):422. doi: 10.1186/s12888-019-2416-9.