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

NCT ID: NCT03630822

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 399 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-02
• Study Completion Date: 2022-01-02

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.

Conditions

Schizophrenia; Bipolar I Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

beneficiary of the advance directive program

Group Type: EXPERIMENTAL

Psychiatric Advanced Directive

Intervention Type: BEHAVIORAL

The patient completes a questionnaire to express in advance his wishes regarding his future care in psychiatry.

beneficiary of standard Support

Group Type: ACTIVE_COMPARATOR

Standard care

Intervention Type: BEHAVIORAL

standardized maintenance with the patient

Interventions

Psychiatric Advanced Directive

The patient completes a questionnaire to express in advance his wishes regarding his future care in psychiatry.

Intervention Type: BEHAVIORAL

Standard care

standardized maintenance with the patient

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Olivier ARNAUD, Director

Role: STUDY_DIRECTOR

Assistance Publique Hôpitaux de Marseille

Locations

Assistance Publique Hôpitaux de Marseille

Marseille, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 35662314 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31881954 (View on PubMed)

Other Identifiers

2018-A00146-49

Identifier Type: REGISTRY

Identifier Source: secondary_id

2018-04

Identifier Type: -

Identifier Source: org_study_id