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

NCT03630822 | Completed

• 2 other identifiers: 2018-042018-A00146-49
• Study Type: interventional
• Target: 399
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Rate of patients with compulsory admission

  Evaluation of the hospitalization rate by comparing the two groups

  12 months

Secondary Outcomes (11)

• Evaluation of patient recovery rates

  12 months

• Evaluation of the empowerment rate

  12 months

• Measuring the health-related quality of life of patients

  12 months

• Measuring mental health symptoms of patients

  12 months

• Evaluation of the therapeutic alliance between the patient and his psychiatrist

  12 months

Study Arms (2)

beneficiary of the advance directive program

EXPERIMENTAL

Behavioral: Psychiatric Advanced Directive

beneficiary of standard Support

ACTIVE COMPARATOR

Behavioral: Standard care

Interventions

Psychiatric Advanced Directive BEHAVIORAL

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

beneficiary of the advance directive program

Standard care BEHAVIORAL

standardized maintenance with the patient

beneficiary of standard Support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• over 18 years old;
• diagnosed with schizophrenia, bipolar I disorder, or schizoaffective disorder
• receiving ambulatory care by a treating psychiatrist, investigator
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

Location

Related Publications (2)

• 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.

  PMID: 35662314 DERIVED

• 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.

  PMID: 31881954 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jean-Olivier ARNAUD, Director

  Assistance Publique Hôpitaux de Marseille

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2018
• First Posted: August 15, 2018
• Study Start: January 2, 2019
• Primary Completion: May 10, 2021
• Study Completion: January 2, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)