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 (DAiP)

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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Bipolar I Disorder
• Intervention / Treatment: Behavioral: Psychiatric Advanced Directive; Behavioral: Standard care

• Study Type: Interventional
• Enrollment (Actual): 399
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13354
    • Assistance Publique Hopitaux de Marseille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: beneficiary of the advance directive program	Behavioral: Psychiatric Advanced Directive; The patient completes a questionnaire to express in advance his wishes regarding his future care in psychiatry.
Active Comparator: beneficiary of standard Support	Behavioral: Standard care; standardized maintenance with the patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of patients with compulsory admission	Evaluation of the hospitalization rate by comparing the two groups	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of patient recovery rates	The rate is assessed by the Recovery Assessment Scale (RAS)	12 months
Evaluation of the empowerment rate	The rate is assessed by the Empowerment Scale (ES)	12 months
Measuring the health-related quality of life of patients	Health-related quality of life is measured using a specific scale: the S-QOL. It is a self-reported instrument of 41 items that assesses the quality of life in patients with schizophrenia	12 months
Measuring mental health symptoms of patients	Mental health symptoms are measured by Modified Colorado Symptom Index (MCSI)	12 months
Evaluation of the therapeutic alliance between the patient and his psychiatrist	The therapeutic alliance between the patient and his psychiatrist is assessed by the 4-Point Alliance Self Report (4-PAS) questionnaire	12 months
Measuring Disease Awareness	Disease Awareness is assessed by the évaluée par l'échelle SUMD (Scale to Assess Unawareness in Mental Disorder	12 months
Evaluation of the severity of the psychiatric disorder by the psychiatrist	The severity of the psychiatric disorder is assessed by the Clinical Global Impression (ICG) scale	12 months
Medico-economic analysis (cost-utility)	Number of inpatient	12 months
Medico-economic analysis (cost-utility)	Number of emergency department visits	12 months
Medico-economic analysis (cost-utility)	Number of outpatient visits	12 months
Medico-economic analysis (cost-utility)	Loss of productivity	12 months

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2019
• Primary Completion (Actual): May 10, 2021
• Study Completion (Actual): January 2, 2022

Study Registration Dates

• First Submitted: August 10, 2018
• First Submitted That Met QC Criteria: August 10, 2018
• First Posted (Actual): August 15, 2018

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 16, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: 2018-04; 2018-A00146-49 (Registry Identifier: ID RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No