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

Study Overview
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Brief Summary
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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.

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

Conditions
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Schizophrenia, Bipolar I Disorder

Intervention / Treatment
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* Behavioral: Psychiatric Advanced Directive
* Behavioral: Standard care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |