Experimentation of a Protocol of Psychiatric Advance Directives: Randomized Controlled Multi-site Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 399
- Locations
- 1
- Primary Endpoint
- Rate of patients with compulsory admission
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
beneficiary of the advance directive program
Intervention: Psychiatric Advanced Directive (Behavioral)
beneficiary of standard Support
Intervention: Standard care (Behavioral)
Outcomes
Primary Outcomes
Rate of patients with compulsory admission
Time Frame: 12 months
Evaluation of the hospitalization rate by comparing the two groups
Secondary Outcomes
- Measuring the health-related quality of life of patients(12 months)
- Medico-economic analysis (cost-utility)(12 months)
- Evaluation of the therapeutic alliance between the patient and his psychiatrist(12 months)
- Evaluation of the severity of the psychiatric disorder by the psychiatrist(12 months)
- Measuring mental health symptoms of patients(12 months)
- Evaluation of the empowerment rate(12 months)
- Evaluation of patient recovery rates(12 months)
- Measuring Disease Awareness(12 months)