Assistance Publique Hôpitaux de Marseille
Marseille, 13354, France
NCT Number: NCT03630822
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Marseille, 13354, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The patient completes a questionnaire to express in advance his wishes regarding his future care in psychiatry.
standardized maintenance with the patient
Time frame: 12 months
Evaluation of the hospitalization rate by comparing the two groups
Time frame: 12 months
The rate is assessed by the Recovery Assessment Scale (RAS)
Time frame: 12 months
The rate is assessed by the Empowerment Scale (ES)
Time frame: 12 months
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
Time frame: 12 months
Mental health symptoms are measured by Modified Colorado Symptom Index (MCSI)
Time frame: 12 months
The therapeutic alliance between the patient and his psychiatrist is assessed by the 4-Point Alliance Self Report (4-PAS) questionnaire
Time frame: 12 months
Disease Awareness is assessed by the évaluée par l'échelle SUMD (Scale to Assess Unawareness in Mental Disorder
Time frame: 12 months
The severity of the psychiatric disorder is assessed by the Clinical Global Impression (ICG) scale
Time frame: 12 months
Number of inpatient
Time frame: 12 months
Number of emergency department visits
Time frame: 12 months
Number of outpatient visits
Time frame: 12 months
Loss of productivity
Assistance Publique Hopitaux De Marseille
Other
Experimentation of a Protocol of Psychiatric Advance Directives: Randomized Controlled Multi-site Trial
Acronym: DAiP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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