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)
Primary Purpose
Schizophrenia, Bipolar I Disorder
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Psychiatric Advanced Directive
Standard care
Sponsored by

About this trial
This is an interventional supportive care trial for Schizophrenia
Eligibility Criteria
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.
Sites / Locations
- Assistance Publique Hôpitaux de Marseille
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
beneficiary of the advance directive program
beneficiary of standard Support
Arm Description
Outcomes
Primary Outcome Measures
Rate of patients with compulsory admission
Evaluation of the hospitalization rate by comparing the two groups
Secondary Outcome Measures
Evaluation of patient recovery rates
The rate is assessed by the Recovery Assessment Scale (RAS)
Evaluation of the empowerment rate
The rate is assessed by the Empowerment Scale (ES)
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
Measuring mental health symptoms of patients
Mental health symptoms are measured by Modified Colorado Symptom Index (MCSI)
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
Measuring Disease Awareness
Disease Awareness is assessed by the évaluée par l'échelle SUMD (Scale to Assess Unawareness in Mental Disorder
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
Medico-economic analysis (cost-utility)
Number of inpatient
Medico-economic analysis (cost-utility)
Number of emergency department visits
Medico-economic analysis (cost-utility)
Number of outpatient visits
Medico-economic analysis (cost-utility)
Loss of productivity
Full Information
NCT ID
NCT03630822
First Posted
August 10, 2018
Last Updated
March 16, 2022
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT03630822
Brief Title
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
Acronym
DAiP
Official Title
Experimentation of a Protocol of Psychiatric Advance Directives: Randomized Controlled Multi-site Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 2, 2019 (Actual)
Primary Completion Date
May 10, 2021 (Actual)
Study Completion Date
January 2, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Bipolar I Disorder
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
399 (Actual)
8. Arms, Groups, and Interventions
Arm Title
beneficiary of the advance directive program
Arm Type
Experimental
Arm Title
beneficiary of standard Support
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Psychiatric Advanced Directive
Intervention Description
The patient completes a questionnaire to express in advance his wishes regarding his future care in psychiatry.
Intervention Type
Behavioral
Intervention Name(s)
Standard care
Intervention Description
standardized maintenance with the patient
Primary Outcome Measure Information:
Title
Rate of patients with compulsory admission
Description
Evaluation of the hospitalization rate by comparing the two groups
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Evaluation of patient recovery rates
Description
The rate is assessed by the Recovery Assessment Scale (RAS)
Time Frame
12 months
Title
Evaluation of the empowerment rate
Description
The rate is assessed by the Empowerment Scale (ES)
Time Frame
12 months
Title
Measuring the health-related quality of life of patients
Description
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
Title
Measuring mental health symptoms of patients
Description
Mental health symptoms are measured by Modified Colorado Symptom Index (MCSI)
Time Frame
12 months
Title
Evaluation of the therapeutic alliance between the patient and his psychiatrist
Description
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
Title
Measuring Disease Awareness
Description
Disease Awareness is assessed by the évaluée par l'échelle SUMD (Scale to Assess Unawareness in Mental Disorder
Time Frame
12 months
Title
Evaluation of the severity of the psychiatric disorder by the psychiatrist
Description
The severity of the psychiatric disorder is assessed by the Clinical Global Impression (ICG) scale
Time Frame
12 months
Title
Medico-economic analysis (cost-utility)
Description
Number of inpatient
Time Frame
12 months
Title
Medico-economic analysis (cost-utility)
Description
Number of emergency department visits
Time Frame
12 months
Title
Medico-economic analysis (cost-utility)
Description
Number of outpatient visits
Time Frame
12 months
Title
Medico-economic analysis (cost-utility)
Description
Loss of productivity
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Olivier ARNAUD, Director
Organizational Affiliation
Assistance Publique Hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35662314
Citation
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.
Results Reference
derived
PubMed Identifier
31881954
Citation
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.
Results Reference
derived
Learn more about this trial
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
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