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Completed

NCT Number: NCT03630822

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Psychiatric Advanced Directive

Behavioral

The patient completes a questionnaire to express in advance his wishes regarding his future care in psychiatry.

Standard Care

Behavioral

standardized maintenance with the patient

Primary outcomes

  1. Rate of patients with compulsory admission

    Time frame: 12 months

    Evaluation of the hospitalization rate by comparing the two groups

Secondary outcomes

  1. Evaluation of patient recovery rates

    Time frame: 12 months

    The rate is assessed by the Recovery Assessment Scale (RAS)

  2. Evaluation of the empowerment rate

    Time frame: 12 months

    The rate is assessed by the Empowerment Scale (ES)

  3. Measuring the health-related quality of life of patients

    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

  4. Measuring mental health symptoms of patients

    Time frame: 12 months

    Mental health symptoms are measured by Modified Colorado Symptom Index (MCSI)

  5. Evaluation of the therapeutic alliance between the patient and his psychiatrist

    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

  6. Measuring Disease Awareness

    Time frame: 12 months

    Disease Awareness is assessed by the évaluée par l'échelle SUMD (Scale to Assess Unawareness in Mental Disorder

  7. Evaluation of the severity of the psychiatric disorder by the psychiatrist

    Time frame: 12 months

    The severity of the psychiatric disorder is assessed by the Clinical Global Impression (ICG) scale

  8. Medico-economic analysis (cost-utility)

    Time frame: 12 months

    Number of inpatient

  9. Medico-economic analysis (cost-utility)

    Time frame: 12 months

    Number of emergency department visits

  10. Medico-economic analysis (cost-utility)

    Time frame: 12 months

    Number of outpatient visits

  11. Medico-economic analysis (cost-utility)

    Time frame: 12 months

    Loss of productivity

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study title

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

Acronym: DAiP

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Aug 15, 2018
Registry last updated
Mar 31, 2022

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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