MonPsy&Moi: A Digital Platform for Collecting Patient-Reported Experience and Outcome Measures in Psychiatry

NCT06818227 | Not Yet Recruiting

• 1 other identifier: RCAPHM21_0429
• Study Type: observational
• Target: 23,660
• Locations: 1 country
• Sites: 1

Brief Summary

Mental health disorders, with a 30% annual prevalence rate, are a leading cause of disability and reduced life expectancy. Despite their impact, patient-reported experience measures (PREMs) and outcome measures (PROMs) are underutilized in psychiatry. MonPsy\&Moi®, a digital platform funded by ATIH and DGOS, addresses this gap by providing a user-friendly tool to assess patient experiences and outcomes in real-time, aiming to improve the quality of psychiatric care across France. The study consists of two stages: Stage 1 (No Feedback): MonPsy\&Moi® is deployed across 12 psychiatric facilities, collecting patient data without feedback to clinicians. Objectives include assessing implementation feasibility, validating adaptive questionnaires (PREMIUM), and identifying predictors of patient outcomes, such as relapse and healthcare utilization. Stage 2 (With Feedback): Focuses on patients with severe mental illnesses (schizophrenia, bipolar disorders, and major depressive disorders). This stage evaluates the impact of providing PREMs/PROMs feedback to clinicians on relapse rates, healthcare costs, and overall patient outcomes. MonPsy\&Moi® uses adaptive questionnaires tailored to psychiatric care, covering key domains such as dignity, information, interpersonal relationships, care environment, and treatment. It also evaluates health-related quality of life, including psychological well-being, autonomy, self-esteem, and social relationships. The platform integrates with national healthcare databases (SNDS) to enhance data analysis and predict patient trajectories. The study will involve over 22,000 participants in Stage 1 and 1,100 participants in Stage 2, using a quasi-experimental design to compare feedback and non-feedback strategies. Results aim to demonstrate the feasibility, acceptability, and efficacy of MonPsy\&Moi® in improving mental health outcomes and guiding national psychiatric care policies. By empowering patients and clinicians with actionable insights, MonPsy\&Moi® aspires to set a new standard for patient-centered mental healthcare in real-world settings

Conditions

Schizophrenia Disorders; Bipolar Disorders; Major Depression

Outcome Measures

Primary Outcomes (1)

• Relapse at 12 Months

  Relapse is defined as one or more of the following events occurring within 12 months:Full-time psychiatric hospitalization, Psychiatric emergency care. Hospitalization due to a suicide attempt, Death.

  within 12 months

Secondary Outcomes (2)

• Impact of Feedback on healthcare resource utilization

  6 and 12 months post-inclusion

• Cost-Effectiveness Analysis

  12 months post-inclusion

Study Arms (1)

Psychiatric patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes adults residing in France and receiving care in 12 participating psychiatric facilities. The focus is on adults aged 18-65 with severe mental illnesses, such as schizophrenia spectrum disorders, bipolar disorders, and major depressive disorders. Participants must have a valid email address, understand French, and not oppose participation. Vulnerable populations, such as those under involuntary psychiatric care, are included to assess care quality, while individuals with organic mental disorders or those deprived of liberty are excluded.

You may qualify if:

• Receiving care in one of the 12 participating psychiatric facilities, with a confirmed diagnosis of:
• Schizophrenia Spectrum Disorders (e.g., schizophrenia, schizoaffective disorder).
• Bipolar Disorders. Major Depressive Disorders. A valid email address. Ability to read and understand French. Non-opposition to participating in the study (based on informed consent).

You may not qualify if:

• Primary diagnosis of an organic mental disorder, including:
• Dementia. Stroke. Traumatic brain injury. Individuals deprived of liberty by judicial decision (e.g., incarcerated patients).

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

MeSH Terms

Conditions

Schizophrenia; Bipolar Disorder; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders; Depressive Disorder

Central Study Contacts

Laurent BOYER, Pr

CONTACT

+33491835266; Laurent.BOYER@ap-hm.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: February 10, 2025
• Study Start: February 2, 2025
• Primary Completion (Estimated): September 21, 2026
• Study Completion (Estimated): September 21, 2026
• Last Updated: February 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)