Clinical trial NCT06818227: MonPsy&Moi: A Digital Platform for Collecting Patient-Reported Experience and Outcome Measures in Psychiatry
Official title: MonPsyMoi: Etude Des Conditions d'implémentation et de l'Impact de la Plateforme Digitale française de Recueil de l'expérience Patient en Psychiatrie (Modules Avec et Sans " Feedback ")
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Schizophrenia Disorders
Bipolar Disorders
Major Depression
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 23660
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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


Eligibility criteria: Inclusion Criteria:

* Residing in France. Age between 18 and 65 years at the time of inclusion.

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).

Exclusion Criteria:

* Primary diagnosis of an organic mental disorder, including:

Dementia. Stroke. Traumatic brain injury. Individuals deprived of liberty by judicial decision (e.g., incarcerated patients).

Primary outcomes:
measure: Relapse at 12 Months
timeFrame: within 12 months
Secondary outcomes:
measure: Impact of Feedback on healthcare resource utilization
timeFrame: 6 and 12 months post-inclusion
measure: Cost-Effectiveness Analysis
timeFrame: 12 months post-inclusion
Other outcomes:
Locations:
city: MArseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
References: