Patient Safety Incidents in Coordinated Primary Care Teams: a Multi-method Study

NCT06230341 · tracked via the Priya Life Science France tracker

Sponsor

Nantes University Hospital

Phase

Not applicable

Started

2024-12-10

Last updated

2026-07-20

Condition(s) studied

Adverse Event

Investigational drug(s) / intervention(s)

Health Services Research

Health Services Research: MSPs benefit from a learning system. The learning system combines an individualised support programme provided by a regional support structure for quality and safety in health care (QualiREL Santé) and the provision of a web platform. Based on the 4 dimensions of the Shortell model, the support programme includes initial training (6 months) and personalised methodological support (18 months) for each MSP. A web platform is provided to MSPs to enable them to implement the full approach of the Risk Management Support Programme. It provides support for reporting, analysis and management of PSIs.

Study summary

In France, improving the practice of health professionals working in coordinated primary care teams (health centres called Maisons de Santé Pluriprofessionnelles - MSPs) could be facilitated by a learning system consisting of (i) a risk management support programme and (ii) the provision of a comprehensive online system combining training, reporting and support for the analysis and management of patient safety incidents (PSIs).

EVIDENS-Prim is a multi-method, multi-centre, prospective study. It aims to describe the PSIs that occur in MSPs, using an international classification system, and to describe the ways in which professionals have adopted a global approach to PSIs management, from PSI reporting to feedback.

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

Inclusion Criteria: * Characteristics of the MSPs included in the study: * Located in the Pays de la Loire region; * Having a contract with a health insurance (specifications and financing defined nationally) for at least 1 year; * Agreeing to take part in the project; * Having a quality representative or committing to appoint one when they join the project. Characteristics of professionals working in MSPs included: * All independent health professionals involved in the MSP: general practitioners and, depending on the MSP, nurses, pharmacists, podiatrists, physiotherapists, midwives, speech therapists, dentists, occupational therapists, psychomotor therapists, etc,) * All professionals involved in MSP outside the health sector: (coordinators, medical assistants, independent psychologists, etc.), * agree to take part in the project. Exclusion Criteria: Other group exercise modalities or other forms of coordinated exercise (other than MSP) do not have a quality representative on their team and will not be considered for inclusion. Characteristics of MSPs not included in the research: \- Where the members of the research team work. Characteristics of professionals working in MSPs included: \- Not included.

Primary outcome measure(s)

Distribution of PSIs occurring in MSPs according to the 4 coding frameworks of the PISA classification: 1-by type — PSIs reported by MSP professionals in the 18 months following the initial training provided
Repartition, according to the PISA classification, of PSIs reported by MSP professionals in the 18 months following the initial training provided, by type: the number of PSIs for each type out of the total number of PSIs reported.
Distribution of PSIs occurring in MSPs according to the 4 coding frameworks of the PISA classification: 2- by contributing factors — 18 months
Repartition, according to the PISA classification, of PSIs reported by MSP professionals in the 18 months following the initial training provided, by contributing factors : number of PSIs for each contributing factor (e.g. factors related to the patient, staff, equipment, organisation, etc.) out of the total number of PSIs reported.
Distribution of PSIs occurring in MSPs according to the 4 coding frameworks of the PISA classification: 3-by results — 18 months
Repartition, according to the PISA classification, of PSIs reported by MSP professionals in the 18 months following the initial training provided, by results: number of PSIs for each result (no harm, clinical harm, team harm) out of the total number of PSIs reported.
Distribution of PSIs occurring in MSPs according to the 4 coding frameworks of the PISA classification: 4-by severity — 18 months
Repartition, according to the PISA classification, of PSIs reported by MSP professionals in the 18 months following the initial training provided, by severity: number of PSIs of each severity (e.g. no harm, mild, moderate or severe harm, death) out of the total number of PSIs reported.

Trial sites (1)

Facility	City	Region	Status
Nantes Université	Nantes	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06230341 on ClinicalTrials.gov ↗ ← All trials in France