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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

This method combines: - (i) A sequential study of PSIs analysis. The sequential study will take place in three stages (coder training, collection of PSIs data via the web platform, PSIs coding). Each PSIs reported by professionals during the implementation of the risk management support programme will be coded using the PISA multi-axial classification system (based on the WHO's International Classification for Patient Safety in Primary Care). These codes will be used to describe PSIs in coordinated practice. - (ii) An implementation study of the learning system. The learning system is described in the intervention section. During the implementation study, two types of data collection (quantitative and qualitative) will be mobilised at the end of the support to the QualiREL Santé Regional Support Structure. The main objective of the study is: - To Describe PSIs occurring in MSPs as part of the coordinated exercise and over an 18-month period, according to the 4 coding frameworks of the PISA classification: (i) types of events (main and contributing), (ii) contributing factors, (iii) outcomes of PSIs, (iv) severity of harm. The secondary objectives, linked to the evaluation of the implementation of the learning system, are - To examine the acceptance of the learning system by the teams, - To describe the effective use of the web platform by professionals, - To describe the MSP's ownership of the risk management support programme. ;

Study Design

Related Conditions & MeSH terms

Adverse Event

Clinical Trial Details

NCT number	NCT06230341
Study type	Interventional
Source	Nantes University Hospital
Contact	Jean-Baptiste Amélineau, MD
Phone	02 40 41 28 28
Email	jean-baptiste.amelineau@univ-nantes.fr
Status	Not yet recruiting
Phase	N/A
Start date	April 1, 2024
Completion date	August 1, 2026

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms