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

NCT ID: NCT06230341

Last Updated: 2024-01-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2026-08-01

Brief 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.

Detailed 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.

Conditions

Adverse Event

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Learning system benefits MSPs

MSPs benefit from a learning system (described in the intervention section). MSPs are encouraged to report PSIs through the web platform provided after the initial training in each MSP and during the period of methodological support.

Group Type: EXPERIMENTAL

Health Services Research

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Université de Nantes

OTHER

Sponsor Role: collaborator

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Jean-Baptiste Amélineau, MD

Role: CONTACT

jean-baptiste.amelineau@univ-nantes.fr

02 40 41 28 28

Other Identifiers

RSP22N005

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

RC23_0402

Identifier Type: -

Identifier Source: org_study_id