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

Nantes University Hospital (NUH)

Status: Not yet enrolling

Conditions: Adverse Event

Treatments: Other: Health Services Research

Study type: Interventional

Funder types: Other

Identifiers

NCT06230341

RC23_0402

RSP22N005 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Volunteers: No 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.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

15 participants in 1 patient group

Learning system benefits MSPs

Experimental group

Description:

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.

Treatment:

Other: Health Services Research