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

Adverse Event Clinical Trial

— EVIDENS-Prim  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06230341
• Other study ID #: RC23_0402
• Secondary ID: RSP22N005
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: August 1, 2026

Study information

• Verified date: January 2024
• Source: Nantes University Hospital
• Contact: Jean-Baptiste Amélineau, MD
• Phone: 02 40 41 28 28
• Email: jean-baptiste.amelineau[@]univ-nantes.fr
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: August 1, 2026
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Adverse Event

Intervention

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Nantes University Hospital	Université de Nantes

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distribution of PSIs occurring in MSPs according to the 4 coding frameworks of the PISA classification: 1-by type	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.	PSIs reported by MSP professionals in the 18 months following the initial training provided
Primary	Distribution of PSIs occurring in MSPs according to the 4 coding frameworks of the PISA classification: 2- by contributing factors	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.	18 months
Primary	Distribution of PSIs occurring in MSPs according to the 4 coding frameworks of the PISA classification: 3-by results	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.	18 months
Primary	Distribution of PSIs occurring in MSPs according to the 4 coding frameworks of the PISA classification: 4-by severity	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.	18 months
Secondary	Description of MSP professionals' acceptance of learning system	Analysis of the main themes and sub-themes of the acceptability of the learning system from the semi-directed interviews and focus groups conducted with MSP professionals.	3 months
Secondary	Description of the behaviour of users of the online system in the 18 months following the provision of initial training	Export from the web platform of; the number of professionals who have validated the opening of their account on the web platform,; the number of professionals who have declared at least one PSI,; the number of modifications made to the PSIs declaration,; the number of declarations in anonymous mode,; the number of updates of action sheets corresponding to improvement actions.	18 months
Secondary	Description of the MSP's behaviour in implementing the risk management support programme during the 18 months following the provision of the initial training.	Description: Export from the web platform of; the number of PSI declarations; the number of systemic analyses of PSIs carried out,; the number of types of contributing factors identified by the analysis (variable categories defined according to the analysis methods),; the number of analyses identifying security barriers (by type: present and effective / present and ineffective / absent),; the number of improvement actions planned / completed / abandoned.	18 months