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

NCT06230341 | Not Yet Recruiting

• 2 other identifiers: RC23_0402RSP22N005
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Adverse Event

Keywords

Healthcare; Adverse event; Safety culture; Patient safety; Learning

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (3)

• Description of MSP professionals' acceptance of learning system

  3 months

• Description of the behaviour of users of the online system in the 18 months following the provision of initial training

  18 months

• Description of the MSP's behaviour in implementing the risk management support programme during the 18 months following the provision of the initial training.

  18 months

Study Arms (1)

Learning system benefits MSPs

EXPERIMENTAL

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.

Other: Health Services Research

Interventions

Health Services Research 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.

Learning system benefits MSPs

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nantes University Hospital: lead
• Université de Nantes: collaborator

MeSH Terms

Interventions

Health Services Research

Intervention Hierarchy (Ancestors)

Health Planning; Health Care Economics and Organizations; Health Care Quality, Access, and Evaluation

Central Study Contacts

Jean-Baptiste Amélineau, MD

CONTACT

02 40 41 28 28; jean-baptiste.amelineau@univ-nantes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Descriptive study

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: January 30, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share