Clinical trial NCT06230341: Patient Safety Incidents in Coordinated Primary Care Teams: a Multi-method Study
Official title: Patient Safety Incidents in Coordinated Primary Care Teams: a Multi-method Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Adverse Event
Keywords: Healthcare
Adverse event
Safety culture
Patient safety
Learning
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Université de Nantes
First posted: 2024-01-30
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Descriptive study
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Distribution of PSIs occurring in MSPs according to the 4 coding frameworks of the PISA classification: 1-by type
timeFrame: PSIs reported by MSP professionals in the 18 months following the initial training provided
measure: Distribution of PSIs occurring in MSPs according to the 4 coding frameworks of the PISA classification: 2- by contributing factors
timeFrame: 18 months
measure: Distribution of PSIs occurring in MSPs according to the 4 coding frameworks of the PISA classification: 3-by results
timeFrame: 18 months
measure: Distribution of PSIs occurring in MSPs according to the 4 coding frameworks of the PISA classification: 4-by severity
timeFrame: 18 months
Secondary outcomes:
measure: Description of MSP professionals' acceptance of learning system
timeFrame: 3 months
measure: Description of the behaviour of users of the online system in the 18 months following the provision of initial training
timeFrame: 18 months
measure: Description of the MSP's behaviour in implementing the risk management support programme during the 18 months following the provision of the initial training.
timeFrame: 18 months
Other outcomes:
Locations:
Study officials:
References: