Patient Safety Incidents in Coordinated Primary Care Teams: a Multi-method Study
ConditionAdverse Event
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorNantes University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Health Services Research
Other interventionMSPs 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.
Treatment groups
16 Participants
are divided into 1 treatment groupGroup A: Learning system benefits MSPsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
PSIs reported by MSP professionals in the 18 months following the initial training provided2
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.
Time frame
18 months3
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.
Time frame
18 months4
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.
Time frame
18 monthsSecondary outcomes
1
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.
Time frame
3 months2
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.
Time frame
18 months3
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.
Time frame
18 monthsSponsors and contacts
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Nantes University Hospital
Lead sponsor
Université de Nantes
Collaborator
Source ClinicalTrials.gov