Adverse EventEVIDENS-PrimNCT06230341
Patient Safety Incidents in Coordinated Primary Care Teams: a Multi-method Study
A study testing Health Services Research in people with Adverse Event, run by Nantes University Hospital at 1 site in France.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adverse Event
- What is being tested?
- Health Services Research
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- 10 Dec 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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:
Show all 9Show fewer
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Nantes Université
Nantes, France, 44000
Amélineau Jean-Baptiste, MD, 02 40 41 11 29, Jean-Baptiste.Amelineau@univ-nantes.fr
About this study
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.
Read the 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.
- Conditions
- Adverse Event
- Being tested
- Health Services Research
- Keywords
- Healthcare, Adverse event, Safety culture, Patient safety, Learning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Services ResearchOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Health Services Research |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 18 months
Secondary outcomes (3)
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.
Measured: 3 months
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.
Measured: 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.
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start10 Dec 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse EventStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Descriptive study
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Nantes
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230341
- Sponsor's protocol ID
- RC23_0402
- Other IDs
- RSP22N005
- Acronym
- EVIDENS-Prim
- Status last verified
- Jul 2026
- First submitted
- 19 Jan 2024
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Safety Incidents in Coordinated Primary Care Teams: a Multi-method Study
- ClinicalTrials.gov ID
- NCT06230341
- Acronym / sponsor ID
- EVIDENS-Prim / RC23_0402
- Conditions
- Adverse Event
- Keywords
- Healthcare, Adverse event, Safety culture, Patient safety, Learning
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Université de Nantes
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Descriptive study
| Arm | Type | Receives |
|---|---|---|
| Learning system benefits MSPs | Experimental | Other: Health Services ResearchMSPs 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
- Where the members of the research team work.
- Not included.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Services ResearchMSPs 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. | Other | Learning system benefits MSPs |
Primary outcome
Distribution of PSIs occurring in MSPs according to the 4 coding frameworks of the PISA classification: 1-by type
Time frame: PSIs reported by MSP professionals in the 18 months following the initial training provided
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.
Distribution of PSIs occurring in MSPs according to the 4 coding frameworks of the PISA classification: 2- by contributing factors
Time frame: 18 months
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.
Distribution of PSIs occurring in MSPs according to the 4 coding frameworks of the PISA classification: 3-by results
Time frame: 18 months
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.
Distribution of PSIs occurring in MSPs according to the 4 coding frameworks of the PISA classification: 4-by severity
Time frame: 18 months
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.
3 secondary outcomes
Description of MSP professionals' acceptance of learning system
Time frame: 3 months
Description of the behaviour of users of the online system in the 18 months following the provision of initial training
Time frame: 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.
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Services Research in people with Adverse Event, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Baptiste Amélineau, MD (02 40 41 28 28, jean-baptiste.amelineau@univ-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of PSIs occurring in MSPs according to the 4 coding frameworks of the PISA classification: 1-by type (time frame: PSIs reported by MSP professionals in the 18 months following the initial training provided). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.