Risk ManagementPRisMNCT02403388
Assessment of a Multifaceted Risk Management Program in French Multiprofessional Offices in Primary Care
An observational study of Risk Management and Primary Health Care, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Avoidable care associated incidents are relatively frequent in primary care. In France for example, avoidable incidents rate is estimated to 22/1000 medical acts from general practitioners. Patient safety is now a growing issue in primary care. One tool to increase patient safety is incident reporting and analysis. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Risk Management, Primary Health Care, Patient Safety
- What is being tested?
- PRisM
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2016to 9 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Multiprofessional primary care offices in France (MSP, SS, PS)
Who may be able to join
- Voluntary multiprofessional primary care offices
- With at least 10 Full Time Equivalent (FTE)
- With at least general practitioners and 3 different occupations in care
Who cannot join
- Monoprofessional primary care offices
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation and Assessment of a Multifaceted Risk Management Program in French Multiprofessional Offices in Primary Care : the PRisM Study
Avoidable care associated incidents are relatively frequent in primary care. In France for example, avoidable incidents rate is estimated to 22/1000 medical acts from general practitioners. Patient safety is now a growing issue in primary care. One tool to increase patient safety is incident reporting and analysis. It could reduce some important consequences for patients and could allow implementing substantial corrective actions.
The aim of the PRisM study is to assess and compare the efficiency of a multifaceted risk management program implemented in the french pluridisciplinary offices in primary care in association with a centralized incident reporting system, versus a centralized incident reporting system only.
- Conditions
- Risk Management, Primary Health Care, Patient Safety
- Being tested
- PRisM
- Keywords
- Patient safety, Primary care, Incident reporting, Pluridisciplinary care offices, Risk management, Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRisMOther
A risk management program for each professional of care in multiprofessional primary care offices in France.
| Study group | Role | What they receive |
|---|---|---|
| Multiprofessional primary care offices with PRisM | 25 multiprofessional primary care offices. Each professional of care of the offices (about 10 FTE / office) have to declare each adverse event that occurs in their office during 18 months. Receives: Other: PRisM | |
| Multiprofessional primary care offices without PRisM | 25 multiprofessional primary care offices. Each professional of care of the offices (about 10 FTE / office) have to declare each adverse event that occurs in their office during 18 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annual incident declaration rate by full-time equivalent in both groups.
Measured: 18 months
Secondary outcomes (8)
Declaration rate of incident associated with patient injury in both groups
Measured: 18 months
Repartition of patient injury in different classes in both groups.
Measured: 18 months
Repartition of incidents causes in different classes in both groups.
Measured: 18 months
Repartition of preventive actions in different classes in both groups.
Measured: 18 months
Repartition of correctives actions in different classes in both groups.
Measured: 18 months
A mean score of french version of Medical Office Survey on Patient Safety (MOSPS) in both groups, including a mean score for each dimension of the survey.
Measured: 1 &18 months
Identification of brakes and levers (qualitative assessment) of program implementation in intervention group.
Measured: after 18 months
Psychometric analysis of Medical Office Survey on Patient Safety (french translation) for dimensional structuration of the survey.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study start1 Mar 2016
- Primary completion9 Apr 2018
- Study completion9 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Risk ManagementStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc CHANELIERE, MD, Principal investigator, Hospices Civils de Lyon, Pôle Information Médicale Evaluation Recherche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02403388
- Sponsor's protocol ID
- 69HCL14_0265
- Acronym
- PRisM
- Status last verified
- Sep 2019
- First submitted
- 26 Mar 2015
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Chaneliere M, Buchet-Poyau K, Keriel-Gascou M, Rabilloud M, Colin C, Langlois-Jacques C, Touzet S. A multifaceted risk management program to improve the reporting rate of patient safety incidents in primary care: a cluster-randomised controlled trial. BMC Prim Care. 2024 Jul 6;25(1):244. doi: 10.1186/s12875-024-02476-4.
PubMed 38971743
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Assessment of a Multifaceted Risk Management Program in French Multiprofessional Offices in Primary Care : the PRisM Study
- ClinicalTrials.gov ID
- NCT02403388
- Acronym / sponsor ID
- PRisM / 69HCL14_0265
- Conditions
- Risk Management, Primary Health Care, Patient Safety
- Keywords
- Patient safety, Primary care, Incident reporting, Pluridisciplinary care offices, Risk management, Assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 9 Apr 2018 (actual)
- Study completion
- 9 Apr 2018 (actual)
- First posted
- 31 Mar 2015 (estimated)
- 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.
Avoidable care associated incidents are relatively frequent in primary care. In France for example, avoidable incidents rate is estimated to 22/1000 medical acts from general practitioners. Patient safety is now a growing issue in primary care. One tool to increase patient safety is incident reporting and analysis. It could reduce some important consequences for patients and could allow implementing substantial corrective actions.
The aim of the PRisM study is to assess and compare the efficiency of a multifaceted risk management program implemented in the french pluridisciplinary offices in primary care in association with a centralized incident reporting system, versus a centralized incident reporting system only.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiprofessional primary care offices with PRisM | – | Other: PRisM25 multiprofessional primary care offices. Each professional of care of the offices (about 10 FTE / office) have to declare each adverse event that occurs in their office during 18 months. |
| Multiprofessional primary care offices without PRisM | – | –25 multiprofessional primary care offices. Each professional of care of the offices (about 10 FTE / office) have to declare each adverse event that occurs in their office during 18 months. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Multiprofessional primary care offices in France (MSP, SS, PS)
Key inclusion criteria (3 listed)
- Voluntary multiprofessional primary care offices
- With at least 10 Full Time Equivalent (FTE)
- With at least general practitioners and 3 different occupations in care
Key exclusion criteria (1 listed)
- Monoprofessional primary care offices
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 |
|---|---|---|
| PRisMA risk management program for each professional of care in multiprofessional primary care offices in France. | Other | Multiprofessional primary care offices with PRisM |
Primary outcome
Annual incident declaration rate by full-time equivalent in both groups.
Time frame: 18 months
8 secondary outcomes
Declaration rate of incident associated with patient injury in both groups
Time frame: 18 months
Repartition of patient injury in different classes in both groups.
Time frame: 18 months
Repartition of incidents causes in different classes in both groups.
Time frame: 18 months
Repartition of preventive actions in different classes in both groups.
Time frame: 18 months
Repartition of correctives actions in different classes in both groups.
Time frame: 18 months
A mean score of french version of Medical Office Survey on Patient Safety (MOSPS) in both groups, including a mean score for each dimension of the survey.
Time frame: 1 &18 months
Identification of brakes and levers (qualitative assessment) of program implementation in intervention group.
Time frame: after 18 months
Psychometric analysis of Medical Office Survey on Patient Safety (french translation) for dimensional structuration of the survey.
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
- Derived from this study: PubMed 38971743Chaneliere M, Buchet-Poyau K, Keriel-Gascou M, Rabilloud M, Colin C, Langlois-Jacques C, Touzet S. A multifaceted risk management program to improve the reporting rate of patient safety incidents in primary care: a cluster-randomised controlled trial. BMC Prim Care. 2024 Jul 6;25(1):244. doi: 10.1186/s12875-024-02476-4.
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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. This study is not recruiting at the moment.
Marc CHANELIERE, MD principal investigator
Hospices Civils de Lyon, Pôle Information Médicale Evaluation Recherche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Risk Management and Primary Health Care, run by Hospices Civils de Lyon 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 12 Aug 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annual incident declaration rate by full-time equivalent in both groups. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02403388, which also lists 1 linked publication.
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 12 Aug 2020.