Hospital Adverse EventRMM SimulationNCT02771613
Impact on the Adverse Event (AE) Incidence of Two Types of Experience Feedback on AE Analyzed During Local Morbidity Mortality Reviews
An observational study of Hospital Adverse Event, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
After implementing a French version of a trigger tool validated for computerized detection of adverse events in patient's medical record, the study will be performed in three parallel randomized arms of three identical departments (each steaming from 6 types of medical, surgical or obstetrical departments with a total… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hospital Adverse Event
- What is being tested?
- Multi professional in situ simulation and Large diffusion of information
- How many people
- 144,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2017to Oct 2021
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: any stage of patients in the involved departments during the two-years intervention's period
Who may be able to join
- patients aged > 18 years old
- patients hospitalized in the involved departments during the two-years intervention's period
Who cannot join
- patient aged < 18 years old
- no other exclusion criteria
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hospices Civils de Lyon - Direction DOQRU
Lyon, 69002
Bernard BUI-XUAN, MD, PhD, +33 4 72 11 63 48, bernard.bui-xuan@chu-lyon.fr
Philippe MICHEL, MD, PhD, +33 4 72 40 71 03, philippe.michel@chu-lyon.fr
About this study
Official title: Impact on Adverse Events (AE) Occurrence of Two Types of Experience Feedback on AE Analysed During Local Morbidity Mortality Reviews (MMR), (by Multi Professional Simulation Education Versus Simple Diffusion of MMR Decisions)
After implementing a French version of a trigger tool validated for computerized detection of adverse events in patient's medical record, the study will be performed in three parallel randomized arms of three identical departments (each steaming from 6 types of medical, surgical or obstetrical departments with a total of 18 departments involved). This three arms will be: no intervention, education of department's staff by multi professional in situ simulation (adapted to the discovered adverse events), or simple but large diffusion of results and decisions of Morbidity Mortality Reviews.
The interventions will be performed during a two-years period.
- Conditions
- Hospital Adverse Event
- Being tested
- Multi professional in situ simulation, Large diffusion of information
- Keywords
- Morbidity Mortality Review, medical simulation, in situ simulation, multi professional simulation, hospital adverse event
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi professional in situ simulationOther
After the analysis of adverse effects in Morbidity Mortality reviews, we will create scenarios adapted to these events. Education of the randomized department's arm's staff will be performed by multi professional in situ simulation with these scenarios
Large diffusion of informationOther
After the analysis of adverse effects in Morbidity Mortality reviews a large scale dissemination activity of information about discussions and decisions towards the staff of the randomized departments' arms will be carried out
| Study group | Role | What they receive |
|---|---|---|
| Active experience feedback | Multi professional, in situ simulation , with scenarios based on the adverse events analyzed in MMR : After analysis of adverse effects in Morbidity Mortality reviews, we will create scenarios adapted to these events. Education of the randomized department's arm's staff will be performed by multi professional in situ simulation with these scenarios Receives: Other: Multi professional in situ simulation | |
| Passive experience feedback | Large diffusion of information about discussions and decisions of Morbidity Mortality Reviews : after the analysis of adverse effects in Morbidity Mortality reviews, a large scale dissemination activity of information about discussions and decisions towards the staff of the randomized departments' arms will be carried out. Receives: Other: Large diffusion of information | |
| No experience feedback | MMR will be performed as usual, without any feedback to the medical staff |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of adverse events related to medical care
Occurrence of any adverse effects detected by the trigger tool. Trigger tool is used to detect more patient's adverse events that voluntary medical report
Measured: During patient hospitalization, up to 2 years
Secondary outcomes (2)
Severity of adverse events related to medical care
Severity of any patient's adverse effect detected by trigger tool. Severity of adverse events is measured by a severity score scale.
Measured: During patient hospitalization, up to 2 years
Contributive factors identification
Contributive factors of adverse events using the "ALARM Method". The Alarm Method allows to determine the contributive factors which together create the adverse patients events.
Measured: During patient hospitalization, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study start1 May 2017
- Primary completionOct 2021 (estimated)
- Study completionOct 2021 (estimated)
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 Hospital Adverse EventStudies 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
- 144,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernard BUI-XUAN, MD, PhD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02771613
- Sponsor's protocol ID
- 69HCL16_0093
- Acronym
- RMM Simulation
- Status last verified
- Oct 2020
- First submitted
- 12 May 2016
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Michel N, Bui-Xuan B, Bapteste L, Rimmele T, Lilot M, Chollet F, Favre H, Duclos A, Michel P. Implementation of an in situ simulation-based training adapted from Morbidity and Mortality conference cases: effect on the occurrence of adverse events-study protocol of a cluster randomised controlled trial. Trials. 2022 Feb 2;23(1):106. doi: 10.1186/s13063-022-06040-2.
PubMed 35109900
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on Adverse Events (AE) Occurrence of Two Types of Experience Feedback on AE Analysed During Local Morbidity Mortality Reviews (MMR), (by Multi Professional Simulation Education Versus Simple Diffusion of MMR Decisions)
- ClinicalTrials.gov ID
- NCT02771613
- Acronym / sponsor ID
- RMM Simulation / 69HCL16_0093
- Conditions
- Hospital Adverse Event
- Keywords
- Morbidity Mortality Review, medical simulation, in situ simulation, multi professional simulation, hospital adverse event
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 144,000 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 13 May 2016 (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.
After implementing a French version of a trigger tool validated for computerized detection of adverse events in patient's medical record, the study will be performed in three parallel randomized arms of three identical departments (each steaming from 6 types of medical, surgical or obstetrical departments with a total of 18 departments involved). This three arms will be: no intervention, education of department's staff by multi professional in situ simulation (adapted to the discovered adverse events), or simple but large diffusion of results and decisions of Morbidity Mortality Reviews.
The interventions will be performed during a two-years period.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active experience feedback | – | Other: Multi professional in situ simulationMulti professional, in situ simulation , with scenarios based on the adverse events analyzed in MMR : After analysis of adverse effects in Morbidity Mortality reviews, we will create scenarios adapted to these events. Education of the randomized department's arm's staff will be performed by multi professional in situ simulation with these scenarios |
| Passive experience feedback | – | Other: Large diffusion of informationLarge diffusion of information about discussions and decisions of Morbidity Mortality Reviews : after the analysis of adverse effects in Morbidity Mortality reviews, a large scale dissemination activity of information about discussions and decisions towards the staff of the randomized departments' arms will be carried out. |
| No experience feedback | – | –MMR will be performed as usual, without any feedback to the medical staff |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- any stage of patients in the involved departments during the two-years intervention's period
Key inclusion criteria (2 listed)
- patients aged > 18 years old
- patients hospitalized in the involved departments during the two-years intervention's period
Key exclusion criteria (2 listed)
- patient aged < 18 years old
- no other exclusion criteria
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 |
|---|---|---|
| Multi professional in situ simulationAfter the analysis of adverse effects in Morbidity Mortality reviews, we will create scenarios adapted to these events. Education of the randomized department's arm's staff will be performed by multi professional in situ simulation with these scenarios | Other | Active experience feedback |
| Large diffusion of informationAfter the analysis of adverse effects in Morbidity Mortality reviews a large scale dissemination activity of information about discussions and decisions towards the staff of the randomized departments' arms will be carried out | Other | Passive experience feedback |
Primary outcome
Occurence of adverse events related to medical care
Time frame: During patient hospitalization, up to 2 years
Occurrence of any adverse effects detected by the trigger tool. Trigger tool is used to detect more patient's adverse events that voluntary medical report
2 secondary outcomes
Severity of adverse events related to medical care
Time frame: During patient hospitalization, up to 2 years
Contributive factors identification
Time frame: During patient hospitalization, up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Derived from this study: PubMed 35109900Michel N, Bui-Xuan B, Bapteste L, Rimmele T, Lilot M, Chollet F, Favre H, Duclos A, Michel P. Implementation of an in situ simulation-based training adapted from Morbidity and Mortality conference cases: effect on the occurrence of adverse events-study protocol of a cluster randomised controlled trial. Trials. 2022 Feb 2;23(1):106. doi: 10.1186/s13063-022-06040-2.
- 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. This study is not recruiting at the moment.
Bernard BUI-XUAN, MD, PhD principal investigator
Hospices Civils de Lyon
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 Hospital Adverse Event, 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 5 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bernard BUI-XUAN, MD, PhD (+33 4 72 11 63 48, bernard.bui-xuan@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurence of adverse events related to medical care (time frame: During patient hospitalization, up to 2 years). 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 NCT02771613, 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 5 Oct 2020.