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Impact on the Adverse Event (AE) Incidence of Two Types of Experience Feedback on AE Analyzed During Local Morbidity Mortality Reviews

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)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02771613
Acronym
RMM Simulation
Enrollment
144000
Registered
2016-05-13
Start date
2017-05-01
Completion date
2021-10-31
Last updated
2020-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hospital Adverse Event

Keywords

Morbidity Mortality Review, medical simulation, in situ simulation, multi professional simulation, hospital adverse event

Brief 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 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.

Interventions

OTHERMulti professional in situ simulation

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

OTHERLarge diffusion of information

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

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* patients aged \> 18 years old * patients hospitalized in the involved departments during the two-years intervention's period

Exclusion criteria

* patient aged \< 18 years old * no other

Design outcomes

Primary

MeasureTime frameDescription
Occurence of adverse events related to medical careDuring patient hospitalization, up to 2 yearsOccurrence of any adverse effects detected by the trigger tool. Trigger tool is used to detect more patient's adverse events that voluntary medical report

Secondary

MeasureTime frameDescription
Severity of adverse events related to medical careDuring patient hospitalization, up to 2 yearsSeverity of any patient's adverse effect detected by trigger tool. Severity of adverse events is measured by a severity score scale.
Contributive factors identificationDuring patient hospitalization, up to 2 yearsContributive factors of adverse events using the ALARM Method. The Alarm Method allows to determine the contributive factors which together create the adverse patients events.

Countries

France

Contacts

Primary ContactBernard BUI-XUAN, MD, PhD
bernard.bui-xuan@chu-lyon.fr+33 4 72 11 63 48
Backup ContactPhilippe MICHEL, MD, PhD
philippe.michel@chu-lyon.fr+33 4 72 40 71 03

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026