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

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.

Study Overview

• Status: Unknown
• Conditions: Hospital Adverse Event
• Intervention / Treatment: Other: Multi professional in situ simulation; Other: Large diffusion of information

• Study Type: Observational
• Enrollment (Anticipated): 144000

Contacts and Locations

• Study Contact: Name: Bernard BUI-XUAN, MD, PhD; Phone Number: +33 4 72 11 63 48; Email: bernard.bui-xuan@chu-lyon.fr
• Study Contact Backup: Name: Philippe MICHEL, MD, PhD; Phone Number: +33 4 72 40 71 03; Email: philippe.michel@chu-lyon.fr

Study Locations

• France
  • Lyon, France, 69002
    • Recruiting
    • Hospices Civils de Lyon - Direction DOQRU
    • Contact: Bernard BUI-XUAN, MD, PhD; Phone Number: +33 4 72 11 63 48; Email: bernard.bui-xuan@chu-lyon.fr
    • Contact: Philippe MICHEL, MD, PhD; Phone Number: +33 4 72 40 71 03; Email: philippe.michel@chu-lyon.fr
    • Principal Investigator: Bernard BUI-XUAN, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

any stage of patients in the involved departments during the two-years intervention's period

Description

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 exclusion criteria

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: Multi 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
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.	Other: Large 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
No experience feedback; MMR will be performed as usual, without any feedback to the medical staff

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	During patient hospitalization, up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	During patient hospitalization, up to 2 years

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Bernard BUI-XUAN, MD, PhD, Hospices Civils de Lyon

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: May 12, 2016
• First Submitted That Met QC Criteria: May 12, 2016
• First Posted (Estimate): May 13, 2016

Study Record Updates

• Last Update Posted (Actual): October 5, 2020
• Last Update Submitted That Met QC Criteria: October 1, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: medical simulation; Morbidity Mortality Review; in situ simulation; multi professional simulation; hospital adverse event
• Other Study ID Numbers: 69HCL16_0093

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No