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

• Conditions: Hospital Adverse Event

• Registration Number: NCT02771613
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-12
• Study First Submitted QC: 2016-05-12
• Study First Posted: 2016-05-13
• Study Start: 2017-05-01
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-01
• Last Update Posted: 2020-10-05
• Primary Completion: 2021-10
• Study Completion: 2021-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 144000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurence of adverse events related to medical care	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

Secondary Outcome Measures

Name	Time	Method
Contributive factors identification	During patient hospitalization, up to 2 years	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.
Severity of adverse events related to medical care	During patient hospitalization, up to 2 years	Severity of any patient's adverse effect detected by trigger tool. Severity of adverse events is measured by a severity score scale.

Trial Locations

Locations (1)

Hospices Civils de Lyon - Direction DOQRU; 🇫🇷 Lyon, France