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

Study Overview
=================
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.

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)

Conditions
-----------------
Hospital Adverse Event

Intervention / Treatment
-----------------
* Other: Multi professional in situ simulation
* Other: Large diffusion of information


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active experience feedback<br>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<br>* 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<br>|
| Passive experience feedback<br>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<br>* 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<br>|
| No experience feedback<br>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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Morbidity Mortality Review, medical simulation, in situ simulation, multi professional simulation, hospital adverse event