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

NCT ID: NCT02771613

Last Updated: 2020-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

144000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-01

Study Completion Date

2021-10-31

Brief Summary

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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

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Conditions

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Hospital Adverse Event

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Multi professional in situ simulation

Intervention Type OTHER

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.

Large diffusion of information

Intervention Type OTHER

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

No interventions assigned to this group

Interventions

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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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bernard BUI-XUAN, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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Hospices Civils de Lyon - Direction DOQRU

Lyon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Bernard BUI-XUAN, MD, PhD

Role: CONTACT

+33 4 72 11 63 48

Philippe MICHEL, MD, PhD

Role: CONTACT

+33 4 72 40 71 03

Facility Contacts

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Bernard BUI-XUAN, MD, PhD

Role: primary

+33 4 72 11 63 48

Philippe MICHEL, MD, PhD

Role: backup

+33 4 72 40 71 03

References

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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.

Reference Type DERIVED
PMID: 35109900 (View on PubMed)

Other Identifiers

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69HCL16_0093

Identifier Type: -

Identifier Source: org_study_id

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