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Clinical Trials/NCT02880826
NCT02880826CompletedNot Applicable

Study on the Measurement of Care Safety Culture in French ICU, Correlation With the Characteristics of Morbi-mortality Reviews

Nantes University Hospital1 site in 1 country4,800 target enrollmentStarted: August 1, 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
4,800
Locations
1
Primary Endpoint
The measure of the CS of intensive care units in France using a validated questionnaire

Study Overview

Brief Summary

The tools to measure safety culture (CS) have recently become available. No study has focused on the measure in France, apart from pilot studies. intensive services are particularly at risk of serious adverse events occurred (SAEs). Patients who are hospitalized are in fact fragile and precarious clinical condition requires rapid decision taken often. Diagnostic or therapeutic strategies have report "risk-benefit" narrow. They may well be complicated by EIG.Safety of care is a priority in the field of health in general, and especially in intensive care. CS measure in this context seems particularly relevant.

The main objective is to describe the CS intensive care units in France. The study will explore the development of the CS level for the units investigated.

This study will also describe the main features of RMM practiced in intensive care units in France.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •practicing resuscitation activity (this practice is medical or surgical, pediatric or adult, in public or private sector)
  • •volunteer to participate in the study (agreement of the head of the unit)
  • •for which at least 2 matching / references for the study were identified:
  • •a medical officer,
  • •caregiver responsible (Health Framework).

Exclusion Criteria

  • •measurement safety culture done in a period of significant change during a period where the staff and activities of the respondent unit of work is relatively stable.
  • •the responses of professionals to the questionnaire can be influenced by internal factors in their work unit (recent accident occurred, change of close supervision, personnel changes ...) and by factors external to their unit work (establishment certification period, arrival of a new director, recent media coverage of medical accidents ...).

Outcomes

Primary Outcomes

The measure of the CS of intensive care units in France using a validated questionnaire

Time Frame: The planned project duration is 12 months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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