Measurement of Care Safety Culture in French ICU, Correlation With the Characteristics of Morbi-mortality Reviews (REA-C-SUR)

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

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 Overview

• Status: Completed
• Conditions: Emergency
• Intervention / Treatment: Behavioral: Measure the culture of safety in the reanimation units

• Study Type: Observational
• Enrollment (Actual): 4800

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

60 intensive care units in France. Each unit is estimated that an average of 80 professionals will be subject to the evaluation of the CS (doctors, IDE, assistant nurses, physiotherapists...) and thus nearly 4800 people will be included for the CS measurement.

Includes: all professionals providing care to patients and working full-time or part-time work in the respondent unit.

Description

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 ...).

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The measure of the CS of intensive care units in France using a validated questionnaire	The planned project duration is 12 months

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: August 18, 2016
• First Submitted That Met QC Criteria: August 25, 2016
• First Posted (Estimate): August 26, 2016

Study Record Updates

• Last Update Posted (Estimate): August 26, 2016
• Last Update Submitted That Met QC Criteria: August 25, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: RC13_0028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided