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

Emergency Clinical Trial

— REA-C-SUR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02880826
• Other study ID #: RC13_0028
• Status: Completed
• Phase: N/A
• First received: August 18, 2016
• Last updated: August 25, 2016
• Start date: August 2013
• Est. completion date: April 2014

Study information

• Verified date: August 2016
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4800
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Emergencies
• Emergency

Intervention

Behavioral:
• Measure the culture of safety in the reanimation units

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The measure of the CS of intensive care units in France using a validated questionnaire		The planned project duration is 12 months	No