NCT02880826

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2013

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 26, 2016

Completed
Last Updated

August 26, 2016

Status Verified

August 1, 2016

Enrollment Period

8 months

First QC Date

August 18, 2016

Last Update Submit

August 25, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

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

    The planned project duration is 12 months

Interventions

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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).

You may not qualify if:

  • 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 ...).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2016

First Posted

August 26, 2016

Study Start

August 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

August 26, 2016

Record last verified: 2016-08