Measurement of Care Safety Culture in French ICU, Correlation With the Characteristics of Morbi-m… (NCT02880826) | Clinical Trial Compass
CompletedNot Applicable
Measurement of Care Safety Culture in French ICU, Correlation With the Characteristics of Morbi-mortality Reviews
France4,800 participantsStarted 2013-08
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ...).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The measure of the CS of intensive care units in France using a validated questionnaire
Timeframe: The planned project duration is 12 months