- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02880826
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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.
Beskrivelse
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 ...).
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kun etui
- Tidsperspektiver: Fremadrettet
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
The measure of the CS of intensive care units in France using a validated questionnaire
Tidsramme: The planned project duration is 12 months
|
The planned project duration is 12 months
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RC13_0028
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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