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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02820545
Other study ID # 69HCL14_0452
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2016
Est. completion date October 2020

Study information

Verified date February 2021
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study aims to construct and validate a self-administrated questionnaire to assess the patients' perception of patient safety in surgical care units. The originality of the study is to perform sociological interviews of hospitalized patients to assess their own perception on the safety of their care and to create corresponding items which will be included in a new questionnaire. In a second step, patients' perception of patient safety will be assessed in numerous surgical care units in France, in order to analyze the psychometric properties of the questionnaire and consequently to validate the questionnaire. The patients' perception will be compared to the healthcare professionals' perception on patient safety and to the patient safety strategies in place in the care units.


Recruitment information / eligibility

Status Completed
Enrollment 1277
Est. completion date October 2020
Est. primary completion date October 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient hospitalized in a surgical care unit for at least 1 night stay - Patient hospitalized for a scheduled surgery - French speaking patient Exclusion Criteria: - Ambulatory surgery - Hospitalization in emergency - Unable to answer a survey - Patient transfer from another unit of the same hospital

Study Design


Related Conditions & MeSH terms

  • Patient Safety in Surgical Care Units

Intervention

Other:
Sociological interview
A sociological interview will be performed with each patient by a sociologist, during their hospital stay
Self-administrated questionnaire
Self-administrated questionnaire will be performed by patients themselves at the end of hospital stay and one week after they left hospital

Locations

Country Name City State
France Hospices Civils de Lyon, Pole Information Médicale Evaluation Recherche Lyon cedex 03

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient's perception of patient safety in hospital measured by sociological interviews (qualitative outcome) This qualitative outcome is measured by sociological interviews of hospitalized patients to construct a new questionnaire. Sociological interviews will be analyzed to identify items and dimensions of the patient's perception to introduce in the questionnaire. During patient's hospital stay, up to 2 weeks
Secondary Care safety perception score This score is measured by patient himself thanks to the self-administrated questionnaire 7 days after patient left hospital
Secondary Care safety perception score This score is measured by patient himself thanks to the self-administrated questionnaire The day patient leave hospital, up to 2 weeks
Secondary Patient Safety Strategies (PSS) score The PSS questionnaire is completed for each patient by health care professionals During patient's hospital stay, up to 2 weeks