- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02820545
Patient's Perception of Hospital Safety (PERSEPOLIS)
February 9, 2021 updated by: Hospices Civils de Lyon
Patient's Perception of Hospital Safety: Measure of the Patients' Perception and Correlation With Patient Safety Strategies in the Surgical Care Units
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
1277
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Lyon cedex 03, France, 690424
- Hospices Civils de Lyon, Pole Information Médicale Evaluation Recherche
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients hospitalized in surgical care units
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Sociological interview
Patients will take a sociological interview with a sociologist during their hospital stay
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A sociological interview will be performed with each patient by a sociologist, during their hospital stay
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Self-administrated questionnaire
Patients will take a self-administrated questionnaire at the end of their hospital stay and one week after they left hospital
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Self-administrated questionnaire will be performed by patients themselves at the end of hospital stay and one week after they left hospital
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient's perception of patient safety in hospital measured by sociological interviews (qualitative outcome)
Time Frame: During patient's hospital stay, up to 2 weeks
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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.
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During patient's hospital stay, up to 2 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Care safety perception score
Time Frame: 7 days after patient left hospital
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This score is measured by patient himself thanks to the self-administrated questionnaire
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7 days after patient left hospital
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Care safety perception score
Time Frame: The day patient leave hospital, up to 2 weeks
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This score is measured by patient himself thanks to the self-administrated questionnaire
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The day patient leave hospital, up to 2 weeks
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Patient Safety Strategies (PSS) score
Time Frame: During patient's hospital stay, up to 2 weeks
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The PSS questionnaire is completed for each patient by health care professionals
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During patient's hospital stay, up to 2 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Pauline OCCELLI, MD, PhD, Hospices Civils de Lyon
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2016
Primary Completion (Actual)
October 1, 2020
Study Completion (Actual)
October 1, 2020
Study Registration Dates
First Submitted
June 13, 2016
First Submitted That Met QC Criteria
June 28, 2016
First Posted (Estimate)
July 1, 2016
Study Record Updates
Last Update Posted (Actual)
February 10, 2021
Last Update Submitted That Met QC Criteria
February 9, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 69HCL14_0452
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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