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

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

      • Lyon cedex 03, France, 690424
        • Hospices Civils de Lyon, Pole Information Médicale Evaluation Recherche

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

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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Care safety perception score
Time Frame: 7 days after patient left hospital
This score is measured by patient himself thanks to the self-administrated questionnaire
7 days after patient left hospital
Care safety perception score
Time Frame: The day patient leave hospital, up to 2 weeks
This score is measured by patient himself thanks to the self-administrated questionnaire
The day patient leave hospital, up to 2 weeks
Patient Safety Strategies (PSS) score
Time Frame: During patient's hospital stay, up to 2 weeks
The PSS questionnaire is completed for each patient by health care professionals
During patient's hospital stay, up to 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

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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