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Patient's Perception of Hospital Safety (PERSEPOLIS)

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ClinicalTrials.gov Identifier: NCT02820545
Recruitment Status : Recruiting
First Posted : July 1, 2016
Last Update Posted : August 9, 2017
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief 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.

Condition or disease Intervention/treatment
Patient Safety in Surgical Care Units Other: Sociological interview Other: Self-administrated questionnaire

Study Type : Observational
Estimated Enrollment : 1290 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient's Perception of Hospital Safety: Measure of the Patients' Perception and Correlation With Patient Safety Strategies in the Surgical Care Units
Study Start Date : February 2016
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Sociological interview
Patients will take a sociological interview with a sociologist during their hospital stay
Other: Sociological interview
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
Other: 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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients hospitalized in surgical care units
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02820545


Contacts
Contact: Pauline OCCELLI, MD, PhD +33 (0)4 72 11 57 59 pauline.occelli@chu-lyon.fr
Contact: Karine POYAU, CRA +33 (0)4 72 11 53 81 karine.poyau@chu-lyon.fr

Locations
France
Hospices Civils de Lyon, Pole Information Médicale Evaluation Recherche Recruiting
Lyon cedex 03, France, 690424
Contact: Pauline OCCELLI, MD, PhD    +33 (0)4 72 11 57 59    pauline.occelli@chu-lyon.fr   
Contact: Karine POYAU, CRA    +33 (0)4 72 11 53 81    karine.poyau@chu-lyon.fr   
Principal Investigator: Pauline OCCELLI, MD, PhD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Pauline OCCELLI, MD, PhD Hospices Civils de Lyon

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02820545     History of Changes
Other Study ID Numbers: 69HCL14_0452
First Posted: July 1, 2016    Key Record Dates
Last Update Posted: August 9, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Hospices Civils de Lyon:
patient safety culture
hospital
patient perception
healthcare professional perception
sociological
qualitative
questionnaire construct
psychometrics