NCT02820545

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,277

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 1, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

4 years

First QC Date

June 13, 2016

Last Update Submit

February 9, 2021

Conditions

Keywords

patient safety culturehospitalpatient perceptionhealthcare professional perceptionsociologicalqualitativequestionnaire constructpsychometrics

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Care safety perception score

    7 days after patient left hospital

  • Care safety perception score

    The day patient leave hospital, up to 2 weeks

  • Patient Safety Strategies (PSS) score

    During patient's hospital stay, up to 2 weeks

Study Arms (2)

Sociological interview

Patients will take a sociological interview with a sociologist during their hospital stay

Other: Sociological interview

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

Interventions

A sociological interview will be performed with each patient by a sociologist, during their hospital stay

Sociological interview

Self-administrated questionnaire will be performed by patients themselves at the end of hospital stay and one week after they left hospital

Self-administrated questionnaire

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients hospitalized in surgical care units

You may qualify if:

  • Patient hospitalized in a surgical care unit for at least 1 night stay
  • Patient hospitalized for a scheduled surgery
  • French speaking patient

You may not qualify if:

  • Ambulatory surgery
  • Hospitalization in emergency
  • Unable to answer a survey
  • Patient transfer from another unit of the same hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon, Pole Information Médicale Evaluation Recherche

Lyon, 690424, France

Location

Related Publications (1)

  • Occelli P, Mougeot F, Robelet M, Buchet-Poyau K, Touzet S, Michel P. Feelings of Trust and of Safety Are Related Facets of the Patient's Experience in Surgery: A Descriptive Qualitative Study in 80 Patients. J Patient Saf. 2022 Aug 1;18(5):415-420. doi: 10.1097/PTS.0000000000000950. Epub 2021 Dec 17.

Study Officials

  • Pauline OCCELLI, MD, PhD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2016

First Posted

July 1, 2016

Study Start

October 1, 2016

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

February 10, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations