Patient Safety in Surgical Care Units Clinical Trial
— PERSEPOLISOfficial title:
Patient's Perception of Hospital Safety: Measure of the Patients' Perception and Correlation With Patient Safety Strategies in the Surgical Care Units
| 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 |
| Verified date | February 2021 |
| Source | Hospices Civils de Lyon |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Hospices Civils de Lyon, Pole Information Médicale Evaluation Recherche | Lyon cedex 03 |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
| 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 |