Patient Safety in Surgical Care UnitsPERSEPOLISNCT02820545
Patient's Perception of Hospital Safety
An observational study of Patient Safety in Surgical Care Units, run by Hospices Civils de Lyon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Safety in Surgical Care Units
- What is being tested?
- Sociological interview and Self-administrated questionnaire
- How many people
- 1,277 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2016to Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized in surgical care units
Who may be able to join
- Patient hospitalized in a surgical care unit for at least 1 night stay
- Patient hospitalized for a scheduled surgery
- French speaking patient
Who cannot join
- Ambulatory surgery
- Hospitalization in emergency
- Unable to answer a survey
- Patient transfer from another unit of the same hospital
Trial locations and contacts
1 site in 1 country.
France1 site
Hospices Civils de Lyon, Pole Information Médicale Evaluation Recherche
Lyon, 690424
About this study
Official title: 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.
- Conditions
- Patient Safety in Surgical Care Units
- Being tested
- Sociological interview, Self-administrated questionnaire
- Keywords
- patient safety culture, hospital, patient perception, healthcare professional perception, sociological, qualitative, questionnaire construct, psychometrics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sociological interviewOther
A sociological interview will be performed with each patient by a sociologist, during their hospital stay
Self-administrated questionnaireOther
Self-administrated questionnaire will be performed by patients themselves at the end of hospital stay and one week after they left hospital
| Study group | Role | What they receive |
|---|---|---|
| Sociological interview | Patients will take a sociological interview with a sociologist during their hospital stay Receives: 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 Receives: Other: Self-administrated questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During patient's hospital stay, up to 2 weeks
Secondary outcomes (3)
Care safety perception score
This score is measured by patient himself thanks to the self-administrated questionnaire
Measured: 7 days after patient left hospital
Care safety perception score
This score is measured by patient himself thanks to the self-administrated questionnaire
Measured: The day patient leave hospital, up to 2 weeks
Patient Safety Strategies (PSS) score
The PSS questionnaire is completed for each patient by health care professionals
Measured: During patient's hospital stay, up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2020
- Study completionOct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient Safety in Surgical Care UnitsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,277 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pauline OCCELLI, MD, PhD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02820545
- Sponsor's protocol ID
- 69HCL14_0452
- Acronym
- PERSEPOLIS
- Status last verified
- Feb 2021
- First submitted
- 13 Jun 2016
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 35948291
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient's Perception of Hospital Safety: Measure of the Patients' Perception and Correlation With Patient Safety Strategies in the Surgical Care Units
- ClinicalTrials.gov ID
- NCT02820545
- Acronym / sponsor ID
- PERSEPOLIS / 69HCL14_0452
- Conditions
- Patient Safety in Surgical Care Units
- Keywords
- patient safety culture, hospital, patient perception, healthcare professional perception, sociological, qualitative, questionnaire construct, psychometrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,277 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Oct 2020 (actual)
- Study completion
- Oct 2020 (actual)
- First posted
- 1 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sociological interview | – | Other: Sociological interviewPatients will take a sociological interview with a sociologist during their hospital stay |
| Self-administrated questionnaire | – | Other: Self-administrated questionnairePatients will take a self-administrated questionnaire at the end of their hospital stay and one week after they left hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in surgical care units
Key inclusion criteria (3 listed)
- Patient hospitalized in a surgical care unit for at least 1 night stay
- Patient hospitalized for a scheduled surgery
- French speaking patient
Key exclusion criteria (4 listed)
- Ambulatory surgery
- Hospitalization in emergency
- Unable to answer a survey
- Patient transfer from another unit of the same hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sociological interviewA sociological interview will be performed with each patient by a sociologist, during their hospital stay | Other | Sociological interview |
| Self-administrated questionnaireSelf-administrated questionnaire will be performed by patients themselves at the end of hospital stay and one week after they left hospital | Other | Self-administrated questionnaire |
Primary outcome
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.
3 secondary outcomes
Care safety perception score
Time frame: 7 days after patient left hospital
Care safety perception score
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Derived from this study: PubMed 35948291Occelli 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pauline OCCELLI, MD, PhD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Safety in Surgical Care Units, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02820545, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.