Nantes University Hospital
Nantes, France
Completed
NCT Number: NCT02908373
Risk Management in Nursing Homes
The Réseau QualiSanté (risk management network) hardly works on risk management in nursing homes. A model to help nursing homes managers to structure and analyze adverse events has been constructed by a working group of health professionals in the Réseau QualiSanté. Several questions appeared: is the model able to increase patient safety culture of professionals working in nursing homes? How to characterize adverse events in nursing homes? How frequent are they? The main objective of this research project EHPAGE is to measure the impact of the model to structure and analyze adverse events in nursing homes on the patient safety culture of professionals. The project combines quantitative data (questionnaire) and qualitative data (interviews).
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Conditions
Age range
65 year–105 year
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
The main objective of this research project EHPAGE is to measure the impact of the model to structure and analyze adverse events in nursing homes on the patient safety culture of professionals. The coaching model is composed of a 20 hours methodological help for each nursing home and of an implementation kit.
To answer to the main objective, quantitative and qualitative data will be collected twice during the project: before the implementation of the coaching model and 12 months after.
Secondary objectives are:
- To encourage the place of patient safety culture in strategic issues of nursing homes
- To develop patient safety culture of professionals working in nursing homes
- To develop a way to structure and make the reporting of adverse events in nursing homes more sustainable
- To describe epidemiologic characteristic of adverse events in nursing homes
- To propose a French validated questionnaire to evaluate patient safety culture reported by professionals in nursing homes An ancillary study is perform to describe epidemiologic characteristic of adverse events in nursing homes
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Nursing homes members of the Réseau QualiSanté (risk management network)
- Public or private legal status
- Agreeing to participate in the project
Exclusion criteria
- None
Treatment and study plan
Implementation of the coaching model
Other20 hours methodological help for each nursing home and an implementation kit
Primary outcomes
-
impact of the coaching of the réseau QualiSanté: score expressed by the average percentages of positive responses to the "Overall perception of the safety of residents" dimension (= sum of 2 terms of positive response from the Likert scale)
Time frame: 14 months after initial diagnosis.
Initial analysis: estimate baseline characteristics of nursing homes (2 groups) Analysis of the primary endpoint primarily for professionals and secondly for nursing homes (consideration of cluster randomization)
Professionals Analysis:
Score of each professional "Overall perception of the safety of residents - OPOTSOR" dimension of NHSOPS questionnaire calculated for both measures in each arm Linear mixed model implemented to reflect the hierarchical data structure: score of the dimension "OPOTSOR" at assessment2 explained by the fixed effect group and the random effect of nursing homes.
Adjustment with other variables if necessary Facility effect estimated with Intraclass correlation coefficient
Nursing homes analysis:
"Global perception of the safety of residents" dimension score of each nursing home calculated at assessment1 and 2 in each group Comparison of the average test scores at assessment2 for each nursing home
Sponsors and collaborators
Lead sponsor
Nantes University Hospital
Other
Registry information
Official study title
Measuring Impact on Safety Culture in Nursing Homes, a Multifaceted Device for the Analysis of Care Associated Adverse Events
Acronym: EHPAGE
Important dates
- Study start
- 2015
- Primary completion
- 2018
- Study completion
- 2018
- First posted
- Sep 21, 2016
- Registry last updated
- May 10, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.