Clinical trial NCT02908373: Risk Management in Nursing Homes
Official title: Measuring Impact on Safety Culture in Nursing Homes, a Multifaceted Device for the Analysis of Care Associated Adverse Events
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adverse Events Management in Nursing Homes
Keywords: risk management
nursing home
elderly
care
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2016-09-21
Enrollment: 1608
Sex: ALL
Minimum age (years): 65
Maximum age (years): 105
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 61 nursing home located in Loire-Atlantique and Vendée departments in France. Loire-Atlantique and Vendée departments already benefit the risk management model from the réseau qualisanté located in Nantes University Hospital

Brief summary: 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).

Detailed description: 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:

1. To encourage the place of patient safety culture in strategic issues of nursing homes
2. To develop patient safety culture of professionals working in nursing homes
3. To develop a way to structure and make the reporting of adverse events in nursing homes more sustainable
4. To describe epidemiologic characteristic of adverse events in nursing homes
5. 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

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: 14 months after initial diagnosis.
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Leila MORET, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Teigne D, Mabileau G, Anthoine E, Lucas M, Leclere B, Moret L, Terrien N. Transcultural adaptation and psychometric study of the French version of the nursing home survey on patient safety culture questionnaire. BMC Health Serv Res. 2019 Jul 15;19(1):490. doi: 10.1186/s12913-019-4333-5.