Risk Management in Nursing Homes

Adverse Events Management in Nursing Homes Clinical Trial

— EHPAGE  

Official title:

Measuring Impact on Safety Culture in Nursing Homes, a Multifaceted Device for the Analysis of Care Associated Adverse Events

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02908373
• Other study ID #: RC15_0053
• Status: Completed
• Start date: December 1, 2015
• Est. completion date: January 11, 2018

Study information

• Verified date: May 2019
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1608
• Est. completion date: January 11, 2018
• Est. primary completion date: January 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 105 Years

Eligibility

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

Related Conditions & MeSH terms

• Adverse Events Management in Nursing Homes

Intervention

Other:
• Implementation of the coaching model
20 hours methodological help for each nursing home and an implementation kit

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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	14 months after initial diagnosis.