Risk Management in Nursing Homes (EHPAGE)

May 9, 2019 updated by: Nantes University Hospital

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

1608

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France
        • Nantes University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 105 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Case group
Nursing homes benefiting first the implementation of the coaching model (methodological help for professionals on the patient safety culture): just after the first measure (overview of the situation)
Other: Implementation of the coaching model
20 hours methodological help for each nursing home and an implementation kit
Control group
Nursing homes benefiting the implementation of the coaching model (methodological help for professionals on the patient safety culture): after the second measure (impact of the device on case group)
Other: Implementation of the coaching model
20 hours methodological help for each nursing home and an implementation kit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
14 months after initial diagnosis.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Leila MORET, MD PhD, Nantes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Actual)

January 11, 2018

Study Completion (Actual)

January 11, 2018

Study Registration Dates

First Submitted

September 12, 2016

First Submitted That Met QC Criteria

September 15, 2016

First Posted (Estimate)

September 21, 2016

Study Record Updates

Last Update Posted (Actual)

May 10, 2019

Last Update Submitted That Met QC Criteria

May 9, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RC15_0053

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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