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Risk Management in Nursing Homes (EHPAGE)

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ClinicalTrials.gov Identifier: NCT02908373
Recruitment Status : Recruiting
First Posted : September 21, 2016
Last Update Posted : September 21, 2016
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment
Adverse Events Management in Nursing Homes Other: Implementation of the coaching model

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
Estimated Enrollment : 61 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Measuring Impact on Safety Culture in Nursing Homes, a Multifaceted Device for the Analysis of Care Associated Adverse Events
Study Start Date : September 2015
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nursing Homes

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




Primary Outcome Measures :
  1. 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




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Ages Eligible for Study:   65 Years to 105 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02908373


Contacts
Contact: Noémie Terrien noemie.terrien@chu-nantes.fr
Contact: Leila Moret, MD - PhD - Prof leila.moret@chu-nantes.fr

Locations
France
Nantes University Hospital Recruiting
Nantes, France
Contact: Noémie Terrien       noemie.terrien@chu-nantes.fr   
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Leila MORET, MD PhD Nantes University Hospital

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02908373     History of Changes
Other Study ID Numbers: RC15_0053
First Posted: September 21, 2016    Key Record Dates
Last Update Posted: September 21, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Nantes University Hospital:
risk management
nursing home
elderly
care