Adverse Events Management in Nursing HomesEHPAGENCT02908373
Risk Management in Nursing Homes
An observational study of Adverse Events Management in Nursing Homes, run by Nantes University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 65 to 105 years
- Conditions the study is for
- Adverse Events Management in Nursing Homes
- What is being tested?
- Implementation of the coaching model
- How many people
- 1,608 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2015to 11 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 105 years
- All sexes
- No healthy volunteers
- Older adult
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
Who may be able to join
- Nursing homes members of the Réseau QualiSanté (risk management network)
- Public or private legal status
- Agreeing to participate in the project
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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:
- 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
- Being tested
- Implementation of the coaching model
- Keywords
- risk management, nursing home, elderly, care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of the coaching modelOther
20 hours methodological help for each nursing home and an implementation kit
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Implementation of the coaching model | |
| 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) Receives: Other: Implementation of the coaching model |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 14 months after initial diagnosis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study start1 Dec 2015
- Primary completion11 Jan 2018
- Study completion11 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adverse Events Management in Nursing HomesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,608 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leila MORET, MD PhD, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02908373
- Sponsor's protocol ID
- RC15_0053
- Acronym
- EHPAGE
- Status last verified
- May 2019
- First submitted
- 12 Sep 2016
- Last updated
- 10 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Teigne D, Mabileau G, Lucas M, Moret L, Terrien N. Safety culture in French nursing homes: A randomised controlled study to evaluate the effectiveness of a risk management intervention associated with care. PLoS One. 2022 Dec 1;17(12):e0277121. doi: 10.1371/journal.pone.0277121. eCollection 2022.
PubMed 36454806Teigne 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.
PubMed 31307443
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Impact on Safety Culture in Nursing Homes, a Multifaceted Device for the Analysis of Care Associated Adverse Events
- ClinicalTrials.gov ID
- NCT02908373
- Acronym / sponsor ID
- EHPAGE / RC15_0053
- Keywords
- risk management, nursing home, elderly, care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,608 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 11 Jan 2018 (actual)
- Study completion
- 11 Jan 2018 (actual)
- First posted
- 21 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | – | Other: Implementation of the coaching modelNursing 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) |
| Control group | – | Other: Implementation of the coaching modelNursing 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) |
Who may qualify
- Ages
- 65 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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
Key inclusion criteria (3 listed)
- Nursing homes members of the Réseau QualiSanté (risk management network)
- Public or private legal status
- Agreeing to participate in the project
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementation of the coaching model20 hours methodological help for each nursing home and an implementation kit | Other | Case group, Control group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
- Derived from this study: PubMed 36454806Teigne D, Mabileau G, Lucas M, Moret L, Terrien N. Safety culture in French nursing homes: A randomised controlled study to evaluate the effectiveness of a risk management intervention associated with care. PLoS One. 2022 Dec 1;17(12):e0277121. doi: 10.1371/journal.pone.0277121. eCollection 2022.
- Derived from this study: PubMed 31307443Teigne 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leila MORET, MD PhD principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adverse Events Management in Nursing Homes, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: 14 months after initial diagnosis.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02908373, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2019.