- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06034444
Better tArgetting, Better Outcomes for Frail ELderly Patients (BABEL)
September 5, 2023 updated by: Centre hospitalier de l'Université de Montréal (CHUM)
Better tArgetting, Better Outcomes for Frail ELderly Patients: A Quality Improvement Initiative in Long-term Care Facilities Using interRAI Long-term Care Assessment in Quebec
The acronym for this proposal, BABEL, refers to the fact that a common "language" - the interRAI risk-stratification and decision-making tool - will be used in this project, allowing several measures of care quality in long-term care facilities to be compared with those in other provinces for the first time.
The impact of the use of this assessment system and associated care planning protocols will also be investigated using usual practice as the point of reference.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
5692
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
-
-
Quebec
-
Montréal, Quebec, Canada, H4W 2Y6
- Donald Berman Maimonides
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Residents in a long-term care facility (nursing home)
Description
Inclusion Criteria:
- All nursing home residents in a particular unit where standardized evaluations are being introduced (for example, all residents in a particular floor or wing of the longterm care facility)
Exclusion Criteria:
- Residents who are admitted to a nursing home unit for less than 1 week.
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 |
|---|---|
|
interRAI LTCF
Nursing homes in Quebec where interRAI evaluations and care plans will be introduced.
|
Standardized evaluations (interRAI LTCF) will be introduced to selected nursing homes in Quebec.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in depression prevalence
Time Frame: Every 3 months, for a minimum of 6 months and a maximum of 36 months
|
Depression rating scale score of 3 or more (from interRAI LTCF)
|
Every 3 months, for a minimum of 6 months and a maximum of 36 months
|
|
Change in prevalence of potentially inappropriate antipsychotic use
Time Frame: Every 3 months, for a minimum of 6 months and a maximum of 36 months
|
Use of antipsychotics in the absence of an appropriate diagnosis
|
Every 3 months, for a minimum of 6 months and a maximum of 36 months
|
|
Change in falls prevalence
Time Frame: Every 3 months, for a minimum of 6 months and a maximum of 36 months
|
Prevalence of falls among residents under study
|
Every 3 months, for a minimum of 6 months and a maximum of 36 months
|
|
Change in prevalence of pain
Time Frame: Every 3 months, for a minimum of 6 months and a maximum of 36 months
|
Using interRAI pain scale scores greater than 0
|
Every 3 months, for a minimum of 6 months and a maximum of 36 months
|
|
Change in the prevalence of physical restraints use
Time Frame: Every 3 months, for a minimum of 6 months and a maximum of 36 months
|
Use of physical restraints on residents as assessed using interRAI LTCF
|
Every 3 months, for a minimum of 6 months and a maximum of 36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in prevalence of pressure ulcers
Time Frame: Every 3 months, for a minimum of 6 months and a maximum of 36 months
|
Stage 2 pressure ulcer on the interRAI pressure ulcer scale
|
Every 3 months, for a minimum of 6 months and a maximum of 36 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in other interRAI LTCF quality indicators
Time Frame: Every 3 months, for a minimum of 6 months and a maximum of 36 months
|
interRAI LTCF evaluation leads to a number of quality indicators being generated each of which will be tracked over time for each facility to compare before and after effects, as well as comparisons with other centers in Canada
|
Every 3 months, for a minimum of 6 months and a maximum of 36 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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)
August 16, 2018
Primary Completion (Actual)
March 31, 2020
Study Completion (Actual)
March 31, 2020
Study Registration Dates
First Submitted
June 20, 2018
First Submitted That Met QC Criteria
September 5, 2023
First Posted (Actual)
September 13, 2023
Study Record Updates
Last Update Posted (Actual)
September 13, 2023
Last Update Submitted That Met QC Criteria
September 5, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 17.205
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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