Residents in Longterm Care FacilitiesBABELNCT06034444
Better tArgetting, Better Outcomes for Frail ELderly Patients
An observational study of Residents in Longterm Care Facilities, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Residents in Longterm Care Facilities
- What is being tested?
- interRAI LTCF
- How many people
- 5,692 participants
- Where
- 1 siteCanada
- Study dates
- 16 Aug 2018to 31 Mar 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Residents in a long-term care facility (nursing home)
Who may be able to join
- 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)
Who cannot join
- Residents who are admitted to a nursing home unit for less than 1 week.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Residents in Longterm Care Facilities
- Being tested
- interRAI LTCF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interRAI LTCFOther
Standardized evaluations (interRAI LTCF) will be introduced to selected nursing homes in Quebec.
| Study group | Role | What they receive |
|---|---|---|
| interRAI LTCF | Nursing homes in Quebec where interRAI evaluations and care plans will be introduced. Receives: Other: interRAI LTCF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depression prevalence
Depression rating scale score of 3 or more (from interRAI LTCF)
Measured: Every 3 months, for a minimum of 6 months and a maximum of 36 months
Change in prevalence of potentially inappropriate antipsychotic use
Use of antipsychotics in the absence of an appropriate diagnosis
Measured: Every 3 months, for a minimum of 6 months and a maximum of 36 months
Change in falls prevalence
Prevalence of falls among residents under study
Measured: Every 3 months, for a minimum of 6 months and a maximum of 36 months
Change in prevalence of pain
Using interRAI pain scale scores greater than 0
Measured: Every 3 months, for a minimum of 6 months and a maximum of 36 months
Change in the prevalence of physical restraints use
Use of physical restraints on residents as assessed using interRAI LTCF
Measured: Every 3 months, for a minimum of 6 months and a maximum of 36 months
Secondary outcomes (1)
Change in prevalence of pressure ulcers
Stage 2 pressure ulcer on the interRAI pressure ulcer scale
Measured: Every 3 months, for a minimum of 6 months and a maximum of 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start16 Aug 2018
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Residents in Longterm Care FacilitiesStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,692 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Frailty Network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06034444
- Sponsor's protocol ID
- 17.205
- Acronym
- BABEL
- Status last verified
- Sep 2023
- First submitted
- 20 Jun 2018
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06034444
- Acronym / sponsor ID
- BABEL / 17.205
- Conditions
- Residents in Longterm Care Facilities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,692 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Canadian Frailty Network
- Study start
- 16 Aug 2018 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 13 Sep 2023 (actual)
- 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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| interRAI LTCF | – | Other: interRAI LTCFNursing homes in Quebec where interRAI evaluations and care plans will be introduced. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Residents in a long-term care facility (nursing home)
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- Residents who are admitted to a nursing home unit for less than 1 week.
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 |
|---|---|---|
| interRAI LTCFStandardized evaluations (interRAI LTCF) will be introduced to selected nursing homes in Quebec. | Other | interRAI LTCF |
Primary outcome
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)
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
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
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
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
1 secondary outcome
Change in prevalence of pressure ulcers
Time frame: Every 3 months, for a minimum of 6 months and a maximum of 36 months
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 13 Sep 2023.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Residents in Longterm Care Facilities, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 1 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 13 Sep 2023. 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 Canada. 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?
Change in depression prevalence (time frame: Every 3 months, for a minimum of 6 months and a maximum of 36 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Sep 2023.