NCT06034444

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,692

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

August 16, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
3.5 years until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

1.6 years

First QC Date

June 20, 2018

Last Update Submit

September 5, 2023

Conditions

Outcome Measures

Primary Outcomes (5)

  • Change in depression prevalence

    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

    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

    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

    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

    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 Outcomes (1)

  • Change in prevalence of pressure ulcers

    Every 3 months, for a minimum of 6 months and a maximum of 36 months

Other Outcomes (1)

  • Change in other interRAI LTCF quality indicators

    Every 3 months, for a minimum of 6 months and a maximum of 36 months

Study Arms (1)

interRAI LTCF

Nursing homes in Quebec where interRAI evaluations and care plans will be introduced.

Other: interRAI LTCF

Interventions

Standardized evaluations (interRAI LTCF) will be introduced to selected nursing homes in Quebec.

interRAI LTCF

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Residents in a long-term care facility (nursing home)

You may qualify if:

  • 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)

You may not qualify if:

  • Residents who are admitted to a nursing home unit for less than 1 week.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Donald Berman Maimonides

Montreal, Quebec, H4W 2Y6, Canada

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2018

First Posted

September 13, 2023

Study Start

August 16, 2018

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

September 13, 2023

Record last verified: 2023-09

Locations