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Clinical Trials/NCT05371782
NCT05371782
Completed
Not Applicable

The Development and Validation of a Clinical Prediction Tool to Estimate 1-year Mortality Among Hospitalized Patients With Dementia

University of Toronto0 sites298,576 target enrollmentApril 1, 2009
ConditionsDementia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dementia
Sponsor
University of Toronto
Enrollment
298576
Primary Endpoint
Mortality
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The objective of this study is to develop and validate a clinical prediction tool to estimate 1-year mortality among hospitalized patients with dementia.

Detailed Description

Patients with dementia are frequently hospitalized. Despite having specialist palliative care needs, they have infrequent and late access to corresponding services. Accurate and personalized predictions of mortality risk among hospitalized patients with dementia could inform clinical care decisions made during admission and upon discharge, including whether or not to engage specialist palliative care services. Existing prognostic tools have limitations. We seek to develop and validate a clinical prediction tool to estimate 1-year mortality in this patient population. The derivation cohort will comprise about 235,000 patients with dementia, who were admitted to a hospital in Ontario from April 1st, 2009 to December 31st, 2017. Predictor variables have been fully prespecified based on a literature review and on subject-matter expertise, and were categorized as follows: sociodemographic factors, comorbidities, previous interventions, cognitive status, functional status, nutritional status, admission information, and previous health care utilization. The outcome variable will be mortality within 1 year of admission, which will be modelled as a binary variable, such that a logistic regression model will be estimated. Predictor and outcome variables will be derived from linked population-based administrative databases. The validation cohort will comprise about 63,000 dementia patients, who were admitted to a hospital in Ontario from January 1st, 2018 to March 31st, 2019. Model performance, measured by predictive ability, discrimination, and calibration, will be assessed in the validation cohort. The final model will be based on the full cohort.

Registry
clinicaltrials.gov
Start Date
April 1, 2009
End Date
March 31, 2020
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michael Bonares

Lecturer

University of Toronto

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of dementia using a validated algorithm to identify cases based on a combination of hospital codes, physician claims, and prescribed medications that are specific to dementia
  • Hospitalization at least once from March 31st, 2009, to April 1st, 2019

Exclusion Criteria

  • Age \<65 years at the time of index admission
  • Ineligibility for universal health insurance at the time of admission

Outcomes

Primary Outcomes

Mortality

Time Frame: Within 1 year of admission

Derived from population-based administrative database

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