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Completed

NCT Number: NCT05371782

Mortality Risk Prediction Tool in Hospitalized Dementia Patients

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

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Mortality

    Time frame: Within 1 year of admission

    Derived from population-based administrative database

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • ICES

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2020
Study completion
2020
First posted
May 12, 2022
Registry last updated
May 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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