Mortality Risk Prediction Tool in Hospitalized Dementia Patients

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05371782
• Other study ID #: 20200663
• Status: Completed
• Start date: April 1, 2009
• Est. completion date: March 31, 2020

Study information

• Verified date: May 2022
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 298576
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Toronto	Canadian Institutes of Health Research (CIHR), ICES

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Derived from population-based administrative database	Within 1 year of admission