Study Protocol for the Development and Validation of a Clinical Prediction Tool to Estimate the Risk of 1-Year Mortality among Hospitalized Patients with Dementia

Background Patients with dementia and their caregivers could benefit from advance care planning though may not be having these discussions in a timely manner or at all. A prognostic tool could serve as a prompt to healthcare providers to initiate advance care planning among patients and their caregivers, which could increase the receipt of care that is concordant with their goals. Existing prognostic tools have limitations. We seek to develop and validate a clinical prediction tool to estimate the risk of 1-year mortality among hospitalized patients with dementia. Methods The derivation cohort will include approximately 235,000 patients with dementia, who were admitted to hospital in Ontario from April 1st, 2009, to December 31st, 2017. Predictor variables will be fully prespecified based on a literature review of etiological studies and existing prognostic tools, and on subject-matter expertise; they will be categorized as follows: sociodemographic factors, comorbidities, previous interventions, functional status, nutritional status, admission information, previous health care utilization. Data-driven selection of predictors will be avoided. Continuous predictors will be modelled as restricted cubic splines. 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-level healthcare administrative databases. The validation cohort will comprise about 63,000 dementia patients, who were admitted to hospital in Ontario from January 1st, 2018, to March 31st, 2019. Model performance, measured by predictive accuracy, discrimination, and calibration, will be assessed using internal (temporal) validation. Calibration will be evaluated in the total validation cohort and in subgroups of importance to clinicians and policymakers. The final model will be based on the full cohort. Discussion We seek to develop and validate a clinical prediction tool to estimate the risk of 1-year mortality among hospitalized patients with dementia. The model would be integrated into the electronic medical records of hospitals to automatically output 1-year mortality risk upon hospitalization. The tool could serve as a trigger for advance care planning and inform access to specialist palliative care services with prognosis-based eligibility criteria. Before implementation, the tool will require external validation and study of its potential impact on clinical decision-making and patient outcomes. Trial registration NCT05371782.