Clinical trial NCT02779309: Risk Evaluation for Support: Predicting Elder Life in the Community Tool (RESPECT)
Official title: An Algorithm for Predicting Death Among Older Adults in the Home Care Setting: Study Protocol for the Risk Evaluation for Support: Predicting Elder Life in the Community Tool (RESPECT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Death
Keywords: Frail Older Adults
Mortality
Home Care
Survival Analysis
Clinical Prediction Rule
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Institute for Clinical Evaluative Sciences
name: Canadian Institutes of Health Research (CIHR)
First posted: 2016-05-20
Enrollment: 486000
Sex: ALL
Minimum age (years): 50
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Older adults receiving home care in Ontario, Canada, who have received a structured Resident Assessment Instrument for Home Care (RAI-HC) assessment between January 1, 2007 and December 31, 2013.

Brief summary: To develop a mortality risk prediction model that can be applied to the wide spectrum of risks that are seen in the home care setting.

Detailed description: ABSTRACT

Introduction: Older adults living in the community often have multiple, chronic conditions and functional impairments. A challenge for healthcare providers working in the community is the lack of a predictive tool that can be applied to the broad spectrum of mortality risks observed and may be used to inform care planning.

Objective: To develop a mortality risk prediction model for older adults in the home care setting. The final algorithm will be implemented as a web-based calculator that can be used by older adults needing care, as well as their informal and formal caregivers.

Design: Open cohort study using the Resident Assessment Instrument for Home Care (RAI-HC) data in Ontario, Canada, from January 1, 2007, to December 31, 2013.

Participants: The derivation cohort will consist of approximately 437 000 home care recipients from January 1, 2007, to December 31, 2012. A split sample validation cohort will include approximately 122 000 recipients from January 1 to December 31, 2013.

Main outcome measures: Predicted survival from the time of an RAI-HC assessment. All deaths (N ≈ 245 000) will be ascertained through linkage to the provincial vital statistics records.

Statistical analysis: Proportional hazards regression will be estimated after assessment of assumptions. Predictors will include sociodemographic characteristics, social support, health conditions, functional status, cognition, symptoms of decline, and prior healthcare use. Model performance will be evaluated for 6- and 12-month predicted risks, including measures of calibration (e.g., calibration plots) and discrimination (e.g., c-statistics). The final algorithm will be generated by combining development and validation data.

Eligibility criteria: Inclusion Criteria:

* Have received a structured RAI-HC assessment
* Between 50 and 105 years of age

Exclusion Criteria:

* Not eligible for Ontario's universal health insurance program (OHIP)
* Did not receive a structured RAI-HC assessment

Primary outcomes:
measure: 6-month Mortality
timeFrame: 6 months
Secondary outcomes:
measure: 12-month Mortality
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
citation: Hsu AT, Manuel DG, Taljaard M, Chalifoux M, Bennett C, Costa AP, Bronskill S, Kobewka D, Tanuseputro P. Algorithm for predicting death among older adults in the home care setting: study protocol for the Risk Evaluation for Support: Predictions for Elder-life in the Community Tool (RESPECT). BMJ Open. 2016 Dec 1;6(12):e013666. doi: 10.1136/bmjopen-2016-013666.