- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02779309
Risk Evaluation for Support: Predicting Elder Life in the Community Tool (RESPECT) (RESPECT)
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 Overview
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.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Development Cohort
437,000 home care recipients who received services from January 1, 2007 to December 31, 2012.
|
Home care recipients who have received a comprehensive health assessment using the Resident Assessment Instrument for Home Care (RAI-HC).
|
Validation Cohort
122,000 home care recipients who received services from January 1, 2013 to December 31, 2013.
|
Home care recipients who have received a comprehensive health assessment using the Resident Assessment Instrument for Home Care (RAI-HC).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
6-month Mortality
Time Frame: 6 months
|
Mortality status at 6 months after receiving a structured Resident Assessment Instrument for Home Care (RAI-HC) Assessment.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
12-month Mortality
Time Frame: 12 months
|
Mortality status at 12 months after receiving a structured Resident Assessment Instrument for Home Care (RAI-HC) Assessment.
|
12 months
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIHR FRN - 142876
- Trim no. P0901 074 (Other Identifier: Institute for Clinical Evaluative Sciences)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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