Risk Evaluation for Support: Predicting… | Clinical Trial

Key information

Conditions

Death Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

50 year–105 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Home Care/RAI-HC Assessment

Procedure

Home care recipients who have received a comprehensive health assessment using the Resident Assessment Instrument for Home Care (RAI-HC).

Primary outcomes

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.

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Collaborators

Canadian Institutes of Health Research (CIHR)
Institute for Clinical Evaluative Sciences

Registry information

Official study 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)

Acronym: RESPECT

Important dates

Study start: 2007
Primary completion: 2013
Study completion: 2017
First posted: May 20, 2016
Registry last updated: May 9, 2018

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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Completed