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Risk Evaluation for Support: Predicting Elder Life in the Community Tool (RESPECT) (RESPECT)

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ClinicalTrials.gov Identifier: NCT02779309
Recruitment Status : Completed
First Posted : May 20, 2016
Last Update Posted : May 9, 2018
Sponsor:
Collaborators:
Institute for Clinical Evaluative Sciences
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

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.

Condition or disease Intervention/treatment
Death Procedure: Home Care/RAI-HC Assessment

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.

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Study Type : Observational
Actual Enrollment : 486000 participants
Observational Model: Cohort
Time Perspective: Retrospective
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 Start Date : January 2007
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2017

Group/Cohort Intervention/treatment
Development Cohort
437,000 home care recipients who received services from January 1, 2007 to December 31, 2012.
Procedure: Home Care/RAI-HC Assessment
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.
Procedure: Home Care/RAI-HC Assessment
Home care recipients who have received a comprehensive health assessment using the Resident Assessment Instrument for Home Care (RAI-HC).




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.



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Ages Eligible for Study:   50 Years to 105 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02779309    
Other Study ID Numbers: CIHR FRN - 142876
Trim no. P0901 074 ( Other Identifier: Institute for Clinical Evaluative Sciences )
First Posted: May 20, 2016    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ottawa Hospital Research Institute:
Frail Older Adults
Mortality
Home Care
Survival Analysis
Clinical Prediction Rule
Additional relevant MeSH terms:
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Death
Pathologic Processes