DeathRESPECTNCT02779309
Risk Evaluation for Support: Predicting Elder Life in the Community Tool (RESPECT)
An observational study of Death, run by Ottawa Hospital Research Institute.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 105 yearsHealthy volunteers can take part
- Conditions the study is for
- Death
- What is being tested?
- Home Care/RAI-HC Assessment
- Type of treatment
- Surgery or procedure
- How many people
- 486,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 105 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Have received a structured RAI-HC assessment
- Between 50 and 105 years of age
Who cannot join
- Not eligible for Ontario's universal health insurance program (OHIP)
- Did not receive a structured RAI-HC assessment
About this study
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)
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.
Read the 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.
- Conditions
- Death
- Being tested
- Home Care/RAI-HC Assessment
- Keywords
- Frail Older Adults, Mortality, Home Care, Survival Analysis, Clinical Prediction Rule
- Medical subject headings
- Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Care/RAI-HC AssessmentProcedure or surgery
Home care recipients who have received a comprehensive health assessment using the Resident Assessment Instrument for Home Care (RAI-HC).
| Study group | Role | What they receive |
|---|---|---|
| Development Cohort | 437,000 home care recipients who received services from January 1, 2007 to December 31, 2012. Receives: Procedure: Home Care/RAI-HC Assessment | |
| Validation Cohort | 122,000 home care recipients who received services from January 1, 2013 to December 31, 2013. Receives: Procedure: Home Care/RAI-HC Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month Mortality
Mortality status at 6 months after receiving a structured Resident Assessment Instrument for Home Care (RAI-HC) Assessment.
Measured: 6 months
Secondary outcomes (1)
12-month Mortality
Mortality status at 12 months after receiving a structured Resident Assessment Instrument for Home Care (RAI-HC) Assessment.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study startJan 2007
- Primary completionDec 2013
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DeathStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 486,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Institute for Clinical Evaluative Sciences, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02779309
- Sponsor's protocol ID
- CIHR FRN - 142876
- Other IDs
- Trim no. P0901 074
- Acronym
- RESPECT
- Status last verified
- May 2018
- First submitted
- 18 May 2016
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 27909039
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02779309
- Acronym / sponsor ID
- RESPECT / CIHR FRN - 142876
- Conditions
- Death
- Keywords
- Frail Older Adults, Mortality, Home Care, Survival Analysis, Clinical Prediction Rule
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 486,000 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Institute for Clinical Evaluative Sciences, Canadian Institutes of Health Research (CIHR)
- Study start
- Jan 2007
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 20 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Development Cohort | – | Procedure: Home Care/RAI-HC Assessment437,000 home care recipients who received services from January 1, 2007 to December 31, 2012. |
| Validation Cohort | – | Procedure: Home Care/RAI-HC Assessment122,000 home care recipients who received services from January 1, 2013 to December 31, 2013. |
Who may qualify
- Ages
- 50 to 105 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Have received a structured RAI-HC assessment
- Between 50 and 105 years of age
Key exclusion criteria (2 listed)
- Not eligible for Ontario's universal health insurance program (OHIP)
- Did not receive a structured RAI-HC assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home Care/RAI-HC AssessmentHome care recipients who have received a comprehensive health assessment using the Resident Assessment Instrument for Home Care (RAI-HC). | Procedure or surgery | Development Cohort, Validation Cohort |
Primary outcome
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.
1 secondary outcome
12-month Mortality
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2018.
- Derived from this study: PubMed 27909039Hsu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Death, run by Ottawa Hospital Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month Mortality (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02779309, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2018.