Frail Elderly SyndromeNCT03354546
Development and Validation of a Preoperative Frailty Index Using Health Administrative Data
An observational study of Frail Elderly Syndrome and Surgery, run by Ottawa Hospital Research Institute.
Trial summary
The investigators will create a frailty index using health administrative data available for older people having surgery. The index will be based on the Canadian Study of Health and Aging Frailty Index and standard recommendations for creation of frailty indices. Read more about this study
- Who is it for?
- Ages 66 years and older
- Conditions the study is for
- Frail Elderly Syndrome, Surgery, Outcomes
- What is being tested?
- Frailty index
- How many people
- 511,285 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2002to 31 Mar 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 66 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: All individuals 66 years of older on the day of their surgery
Who may be able to join
- Having elective or emergency noncardiac surgery
Who cannot join
- no provincial health insurance number
About this study
Official title: Creation, Evaluation and Validation of a Preoperative Frailty Index Using Health Administrative Data: a Population-based Cohort Study
The investigators will create a frailty index using health administrative data available for older people having surgery. The index will be based on the Canadian Study of Health and Aging Frailty Index and standard recommendations for creation of frailty indices.
Read the detailed description
The investigators will create a frailty index using health administrative data available for older people having surgery. The index will be based on the Canadian Study of Health and Aging Frailty Index and standard recommendations for creation of frailty indices.
Once derived the index will be tested to measure its association with outcomes, as well as its discrimination. Various representations of the frailty index will be tested (primary-as a continuous measure; secondary as a binary, categorical and fractional polynomial variable). Performance in subgroups will also be evaluated,
- Conditions
- Frail Elderly Syndrome, Surgery, Outcomes, Predictive Value of Tests
- Being tested
- Frailty index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frailty indexDiagnostic test
A frailty index composed of variables from health administrative data that cover multi-system health issues. Deficits will be coded as present or absent, and the number of deficits present will be divided by the total number of deficits present to provide an overall score between 0-1.
| Study group | Role | What they receive |
|---|---|---|
| Elective noncardiac surgery | Individuals having major noncardiac surgery following an elective hospital admission Receives: Diagnostic Test: Frailty index | |
| Emergency general surgery | Individuals having general surgery following an urgent hospital admission Receives: Diagnostic Test: Frailty index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival for One Year After Surgery
Still being alive (no death date) in the registered persons database Outcome is binary, exposure is per 0.1 unit increase
Measured: Date of surgery to 365 days after surgery
Secondary outcomes (1)
Institutional Discharge
Discharge to long term care or continuing care facility at the time of hospital discharge
Measured: Date of surgery to date of hospital discharge, or up to one year after surgery (whichever comes first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start1 Apr 2002
- Primary completion31 Mar 2016
- Study completion31 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Frail Elderly SyndromeStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- 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
- 511,285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03354546
- Sponsor's protocol ID
- DM8
- Status last verified
- May 2024
- First submitted
- 17 Nov 2017
- Last updated
- 23 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creation, Evaluation and Validation of a Preoperative Frailty Index Using Health Administrative Data: a Population-based Cohort Study
- ClinicalTrials.gov ID
- NCT03354546
- Acronym / sponsor ID
- DM8
- Conditions
- Frail Elderly Syndrome, Surgery, Outcomes, Predictive Value of Tests
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 511,285 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 1 Apr 2002 (actual)
- Primary completion
- 31 Mar 2016 (actual)
- Study completion
- 31 Mar 2016 (actual)
- First posted
- 28 Nov 2017 (actual)
- Results
- Posted 23 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will create a frailty index using health administrative data available for older people having surgery. The index will be based on the Canadian Study of Health and Aging Frailty Index and standard recommendations for creation of frailty indices.
Detailed description
The investigators will create a frailty index using health administrative data available for older people having surgery. The index will be based on the Canadian Study of Health and Aging Frailty Index and standard recommendations for creation of frailty indices.
Once derived the index will be tested to measure its association with outcomes, as well as its discrimination. Various representations of the frailty index will be tested (primary-as a continuous measure; secondary as a binary, categorical and fractional polynomial variable). Performance in subgroups will also be evaluated,
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elective noncardiac surgery | – | Diagnostic Test: Frailty indexIndividuals having major noncardiac surgery following an elective hospital admission |
| Emergency general surgery | – | Diagnostic Test: Frailty indexIndividuals having general surgery following an urgent hospital admission |
Who may qualify
- Ages
- 66 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- All individuals 66 years of older on the day of their surgery
Key inclusion criteria (1 listed)
- Having elective or emergency noncardiac surgery
Key exclusion criteria (1 listed)
- no provincial health insurance number
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 |
|---|---|---|
| Frailty indexA frailty index composed of variables from health administrative data that cover multi-system health issues. Deficits will be coded as present or absent, and the number of deficits present will be divided by the total number of deficits present to provide an overall score between 0-1. | Diagnostic test | Elective noncardiac surgery, Emergency general surgery |
Primary outcome
Survival for One Year After Surgery
Time frame: Date of surgery to 365 days after surgery
Still being alive (no death date) in the registered persons database Outcome is binary, exposure is per 0.1 unit increase
1 secondary outcome
Institutional Discharge
Time frame: Date of surgery to date of hospital discharge, or up to one year after surgery (whichever comes first)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 Frail Elderly Syndrome and Surgery, 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 1 inclusion and 1 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 23 Sep 2024. 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?
Yes. Results are posted in the registry (first posted 23 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Survival for One Year After Surgery (time frame: Date of surgery to 365 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2024.