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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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

Read the detailed description

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 groups in NCT03354546
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.

1 Apr 200231 Mar 2016

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Recruiting
Comparıson of the Effıcacy of Conventıonal Exercıse and Pılates ın Pre-fraıl and Fraıl Older Adults
Frailty Syndrome, Prefrail Elderly
Not yet recruiting
Effect of Animation-Based Digital Education on Risk Knowledge and Frailty in Older Adults
Aging, Frail Elderly
Active, not recruiting
Implementing, Evaluating, and Scaling Up of the Strengthening a Palliative Approach in Long Term Care (SPA-LTC) Program
Frail Elderly Syndrome
Recruiting
Involvement of Muscle Mitochondrial Dysfunction in Frailty in Older Adults. Role of Exercise
Diabetes Type 2, Frail Elderly Syndrome
Recruiting
The Impact of Geriatric Assessment on the Treatment Plan of Elderly Patients With T2DM
Type2diabetes, Frail Elderly Syndrome

All Frail Elderly Syndrome trials

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.

Detailed description

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

Results posted to the registry on 23 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Elective	415,704	415,704
Emergency	95,581	95,581

Primary outcome: Survival for One Year After Surgery

Time frame: Date of surgery to 365 days after surgery. Count of participants. Unit: Participants

Measure	Elective Surgery n = 415704	Emergency Surgery n = 0
Value	396164	0

Population analysed: We measured the unadjusted and adjusted associations between the pFI and postoperative outcomes in our elective surgery cohort. The unadjusted analysis contained only the pFI. Data was not collected from Emergency Surgery patients.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Elective Noncardiac Surgery	0 of 0	0 of 0	19,540 of 415,704
Emergency General Surgery	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): Some variables underlying the pFI, such as pharmacy and home-support care data, may not be available in all data systems. Additionally, while the ACG system is the most widely used population-risk software in the world, it is not universally available, and diagnostic codes underlying its clusters are not openly disseminated. Our results represent associations, not causal relationships.

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

Related trials for Frail Elderly Syndrome

Recruiting
Comparıson of the Effıcacy of Conventıonal Exercıse and Pılates ın Pre-fraıl and Fraıl Older Adults
Frailty Syndrome, Prefrail Elderly
Not yet recruiting
Effect of Animation-Based Digital Education on Risk Knowledge and Frailty in Older Adults
Aging, Frail Elderly
Active, not recruiting
Implementing, Evaluating, and Scaling Up of the Strengthening a Palliative Approach in Long Term Care (SPA-LTC) Program
Frail Elderly Syndrome
Recruiting
Involvement of Muscle Mitochondrial Dysfunction in Frailty in Older Adults. Role of Exercise
Diabetes Type 2, Frail Elderly Syndrome
Recruiting
The Impact of Geriatric Assessment on the Treatment Plan of Elderly Patients With T2DM
Type2diabetes, Frail Elderly Syndrome

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?

On the ClinicalTrials.gov record for NCT03354546.

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; AzTrials last refreshed its copy on 7 Nov 2026.