Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000367347
Ethics application status
Approved
Date submitted
2/03/2017
Date registered
10/03/2017
Date last updated
12/02/2019
Date data sharing statement initially provided
12/02/2019
Date results information initially provided
12/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
What Happened to Older People after Surgical Repair of a Broken Hip and How Much Did it Cost?
Scientific title
Clinical and Health Economic Outcomes in Elderly Patients with an Operative Neck of Femur Fracture (CHIEF Study)
Secondary ID [1] 291334 0
None
Universal Trial Number (UTN)
Trial acronym
CHIEF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip Fracture 302318 0
Geriatric
 302319 0
Condition category
Condition code
Anaesthesiology 301900 301900 0 0
Other anaesthesiology
Injuries and Accidents 301901 301901 0 0
Fractures
Public Health 301902 301902 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a retrospective observational study in patients over the age of 70 who underwent hip fracture surgery between July 2011 and July 2015 at a Victorian Metropolitan Hospital.
This pilot study, with a view to developing into a larger scale study, is designed to find out whether some peri-operative variables are independent risk factors, being increased risk of death, greater hospital costs or both.
In summary, perioperative variables, mortality rates and associated hospital costs will be evaluated over the period from July 2011 to July 2016.
Intervention code [1] 297364 0
Diagnosis / Prognosis
Intervention code [2] 297365 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301335 0
all-cause mortality after hip fracture surgery
Timepoint [1] 301335 0
30 days post surgery
Primary outcome [2] 301386 0
all-cause mortality after hip fracture surgery
Timepoint [2] 301386 0
inpatient (before hospital discharge post surgery)
Primary outcome [3] 301387 0
all-cause mortality after hip fracture surgery
Timepoint [3] 301387 0
one year post surgery
Secondary outcome [1] 332314 0
The associated hospital costs for each fracture.
This will be provided by the hospital Diagnostic Related Group Database (Eastern Health Decision Support Service)
Timepoint [1] 332314 0
Initial admission costs, being the costs during the initial admission (from admission till hospital discharge)
Secondary outcome [2] 332315 0
The associated hospital costs for each fracture.
This will be provided by the hospital Diagnostic Related Group Database (Eastern Health Data Analyst, Decision Support Services)
Timepoint [2] 332315 0
First year cost, being the costs within one year post initial admission
Secondary outcome [3] 332403 0
The associated hospital costs for each fracture.
This will be provided by the hospital Diagnostic Related Group Database (Eastern Health Data Analyst, Decision Support Services)
Timepoint [3] 332403 0
Total costs from initial admission up to 1st August 2016

Eligibility
Key inclusion criteria
1. Aged 70 years or older
2. Admission diagnosis was hip fracture
3. Underwent an operation to repair the hip fracture during the study period July 2011 to July 2015
Minimum age
70 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients with a hip fracture medically managed

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
A pilot study (n = 62) was conducted, which assisted the calculation of sample size and established the feasibility of data collection.
The mortality fractions and the 95% confidence levels will be determined first. In order to examine the association between testing variables and mortality, a survival analysis will be used to estimate the hazard ratios (or similar measures of association) taking into account the time until death and censoring.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2017
Actual
10/04/2017
Date of last participant enrolment
Anticipated
31/03/2018
Actual
21/12/2018
Date of last data collection
Anticipated
31/12/2018
Actual
12/02/2019
Sample size
Target
411
Accrual to date
Final
892
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 7593 0
Maroondah Hospital - Ringwood East
Recruitment postcode(s) [1] 15492 0
3135 - Ringwood East

Funding & Sponsors
Funding source category [1] 295803 0
Hospital
Name [1] 295803 0
Maroondah Hospital of Eastern Health
Country [1] 295803 0
Australia
Funding source category [2] 298934 0
Charities/Societies/Foundations
Name [2] 298934 0
ANZCA Novice Grant N18/003
Country [2] 298934 0
Australia
Primary sponsor type
Individual
Name
Dr Aihua Wu
Address
Department of Anaesthesia and Pain Management
Maroondah Hospital
1-15 Davey Drive
East Ringwood
VIC 3135
Country
Australia
Secondary sponsor category [1] 294646 0
Hospital
Name [1] 294646 0
Maroondah Hospital
Address [1] 294646 0
Department of Anaesthesia and Pain Management
Maroondah Hospital
1-15 Davey Drive
East Ringwood
VIC 3135
Country [1] 294646 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297093 0
Eastern Health Human Research Ethics Committee
Ethics committee address [1] 297093 0
Level 2
The Office of Research and Ethics
5 Arnold Street
Box Hill
VIC 3128
Ethics committee country [1] 297093 0
Australia
Date submitted for ethics approval [1] 297093 0
30/07/2015
Approval date [1] 297093 0
11/08/2015
Ethics approval number [1] 297093 0
LR86/2015

Summary
Brief summary
Australian Medicare expenditure will continue to increase at potentially an ever-increasing rate with more complex and expensive health care and an aging population. Older people are more prone to hip fractures. In 2013, there were 23,000 cases with direct health care costs estimated at $762 Million, which is forecast to reach 32,000 cases with a cost of over $1 billion by 2022. Of this, most are spent on hospital treatment but these expenditure estimates do not include informal community care and productivity loss due to fractures.
Despite advances in perioperative care, the death rate remains high in the elderly after hip fracture surgery. In Australia, there unfortunately exists a gap in this regard, since local data on such outcomes are limited in literature. Up to date, only a handful of small studies reported death rates with little research on the “dollar”.
Given that hip fracture imposes such heavy medico-economic burden on our health system and current evidence base is weak, particularly in relation to its financial implications, a recent editorial has called for more international large observational studies so that cost-effectiveness analysis is possible for this population.
Since identifying risk factors (and then, risk adjustment) may improve patient outcomes, a pilot study was designed for patients over the age of 70 who underwent hip fracture surgery between July 2011 and July 2015 at a Victorian Metropolitan Hospital. This study intends to find out whether some variables are independent risk factors, being increased risk of death, greater hospital costs or both.
After institutional ethics approval, the hospital Database identified 1163 eligible patients and their data were retrieved. The investigators will then break down these data and assess the impact of perioperative variables on the early (30-day) deaths and associated hospital costs. To achieve the study goals, it is necessary to clearly define those to-be-tested variables, since there exist diverse definitions for certain variables, for example, early surgery is recommended in the current guidelines, but its definition varies from 24h to 72h. This is unsatisfactory because such inconsistent definitions could lead to different interpretations, and thus, inconclusive results. Accordingly in this instance, delayed surgery will be defined as operations undertaken after 48h post orthopaedic admission and then to examine whether such delay causes more deaths and/or costs, if so, delayed surgery is an independent risk factor and should be avoided in future practice.
This pilot study is expected to provide valuable local data on some potentially unfavorable perioperative variables and also to fill the gap by estimating associated hospital costs for each fracture. Based on this information, a future multi-center study should facilitate and guide further research into potentially modifiable variables that may reduce the death rates and/or hospital costs of elderly hip fractures
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1551 1551 0 0
/AnzctrAttachments/372474-Research Proposal .pdf (Protocol)
Attachments [2] 1552 1552 0 0
/AnzctrAttachments/372474-Ethics Approval.pdf (Ethics approval)
Attachments [3] 1553 1553 0 0
/AnzctrAttachments/372474-Ethics Amendment Approval.pdf (Ethics approval)
Attachments [4] 1554 1554 0 0
/AnzctrAttachments/372474-data entry form.pdf (Supplementary information)

Contacts
Principal investigator
Name 72954 0
Dr AIHUA WU
Address 72954 0
Department of Anaesthesia and Pain Management
Maroondah Hospital
East Ringwood
VIC 3135
Country 72954 0
Australia
Phone 72954 0
+61 (03)98713448
Fax 72954 0
+61 (03)98713439
Email 72954 0
[email protected]
Contact person for public queries
Name 72955 0
Dr Aihua Wu
Address 72955 0
Department of Anaesthesia and Pain Management
Maroondah Hospital
East Ringwood
VIC 3135
Country 72955 0
Australia
Phone 72955 0
+61 (03)98713448
Fax 72955 0
Email 72955 0
[email protected]
Contact person for scientific queries
Name 72956 0
Dr AIHUA WU
Address 72956 0
Department of Anaesthesia and Pain Management
Maroondah Hospital
East Ringwood
VIC 3135
Country 72956 0
Australia
Phone 72956 0
+61 (03)98713448
Fax 72956 0
+61 (03)98713439
Email 72956 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
the data all are pooled data


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.