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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

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]

None

Universal Trial Number (UTN)

Trial acronym

CHIEF

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Hip Fracture

Geriatric

Condition category

Condition code

Anaesthesiology

Other anaesthesiology

Injuries and Accidents

Fractures

Public Health

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]

Diagnosis / Prognosis

Intervention code [2]

Early Detection / Screening

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

all-cause mortality after hip fracture surgery

Timepoint [1]

30 days post surgery

Primary outcome [2]

all-cause mortality after hip fracture surgery

Timepoint [2]

inpatient (before hospital discharge post surgery)

Primary outcome [3]

all-cause mortality after hip fracture surgery

Timepoint [3]

one year post surgery

Secondary outcome [1]

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]

Initial admission costs, being the costs during the initial admission (from admission till hospital discharge)

Secondary outcome [2]

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]

First year cost, being the costs within one year post initial admission

Secondary outcome [3]

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]

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?

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]

Maroondah Hospital - Ringwood East

Recruitment postcode(s) [1]

3135 - Ringwood East

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Maroondah Hospital of Eastern Health

Address [1]

1-15 Davey Drive
East Ringwood
VIC 3135

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

ANZCA Novice Grant N18/003

Address [2]

Australian and New Zealand College of Anaesthetists
ANZCA House,
630 St Kilda Road,
Melbourne, Victoria 3004,
Australia.

Country [2]

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]

Hospital

Name [1]

Maroondah Hospital

Address [1]

Department of Anaesthesia and Pain Management
Maroondah Hospital
1-15 Davey Drive
East Ringwood
VIC 3135

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Eastern Health Human Research Ethics Committee

Ethics committee address [1]

Level 2
The Office of Research and Ethics
5 Arnold Street
Box Hill 
VIC 3128

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/07/2015

Approval date [1]

11/08/2015

Ethics approval number [1]

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]

/AnzctrAttachments/372474-Research Proposal .pdf (Protocol)

Attachments [2]

/AnzctrAttachments/372474-Ethics Approval.pdf (Ethics approval)

Attachments [3]

/AnzctrAttachments/372474-Ethics Amendment Approval.pdf (Ethics approval)

Attachments [4]

/AnzctrAttachments/372474-data entry form.pdf (Supplementary information)

Contacts

Principal investigator

Name

Dr AIHUA WU

Address

Department of Anaesthesia and Pain Management
Maroondah Hospital
East Ringwood
VIC 3135

Country

Australia

Phone

+61 (03)98713448

Fax

+61 (03)98713439

[email protected]

Contact person for public queries

Name

Aihua Wu

Address

Department of Anaesthesia and Pain Management
Maroondah Hospital
East Ringwood
VIC 3135

Country

Australia

Phone

+61 (03)98713448

Fax

[email protected]

Contact person for scientific queries

Name

AIHUA WU

Address

Department of Anaesthesia and Pain Management
Maroondah Hospital
East Ringwood
VIC 3135

Country

Australia

Phone

+61 (03)98713448

Fax

+61 (03)98713439

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

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