ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12622001281785p

Ethics application status

Submitted, not yet approved

Date submitted

20/09/2022

Date registered

29/09/2022

Date last updated

29/09/2022

Date data sharing statement initially provided

29/09/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

Quality of Life in older Australians after Hip Fracture

Scientific title

Quality of Life in older Australians after Hip Fracture: a longitudinal study

Secondary ID [1]

none

Universal Trial Number (UTN)

Trial acronym

QoLAHF

Linked study record

Health condition

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

hip fracture

hip fracture surgery

cognitive dysfunction

renal dysfunction

hypotension

myocardial injury after non-cardiac surgery

Condition category

Condition code

Injuries and Accidents

Fractures

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

Target follow-up type

Months

Description of intervention(s) / exposure

Establish baseline and change quality of life (QoL) levels using the EQ-5D-5L for up to one year in older adults with a fragility hip fracture. Patients will be followed up from presentation to hospital for hip fracture up to 12 months post hip fracture. Measurement of disability will also take place using the Barthel Index. Additionally, the days alive and out of hospital (DAOH) proxy measure will be utilised to evaluate post-operative recovery, complications and mortality following hip fracture surgery. Mini-Mental State Examination (MMSE) and Adult Lifestyles and Function Interview Mini-Mental State Examination (ALFI-MMSE) will be used to screen for cognitive dysfunction.

Patients will be assessed during their initial hospital stay and followed up over the phone at 4 and 12 months. We anticipate that each encounter will take approximately 20 minutes total of the patients' time to complete all questionnaires with the following breakdown: EQ-5D-5L approx 3 minutes, Barthel Index approx 3 minutes, DAOH approx 1 minute, MMSE/ALFI-MMSE approx 10 minutes. Patient involvement will require active participation to respond to questionnaires, but other data about the patient's hospital stay and hip fracture surgery will be obtained from the medical record.

Intervention code [1]

Diagnosis / Prognosis

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

quality of life using EuroQol EQ-5D-5L

Timepoint [1]

4 months and 12 months post hip fracture

Secondary outcome [1]

disability using the Barthel Index

Timepoint [1]

4 months and 12 months post hip fracture

Secondary outcome [2]

American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) risk calculator complications

Timepoint [2]

assessed once only at the time of discharge from hospital

Secondary outcome [3]

cognitive function using the ALFI-MMSE

Timepoint [3]

4 months and 12 months post hip fracture

Secondary outcome [4]

renal function using creatinine/eGFR

Timepoint [4]

with routine blood tests up to 30 days post-operative

Secondary outcome [5]

intraoperative hypotension assessed through audit of patient medical record (intraoperative anaesthetic report and post-operative nursing vital sign observations)

Timepoint [5]

preoperative to postoperative day-7 using routine vital sign measurements

Secondary outcome [6]

Myocardial injury after noncardiac surgery by assessing troponin

Timepoint [6]

pre-operative up to postoperative 48 hrs on routine blood tests

Secondary outcome [7]

intraoperative heart rate assessed through audit of patient medical record (intraoperative anaesthetic report and post-operative nursing vital sign observations)

Timepoint [7]

preoperative to postoperative day-7 using routine vital sign measurements

Secondary outcome [8]

arterial line use assessed through audit of patient medical record (intraoperative anaesthetic report)

Timepoint [8]

intra-operative

Secondary outcome [9]

CVC line use assessed through audit of patient medical record (intraoperative anaesthetic report)

Timepoint [9]

intra-operative

Secondary outcome [10]

use of vasopressors assessed through audit of patient medical record (intraoperative anaesthetic report)

Timepoint [10]

intra-operative

Secondary outcome [11]

use of inotropes assessed through audit of patient medical record (intraoperative anaesthetic report)

Timepoint [11]

intra-operative

Secondary outcome [12]

cardiac arrest assessed through audit of patient medical. record (intraoperative anaesthetic report)

Timepoint [12]

intra-operative

Secondary outcome [13]

anaphylaxis assessed through audit of patient medical record (intraoperative anaesthetic report)

Timepoint [13]

intra-operative

Secondary outcome [14]

estimated blood loss assessed through audit of patient medical record (intraoperative anaesthetic report + operation report)

Timepoint [14]

intra-operative

Secondary outcome [15]

vital status (including operative and non-operative patients) through audit of hospital medical records and on follow-up phone calls (at 4 months and 12 months post-discharge) to patients and/or their next of kin/medical treatment decision maker

Timepoint [15]

at the time of discharge
30 days post-operative
90 days post-operative
4 months post hip fracture
12 months post hip fracture

Secondary outcome [16]

operation performed through audit of operation reports and anaesthetic reports

Timepoint [16]

intra-operative

Secondary outcome [17]

Development of complications post-operative through audit of discharge summary and inpatient progress notes
o Pneumonia
o Cardiac complication
o Myocardial injury after noncardiac surgery (MINS)
o Surgical site infection
o Urinary tract infection
o VTE
o Renal failure
o Renal replacement therapy
o Return to theatre
o ICU admission post-op
o Sepsis
o Delirium / post-operative cognitive dysfunction
o Stroke
o MET calls

Timepoint [17]

up to 30 days post-operative, assessed at time of discharge

Secondary outcome [18]

blood loss using blood haemoglobin levels

Timepoint [18]

pre-operative up to 7 days post-operative on routine blood tests

Secondary outcome [19]

discharge destination through audit of discharge summary and inpatient progress notes – home vs nursing home vs rehab facility

Timepoint [19]

at time of discharge

Secondary outcome [20]

days alive and out of the hospital (DAOH) 30 days through audit of patient medical record length of stay and follow-up phone call with the patient at 4 months post hip fracture to evaluate readmissions

Timepoint [20]

30 days post-operative

Secondary outcome [21]

days alive and out of the hospital (DAOH) 90 days through audit of patient medical record length of stay and follow-up phone call with the patient at 4 months post hip fracture to evaluate readmissions

Timepoint [21]

90 days post-operative

Eligibility

Key inclusion criteria

• patients aged 65 years or older
• present to Eastern Health (Maroondah or Box Hill Hospital)
• low-trauma hip fracture

This will include patients that are for both operative and non-operative management.

Minimum age

65 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

• high-energy trauma
• pathological fracture
• history of previous hip fracture on the same side
• periprosthetic fractures
• palliative care patients
• patients having not decided prior to surgery and within 72 hours of admission
• non-English speaking patients or proxy respondents
• patients and proxy respondents being unable or unwilling to give valid consent (including visual, hearing, mental incompetence)

Study design

Purpose

Screening

Duration

Longitudinal

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

We expect to have a non-normal distribution of data. A non-parametric paired test will likely be utilised to evaluate this data. Descriptive statistics and analysis of variance will be used to analyse factors associated with the change in HRQoL. All the values will be averaged with a 95% confidence interval. Further details will be evaluated by a statistician assisting with data analysis.

A 6/12-month interim analysis will be performed to calculate sample size. Our goal is to detect a medium effect size (or a clinically meaningful effect) with 80% or above power at 5% statistical significance.
We estimate that within a six-month sample will recruit approximately 50 patients from Maroondah Hospital and a further 50 from Box Hill Hospital. We will aim to reach a sample size of at least 200 to achieve statistically significant data.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/10/2022

Actual

Date of last participant enrolment

Anticipated

1/10/2027

Actual

Date of last data collection

Anticipated

1/10/2028

Actual

Sample size

Target

200

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Maroondah Hospital - Ringwood East

Recruitment hospital [2]

Box Hill Hospital - Box Hill

Recruitment postcode(s) [1]

3135 - Ringwood East

Recruitment postcode(s) [2]

3128 - Box Hill

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Eastern Health

Address [1]

5 Arnold St, Box Hill VIC 3128

Country [1]

Australia

Primary sponsor type

Hospital

Name

Department of Anaesthesia Maroondah Hospital

Address

1-15 Davey Dr, Ringwood East VIC 3135

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Eastern Health Human Research Ethics Committee (EHHREC)

Ethics committee address [1]

5 Arnold St, Box Hill VIC 3128

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/09/2022

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

The primary aim is to establish baseline and change quality of life (QoL) levels for up to one year in older adults who present to Eastern Health with a fragility hip fracture (HF).

Secondary aims are:
1) to validate ACS NSQIP risk calculator in older Australians after hip fracture surgery;
2) assess the correlation of MMSE score to post-operative outcomes and HRQoL
3) evaluate the relevance of intraoperative/postoperative data relating to renal function, intraoperative hypotension, and postoperative S. troponin

This study will be a prospective observational cohort study. Patients will be identified after presenting with a hip fracture and be assessed for eligibility by one of the team members. Patient recruitment will occur at Box Hill Hospital or Maroondah Hospital, depending on where the patient presents or is transferred to at the time of review.

Eligibility criteria includes patients aged 65 years or older who present to Eastern Health for low-trauma hip fracture, including both operative and non-operative patients. Potential participants will be evaluated within 72 hours after admission and prior to surgery.
The exclusion criteria include high-energy trauma, pathological fracture, patients receiving palliative care, a history of previous hip fracture on the same side, periprosthetic fractures, patients having not decided on participation prior to surgery or after 72 hours from the time of admission, patients and proxy respondents being unable or unwilling to give valid consent, including visual, hearing, mental incompetence and non- English speaking patients or proxy respondents. Patients who die or sustain a second fracture during the follow-up period will also need to be excluded from HRQoL and functional capacity analysis.

Quality of life will be assessed using the EQ-5D-5L questionnaire. Functional capacity will be evaluated using the Barthel Index. Preinjury HRQoL and disability will be assessed at time of recruitment. Participants will then be followed up at 4 and 12 months by telephone.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Thomas Callaghan

Address

Maroondah Hospital
1-15 Davey Drive
Ringwood East
Victoria 3135

Country

Australia

Phone

+61 04 3588 2560

Fax

[email protected]

Contact person for public queries

Name

Jack Dale

Address

Maroondah Hospital
1-15 Davey Drive
Ringwood East
Victoria 3135

Country

Australia

Phone

+61 04 9259 7545

Fax

[email protected]

Contact person for scientific queries

Name

Jack Dale

Address

Maroondah Hospital
1-15 Davey Drive
Ringwood East
Victoria 3135

Country

Australia

Phone

+61 04 9259 7545

Fax

[email protected]

Data sharing statement

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

No/undecided IPD sharing reason/comment

At this stage, the study team does not plan on making raw individual participant data publicly available. Overall findings of the data will however be conveyed and made available.

After collection, data will be de-identified for analysis purposes. Should this data be shared, it will align with the ARDCs guide on sharing sensitive data to ensure data is appropriately non-identifiable.

What supporting documents are/will be available?

Doc. No.	Type	Attachment
17149	Study protocol	384690-(Uploaded-20-09-2022-00-56-28)-Study-related document.pdf
17150	Informed consent form	384690-(Uploaded-28-09-2022-23-06-47)-Study-related document.pdf
17152	Informed consent form	384690-(Uploaded-28-09-2022-23-06-55)-Study-related document.pdf

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.

Trial Review

Documents added manually

Documents added automatically