Trial Review

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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] 308003 0
none
Universal Trial Number (UTN)
Trial acronym
QoLAHF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hip fracture 327672 0
hip fracture surgery 327675 0
cognitive dysfunction 327714 0
renal dysfunction 327715 0
hypotension 327716 0
myocardial injury after non-cardiac surgery 327717 0
Condition category
Condition code
Injuries and Accidents 324760 324760 0 0
Fractures

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
12
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] 324456 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332581 0
quality of life using EuroQol EQ-5D-5L
Timepoint [1] 332581 0
4 months and 12 months post hip fracture
Secondary outcome [1] 413963 0
disability using the Barthel Index
Timepoint [1] 413963 0
4 months and 12 months post hip fracture
Secondary outcome [2] 413965 0
American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) risk calculator complications
Timepoint [2] 413965 0
assessed once only at the time of discharge from hospital
Secondary outcome [3] 413966 0
cognitive function using the ALFI-MMSE
Timepoint [3] 413966 0
4 months and 12 months post hip fracture
Secondary outcome [4] 414078 0
renal function using creatinine/eGFR
Timepoint [4] 414078 0
with routine blood tests up to 30 days post-operative
Secondary outcome [5] 414079 0
intraoperative hypotension assessed through audit of patient medical record (intraoperative anaesthetic report and post-operative nursing vital sign observations)
Timepoint [5] 414079 0
preoperative to postoperative day-7 using routine vital sign measurements
Secondary outcome [6] 414080 0
Myocardial injury after noncardiac surgery by assessing troponin
Timepoint [6] 414080 0
pre-operative up to postoperative 48 hrs on routine blood tests
Secondary outcome [7] 414081 0
intraoperative heart rate assessed through audit of patient medical record (intraoperative anaesthetic report and post-operative nursing vital sign observations)
Timepoint [7] 414081 0
preoperative to postoperative day-7 using routine vital sign measurements
Secondary outcome [8] 414082 0
arterial line use assessed through audit of patient medical record (intraoperative anaesthetic report)
Timepoint [8] 414082 0
intra-operative
Secondary outcome [9] 414083 0
CVC line use assessed through audit of patient medical record (intraoperative anaesthetic report)
Timepoint [9] 414083 0
intra-operative
Secondary outcome [10] 414084 0
use of vasopressors assessed through audit of patient medical record (intraoperative anaesthetic report)
Timepoint [10] 414084 0
intra-operative
Secondary outcome [11] 414085 0
use of inotropes assessed through audit of patient medical record (intraoperative anaesthetic report)
Timepoint [11] 414085 0
intra-operative
Secondary outcome [12] 414086 0
cardiac arrest assessed through audit of patient medical. record (intraoperative anaesthetic report)
Timepoint [12] 414086 0
intra-operative
Secondary outcome [13] 414087 0
anaphylaxis assessed through audit of patient medical record (intraoperative anaesthetic report)
Timepoint [13] 414087 0
intra-operative
Secondary outcome [14] 414088 0
estimated blood loss assessed through audit of patient medical record (intraoperative anaesthetic report + operation report)
Timepoint [14] 414088 0
intra-operative
Secondary outcome [15] 414091 0
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] 414091 0
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] 414096 0
operation performed through audit of operation reports and anaesthetic reports
Timepoint [16] 414096 0
intra-operative
Secondary outcome [17] 414102 0
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] 414102 0
up to 30 days post-operative, assessed at time of discharge
Secondary outcome [18] 414103 0
blood loss using blood haemoglobin levels
Timepoint [18] 414103 0
pre-operative up to 7 days post-operative on routine blood tests
Secondary outcome [19] 414104 0
discharge destination through audit of discharge summary and inpatient progress notes – home vs nursing home vs rehab facility
Timepoint [19] 414104 0
at time of discharge
Secondary outcome [20] 414105 0
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] 414105 0
30 days post-operative
Secondary outcome [21] 414106 0
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] 414106 0
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?
No
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] 23178 0
Maroondah Hospital - Ringwood East
Recruitment hospital [2] 23179 0
Box Hill Hospital - Box Hill
Recruitment postcode(s) [1] 38543 0
3135 - Ringwood East
Recruitment postcode(s) [2] 38544 0
3128 - Box Hill

Funding & Sponsors
Funding source category [1] 312267 0
Hospital
Name [1] 312267 0
Eastern Health
Country [1] 312267 0
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] 313808 0
None
Name [1] 313808 0
Address [1] 313808 0
Country [1] 313808 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311641 0
Eastern Health Human Research Ethics Committee (EHHREC)
Ethics committee address [1] 311641 0
5 Arnold St, Box Hill VIC 3128
Ethics committee country [1] 311641 0
Australia
Date submitted for ethics approval [1] 311641 0
28/09/2022
Approval date [1] 311641 0
Ethics approval number [1] 311641 0

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 121818 0
Dr Thomas Callaghan
Address 121818 0
Maroondah Hospital
1-15 Davey Drive
Ringwood East
Victoria 3135
Country 121818 0
Australia
Phone 121818 0
+61 04 3588 2560
Fax 121818 0
Email 121818 0
[email protected]
Contact person for public queries
Name 121819 0
Dr Jack Dale
Address 121819 0
Maroondah Hospital
1-15 Davey Drive
Ringwood East
Victoria 3135
Country 121819 0
Australia
Phone 121819 0
+61 04 9259 7545
Fax 121819 0
Email 121819 0
[email protected]
Contact person for scientific queries
Name 121820 0
Dr Jack Dale
Address 121820 0
Maroondah Hospital
1-15 Davey Drive
Ringwood East
Victoria 3135
Country 121820 0
Australia
Phone 121820 0
+61 04 9259 7545
Fax 121820 0
Email 121820 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
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.TypeCitationLinkEmailOther DetailsAttachment
17149Study protocol    384690-(Uploaded-20-09-2022-00-56-28)-Study-related document.pdf
17150Informed consent form    384690-(Uploaded-28-09-2022-23-06-47)-Study-related document.pdf
17152Informed 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.