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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12623001292662
Ethics application status
Approved
Date submitted
8/09/2023
Date registered
12/12/2023
Date last updated
12/12/2023
Date data sharing statement initially provided
12/12/2023
Type of registration
Retrospectively registered
Titles & IDs
Public title
A retrospective review of rib fracture management at inpatient facilities in Sydney Local Health District from January 2018 - December 2019
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Scientific title
A retrospective review of rib fracture management at inpatient facilities in Sydney Local Health District from January 2018 - December 2019
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Secondary ID [1]
310260
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rib fracture
330943
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Condition category
Condition code
Musculoskeletal
327765
327765
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0
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Normal musculoskeletal and cartilage development and function
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Public Health
328922
328922
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0
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Health service research
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Retrospective clinical audit of patient electronic medical records from January 2018 - December 2019. Patients admitted to hospital with one or more fractured ribs over a two-year period. Only information related to their hospital admission / encounter for the fractured ribs will be obtained.
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Intervention code [1]
326965
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Not applicable
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
336032
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Number of hospital admissions assessed from audit of patient medical records.
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Assessment method [1]
336032
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Timepoint [1]
336032
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January 2018 - December 2019
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Primary outcome [2]
336033
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Frequency and type of imaging assessed from audit of patient medical records.
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Assessment method [2]
336033
0
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Timepoint [2]
336033
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January 2018 - December 2019
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Primary outcome [3]
336725
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Duration of hospital length of stay assessed from audit of hospital medical records.
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Assessment method [3]
336725
0
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Timepoint [3]
336725
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January 2018 - December 2019
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Secondary outcome [1]
426521
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Primary outcome - Duration of intensive care length of stay assessed from audit of hospital medical records.
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Assessment method [1]
426521
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Timepoint [1]
426521
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January 2018 - December 2019
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Secondary outcome [2]
429479
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Determine patterns of analgesia use from audit of hospital records.
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Assessment method [2]
429479
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Timepoint [2]
429479
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January 2018 - December 2019.
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Secondary outcome [3]
429480
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Review pain scores during admission and at discharge from hospital via audit of hospital electronic medical records.
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Assessment method [3]
429480
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Timepoint [3]
429480
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January 2018 - December 2019
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Secondary outcome [4]
429785
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Review any complications the patient experienced as an inpatient via audit of hospital electronic medical records.
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Assessment method [4]
429785
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Timepoint [4]
429785
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January 2018 - December 2019
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Secondary outcome [5]
429786
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Review of any mortality via audit of hospital electronic medical records.
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Assessment method [5]
429786
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Timepoint [5]
429786
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January 2018 - December 2019
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Eligibility
Key inclusion criteria
1-disease status / or disease group for study: admitted patient diagnosed with one more more fractured rib from January 2018 - December 2019. 2-all genders. 3-patients aged greater than or equal to 15 years old. 4-others: must have at least one radiographs or CT-scan; standard of care for diagnosing one or more fractured ribs
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Minimum age
15
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1-Patients younger than 15 years old. 2-patients who are pregnant
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Retrospective
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Statistical methods / analysis
Because this is a descriptive study with a number of outcomes of interest, no formal sample size calculations were performed.Descriptive statistics will be calculated upon the data collected. The research team would like to see the frequency distribution of patient characteristics across trends in analgesia use for patients admitted to hospital with fractured ribs. Explanatory variables and outcome measures will be summarized using descriptive statistics. Trajectories of analgesia requirement and pain scores will also be analysed using multilevel modelling, with measurement occasions treated as level 1 units and individuals as level 2 units. Missing data will be handled using complete case analysis.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
29/05/2023
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Date of last participant enrolment
Anticipated
31/01/2024
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Actual
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Date of last data collection
Anticipated
31/01/2024
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Actual
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Sample size
Target
300
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Accrual to date
293
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
25502
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [2]
25503
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Canterbury Hospital - Campsie
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Recruitment hospital [3]
25504
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Concord Repatriation Hospital - Concord
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Recruitment postcode(s) [1]
41313
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2050 - Camperdown
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Recruitment postcode(s) [2]
41314
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2194 - Campsie
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Recruitment postcode(s) [3]
41315
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2139 - Concord
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Funding & Sponsors
Funding source category [1]
314468
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Hospital
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Name [1]
314468
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RPA Virtual Hospital
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Address [1]
314468
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King George V Building: Level 9, Missenden Road, Camperdown NSW 2050
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Country [1]
314468
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Australia
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Primary sponsor type
Hospital
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Name
RPA Virtual Hospital
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Address
King George V Building: Level 9, Missenden Road, Camperdown NSW 2050
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Country
Australia
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Secondary sponsor category [1]
316756
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None
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Name [1]
316756
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Address [1]
316756
0
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Country [1]
316756
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
313519
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Sydney Local Health District Ethics Review Committee (RPAH Zone)
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Ethics committee address [1]
313519
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Royal Prince Alfred Hospital, Research Ethics & Governance Office, Missenden Road, Camperdown NSW 2050
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Ethics committee country [1]
313519
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Australia
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Date submitted for ethics approval [1]
313519
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26/04/2023
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Approval date [1]
313519
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29/05/2023
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Ethics approval number [1]
313519
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X23-0147 & 2023/ETH00808
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Summary
Brief summary
A retrospective clinical audit of patients admitted with rib fractures will provide a district wide summary of inpatient rib fracture management. This audit will assess patterns and outcomes of patients admitted with fractured ribs, and patterns in any complications the patients experienced. The audit has the potential to contribute to the body of evidence in the management of patients with fractured ribs. Pain management is a common priority when it comes to the management of patients with fractured ribs. Trends and patterns of analgesic use will provide insight into the current trends of pain management provided to patients with fractured ribs. Foreshadowing future complications from patients with fracture ribs will help refine the current management, pathways, and guidelines for rib fracture management.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Ms Jameela E. Truman
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Address
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RPA Virtual Hospital, King George V Building: Level 9, Missenden Road, Camperdown NSW 2050
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Country
128422
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Australia
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Phone
128422
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+61449698950
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Fax
128422
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Email
128422
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[email protected]
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Contact person for public queries
Name
128423
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Ms Jameela E. Truman
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Address
128423
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RPA Virtual Hospital, King George V Building: Level 9, Missenden Road, Camperdown NSW 2050
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Country
128423
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Australia
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Phone
128423
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+61449698950
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Fax
128423
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Email
128423
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[email protected]
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Contact person for scientific queries
Name
128424
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Ms Jameela E. Truman
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Address
128424
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RPA Virtual Hospital, King George V Building: Level 9, Missenden Road, Camperdown NSW 2050
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Country
128424
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Australia
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Phone
128424
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+61449698950
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Fax
128424
0
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Email
128424
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Research data management plan elected not to share any data following the project
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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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