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
Scientific title
A retrospective review of rib fracture management at inpatient facilities in Sydney Local Health District from January 2018 - December 2019
Secondary ID [1] 310260 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rib fracture 330943 0
Condition category
Condition code
Musculoskeletal 327765 327765 0 0
Normal musculoskeletal and cartilage development and function
Public Health 328922 328922 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
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.
Intervention code [1] 326965 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336032 0
Number of hospital admissions assessed from audit of patient medical records.
Timepoint [1] 336032 0
January 2018 - December 2019
Primary outcome [2] 336033 0
Frequency and type of imaging assessed from audit of patient medical records.
Timepoint [2] 336033 0
January 2018 - December 2019
Primary outcome [3] 336725 0
Duration of hospital length of stay assessed from audit of hospital medical records.
Timepoint [3] 336725 0
January 2018 - December 2019
Secondary outcome [1] 426521 0
Primary outcome - Duration of intensive care length of stay assessed from audit of hospital medical records.
Timepoint [1] 426521 0
January 2018 - December 2019
Secondary outcome [2] 429479 0
Determine patterns of analgesia use from audit of hospital records.
Timepoint [2] 429479 0
January 2018 - December 2019.
Secondary outcome [3] 429480 0
Review pain scores during admission and at discharge from hospital via audit of hospital electronic medical records.
Timepoint [3] 429480 0
January 2018 - December 2019
Secondary outcome [4] 429785 0
Review any complications the patient experienced as an inpatient via audit of hospital electronic medical records.
Timepoint [4] 429785 0
January 2018 - December 2019
Secondary outcome [5] 429786 0
Review of any mortality via audit of hospital electronic medical records.
Timepoint [5] 429786 0
January 2018 - December 2019

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
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1-Patients younger than 15 years old. 2-patients who are pregnant

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
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.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
29/05/2023
Date of last participant enrolment
Anticipated
31/01/2024
Actual
Date of last data collection
Anticipated
31/01/2024
Actual
Sample size
Target
300
Accrual to date
293
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25502 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 25503 0
Canterbury Hospital - Campsie
Recruitment hospital [3] 25504 0
Concord Repatriation Hospital - Concord
Recruitment postcode(s) [1] 41313 0
2050 - Camperdown
Recruitment postcode(s) [2] 41314 0
2194 - Campsie
Recruitment postcode(s) [3] 41315 0
2139 - Concord

Funding & Sponsors
Funding source category [1] 314468 0
Hospital
Name [1] 314468 0
RPA Virtual Hospital
Country [1] 314468 0
Australia
Primary sponsor type
Hospital
Name
RPA Virtual Hospital
Address
King George V Building: Level 9, Missenden Road, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 316756 0
None
Name [1] 316756 0
Address [1] 316756 0
Country [1] 316756 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313519 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 313519 0
Ethics committee country [1] 313519 0
Australia
Date submitted for ethics approval [1] 313519 0
26/04/2023
Approval date [1] 313519 0
29/05/2023
Ethics approval number [1] 313519 0
X23-0147 & 2023/ETH00808

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128422 0
Ms Jameela E. Truman
Address 128422 0
RPA Virtual Hospital, King George V Building: Level 9, Missenden Road, Camperdown NSW 2050
Country 128422 0
Australia
Phone 128422 0
+61449698950
Fax 128422 0
Email 128422 0
[email protected]
Contact person for public queries
Name 128423 0
Jameela E. Truman
Address 128423 0
RPA Virtual Hospital, King George V Building: Level 9, Missenden Road, Camperdown NSW 2050
Country 128423 0
Australia
Phone 128423 0
+61449698950
Fax 128423 0
Email 128423 0
[email protected]
Contact person for scientific queries
Name 128424 0
Jameela E. Truman
Address 128424 0
RPA Virtual Hospital, King George V Building: Level 9, Missenden Road, Camperdown NSW 2050
Country 128424 0
Australia
Phone 128424 0
+61449698950
Fax 128424 0
Email 128424 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Research data management plan elected not to share any data following the project



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.