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Trial registered on ANZCTR


Registration number
ACTRN12618000213246
Ethics application status
Not required
Date submitted
23/01/2018
Date registered
9/02/2018
Date last updated
3/02/2020
Date data sharing statement initially provided
3/02/2020
Type of registration
N/A

Titles & IDs
Public title
Does Senior Emergency Medicine Physician Referral for Computed Tomography of Kidneys, Ureter and Bladder (CT KUB) result in increased utilisation of radiology resources at Middlemore Hospital?
Scientific title
Does Senior Emergency Medicine Physician Referral for CT KUBs result in increased utilisation of radiology resources at Middlemore Hospital?
Secondary ID [1] 293856 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal colic 306318 0
Pain 306341 0
Condition category
Condition code
Renal and Urogenital 305397 305397 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
In our tertiary-level urban hospital, any Emergency Department (ED) doctor can refer a patient to radiology for a CT KUB. However, all referrals for diagnostic imaging modalities other than plain radiography are discussed with a liaison radiologist for vetting and acceptance prior to the imaging being performed. After-hours (1630h to 0830h), the liaison radiologist is the lone on-call radiology registrar, who is also responsible for all acute CT reporting. Historically, this referral process has been put in place to rationalise radiology resources and prevent unnecessary or inappropriate imaging.

However, the current referral process is time- and resource-intensive. The typical process necessitates multiple steps: (1) ED medical staff locates the liaison radiologist by telephone or in person; (2) ED medical staff summarises relevant clinical findings and justification for CT KUB imaging to liaison radiologist; (3) liaison radiologist accepts CT KUB referral; (4) ED medical staff delivers the accepted CT KUB referral form to radiographer. Delays in the current process occur depending on the clinical workload and the concurrent availability of ED medical staff and the liaison radiologist at the time when the clinical decision to proceed with imaging is made. The current referral process is perceived by the ED medical staff to unnecessarily time-consuming, for what is a common ED clinical presentation with a usually straightforward management pathway.

To streamline the CT KUB referral process, we will institute a process change between the ED and radiology for auto-acceptance of CT KUB referrals. Patients presenting to the ED with suspected renal colic will be automatically accepted for CT KUB imaging by the radiographers, after approval from the ED senior medical officer (SMO) on duty. This would bypass the previous vetting process through the liaison radiologist. The auto-acceptance referral process is designed to improve access to CT KUBs when clinically indicated, and reduce the time spent on vetting referrals, thereby allowing more time for discussion of complex cases.

Duration of observation period 6 months
Intervention code [1] 300115 0
Not applicable
Comparator / control treatment
See above. Historical data will be collected 6 months prior to the institution of the cT KUB auto-acceptance referral process
Control group
Historical

Outcomes
Primary outcome [1] 304538 0
Positive rate of urolithiasis of CT KUBs

CT KUBs are defined as positive if high-attenuation calculi are detected in the kidney, ureter or bladder ipsilateral to the patient’s symptoms. In positive cases, the following CT findings will be recorded: maximal axial measurement of the calculus; location of the calculus; presence and degree of hydronephrosis. In the absence of calculi, CT findings likely to account for recent passage of a calculus will be recorded. Alternative diagnosis is defined as an abnormality detected on CT KUB that accounts for the patient’s symptoms or would require further evaluation.

Based on these radiological findings, CT KUBs were categorised into five diagnostic groups:
I. Positive renal colic: calculus ipsilateral to the patient’s symptoms clearly detected by CT
II. Probable renal colic: no detectable calculus on the side of pain but signs indicating possible recent passage (hydronephrosis, ureteral dilatation, perinephric or periureteric stranding, swollen kidney)
III. Equivocal: high-attenuation material in the line of the ureter but not definitely within the ureter
IV. Negative: no renal tract calculus ipsilateral to the patient’s symptoms (includes contralateral renal calculi)
V. Significant alternative diagnosis: other diagnosis accounting for the patient’s symptoms.
Timepoint [1] 304538 0
Cross-sectional
Outcome will be collected 1 month after discharge
Secondary outcome [1] 342297 0
Rate of alternative diagnosis on CT KUB from CT KUB report
Timepoint [1] 342297 0
1 month after discharge
Secondary outcome [2] 342394 0
Total ED length of stay (ED LOS) - from hospital database
Timepoint [2] 342394 0
1 month after discharge
Secondary outcome [3] 342395 0
Seen-by to scan time (time from being seen by an ED doctor to CT KUB scan) - from hospital database
Timepoint [3] 342395 0
1 month after discharge
Secondary outcome [4] 342396 0
Seen-by to ED discharge (time from being seen by an ED doctor to discharge from the ED) - from hospital database
Timepoint [4] 342396 0
1 month after discharge

Eligibility
Key inclusion criteria
Participants are adult patients (>18 years old) presenting to the Middlemore Hospital ED who are investigated with CT KUB for suspected renal colic.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
<18 years old

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
Data will be presented as mean values, medians or proportions with accompanying 95% confidence intervals (CIs). Analytical statistical tests will include the Student t-test for continuous normally-distributed data, and the Mann–Whitney U-test for non-normal data. The Fisher’s exact test will be used to compare proportions. A P-value of <0.05 will be considered statistically significant. A multiple logistic regression analysis will be used to determine factors associated with a positive CT KUB

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
31/05/2018
Actual
Date of last data collection
Anticipated
30/06/2018
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment outside Australia
Country [1] 9517 0
New Zealand
State/province [1] 9517 0
Auckland

Funding & Sponsors
Funding source category [1] 298477 0
Hospital
Name [1] 298477 0
Middlemore Hospital
Country [1] 298477 0
New Zealand
Primary sponsor type
Hospital
Name
Middlemore Hospital
Address
100 Hospital Rd
Otahuhu
Auckland 2025
Country
New Zealand
Secondary sponsor category [1] 297615 0
None
Name [1] 297615 0
Address [1] 297615 0
Country [1] 297615 0

Ethics approval
Ethics application status
Not required
Ethics committee name [1] 299463 0
Ethics committee address [1] 299463 0
Ethics committee country [1] 299463 0
Date submitted for ethics approval [1] 299463 0
Approval date [1] 299463 0
Ethics approval number [1] 299463 0

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

Contacts
Principal investigator
Name 80490 0
Dr Eunicia Tan
Address 80490 0
c/- Emergency Department
Middlemore Hospital
100 Hospital Road
Otahuhu
Auckland 2025
Country 80490 0
New Zealand
Phone 80490 0
+6421487771
Fax 80490 0
Email 80490 0
eunicia.tan@middlemore.co.nz
Contact person for public queries
Name 80491 0
Eunicia Tan
Address 80491 0
c/- Emergency Department
Middlemore Hospital
100 Hospital Road
Otahuhu
Auckland 2025
Country 80491 0
New Zealand
Phone 80491 0
+6421487771
Fax 80491 0
Email 80491 0
eunicia.tan@middlemore.co.nz
Contact person for scientific queries
Name 80492 0
Eunicia Tan
Address 80492 0
c/- Emergency Department
Middlemore Hospital
100 Hospital Road
Otahuhu
Auckland 2025
Country 80492 0
New Zealand
Phone 80492 0
+6421487771
Fax 80492 0
Email 80492 0
eunicia.tan@middlemore.co.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
study withdrawn


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.