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Trial registered on ANZCTR


Registration number
ACTRN12619000245190p
Ethics application status
Submitted, not yet approved
Date submitted
8/01/2019
Date registered
19/02/2019
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Acceptability and effectiveness of using a secure electronic collaboration platform (myBeepr) to improve communication of test results between radiologists and emergency department doctors: controlled pre-post, mixed-methods, pragmatic trial
Scientific title
Acceptability and effectiveness of using a secure electronic collaboration platform (myBeepr) to improve communication of test results between radiologists and emergency department doctors: controlled pre-post, mixed-methods, pragmatic trial
Secondary ID [1] 296962 0
None
Universal Trial Number (UTN)
U1111-1226-1723
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Misdiagnosis 310926 0
Condition category
Condition code
Public Health 309588 309588 0 0
Health service research
Emergency medicine 309589 309589 0 0
Other emergency care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involves implementing a secure electronic collaboration app, called myBeepr (www.mybeepr.com), at an intervention hospital in Victoria, Australia, the Monash Health Clayton Hospital. During the one-month intervention period, radiology technicians completing abdomen CT scans ordered by the hospital's Emergency Department (ED) will be required to send a short, time-stamped message via myBeepr to the ED relevant doctor. All CT scans that include the abdomen (e.g. full body scans) will be included.

The message sent will indicatively include the following information: (a) a note that the scan is complete (e.g. "CT scan complete"); (b) a patient identifier and name; and, (c) a 2-3 word summary of findings (e.g. 'normal finding', 'incidental finding', 'urgent finding').

Radiologists and doctors at the intervention hospital will be introduced and trained in how to use the app during two short launch events (run separately for radiologists and ED doctors) that will occur in the weeks prior to the intervention beginning. These sessions will be run primarily by the app developer, with the assistance of a representatives from the research team.

Doctors' adherence to using the app will be monitored by comparing the number of test results communicated via myBeepr (as per app analytics) with the number of abdomen CT scans ordered by ED doctors (as per hospital records).
Intervention code [1] 313233 0
Early detection / Screening
Intervention code [2] 313234 0
Behaviour
Intervention code [3] 313235 0
Diagnosis / Prognosis
Comparator / control treatment
Clinicians at the control site, Casey Hospital, will not be required to use the intervention process. They will instead continue to use their standard practice. Some informal standard practices may include radiologists following up test results, including calling or messaging clinicians.
Control group
Active

Outcomes
Primary outcome [1] 318547 0
Time elapsed before radiology report is opened by ED clinician in hospital EMR (assessed using hospital electronic records).
Timepoint [1] 318547 0
The time count will begin when the radiology report is entered into the hospital EMR, and stop when a doctor opens the report.
Primary outcome [2] 318548 0
Compliance rate with intervention, measured as the percentage of relevant tests (i.e abdomen CT scans ordered by ED doctors, as recorded in hospital EMR systems) the radiology technician sent a message to the ED clinician using myBeepr.
Timepoint [2] 318548 0
All tests in the one month post-intervention commencement.
Primary outcome [3] 318549 0
Percentage of messages sent by radiology technicians viewed by ED clinicians on myBeepr, as measured by app analytics..
Timepoint [3] 318549 0
All tests in the one month post-intervention commencement.
Secondary outcome [1] 365348 0
Primary outcome 4: Clinicians' perceptions about the usability of the myBeepr system, assessed using the Usability Metric for User Experience scale (Finstad 2010; Lewis 2018).

Finstad, K. 2010. The Usability Metric for User Experience, Interacting with Computers, DOI: 10.1016/j.intcom.2010.04.004

Lewis, J.R. 2018. Measuring Perceived Usability: SUS, UMUX, and CSUQ Ratings for Four Everyday Products, International Journal of Human–Computer Interaction, DOI: 10.1080/10447318.2018.1533152
Timepoint [1] 365348 0
One-month post-intervention commencement
Secondary outcome [2] 365349 0
Primary outcome 5: Participating clinicians' confidence that test results are being acted upon appropriately. Survey questions developed specifically for this study.
Timepoint [2] 365349 0
One-month post-intervention commencement.
Secondary outcome [3] 365350 0
Patient representations to hospital within 48 hours of discharge, as assessed by hospital EMR systems.
Timepoint [3] 365350 0
Recorded at patient re-presentation..
Secondary outcome [4] 365351 0
ED discharge location, as recorded in hospital EMR systems.
Timepoint [4] 365351 0
Recorded when the patient is discharged from the ED.
Secondary outcome [5] 365352 0
ED length of stay, which is the amount of time between a patients' initial presentation to ED, and their discharge from the ED, as recorded in hospital EMR systems.
Timepoint [5] 365352 0
Recorded when the patient is discharged from the ED.
Secondary outcome [6] 365353 0
Number of incident reports recorded, as per hospital records.
Timepoint [6] 365353 0
Assessed at the conclusion of the trial period (i.e. 1 to 8 weeks post-patient discharge).
Secondary outcome [7] 365354 0
Number of blood tests ordered, as recorded in hospital EMR systems.
Timepoint [7] 365354 0
Assessed at the conclusion of the trial period (i.e. 1 to 8 weeks post-patient discharge).
Secondary outcome [8] 365355 0
Number of urine tests ordered, as recorded in hospital EMR systems.
Timepoint [8] 365355 0
Assessed at the conclusion of the trial period (i.e. 1 to 8 weeks post-patient discharge).
Secondary outcome [9] 365356 0
Number of imaging tests ordered, as recorded in hospital EMR systems.
Timepoint [9] 365356 0
Assessed at the conclusion of the trial period (i.e. 1 to 8 weeks post-patient discharge).
Secondary outcome [10] 365357 0
Intervention ED clinicians' feedback on the myBeepr tool. This outcome will be captured qualitatively using open-ended survey questions specifically designed for this study.
Timepoint [10] 365357 0
1 month post-intervention commencement.

Eligibility
Key inclusion criteria
Participants will be included if they are the radiologist or ED clinician of a patient who has had an abdomen CT scan ordered from the Emergency Department at Monash Health Clayton hospital. All types of abdomen CTs will be included, including CT chest/abdomen or whole body trauma CT.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
There are no exclusion criteria for the radiologists or ED clinicians.

For patient outcomes, all patients who receive an abdomen CT scan ordered by an ED doctor will be included. No exclusion criteria apply.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
n/a
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analysis methods: For all quantitative variables collected at pre- and post- time points in both intervention and comparison hospitals, we will use a difference-in-differences approach to measuring intervention impacts. This approach compares the before-after change in the intervention group, with the before-after change in the control group to estimate the effect of the intervention. The approach is equivalent to examining the time (0 = pre, 1 = post) by condition (0 = control, 1 = intervention) interaction effects in a regression model. Descriptive statistics will also be reported all quantitative outcomes.

For all qualitative outcomes, we will use thematic analysis to identify substantive themes in participants' open-ended responses.


Sample size: Sample size was selected based on the pragmatics of recruitment in available time and budget constraints. All clinicians in the intervention hospital during the one-month intervention period will be included. For patient outcomes, all patients who receive an abdomen CT scan while admitted to the ED in the intervention or control hospitals during the trial period will be included in analyses.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/02/2019
Actual
Date of last participant enrolment
Anticipated
25/03/2019
Actual
Date of last data collection
Anticipated
25/04/2019
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12813 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 12814 0
Casey Hospital - Berwick
Recruitment postcode(s) [1] 25283 0
3168 - Clayton
Recruitment postcode(s) [2] 25284 0
3806 - Berwick

Funding & Sponsors
Funding source category [1] 301532 0
Government body
Name [1] 301532 0
Victorian Managed Insurance Authority
Country [1] 301532 0
Australia
Primary sponsor type
University
Name
Monash University
Address
8 Scenic Blvd, Clayton, Victoria, 3800
Country
Australia
Secondary sponsor category [1] 301234 0
Hospital
Name [1] 301234 0
Monash Health
Address [1] 301234 0
246 Clayton Road, Clayton, Victoria 3168
Country [1] 301234 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 302271 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 302271 0
Ethics committee country [1] 302271 0
Australia
Date submitted for ethics approval [1] 302271 0
21/11/2018
Approval date [1] 302271 0
Ethics approval number [1] 302271 0

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

Contacts
Principal investigator
Name 89646 0
A/Prof Peter Bragge
Address 89646 0
BehaviourWorks Australia, 8 Scenic Blvd, Monash University, Clayton, Victoria, 3800
Country 89646 0
Australia
Phone 89646 0
+61 3 9905 9664
Fax 89646 0
Email 89646 0
peter.bragge@monash.edu
Contact person for public queries
Name 89647 0
Breanna Wright
Address 89647 0
BehaviourWorks Australia, 8 Scenic Blvd, Monash University, Clayton, Victoria, 3800
Country 89647 0
Australia
Phone 89647 0
+61 4 2231 6401
Fax 89647 0
Email 89647 0
breanna.wright@monash.edu
Contact person for scientific queries
Name 89648 0
Nicholas Faulkner
Address 89648 0
BehaviourWorks Australia, 8 Scenic Blvd, Monash University, Clayton, Victoria, 3800
Country 89648 0
Australia
Phone 89648 0
+61 3 99052712
Fax 89648 0
Email 89648 0
nicholas.faulkner@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will not be made publicly available in accordance with the quality assurance ethics approval.


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.