Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000854235
Ethics application status
Approved
Date submitted
26/04/2018
Date registered
21/05/2018
Date last updated
21/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A Rapid Diagnosis Discussion (RaDD) tool for reducing misdiagnoses of patients presenting to emergency rooms with abdominal pain
Scientific title
A Rapid Diagnosis Discussion (RaDD) tool for reducing clinicians' misdiagnoses of patients presenting to emergency rooms with abdominal pain
Secondary ID [1] 294184 0
None
Universal Trial Number (UTN)
U1111-1210-0902
Trial acronym
Rapid Diagnosis Discussion (RaDD) tool
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Abdominal pain
 306820 0
Misdiagnosis 306821 0
Condition category
Condition code
Public Health 305926 305926 0 0
Health service research
Emergency medicine 305927 305927 0 0
Other emergency care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The purpose of this project is to address cognitive bias in diagnostic decision-making in Emergency Departments (ED). To do this, an intervention will be implemented for a 4-week period which involves performing a second independent review of all abdominal pain cases presenting to Box Hill Hospital Emergency Department, followed by a short (approx 3-5 minute) structured discussion to prompt questions, broaden thinking and challenge assumptions.

After the first clinician’s assessment, an independent review will be conducted by a second clinician in the ED, followed by a face-to-face structured discussion between the first clinician and the second clinician. The clinicians involved will be doctors (ranging from interns to consultants). The structured discussion will be guided by the following set of questions, which will be provided to clinicians on a paper form for each patient:

a. What else could this be?
b. Are there any symptoms or signs that don't fit? Any red flags?
c. Are any additional tests/investigations needed or do you already have sufficient confidence in the diagnosis to proceed without them?
d. Do we have all the relevant information about the patient?

The intervention will be introduced to ED doctors by two senior Box Hill Hospital ED doctors and several university academics involved in designing the trial. This introduction will include a lunchtime launch event, along with emails and other communications to ensure all doctors at the hospital are trained in when and how to complete a RaDD during the trial period.

Adherence to the intervention will be monitored by using a case report sheet that will completed each time a RaDD is performed and left in a collection box within the ED.
Intervention code [1] 300480 0
Diagnosis / Prognosis
Intervention code [2] 300481 0
Behaviour
Comparator / control treatment
Clinicians at control hospitals will not be required to use the RaDD process, They will instead continue to use their standard practices. According to these informal standard practices, doctors may occasionally seek a second opinion from another doctor, but they are never required to do so, and these second opinion discussions are not conducted in a standardised manner.
Control group
Active

Outcomes
Primary outcome [1] 304962 0
Prmary outcome 1: ED length of stay, which is the amount of time between a patients' initial presentation to ED, and their discharge from the ED.

Note: Although it would be desirable to measure the number of misdiagnoses directly, it is not possible to measure this outcome directly. Accordingly, primary outcomes consist of a range of health outcomes that may be associated with misdiagnoses. Data on patients with abdominal pain during the trial period will be extracted from the Electronic Medical Record (EMR).
Timepoint [1] 304962 0
All patients who present at the ED in the one pre- or one month post-intervention commencement.
Primary outcome [2] 305669 0
Primary outcome 2: Return to ED within 48 hours, which occurs when a patient returns to the ED within 48 hours post-discharge from the ED. This data will be extracted from the Electronic Medical Record (EMR).
Timepoint [2] 305669 0
All patients who present at the ED in the one pre- or one month post-intervention commencement.
Primary outcome [3] 305751 0
Primary outcome 3: time to bed request. This data will be extracted from the Electronic Medical Record (EMR).
Timepoint [3] 305751 0
All patients who present at the ED in the one pre- or one month post-intervention commencement.
Secondary outcome [1] 346365 0
Primary outcome 4: discharge destination. This data will be extracted from the Electronic Medical Record (EMR).
Timepoint [1] 346365 0
All patients who present at the ED in the one pre- or one month post-intervention commencement.
Secondary outcome [2] 346366 0
Primary outcome 5: Change in diagnosis after completing a RaDD. This outcome will be measured in the intervention hospital by having clinicians complete a paper case-report sheet which records whether there was a change in diagnosis as a result of completing the RaDD.
Timepoint [2] 346366 0
Assessed immediately after each RaDD.
Secondary outcome [3] 346368 0
Secondary outcome 1: Intervention ED clinicians' feedback on the RaDD tool. This outcome will be captured qualitatively using open-ended survey questions specifically designed for this study.
Timepoint [3] 346368 0
1 month post intervention commencement.
Secondary outcome [4] 346369 0
Secondary outcome 2: Intervention ED clinicians' self-reported confidence in decision making while diagnosing patients with abdominal pain. Surveys questions have been designed specifically for this study, but were adapted from items in the the Provider Decision Process Assessment Instrument (Dolan 1999).

Dolan, J. G. (1999). A method for evaluating health care providers' decision making: the Provider Decision Process Assessment Instrument. Medical Decision Making, 19(1), 38-41.
Timepoint [4] 346369 0
1 month post intervention commencement.

Eligibility
Key inclusion criteria
Participants will be included if they are a clinician treating a patient presenting to one of the three Eastern Health Emergency Departments with abdominal pain as the main presenting symptom as recorded by the triage nurse.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
There are no exclusion criteria for ED clinicians.

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



Intervention assignment
Parallel
Other design features
Box Hill Hospital will be the intervention hospital, while Angliss and Maroondah Hospitals will be monitored as control sites.
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 that present to 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
24/05/2018
Actual
Date of last participant enrolment
Anticipated
24/06/2018
Actual
Date of last data collection
Anticipated
24/07/2018
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 10232 0
Box Hill Hospital - Box Hill
Recruitment hospital [2] 10233 0
Angliss Hospital - Upper Ferntree Gully
Recruitment hospital [3] 10234 0
Maroondah Hospital - Ringwood East
Recruitment postcode(s) [1] 21897 0
3128 - Box Hill
Recruitment postcode(s) [2] 21898 0
3156 - Upper Ferntree Gully
Recruitment postcode(s) [3] 21899 0
3135 - Ringwood East

Funding & Sponsors
Funding source category [1] 298818 0
Government body
Name [1] 298818 0
Victorian Managed Insurance Authority
Country [1] 298818 0
Australia
Primary sponsor type
University
Name
Monash University
Address
8 Scenic Blvd, Clayton, Victoria, 3800
Country
Australia
Secondary sponsor category [1] 298019 0
Hospital
Name [1] 298019 0
Eastern Health
Address [1] 298019 0
5 Arnold Street, Box Hill, Victoria, 3128
Country [1] 298019 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299765 0
Eastern Health Human Research Ethics Committee
Ethics committee address [1] 299765 0
Office for Research and Ethics
Eastern Health
Level 2, 5 Arnold Street
Box Hill, Victoria, 3128
Ethics committee country [1] 299765 0
Australia
Date submitted for ethics approval [1] 299765 0
27/03/2018
Approval date [1] 299765 0
24/04/2018
Ethics approval number [1] 299765 0
LR24-2018
Ethics committee name [2] 300292 0
Monash University Human Research Ethics Committee
Ethics committee address [2] 300292 0
Monash Research Office
26 Sports Walk
Monash University
Wellington Road
Clayton, Victoria, 3800
Ethics committee country [2] 300292 0
Australia
Date submitted for ethics approval [2] 300292 0
26/04/2018
Approval date [2] 300292 0
01/05/2018
Ethics approval number [2] 300292 0
13774

Summary
Brief summary
Errors in diagnosis, including delays and receiving an incorrect diagnosis, have serious consequences for patient safety and patient outcomes. Whilst system factors play a role in diagnostic errors, cognitive biases have been identified as being a significant contributor to diagnostic error. Evidence suggests that to address cognitive bias in diagnostic decision-making, getting a second opinion and asking questions designed to challenge bias may be effective at reducing diagnostic error.

The purpose of this project is to address cognitive bias in diagnostic decision-making in Emergency Departments (ED). To do this, an intervention will be trialled which involves performing a second independent review of all abdominal pain cases presenting to Box Hill Hospital Emergency Department, followed by a structured discussion to prompt questions, broaden thinking and challenge assumptions.

Following the first clinician’s assessment, an independent review will be conducted by a second clinician in the ED followed by a structured discussion between the first clinician and the second opinion. The second part of this intervention, the structured discussion, will be guided by a standard set of questions.

Existing ED practices typically involve repeated ad hoc clinical examination by multiple clinicians, so it is anticipated that patients presenting to the ED with abdominal pain will not notice a change in their care, or find this process burdensome.

References
Blumenthal-Barby, J., & Krieger, H. (2014). Cognitive biases and heuristics in medical decision making: A critical review using a systematic search strategy. Medical Decision Making, 35(4), 539-557.
Croskerry. (2003). The importance of cognitive errors in diagnosis and strategies to minimize them. Academic medicine, 78(8), 775-780.
Graber, M. L., Franklin, N., & Gordon, R. (2005). Diagnostic error in internal medicine. Arch Intern Med, 165(13), 1493-1499.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81498 0
A/Prof Peter Bragge
Address 81498 0
BehaviourWorks Australia, 8 Scenic Blvd, Monash University, Clayton, Victoria, 3800
Country 81498 0
Australia
Phone 81498 0
+61 3 9905 9664
Fax 81498 0
Email 81498 0
[email protected]
Contact person for public queries
Name 81499 0
Dr Breanna Wright
Address 81499 0
BehaviourWorks Australia, 8 Scenic Blvd, Monash University, Clayton, Victoria, 3800
Country 81499 0
Australia
Phone 81499 0
+61 4 2231 6401
Fax 81499 0
Email 81499 0
[email protected]
Contact person for scientific queries
Name 81500 0
Dr Nicholas Faulkner
Address 81500 0
BehaviourWorks Australia, 8 Scenic Blvd, Monash University, Clayton, Victoria, 3800
Country 81500 0
Australia
Phone 81500 0
+61 3 99052712
Fax 81500 0
Email 81500 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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