Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000607572
Ethics application status
Approved
Date submitted
1/05/2015
Date registered
10/06/2015
Date last updated
1/02/2019
Date data sharing statement initially provided
1/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Cabrini Scribe Trial - a pilot study of the relationship between emergency department scribes and emergency physician productivity using locally trained, Australian scribes
Scientific title
A pilot study of the relationship between Australian trained emergency department scribes and emergency physicians productivity
Secondary ID [1] 286626 0
Nil
Universal Trial Number (UTN)
U1111-1169-8051
Trial acronym
Linked study record
ACTRN12616000618459

Health condition
Health condition(s) or problem(s) studied:
emergency physician efficiency
 294945 0
medical scribe training costs 295026 0
Condition category
Condition code
Public Health 295204 295204 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A scribe or scribes will be trained on a 25-30 hour web-based, American training program in August 2015 ("The ultimate medical scribe handbook and training course - Aaron Thompson"), followed by working as a trainee medical scribe at Cabrini Emergency Department with an Emergency Physician Trainer. They will take notes as directed and will assist the physician with clerical tasks as directed. Once they achieve competency they will work with an Emergency physician or physicians at Cabrini Emergency Department. They will work with the trainer from September 1st 2015 to November 30th 2015 and with the physicians from December 1st 2015 to May 31st 2016.
Intervention code [1] 291762 0
Other interventions
Comparator / control treatment
The same emergency physician trainer will carry out their usual work without the assistance of a scribe which includes their usual note taking and clerical duties from January 1st 2015 to May 31st 2016. (including all shifts worked without a scribe - they will work some scribed shifts and some un-scribed shifts during the scribe trial period)

There will be another control group which is the emergency physicians not enrolled in the study group who work at Cabrini permanently and are not authors of the study or administrators from January 1st 2015 to May 31st 2016.
Control group
Historical

Outcomes
Primary outcome [1] 294959 0
Data on trainer physician and physician patients seen per hour in similar circumstances at the same Emergency Department in close time proximity to the intervention sampling.
Mean and standard deviation of the number of patients seen by each physician per hour.
Timepoint [1] 294959 0
Intervention:
Trainer physician: September 1st to november 30th 2015
Physician/s: December 1st 2015 to May 31st 2016
Control: January 1st to August 31st 2015
Secondary outcome [1] 314471 0
Number of shifts required for the scribe to be able to work independently, measured using a learner competency scale after each trainee shift, assessed by the physician trainer
Timepoint [1] 314471 0
September 1st to november 30th 2015
Secondary outcome [2] 314472 0
the cost of training a scribe - measured by the cost of educational tools and the cost in reduced productivity in terms of patients per hour for the physician trainer and billings per hour for the physician trainer
Timepoint [2] 314472 0
August 1st to november 30th 2015
Secondary outcome [3] 314703 0
Mean billing rates per patient - measured by including medicare fee rates for consultations and procedures in the ED: facility fees excluded, consumables excluded, gap fees excluded, pathology and radiology fees excluded, ED admission fees excluded
Timepoint [3] 314703 0
september 1st 2015 to May 2016
Secondary outcome [4] 314706 0
staff and patient satisfaction regarding the scribe - measured informally by spontaneous and requested feedback
Timepoint [4] 314706 0
September 1st 2015 to May 30th 2016
Secondary outcome [5] 315127 0
patient wait times
Timepoint [5] 315127 0
door-to-doc, from Sept 1st 2015 to May 30th 2015
Secondary outcome [6] 315128 0
total patient time in the Emergency Department
Timepoint [6] 315128 0
door-to-discharge time, from Sept 1st 2015 to May 30th 2015
Secondary outcome [7] 315129 0
time per shift that the Emergency Department is on ambulance bypass/diversion
Timepoint [7] 315129 0
total bypass time / total shift time in minutes, from Sept 1st 2015 to May 30th 2015
Secondary outcome [8] 315130 0
complaints - any written or verbal complaints received about the scribe/scribe program
Timepoint [8] 315130 0
from Sept 1st 2015 to May 30th 2015

Eligibility
Key inclusion criteria
Patient encounters:
All patients seen during scribed shifts and scribed patient encounters during the trial period including any where the scribe was supposed to be present but wasn't. If the scribe was asked to leave an encounter by the patient or physician the encounter will be included in the analysis.

Scribe:
The scribe/s enrolled to participate will be all those hired to train and work as scribes at Cabrini ED during the study period.

Physicians:
FACEMs working on a permanent full-time or part-time contract at Cabrini Emergency Department
Minimum age
20 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
FACEMs unwilling to work with a scribe or unwilling to consent to the study
FACEMs working less than 1 shift per week
Primary investigator of the study

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Phase 1 of the study - training the scribes, will remain unchanged. When the scribes reach competency (defined by a modified Anghoff scale grading after each shift - receiving 3 competent shift gradings in a row) they will be randomly allocated to physicians who are eligible enrolment.

Blocks of time, chosen in advance for containing at least 2 eligible physicians per block are allocated a scribe (e.g. Monday late shift). The same trained scribe regularly works this shift. The physician the scribe is allocated to each shift is chosen randomly (blinded random allocation by computer program) (e.g. next Monday late shift - 3 eligible physicians are rostered to work, the computer allocates the scribe to physician B).

All physicians eligible for the study will be asked to consent to participate.
Those choosing to participate will be required to complete a 1-2 hour on-line training module in how to use a scribe effectively. Physicians will then be asked to dial-in to a training session to offer them the opportunity to ask questions about how to use a scribe prior to proceeding to randomisation.

Participating physicians will then all be included in the intervention group. The intervention group will be allocated scribes for some of their shifts. Two control groups will be formed.
1. Participating physicians working shifts without being allocated a scribe.
2. Ineligible physicians (for this study) who work at the study institution other than those that declined to give permission for their data to be analysed.

All physician productivity data will then be collected.
Three final groups will be analysed.
1. control group not receiving a scribe
2. intervention group with a scribe
3. intervention group working shifts without a scribe
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The scribe will be allocated to an emergency physician working at Cabrini ED. The physicians that don't receive a scribe will form the control group for the same time period.
The scribe will work allocated shifts with the physician they have been paired with. This may be a proportion of the total shifts worked by that physician or it may be all the shifts worked by that physician. This will depend on the availability and compatibility of the rosters and total work time of the physician and the scribe.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
we will look for a minimum effect size of 15% rather than 20%, all else will remain unchanged

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2015
Actual
14/10/2015
Date of last participant enrolment
Anticipated
24/07/2016
Actual
30/06/2016
Date of last data collection
Anticipated
Actual
30/06/2016
Sample size
Target
100
Accrual to date
Final
150
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3741 0
Cabrini Hospital - Malvern - Malvern
Recruitment postcode(s) [1] 9624 0
3144 - Malvern

Funding & Sponsors
Funding source category [1] 291197 0
Charities/Societies/Foundations
Name [1] 291197 0
Equity Trustees Limited
(AFSL No. 240975)
funds administered by equity trustees on behalf of several donors
Country [1] 291197 0
Australia
Primary sponsor type
Individual
Name
Dr Katie Walker
Address
Emergency Department
Cabrini Hospital
183 Wattletree Rd
Malvern
3144
VIC
Country
Australia
Secondary sponsor category [1] 289876 0
Individual
Name [1] 289876 0
Dr Michael Ben-Meir
Address [1] 289876 0
Emergency Department
Cabrini Hospital
183 Wattletree Rd
Malvern
3144
VIC
Country [1] 289876 0
Australia
Secondary sponsor category [2] 289877 0
Individual
Name [2] 289877 0
Dr Margaret Staples
Address [2] 289877 0
Monash Department of Clinical Epidemiology
Cabrini Hospital
Department of Epidemiology and Preventative medicine
183 Wattletree Rd
malvern
VIC 3144
Country [2] 289877 0
Australia
Other collaborator category [1] 278450 0
Individual
Name [1] 278450 0
Dr David Phillips
Address [1] 278450 0
Finance Department
Cabrini Hospital
183 Wattletree Rd
Malvern
3144
VIC
Country [1] 278450 0
Australia
Other collaborator category [2] 278453 0
Individual
Name [2] 278453 0
Mr Matthew Johnson
Address [2] 278453 0
Cabrini Institute
Department of Education
154 Wattletree Rd
Malvern
3144 VIC
Country [2] 278453 0
Australia
Other collaborator category [3] 278566 0
Individual
Name [3] 278566 0
Dr Hamish Rodda
Address [3] 278566 0
Emergency Department
Cabrini
183 Wattletree Rd
Malvern
3144
VIC
Country [3] 278566 0
Australia
Other collaborator category [4] 278705 0
Individual
Name [4] 278705 0
Diana Egerton-Warburton
Address [4] 278705 0
Emergency Department
Monash medical centre
246 Clayton Rd
Clayton
3168
Country [4] 278705 0
Australia
Other collaborator category [5] 278836 0
Individual
Name [5] 278836 0
Ian Turner
Address [5] 278836 0
Cabrini ED
183 Wattletree Rd
Malvern
3144
vic
Country [5] 278836 0
Australia
Other collaborator category [6] 279084 0
Individual
Name [6] 279084 0
Prof Danny Liew
Address [6] 279084 0
Department of Epidemiology and Preventative Medicine
Monash University
The Alfred Centre
99 Commercial Rd
Melbourne
VIC
3004
Country [6] 279084 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292767 0
cabrini HREC, initial submission May 11th 2015
Ethics committee address [1] 292767 0
Ethics committee country [1] 292767 0
Australia
Date submitted for ethics approval [1] 292767 0
29/05/2015
Approval date [1] 292767 0
16/07/2015
Ethics approval number [1] 292767 0
Cabrini HREC

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

Contacts
Principal investigator
Name 56918 0
Dr Katie Walker
Address 56918 0
Emergency Department
Cabrini Hospital
183 Wattletree Rd
Malvern
3144, VIC
Country 56918 0
Australia
Phone 56918 0
+61 431 272 262
Fax 56918 0
+61 3 9508 1501
Email 56918 0
[email protected]
Contact person for public queries
Name 56919 0
Katie Walker
Address 56919 0
Emergency Department
Cabrini hospital
183 Wattletree Rd
Malvern
3144, VIC
Country 56919 0
Australia
Phone 56919 0
+61 431 272 262
Fax 56919 0
+61 3 9508 1501
Email 56919 0
[email protected]
Contact person for scientific queries
Name 56920 0
Katie Walker
Address 56920 0
Emergency Department
Cabrini hospital
183 Wattletree Rd
Malvern
3144, VIC
Country 56920 0
Australia
Phone 56920 0
+61 431 272 262
Fax 56920 0
+61 3 9508 1501
Email 56920 0
[email protected]

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


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
SourceTitleYear of PublicationDOI
EmbaseAn economic evaluation of the costs of training a medical scribe to work in Emergency Medicine.2016https://dx.doi.org/10.1136/emermed-2016-205934
Dimensions AIThe 9-Item Physician Documentation Quality Instrument (PDQI-9) score is not useful in evaluating EMR (scribe) note quality in Emergency Medicine2017https://doi.org/10.4338/aci2017050080
EmbaseEmergency consultants value medical scribes and most prefer to work with them, a few would rather not: A qualitative Australian study.2018https://dx.doi.org/10.1136/emermed-2017-206637
N.B. These documents automatically identified may not have been verified by the study sponsor.