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Trial registered on ANZCTR


Registration number
ACTRN12616000618459
Ethics application status
Approved
Date submitted
26/04/2016
Date registered
12/05/2016
Date last updated
1/02/2019
Date data sharing statement initially provided
5/12/2018
Date results provided
5/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Multi-centre medical scribe study - testing scribes in Victorian public Emergency Departments
Scientific title
A prospective, multi-center cohort study, evaluating emergency doctor productivity with medical scribe assistance
Secondary ID [1] 289049 0
Nil
Universal Trial Number (UTN)
U1111-1182-1406
Trial acronym
SCRIBE study - Scribe multi-Centre Research Investigation in Emergency departments
Linked study record
ACTRN12615000607572

Health condition
Health condition(s) or problem(s) studied:
Emergency health care provision 298478 0
Emergency consultation documentation quality 298479 0
Productivity of Emergency doctors using dictatation systems to write medical notes 298532 0
Stress levels of Emergency Doctors working clinical shifts 298533 0
Door to doctor time for patients when the doctor is an Emergency Doctor performing a medical triage role 298534 0
Condition category
Condition code
Public Health 298571 298571 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Medical scribe use by Emergency Doctors.

A trained medical scribe will assist an emergency doctor during emergency consultations. Doctors will be allocated scribes by randomisation of scribes into available shifts. They may work with one or more scribes over the whole study, but only with one scribe per clinical shift.

The training the scribes have received is a pre-work course with additional tutorials and simulation training, followed by observer shifts as a trainee with gradually increasing responsibility (between 7 and 16 clinical shifts). They are deemed to be competent when they have undertaken three shifts in a row and been evaluated as competent after each shift on a modified Angoff scribe performance score.

Scribes will take clinical consultation notes as directed and will assist with clerical tasks as directed. Scribes will be randomly allocated to shifts of public Emergency Department doctors in Victoria (at enrolled sites) over a one year period from November 2016 to October 2017.

Each site will require 100 clinical shifts and 100 controls. We estimate that this will require 3 months of 1 EFT of scribe per site. Scribes will also be required to work initial orientation shifts at each new site prior to commencing collecting study data (to learn the site processes and electronic medical record functionality). We estimate this period to be 2 weeks per site.

There will be no minimum or maximum number of shifts for a physician to be exposed to, however it is likely that 4 physicians will be required per site - anticipating an even spread of about 12-13 shifts per physician at each site.
Intervention code [1] 294537 0
Other interventions
Comparator / control treatment
1. Emergency doctors (eligible to participate in the study who were allocated to receive scribes for some shifts) will carry out their usual work without the assistance of a medical scribe which includes their usual note taking and clerical duties during the same study time period.

2. Emergency doctors (eligible to participate in the study who were not allocated scribes for any shift) will carry out their usual work without the assistance of a medical scribe which includes their usual note taking and clerical duties during the same study time period.
Control group
Active

Outcomes
Primary outcome [1] 298062 0
Emergency doctor productivity (patients per hour per doctor) working with a scribe, compared to working without a scribe.

This will be measured by integrating 3 sources of information from 3 databases.
1. Electronic metadata collected during usual care for each patient from each ED
(demorgraphics (age, gender), triage category, arrival and departure time from the ED, name of physician allocated to the patient)

2. Doctor's rosters

3. Scribe's rosters
Timepoint [1] 298062 0
August 2016 to October 2017
Secondary outcome [1] 323210 0
Door to medical triage time for patients at Monash Paediatric Emergency Department comparing shifts using a medical scribe to shifts without a medical scribe

This will be assessed using the main primary outcome merged databases as a subgroup analysis.
Assessment will be via hospital administrative databases which collect data on income achieved per patient after coding processes are undertaken for the patient attendances; combined with the ED administrative databases on time of patient arrival and discharge; compared to doctor and scribe rosters.
Timepoint [1] 323210 0
August 2016 to November 2017
Secondary outcome [2] 323212 0
Patient door-to-doctor times comparing scribed to unscribed shifts

This will be assessed using the main primary outcome merged databases as a subgroup analysis.

Assessment will be via hospital administrative databases which collect data on income achieved per patient after coding processes are undertaken for the patient attendances; combined with the ED administrative databases on time of patient arrival and discharge; compared to doctor and scribe rosters.
Timepoint [2] 323212 0
August 2016 to November 2017
Secondary outcome [3] 323213 0
Patient door-to-discharge times comparing scribed to unscribed shifts

This will be assessed using the main primary outcome merged databases as a subgroup analysis.
Assessment will be via hospital administrative databases which collect data on income achieved per patient after coding processes are undertaken for the patient attendances; combined with the ED administrative databases on time of patient arrival and discharge; compared to doctor and scribe rosters.
Timepoint [3] 323213 0
August 2016 to November 2017

Eligibility
Key inclusion criteria
Emergency department doctors:
working at each site during the sampling time period
working at least two clinical shifts per week
performing a clinical patient consultation role
either consultants or senior registrars
Minimum age
23 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Doctor unwilling to consent to participate

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)
All doctors eligible for inclusion into the study will be enrolled at each site. Doctors enrolled will then be randomly allocated to either receive or not receive scribes for the duration of the study. Doctors allocated to receive scribes will then have their available shifts determined and those shifts will randomly have scribes allocated to them or not.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Doctors and shifts will be allocated using the Excel random number generator program by an investigator in advance of the study being undertaken (as soon as each roster becomes available for analysis).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Doctors will have many shifts available for scribes. A proportion of these available shifts will receive scribes (randomly allocated). This will mean that sometimes the study doctors have scribes allocated during the study period, sometimes they won't.
There will be another group of doctors who will be eligible for scribes but aren't randomised into this arm of the study. They will form a contemporaneous comparator group.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Demographics of patients and doctors will largely be compared using Kruskall–Wallis equality-of-populations rank test for age and X2-tests for other variables.
Differences between scribed and un-scribed shifts in patient age, wait time and duration of stay will be assessed using linear regression (scribe predictor).
Stress levels of doctors will be measured by survey and 5 point Likert scales will be generated. These will be analysed using non-parametric comparisons.
Documentation quality will be compared using blinded analysis (to patient identifiers and to whether the notes were scribed or generated by the physician without the use of a scribe) of individual medical notes, marked on a 5 point Likert scale by emergency physicians. They will be analysed using non-parametric comparisons.

The sample size was calculated using a medical productivity of 0.86 patients per hour per doctor (generated from the current initial results of medical productivity at Cabrini Emergency Department, evaluated in study ACTRN12615000607572), using a 2-tailed test with a significance level of 5%, seeking a productivity improvement of 15% (which is an estimate of the economic viability/breakeven point for the role in Australia). This requires 100 shifts and 100 controls and each site requires the same on iterative sample size testing.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2016
Actual
1/12/2016
Date of last participant enrolment
Anticipated
31/01/2018
Actual
14/01/2018
Date of last data collection
Anticipated
31/01/2018
Actual
14/01/2018
Sample size
Target
800
Accrual to date
Final
1025
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5641 0
Bendigo Health Care Group - Bendigo Hospital - Bendigo
Recruitment hospital [2] 5642 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [3] 5643 0
Dandenong Hospital - Dandenong
Recruitment hospital [4] 5644 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [5] 6692 0
Cabrini Hospital - Malvern - Malvern
Recruitment postcode(s) [1] 13170 0
3550 - Bendigo
Recruitment postcode(s) [2] 13171 0
3084 - Heidelberg
Recruitment postcode(s) [3] 13172 0
3168 - Clayton
Recruitment postcode(s) [4] 13173 0
3175 - Dandenong
Recruitment postcode(s) [5] 14325 0
3144 - Malvern

Funding & Sponsors
Funding source category [1] 293460 0
Charities/Societies/Foundations
Name [1] 293460 0
Phyllis Connor Memorial Fund
Country [1] 293460 0
Australia
Primary sponsor type
Individual
Name
Dr Katherine Walker
Address
Cabrini Emergency Department
183 Wattletree Rd
Malvern
3144
VIC
Country
Australia
Secondary sponsor category [1] 292281 0
None
Name [1] 292281 0
Address [1] 292281 0
Country [1] 292281 0
Other collaborator category [1] 278959 0
Individual
Name [1] 278959 0
Prof David Taylor
Address [1] 278959 0
Austin Hospital
145 Studley Rd
Heidelberg
Vic
3084
Country [1] 278959 0
Australia
Other collaborator category [2] 278960 0
Individual
Name [2] 278960 0
A/Prof Diana Badcock
Address [2] 278960 0
Bendigo Hospital
62 Lucan Street
Bendigo
Vic
3550
Country [2] 278960 0
Australia
Other collaborator category [3] 278969 0
Individual
Name [3] 278969 0
Dr Rachel Rosler
Address [3] 278969 0
Dandenong Emergency Department
105 David Street
Dandenong
Vic
3175
Country [3] 278969 0
Australia
Other collaborator category [4] 278970 0
Individual
Name [4] 278970 0
Dr Robert Meek
Address [4] 278970 0
Dandenong Emergency Department
105 David Street
Dandenong
Vic
3175
Country [4] 278970 0
Australia
Other collaborator category [5] 278971 0
Individual
Name [5] 278971 0
Dr Thomas Chan
Address [5] 278971 0
Austin Hospital
145 Studley Rd
Heidelberg
Vic
3084
Country [5] 278971 0
Australia
Other collaborator category [6] 278972 0
Individual
Name [6] 278972 0
Dr Gabrielle O'Connor
Address [6] 278972 0
Austin Hospital
145 Studley Rd
Heidelberg
Vic
3084
Country [6] 278972 0
Australia
Other collaborator category [7] 278973 0
Individual
Name [7] 278973 0
Mr William Dunlop
Address [7] 278973 0
Cabrini Hospital
183 Wattletree Rd
Malvern
3144
VIC
Country [7] 278973 0
Australia
Other collaborator category [8] 278974 0
Individual
Name [8] 278974 0
Dr Margaret Staples
Address [8] 278974 0
Cabrini Hospital
183 Wattletree Rd
Malvern
3144
VIC
Country [8] 278974 0
Australia
Other collaborator category [9] 278975 0
Individual
Name [9] 278975 0
Dr Michael Ben-Meir
Address [9] 278975 0
Cabrini Hospital
183 Wattletree Rd
Malvern
3144
VIC
Country [9] 278975 0
Australia
Other collaborator category [10] 278976 0
Individual
Name [10] 278976 0
Prof Danny Liew
Address [10] 278976 0
Monash University
Department of Epidemiology and Preventative Medicine
The Alfred centre
99 Commercial Rd
Melbourne
VIC 3004
Country [10] 278976 0
Australia
Other collaborator category [11] 278977 0
Individual
Name [11] 278977 0
Prof Diana Egerton-Warburton
Address [11] 278977 0
Monash Emergency Department
Monash Medical Centre
246 Clayton Rd
Clayton
3168
Country [11] 278977 0
Australia
Other collaborator category [12] 278978 0
Individual
Name [12] 278978 0
Dr Adam West
Address [12] 278978 0
Monash Paediatric Emergency Department
246 Clayton Rd
Clayton
Vic
3168
Country [12] 278978 0
Australia
Other collaborator category [13] 278983 0
Individual
Name [13] 278983 0
Prof Andis Graudins
Address [13] 278983 0
Monash Emergency Department
Monash Medical Centre
246 Clayton Rd
Clayton
3168
Country [13] 278983 0
Australia
Other collaborator category [14] 278992 0
Individual
Name [14] 278992 0
Dr Neil Goldie
Address [14] 278992 0
Dandenong Emergency Department
105 David Street
Dandenong
Vic
3175
Country [14] 278992 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294871 0
Cabrini Human Research Ethics Committee
Ethics committee address [1] 294871 0
Ethics committee country [1] 294871 0
Australia
Date submitted for ethics approval [1] 294871 0
01/05/2016
Approval date [1] 294871 0
09/09/2016
Ethics approval number [1] 294871 0
HREC/16/MonH/198, Submission Code: AU/13/19C7214
Ethics committee name [2] 295969 0
Monash HREC
Ethics committee address [2] 295969 0
Ethics committee country [2] 295969 0
Australia
Date submitted for ethics approval [2] 295969 0
09/07/2016
Approval date [2] 295969 0
09/09/2016
Ethics approval number [2] 295969 0
HREC/16/MonH/198, Submission Code: AU/13/19C7214

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

Contacts
Principal investigator
Name 65298 0
Dr Katherine Walker
Address 65298 0
Emergency Department
Cabrini
183 Wattletree Rd
Malvern
3144
VIC
Country 65298 0
Australia
Phone 65298 0
+61 431 272 262
Fax 65298 0
Email 65298 0
katie_walker01@yahoo.com.au
Contact person for public queries
Name 65299 0
Katherine Walker
Address 65299 0
Emergency Department
Cabrini
183 Wattletree Rd
Malvern
3144
VIC
Country 65299 0
Australia
Phone 65299 0
+61 431 272 262
Fax 65299 0
Email 65299 0
katie_walker01@yahoo.com.au
Contact person for scientific queries
Name 65300 0
Katherine Walker
Address 65300 0
Emergency Department
Cabrini
183 Wattletree Rd
Malvern
3144
VIC
Country 65300 0
Australia
Phone 65300 0
+61 431 272 262
Fax 65300 0
Email 65300 0
katie_walker01@yahoo.com.au

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
No additional documents have been identified.