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Trial registered on ANZCTR


Registration number
ACTRN12614000360617
Ethics application status
Approved
Date submitted
27/03/2014
Date registered
4/04/2014
Date last updated
17/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Cabrini Scribe Trial 2014 - a study to investigate the relationship between emergency department scribes and emergency physician productivity - to compare physician productivity, billing and staff satisfaction with and without the assistance of a scribe during emergency medicine consultations
Scientific title
A study of the relationship between emergency department scribes and emergency physician productivity, billing and staff satisfaction
Secondary ID [1] 284348 0
Nil
Universal Trial Number (UTN)
U1111-1170-0717
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Emergency physician efficiency 291501 0
Emergency department staff satisfaction related to medical scribes 291502 0
Condition category
Condition code
Public Health 291872 291872 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A trained medical scribe will assist an emergency physician during emergency consultations. They will take notes as directed and will assist with clerical tasks as directed. The intervention will take place for six consecutive months commencing July 2014
Intervention code [1] 289073 0
Other interventions
Comparator / control treatment
An emergency physician will carry out their usual work without the assistance of a medical scribe which includes their usual note taking and clerical duties. Emergency physician shifts matched in advance for physician, day, time and work area will be selected from January to June shifts in 2014.
Control group
Historical

Outcomes
Primary outcome [1] 291791 0
Data on physician patients seen per hour in similar circumstances in close time proximity to the intervention sampling Mean and standard deviation (SD) of the number of patients seen by each physician per hour
Timepoint [1] 291791 0
Intervention: July 1st 2014 and onwards for a period of 6 months Control: January to June 2014 inclusive
Secondary outcome [1] 307550 0
billing rates per patient obtained from hospital database
Timepoint [1] 307550 0
Intervention: July 1st 2014 and onwards for a period of 6 months Control: January to July 2014 inclusive
Secondary outcome [2] 307551 0
patient waiting times - obtained from hospital database
Timepoint [2] 307551 0
Intervention: July 2014 and onwards for a period of 6 months Control: January to June 2014 inclusive
Secondary outcome [3] 307552 0
ambulance bypass times - obtained from hospital database
Timepoint [3] 307552 0
Intervention: July 2014 and onwards for a period of 6 months Control: January to June 2014 inclusive
Secondary outcome [4] 307553 0
complaints or adverse events - obtained from hospital database and from intervention physicians
Timepoint [4] 307553 0
Intervention: July 2014 and onwards for a period of 6 months Control: January to June 2014 inclusive

Eligibility
Key inclusion criteria
All 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.
The physicians enrolled to participate will be a convenience sample of physicians available during the specified time period. They will be voluntarily consenting to participate.
The scribe used will be one trained scribe identified in advance. This scribe will work with all the physicians.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
unscribed shifts

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The scribed shifts will be allocated to selected willing participant physicians a month preceeding the trial intervention. The physicians will be regular cabrini physicians who are agreable to participate in the trial. These physicians will be aware of the trial aims. The scribe will attend for a month and will work preallocated shifts with the physicians. The patient encounters within each shift will not be able to be chosen as these are defined by rules surrounding patient allocation that are always the same. There is computer generated allocation of the next patient to be seen and there are shift rules around regional allocation of emergency department physician allocation of work duties. These are closely enforced and only interrupted by a patient requiring resuscitation or immediate medical attention.
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The minimal clinical effect size that would be useful to pursue would be an efficiency gain from 1.0 patient per hour to 1.2 patients per hour (a 20% increase). A sample size of 100 in each period would allow this difference to be detected at a 5% significance level and 80% power (two-sided) assuming a relatively conservative estimate of the SD of the number of patients seen per hour of 0.5.
The mean number of encounters per hour will be compared for the two groups using t-tests. Similarly, the mean billing rates, total ambulance bypass times and patient waiting times will be compared for the groups using parametric or non-parametric tests as appropriate.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2014
Actual
27/06/2014
Date of last participant enrolment
Anticipated
Actual
19/12/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
108
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2252 0
Cabrini Hospital - Malvern - Malvern
Recruitment postcode(s) [1] 7919 0
3144 - Malvern

Funding & Sponsors
Funding source category [1] 288982 0
Hospital
Name [1] 288982 0
Cabrini
Country [1] 288982 0
Australia
Primary sponsor type
Individual
Name
Dr Katherine Walker
Address
Emergency department Cabrini Hospital 183 Wattletree Rd Malvern
3144 VIC
Country
Australia
Secondary sponsor category [1] 287661 0
Individual
Name [1] 287661 0
Dr Michael Ben-Meir
Address [1] 287661 0
Emergency department
Cabrini Hospital
183 Wattletree Rd Malvern
3144 VIC
Country [1] 287661 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290794 0
Cabrini HREC
Ethics committee address [1] 290794 0
Ethics committee country [1] 290794 0
Australia
Date submitted for ethics approval [1] 290794 0
28/03/2014
Approval date [1] 290794 0
21/05/2014
Ethics approval number [1] 290794 0
01-16-06-14

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

Contacts
Principal investigator
Name 47298 0
Dr Katherine Walker
Address 47298 0
Emergency department Cabrini Hospital 183 Wattletree Rd malvern 3144 VIC
Country 47298 0
Australia
Phone 47298 0
+61 431 272 262
Fax 47298 0
+61 3 9508 1501
Email 47298 0
[email protected]
Contact person for public queries
Name 47299 0
Katie Walker
Address 47299 0
Emergency department Cabrini Hospital 183 Wattletree Rd malvern 3144 VIC
Country 47299 0
Australia
Phone 47299 0
+61 431 272 262
Fax 47299 0
+61 3 9508 1501
Email 47299 0
[email protected]
Contact person for scientific queries
Name 47300 0
Katie Walker
Address 47300 0
Emergency department Cabrini Hospital 183 Wattletree Rd malvern 3144 VIC
Country 47300 0
Australia
Phone 47300 0
+61 431 272 262
Fax 47300 0
+61 3 9508 1501
Email 47300 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.