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Trial registered on ANZCTR


Registration number
ACTRN12616000308493
Ethics application status
Approved
Date submitted
3/03/2016
Date registered
9/03/2016
Date last updated
9/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Patient experiences of and attitudes regarding medical scribes in an Australian Emergency Department
Scientific title
Patient experiences of and attitudes regarding medical scribes in an Australian Emergency Department
Secondary ID [1] 288382 0
None
Universal Trial Number (UTN)
U1111-1178-7798
Trial acronym
Linked study record
ACTRN12616000223437

Health condition
Health condition(s) or problem(s) studied:
medical scribes - patient responses to their presence during emergency medicine consultations 297628 0
Condition category
Condition code
Public Health 297814 297814 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Medical scribes are being used during consultations in emergency departments at Cabrini Emergency Department during a study on the economics and utility of medical scribes in Australian Emergency Departments (September 2015-September 2016, ACTRN12615000607572).
A medical scribe is a personal assistant to the emergency physician who stands near the physician during consultations documenting the consultation and arranging tests, consultations and hospital beds as required. They use a computer-on-wheels connected to the hospital electronic medical record.

This study will administer a survey to patients or their representatives, seeking to determine their thoughts and attitudes towards the scribe being in the room and assisting with the consultation. It will be administered to the patient/representative on a single occasion only, whilst the patient is in the Emergency Department
Intervention code [1] 293906 0
Not applicable
Comparator / control treatment
The controls will be patients who attend the Emergency Department during the same time periods who don't have a medical scribe allocated to their doctor that visit.
Control group
Active

Outcomes
Primary outcome [1] 297340 0
Net promoter score for the ED visit/consultation as a measure of patient satisfaction - provided by the patient/representative
Timepoint [1] 297340 0
April 2016 to September 2016, during the ED visit
Secondary outcome [1] 320761 0
Patient's general satisfaction with the consultation while a scribe is present in the room during a consultation, with items taken from the Press Ganey survey, overall satisfaction with consultation questions
Timepoint [1] 320761 0
April 2016 to September 2016, whilst the patient is in the Emergency Department
Secondary outcome [2] 320762 0
Patient's self-reported ability to give the physician personal medical information with the scribe in the room, measured by survey questions, measured on a 5 point Likert scale, completed by the patient or their representative
Timepoint [2] 320762 0
April 2016 to September 2016, whilst the patient is in the Emergency Department
Secondary outcome [3] 321495 0
Patients' tolerance of the scribe being present in the room during a medical physical examination, measured by survey questions, measured on a 5 point Likert scale, completed by the patient or their representative
Timepoint [3] 321495 0
April 2016 to September 2016, whilst the patient is in the Emergency Department
Secondary outcome [4] 321496 0
Patients' ability to tolerate the increased crowding in the room during a consultation with the medical scribe in the room, measured by survey questions, measured on a 5 point Likert scale, completed by the patient or their representative
Timepoint [4] 321496 0
April 2016 to September 2016, whilst the patient is in the Emergency Department
Secondary outcome [5] 321497 0
Patients' views on the perceived professionalism of the physician whilst the scribe is present for the consultation, measured by survey questions, measured on a 5 point Likert scale, completed by the patient or their representative
Timepoint [5] 321497 0
April 2016 to September 2016, whilst the patient is in the Emergency Department

Eligibility
Key inclusion criteria
Patient attending Cabrini Emergency Department between April 2016 and September 2016
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who decline to participate/give consent to the study
Patients who are unable to communicate in written English who do not have an advocate/friend/family member attending who can fill in the survey and give consent on their behalf
Patients who are at risk of spreading infection to research staff
Patients who are immunocompromised and for whom contact with research staff poses a risk

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Press Ganey patient net-promoter scores relating to Cabrini ED became available mid study to us from 2015.

We used a non-inferiority calculation with a clinically important drop in net promotor score being thought to be 10% - a small informal survey of our hospital administrators indicated that a scribe program would be at risk even if scribes provided strong economic gains if there was a more than 10% drop in net-promotor score.

We used the net promoter score and the 2015 data was as follows:

The proportion of ‘net promoters’ is 92% and non-inferiority is defined as no more than 10% less than this (i.e., 82%), the number of patient interviews is set out -
92 cases: 92 controls - balanced groups
69 cases: 104 controls - 1:2 ratio
We opted to recruit 92 patients to each group

Secondary outcomes: descriptive and qualitative analysis based on 5-point Likert scores and free-text responses.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2016
Actual
7/05/2016
Date of last participant enrolment
Anticipated
30/09/2016
Actual
31/05/2016
Date of last data collection
Anticipated
Actual
31/05/2016
Sample size
Target
184
Accrual to date
Final
213
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5269 0
Cabrini Hospital - Malvern - Malvern
Recruitment postcode(s) [1] 12732 0
3144 - Malvern

Funding & Sponsors
Funding source category [1] 292879 0
Self funded/Unfunded
Name [1] 292879 0
Mr Lachlan Hegarty
Country [1] 292879 0
Australia
Funding source category [2] 292880 0
Charities/Societies/Foundations
Name [2] 292880 0
Equity Trustees on behalf of donors
Country [2] 292880 0
Australia
Funding source category [3] 292881 0
Charities/Societies/Foundations
Name [3] 292881 0
Cabrini Foundation
Country [3] 292881 0
Australia
Primary sponsor type
Individual
Name
Dr Katherine Walker
Address
Emergency Department
Cabrini
184 Wattletree Rd
Malvern
3144
VIC
Country
Australia
Secondary sponsor category [1] 291624 0
None
Name [1] 291624 0
na
Address [1] 291624 0
na
Country [1] 291624 0
Other collaborator category [1] 278821 0
Individual
Name [1] 278821 0
Dr Margaret Staples
Address [1] 278821 0
Cabrini Institute
184 Wattletree Rd
Malvern
3144
VIC
Country [1] 278821 0
Australia
Other collaborator category [2] 278822 0
Individual
Name [2] 278822 0
Will Dunlop
Address [2] 278822 0
Emergency Department
Cabrini
184 Wattletree Rd
Malvern
3144
VIC
Country [2] 278822 0
Australia
Other collaborator category [3] 278823 0
Individual
Name [3] 278823 0
Michael Ben-Meir
Address [3] 278823 0
Emergency Department
Cabrini
184 Wattletree Rd
Malvern
3144
VIC
Country [3] 278823 0
Australia
Other collaborator category [4] 278824 0
Individual
Name [4] 278824 0
Michele Levinson
Address [4] 278824 0
Department of Medicine
Cabrini Institute
184 Wattletree Rd
Malvern
3144
VIC
Country [4] 278824 0
Australia
Other collaborator category [5] 279083 0
Individual
Name [5] 279083 0
Madeline Collings
Address [5] 279083 0
Cabrini Emergency Department
183 Wattletree Rd
Malvern
VIC
3144
Country [5] 279083 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294383 0
Cabrini HREC
Ethics committee address [1] 294383 0
Ethics committee country [1] 294383 0
Australia
Date submitted for ethics approval [1] 294383 0
10/03/2016
Approval date [1] 294383 0
02/05/2016
Ethics approval number [1] 294383 0
CHREC 02-06-06-16

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 877 877 0 0
/AnzctrAttachments/369972-CHREC 02-06-06-16.pdf

Contacts
Principal investigator
Name 62946 0
Mr Lachlan James Philip Hegarty
Address 62946 0
Emergency Department
Cabrini
183 Wattletree Rd
Malvern
3144
VIC
Country 62946 0
Australia
Phone 62946 0
+61418188037
Fax 62946 0
Email 62946 0
[email protected]
Contact person for public queries
Name 62947 0
Katie Walker
Address 62947 0
Emergency Department
Cabrini
183 Wattletree Rd
Malvern
3144
VIC
Country 62947 0
Australia
Phone 62947 0
+61431272262
Fax 62947 0
Email 62947 0
[email protected]
Contact person for scientific queries
Name 62948 0
Lachlan Heagrty
Address 62948 0
Emergency Department
Cabrini
183 Wattletree Rd
Malvern
3144
VIC
Country 62948 0
Australia
Phone 62948 0
+61418188037
Fax 62948 0
Email 62948 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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