Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001128583
Ethics application status
Approved
Date submitted
27/08/2024
Date registered
18/09/2024
Date last updated
18/09/2024
Date data sharing statement initially provided
18/09/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Lost in Transcription – How accurately are we documenting the surgical ward round?
Scientific title
Lost in Transcription – How accurately are we documenting the surgical ward round in patients admitted to the Department of Surgery at The Queen Elizabeth Hospital?
Secondary ID [1] 312821 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgery 334907 0
Condition category
Condition code
Surgery 331454 331454 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
General Surgical Patients admitted to South 2 Ward of the Queen Elizabeth Hospital were enrolled in this study. Patients were audio-visually recorded using a small camera during ward rounds. The videos were then transcribed verbatim and compared to the patient case notes retrospectively to assess how accurately the notes captured the discussions had and decisions made. Observations that were being collected involved, number of times patient asked a question and duration of speaking time from the patient. Patients were note asked to complete any questionaries. The overall time of observation was for the duration of the surgical ward round which usually lasted between 2 and 10 minutes. The video recording started when the surgical team walked in, and was stopped as soon as the last member left.
Intervention code [1] 329363 0
Not applicable
Comparator / control treatment
General Surgical Patients admitted to South 2 Ward of the Queen Elizabeth Hospital.

During this study, patients act as their own control as the audio-visual recording will be compared to the patient case notes.
Control group
Active

Outcomes
Primary outcome [1] 339203 0
Documentation accuracy of patient case notes
Timepoint [1] 339203 0
The documentation accuracy was assessed once all video recordings were captured and all patients had left the hospital.
Secondary outcome [1] 439064 0
Length of stay
Timepoint [1] 439064 0
Patient length of stay was assessed at hospital discharge.

Eligibility
Key inclusion criteria
Patients will be eligible and approached by study investigators if admitted to the South 2 ward of The Queen Elizabeth Hospital, over the age of 18 and under the care of clinician(s) enrolled in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The absence of informed consent, either by lack of capacity or rejection of participation. Non-English speaking patients will also be excluded

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

To address the primary objective, of determining how accurate patient case notes were, the number of Major, Minor and Not significant points in each audio-visual recording were tallied. To address the secondary objective, to determine what factors affected the accuracy of case note documentation, two multivariable linear mixed-effect models were performed between outcomes which were determined on an a priori basis determined by the literature: Percentage of ‘Major’ and ‘Minor’ and the covariates: patient age, location (rural or metropolitan hospital), patient sex (male, female), day of the week of the encounter, length of stay at the time of the ward round, clinician experience, and clinician time spent on the unit. The implementation of the checklist intervention was also included as a covariate to measure its effect on case note documentation. An Intraclass Correlation Coefficient (ICC) was calculated, and clustering was adjusted for using a random effect on the group that produced the highest ICC.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
12/05/2020
Date of last participant enrolment
Anticipated
Actual
1/07/2023
Date of last data collection
Anticipated
Actual
12/05/2024
Sample size
Target
140
Accrual to date
Final
135
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 27006 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 43080 0
5011 - Woodville

Funding & Sponsors
Funding source category [1] 317259 0
Other
Name [1] 317259 0
Avant Foundation
Country [1] 317259 0
Australia
Primary sponsor type
University
Name
The University of Adelaide
Address
Country
Australia
Secondary sponsor category [1] 319537 0
None
Name [1] 319537 0
Address [1] 319537 0
Country [1] 319537 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315995 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 315995 0
Ethics committee country [1] 315995 0
Australia
Date submitted for ethics approval [1] 315995 0
09/04/2020
Approval date [1] 315995 0
12/05/2020
Ethics approval number [1] 315995 0
12993

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

Contacts
Principal investigator
Name 136450 0
Prof Guy Maddern
Address 136450 0
The University of Adelaide, The Queen Elizabeth Hospital, 28 Woodville Rd, Woodville South SA 5011
Country 136450 0
Australia
Phone 136450 0
+61 8 82226750
Fax 136450 0
Email 136450 0
guy.maddern@adelaide.edu.au
Contact person for public queries
Name 136451 0
Guy Maddern
Address 136451 0
The University of Adelaide, The Queen Elizabeth Hospital, 28 Woodville Rd, Woodville South SA 5011
Country 136451 0
Australia
Phone 136451 0
+61 8 82226750
Fax 136451 0
Email 136451 0
guy.maddern@adelaide.edu.au
Contact person for scientific queries
Name 136452 0
Guy Maddern
Address 136452 0
The University of Adelaide, The Queen Elizabeth Hospital, 28 Woodville Rd, Woodville South SA 5011
Country 136452 0
Australia
Phone 136452 0
+61 8 82226750
Fax 136452 0
Email 136452 0
guy.maddern@adelaide.edu.au

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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24182Ethical approval    388348-(Uploaded-10-09-2024-09-05-38)-12993 Maddern CALHN Ethics and Governance Approval Letter.pdf


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.