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Trial registered on ANZCTR
Registration number
ACTRN12624001115527
Ethics application status
Approved
Date submitted
27/08/2024
Date registered
17/09/2024
Date last updated
17/09/2024
Date data sharing statement initially provided
17/09/2024
Type of registration
Retrospectively registered
Titles & IDs
Public title
A pilot study to assess the utility of a ‘sterile cockpit’ on the quality of the Surgical Ward Round
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Scientific title
A pilot study to assess the utility of a ‘sterile cockpit’ to improve quality of the Surgical Ward Round in patients 18 and over
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Secondary ID [1]
312822
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Surgery
334908
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Condition category
Condition code
Public Health
331455
331455
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0
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Health service research
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Surgery
331597
331597
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0
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Other surgery
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The ‘sterile cockpit’ intervention will involve enforcing no interruptions/distractions and essential activities only in the ward round, it also involves asking the nursing and allied health staff if they had any questions or concerns, and asking the scribe to repeat back the plan at the end.
Patients involved in this study receive normal surgical care throughout the duration of their stay from all members of the team (nursing staff, allied health, doctors). All staff will be trained in the 'Sterile Cockpit' design, and patients in the intervention group will experience a modified rounding experience. This 'Sterile Cockpit' design seeks to focus the doctors discussion more on the patient, and does not change the normal process that would occur in the ward round. To assess the intervention, investigators perform medical case note review, and compare the case notes to audio-visual footage of the spoken discussion. This study is not randomised and was selected based on convenience sampling. Therefore, all patients who did not have gastroenteritis, were not on contact precautions and were over the age of 18 with the capacity to consent were approached and asked about their participation in the trial.
For the Sterile Cockpit intervention, an education session was given to all members of staff one week before the intervention began. This consisted of a 20 minute presentation, followed by 10 minutes of question time.This involved a powerpoint presentation of the problems, aims, and step-by step methodology of how to conduct the Sterile Cockpit. Staff were consistently reminded by study investigators to adhere to the Sterile Cockpit design. The only physicial material that was used was a 'Do Not Disturb' sign which was placed outside the patients door while the team was speaking to the patient.
The intervention was carried out by any member that was on the Surgical team (nursing staff, dietician, intern, RMO, Registrar, consultants) with the team leader (most senior in the group) taking on the responsibility to ensure that the Sterile Cockpit ran smoothly. The Intervention was performed every day consecutively in person until the target number (n=70, as per biostatistician power calculation) was achieved. A patient was exposed to the 'Sterile Cockpit' ward round each day during their inpatient admission. Each morning, the team would check with the patient that they were still happy to participate. The ward rounds run every morning for approximately one hour.
To measure adherence of the intervention, study investigators collected the following datapoints from the audio-visual recording: 'whether the nurse was present',
whether the nurse or allied health team was asked for their input', 'the number of parallel conversations', ' the number of distractions' and if the intern repeated back the plan to the team at the end.
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Intervention code [1]
329364
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Behaviour
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Comparator / control treatment
A regular general Surgery ward round involves the team meeting at 8am, and rounding on each of the patients in their care. The point of this is to assess the patients progress, answer any questions they may have, and plan for discharge. In a surgical ward round, doctors usually visit each patient for 3-10 minutes, and have a varying number of people in the room.
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Control group
Active
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Outcomes
Primary outcome [1]
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Length of stay
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Assessment method [1]
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Using the patient medical record
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Timepoint [1]
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This was collected at the cessation of the study after all patients had been discharged from hospital.
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Secondary outcome [1]
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Patient Satisfaction
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Assessment method [1]
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8-point likert scale
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Timepoint [1]
439065
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A patient satisfaction survey was given to patients immediately after each ward round (once the surgical team has left the room) by investigators. The results were calculated at the cessation of the study, after all patients had been discharged from hospital.
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Eligibility
Key inclusion criteria
Patients admitted to a Surgical Ward at The Queen Elizabeth Hospital and The Royal Adelaide Hospital
Patients 18 years and over.
Any staff member working for the Central Adelaide Local Health Network in the South 2 ward of the Queen Elizabeth Hospital that is amenable to participation in the study.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Declining to participate
Patients who require a translator
Patients held in isolation rooms such as those for multi-resistant organisms, confirmed or potential respiratory tract infections, COVID-19 or gastroenteritis
Patients under the age of 18
Staff members will be excluded if they are not employed by the Central Adelaide Local Health Network, or if they are not amenable to participation
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
25/07/2023
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Date of last participant enrolment
Anticipated
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Actual
17/05/2024
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Date of last data collection
Anticipated
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Actual
27/08/2024
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Sample size
Target
140
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Accrual to date
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Final
141
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Recruitment in Australia
Recruitment state(s)
SA
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Funding & Sponsors
Funding source category [1]
317260
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Other
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Name [1]
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Avant Foundation
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Address [1]
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Country [1]
317260
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Australia
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Primary sponsor type
University
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Name
The University of Adelaide
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Address
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Country
Australia
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Secondary sponsor category [1]
319538
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None
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Name [1]
319538
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Address [1]
319538
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Country [1]
319538
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315996
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Central Adelaide Local Health Network HREC
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Ethics committee address [1]
315996
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https://www.rah.sa.gov.au/research/for-researchers/central-adelaide-local-health-network-human-research-ethics-committee
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Ethics committee country [1]
315996
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Australia
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Date submitted for ethics approval [1]
315996
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06/03/2023
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Approval date [1]
315996
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20/06/2023
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Ethics approval number [1]
315996
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Summary
Brief summary
The aviation industry has been successful in mitigating human error using a ‘Sterile Cockpit’ to reduce interruptions and non-essential activities. The aim of this study was to therefore implement a ‘Sterile Cockpit’ into the surgical ward round, with aims to improve patient outcomes, satisfaction, and documentation of care. The hypothesis of this study is that the Sterile Cockpit intervention will improve the accuracy of documentation of patient care, therefore reducing length of stay, and improving patient satisfaction.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Guy Maddern
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Address
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The University of Adelaide, The Queen Elizabeth Hospital 28 Woodville Rd, Woodville South SA 5011
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Country
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Australia
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Phone
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+61 8 82226750
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Guy Maddern
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Address
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The University of Adelaide, The Queen Elizabeth Hospital 28 Woodville Rd, Woodville South SA 5011
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Country
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Australia
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Phone
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+61 8 82226750
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Guy Maddern
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Address
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The University of Adelaide, The Queen Elizabeth Hospital 28 Woodville Rd, Woodville South SA 5011
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Country
136456
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Australia
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Phone
136456
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+61 8 82226750
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Fax
136456
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Email
136456
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
24134
Ethical approval
388349-(Uploaded-27-08-2024-10-48-22)-17590 Maddern.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.
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