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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
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
Secondary ID [1] 312822 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgery 334908 0
Condition category
Condition code
Public Health 331455 331455 0 0
Health service research
Surgery 331597 331597 0 0
Other surgery

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 329364 0
Behaviour
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.
Control group
Active

Outcomes
Primary outcome [1] 339205 0
Length of stay
Timepoint [1] 339205 0
This was collected at the cessation of the study after all patients had been discharged from hospital.
Secondary outcome [1] 439065 0
Patient Satisfaction
Timepoint [1] 439065 0
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.

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
25/07/2023
Date of last participant enrolment
Anticipated
Actual
17/05/2024
Date of last data collection
Anticipated
Actual
27/08/2024
Sample size
Target
140
Accrual to date
Final
141
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 317260 0
Other
Name [1] 317260 0
Avant Foundation
Country [1] 317260 0
Australia
Primary sponsor type
University
Name
The University of Adelaide
Address
Country
Australia
Secondary sponsor category [1] 319538 0
None
Name [1] 319538 0
Address [1] 319538 0
Country [1] 319538 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315996 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 315996 0
https://www.rah.sa.gov.au/research/for-researchers/central-adelaide-local-health-network-human-research-ethics-committee
Ethics committee country [1] 315996 0
Australia
Date submitted for ethics approval [1] 315996 0
06/03/2023
Approval date [1] 315996 0
20/06/2023
Ethics approval number [1] 315996 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136454 0
Prof Guy Maddern
Address 136454 0
The University of Adelaide, The Queen Elizabeth Hospital 28 Woodville Rd, Woodville South SA 5011
Country 136454 0
Australia
Phone 136454 0
+61 8 82226750
Fax 136454 0
Email 136454 0
[email protected]
Contact person for public queries
Name 136455 0
Guy Maddern
Address 136455 0
The University of Adelaide, The Queen Elizabeth Hospital 28 Woodville Rd, Woodville South SA 5011
Country 136455 0
Australia
Phone 136455 0
+61 8 82226750
Fax 136455 0
Email 136455 0
[email protected]
Contact person for scientific queries
Name 136456 0
Guy Maddern
Address 136456 0
The University of Adelaide, The Queen Elizabeth Hospital 28 Woodville Rd, Woodville South SA 5011
Country 136456 0
Australia
Phone 136456 0
+61 8 82226750
Fax 136456 0
Email 136456 0
[email protected]

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
24134Ethical approval    388349-(Uploaded-27-08-2024-10-48-22)-17590 Maddern.pdf



Results publications and other study-related documents

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