Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001196336
Ethics application status
Approved
Date submitted
11/08/2017
Date registered
16/08/2017
Date last updated
22/12/2021
Date data sharing statement initially provided
25/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Using scripts to improve the state-wide delivery of simulated resuscitation education
Scientific title
Efficacy of a pre-scripted debriefing for improving delivery of paediatric simulation associated with resuscitation education to healthcare staff
Secondary ID [1] 292506 0
Nil known
Universal Trial Number (UTN)
U1111-1200-5733
Trial acronym
PREPARE: PRE-scripted debriefing for Paediatric simulation Associated with Resuscitation Education
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Medical simulation 304362 0
Paediatric resuscitation 304363 0
Recognition and management of the deteriorating child 304364 0
Medical education and training 304365 0
Condition category
Condition code
Public Health 303698 303698 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Multi-centre cluster randomised control trial of scripts versus no scripts for the quality of debrief of medical simulation within a paediatric resuscitation course.

The Recognition and Management of the Deteriorating Paediatric Patient (RMDPP) is a resuscitation course currently delivered at 30 sites in all 16 Hospital and Health Service districts of Queensland, the most decentralised state in Australia. Resuscitation skills are contextualised into 2 simulated scenarios using medical manikins, which run for about 10 minutes. These scenarios are immediately debriefed, which entails staff sitting down with participants and discussing the scenario to make sense of what occurred, what went well and what could be improved upon. Many of the staff at regional sites have limited or no previous experience in debriefing simulated scenarios, which can impact on how effectively they meet the participants’ learning objectives. Each site is supported by staff from Children's Health Queensland, who undertake 2 annual visits. Feedback is provided for debriefing the scenarios in the form of a tool, which has been proven to be objective and reliable.[1] This study specifically looks at whether the addition of a script for debriefing at each of the sites improves the score on the feedback tool for each debrief. The overall goal being to provide consistent training in paediatric resuscitation throughout Queensland to better patient outcomes, particularly in rural and remote locations, where resources are limited.

Intervention
The concept of the debriefing scripts was adapted from the ExPRESS trial and based on the debriefing theory known as “advocacy-inquiry”.[2-4] Our scripts were constructed from each of the scenario’s learning objectives, with a mixture of both crisis resource management and technical issues, which reflect the course skills stations. The scripts are delivered by the faculty at each RMDPP site across Queensland that are randomised to the intervention arm. The duration of the scripted debriefing is around 10 minutes, as per a standard debrief.

Blinding
Blinding is an issue given the potential pattern recognition amongst assessors and is likely to be a limitation of this study. However, it is also probable that experienced debriefers will not stick to the script and may perform debriefs that are harder to recognise. It was noted that in the ExPRESS trial all debriefers held a clipboard that was purported to allow for blinding of the video reviewers to non-scripted versus scripted debriefing, but there was no mention in the study of its effectiveness.[2] This could be replicated in our study but may not mitigate this bias. As this will be a real-world trial, adherence to the script will not be scrutinised.

As a multi-centre randomised controlled trial, sites currently delivering the RMDPP program will be clustered where SToRK staff routinely work, stratified into large and small centres and then randomised into intervention and control groups. Consent will be obtained to video all debriefs undertaken at moderation visits and have these videos scored using the OSAD tool by a common blinded assessor in a physically and temporally removed setting.[1] We will assess the between-arm difference using a mixed– effects linear regression, with treatment arm included as a fixed effect and site as a random effect. This method will account for any within-site correlation in debrief outcomes. We will conduct pre-specified subgroup analyses to account for centre size and faculty debriefing experience.

References:

[1] Arora S, et al. Objective Structured Assessment of Debriefing (OSAD): Bringing science to the art of debriefing in surgery. Annals of Surgery. 2012. 256(6):982-988.

[2] Cheng A et al. Examining Pediatric Resuscitation Education Using Simulation and Scripted Debriefing. A Multicenter Randomized Trial. JAMA Pediatr. 2013; 167(6):528-536.

[3] Rudolph JW, Simon R, Rivard P, Dufresne RL, Raemer DB. Debriefing with good judgment: combining rigorous feedback with genuine inquiry. Anesthesiol Clin. 2007;25(2):361-376.

[4] Rudolph JW, Simon R, Dufresne RL, Raemer DB. There’s no such thing as “non- judgmental” debriefing: a theory and method for debriefing with good judgment. Simul Healthc. 2006;1(1):49-55.
Intervention code [1] 298870 0
Treatment: Other
Comparator / control treatment
Control group is standard debriefing without use of a script
Control group
Active

Outcomes
Primary outcome [1] 303060 0
OSAD score: Objective Structured Assessment of Debriefing
Timepoint [1] 303060 0
OSAD scores will be collected with every debrief
Secondary outcome [1] 337797 0
Verification of OSAD score by an independent reviewer of videoed debrief
Timepoint [1] 337797 0
No specific timeframe (currently unfunded)

Eligibility
Key inclusion criteria
All faculty involved in debriefing the course scenarios at each site will be eligible, regardless of previous experience. All course participants at each site will be eligible to receive the debriefing.

Sites were sorted into large and small centres and then randomised to intervention or control. Large centres will be defined by service to a population equal or greater than 100,000 and small centres will be defined by service to a population less than 100,000.
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Sites without HREC approval.
Faculty who do not consent to the trial.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation in this study was by hospital. Randomisation occurred after hospitals were ranked according to the expected number of paediatric ED presentations annually. Using the ranked list hospitals were formed into pairs. A list of computer-generated random numbers was used to allocate either the intervention or control treatment to the first of each pair; the second in each pair was allocated the alternative treatment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
To identify a clinically important effect of the structured debriefs, with 80% power and alpha=0.05, we are required to conduct 46 scored debriefs in each treatment arm in our trial. To adjust for the clustered nature of the trial, we assume that the median number of faculty debriefing at each site is 4 and conservatively estimate the Intraclass Correlation Coefficient = 0.05. This gives a total number of 53 debrief scores in each treatment arm in order to detect a clinically important between-arm difference. We will assess the between-arm difference using a mixed–effects linear regression, with treatment arm included as a fixed effect and site as a random effect. This method will account for any within-site correlation in debrief outcomes. We will conduct pre-specified subgroup analyses to account for centre size and faculty debriefing experience.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
COVID-19
Date of first participant enrolment
Anticipated
21/08/2017
Actual
21/08/2017
Date of last participant enrolment
Anticipated
31/03/2021
Actual
25/02/2020
Date of last data collection
Anticipated
25/02/2020
Actual
25/02/2020
Sample size
Target
106
Accrual to date
Final
70
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 8758 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment hospital [2] 8759 0
Logan Hospital - Meadowbrook
Recruitment hospital [3] 8760 0
Redland Hospital - Cleveland
Recruitment hospital [4] 8761 0
Caboolture Hospital - Caboolture
Recruitment hospital [5] 8762 0
Redcliffe Hospital - Redcliffe
Recruitment hospital [6] 8763 0
The Prince Charles Hospital - Chermside
Recruitment hospital [7] 8764 0
Gold Coast University Hospital - Southport
Recruitment hospital [8] 8765 0
Ipswich Hospital - Ipswich
Recruitment hospital [9] 8766 0
Toowoomba Hospital - Toowoomba
Recruitment hospital [10] 8767 0
Kingaroy Hospital & Community Health Centre - Kingaroy
Recruitment hospital [11] 8768 0
Stanthorpe Hospital - Stanthorpe
Recruitment hospital [12] 8769 0
Warwick Hospital - Warwick
Recruitment hospital [13] 8770 0
Roma Hospital - Roma
Recruitment hospital [14] 8771 0
Longreach Hospital - Longreach
Recruitment hospital [15] 8772 0
Hervey Bay Hospital - Pialba
Recruitment hospital [16] 8773 0
Bundaberg Hospital - Bundaberg
Recruitment hospital [17] 8774 0
Emerald Hospital - Emerald
Recruitment hospital [18] 8775 0
Rockhampton Base Hospital - Rockhampton
Recruitment hospital [19] 8776 0
Proserpine Hospital - Proserpine
Recruitment hospital [20] 8777 0
Mackay Base Hospital - Mackay
Recruitment hospital [21] 8779 0
Ayr Hospital - Ayr
Recruitment hospital [22] 8780 0
Joyce Palmer Health Service - Palm Island
Recruitment hospital [23] 8781 0
Charters Towers Hospital - Charters Towers
Recruitment hospital [24] 8782 0
Ingham Hospital - Ingham
Recruitment hospital [25] 8783 0
Cairns Base Hospital - Cairns
Recruitment hospital [26] 8784 0
Mareeba Hospital - Mareeba
Recruitment hospital [27] 8785 0
Innisfail Hospital - Innisfail
Recruitment hospital [28] 8786 0
Mount Isa Base Hospital - Mount Isa
Recruitment hospital [29] 8787 0
Thursday Island Hospital - Thursday Island
Recruitment hospital [30] 8788 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [31] 8789 0
Queen Elizabeth II Jubilee Hospital - Coopers Plains
Recruitment hospital [32] 11451 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [33] 11452 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [34] 11453 0
Dalby Hospital Health Service - Dalby
Recruitment hospital [35] 11454 0
Miles Hospital - Miles
Recruitment hospital [36] 11455 0
Goondiwindi Hospital - Goondiwindi
Recruitment hospital [37] 11456 0
Gladstone Hospital - Gladstone
Recruitment postcode(s) [1] 16878 0
4101 - South Brisbane
Recruitment postcode(s) [2] 16879 0
4131 - Meadowbrook
Recruitment postcode(s) [3] 16880 0
4163 - Cleveland
Recruitment postcode(s) [4] 16881 0
4510 - Caboolture
Recruitment postcode(s) [5] 16882 0
4020 - Redcliffe
Recruitment postcode(s) [6] 16883 0
4032 - Chermside
Recruitment postcode(s) [7] 16884 0
4215 - Southport
Recruitment postcode(s) [8] 16885 0
4305 - Ipswich
Recruitment postcode(s) [9] 16886 0
4350 - Toowoomba
Recruitment postcode(s) [10] 16887 0
4610 - Kingaroy
Recruitment postcode(s) [11] 16888 0
4380 - Stanthorpe
Recruitment postcode(s) [12] 16889 0
4370 - Warwick
Recruitment postcode(s) [13] 16890 0
4455 - Roma
Recruitment postcode(s) [14] 16891 0
4730 - Longreach
Recruitment postcode(s) [15] 16892 0
4655 - Pialba
Recruitment postcode(s) [16] 16893 0
4670 - Bundaberg
Recruitment postcode(s) [17] 16894 0
4720 - Emerald
Recruitment postcode(s) [18] 16895 0
4700 - Rockhampton
Recruitment postcode(s) [19] 16896 0
4800 - Proserpine
Recruitment postcode(s) [20] 16897 0
4740 - Mackay
Recruitment postcode(s) [21] 16899 0
4807 - Ayr
Recruitment postcode(s) [22] 16900 0
4816 - Palm Island
Recruitment postcode(s) [23] 16901 0
4820 - Charters Towers
Recruitment postcode(s) [24] 16902 0
4850 - Ingham
Recruitment postcode(s) [25] 16903 0
4870 - Cairns
Recruitment postcode(s) [26] 16904 0
4880 - Mareeba
Recruitment postcode(s) [27] 16905 0
4860 - Innisfail
Recruitment postcode(s) [28] 16906 0
4825 - Mount Isa
Recruitment postcode(s) [29] 16907 0
4875 - Thursday Island
Recruitment postcode(s) [30] 16908 0
4575 - Birtinya
Recruitment postcode(s) [31] 16909 0
4108 - Coopers Plains
Recruitment postcode(s) [32] 23470 0
4102 - Woolloongabba
Recruitment postcode(s) [33] 23471 0
4029 - Herston
Recruitment postcode(s) [34] 23472 0
4405 - Dalby
Recruitment postcode(s) [35] 23473 0
4415 - Miles
Recruitment postcode(s) [36] 23474 0
4390 - Goondiwindi
Recruitment postcode(s) [37] 23475 0
4680 - Gladstone

Funding & Sponsors
Funding source category [1] 297078 0
Hospital
Name [1] 297078 0
Lady Cilento Childrens Hospital
Country [1] 297078 0
Australia
Primary sponsor type
Hospital
Name
Lady Cilento Childrens Hospital
Address
501 Stanley St
South Brisbane, Qld 4101
Country
Australia
Secondary sponsor category [1] 296081 0
None
Name [1] 296081 0
Address [1] 296081 0
Country [1] 296081 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298256 0
Children's Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 298256 0
Ethics committee country [1] 298256 0
Australia
Date submitted for ethics approval [1] 298256 0
29/06/2017
Approval date [1] 298256 0
12/07/2017
Ethics approval number [1] 298256 0
HREC/16/QRCH/83

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

Contacts
Principal investigator
Name 76494 0
Dr Peter James Snelling
Address 76494 0
7F Directorate, Level 7
Lady Cilento Children's Hospital
501 Stanley Street
South Brisbane
Qld 4101
Country 76494 0
Australia
Phone 76494 0
+61730681111
Fax 76494 0
Email 76494 0
[email protected]
Contact person for public queries
Name 76495 0
Peter James Snelling
Address 76495 0
7F Directorate, Level 7
Lady Cilento Children's Hospital
501 Stanley Street
South Brisbane
Qld 4101
Country 76495 0
Australia
Phone 76495 0
+61730681111
Fax 76495 0
Email 76495 0
[email protected]
Contact person for scientific queries
Name 76496 0
Peter James Snelling
Address 76496 0
7F Directorate, Level 7
Lady Cilento Children's Hospital
501 Stanley Street
South Brisbane
Qld 4101
Country 76496 0
Australia
Phone 76496 0
+61730681111
Fax 76496 0
Email 76496 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
Not planned for in the original ethics submission


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.