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Trial registered on ANZCTR


Registration number
ACTRN12616001456448
Ethics application status
Approved
Date submitted
17/10/2016
Date registered
18/10/2016
Date last updated
18/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The Trial of Emergency Medicine Protocols In Simulation Sraining (TEMPIST) study
Scientific title
Effectiveness of the Handbook of Emergency Protocols on adherence to current resuscitation guidelines compared to no handbook among medical and nursing staff in a simulated environment: a block randomised controlled trial.
Secondary ID [1] 290267 0
Nil
Universal Trial Number (UTN)
Trial acronym
TEMPIST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Resuscitation 300496 0
Condition category
Condition code
Injuries and Accidents 300356 300356 0 0
Other injuries and accidents
Public Health 300480 300480 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In the TEMPIST study we will evaluate the standard list of emergency guidelines in current use in Australia. The Handbook of Emergency Medicine Protocols has been designed as a cognitive aid for medical staff who have to manage medical emergencies that are both life threatening and time critical. Current protocols have been reformatted as simple, single step by step pathways, The content of the protocols has not been altered. Careful consideration has been given to the graphic design, text, diagrams and fonts used on each page, following consultation with experts from the aviation industry who design pilot manuals. Instructions are delivered in an easy to follow, step by step format designed to be read out loud during a resuscitation event.

The TEMPIST trial will investigate the feasibility of using the Handbook Emergency Protocols during simulated medical emergencies.

Objective: The aim of this study is to determine whether the use of the Handbook of Emergency Protocols leads to, or detracts from, the provision of correct care, in accordance with current Australian and New Zealand Resuscitation Committee guidelines.

The research will be conducted in a high fidelity simulation laboratory. Study participants will be asked to manage four simulated emergency medicine scenarios. Groups of medical staff will be asked to manage four simulated emergency medicine scenarios. Groups will receive either the Checklist scenario or usual care. Each group will manage two scenarios with the emergency protocol handbook and two scenarios using only the wall charts and drug administration handbooks that are found in every Australian Emergency Department. Each group will perform each scenario only once, either with or without the emergency protocol handbook.

The Groups will be randomly assigned, using a computer generated number table, to manage the emergency scenario, with or without, the Handbook of Emergency Protocols.

Each group will be given a verbal prompt leading into the scenario and advised whether the protocol book will or will not be available. Each group will then be asked to manage the emergency scenario within the simulation laboratory. Each scenario will be conducted in the simulation laboratory with a set up designed to replicate a resuscitation bay in an Emergency Department. High fidelity manikins will be used and the room will contain standard patient monitoring and resuscitation equipment.

The group being studied will be given a brief clinical prompt and then advised to proceed with the resuscitation. Initial observations (Pulse, BP, ECG rhythm, Oxygen saturation) will be exactly the same, each time the scenario is performed. A video recording will be made of the resuscitation effort. If a group fails to intervene in a timely manner, the simulated patient will be programmed to deteriorate clinically. Correct interventions will be reflected by improving clinical observations where relevant. Each scenario will be limited to a 15 minute duration.

The four scenarios are:
1. Paediatric seizure
2. Adult pulseless ventricular tachycardia
3. Newborn resuscitation
4. Tricyclic antidepressant overdose.

The patient will be a simulation manikin (Sim man 3G). The trial groups will be made up from doctors and nurses with a mixed level of emergency medical training. It is expected that use of the handbook will be at least as effective as current models of care.

At the end of all 4 clinical scenarios, participants will be asked to fill out a questionnaire to evaluate their subjective experience of using the emergency protocol handbook and to try and identify potential hurdles to its adoption.


Intervention code [1] 296066 0
Behaviour
Comparator / control treatment
The same as the intervention group but without the handbook.
Control group
Active

Outcomes
Primary outcome [1] 299813 0
There are 4 scenarios. .Each scenario will be recorded on video and the primary outcome measures will be a list of 15 predetermined tasks that are expected to be completed within the 15 minute time frame. Thus across four scenarios, each team will be measured on a total of 60 key processes for adherence (yes or no) with half the processes for a given team with the handbook available. Two clinicians will observe the video recorded data and rate whether the group has performed the required tasks.
Timepoint [1] 299813 0
After completing all four simulation training scenarios.
Secondary outcome [1] 328193 0
Completion of the questionnaire specifically designed for this study. The composite secondary outcome measure will look at the quality and usefulness of the sessions. These will be scored on a five-point Likert scale.
Timepoint [1] 328193 0
After completing all four simulation training scenarios.
Secondary outcome [2] 328511 0
Completion of the questionnaire specifically designed for this study. The composite secondary outcome measure will look at the quality and usefulness of the protocols These will be scored on a five-point Likert scale.
Timepoint [2] 328511 0
After completing all four simulation training scenarios.

Eligibility
Key inclusion criteria
Doctors and Nurses from the Local Health District who are already attending resuscitation training courses at the UCRH or volunteer to participate in their own time. It is anticipated that groups will vary in their preexisting skill level and level of experience.

Inclusion criteria:
* Recruited staff will need to have worked within an Australian Emergency Department within the last 12 months.
* Age 18 or above.

Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria:
* Nursing and Medical Students will be excluded from the trial.
Study personnel will be excluded.

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)
Study participants will be recruited from qualified medical and nursing staff who have expressed interest in participating in education and training sessions within the simulation laboratory. Potential participants will receive an information sheet regarding the trial. They will have opportunity to discuss trial participation with the investigators. If they decide to participate they will be required to sign a consent form.
Study participants will then be asked to manage four simulated emergency medicine scenarios. The Groups will be randomly assigned, using a computer generated number table, to manage the emergency scenario, with or without, the Handbook of Emergency Protocols.
A biostatistician, with no clinical involvement in the trial, will create a computer generated randomization sequence using a Microsoft Excel spread sheet random number generator. The researchers will prepare sequentially numbered, opaque envelopes enclosing the list of scenarios (identified by their number only) and the groups allocation as to whether they are to perform the scenario with or without the protocol book.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The simulation laboratory staff member running the workshop will assign the envelopes in numerical sequence to the groups, once they have agreed to participate in the study. This staff member will be ignorant towards the allocation contained in the envelope to prevent selection bias. The envelope will be opened by a member of the study group just prior to commencement of the scenario. Each group will be given a verbal prompt leading into the
scenario and advised whether the protocol book will or will not be available.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 6770 0
Lismore Base Hospital - Lismore
Recruitment hospital [2] 6771 0
Casino and District Memorial Hospital - Casino
Recruitment hospital [3] 6772 0
Grafton Base Hospital - Grafton
Recruitment hospital [4] 6773 0
Ballina District Hospital - Ballina
Recruitment hospital [5] 6774 0
Byron District Hospital - Byron Bay
Recruitment hospital [6] 6775 0
The Tweed Hospital - Tweed Heads
Recruitment hospital [7] 6776 0
Maclean District Hospital - Maclean
Recruitment postcode(s) [1] 14416 0
2480 - Lismore
Recruitment postcode(s) [2] 14417 0
2470 - Casino
Recruitment postcode(s) [3] 14418 0
2460 - Grafton
Recruitment postcode(s) [4] 14419 0
2478 - Ballina
Recruitment postcode(s) [5] 14420 0
2481 - Byron Bay
Recruitment postcode(s) [6] 14421 0
2485 - Tweed Heads
Recruitment postcode(s) [7] 14422 0
2463 - Maclean

Funding & Sponsors
Funding source category [1] 294638 0
University
Name [1] 294638 0
University Centre for Rural Health
Address [1] 294638 0
61 Uralba Street
Lismore NSW 2480
Country [1] 294638 0
Australia
Funding source category [2] 294639 0
Commercial sector/Industry
Name [2] 294639 0
Laerdal Pty Ltd
Address [2] 294639 0
Laerdal Pty Ltd
PO Box 52
OAKLEIGH VIC 3166
Country [2] 294639 0
Australia
Primary sponsor type
University
Name
University Centre for Rural Health
Address
61 Uralba Street
Lismore NSW 2480
Country
Australia
Secondary sponsor category [1] 293503 0
None
Name [1] 293503 0
Address [1] 293503 0
Country [1] 293503 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296074 0
North Coast New South Wales HREC
Ethics committee address [1] 296074 0
PO Box 821 Murwillumbah NSW 2484
Ethics committee country [1] 296074 0
Australia
Date submitted for ethics approval [1] 296074 0
08/05/2016
Approval date [1] 296074 0
26/07/2016
Ethics approval number [1] 296074 0
LNR138

Summary
Brief summary
The primary purpose of the study is to investigate the feasibility of using the Handbook Emergency Protocols during simulated medical emergencies.

It is expected that use of the handbook of emergency protocols will be at least be as effective as current models of care. It is anticipated that use of these protocols may lead to more accurate adherence to current resuscitation guidelines.

In the TEMPIST study we will evaluate the standard list of emergency guidelines in current use in Australia. All of these guidelines have been reformatted into a step by step, easy to follow format, presented as a Handbook of Emergency Protocols. It is the presentation of this information that has been modified in order to produce a simple cognitive aid for medical staff. Experts from the aircraft industry and graphic designers have been consulted in an attempt to produce a handbook that is free of excessive information and visual distraction. Attention has been given to the colour and size of the text used and diagrams have been designed to be clear and well presented. Instructions are delivered in an easy to follow, step by step format designed to be read out loud during a resuscitation event.

The TEMPIST trial will investigate the feasibility of using the Handbook Emergency Protocols during simulated medical emergencies.

Objective: The aim of this study is to determine whether the use of the Handbook of Emergency Protocols leads to, or detracts from, the provision of correct care, in accordance with current Australian and New Zealand Resuscitation Committee guidelines.

Method : A prospective block randomized controlled trial will be conducted. The research will be conducted in a high fidelity simulation laboratory. Groups of medical staff will be asked to manage four simulated emergency medicine scenarios.Groups will receive either the Checklist scenario or usual
care. Each group will manage two scenarios with the emergency protocol handbook and two scenarios using only the wall charts and drug administration handbooks that are found in every Australian Emergency Department.

Each group will perform each scenario only once, either with or without the emergency protocol handbook. The four scenarios are:
1. Paediatric seizure
2. Adult pulseless ventricular tachycardia
3. Newborn resuscitation.
4. Tricyclic antidepressant overdose.

Each scenario will be recorded on video and the primary outcome measures will be a list of 15 tasks per scenario that are expected to be completed within the 15 minute time frame.

At the end of all 4 clinical scenarios, participants will be asked to fill out a brief questionnaire to evaluate their subjective experience of using the emergency protocol handbook and to try and identify potential hurdles to its adoption.

The patient will be a simulation manikin (Sim man 3G). The trial groups will be made up from doctors and nurses with a mixed level of emergency medical training.
Trial website
EmergencyProtocols.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67942 0
A/Prof Charlotte Hall
Address 67942 0
University Centre for Rural Health, 61 Uralba Street, Lismore NSW 2480
Country 67942 0
Australia
Phone 67942 0
+612 6620 7570
Fax 67942 0
Email 67942 0
Charlotte.hall@ncahs.health.nsw.gov.au
Contact person for public queries
Name 67943 0
A/Prof Charlotte Hall
Address 67943 0
University Centre for Rural Health, 61 Uralba Street, Lismore NSW 2480
Country 67943 0
Australia
Phone 67943 0
+612 6620 7570
Fax 67943 0
Email 67943 0
Charlotte.hall@ncahs.health.nsw.gov.au
Contact person for scientific queries
Name 67944 0
A/Prof Charlotte Hall
Address 67944 0
University Centre for Rural Health, 61 Uralba Street, Lismore NSW 2480
Country 67944 0
Australia
Phone 67944 0
+612 6620 7570
Fax 67944 0
Email 67944 0
Charlotte.hall@ncahs.health.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
No Results