Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000775910
Ethics application status
Approved
Date submitted
18/05/2020
Date registered
30/07/2020
Date last updated
30/07/2020
Date data sharing statement initially provided
30/07/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does a structured practical disaster training program improve emergency nurses’ confidence and knowledge towards disaster response preparedness?
Scientific title
Does a structured practical disaster training program improve emergency nurses’ confidence and knowledge towards disaster response preparedness?
Secondary ID [1] 300714 0
NIl
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
emergency and disaster health response 317505 0
Condition category
Condition code
Emergency medicine 315604 315604 0 0
Other emergency care
Public Health 315605 315605 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be a group face to face structured education program consisting of 3 sessions.
• Session 1: Disaster Triage/Streaming
• Session 2: Responding to an external disaster event (e.g. bomb explosion / heat wave)
• Session 3: Responding to a Chemical, Biological, Radiological warfare incident.

These sessions have been developed and delivered by the principle investigator who is the Emergency Disaster preparedness and response lead, accredited MIMMS (major incident medical management support) commanders, completed formal AIIMS (Australasian inter service incident manager system) education and academic teaching higher education disaster health. These programs have also been validated by a member of the investigation team who holds a Graduate Diploma in Emergency Response.

Each session will run for approximately 1.5 hours. In these session’s staff will have both lecture style presentation aiming to increase knowledge and understanding of the specific topic response plan and associated skills. As well as practical hands on activities and exercises that will assist staff to consolidate the knowledge and skills.
Participants allocated to the intervention group (Group B) will be required to attend all 3 sessions. In order to make this achievable each session will run multiple times during its allocated month.
Intervention code [1] 317615 0
Other interventions
Comparator / control treatment
the control group will undergo the standard electronic hospital training program that is mandated by the organisation. This is a 30 min online education program that explore emergency response process that staff may be expected to complete. Included in this are assessment questions to consolidate participants knowledge. Participants from both the control and the intervention group will be asked to complete a pre-test survey. The survey will ask them to indicate their level of agreement with statements relating to confidence in preparing for and responding to disaster events using a 5 point Likert scale (1 Strongly disagree through to 5 Strongly Agree). There will also be a number of multiple-choice questions relating to disaster response to assess level of disaster response knowledge.
Control group
Active

Outcomes
Primary outcome [1] 323840 0
Emergency nurses’ confidence to prepare and respond to a disaster incident if one were to occur assessed via a staff survey consisting of a 5 point likart scale.
Timepoint [1] 323840 0
Pre intervention survey will indicate base line confidence and then be compared to a completion of the same survey post intervention. Post intervention survey will be completed by the control group post completion of the on-line training. Post intervention survey will be completed by the intervention group post completion of the last face to face session.
Secondary outcome [1] 383034 0
Emergency nurses’ knowledge to prepare and respond to a disaster incident if one were to occur assessed via a staff survey. This survey consisting of multiple choice questions relating to emergency nurses role in disaster response.
Timepoint [1] 383034 0
Post intervention survey will be completed by the control group post completion of the on-line training. Post intervention survey will be completed by the intervention group post completion of the last face to face session.

Eligibility
Key inclusion criteria
Registered nurses employed in the Alfred Emergency and Trauma Centre
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Nurses working in the Alfred Emergency and Trauma Centre on a casual basis
• New registered nurses who commence employment in the Alfred Emergency & Trauma Centre once the intervention has commenced
• Nurse who have planned leave (e.g. annual, maternity, paternity) during the implementation phase of the intervention
• Emergency Nurses whose working arrangements require them to rotate between both Alfred Emergency & trauma Centre and Sandringham Emergency Department

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization
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
Completed
Date of first participant enrolment
Anticipated
Actual
12/12/2019
Date of last participant enrolment
Anticipated
Actual
15/03/2020
Date of last data collection
Anticipated
Actual
16/05/2020
Sample size
Target
110
Accrual to date
Final
103
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 16700 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 30299 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 305832 0
Hospital
Name [1] 305832 0
Alfred Health
Country [1] 305832 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health
Address
55 Commercial Rd Melbourne VIC 3000
Country
Australia
Secondary sponsor category [1] 306277 0
None
Name [1] 306277 0
Address [1] 306277 0
Country [1] 306277 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305527 0
Alfred Ethics
Ethics committee address [1] 305527 0
Ethics committee country [1] 305527 0
Australia
Date submitted for ethics approval [1] 305527 0
29/10/2019
Approval date [1] 305527 0
11/11/2019
Ethics approval number [1] 305527 0
755/19

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

Contacts
Principal investigator
Name 100674 0
Mr Nathan Durbridge
Address 100674 0
Alfred Health 55 Commercial Rd Melbourne Vic 3000
Country 100674 0
Australia
Phone 100674 0
+610428758500
Fax 100674 0
Email 100674 0
[email protected]
Contact person for public queries
Name 100675 0
Nathan Durbridge
Address 100675 0
Alfred Health 55 Commercial Rd Melbourne Vic 3000
Country 100675 0
Australia
Phone 100675 0
+610428758500
Fax 100675 0
Email 100675 0
[email protected]
Contact person for scientific queries
Name 100676 0
Nathan Durbridge
Address 100676 0
Alfred Health 55 Commercial Rd Melbourne Vic 3000
Country 100676 0
Australia
Phone 100676 0
+610428758500
Fax 100676 0
Email 100676 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• By request to principle investigator by researchers who have submit methodological sound proposal and clear intent of use.

Conditions for requesting access:
• -

What individual participant data might be shared?
• All de-identified survey data

What types of analyses could be done with individual participant data?
• External requests for data and analysis will be assessed on a case by case base.

When can requests for individual participant data be made (start and end dates)?
From:
At the conclusion of the study with no end data

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• By request to principle investigator .
[email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol  [email protected]
Ethical approval  [email protected]


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.