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Trial registered on ANZCTR


Registration number
ACTRN12622000448741
Ethics application status
Approved
Date submitted
9/03/2022
Date registered
22/03/2022
Date last updated
8/09/2024
Date data sharing statement initially provided
22/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A study on patients in cardiac arrest to determine the effect of equipping GoodSAM responders with an ultraportable defibrillator on 30-day survival
Scientific title
The FIrst Responder Shock Trial (FIRST): A cluster randomised controlled trial of the effect of smartphone-activated first responders with ultraportable defibrillators on 30-day survival in out-of-hospital cardiac arrest (OHCA)
Secondary ID [1] 306597 0
None
Universal Trial Number (UTN)
Trial acronym
FIRST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Out of Hospital Cardiac Arrest (OHCA) 325549 0
Condition category
Condition code
Cardiovascular 322920 322920 0 0
Coronary heart disease
Cardiovascular 322992 322992 0 0
Other cardiovascular diseases
Emergency medicine 322993 322993 0 0
Resuscitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In 2018, Ambulance Victoria and St John Ambulance New Zealand rolled out the Smartphone Activated Medics smartphone application (GoodSAM). GoodSAM application alerts off-duty health professionals, emergency services workers, and public members with CPR training to potential OHCA events in their vicinity, allowing them to respond and deliver life-saving Cardiopulmonary resuscitation (CPR) and defibrillation. Importantly, the app also alerts first responders to the location of a nearby Automated External Defibrillator (AED) if one exists. The GoodSAM app is integrated into the emergency call system (Triple Zero (000) in Australia or Triple One (111) in New Zealand), and if available, GoodSAM responders are activated simultaneously with emergency ambulances in each region, ensuring no additional delays to care. Dispatch of GoodSAM responder results in a loud warning siren being emitted from a first responder’s mobile. GoodSAM responders can either accept or reject an alert, and if no response is received within 20 seconds, the GoodSAM system automatically alerts another nearby responder. To ensure responder safety, the alerts are cancelled if the call-taker suspects the situation is unsafe. GoodSAM responders who accept the alert are provided with the location of the patient and the nearest public access defibrillation (PAD) if available. The GoodSAM responder then may collect the AED (if available) and proceed to the patient to render assistance or proceed directly without an AED.

Registered GoodSAM responders identified as high-frequency responders (clusters) will be randomised 1:1 to receive either a CellAED® or no CellAED®. CellAED® is an ultraportable, fully automated AED that can be carried in a handbag or pocket and is simple to use. High-frequency responders will be defined as GoodSAM responders who have accepted at least 3 OHCA alerts over the last three years. The treatment allocation will remain unchanged over the life of the trial (24 months).

For all high-frequency GoodSAM responders randomised to the CellAED® arm:
1. Responders will receive a CellAED® by post and will be asked to watch a short (10 minute) instructional video on its application. An instructional pamphlet detailing the operation of the CellAED® will also be provided. The instructional video and pamphlet will be designed specifically for the trial. Information regarding the storage and carriage of the CellAED® will be explicitly covered in detail. The CellAED® will be replaced automatically on the date of expiry or after every use.

2. Normal activation procedures will apply according to the region’s default response radius. In Victoria, any local government area with a population >7500 receives up to three GoodSAM activations within 500 metres of the scene location. Less populated areas have an activation radius of 5000 metres. In New Zealand, up to 3 GoodSAM activations occur for responders within 1000 metres of the scene location.

3. Responders will be flagged within the GoodSAM app as having an AED in their possession. In addition, the location of the next closest public access defibrillation (PAD) will be provided during alert activation.

4. For alerts where two or more GoodSAM responders with a CellAED® device accept the alert, one of the responders will still be instructed to retrieve the closest AED according to standard operating procedures.

5. Monthly emails and push notifications will be sent to GoodSAM responders with reminders about the optimal storage and carriage of the CellAED® device. Monitoring adherence of the intervention will be through the Victorian Ambulance Cardiac Arrest Registry (VACAR), and The St John New Zealand OHCA Registry (SOCAR), which routinely collect such information.
Intervention code [1] 323069 0
Treatment: Devices
Comparator / control treatment
For all high-frequency GoodSAM responders randomised to usual protocols (no CellAED®):
1. Normal activation procedures apply according to the region’s default response radius.
2. The location of the closest PAD will be provided during alert activation.
3. For alerts where two or more GoodSAM responders, one will still be instructed to retrieve the next closest PAD prior to arriving on the scene.
Control group
Active

Outcomes
Primary outcome [1] 330691 0
30-day survival to hospital discharge- this data will be obtained from the Victorian Ambulance Cardiac Arrest Registry (VACAR) and St John New Zealand OHCA Registry (SOCAR)
Timepoint [1] 330691 0
Hospital discharge
Secondary outcome [1] 407230 0
Proportion of patients with return of spontaneous circulation (ROSC)- this will be obtained by reviewing VACAR and SOCAR records
Timepoint [1] 407230 0
At the conclusion of the study
Secondary outcome [2] 407231 0
Proportion of patients who survive the event (as determined by pulse present on arrival to hospital by manual assessment and Zoll monitor. This will be obtained by reviewing VACAR and SOCAR records
Timepoint [2] 407231 0
At the conclusion of the study
Secondary outcome [3] 407232 0
Proportion of patients with defibrillation pads applied- this will be obtained by reviewing VACAR and SOCAR records
Timepoint [3] 407232 0
At the conclusion of the study
Secondary outcome [4] 407233 0
Proportion of patients receiving bystander defibrillation- this will be obtained by reviewing VACAR and SOCAR records
Timepoint [4] 407233 0
At the conclusion of the study
Secondary outcome [5] 407234 0
Proportion of patients with initially shockable rhythms- this will be obtained by reviewing VACAR and SOCAR records
Timepoint [5] 407234 0
At the conclusion of the study
Secondary outcome [6] 407252 0
Time from emergency call to first shock delivery- this will be obtained by reviewing VACAR and SOCAR records
Timepoint [6] 407252 0
At the conclusion of the study
Secondary outcome [7] 413406 0
Proportion with good functional recovery (Glasgow Outcome Scale Extended Score =7)- this will be obtained by reviewing VACAR and SOCAR records
Timepoint [7] 413406 0
At 12-month post cardiac arrest
Secondary outcome [8] 413407 0
Median Euroqol 5D score.- this will be obtained by reviewing VACAR and SOCAR records
Timepoint [8] 413407 0
12 months post cardiac arrest
Secondary outcome [9] 413408 0
Proportion returning to work (who worked prior to their arrest)- this will be obtained by reviewing VACAR and SOCAR records
Timepoint [9] 413408 0
12 months post cardiac arrest

Eligibility
Key inclusion criteria
All Out-of-hospital cardiac arrest confirmed by emergency medical services (EMS)

Activation of an eligible GoodSAM first responder where the responder accepts the alert and arrives on scene before EMS
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with a Do Not Resuscitate (DNR) order or Advanced Care Directive

Cardiac arrests secondary to trauma or hanging

Locations where scene safety issues apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence generation will be computer-generated (1:1 ratio), with stratification of responder by local government areas.
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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation:
Based on historical data captured by the VACAR and SOCAR (2018-2022), there were 2194 GoodSAM responders with an annual alert accept frequency = 0.5. These responders arrived on scene to 1047 OHCA patients, of which the rate of initially shockable rhythms was 22%, the bystander defibrillation rate was 13% (for initially shockable rhythms), and the 30 day survival rate was 9%. As the majority of eligible responders will only attended one OHCA during the study period, we assumed that the within cluster variation (intraclass correlation coefficient) would be very low or negligible (ICC ~0.01). We aim to detect a 7% increase in the proportion of 30 day survivors, from 9% in control responders to 16% in responders randomised to the CellAED®. With 80% power, an alpha of 0.05, a cluster size of 1.5 and a coefficient of variation for cluster sizes of 1, the sample size required to detect this difference is 714 (357 per arm).

Data analysis:
All patients treated by a participating GoodSAM responder prior to the arrival of EMS comprised the intention-to-treat population for all primary and secondary outcomes. Patients treated by a GoodSAM responder allocated to the CellAED arm at any time before the arrival of EMS (in the case of multiple responders) will be allocated to the intervention arm. Data analyses will be performed by an independent biostatistician. Variables that approximate a normal distribution will be summarised as mean ± standard deviation, and groups compared using t-tests. Non-normal variables will be summarised as median and first and third quartiles (Q1, Q3), and groups compared using Mann-Whitney rank sum tests with exact inference. Binomial variables will be expressed as proportions and 95% confidence intervals (exact binomial) and groups compared using the chi-squared test. The primary outcome will be examined using mixed-effects logistic regression analysis, controlling for clustering by responder. If the intraclass correlation coefficient is deemed to be negligible (<0.01), simple logistic regression will be used instead.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2022
Actual
6/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
714
Accrual to date
281
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment outside Australia
Country [1] 24650 0
New Zealand
State/province [1] 24650 0

Funding & Sponsors
Funding source category [1] 310932 0
Charities/Societies/Foundations
Name [1] 310932 0
Heart Foundation
Country [1] 310932 0
Australia
Primary sponsor type
Government body
Name
Ambulance Victoria
Address
31 Joseph Street
Blackburn North VIC 3130
Country
Australia
Secondary sponsor category [1] 312226 0
Charities/Societies/Foundations
Name [1] 312226 0
St John Ambulance (New Zealand)
Address [1] 312226 0
604 Great South Road,
Ellerslie, Auckland, 1051
Country [1] 312226 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310488 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [1] 310488 0
Ethics committee country [1] 310488 0
Australia
Date submitted for ethics approval [1] 310488 0
07/03/2022
Approval date [1] 310488 0
11/04/2022
Ethics approval number [1] 310488 0

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

Contacts
Principal investigator
Name 117846 0
Dr Ziad Nehme
Address 117846 0
Ambulance Victoria
31 Joseph Street
Blackburn North VIC 3031
Country 117846 0
Australia
Phone 117846 0
+61 3 9896 6091
Fax 117846 0
Email 117846 0
[email protected]
Contact person for public queries
Name 117847 0
Ziad Nehme
Address 117847 0
Ambulance Victoria
31 Joseph Street
Blackburn North VIC 3031
Country 117847 0
Australia
Phone 117847 0
+61 3 9896 6091
Fax 117847 0
Email 117847 0
[email protected]
Contact person for scientific queries
Name 117848 0
Daniel Okyere
Address 117848 0
Ambulance Victoria
31 Joseph Street
Blackburn North VIC 3031
Country 117848 0
Australia
Phone 117848 0
+61 418 962 824
Fax 117848 0
Email 117848 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
20555Study protocol https://authors.elsevier.com/sd/article/S2666520423001091 



Results publications and other study-related documents

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