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Trial registered on ANZCTR


Registration number
ACTRN12615000474550
Ethics application status
Approved
Date submitted
10/04/2015
Date registered
14/05/2015
Date last updated
24/05/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Paramedic Initiated Helivac to Tertiary Hospital for Primary Percutaneous Coronary Intervention
Scientific title
Paramedic Initiated Helivac to Tertiary Hospital for Primary Percutaneous Coronary Intervention: A Strategy for Improving Treatment Delivery Times for ST-Elevation Myocardial Infarction Patients.
Secondary ID [1] 286504 0
Nil
Universal Trial Number (UTN)
U1111-1161-7421
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ST-Elevation Myocardial Infarction 294722 0
Condition category
Condition code
Cardiovascular 295011 295011 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This proposed research will be an experimental study trialling a Whangarei-based programme of paramedic initiated helivac of STEMI patients to a tertiary hospital for Primary Percutaneous Coronary Intervention (PPCI) directly from the field. This will be compared to a previous programme where patients were firstly routed through the local receiving hospital's Emergency Department and the decision for patient helivac was made by the treating physician. This programme involves paramedics from St John Ambulance Service, New Zealand’s largest ambulance provider and occurs without physician oversight. It is also the first programme of its kind to be introduced within the country. We hypothesise that adopting such an approach will lead to improved patient outcomes, with reduced hospital admission times compared to previous physician authorised systems. Economic benefits are also likely.

The inclusion criteria for paramedic initiated helivac of STEMI patients from the field to a tertiary hospital from PPCI include:

1. 12-lead ECG with persistent ST-elevation > 1mm in two or more contiguous limbs leads (I, II, III, aVL or aVF) OR ST-elevation > 2mm in two or more contiguous chest leads (V1-V6) including postyerior leads V7-V9.

2. Monitor interpretation indicates >>> Acute MI <<< OR ***ACUTE MI SUSPECTED*** on two consectutive ECGs

3. Normal QRS width (less than or equal to 0.12secs) OR Right Bundle Branch Block identified on 12-lead ECG

4. Symptoms consistent with myocardial ischemia of < 10 hours duration

5. Ambulance transport time from the patient's location to the helicopter base < 15 minutes.

The exclusion criteria for this pathway includes:

1. Left Bundle Branch Block identified on 12-lead ECG

2. History of serious systemic disease e.g. advanced / terminal cancer, severe liver or kidney disease

3. Severe Dementia

4. Severe dependent living i.e. resident of an aged care facility requiring significant assistance with activities of daily living

5. Ongoing cardiac arrest requiring repeated CPR

Note: those patients who are not candidates for helivac will continue to be transported by ambulance to the normal local receiving hospital which is not PCI capable.

The overall intervention period for this study is 46 months.
Intervention code [1] 291599 0
Diagnosis / Prognosis
Intervention code [2] 291600 0
Early detection / Screening
Comparator / control treatment
We will compare two groups of STEMI patients both of which have received PPCI following EMS helicopter transfer from the same non-interventional region but following two different models of patient identification and admission to the Cardiac Catheterisation Lab (CCL). The first group, a historic retrospective cohort, will have received PPCI under a previous model where identification of patient eligibility was first made in the local receiving hospital ED, and admission to the CCL was activated by ED physicians. In contrast, the second group, a prospective cohort, will receive PPCI following direct admission from the field to the CCL by paramedics who will make an autonomous clinical decision as to patient eligibility and will then activate the CCL independently. The difference between these two groups is the ‘experimental intervention’ – an autonomous paramedic referral protocol that authorises this new model of pre-hospital management of STEMI patients eligible for PPCI. This new protocol has been taught to paramedics in an Education Package and it identifies those patients for whom direct admission from the field to the CCL is indicated / contraindicated.

Data for the historical cohort has already been collected following ethics approval on 23/12/2014 and Northland District Health Board approval on 12/09/2014. Data was sourced from the Northland District Healthboard.

Historic data collected was for all patients transported to Auckland City Hospital (ACH) CCL from Northland Base Hospital (NBH) ED via the Northland Emergency Services Trust (NEST) Helicopter Service for PPCI between the period May 1st 2010 and May 1st 2013 as part of the NBH-ED 'Code STEMI' pathway.
Control group
Historical

Outcomes
Primary outcome [1] 294763 0
Primary outcome 1: Time from patient symptom onset and/or call for ambulance assistance until balloon inflation time for PPCI.
Timepoint [1] 294763 0
The timepoint at which this outcome will be assessed will be at the time of PCI balloon inflation.
Primary outcome [2] 294764 0
Primary outcome 2: Patient outcomes - morbidity and all cause mortality as assessed by data linkage to medical records.

Morbidity factors and mortality include:

1. Vessel/s receiving PCI
2. Infarct location
3. Rates of complications post PCI e.g. arrhythmias, bleeding or cardiac arrest
4. Rates of failed PCI plus or minus coronary artery bypass surgery
5. In-hospital and 30-day incidence of death
Timepoint [2] 294764 0
The timepoint at which this outcome will be assessed will be 30 days following patient enrolment.
Primary outcome [3] 294765 0
Primary outcome 3: Patient hospital admission time (days). This outcome will be assessed through patient medical records.
Timepoint [3] 294765 0
The timepoint at which this outcome will be assessed will be at discharge from hospital.
Secondary outcome [1] 314011 0
Secondary outcome 1: Accuracy of Paramedic Application of the new Protocol.

The sensitivity and specificity along with PPV and NPV of the paramedics’ clinical diagnoses will be determined from their identification of patients suitable for PCI or not, and their activation or non-activation of the CCL. This will occur in the prospective cohort. Three independent cardiologists (experts) will review all cases to determine actual field diagnosis. Accuracy of paramedic application of the protocol will be measured against this ‘gold standard’.
In the prospective cohort, the rate of True Positive and True Negative cases, along with Inappropriate Activations, False Positive and False Negative cases will be determined. To clarify further, Inappropriate Activation is defined as ‘patient clinical presentation and/or ECG used to activate CCL does not meet activation criteria or ECG misinterpreted’. False Positive is defined as ‘patient clinical presentation and ECG used to activate CCL does meet activation criteria, but no culprit artery was found and negative biomarkers’. Each of these five cases will be described as proportions of the total number of clinical decisions made. Causes of False Positives and False Negatives will be investigated.
Timepoint [1] 314011 0
Following completion of study at 24 months.

Eligibility
Key inclusion criteria
a) The retrospective cohort (n = 30) will include: all patients at/or greater than 18 years of age who were transported to Auckland City Hospital (ACH) CCL from Northland Base Hospital (NBH) ED via the Northland Emergency Services Trust (NEST) Helicopter Service for PPCI between the period May 1st 2010 and May 1st 2013 as part of the historic Code STEMI programme.

b) The prospective cohort (n = 30) will include: all patients at/or greater than 18 years of age up to 85 years of age who have been transported to ACH-CCL from Whangarei via the NEST Helicopter Service for PPCI between the period December 23rd 2014 and December 23rd 2017 as part of the paramedic STEMI Bypass programme. The study will also investigate all patients transported by road-based paramedics to the NEST helicopter base over the same time period but who were re-directed to NBH-ED following re-assessment by the Flight Intensive Care Paramedic (ICP).
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Key patient exclusion criteria is essentially those that do not meet our inclusion criteria for either the historic or prospective cohort.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be enrolled in the study via two pathways:

1. Historic Cohort: Patients who have been transfered from Whangarei Hospital Emergency Department via ambulance helicopter to Auckland City Hospital CCL for primary PCI following physician referal, or

2. Prospective Cohort: Whangarei-based patients transported via ambulance helicopter to Auckland City Hospital CCL for primary PCI directly from the field and following autonomous paramedic referal.

Patients in the two observed cohorts will also need to meet the inclusion criteria as previously discussed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
This proposed study has a prospective analysis of differences design. Data from two separate groups of STEMI patients (an historic retrospective cohort and a prospective cohort) will be collected and analysed and a post-intervention comparison made. The Prospective data analysis enables standardisation of measures used in the study and provides stronger confidence in the design. A true experimental design with randomisation was considered neither ethical nor pragmatic due to the impossibility of blinding the protocol application, as well as the lengthy time frame required to reach statistically significant levels of patient numbers. Therefore, our selected design provides a reasonable alternative with efficient use of available patient data. Data will be collected from patient medical records within the Ambulance Service and the receiving hospital. Medical records provide an abundance of information that can be evaluated in context. However, inconsistencies may exist and information may be incomplete. For these reasons we intend to primarily draw on data in the records that are part of gold standard routine assessments conducted on all patients in context with the study.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Based on the autonomous paramedic primary PCI referral study involving 175 patients by Cheskes et al (2011) and an a priori power analysis using their data, 60 patients are required, resulting in 30 patients within each of the two observed groups.. This was assuming a sensitivity of 70%, an accuracy measure of +/- 10%, and a statistical significance level of a = 0.05, denoting a 95% confidence interval.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/12/2014
Actual
24/12/2014
Date of last participant enrolment
Anticipated
23/12/2017
Actual
23/12/2017
Date of last data collection
Anticipated
Actual
23/05/2018
Sample size
Target
60
Accrual to date
Final
92
Recruitment outside Australia
Country [1] 6800 0
New Zealand
State/province [1] 6800 0
Northland

Funding & Sponsors
Funding source category [1] 291072 0
Commercial sector/Industry
Name [1] 291072 0
Clinical Audit and Research Group St John Ambulance Service NewZealand
Country [1] 291072 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology (AUT)
Address
Auckland University of Technology (AUT)
Research and Innovation Office
Private Bag 92006
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 289752 0
Commercial sector/Industry
Name [1] 289752 0
Clinical Audit and Research Group St John Ambulance Service New Zealand
Address [1] 289752 0
c/o

Dr Craig Ellis
Deputy Medical Director
Department: Clinical Development

Mailing address:

St John
62 Tait Drive
Napier 4112
New Zealand
Country [1] 289752 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292656 0
Health and Disability Ethics Committee (HDEC)
Ethics committee address [1] 292656 0
Ethics committee country [1] 292656 0
New Zealand
Date submitted for ethics approval [1] 292656 0
Approval date [1] 292656 0
23/12/2014
Ethics approval number [1] 292656 0
14/NTA/221
Ethics committee name [2] 292657 0
Auckland University of Technology Ethics Committee (AUTEC)
Ethics committee address [2] 292657 0
Ethics committee country [2] 292657 0
New Zealand
Date submitted for ethics approval [2] 292657 0
Approval date [2] 292657 0
10/02/2015
Ethics approval number [2] 292657 0
15/04

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

Contacts
Principal investigator
Name 56418 0
Mr Paul Davis
Address 56418 0
c/o St John Ambulance
43 Western Hills Drive
Kensington 0112
WHANGAREI
Country 56418 0
New Zealand
Phone 56418 0
+0064 09 437 2199
Fax 56418 0
Email 56418 0
paul.davis@stjohn.org.nz
Contact person for public queries
Name 56419 0
Paul Davis
Address 56419 0
c/o St John Ambulance
43 Western Hills Drive
Kensington 0112
WHANGAREI
Country 56419 0
New Zealand
Phone 56419 0
+0064 09 437 2199
Fax 56419 0
Email 56419 0
paul.davis@stjohn.org.nz
Contact person for scientific queries
Name 56420 0
Paul Davis
Address 56420 0
c/o St John Ambulance
43 Western Hills Drive
Kensington 0112
WHANGAREI
Country 56420 0
New Zealand
Phone 56420 0
+0064 09 437 2199
Fax 56420 0
Email 56420 0
paul.davis@stjohn.org.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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