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Trial registered on ANZCTR


Registration number
ACTRN12614000394640
Ethics application status
Date submitted
29/03/2014
Date registered
10/04/2014
Date last updated
15/05/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Autonomous Paramedic Referral for Primary Percutaneous Coronary Intervention: A new Approach in the Management of ST-Elevation Myocardial Infarction Patients.
Scientific title
Autonomous Paramedic Referral for Primary Percutaneous Coronary Intervention: A new approach in the management of ST-elevation myocardial infarction patients to determine if this new model may improve treatment delivery times, patient outcomes and reduce hospital admission times.
Secondary ID [1] 284360 0
Nil Known
Universal Trial Number (UTN)
U1111-1155-1119
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ST-Elevation Myocardial Infarction 291519 0
Condition category
Condition code
Cardiovascular 291890 291890 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This proposed research will be an experimental study trialling an autonomous paramedic model for field activation of the cardiac catheterisation lab (CCL) within St John Ambulance Service, New Zealand’s largest ambulance provider, without physician oversight and authorisation. We hypothesise that adopting such an approach will lead to improved patient outcomes, with reduced hospital admission times compared to the existing physician authorised systems. Economic benefits are also likely.

The criteria for autonomous paramedic CCL activation include:

1. DEFINITE STEMI ONLY: Paramedic and heart monitor interpretation of STEMI (>>> Acute MI <<<)

2. ST elevation equal to or greater than 1mm in two or more limbs leads (I, II, III, aVL or aVF) or

3. ST elevation equal to or greater than 2mm in two or more contiguous chest leads (V1-V6) AND

4. Symptoms consistent with myocardial ischemia of less than 12hrs duration AND

5. Transport time to hospital less than 60 minutes from time of diagnosis

The exclusion criteria include:

*Severe Dementia

*Severe dependent living

*On-going cardiac arrest requiring repeated or continual CPR/ACLS (go to ED). Can proceed on STEMI Bypass if a single shock is required to obtain ROSC.

CCL Activation Procedure:

*Provide an early radio call to the receiving Coronary Care Unit from the scene prior to transport.

*Ensure to provide your approximate ETA and the patients NHI number if known.

*Minimise scene time (GOAL Scene Time <15 minutes)

*Continue to manage patient as per the Clinical Practice Guidelines

The overall duration of the intervention period is 20 months.
Intervention code [1] 289089 0
Early detection / Screening
Intervention code [2] 289127 0
Diagnosis / Prognosis
Comparator / control treatment
We will compare two groups of STEMI patients both of which have received percutaneous coronary intervention (PCI) but following two different models of patient identification and admission to the CCL. The first group, a historic retrospective cohort, will have already received PCI under the existing model where identification of patient eligibility was first made in the Emergency Department, and admission to the CCL was activated by Emergency Department physicians. In contrast, the second group, a prospective cohort, will receive PCI following direct admission from the field to the CCL by paramedics who make an autonomous clinical decision as to patient eligibility and then activate the CCL independently. The difference between these two groups is the ‘intervention’ – the new autonomous paramedic CCL activation protocol that permits this new model of pre-hospital intervention for STEMI patients eligible for PCI.

Data for the historic cohort will be collected from patient medical records within the Ambulance Service and the receiving hospital. This will be from within a 36 month period from October 2008 to October 2011.
Control group
Historical

Outcomes
Primary outcome [1] 291811 0
Primary outcome 1: Time from patient symptom onset and/or call for
ambulance assistance until PCI balloon inflation
Timepoint [1] 291811 0
The timepoint at which this outcome will be assessed will be at the time of PCI balloon inflation.
Primary outcome [2] 291812 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] 291812 0
The timepoint at which this outcome will be assessed will be 30 days following patient enrolment.
Primary outcome [3] 291813 0
Primary outcome 3: Patient hospital admission time (days).
Timepoint [3] 291813 0
The timepoint at which this outcome will be assessed will be at discharge from hospital.
Secondary outcome [1] 307599 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] 307599 0
Following completion of study at 20 months.

Eligibility
Key inclusion criteria
a) The retrospective cohort (n = 72) will include: all patients at/or greater than 18 years of age who were transported to Auckland City Hospital Emergency Department via an ambulance paramedic crew over the last two years; who received an Emergency Department diagnosis of STEMI; and who received primary PCI.

b) The prospective cohort (n = 72) will include all patients at/or greater than 18 years of age transported to Auckland City Hospital CCL following autonomous paramedic CCL activation over a prospective 20 month period in-line with protocol criteria. The study will also investigate all patients transported by paramedics to Auckland City Hospital without autonomous paramedic CCL activation, but who went on to receive primary PCI following an Emergency Department diagnosis of STEMI, during the same 20 month period.
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 if they have been transported by ambulance paramedics to hospital and have recieved primary PCI following activation of the CCL following either the physician-authorised telemetry model, or
autonomous paramedic model. 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
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
Efficacy
Statistical methods / analysis
Based on the paramedic CCL activation study involving 175 patients by Cheskes and colleagues and an a priori power analysis using their data, 143 patients are required, resulting in 72 patients within each of the two observed groups. This was assuming a statistical significance level of alpha = 0.05, denoting a 95% confidence interval, a power of 0.80 and an expected effect size of 0.30.

The current version of SPSS statistical software will be used for statistical analysis and the significance level will be set at 0.05. Initial analysis will be primarily descriptive, producing frequencies, mean and standard deviations, or medians and interquartile ranges where relevant and testing for normal distributions of continuous measures e.g. time between events. If normality is not achieved, transformations such as the log of measure will be examined.

To test Hypothesis One, the rates of True Positive and True Negative cases, along with Inappropriate Activations and False Negative cases will be identified. The sensitivity, specificity, PPVs and NPVs of paramedic protocol application will then be calculated. This will be achieved by use of a frequency score and subsequent presentation of results utilising a frequency distribution table, with comparison of scores to the standard (a dummy variable) as determined by three independent cardiology consultants (experts).

In order to test Hypothesis Two, both observed groups will initially be compared using Chi-squared tests and comparisons of medians will be made using Mann-Whitney U tests. Primary analyses will compare the two groups using logistic regression for dichotomous outcome measures such as mortality, and general linear models for continuous measures such as length of hospital stay.

Confounders such as time to PCI, time to hospital, patient demographics, time of day and severity of condition will also be examined. Presentation characteristics of patients before and after initiation of the intervention will be compared (e.g. demographics, distance from hospital, presentation symptoms). If significant differences are present, those characteristics will be added as covariates to the model after examination for potential correlations.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
30/09/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
143
Accrual to date
Final
Recruitment outside Australia
Country [1] 5942 0
New Zealand
State/province [1] 5942 0
Auckland

Funding & Sponsors
Funding source category [1] 288999 0
Commercial sector/Industry
Name [1] 288999 0
Clinical Audit and Research Group

St John Ambulance Service

NewZealand
Country [1] 288999 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] 287679 0
Commercial sector/Industry
Name [1] 287679 0
Clinical Audit and Research Group

St John Ambulance Service

New Zealand
Address [1] 287679 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] 287679 0
New Zealand

Ethics approval
Ethics application status
Ethics committee name [1] 290809 0
Health and Disability Ethics Committee (HDEC)
Ethics committee address [1] 290809 0
Ethics committee country [1] 290809 0
New Zealand
Date submitted for ethics approval [1] 290809 0
01/05/2014
Approval date [1] 290809 0
Ethics approval number [1] 290809 0
Ethics committee name [2] 290810 0
Auckland University of Technology Ethics Committee (AUTEC)
Ethics committee address [2] 290810 0
Ethics committee country [2] 290810 0
New Zealand
Date submitted for ethics approval [2] 290810 0
01/05/2014
Approval date [2] 290810 0
Ethics approval number [2] 290810 0

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

Contacts
Principal investigator
Name 47350 0
Mr Paul Davis
Address 47350 0
St John Ambulance Service

39C Ketenikau Road
Kamo
Whangarei 0112
Country 47350 0
New Zealand
Phone 47350 0
+64 021 295 0951
Fax 47350 0
Email 47350 0
[email protected]
Contact person for public queries
Name 47351 0
Paul Davis
Address 47351 0
c/o

St John Ambulance
43 Western Hills Drive
Kensington 0112
WHANGAREI
Country 47351 0
New Zealand
Phone 47351 0
+64 021 295 0951
Fax 47351 0
Email 47351 0
[email protected]
Contact person for scientific queries
Name 47352 0
Paul Davis
Address 47352 0
c/o

St John Ambulance
43 Western Hills Drive
Kensington 0112
WHANGAREI
Country 47352 0
New Zealand
Phone 47352 0
+64 021 295 0951
Fax 47352 0
Email 47352 0
[email protected]

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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