Myocardial Infarction Clinical Trial
To measure survival to hospital discharge of patients with out-of-hospital cardiac arrest in community units (e.g., apartment or office buildings, gated communities, sports venues, senior centers, shopping malls) served by trained non-medical responders using automated external defibrillators (AEDs), an approach called Public Access Defibrillation, compared to units receiving the traditional optimum community standard of care (i.e., rescuers trained to recognize a cardiac emergency, call 911, and initiate CPR).
BACKGROUND:
Sudden out-of-hospital cardiac arrest (OOH-CA) remains a significant cause of death, in
spite of recent declines in overall mortality from cardiovascular disease. Existing methods
of emergency resuscitation are inadequate due to time delays inherent in the transport of a
trained responder with defibrillation capabilities to the side of the OOH-CA victim.
Existing Emergency Medical Services (EMS) systems typically combine paramedic Emergency
Medical Technician (EMT) services with some level of community involvement, such as
bystander cardiopulmonary resuscitation (CPR) training. Some communities include automated
external defibrillators (AEDs) at isolated sites or in mobile police or fire vehicles. Such
an approach typically varies in effectiveness, with an incremental improvement in
effectiveness seen in communities that organize and integrate services with the existing EMS
system. However, optimal improvement in survival from sudden OOH-CA may require a program
that utilizes volunteer non-medical responders (who may not have a traditional duty to
respond to an emergency) who are successfully trained to use AEDs. A comprehensive,
integrated community approach to treatment with AEDs would have community units served by
these volunteer non-medical responders who can quickly identify and treat a patient with
OOH-CA. Such an approach is termed Public Access Defibrillation (PAD).
Some observational studies suggest support for the PAD approach. These studies have targeted
traditional public safety responders such as police and firefighters or other laypersons in
leadership positions who are trained and regularly called upon to take command in an
emergency (e.g., airline flight attendants, security officers in Las Vegas casinos). Other
studies, both randomized and observational, where trainees have been spouses or family
members of at-risk patients, suggest that not all laypersons can effectively utilize AEDs in
the setting of OOH-CA, even with extensive training. This study differs from those conducted
previously by focusing on an intermediate group, namely, volunteer non-medical responders
(e.g., merchants, bank tellers, building superintendents, and co-workers). This study will
provide results that may help to develop informed public policy regarding the use of AEDs by
volunteer non-medical persons.
DESIGN NARRATIVE:
This was a study of a comprehensive, integrated community approach in which volunteer
non-medical responders (lay volunteers without a traditional responsibility to take charge
in medical emergencies as their primary job description) were trained to use automated
external defibrillators (AEDs). This approach is called Public Access Defibrillation (PAD).
The hypothesis investigated was that PAD would significantly increase survival in
out-of-hospital cardiac arrest by reducing the time interval from collapse to
defibrillation. The specific aim of this randomized, controlled trial was to measure
survival to hospital discharge following out-of-hospital cardiac arrest in community units
trained and equipped to provide public access defibrillation in addition to optimal standard
care, compared to community units trained to provide optimal standard care (recognition of
out-of-hospital cardiac arrest, 911 access, cardiopulmonary resuscitation). Secondary aims
included the comparison using Utstein criteria (Annals of Emergency Medicine
1991;20:861-74), neurological status, quality of life, cost, and cost-effectiveness between
the two groups.
Participating research sites identified 1,000 units (e.g., public areas, gated communities,
shopping malls, airport terminals, casinos, business parks) within their service area that
anticipated at least 0.6 treatable out-of-hospital cardiac arrests within a 15 month period.
Each unit was randomized to serve as either an intervention or control group, with
comparative episode data collected for a 15 month period following a short preliminary data
collection period (approximately 2 months to evaluate the ability for the site to capture
event data) after training. Within each site, units were sub-randomized to a retraining
strategy. Performance at retraining was monitored, and strategies modified if indicated.
Volunteer non-medical responders (e.g., office staff, bank tellers, merchants, and
neighborhood volunteers) in both the intervention and control groups will be trained to
provide the optimal standard of care: (a) recognize out-of-hospital cardiac arrest; (b)
access 911 or its equivalent; and, (c) administer CPR. Volunteers in the intervention group
will also be taught to use an AED promptly while awaiting arrival of the first public safety
emergency medical team. The criteria for number and location of trained volunteers and
devices will be a maximum 3-minute "walk through" to have the AED at the patient's side.
Out-of-hospital cardiac arrest victims in each of the two groups will be compared over the
15 month intervention period with respect to their: (a) survival to hospital discharge
(primary outcome); (b) neurological status; (c) quality of life; and, (d) resource
use/costs. The incremental cost-effectiveness of volunteer non-medical responder
defibrillation will be calculated.
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Allocation: Randomized, Primary Purpose: Treatment
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