Public Access Defibrillation (PAD) Community Trial
Condition: Arrhythmia; Heart Arrest; Heart Diseases; Myocardial Infarction; Ventricular Fibrillation; Death, Sudden, Cardiac
MeSH terms: Heart Diseases; Myocardial Infarction; Ventricular Fibrillation; Heart Arrest; Death, Sudden, Cardiac; Infarction; Death, Sudden
Study type: Interventional
Phase: Phase 3

Summary: 
      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).
    

Detailed description: 
      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.
    

Intervention name(s): defibrillator
Intervention type(s): Device
Allocation: Randomized
Primary purpose: Treatment