Public Access Defibrillation (PAD) Community Trial

April 13, 2016 updated by: National Heart, Lung, and Blood Institute (NHLBI)
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

No eligibility criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1999

Study Completion

February 1, 2004

Study Registration Dates

First Submitted

February 9, 2000

First Submitted That Met QC Criteria

February 9, 2000

First Posted (Estimate)

February 10, 2000

Study Record Updates

Last Update Posted (Estimate)

April 14, 2016

Last Update Submitted That Met QC Criteria

April 13, 2016

Last Verified

November 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 128

Plan for Individual participant data (IPD)

Study Data/Documents

  1. Individual Participant Data Set
    Information identifier: PAD
    Information comments: NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.
  2. Study Forms

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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