At-Home Automated External Defibrillator (AED) Training Study

Home Automatic External Defibrillator Training for High-Risk Patients

The purpose of the research is to determine the best automated external defibrillator (AED) training approach for high-risk patients and their family members with regard to AED skills retention and psychological adjustment.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction; Chest Pain; Heart Arrest; Angina, Unstable; Congestive Heart Failure
• Intervention / Treatment: Behavioral: Group II: Video training + enhanced self-efficacy (SE); Behavioral: Group III: In-person training + enhanced SE; Behavioral: Group IV: In-person training + enhanced SE + support; Behavioral: Group I: Video training

Detailed Description

In the past 3 decades, advances in the understanding of the resuscitation of cardiac arrest have provided opportunities to strengthen the links in the chain of survival. Despite the apparent progress, however, survival has remained poor. Cardiac arrest is a leading cause of mortality in the US, accounting for up to 450,000 deaths annually. Eighty percent of all cardiac arrest events are caused by the arrhythmia, ventricular fibrillation. Prompt electrical defibrillation is the only effective therapy. The time interval from collapse to attempted defibrillation is the most important determinant of outcome. The chance of survival decreases on average by approximately 10-15% for every minute that elapses prior to attempted defibrillation. Thus, methods to decrease the time interval between collapse and electrical defibrillation represent a true opportunity to improve survival from cardiac arrest.

Even in communities where emergency medical systems are best situated to treat cardiac arrest, response intervals are on average greater than 6 minutes. The development of the automated external defibrillator (AED) provides the possibility to decrease the interval from collapse to defibrillation by enabling persons outside the traditional emergency medical services response system who are typically not trained in rhythm recognition to deliver life-saving therapy. The AED is a device that can be applied in case of cardiac arrest and will assess the heart rhythm and instruct the bystander whether to provide a shock. In addition, approximately 75% of cardiac arrests occur in the home and are witnessed or found by a family member. Thus, a family responder AED program, where family members of persons at relatively high risk of cardiac arrest are equipped and trained with AEDs, may in part, decrease the interval from collapse to shock in cardiac arrest and improve outcome. Persons who have recently been hospitalized for an acute coronary syndrome are known to be at elevated risk for cardiac arrest. Indeed, the provision of an AED for home use is already in practice. However, it is not clear what method should be used to train family members in this potentially lifesaving set of skills. The purpose of the proposed study is to evaluate 4 different AED training methods to determine if the training approaches differentially affect AED skill retention or psychological status. Although the programs span the spectrum from streamlined to personalized and intensive, each approach constitutes a potential real-world, generalizable AED training method.

• Study Type: Interventional
• Enrollment (Actual): 305
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98104
      • Division of Emergency Medical Services, Public Health - Seattle and King County

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Hospitalized for acute myocardial infarction, unstable angina, cardiac chest pain, congestive heart failure with ejection fraction less than 40, a cardiac procedure with a documented history of coronary artery disease
• Resides in Pierce, King, or Snohomish Counties, Washington (WA)
• Lives with someone physically and mentally able to operate an AED
• Able to provide written informed consent
• Has a telephone

Exclusion Criteria:

• Lives in a nursing home
• Do not resuscitate (DNR) orders checked on chart
• Suffers from a severe co-morbidity that prevents them from participating in a long-term study
• Has an implantable cardioverter defibrillator
• Non-English speaking patient and/or family member/significant other

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 3	Behavioral: Group III: In-person training + enhanced SE; Participants will receive a face-to-face training session in their home as well as the AED with instructional video, manikin and training materials.
Active Comparator: 4	Behavioral: Group IV: In-person training + enhanced SE + support; Participants will receive a face-to-face training session in their home as well as the AED, instructional video, manikin, and a resource manual with information to enhance the family member's confidence in their role as care provider.
Active Comparator: 2; Group II	Behavioral: Group II: Video training + enhanced self-efficacy (SE); Partcipants will receive the AED with instructional video, a manikin, and additional training materials by mail.
Active Comparator: 1; Group I	Behavioral: Group I: Video training; Participants will receive the AED with a video that provides "instructional" training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AED skills retention when assessed at 9 months from enrollment date	9 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Psychological adjustment measured by a series of validated questionnaires administered at time of enrollment, 3 months, and 9 months	9 months

Collaborators and Investigators

• Sponsor: Public Health - Seattle and King County
• Collaborators: National Institutes of Health (NIH)

Publications and helpful links

General Publications

• Meischke H, Diehr P, Phelps R, Damon S, Rea T. Psychologic effects of automated external defibrillator training: a randomized trial. Heart Lung. 2011 Nov-Dec;40(6):502-10. doi: 10.1016/j.hrtlng.2010.12.009. Epub 2011 Mar 16.

Study record dates

Study Major Dates

• Study Start: July 1, 2004
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 22, 2005

Study Record Updates

• Last Update Posted (Estimate): October 29, 2014
• Last Update Submitted That Met QC Criteria: October 28, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: education; automated external defibrillators; training, defibrillators; home defibrillators; psychological adjustment
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Angina Pectoris; Myocardial Infarction; Infarction; Heart Failure; Chest Pain; Heart Arrest; Angina, Unstable
• Other Study ID Numbers: R01HL074098-01A1 (U.S. NIH Grant/Contract)