ICD Decisional Balance Study
Background: Sudden cardiac death is a well-documented public health problem resulting in 400,000 deaths in the U.S. annually. The Implantable Cardioverter Defibrillator (ICD) has demonstrated benefit in reducing mortality in at risk patients. The ICD is a device used to treat patients at risk for life threatening cardiovascular arrhythmias. The device is typically fixed in the left pectoral region of the upper portion of the chest and wire leads are connected to the right chambers of heart. Despite the benefits of this device in treating life threatening ventricular arrhythmias, prospective patients have specific concerns about the pros and cons of living with an ICD. These concerns include biomedical risks, social deficits, and psychological difficulties. Purpose: The purpose of the current study is to design a measure which assesses patients’ perceptions of the ICD prior to implantation. Methods: The current study will consist of approximately 200 potential ICD recipients receiving care at cardiology clinics. Male and female participants who are at lest 18 years old, who can read and write English, and have an ejection fraction (EF) of < 50% will be approached in clinic visits with their cardiologist. EF is a measure of the heart’s ability to pump blood. Participants will complete a Likert scaled questionnaire, including commonly cited benefits and consequences of the ICD. Statistical Analyses: Factor analyses will be performed to assess the relationship between pro/con variables so that the most relevant factors can be maintained for a refined measure of ICD decision making. Measures of psychopathology (HADS), quality of life (SF-12), religious health fatalism (RHFQ), and locus of control (C-MHLC) will also be completed by participants for preliminary validity estimates. The utility of this measure will allow for the provision of patient driven education and counseling, as well as the eventual development of an ICD-related decision aid.