CLINICAL-TRIAL ENROLLERS VS NONENROLLERS - THE CARDIAC-ARRHYTHMIA SUPPRESSION TRIAL (CAST) RECRUITMENT AND ENROLLMENT ASSESSMENT IN CLINICAL-TRIALS (REACT) PROJECT

The Recruitment and Enrollment Assessment in Clinical Trials (REACT) w as a National Heart, Lung, and Blood Institute (NHLBI)-sponsored subst udy to the Cardiac Arrhythmia Suppression Trial (CAST). Two-hundred-si xty (260) patients who enrolled in CAST and 140 partially or fully eli gible patients who did not enroll were compared across several paramet ers, including demographic variables, disease severity, psychosocial f unctioning, health beliefs, recruitment experience, and understanding of informed consent procedures used in CAST. Significant predictors of enrollment included several demographic variables (e.g., being male, not having medical insurance), episodes of ventricular tachycardia, an d health beliefs (e.g., extra beats are harmful, a higher degree of ge neral health concern). Enrollment was higher for those who read and un derstood the informed consent and those who were initially recruited a fter hospital discharge, particularly nondepressed patients. In the mu ltivariate model, the key variables that emerged were the patient's re ading of the informed consent form and the patient's lack of medical i nsurance. These results suggest that (1) the clinical trial staffs int eraction with the patient and the time when recruitment is initiated c ontribute significantly to the decision to enroll; and (2) it may be a greater challenge to motivate patients to enroll in future clinical t rials if health care reform improves access to medical insurance cover age. Some of the significant variables are modifiable, suggesting inte rventions that may increase enrollment rates in future trials.