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) was a National Heart, Lung, and Blood Institute (NHLBI)-sponsored substudy to the Cardiac Arrhythmia Suppression Trial (CAST). Two-hundred-sixty (260) patients who enrolled in CAST and 140 partially or fully eligible patients who did not enroll were compared across several parameters, including demographic variables, disease severity, psychosocial functioning, 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, and health beliefs (e.g., extra beats are harmful, a higher degree of general health concern). Enrollment was higher for those who read and understood the informed consent and those who were initially recruited after hospital discharge, particularly nondepressed patients. In the multivariate model, the key variables that emerged were the patient's reading of the informed consent form and the patient's lack of medical insurance. These results suggest that (1) the clinical trial staff's interaction with the patient and the time when recruitment is initiated contribute significantly to the decision to enroll; and (2) it may be a greater challenge to motivate patients to enroll in future clinical trials if health care reform improves access to medical insurance coverage. Some of the significant variables are modifiable, suggesting interventions that may increase enrollment rates in future trials.
Gorkin
L
L
Institute for Behavioral Medicine, Cranston, Rhode Island, USA.
Schron
E B
EB
Handshaw
K
K
Shea
S
S
Kinney
M R
MR
Branyon
M
M
Campion
J
J
Bigger
J T
JT
Sylvia
S C
SC
Duggan
J
J
Stylianou
M
M
Lancaster
S
S
Ahern
D K
DK
Follick
M J
MJ
D000368:Aged; D001145:Arrhythmias, Cardiac / Q000503:physiopathology / Q000517:prevention & control*; D001294:Attitude to Health; D002986:Clinical Trials as Topic / Q000379:methods*; D005260:Female; D006801:Humans; D007258:Informed Consent; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D012737:Sex Factors; D012944:Social Support