18 Challenges faced in recruiting patients from primary care practices into a behavioral modification trial

The Activity Counseling Trial (ACT) is a multicenter, randomized clinical trial that is evaluating a primary care-based intervention to increase physical activity in sedentary adults aged 35-75 years old. Eight primary care practices with a total of 54 clinicians (51 physicians. 2 physician assistants and 1 nurse practitioner) are recruiting 810 participants within three U.S. clinical sites. ACT has encountered a variety of recruitment challenges that relate, in great part, to the primary care setting. These include: 1) limiting the target population to patients having regularly scheduled or intend-to-schedule appointments with ACT physicians within the next year; 2) timing randomization into the trial to coincide with the patient’s next physician appointment; 3) involving primary care physicians and their staff, who receive little or no monetary support for the study; and 4) placement of the trial interventionists (2 per clinical site) in the primary care physicians’ offices. Special challenges have also been faced in recruiting males and minorities into the study. Summation of successful (and unsuccessful) ACT recruitment strategies could prove useful for future trials recruiting patients from primary care practices. Strategies employed in ACT include use of office-based questionnaires. creation of mailing lists from patient databases/appointment lists/chart reviews, addition of Physician Assistants and Nurse Practitioners to increase the ACT “cat&rent” population, establishment of incentives for physicians/nurses/staff, inclusion of more physicians and more practices, and examination of the recruitment potential among various types of practices [e.g.. university affiliated, high socioeconomic status (SES) and low SES].