Abstract
Purpose: :
To determine whether an academic associate program (AAP) increases recruitment for clinical research studies in an academic ophthalmology practice, while offloading clinicians and allowing undergraduates to experience medicine.
Methods: :
A 9-month pilot study of an AAP was conducted from July 2010 to April 2011 at the Department of Ophthalmology and Visual Science, Yale University School of Medicine. Yale undergraduate AAs were recruited through email advertisements by the Health Professions Advisory Program advisor and a pre-medical student interest group on campus. All completed training for screening and enrolling patients including. Twenty-five undergraduate applicants were interviewed and accepted to participate in the program as academic associates (AAs). All completed the mandatory orientation and online training. AA attendance was tracked using a database. AAs documented patients screened for 12 studies and independently enrolled subjects in 7 studies. Subject enrollments for two studies were documented and correlated with AA shifts for each month. Surveys were used to assess AA and physician satisfaction. The main outcome measures for the study were subject screening and enrollment by AAs and physician satisfaction with the AAP.
Results: :
AAs completed a total of 385 shifts and 1,286 hours with an average of 56 hours per AA. AAs screened 2,897 patients in 165 clinic sessions, enrolled 446 subjects in 7 observational studies and facilitated screening, enrollment, and data collection in 10 other studies. Enrollments in two studies that spanned this trial period increased 10-fold and closely correlated with AA presence (r= 0.89). After 9 months, 95% of physicians surveyed (20 of 21) reported that the program was an asset to research, and 89% (19 of 21) agreed that it increased the variety of feasible study designs. Physicians emphasized the freedom of physicians to focus on patient care as a key benefit of the AAP. AAs indicated high satisfaction.
Conclusions: :
The AAP was a highly effective tool for increasing study enrollment without significant costs while minimizing impact on patient care.
Keywords: clinical research methodology