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This study investigates how after-hours and weekend services for coordinators and technologists improve patient recruitment and data collection for clinical trials. The ACRIN Accrual Demonstration Project focuses on acute chest pain and chronic angina trials.
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Washington University, PIs: Pamela Woodard, M.D. Tammie Benzinger, M.D. Hypothesis: Availability of a coordinator and technologist after normal working hours and on weekends will provide an increase in patient recruitment/dollar spent by comparison with the current recruitment strategy for such trials. Specific Aim: To determine whether “off hour” late-day/evening and on-call weekend coordinator and technologist services improves accrual to trials requiring more acute coordinator/ technologist involvement, and in completion of data collection. ACRIN ACCRUAL DEMONSTRATION PROJECT
After Hours Weekday Coordinator and CT Technologist • CT technologist from 4-6 PM • Coordinator from 4-6 PM • ROMICAT Trial (NIH Trial) and ACRIN-funded Biomarker Substudy • Acute chest pain trial based out of ED, patients randomized to CCTA vs. SOC. • Hs troponin biomarker component requires 3 blood draws, with last 6 hrs after patient entered into study. • RESCUE Trial (AHRQ/ACRIN) • Chronic angina trial with patients randomized to CCTA vs. SPECT/ICA as means of directing patients to revascularization or optimal medical therapy.
ROMICAT II • ACRIN Accrual Project started 2/2011 • 81 patients enrolled into ROMICAT at WU site since February 2011 (7 months). Total: 150 since 4/2010, 16 months). 6 patients recruited after 3 PM 8 patients CT scanned after 4 PM • 39 patients enrolled into ACRIN Biomarker Substudy at WU site since February 2011 (7 months) Total 71: since 4/2010, 16 months). 15/39 after hours blood draw since 2/2011
RESCUE • WU recruitment began 6/8/11. • 9 patients recruited to date, 4 randomized to CCTA. • None after hours. • However, since these patients are often recruited from the clinic setting, sometimes in the afternoon, we are now asking the following question if they are randomized to CCTA: There is an after hrs (4-6PM) technologist available, so that your CCTA can be done today. Would you like to take advantage of the opportunity to have your study done today? Y N If no, please state why? _________________________________________
Weekend Coordinator ACRIN 6684 GBM Study, PI –Tammie Benzinger, M.D. • NEW RN is available by phone 24/7, responds to email daily, even on weekends. Comes in on weekends to discuss the study with patients if they are scheduled for a Monday surgery. • RESULT • Increased queries about the study. Questions from the surgeons re "possible advanced imaging" come in at least once a week. • “Unfortunately, despite this energy, we still have not found anyone eligible for the particular study due to patient issues. The ones with subtotal resection are too sick to agree to extra imaging. We had one agree verbally before his surgery, did not sign the form, died postop...”