Abstract 89: Instituting a 24/7 Enrollment Plan for Acute Ischemic Stroke Clinical Trials: Feasibility, Implementation and Potential Impact
Background and objectives: Enrollment into acute stroke trials is usually limited to weekday working hours. As a result, a large portion of eligible patients do not receive the opportunity to participate in these trials, hence enrollment rate suffers. We share our experience regarding the feasibility and implementation of a 24/7 enrollment plan for two acute ischemic stroke (AIS) trials. We also compare differences in patients’ characteristics enrolled during working hours (WH) vs. after hours+weekend (AH).
Methods: Data used for this study is from a single-center that actively enrolls AIS patients into 2 time-sensitive, tPA-adjunctive clinical trials (CLOTBUST-HF & ARTSS-2). This center implemented a 24/7 on-call system for research coordinators to respond after-hours (5:01pm-6.59am) and on weekends. Approach for AH comprises a coordinated effort that includes: prompt call to on-call coordinator if in-house physician identifies a potential eligible patient; on-call physician delivers IV-tPA and introduces the study; study PI accesses the electronic medical record from home and if applicable the randomization website to screen and prepare for enrollment. The coordinator arrives at ED to assist in-house physician with study procedures. We conducted descriptive analyses that explore differences between WH (Mon-Fri: 7am-5pm) vs. AH (Mon-Thurs: 5.01pm-6.59am and Fri-Mon: 5.01pm-6.59am).
Results: During 01/2010 - 05/2013, a total of 34 patients were eligible for the 2 trials of whom 33 were enrolled. 17/33 (52%) patients were enrolled AH and had lower NIHSS scores and longer onset-to-tPA times. Table includes data comparing the groups.
Conclusion: 24/7 research enrollment for AIS patients is feasible and increased recruitment by 106% with no delays in randomization or initiation of investigational treatments. Reproducibility in other centers should be explored. Efforts to provide 24/7 coverage should be evaluated as a way to improve recruitment rates.
Author Disclosures: L.F. Shen: None. H. Indupuru: None. A. Jacobs: None. W.R. Guerrero: None. M.H. Rahbar: None. N.R. Gonzales: None. R. Pandurengan: None. J.C. Grotta: None. A.D. Barreto: None.
- © 2014 by American Heart Association, Inc.