Background: The Multi-arm Optimization of Stroke Thrombolysis (MOST) was a multicenter, single-blind, randomized controlled phase 3 hyperacute clinical trial conducted through the National Institute of Health (NIH) StrokeNet at 57 sites across the United States. A centralized 24/7 hotline was established to provide support to study personnel at enrolling sites. Calls were answered by principal investigators (PI). We evaluated calls to identify themes and understand the utility of the hotline. Methods: From October 2019 to July 2023, MOST enrolled 514 patients. Beginning in June 2022, all hotline calls were recorded. After IRB approval, two investigators listened to recorded calls. Six themes were identified: eligibility, consent, study drug administration, protocol related, adverse event, and other. Discrepancies in categorization were resolved through discussion with a third reviewer. Results: Of 201 total recorded hotline calls, 21 were excluded due hangups, voicemails, etc. Of the 180 analyzed calls, 121 (67%) were made for enrolled or soon-to-be enrolled patients (70 unique) and 59 (33%) were made for non-enrolled patients (48 unique). Of all calls, 68% (n=128) were made by study coordinators, 30% (n=54) by physicians, and 2% (n=3) by other site personnel. The median call length was 81 seconds. The most frequent call type was eligibility-related (n=68). Of the 24 eligibility exception requests, 7 were granted and enrolled and 17 were not. Study drug calls (n=42) mainly requested giving the drug outside the 75-minute window (n=22); 20 of these requests were approved. Adverse events calls (n=28) frequently led to study drug discontinuation (n=23). Protocol clarification calls (n=31) involved sites asking about study drug timing between the 60- and 75-minute windows (n=12), IV compatibility (n=6), the use of concomitant procedures and medications (n=6) and other protocol questions (n=7). Consent-related callers (n=13) had questions regarding remote and eConsent (n=10) or identifying an appropriate surrogate (n=3). All other calls (n=3) were related to operational support. Conclusion: In MOST, the major hotline call theme was eligibility, followed by study drug timing, protocol clarification, and adverse event management. To our knowledge, this is the first report of hotline call content during an acute stroke clinical trial. Our findings could inform opportunities to optimize trial operations in the planning of future acute stroke trials.
Pamula et al. (Thu,) studied this question.