Abstract T MP102: Hotline Use for Recruitment Support in Acute Stroke Trials: Lessons learned To Date in Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH)-II

Abstract

Background: Use of hotline services for clinical support and safe operation of a research trial is common and important. The value of such services has not been objectively assessed within the context of a large acute stroke clinical trial. Methods: The use of three different hotline services have been tested, and cell and Email- options have also been explored for their advantages. US and Non-US sites are provided access to central hotline services, but for efficiency a local network for managing calls is established in each region. All sites may access both data management and the trial PI via hotline services when needed and this is supported by other technologies in addition. A means for supporting overall trial communications in light of these interactions has been developed and valuable insights are gained. Results: Data gathered from 211 calls logged at the Clinical Coordinating Center through the course of the ATACH-II trial have been summarized: Total Calls Reviewed: 211; Year 2 of trial: 92 calls, Year 3 of trial: 100 calls. Calls received midnight to 8 AM: 19 (9.0%), 8 AM - 5 PM 130 (61.6 %) 5 PM - 12:00 PM 65 (30.8%). Issues Resolved in < 5 min 143/211 (67.8%) Taking > 30 min to resolution 51/211 (24.2%). Purpose of calls: Eligibility 89 (42.2%). protocol compliance including drug management: 77 (36.5%%), randomization/emergency randomization: 16 (7.6%), protocol deviation:13 (6.2%), technological difficulties: 12 (5.7%), AE/SAE: 9 (4.3%), Subject enrollments directly associated with calls: 57 (20.8% of domestic subjects); excluded candidates directly associated with calls: 46 (% not available). Conclusions: In an international trial requiring rapid enrollment of subjects with intracerebral hemorrhage, the role of direct support via a hotline and other immediate communications means has proven to be instrumental in maintaining good protocol compliance and supporting enrollment by site team members .

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