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Table 2 Recommendations for implementation of the REMAP-COVID trial

From: Implementation of the Randomized Embedded Multifactorial Adaptive Platform for COVID-19 (REMAP-COVID) trial in a US health system—lessons learned and recommendations

Implementation area Challenges Recommendations
Leadership engagement ▪ Balancing dual imperatives of immediate patient care and research
▪ Diffuse interests
▪ Engage early
▪ Inclusive and transparent approach
▪ Align institutional and trial goals
▪ Understand and embrace bedside realities
▪ Share vision of REMAP-COVID as groundwork for learning health system development
Trial embedment • Research procedures can interfere with daily care
• Hospital committee workloads already high
• Embed trial into routine care processes
• Integrate into existing institutional information dissemination, pharmacy, and telemedicine structures
• Embed trial into electronic health record; can start trial using traditional methods
Remote consent and enrollment • Technological challenges
• Patient familiarity with technology
• Mock enrollments to test remote process
• Engage bedside providers to assist patients as needed
• Leverage institutional videoconferencing tools
• Intermittent competency training of research personnel
Regulatory compliance and oversight • Multiple parallel regulatory requirements • Engage local institutional review board (IRB) to partner with the central IRB
• Close contact with US Regional Coordinating Center at UPMC
• Anticipatory management of new trial domains and arms
Modification of traditional trial management procedures • Communication around frequent adaptive trial updates
• COVID-19 travel restrictions limit in-person monitoring
• Identify and celebrate natural points of progress and contributions from local champions
• Leverage electronic health record to facilitate protocol adherence, adverse event monitoring, screening and enrollment logs, and data collection and export
• Start trial using traditional procedures
• Virtual town hall meetings
Alignment with other COVID-19 studies • Multiple studies for same patients • Establish a centralized institutional process to optimize coordination and collaboration
  1. REMAP-COVID Randomized Embedded Multifactorial Adaptive Platform for COVID-19