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Virtual
NU IMPACT: Design and Data Capture for an EHR-Integrated, Stepped-Wedge, Cluster Randomized Effectiveness-Implementation Hybrid Trial (305266)
Michael Bass, Northwestern UniversitySeptember Cahue, Northwestern University
David Cella, Northwestern University
Sofia Garcia, Northwestern University
*Nicola Lancki, Northwestern University
Quan Mai, Northwestern University
Frank Penedo, University of Miami
Denise Scholtens, Northwestern University
JD Smith, University of Utah
Firas Wehbe, Northwestern University
Betina Yanez, Northwestern University
Keywords: study design, data capture, electronic health record, REDCap, stepped-wedge implementation
The goal of NU IMPACT is to test the effectiveness of a system-wide, electronic health record (EHR)-integrated cancer symptom monitoring and management system (cPRO), when implemented across oncology clinics within a large health system. NU IMPACT is a hybrid trial focused on both effectiveness and implementation, which utilizes a modified stepped-wedge, clinic-level randomized intervention roll-out, with an embedded, patient-level randomized controlled trial (RCT) within the post-implementation phase. This presentation will examine EHR-based participant recruitment, intervention activation and data capture for this unique study design, with emphasis on technical innovations, challenges, and lessons learned. We will discuss how the study automated the identification and upload of data on eligible patients from the health system’s EHR to REDCap. We will also review how we integrated randomization assignment into the EHR for the RCT and accomplished intervention implementation. Additional features of the study include an electronic consent protocol; survey-based, longitudinal assessments; a sequential roll-out of clinical units; and capture of research data from multiple sources.