Online Program

NU IMPACT: Design and Data Capture for an EHR-Integrated, Stepped-Wedge, Cluster Randomized Effectiveness-Implementation Hybrid Trial (305266)

Michael Bass, Northwestern University 
September 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.