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Design and rationale of the Radial Access Insertion Sheath Evaluation via the electronic medical record (RAISE-EMR)
Binita Shah1, Johanna Lerner2, Jacob Martin2
1Department of Medicine, Section of Cardiology, VA New York Harbor Health Care System, NY; Department of Medicine, Division of Cardiology, NYU School of Medicine, NY.
Background:
Decisions involving the purchase of procedural equipment at the health system level require balancing efficacy, safety, physician preference, and cost. The application of efficient and low-cost pragmatic study designs has the potential to rapidly generate data to inform health system operations.
Methods:
The aim of the pragmatic Radial Access Insertion Sheath Evaluation via the electronic medical record (RAISE-EMR) study is to determine physician preference between 2 commercially available radial artery introducer sheaths, one of which has a higher acquisition cost, to guide inventory selection in the hospital system's catheterization laboratories. Patients undergoing coronary angiography using 6-French radial artery access were prospectively identified and randomized through the health system's EMR. Among 1696 eligible unique patients, 554 patients (32.7%) were randomized over 37 days across 3 hospitals. Randomization took place through the EMR after the attending interventional cardiologist signed a mandated pre-procedure note. The study was deemed non-human subject research and approved by the New York University (NYU) Langone Health Quality Improvement Oversight Committee. The primary endpoint, a physician satisfaction score, will be ascertained by a mandated semi-quantitative survey within the electronic procedure note. All data, including co-variables and clinical outcomes, will be ascertained using structured data within the EMR.
Conclusions:
The Radial Access Insertion Sheath Evaluation via the EMR study is designed to determine physician preference of 2 commercially available radial artery introducer sheaths and potentially reduce supply costs using an entirely EMR-based randomized study design. Pragmatic study designs leveraging structured data within an EMR can be used to rapidly provide data to inform operational decision-making and have implications for the future of evidence generation.
Trial Registration:
ClinicalTrials.gov (identifier: NCT07218406).
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