Design and rationale of the Radial Access Insertion Sheath Evaluation via the electronic medical record (RAISE-EMR) study.

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).