Contrast-induced Nephropathy Clinical Trial
Official title:
Establishing Clinical Utility of a New Diagnostic Test in Patients Undergoing Cardiac Catheterization: A CPV® Randomized Controlled Trial
This study will collect high-quality randomized controlled data across the U.S. from practicing cardiologists performing invasive/interventional procedures and determine how they currently manage patients at risk for CIN and how the results of Hikari's L-FABP test change clinical decision making.
This study will collect high-quality randomized controlled data across the U.S. from
practicing cardiologists performing invasive/interventional procedures and determine how they
currently manage patients at risk for CIN and how the results of Hikari's L-FABP test change
clinical decision making. Data from this study will better illuminate the clinical use cases
with the most significant impact on clinical decision making (and thus the largest potential
clinical utility) and the associated physician characteristics (e.g., age, practice setting,
training) associated with test adoption.
This study leverages simulated patient cases called Clinical Performance and Value vignettes
(CPVs) in a proven methodology to rapidly measure physician care decisions. CPVs are a unique
and scalable tool that standardizes practice measurement by having all providers care for the
same (virtual) patients. With all providers caring for the same patients, the CPVs generate
unbiased data that yields powerful insights into clinical decision making and how these
decisions change with the introduction of a new product or solution. Data from the CPVs can
quickly demonstrate the clinical utility of a solution, be published in peer-reviewed
literature, inform marketing strategies and positively impact coverage and reimbursement
decisions.
The study is a prospective cohort trial with six steps:
1. Enrollment: The study will enroll 166 practicing cardiologists who perform invasive or
interventional procedures in the U.S. and are determined to be eligible by an
eligibility screener.
2. Provider survey: Once providers are enrolled in the study, they will be asked to
complete a questionnaire describing their practice and professional background.
3. Randomization: The 166 cardiologists will be randomized into equally-sized (83) control
and intervention arms.
4. CPVs (First Round): Physicians will complete three randomly-assigned CPV patient
simulations in random order. Cases will be identical across the intervention and control
arms. All cases are presented on an online platform, participants are provided with
unique weblinks, accessible via any internet-connected computer.
5. Education: The intervention-arm cardiologists will receive educational materials
duplicating what physicians would receive in the real-world market as they adopt the
L-FABP test. These materials may be comprised of a slide deck, fact sheet, webinar, or
case studies.
6. CPVs: Physicians will then complete three additional CPV patient simulations in random
order. Cases will be identical across the intervention and control arms, except that the
intervention arm will receive L-FABP test results at an appropriate point in each
simulated case in the post-intervention round.
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