Establishing Clinical Utility of a New Diagnostic Test in Patients Undergoing Cardiac Catheterization

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 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. Provider survey: Once providers are enrolled in the study, they will be asked to complete a questionnaire describing their practice and professional background. Randomization: The 166 cardiologists will be randomized into equally-sized (83) control and intervention arms. 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. 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. 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.

Official Title
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Establishing Clinical Utility of a New Diagnostic Test in Patients Undergoing Cardiac Catheterization: A CPV® Randomized Controlled Trial

Conditions
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AKI, Contrast-induced Nephropathy

Intervention / Treatment
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* Other: Experimental Arm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Board-certified in cardiology for at least two years Averaging at least 20 hours per week of clinical and patient care duties over the last six months Averaging at least one day per month performing invasive or interventional cardiology procedures over the last six months English speaking Access to the internet Informed, signed and voluntarily consented to be in the study Exclusion Criteria: Non-English speaking Unable to access the internet Do not voluntarily consent to be in the study
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study will enroll practicing cardiologists in the US. All eligible and consented participants will be randomly assigned to either a control or intervention arm. All participants complete two rounds of three patient simulations. The intervention arm only will receive educational material about the Hikari L-FABP test in between these two rounds, and be provided simulated L-FABP test results in the second round of the simulated cases.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Experimental-arm providers will complete two rounds of three simulated patient cases (CPVs) with two additions described in the next column: | Other: Experimental Arm<br>* First, these providers will receive educational materials (e.g. a slide deck and one-page fact sheet) meant to mimic what physicians will receive in the real-world market as they learn about the Hikari DX L-FABP test. Second, within each of their second-round cases, intervention-arm physicians only will receive simulated test results from the L-FABP test at the clinically-appropriate point in each case.<br>|
| No Intervention: Control<br>These providers will complete two rounds of three simulated patient cases (CPVs) only. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CPV-measured pre-/post-difference in quality scores between intervention and control physicians | All physicians' completed simulated CPV cases are scored based upon the quality of care provided. This measure CPV-measured pre-/post-difference in these care quality scores between control physicians using standard of care diagnostic tools and intervention physicians with access to L-FABP test results, including by use case types. | 2-4 weeks | 
| CPV-measured cost difference | Difference in expected cost of care between control and intervention physicians. (Cost will be calculated by measuring differential rates of medical interventions/levels of care selected by each arm, including by each use case, and multiplying by Medicare reimbursement rates for these interventions/levels of care, and/or by modeling the incidence of complications and calculating associated costs per above.) | 2-4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline variation in CPV-measured quality scores | All physicians' completed simulated CPV cases are scored based upon the quality of care provided. This measure assesses the baseline levels of care quality variation in the work-up and management of patients at risk for CIN, including by use case types. | 1 week |