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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

157 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-01

Study Completion Date

2020-06-30

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.

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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:

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.

Conditions

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AKI Contrast-induced Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Experimental

Experimental-arm providers will complete two rounds of three simulated patient cases (CPVs) with two additions described in the next column:

Group Type EXPERIMENTAL

Experimental Arm

Intervention Type OTHER

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.

Control

These providers will complete two rounds of three simulated patient cases (CPVs) only.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Experimental Arm

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Board-certified in cardiology for at least two years
2. Averaging at least 20 hours per week of clinical and patient care duties over the last six months
3. Averaging at least one day per month performing invasive or interventional cardiology procedures over the last six months
4. English speaking
5. Access to the internet
6. Informed, signed and voluntarily consented to be in the study