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| Name | Class |
|---|---|
| Hikari DX | UNKNOWN |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Experimental-arm providers will complete two rounds of three simulated patient cases (CPVs) with two additions described in the next column: |
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| Control | No Intervention | These providers will complete two rounds of three simulated patient cases (CPVs) only. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental Arm | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Peabody, MD, PhD | President, QURE Healthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| QURE Healthcare | San Francisco | California | 94133 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30328782 | Background | Burgon TB, Cox-Chapman J, Czarnecki C, Kropp R, Guerriere R, Paculdo D, Peabody JW. Engaging Primary Care Providers to Reduce Unwanted Clinical Variation and Support ACO Cost and Quality Goals: A Unique Provider-Payer Collaboration. Popul Health Manag. 2019 Aug;22(4):321-329. doi: 10.1089/pop.2018.0111. Epub 2018 Oct 17. | |
| 23667587 |
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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.
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| Peabody JW, Strand V, Shimkhada R, Lee R, Chernoff D. Impact of rheumatoid arthritis disease activity test on clinical practice. PLoS One. 2013 May 7;8(5):e63215. doi: 10.1371/journal.pone.0063215. Print 2013. |
| 19224955 | Background | Solon O, Woo K, Quimbo SA, Shimkhada R, Florentino J, Peabody JW. A novel method for measuring health care system performance: experience from QIDS in the Philippines. Health Policy Plan. 2009 May;24(3):167-74. doi: 10.1093/heapol/czp003. Epub 2009 Feb 18. |
| 28036350 | Background | Peabody J, Martin M, DeMaria L, Florentino J, Paculdo D, Paul M, Vanzo R, Wassman ER, Burgon T. Clinical Utility of a Comprehensive, Whole Genome CMA Testing Platform in Pediatrics: A Prospective Randomized Controlled Trial of Simulated Patients in Physician Practices. PLoS One. 2016 Dec 30;11(12):e0169064. doi: 10.1371/journal.pone.0169064. eCollection 2016. |
| 15545677 | Background | Peabody JW, Luck J, Glassman P, Jain S, Hansen J, Spell M, Lee M. Measuring the quality of physician practice by using clinical vignettes: a prospective validation study. Ann Intern Med. 2004 Nov 16;141(10):771-80. doi: 10.7326/0003-4819-141-10-200411160-00008. |