Clinical trial NCT04266834: Establishing Clinical Utility of a New Diagnostic Test in Patients Undergoing Cardiac Catheterization
Official title: Establishing Clinical Utility of a New Diagnostic Test in Patients Undergoing Cardiac Catheterization: A CPV® Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: AKI
Contrast-induced Nephropathy
Lead sponsor: Qure Healthcare, LLC
Sponsor class: INDUSTRY
Collaborators: name: Hikari DX
First posted: 2020-02-12
Enrollment: 157
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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

Exclusion Criteria:

1. Non-English speaking
2. Unable to access the internet
3. Do not voluntarily consent to be in the study

Primary outcomes:
measure: CPV-measured pre-/post-difference in quality scores between intervention and control physicians
timeFrame: 2-4 weeks
measure: CPV-measured cost difference
timeFrame: 2-4 weeks
Secondary outcomes:
measure: Baseline variation in CPV-measured quality scores
timeFrame: 1 week
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: QURE Healthcare
state: California
Study officials:
affiliation: President, QURE Healthcare
name: John Peabody, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.