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

NCT04266834 | Completed

• 1 other identifier: 01CMC2019
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

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.

Conditions

AKI; Contrast-induced Nephropathy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Baseline variation in CPV-measured quality scores

  1 week

Study Arms (2)

Experimental

EXPERIMENTAL

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

Other: Experimental Arm

Control

NO INTERVENTION

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

Interventions

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.

Experimental

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Non-English speaking
• Unable to access the internet
• Do not voluntarily consent to be in the study

Sponsors & Collaborators

• Qure Healthcare, LLC: lead
• Hikari DX: collaborator

Study Sites (1)

QURE Healthcare

San Francisco, California, 94133, United States

Location

Related Publications (5)

• 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.

  PMID: 30328782 BACKGROUND

• 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.

  PMID: 23667587 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.

  PMID: 19224955 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.

  PMID: 28036350 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.

  PMID: 15545677 BACKGROUND

Study Officials

• John Peabody, MD, PhD

  President, QURE Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: February 12, 2020
• Study Start: December 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: June 30, 2020
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)