Establishing Clinical Utility for a New Diagnostic Test for Patients With Shortness of Breath

NCT04693793 | Completed

• 1 other identifier: 01-ACT-2020
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 1

Brief Summary

This study will collect high-quality data on how practicing specialist physicians, specifically cardiologists and pulmonologists, across the U.S. currently manage patients with unexplained chronic dyspnea and and how the results of Janssen Pharmaceuticals' test change clinical decision making. To do so, this study leverages simulated patient cases called Clinical Performance and Value vignettes (CPVs) in a proven methodology to rapidly measure physician care decisions.

Conditions

Dyspnea; Unexplained Chronic Dyspnea

Outcome Measures

Primary Outcomes (3)

• CPV-measured clinical score difference

  Difference-in-differences regression analysis between the control and the intervention groups' diagnosis and treatment of chronic dyspnea, as measured by the participants diagnostic and treatment CPV case domain scores. In each domain of a CPV (history, physical exam, workup, diagnosis and treatment), participants' care recommendations are evaluated against evidence-based care scoring criteria which can sum from 0 to a high potential score of up to 100 percent in each domain, where higher scores mean better outcomes.

  3 months

• Test Adoption Rate

  Rate of adoption of the Janssen test in Intervention 2 arm participants.

  3 months

• CPV-measured cost difference

  Difference in expected cost of care between control and intervention participants. (Cost will be calculated by measuring differential rates of medical interventions/levels of care selected by each arm, and multiplying by Medicare reimbursement rates for these interventions, and/or by modeling the incidence of expected complications and calculating associated costs.)

  3 months

Secondary Outcomes (3)

• CPV-measured clinical score differences by use case

  3 months

• CPV-measured cost differences by use case

  3 months

• CPV-measured baseline variation

  3 months

Study Arms (3)

Control

NO INTERVENTION

These providers will complete two rounds of three simulated patient cases (CPVs). Control arm physicians will continue to have access to standard of care diagnostic tools, but not the Janssen test results.

Educational Materials and Janssen Test Results (Intervention 1)

EXPERIMENTAL

Participants will care for the same set of CPV patients as the control arm, but will be educated on and will receive the Janssen test results whether they select it or not. Investigators will compare intervention participants' clinical recommendations to those in the control arm.

Other: Education Materials and Janssen Test

Educational Materials and Janssen Test Results when Selected (Intervention 2)

EXPERIMENTAL

Participants will care for the same set of CPV patients as the control arm, but will be educated on and will receive the Janssen test results only if they select it. Investigators will compare intervention participants' clinical recommendations to those in the control arm.

Other: Education Materials and Janssen Test

Interventions

Education Materials and Janssen Test OTHER

Intervention-1- and Intervention-2-arm participants will receive educational materials duplicating what physicians would receive in the real-world market as they adopt the Janssen technology. These materials are comprised of a slide deck, a sample test report, and a frequently asked questions (FAQ) sheet. Intervention 1 participants only will receive the Janssen test results whether they select it or not, and Intervention 2 participants will receive the Janssen test results only if they select it during the second round of case simulations.

Educational Materials and Janssen Test Results (Intervention 1); Educational Materials and Janssen Test Results when Selected (Intervention 2)

Eligibility Criteria

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

You may qualify if:

• Board-certified cardiologist or pulmonologist for at least two years
• Averaging at least 20 hours per week of clinical and patient care duties over the last six months
• Routinely evaluate patients for unexplained or chronic dyspnea in their practice
• Practicing in the U.S.
• English speaking
• Access to the internet
• Informed, signed and voluntarily consented to be in the study

You may not qualify if:

• Non-English speaking
• Practicing in an academic setting
• Unable to access the internet
• Not practicing in the U.S.
• Not averaging at least 20 hours per week of clinical or patient care duties over the last six months
• Do not voluntarily consent to be in the study

Sponsors & Collaborators

• Qure Healthcare, LLC: lead
• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: collaborator

Study Sites (1)

QURE Healthcare

San Francisco, California, 94109, 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• de Belen E, McConnell JW, Elwing JM, Paculdo D, Cabaluna I, Linder J, Peabody JW. Gaps in the Care of Pulmonary Hypertension: A Cross-Sectional Patient Simulation Study Among Practicing Cardiologists and Pulmonologists. J Am Heart Assoc. 2023 Jan 17;12(2):e026413. doi: 10.1161/JAHA.122.026413. Epub 2023 Jan 11.

  PMID: 36628980 DERIVED

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• John W 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 specialist physicians, specifically cardiologists and pulmonologists, practicing in the US. Participants are randomly assigned to either a control, intervention 1, or intervenion 2 arm upon enrollment. All eligible and consented participants will complete two rounds of three patient simulations. The intervention 1 and intervention 2 arms only will receive educational material about the Janssen test in between these two rounds. Intervention 1 arm participants only will receive the Janssen test results whether they select it or not, and Intervention 2 participants will receive the Janssen test results only if they select it in the second round of simulated cases.

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: January 5, 2021
• Study Start: March 5, 2021
• Primary Completion: September 15, 2022
• Study Completion: October 15, 2022
• Last Updated: December 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)