Establishing Clinical Utility for a New Diagnostic Test for Patients With Shortness of Breath
NCT ID: NCT04693793
Last Updated: 2023-12-07
Study Results
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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COMPLETED
NA
219 participants
INTERVENTIONAL
2021-03-05
2022-10-15
Brief Summary
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Detailed Description
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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 249 cardiologists and pulmonologists practicing in the U.S. who are determined to be eligible by an eligibility screener.
2. Provider survey: Once the participants are enrolled in the study, they will be asked to complete a questionnaire describing their practice and professional background.
3. Randomization: The 249 participants will be randomized into three equally-sized arms (83 participants each arm): Control, Intervention 1, and Intervention 2.
4. CPVs (First Round): Participants will complete three randomly-assigned CPV patient simulations. Cases will be identical across the intervention and control arms. All interactive cases are presented on an online platform, and are accessible via unique weblinks and any internet-connected computer.
5. Education: The 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.
6. CPVs (Second Round): All participating physicians will then be asked to complete three additional CPV patient simulations. The cases are given to the doctors in a random order. Cases will be identical across the intervention and control arms. At an appropriate point in each case, 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. Control arm participants will continue to have access to standard of care diagnostic tools, but not the Janssen test. All cases are presented on an online platform, and participants are provided with unique weblinks, accessible via any internet-connected computer.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
DIAGNOSTIC
NONE
Study Groups
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Control
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.
No interventions assigned to this group
Educational Materials and Janssen Test Results (Intervention 1)
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.
Education Materials and Janssen Test
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 when Selected (Intervention 2)
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.
Education Materials and Janssen Test
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.
Interventions
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Education Materials and Janssen Test
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.
Eligibility Criteria
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Inclusion Criteria
2. Averaging at least 20 hours per week of clinical and patient care duties over the last six months
3. Routinely evaluate patients for unexplained or chronic dyspnea in their practice
4. Practicing in the U.S.
5. English speaking
6. Access to the internet
7. Informed, signed and voluntarily consented to be in the study
Exclusion Criteria
2. Practicing in an academic setting
3. Unable to access the internet
4. Not practicing in the U.S.
5. Not averaging at least 20 hours per week of clinical or patient care duties over the last six months
6. Do not voluntarily consent to be in the study
ALL
Yes
Sponsors
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
INDUSTRY
Qure Healthcare, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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John W Peabody, MD PhD
Role: PRINCIPAL_INVESTIGATOR
President, QURE Healthcare
Locations
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QURE Healthcare
San Francisco, California, United States
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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01-ACT-2020
Identifier Type: -
Identifier Source: org_study_id