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

Qure Healthcare

Status: Completed

Conditions: Dyspnea; Unexplained Chronic Dyspnea

Treatments: Other: Education Materials and Janssen Test

Study type: Interventional

Funder types: Industry

Identifiers

NCT04693793

01-ACT-2020

Details and patient eligibility

About

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.

Full description

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. Data from this study will better illuminate the clinical use cases in which the Janssen test has 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 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.

Enrollment: 219 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Board-certified cardiologist or pulmonologist 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. 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

1. Non-English speaking
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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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219 participants in 3 patient groups

Control

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Other: Education Materials and Janssen Test

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

Experimental group

Description:

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.

Treatment:

Other: Education Materials and Janssen Test