DyspneaNCT04693793

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

A study testing Education Materials and Janssen Test in people with Dyspnea and Unexplained Chronic Dyspnea, run by Qure Healthcare, LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Dyspnea, Unexplained Chronic Dyspnea
What is being tested?: Education Materials and Janssen Test
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 219 participants
Where: 1 siteUnited States
Study dates: 5 Mar 2021to 15 Oct 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

QURE Healthcare
San Francisco, California, 94109

Other trials in United States

About this study

Official title: Establishing Clinical Utility for a New Diagnostic Test for Patients With Shortness of Breath: A CPV® Randomized Controlled Trial

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.

Read the detailed 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:

Enrollment: The study will enroll 249 cardiologists and pulmonologists practicing in the U.S. who are determined to be eligible by an eligibility screener.
Provider survey: Once the participants are enrolled in the study, they will be asked to complete a questionnaire describing their practice and professional background.
Randomization: The 249 participants will be randomized into three equally-sized arms (83 participants each arm): Control, Intervention 1, and Intervention 2.
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.
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.
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: Dyspnea, Unexplained Chronic Dyspnea
Being tested: Education Materials and Janssen Test
Medical subject headings: Dyspnea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Education Materials and Janssen TestOther
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.

Study groups in NCT04693793
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Education Materials and Janssen Test

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 3 months
Test Adoption Rate
Rate of adoption of the Janssen test in Intervention 2 arm participants.
Measured: 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.)
Measured: 3 months

Secondary outcomes (3)

CPV-measured clinical score differences by use case
Difference in the overall, and the diagnostic and treatment quality scores between control and intervention participants. Diagnostic and treatment scores are calculated as the percent correct on CPVs, and the overall score is a average score of the subcategory scores (percent correct). This will be examined for each of the use cases to determine in which case(s) CPV scores most improved.
Measured: 3 months
CPV-measured cost differences by use case
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.) This will be examined for each of the use cases to determine in which case(s) cost metrics most improved.
Measured: 3 months
CPV-measured baseline variation
Participants completing the simulated cases, or CPVs, receive scores based upon the quality of care they provide. This measure will assess the baseline levels of variation in the care of pain patients among all participants, including by use case types
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Mar 202115 Oct 2022

First posted5 Jan 2021
Study start5 Mar 2021
Primary completion15 Sep 2022
Study completion15 Oct 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for DyspneaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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.
Masking: None (open label)
Enrolment: 219 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04693793
Sponsor's protocol ID: 01-ACT-2020
Status last verified: Nov 2023
First submitted: 30 Dec 2020
Last updated: 7 Dec 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: No IPD will be shared.

Publications

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.
PubMed 30328782
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.
PubMed 23667587
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.
PubMed 28036350
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.
PubMed 19224955
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.
PubMed 36628980

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Establishing Clinical Utility for a New Diagnostic Test for Patients With Shortness of Breath: A CPV® Randomized Controlled Trial
ClinicalTrials.gov ID: NCT04693793
Acronym / sponsor ID: 01-ACT-2020
Conditions: Dyspnea, Unexplained Chronic Dyspnea
Study type: Interventional
Recruitment status: Completed
Enrolment: 219 participants (actual)
Lead sponsor: Qure Healthcare, LLCIndustry (pharma, biotech, devices)
Collaborators: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study start: 5 Mar 2021 (actual)
Primary completion: 15 Sep 2022 (actual)
Study completion: 15 Oct 2022 (actual)
First posted: 5 Jan 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed 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.

The study is a prospective cohort trial with six steps:

Enrollment: The study will enroll 249 cardiologists and pulmonologists practicing in the U.S. who are determined to be eligible by an eligibility screener.
Provider survey: Once the participants are enrolled in the study, they will be asked to complete a questionnaire describing their practice and professional background.
Randomization: The 249 participants will be randomized into three equally-sized arms (83 participants each arm): Control, Intervention 1, and Intervention 2.
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.
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.
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.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: 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.

Arm	Type	Receives
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	Other: Education Materials and Janssen TestParticipants 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.
Educational Materials and Janssen Test Results when Selected (Intervention 2)	Experimental	Other: Education Materials and Janssen TestParticipants 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.

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Education Materials and Janssen TestIntervention-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.	Other	Educational Materials and Janssen Test Results (Intervention 1), Educational Materials and Janssen Test Results when Selected (Intervention 2)

Primary outcome

CPV-measured clinical score difference
Time frame: 3 months
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.
Test Adoption Rate
Time frame: 3 months
Rate of adoption of the Janssen test in Intervention 2 arm participants.
CPV-measured cost difference
Time frame: 3 months
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 secondary outcomes

CPV-measured clinical score differences by use case
Time frame: 3 months
CPV-measured cost differences by use case
Time frame: 3 months
CPV-measured baseline variation
Time frame: 3 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
Results publication: PubMed 30328782Burgon 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.
Results publication: PubMed 23667587Peabody 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.
Results publication: PubMed 28036350Peabody 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.
Results publication: PubMed 19224955Solon 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.
Derived from this study: PubMed 36628980de 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.
Individual participant dataSharing planned: No. No IPD will be shared.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John W Peabody, MD PhD principal investigator

President, QURE Healthcare

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Education Materials and Janssen Test in people with Dyspnea and Unexplained Chronic Dyspnea, run by Qure Healthcare, LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CPV-measured clinical score difference (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04693793, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.