Clinical trial NCT05702385: Clinical Utility Study for Exo-PDAC
Official title: Establishing Clinical Utility Evidence to Support Coverage and Reimbursement for Biological Dynamic's Exo-PDAC Test: A CPV® Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pancreas Cancer
Lead sponsor: Qure Healthcare, LLC
Sponsor class: INDUSTRY
First posted: 2023-01-27
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will enroll oncologists, interventional gastroenterologists, and primary care providers practicing in the US. Participants are randomly assigned to either control, intervention 1, or intervention 2 arms upon enrollment. All eligible and consented participants will complete two rounds of three patient simulations.

Intervention 1 and intervention 2 arms only will receive educational material about the diagnostic test in between these two rounds. Intervention 1 arm participants only will receive the test results whether they select it or not, and Intervention 2 participants will receive the test results only if they select it in the second round of simulated cases
Primary purpose: DIAGNOSTIC

Brief summary: This is a national-level research study of oncologists, interventional gastroenterologists, and primary care providers. The purpose of this study is to assess the clinical evaluation and management (drug, procedures, counseling and other) of a subset of common patient care indications.

Detailed description: The results of this study could contribute to improved quality of care for patients by encouraging better care practices and adherence to evidence-based guidance. The data from this study will be submitted to a national journal for publication. The study plans to enroll up to 250 physicians.

Upon consenting and agreeing to participate in this study, participants will be asked to care for 3 simulated patient cases, known as Clinical Performance and Value Vignettes (CPV®). CPV®s describe patients physicians typically encounter in their daily practice and are not meant to be difficult. In each vignette, physicians are asked to share their expected care through 5 domains: 1) history, 2) physical exam, 3) diagnostic workup, 4) diagnosis and 5) treatment and follow-up. Each case takes approximately 15-20 minutes to complete and we estimate the time commitment for each round of CPV® administration to be approximately 45 - 60 minutes. All responses to the cases will be completed online and will be kept confidential. Over 2 CPV® administration rounds, the total time to care for the simulated patients is estimated at 1.5-2 hours.

If physicians are randomized to an intervention group in this study, they will receive educational materials on a novel diagnostic test after the first round of CPV® administration. They are asked to review these materials before moving to the next CPV® administration round. The time to review educational materials is estimated to be approximately 15 minutes.

Eligibility criteria: Inclusion Criteria:

* Board-certified 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 at risk for pancreatic cancer in their practice
* Practicing in the U.S.
* English speaking
* Access to the internet
* Informed, signed, and voluntarily consented to be in the study

Exclusion Criteria:

* Non-English speaking
* 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
* Previous exposure to the test
* Do not voluntarily consent to be in the study

Primary outcomes:
measure: Clinical Performance and Value (CPV)-measured variation in Assessment
timeFrame: [4 months]
measure: CPV-measured change in treatment Quality
timeFrame: [4 months]
measure: CPV-measured variation in evidence based decisions between control and intervention arms
timeFrame: [4 months]
measure: CPV-measured variation in evidence based decisions between intervention arms
timeFrame: [4 months]
measure: CPV-measured rate of adoption for the diagnostic test
timeFrame: [4 months]
measure: CPV-measured differences in cost of care between control and intervention arms
timeFrame: [4 months]
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: QURE Healthcare
state: California
Study officials:
References: