Clinical trial NCT05525806: Clinical Utility Study for MyProstateScore+
Official title: Establishing Clinical Utility Evidence to Support Coverage and Reimbursement for LynxDx's MyProstateScore Test: A CPV® Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Qure Healthcare, LLC
Sponsor class: INDUSTRY
First posted: 2022-09-02
Enrollment: 234
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will enroll urologists 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.

The intervention 1 and intervention 2 arms only will receive educational material about the LynxDx test in between these two rounds. Intervention 1 arm participants only will receive the CDMT test results whether they select it or not, and Intervention 2 participants will receive the CDMT 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 urologists. 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®). CPVs 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 education 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. Time to review education materials is estimated to be approximately 15 minutes.

Depending on the results of this randomized controlled trial, there may be an opportunity for physicians to re-enroll into a follow-on study. If they choose to participate in this second study, they will be asked to identify and send de-identified records of patients in their practice that are similar to the simulated patients they previously cared for in this study.

Eligibility criteria: Inclusion Criteria:

* Board-certified urologists 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 prostate 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 MyProstateScore 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 MyProstateScore
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: