NCT05525806

Clinical Utility Study for MyProstateScore+

Establishing Clinical Utility Evidence to Support Coverage and Reimbursement for LynxDx's MyProstateScore Test: A CPV® Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 234 (actual)
• Sponsor: Qure Healthcare, LLC · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
OTHER	Education Materials for MyProstateScore	These materials detail what the test does, how it is used, the validity and specifications of the test, and how to read its test report.

Timeline

• Start date: 2022-09-12
• Primary completion: 2023-06-04
• Completion: 2023-06-04
• First posted: 2022-09-02
• Last updated: 2023-06-13

Locations

1 site across 1 country: United States