Clinical Utility Study for MyProstateScore+

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Other: Education Materials for MyProstateScore

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.

• Study Type: Interventional
• Enrollment (Actual): 234
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: John W Peabody, MD, PhD; Phone Number: 4153213388; Email: jpeabody@qurehealthcare.com

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94109
      • QURE Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Control group treats their simulated patients using standard practice and have no introduction to the new LynxDx test.
Experimental: Intervention Group 1; Intervention Group 1 will receive information regarding the LynxDx rest and will be given the test results, whether selected or not, in Round 2 of CPV administration.	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.; Other Names: MyProstateScore results
Experimental: Intervention Group 2; Intervention Group 2 will receive information regarding the LynxDx test and will be given the test results if selected in Round 2 of CPV administration.	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.; Other Names: MyProstateScore results

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Performance and Value (CPV)-measured variation in Assessment	Measuring the rates of ordering prostate biopsy with proper assessment, recognition, and management of prostate cancer risks in patients with different PSA levels, a negative previous prostate biopsy, and an elevated PI-RADS score.	[4 months]
CPV-measured change in treatment Quality	Measure of the difference in quality of overall diagnostic scores between control physicians using standard of care diagnostic tools and intervention physicians using the MyProstateScore test.	[4 months]
CPV-measured variation in evidence based decisions between control and intervention arms	Measure of the difference in number of evidence-based decisions made by intervention physicians versus control physicians, while controlling for physician and practice characteristics, between rounds 1 and 2.	[4 months]
CPV-measured variation in evidence based decisions between intervention arms	Measure the differences in amount of evidence-based decisions made by intervention group one physicians versus intervention group two physicians to assess whether the choice to order the MyProstateScore test impacts the frequency of prostate biopsies and overall patient care and outcomes.	[4 months]
CPV-measured rate of adoption for MyProstateScore	Rate of adoption of the MyProstateScore test after receiving educational materials on the benefits of testing in patients who are at risk.	[4 months]
CPV-measured differences in cost of care between control and intervention arms	Difference in the cost of care between control and intervention physicians (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 per above).	[4 months]

Collaborators and Investigators

• Sponsor: Qure Healthcare, LLC

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2022
• Primary Completion (Actual): June 4, 2023
• Study Completion (Actual): June 4, 2023

Study Registration Dates

• First Submitted: August 22, 2022
• First Submitted That Met QC Criteria: August 30, 2022
• First Posted (Actual): September 2, 2022

Study Record Updates

• Last Update Posted (Estimated): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 12, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: Pro00065388

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No