Effects of a New Diagnostic Test on the Care of Prostate Cancer Patients: The ProMark™ Clinical Utility Study

Study Summary

The objectives of this study are to assess clinical practice variation in prostate cancer diagnosis and treatment among urologists and how ProMark™ affects clinical practice decision-making. The study uses a randomized controlled study design of urologists. Urologists will be randomly assigned to a control and intervention arm. * Pre-intervention/baseline assessment: will be done using prostate cancer CPV® vignettes and a physician questionnaire to both control and intervention arms. * Intervention: 2-4 weeks after baseline introduce ProMark™ to the intervention group of urologists using a protocol to be determined by Metamark and QURE. * Post-intervention: 6 weeks post-intervention, a second round of prostate cancer CPV® vignettes will be administered to both control and intervention arms. The ProMark™ test will be available to "order" for all physicians taking the vignettes. The Clinical Performance and Value Vignettes (CPV®) used in this study simulate a clinical encounter for a man presenting with prostate cancer. Each urologist will provide responses to open-ended questions regarding clinical care they would provide for that patient. These responses are scored in five domains (taking a medical history, performing a physical examination, ordering appropriate tests, making a diagnosis and prescribing treatment against explicit evidence and criteria as determined by the literature and medical associations. Results are presented as percentage correct. Each case will take approximately 15-20 minutes to complete. All case responses will be completed online and kept confidential. The study hypotheses are: 1. Clinical practice, specifically decisions around prostate cancer treatment post-diagnosis, will vary widely among urologists. This variation in practice will demonstrate the need a new diagnostic, such as ProMark™, would fulfill. 2. ProMark™ will improve clinical decision making of urologists for prostate cancer patients with a Gleason Score of 3+3=6 and 3+4=7

Primary Outcome

Difference in difference between the control and the intervention groups in the diagnosis-treatment quality of care as measured by their combined domain CPV scores (ranging from 0% to 100%) for the 9 patient types in aggregate and by case type.

Interventions

• OTHER ProMark Information and Test Results