NCT04550416

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 217 (actual)
• Sponsor: Qure Healthcare, LLC · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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 by improving the diagnosis and/or treatment CPV® domain score post-intervention versus baseline comparing intervention and control groups The investigators will estimate the effect of ProMark™ on the primary outcomes comparing treatment and control groups using a difference-in-difference analysis comparing differences between groups before and after intervention. The investigators will control for potential confounders, such as age, gender, and other physician and practice characteristics.

Detailed description

Secondary outcome measure include: 1. Difference in overall Clinical Performance and Value Vignettes (CPV®) scores post-intervention versus baseline comparing intervention and control groups 2. Difference between intervention and control for use of active surveillance. 3. Change in utilization of resources in terms of surgery, radiation (in any form), chemotherapy (in any of its forms) between intervention and control groups.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
OTHER	ProMark Information and Test Results	Participants in the intervention arm will receive information (both print and webinar format) about ProMark in between Round 1 and Round 2 data collection, as well as appropriate ProMark test results for each of the vignette-based simulated patients that they care for in the second round of data collection.

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2020-09-16
• Last updated: 2020-09-16

Locations

1 site across 1 country: United States