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

Conditions

• Prostate Cancer

Interventions

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.

Sponsors & Collaborators

• Qure Healthcare, LLC

  lead INDUSTRY

Principal Investigators

• John W Peabody, MD PhD · QURE Healthcare

Study Design

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-05-31

Primary Completion

2015-01-31

Completion

2015-01-31

Countries

• United States

Study Locations