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

NCT04550416 | Completed

• 1 other identifier: 01-MM-14
• Study Type: interventional
• Target: 217
• Locations: 1 country
• Sites: 1

Brief 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:
• 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.
• 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

Conditions

Prostate Cancer

Keywords

prostate cancer; risk assessment; clinical utility

Outcome Measures

Primary Outcomes (1)

• Combined diagnostic and treatment CPV® (Clinical Performance and Value) vignette domain score

  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.

  12 to 16 weeks

Study Arms (2)

ProMark Information and Results

EXPERIMENTAL

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.

Other: ProMark Information and Test Results

Standard Practice

NO INTERVENTION

Physicians will care for online virtual patients as they normally would in practice.

Interventions

ProMark Information and Test Results OTHER

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.

ProMark Information and Results

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide consent to participate in the study
• Currently practicing board certified urologist
• Have practiced as a board-certified urologist for greater than 2 or less than 30 years.
• English-speaking
• Community / non-academic based practice setting
• ≥50 PCa patients under care annually
• Access to the internet

You may not qualify if:

• Not board certified in urology
• Academic based practice
• Have previously used ProMark for prostate cancer care delivery
• Have practiced as a board-certified urologist for less than 2 or greater than 30 years.
• Follow \<50 PCa patients annually
• Non-English speaking
• Unable to access the internet

Sponsors & Collaborators

• Qure Healthcare, LLC: lead

Study Sites (1)

QURE Healthcare

San Rafael, California, 94901, United States

Location

Related Links

• Study Sponsor web page
• Web page for organization implementing the study.

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• John W Peabody, MD PhD

  QURE Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2014
• First Posted: September 16, 2020
• Study Start: May 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: September 16, 2020

Record last verified: 2020-09

Locations

US (1)