NCT04266821

Establishing Clinical Utility of a New Diagnostic Test for Patients Suffering From Pain: A CPV® Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: Qure Healthcare, LLC · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

This study will collect high-quality data on how practicing primary care physicians across the U.S. currently manage patients experiencing chronic pain and how the results of Ethos Laboratories' test change clinical decision making. To do so, this study leverages simulated patient cases called Clinical Performance and Value vignettes (CPVs) in a proven methodology to rapidly measure physician care decisions.

Detailed description

This study will collect high-quality randomized controlled data from a nationally representative sample of practicing physicians, specifically primary care physicians and pain specialists, to determine how they currently manage patients with pain and how the results of Ethos' test change their clinical decision making. Data from this study will better illuminate the clinical use cases in which the Ethos test has the most significant impact on clinical decision making (and thus the largest clinical utility) and the physician characteristics (e.g., age, practice setting, training) associated with practice change. The study is a prospective cohort trial with six steps: 1. Enrollment: The study will enroll an estimated 166 practicing primary care physicians who practice in the U.S. and are determined to be eligible by an eligibility screener. 2. Provider survey: Once providers are enrolled in the study, they will be asked to complete a questionnaire describing their practice and professional background. 3. Randomization: The 166 physicians will be randomized into equally-sized control and intervention arms. 4. CPVs (First Round): Physicians will complete three randomly-assigned CPV patient simulations. Cases will be identical across the intervention and control arms. All interactive cases are presented on an online platform, and are accessible via unique weblinks and any internet-connected computer. 5. Intervention education: Intervention-arm physicians will receive educational materials describing the clinical validation and use cases of the Ethos test. This material will replicate what physicians would receive as part of an actual marketing push introducing them to the Ethos test. These materials may be comprised of a slide deck, fact sheet, webinar, and/or case studies. 6. CPVs (Second Round): All participating physicians will then be asked to complete three additional CPV patient simulations. The cases are given to the doctors in a random order. Cases will be identical across the intervention and control arms, except that the intervention arm will receive Ethos test results at an appropriate point in each simulated case in the post-intervention round. Control arm physicians will continue to have access to standard of care diagnostic tools, but not the Ethos test results.

Conditions

• Pain
• Pain, Chronic

Interventions

Type	Name	Description
OTHER	Experimental Arm	First, these providers will receive educational materials (e.g. a slide deck, mock test result and FAQ handout) meant to mimic what physicians will receive in the real-world market as they learn about the Ethos technology. Second, within each of their second-round cases, intervention-arm physicians only will receive simulated test results from the Ethos test at the clinically-appropriate point in each case.

Timeline

• Start date: 2020-02-01
• Primary completion: 2020-05-04
• Completion: 2020-05-31
• First posted: 2020-02-12
• Last updated: 2020-09-16

Locations

1 site across 1 country: United States