NCT05192590

Establishing Clinical Utility Evidence for Chronic Disease Management Testing

Establishing Clinical Utility Evidence for Chronic Disease Management Testing (CDMT): A CPV® RandomizedControlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 247 (actual)
• Sponsor: Qure Healthcare, LLC · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This is a national-level research study of primary care physicians. The purpose of this study is to assess the clinical evaluation and management (drug, procedures, counseling and other) of a subset of common patient care indications.

Detailed description

The results of this study could contribute to improved quality of care for patients by encouraging better care practices and adherence to evidence-based guidance. The data from this study will be submitted to a national journal for publication. The study plans to enroll up to 300 physicians. Upon consenting and agreeing to participate in this study, participants will be asked to care for 3 simulated patient cases, known as Clinical Performance and Value Vignettes (CPV®). CPVs describe patients physicians typically encounter in their daily practice and are not meant to be difficult. In each vignette, physicians are asked to share their expected care through 5 domains: 1) history, 2) physical exam, 3) diagnostic workup, 4) diagnosis and 5) treatment and follow-up. Each case takes approximately 15-20 minutes to complete and we estimate the time commitment for each round of CPV administration to be approximately 45 - 60 minutes. All responses to the cases will be completed online and will be kept confidential. Over 2 CPV administration rounds, the total time to care for the simulated patients is estimated at 1.5-2 hours. If physicians are randomized to an intervention group in this study, they will receive education materials on a diagnostic test currently available for use in the market after the first round of CPV administration. They are asked to review these materials before moving to the next CPV administration round. Time to review education materials is estimated to be approximately 15 minutes. Depending on the results of this randomized controlled trial, there may be an opportunity for physicians to re-enroll into a follow-on study. If they choose to participate in this second study, they will be asked to identify and send de-identified records of patients in their practice that are similar to the simulated patients they previously cared for in this study.

Conditions

• Cardiometabolic Syndrome

Interventions

Type	Name	Description
OTHER	Educational Materials and Chronic Disease Management Test (CDMT)	Intervention-1- and Intervention-2-arm participants will receive educational materials duplicating what physicians would receive in the real-world market as they adopt the CDMT technology. These materials are comprised of a PowerPoint presentation. Intervention 1 participants only will receive the CDMT test results whether they select it or not, and Intervention 2 participants will receive the CDMT test results only if they select it during the second round of case simulations.

Timeline

• Start date: 2021-10-22
• Primary completion: 2022-02-21
• Completion: 2023-02-22
• First posted: 2022-01-14
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States