NCT05910684

Establishing Clinical Utility Evidence for Chronic Disease Management Testing Patient Study

Establishing Clinical Utility Evidence for Chronic Disease Management Testing: A CPV® and Chart Abstraction Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 114 (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 others) of a subset of common patient care indications.

Detailed description

In the original study protocol (approved on October 19th, 2021), which the investigators are now referring to as Phase 1, the investigators measured changes in clinical practice using Clinical Performance and Value (CPVs) vignettes, described below. Phase 1 utilized simulated patients to determine clinical variation in the management of chronic cardiometabolic diseases and assessed the impact of the CDMT results on physicians' clinical decision-making. CPVs are QURE's scientifically-validated measurement tool, first described in JAMA, 2000, and now used in scores of scientific investigations. In this research and derivative peer-reviewed publications, QURE's CPV studies efficiently measure clinical practice patterns among active physicians to determine if there is value in new technologies to payers. This amendment allows us to ask the same physicians if they change their practice in an actual clinical setting. Phase 2 extends the findings from Phase 1 by measuring the change in clinical practice using CPVs and securing data on practice patterns from abstracted medical records. the investigators will look for the same changes the investigators found in Phase 1 to determine the impact of CDMT on real-world clinical decisions and patient outcomes. The advantage of Phase 2 is that it leverages the same sample frame and the randomization by returning to the physicians in Round 1 who indicated that CDMT would change their practice. These physicians will be given, free of charge, the option of using CDMT on their real patients who share similar medical diagnoses as the CPV simulated patients. Phase 2 will thus provide patient-level data on the impact of medication adherence assessment on quality outcomes including, but not limited to, blood pressure control, blood sugar control, and parameters of disease progression

Conditions

• Cardiometabolic Syndrome

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Aegis CDM Test and Educational Materials	The Aegis CDM diagnostic test will be given to intervention participants to use on their patients. The participants will receive the results of the test through a web portal. Investigators will analyze the differences in quality of care between the control arm and the intervention arm.

Timeline

• Start date: 2022-07-19
• Primary completion: 2024-01-30
• Completion: 2024-01-30
• First posted: 2023-06-20
• Last updated: 2024-04-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study