Establishing Clinical Utility Evidence for Chronic Disease Management Testing Patient Study

Qure Healthcare

Status: Completed

Conditions: Cardiometabolic Syndrome

Treatments: Diagnostic Test: Aegis CDM Test and Educational Materials

Study type: Interventional

Funder types: Industry

Identifiers

NCT05910684

Pro00060013

Details and patient eligibility

About

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.

Full 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

Enrollment: 114 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Board-certified physician currently practicing in either Family Medicine or Internal Medicine.
• Have practiced as a board-certified physician in internal or family medicine or greater than 2 but less than 30 years
• Community/non-academic based practice setting
• ≥ 40 patients under care weekly
• Commonly treats patients with atrial fibrillation, coronary artery disease, congestive heart failure, diabetes, hypertension, and hyperlipidemia
• Patient HIPAA Authorization form signed upon initial enrollment into the provider's practice
• Practicing in the U.S.
• English-speaking
• Access to the internet
• Informed and voluntarily consented to be in the study

Exclusion criteria

• Not a board-certified physician
• Not practicing in the United States
• Not informed and voluntarily consented to be in the study.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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114 participants in 2 patient groups

Control Group

No Intervention group

Description:

These participants will complete their online simulations and treat their real-life patients without access to the Aegis test.

Educational Materials and Test Access

Experimental group

Description:

These participants will complete their online simulations and treat their real-life patients with access to educational materials and the Aegis test results. Investigators will compare intervention participants' clinical recommendations to those in the control arm.

Treatment:

Diagnostic Test: Aegis CDM Test and Educational Materials