Clinical trial NCT05910684: Establishing Clinical Utility Evidence for Chronic Disease Management Testing Patient Study
Official title: Establishing Clinical Utility Evidence for Chronic Disease Management Testing: A CPV® and Chart Abstraction Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiometabolic Syndrome
Lead sponsor: Qure Healthcare, LLC
Sponsor class: INDUSTRY
First posted: 2023-06-20
Enrollment: 114
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will enroll primary care physicians practicing in the US from a population of participants who completed phase 1 of the study. All participants will keep their arm assignments from the phase 1 study. All eligible and consented participants will complete a round of three patient simulations.

The intervention arm will have access to the Aegis test and will be asked to use this test on patients who meet the eligibility criteria.
Primary purpose: DIAGNOSTIC

Brief 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

Eligibility criteria: 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.

Primary outcomes:
measure: Chart abstraction measured variation in quantity of care
timeFrame: [19 months]
measure: Chart abstraction measured variation in quality of care
timeFrame: [19 months]
measure: Chart abstraction measured variation in clinical decisions
timeFrame: [19 months]
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: QURE Healthcare
state: California
Study officials:
References: