Establishing Clinical Utility Evidence for Chronic Disease Management Testing Patient Study

Cardiometabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05910684
• Other study ID #: Pro00060013
• Status: Completed
• Phase: N/A
• Start date: July 19, 2022
• Est. completion date: January 30, 2024

Study information

• Verified date: April 2024
• Source: Qure Healthcare, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: January 30, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiometabolic Syndrome
• Chronic Disease
• Metabolic Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	QURE Healthcare	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Qure Healthcare, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chart abstraction measured variation in quantity of care	Measuring the difference in the quality of care between the control arm and the intervention arm as measured by the number of care decisions made in the second round of chart abstraction.; These care decisions might include decisions such as avoidance of invasive diagnostic tests, reductions in unneeded specialist referrals, increased diagnosis and treatment of drug-drug interactions, or care decisions related to costs.	[19 months]
Primary	Chart abstraction measured variation in quality of care	Measuring the difference in the quality of care between the control arm and the intervention arm as measured by the quality of care decisions made in the second round of chart abstraction.; These care decisions might include decisions such as avoidance of invasive diagnostic tests, reductions in unneeded specialist referrals, increased diagnosis and treatment of drug-drug interactions, or care decisions related to costs.	[19 months]
Primary	Chart abstraction measured variation in clinical decisions	Measuring the variation in amount of evidence based clinical decisions among practicing primary care physicians in the assessment, recognition, and adjustment of treatment due to medication non-adherence and DDIs in patients with chronic cardiometabolic diseases.	[19 months]