Establishing Clinical Utility Evidence for Chronic Disease Management Testing Patient Study

NCT05910684 | Completed FDA Device

• 1 other identifier: Pro00060013
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiometabolic Syndrome

Outcome Measures

Primary Outcomes (3)

• 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]

• 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]

• 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]

Study Arms (2)

Control Group

NO INTERVENTION

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

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.

Diagnostic Test: Aegis CDM Test and Educational Materials

Interventions

Aegis CDM Test and Educational Materials DIAGNOSTIC_TEST

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.

Educational Materials and Test Access

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Qure Healthcare, LLC: lead

Study Sites (1)

QURE Healthcare

San Francisco, California, 94109, United States

Location

Related Publications (1)

• David RE, Ferrara KG, Schrecker J, Paculdo D, Johnson S, Bentley-Lewis R, Heltsley R, Peabody JW. Impact of medication nonadherence and drug-drug interaction testing on the management of primary care patients with polypharmacy: a randomized controlled trial. BMC Med. 2024 Nov 18;22(1):540. doi: 10.1186/s12916-024-03757-6.

  PMID: 39551766 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 20, 2023
• Study Start: July 19, 2022
• Primary Completion: January 30, 2024
• Study Completion: January 30, 2024
• Last Updated: April 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)