Establishing Clinical Utility Evidence for Chronic Disease Management Testing

NCT05192590 | Completed

• 1 other identifier: Pro00057790
• Study Type: interventional
• Target: 247
• 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 other) of a subset of common patient care indications.

Conditions

Cardiometabolic Syndrome

Outcome Measures

Primary Outcomes (3)

• CPV-measured clinical score difference(drug, procedures, counseling and other)

  Difference-in-differences regression analysis between the control and the intervention groups' diagnosis and treatment of chronic dyspnea, as measured by the participants diagnostic and treatment CPV case domain scores. In each domain of a CPV (history, physical exam, workup, diagnosis and treatment), participants' care recommendations are evaluated against evidence-based care scoring criteria which can sum from 0 to a high potential score of up to 100 percent in each domain, where higher scores mean better outcomes.

  12 months

• Test Adoption Rate

  Rate of adoption of the CDMT test in Intervention 2 arm participants.

  12 months

• CPV-measured cost difference

  Difference in expected cost of care between control and intervention participants. (Cost will be calculated by measuring differential rates of medical interventions/levels of care selected by each arm, and multiplying by Medicare reimbursement rates for these interventions, and/or by modeling the incidence of expected complications and calculating associated costs.)

  12 months

Secondary Outcomes (3)

• CPV-measured clinical score differences by use case

  12 months

• CPV-measured cost differences by use case

  12 months

• CPV-measured baseline variation

  12 months

Study Arms (3)

Control

NO INTERVENTION

These providers will complete two rounds of three simulated patient cases (CPVs). Control arm physicians will continue to have access to standard of care diagnostic tools, but not the CDMT test results.

Educational Materials and CDMT Test Results (Intervention 1)

EXPERIMENTAL

Participants will care for the same set of CPV patients as the control arm, but will be educated on and will receive the CDMT test results whether they select it or not. Investigators will compare intervention participants' clinical recommendations to those in the control arm.

Other: Educational Materials and Chronic Disease Management Test (CDMT)

Educational Materials and CDMT Test Results when Selected (Intervention 2)

EXPERIMENTAL

Participants will care for the same set of CPV patients as the control arm, but will be educated on and will receive the CDMT test results only if they select it. Investigators will compare intervention participants' clinical recommendations to those in the control arm.

Other: Educational Materials and Chronic Disease Management Test (CDMT)

Interventions

Educational Materials and Chronic Disease Management Test (CDMT) OTHER

Intervention-1- and Intervention-2-arm participants will receive educational materials duplicating what physicians would receive in the real-world market as they adopt the CDMT technology. These materials are comprised of a PowerPoint presentation. Intervention 1 participants only will receive the CDMT test results whether they select it or not, and Intervention 2 participants will receive the CDMT test results only if they select it during the second round of case simulations.

Educational Materials and CDMT Test Results (Intervention 1); Educational Materials and CDMT Test Results when Selected (Intervention 2)

Eligibility Criteria

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

You may qualify if:

• Subjects must meet the following criteria to be enrolled in the study:
• Board-certified physician currently practicing in the following areas:
• Internal medicine
• Family 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
• 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:

• Non-English speaking
• Practicing in an academic setting
• Unable to access the internet
• Not practicing in the U.S.
• Do not voluntarily consent 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 (2)

• Peabody JW, Ganesan D, Valdenor C, Paculdo D, Schrecker J, Westerfield C, Heltsley R. Randomized prospective trial to detect and distinguish between medication nonadherence, drug-drug interactions, and disease progression in chronic cardiometabolic disease. BMC Prim Care. 2023 Apr 15;24(1):100. doi: 10.1186/s12875-023-02042-4.

  PMID: 37061690 DERIVED

• Valdenor C, Ganesan D, Paculdo D, Schrecker J, Heltsley R, Westerfield C, Peabody JW. Clinical Variation in the Treatment Practices for Medication Nonadherence, Drug-Drug Interactions, and Recognition of Disease Progression in Patients with Chronic Cardiometabolic Diseases: A Cross-Sectional Patient Simulation Study among Primary Care Physicians. Int J Clin Pract. 2022 Jul 30;2022:6450641. doi: 10.1155/2022/6450641. eCollection 2022.

  PMID: 35989865 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: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: The study will enroll primary care physicians practicing in the US. Participants are randomly assigned to either control, intervention 1, or intervention 2 arms upon enrollment. All eligible and consented participants will complete two rounds of three patient simulations. The intervention 1 and intervention 2 arms only will receive educational material about the Aegis test in between these two rounds. Intervention 1 arm participants only will receive the CDMT results whether they select it or not, and Intervention 2 participants will receive the CDMT results only if they select it in the second round of simulated cases

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: January 14, 2022
• Study Start: October 22, 2021
• Primary Completion: February 21, 2022
• Study Completion: February 22, 2023
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)