search
Back to results

Clinical Utility of CDMT Among VillageMD Providers

Primary Purpose

Chronic Disease, Drug Drug Interaction, Medication Adherence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Materials for Chronic Disease Management Test (CDMT)
Sponsored by
Qure Healthcare, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Licensed primary care provider (PCP) (MD, DO, NP, PA) currently practicing in the following areas: a) Internal medicine b) Family medicine Have practiced as a PCP in internal or family medicine for greater than 2 but less than 30 years practicing in a community / non-academic based practice setting ≥ 40 patients under care weekly Commonly treats patients with congestive heart failure/atrial fibrillation, diabetes, hypertension, and COPD Practicing in the United States English-speaking Access to the internet Informed and voluntarily consented to be in the study Exclusion Criteria: Non-English speaking Not a licensed primary care provider Unable to access the internet Not practicing in the U.S. Do not voluntarily consent to be in the study

Sites / Locations

  • QURE Healthcare

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard Practice

Chronic Disease Management Test (CDMT)

Arm Description

The Control group treats their simulated patients using standard practice and has no introduction to the new CDMT test.

The intervention will receive information regarding the CDMT test and will be given the test results, whether selected or not, in Round 2 of CPV administration.

Outcomes

Primary Outcome Measures

Clinical Performance and Value (CPV) -measured variation in assessment
Using the responses to the simulated patient cases to measure the baseline levels of variation in the work-up, recognition, and management of medication non-adherence and/or DDI in patients with more than one cardiometabolic condition and associated polypharmacy. Work-up, recognition, and management scores will be combined to report variation in total assessment of the simulated patient cases.
CPV-measured change in treatment Quality
Measuring the difference in the quality of overall diagnostic scores between control participants using standard-of-care diagnostic tools and intervention participants using the CDMT. Scores will be on a scale of 0-100 with 100 representing the ideal management of a simulated patient.
CPV-measured difference in amount of evidence-based decisions
Differences in number of evidence-based decisions, particularly prescribing decisions, made by intervention providers and control providers, while controlling for provider and practice characteristics, between rounds 1 and 2.

Secondary Outcome Measures

CPV-measured differences in cost of care between control and intervention arms
Difference in the 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 per above).

Full Information

First Posted
December 2, 2022
Last Updated
March 27, 2023
Sponsor
Qure Healthcare, LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT05658653
Brief Title
Clinical Utility of CDMT Among VillageMD Providers
Official Title
Measuring the Clinical Utility of Aegis's Chronic Disease Management Test Among VillageMD Providers: A CPV Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 16, 2022 (Actual)
Primary Completion Date
January 10, 2023 (Actual)
Study Completion Date
January 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qure Healthcare, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a health system-level research study of physicians and care providers. 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.
Detailed Description
The results of this study could contribute to improved quality of care for patients by encouraging better care practices and adherence to evidence-based guidelines. The data from this study will be submitted to a national journal for publication. The study plans to enroll up to 150 physicians. Upon consenting and agreeing to participate in this study, participants will be asked to care for 3 simulated patient cases, known as Clinical Performance and Value Vignettes (CPV®). CPVs describe patients physicians typically encounter in their daily practice and are not meant to be difficult. In each vignette, physicians are asked to share their expected care through 5 domains: 1) history, 2) physical exam, 3) diagnostic workup, 4) diagnosis, and 5) treatment and follow-up. Each case takes approximately 15-20 minutes to complete and the investigators estimate the time commitment for each round of CPV administration to be approximately 45 - 60 minutes. All responses to the cases will be completed online and will be kept confidential. Over 2 CPV administration rounds, the total time to care for the simulated patients is estimated at 1.5-2 hours. If physicians are randomized to the intervention group in this study, they will receive educational materials on a novel diagnostic test after the first round of CPV administration. They are asked to review these materials before moving to the next CPV administration round. The time to review educational materials is estimated to be approximately 15 minutes. Depending on the results of this randomized controlled trial, there may be an opportunity for physicians to re-enroll in a follow-on study. If they choose to participate in this second study, they will be asked to identify and send de-identified records of patients in their practice that are similar to the simulated patients they previously cared for in this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease, Drug Drug Interaction, Medication Adherence

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study will enroll physicians and care providers practicing in the VillageMD health system. Participants are randomly assigned to either control or intervention 1 arms upon enrollment. All eligible and consented participants will complete two rounds of three patient simulations. The intervention arm only will receive educational material about the CDMT test in between these two rounds. Intervention arm participants only will receive the CDMT test results whether they select it or not.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
166 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Practice
Arm Type
No Intervention
Arm Description
The Control group treats their simulated patients using standard practice and has no introduction to the new CDMT test.
Arm Title
Chronic Disease Management Test (CDMT)
Arm Type
Experimental
Arm Description
The intervention will receive information regarding the CDMT test and will be given the test results, whether selected or not, in Round 2 of CPV administration.
Intervention Type
Other
Intervention Name(s)
Educational Materials for Chronic Disease Management Test (CDMT)
Intervention Description
These materials detail what the test does, how it is used, the validity and specifications of the test, and how to read its test report.
Primary Outcome Measure Information:
Title
Clinical Performance and Value (CPV) -measured variation in assessment
Description
Using the responses to the simulated patient cases to measure the baseline levels of variation in the work-up, recognition, and management of medication non-adherence and/or DDI in patients with more than one cardiometabolic condition and associated polypharmacy. Work-up, recognition, and management scores will be combined to report variation in total assessment of the simulated patient cases.
Time Frame
[4 months]
Title
CPV-measured change in treatment Quality
Description
Measuring the difference in the quality of overall diagnostic scores between control participants using standard-of-care diagnostic tools and intervention participants using the CDMT. Scores will be on a scale of 0-100 with 100 representing the ideal management of a simulated patient.
Time Frame
[4 months]
Title
CPV-measured difference in amount of evidence-based decisions
Description
Differences in number of evidence-based decisions, particularly prescribing decisions, made by intervention providers and control providers, while controlling for provider and practice characteristics, between rounds 1 and 2.
Time Frame
[4 months]
Secondary Outcome Measure Information:
Title
CPV-measured differences in cost of care between control and intervention arms
Description
Difference in the 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 per above).
Time Frame
[4 months]

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Licensed primary care provider (PCP) (MD, DO, NP, PA) currently practicing in the following areas: a) Internal medicine b) Family medicine Have practiced as a PCP in internal or family medicine for greater than 2 but less than 30 years practicing in a community / non-academic based practice setting ≥ 40 patients under care weekly Commonly treats patients with congestive heart failure/atrial fibrillation, diabetes, hypertension, and COPD Practicing in the United States English-speaking Access to the internet Informed and voluntarily consented to be in the study Exclusion Criteria: Non-English speaking Not a licensed primary care provider Unable to access the internet Not practicing in the U.S. Do not voluntarily consent to be in the study
Facility Information:
Facility Name
QURE Healthcare
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Clinical Utility of CDMT Among VillageMD Providers

We'll reach out to this number within 24 hrs