Clinical trial NCT05658653: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Drug Drug Interaction
Medication Adherence
Lead sponsor: Qure Healthcare, LLC
Sponsor class: INDUSTRY
First posted: 2022-12-21
Enrollment: 166
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Clinical Performance and Value (CPV) -measured variation in assessment
timeFrame: [4 months]
measure: CPV-measured change in treatment Quality
timeFrame: [4 months]
measure: CPV-measured difference in amount of evidence-based decisions
timeFrame: [4 months]
Secondary outcomes:
measure: CPV-measured differences in cost of care between control and intervention arms
timeFrame: [4 months]
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: QURE Healthcare
state: California
Study officials:
References: