Clinical trial NCT05192590: Establishing Clinical Utility Evidence for Chronic Disease Management Testing
Official title: Establishing Clinical Utility Evidence for Chronic Disease Management Testing (CDMT): A CPV® RandomizedControlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiometabolic Syndrome
Lead sponsor: Qure Healthcare, LLC
Sponsor class: INDUSTRY
First posted: 2022-01-14
Enrollment: 249
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: DIAGNOSTIC

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.

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 guidance. The data from this study will be submitted to a national journal for publication. The study plans to enroll up to 300 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 we 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 an intervention group in this study, they will receive education materials on a diagnostic test currently available for use in the market after the first round of CPV administration. They are asked to review these materials before moving to the next CPV administration round. Time to review education 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 into 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:

* Subjects must meet the following criteria to be enrolled in the study:

  1. Board-certified physician currently practicing in the following areas:

     1. Internal medicine
     2. Family medicine
  2. Have practiced as a board-certified physician in internal or family medicine or greater than 2 but less than 30 years
  3. Community / non-academic based practice setting
  4. ≥ 40 patients under care weekly
  5. Commonly treats patients with atrial fibrillation, coronary artery disease, congestive heart failure, diabetes, hypertension, and hyperlipidemia
  6. Practicing in the U.S.
  7. English-speaking
  8. Access to the internet
  9. Informed and voluntarily consented to be in the study

Exclusion Criteria:

1. Non-English speaking
2. Practicing in an academic setting
3. Unable to access the internet
4. Not practicing in the U.S.
5. Do not voluntarily consent to be in the study

Primary outcomes:
measure: CPV-measured clinical score difference(drug, procedures, counseling and other)
timeFrame: 12 months
measure: Test Adoption Rate
timeFrame: 12 months
measure: CPV-measured cost difference
timeFrame: 12 months
Secondary outcomes:
measure: CPV-measured clinical score differences by use case
timeFrame: 12 months
measure: CPV-measured cost differences by use case
timeFrame: 12 months
measure: CPV-measured baseline variation
timeFrame: 12 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: QURE Healthcare
state: California
Study officials:
References:
citation: 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.