Establishing Clinical Utility Evidence for Chronic Disease Management Testing

Qure Healthcare

Status: Active, not recruiting

Conditions: Cardiometabolic Syndrome

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05192590

Pro00057790

Details and patient eligibility

About

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.

Full 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.

Enrollment: 249 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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249 participants in 3 patient groups

Control

No Intervention group

Description:

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 group

Description:

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.

Treatment:

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

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

Experimental group

Description:

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.

Treatment:

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