Establishing Clinical Utility of a New Diagnostic Test for Rheumatology Patients

Qure Healthcare

Status: Completed

Conditions: Lupus Erythematosus, Systemic; Lupus Nephritis

Treatments: Other: Experimental - Test Results and Education

Study type: Interventional

Funder types: Industry

Identifiers

NCT04266860

01DXT2019

Details and patient eligibility

About

This study will collect high-quality randomized controlled data from a nationally representative sample of practicing rheumatologists to determine how they currently manage patients with SLE (systemic lupus erythematosus) and how the results of DxTerity's IFN-1 (interferon type I) test change clinical decision making.

Full description

This study will collect high-quality randomized controlled data from a nationally representative sample of practicing rheumatologists to determine how they currently manage patients with SLE and how the results of the IFN-1 test change clinical decision making. Data from this study will better illuminate the clinical use cases in which the IFN-1 test has the most significant impact on clinical decision making (and thus the largest clinical utility) and the associated physician characteristics (e.g., age, practice setting, training) associated with test adoption.

This study leverages simulated patient cases, called Clinical Performance and Value vignettes (CPVs), in a proven methodology to rapidly measure physician care decisions. CPVs are a unique and scalable tool that standardizes practice measurement by having all providers care for the same (virtual) patients. With all providers caring for the same patients, the CPVs generate unbiased data that yields powerful insights into clinical decision making and how these decisions change with the introduction of a new product or solution. CPVs have been validated and used effectively in rheumatology. Data from the CPVs can quickly demonstrate the clinical utility of a solution, be published in peer-reviewed literature, inform marketing strategies and positively impact coverage and reimbursement decisions.

The study is a prospective cohort trial with six steps:

1. Enrollment: The study will enroll an estimated 166 practicing rheumatologists who practice in the U.S. and are determined to be eligible by an eligibility screener.
2. Provider survey: Once providers are enrolled in the study, they will be asked to complete a questionnaire describing their practice and professional background.
3. Randomization: The 166 rheumatologists will be randomized into equally-sized control and intervention arms.
4. CPVs (First Round): Physicians will complete three randomly-assigned CPV patient simulations. Cases will be identical across the intervention and control arms. All interactive cases are presented on an online platform, and are accessible via unique weblinks and any internet-connected computer.
5. Intervention education: Intervention-arm rheumatologists will receive educational materials describing the clinical validation and use cases of the IFN-1 test. This material will replicate what physicians would receive as part of an actual marketing push introducing them to the IFN-1 test. These materials may be comprised of a slide deck, fact sheet, webinar, and/or case studies.
6. CPVs (Second Round): Physicians will then complete three additional CPV patient simulations in random order. Cases will be identical across the intervention and control arms, except that the intervention arm will receive IFN-1 test results at an appropriate point in each simulated case in the post-intervention round. Control arm physicians will continue to have access to standard of care diagnostic tools only.

Enrollment: 166 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Board-certified in rheumatology for at least two years
2. Averaging at least 20 hours per week of clinical and patient care duties over the last six months
3. Practicing in the U.S.
4. English speaking
5. Access to the internet
6. Informed, signed 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. Not averaging at least 20 hours per week of clinical or patient care duties over the last six months
6. Do not voluntarily consent to be in the study

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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166 participants in 2 patient groups

Experimental

Experimental group

Description:

Experimental-arm providers will complete two rounds of three simulated patient cases (CPVs) with two additions described in the next column:

Treatment:

Other: Experimental - Test Results and Education

Control

No Intervention group

Description:

These providers will complete two rounds of three simulated patient cases (CPVs) only.