Establishing Clinical Utility of a New Diagnostic Test for Rheumatology Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 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. Provider survey: Once providers are enrolled in the study, they will be asked to complete a questionnaire describing their practice and professional background. Randomization: The 166 rheumatologists will be randomized into equally-sized control and intervention arms. 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. 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. 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.

Official Title
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Establishing Clinical Utility of a New Diagnostic Test for Rheumatology Patients: A CPV® Randomized Controlled Trial

Conditions
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Lupus Nephritis, Lupus Erythematosus, Systemic

Intervention / Treatment
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* Other: Experimental - Test Results and Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Board-certified in rheumatology for at least two years Averaging at least 20 hours per week of clinical and patient care duties over the last six months Practicing in the U.S. English speaking Access to the internet Informed, signed and voluntarily consented to be in the study Exclusion Criteria: Non-English speaking Practicing in an academic setting Unable to access the internet Not practicing in the U.S. Not averaging at least 20 hours per week of clinical or patient care duties over the last six months Do not voluntarily consent to be in the study
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: The study will enroll practicing rheumatologists in the US, who will be randomly assigned to either an intervention or control arm. All eligible and consented participants will complete two rounds of three patient simulations. The intervention arm only will receive educational material about the DxTerity test in between these two rounds, and be provided simulated DxTerity test results in the second round of simulated cases.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Experimental-arm providers will complete two rounds of three simulated patient cases (CPVs) with two additions described in the next column: | Other: Experimental - Test Results and Education<br>* First, these providers will receive educational materials (e.g. a slide deck, mock test result and one-page fact sheet) meant to mimic what physicians will receive in the real-world market as they learn about the DxTerity test. Second, within each of their second-round cases, intervention-arm physicians only will receive simulated test results from the DxTerity test at the clinically-appropriate point in each case.<br>|
| No Intervention: Control<br>These providers will complete two rounds of three simulated patient cases (CPVs) only. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CPV-measured pre-/post-score difference | Doctors receive scores on their simulated cases, or CPVs, based upon their quality of care. This measure will assess the pre- vs post-difference in the overall and the diagnostic and treatment quality scores between control physicians using standard of care diagnostic tools and intervention physicians with access to DxTerity test results, including by use case types. | 2-4 weeks | 
| CPV-measured value of care | Doctors make decisions in their simulated cases, or CPVs, including which tests and/or treatments to order for their virtual patients. This measure will model whether using IFN-1 results in higher-value care decisions in these CPV cases, including more appropriate use of disease modifying agents, for lupus-related care in different use cases. | 2-4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CPV-measured baseline variation | Doctors receive scores on their simulated cases, or CPVs, based upon their quality of care. This measure will assess the baseline levels of score variation in the work-up and management of lupus patients among all participants, including by use case types | 1 week |