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| Name | Class |
|---|---|
| DxTerity Diagnostics | INDUSTRY |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Experimental-arm providers will complete two rounds of three simulated patient cases (CPVs) with two additions described in the next column: |
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| Control | No Intervention | These providers will complete two rounds of three simulated patient cases (CPVs) only. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental - Test Results and Education | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Peabody, MD, PhD | President, QURE Healthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| QURE Healthcare | San Francisco | California | 94133 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30328782 | Background | Burgon TB, Cox-Chapman J, Czarnecki C, Kropp R, Guerriere R, Paculdo D, Peabody JW. Engaging Primary Care Providers to Reduce Unwanted Clinical Variation and Support ACO Cost and Quality Goals: A Unique Provider-Payer Collaboration. Popul Health Manag. 2019 Aug;22(4):321-329. doi: 10.1089/pop.2018.0111. Epub 2018 Oct 17. | |
| 28036350 |
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| ID | Term |
|---|---|
| D008181 | Lupus Nephritis |
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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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.
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| Peabody J, Martin M, DeMaria L, Florentino J, Paculdo D, Paul M, Vanzo R, Wassman ER, Burgon T. Clinical Utility of a Comprehensive, Whole Genome CMA Testing Platform in Pediatrics: A Prospective Randomized Controlled Trial of Simulated Patients in Physician Practices. PLoS One. 2016 Dec 30;11(12):e0169064. doi: 10.1371/journal.pone.0169064. eCollection 2016. |
| 23667587 | Background | Peabody JW, Strand V, Shimkhada R, Lee R, Chernoff D. Impact of rheumatoid arthritis disease activity test on clinical practice. PLoS One. 2013 May 7;8(5):e63215. doi: 10.1371/journal.pone.0063215. Print 2013. |
| 19224955 | Background | Solon O, Woo K, Quimbo SA, Shimkhada R, Florentino J, Peabody JW. A novel method for measuring health care system performance: experience from QIDS in the Philippines. Health Policy Plan. 2009 May;24(3):167-74. doi: 10.1093/heapol/czp003. Epub 2009 Feb 18. |
| 24561410 | Background | DeMaria L, Acelajado MC, Luck J, Ta H, Chernoff D, Florentino J, Peabody JW. Variations and practice in the care of patients with rheumatoid arthritis: quality and cost of care. J Clin Rheumatol. 2014 Mar;20(2):79-86. doi: 10.1097/RHU.0000000000000076. |
| 15545677 | Background | Peabody JW, Luck J, Glassman P, Jain S, Hansen J, Spell M, Lee M. Measuring the quality of physician practice by using clinical vignettes: a prospective validation study. Ann Intern Med. 2004 Nov 16;141(10):771-80. doi: 10.7326/0003-4819-141-10-200411160-00008. |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |