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| Name | Class |
|---|---|
| Ethos Laboratories | UNKNOWN |
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This study will collect high-quality data on how practicing primary care physicians across the U.S. currently manage patients experiencing chronic pain and how the results of Ethos Laboratories' test change clinical decision making. To do so, this study leverages simulated patient cases called Clinical Performance and Value vignettes (CPVs) in a proven methodology to rapidly measure physician care decisions.
This study will collect high-quality randomized controlled data from a nationally representative sample of practicing physicians, specifically primary care physicians and pain specialists, to determine how they currently manage patients with pain and how the results of Ethos' test change their clinical decision making. Data from this study will better illuminate the clinical use cases in which the Ethos test has the most significant impact on clinical decision making (and thus the largest clinical utility) and the physician characteristics (e.g., age, practice setting, training) associated with practice change.
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 Arm | Other | First, these providers will receive educational materials (e.g. a slide deck, mock test result and FAQ handout) meant to mimic what physicians will receive in the real-world market as they learn about the Ethos technology. Second, within each of their second-round cases, intervention-arm physicians only will receive simulated test results from the Ethos test at the clinically-appropriate point in each case. |
| Measure | Description | Time Frame |
|---|---|---|
| CPV-measured pre-/post-difference in quality score between intervention and control physicians | Physicians completing the simulated cases, or CPVs, receive scores based upon the quality of care they provide. This measure will assess the pre-/post-difference in these scores between control physicians using standard of care diagnostic tools and intervention physicians with access to Ethos test results, including by use case types | 2-4 weeks |
| CPV-measured differences in evidence-based decisions made by intervention physicians and control physicians between rounds 1 and 2 | Physicians completing the simulated cases, or CPVs, receive scores based upon the quality of care they provide. This measure will assess differences in evidence-based decisions made by intervention physicians and control physicians between rounds 1 and 2, including by use case types | 2-4 weeks |
| CPV-measured cost difference | Difference in cost of care between control and intervention physicians, including by use case types. (Cost will be calculated by measuring differential rates of medical interventions/levels of care selected by each arm on their CPVs, and multiplying by Medicare reimbursement rates for these interventions, and/or by modeling the incidence of expected complications and calculating associated costs.) | 2-4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| CPV-measured baseline variation | Physicians completing the simulated cases, or CPVs, receive scores based upon the quality of care they provide. This measure will assess the baseline levels of variation in the care of pain 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 |
|---|---|
| D010146 | Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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The study will enroll practicing primary care physicians in the US. Physicians are randomly assigned to either a control or intervention arm upon enrollment.
All eligible and consented participants will complete two rounds of three patient simulations.
The intervention arm only will receive educational material about the Ethos test in between these two rounds, and be provided simulated Ethos 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. |