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| Name | Class |
|---|---|
| Progenity, Inc. | INDUSTRY |
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This study will collect high-quality data on how practicing obstetricians across the U.S. currently manage patients showing signs and/or symptoms of preeclampsia and how the results of Progenity's 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 data on how practicing obstetricians across the U.S. currently manage patients showing signs and/or symptoms of preeclampsia and how the results of Progenity's test change clinical decision making. Data from this study will better illuminate the clinical use cases with the most significant impact on clinical decision making (and thus the largest potential 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. 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 five steps:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Experimental-arm providers will complete four simulated patient cases (CPVs) with two additions described in the next column: |
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| Control | No Intervention | These providers will complete four simulated patient cases (CPVs) only. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental Arm | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| CPV-measured cost difference | Difference in cost of suspected PE-related care between control and intervention physicians. (Cost is 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/levels of care.) | One week |
| CPV-measured clinical score difference | Difference in the overall, and the diagnostic and treatment quality scores between control and intervention physicians. Diagnostic and treatment scores are calculated as the percent correct on CPVs, and the overall score is a average score of the subcategory scores (percent correct). | One week |
| Measure | Description | Time Frame |
|---|---|---|
| CPV-measured cost differences by use case | Difference in cost of suspected PE-related care between control and intervention physicians. (Cost is 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/levels of care.) This will be examined for each of the four use cases to determine in which case(s) cost metrics most improved. |
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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 | 94109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 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. |
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No IPD will be shared.
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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The study will enroll practicing OB/GYNs in the US. All eligible and consented participants will complete 4 patient simulations. The intervention arm only will receive educational material about Progenity's test prior to these simulations, and be provided simulated Progenity test results in the simulated cases.
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|
| One week |
| CPV-measured clinical score differences by use case | Difference in the overall, and the diagnostic and treatment quality scores between control and intervention physicians. Diagnostic and treatment scores are calculated as the percent correct on CPVs, and the overall score is a average score of the subcategory scores (percent correct). This will be examined for each of the four use cases to determine in which case(s) CPV scores most improved. | One week |
| CPV-calculated baseline variation | Baseline (control physicians) levels of variation in the work-up and management of suspected PE patients. Variation is examined by looking at the range and standard deviation of the overall baseline scores for each CPV. | One week |
| 28036350 | Background | 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. |
| 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. |