Measuring Practice Pattern Changes and Clinical Utility of a Novel Test for Preeclampsia

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.

Study Overview

• Status: Completed
• Conditions: Pre-Eclampsia
• Intervention / Treatment: Other: Experimental Arm

Detailed Description

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:

1. Enrollment: The study will enroll 110 practicing obstetrician/gynecologists (OB/GYNs) in the U.S. who 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 110 OB/GYNs will be randomized into equally-sized (55) control and intervention arms.
4. Education: The intervention-arm OB/GYNs will receive educational materials duplicating what physicians would receive in the real-world market as they adopt the Progenity technology. These materials are comprised of a slide deck and/or a fact sheet.
5. CPVs: Physicians will then complete the four CPV patient simulations in random order. Cases will be identical across the intervention and control arms, except that the intervention arm will receive Progenity PE test results at an appropriate point in each simulated case. All cases are presented on an online platform, participants are provided with unique weblinks, accessible via any internet-connected computer.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94109
      • QURE Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Board-certified in obstetrics/gynecology
2. Averaging at least 20 hours per week of clinical duties over the last six months
3. English speaking
4. Access to the internet
5. Informed, signed and voluntarily consented to be in the study

Exclusion Criteria:

1. Not board certified in obstetrics/gynecology at least 2 years prior
2. Averaging less than 20 hours per week of clinical duties over the last six months
3. Non-English speaking
4. Unable to access the internet
5. Do not voluntarily consent to be in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental; Experimental-arm providers will complete four simulated patient cases (CPVs) with two additions described in the next column:	Other: Experimental Arm; First, these providers will receive educational materials (e.g. a slide deck) meant to mimic what physicians will receive in the real-world market as they learn about the Progenity technology.; Second, within each of their four cases, intervention-arm physicians only will receive simulated test results from the Progenity PE test at the clinically-appropriate point in each case.
NO_INTERVENTION: Control; These providers will complete four simulated patient cases (CPVs) only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Qure Healthcare, LLC
• Collaborators: Progenity, Inc.
• Investigators: Principal Investigator: John Peabody, MD PhD, President, QURE Healthcare

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 22, 2019
• Primary Completion (ACTUAL): December 23, 2019
• Study Completion (ACTUAL): December 23, 2019

Study Registration Dates

• First Submitted: November 15, 2019
• First Submitted That Met QC Criteria: December 16, 2019
• First Posted (ACTUAL): December 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2020
• Last Update Submitted That Met QC Criteria: February 6, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Eclampsia; Pre-Eclampsia
• Other Study ID Numbers: 01PRO2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No