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

NCT04204018 | Completed

• 1 other identifier: 01PRO2019
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pre-Eclampsia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• CPV-measured cost differences by use case

  One week

• CPV-measured clinical score differences by use case

  One week

• CPV-calculated baseline variation

  One week

Study Arms (2)

Experimental

EXPERIMENTAL

Experimental-arm providers will complete four simulated patient cases (CPVs) with two additions described in the next column:

Other: Experimental Arm

Control

NO INTERVENTION

These providers will complete four simulated patient cases (CPVs) only.

Interventions

Experimental Arm OTHER

* 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.

Experimental

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Qure Healthcare, LLC: lead
• Progenity, Inc.: collaborator

Study Sites (1)

QURE Healthcare

San Francisco, California, 94109, United States

Location

Related Publications (4)

• 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.

  PMID: 15545677 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.

  PMID: 23667587 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.

  PMID: 28036350 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.

  PMID: 19224955 BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• John Peabody, MD PhD

  President, QURE Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: December 18, 2019
• Study Start: November 22, 2019
• Primary Completion: December 23, 2019
• Study Completion: December 23, 2019
• Last Updated: February 10, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)