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

Qure Healthcare

Status: Completed

Conditions: Pre-Eclampsia

Treatments: Other: Experimental Arm

Study type: Interventional

Funder types: Industry

Identifiers

NCT04204018

01PRO2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

Experimental

Experimental group

Description:

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

Treatment:

Other: Experimental Arm

Control

No Intervention group

Description:

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