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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-22

Study Completion Date

2019-12-23

Brief Summary

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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.

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Detailed Description

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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. 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.

Conditions

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Pre-Eclampsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Experimental

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

Group Type EXPERIMENTAL

Experimental Arm

Intervention Type 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.

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes