Pre-EclampsiaNCT04204018
Measuring Practice Pattern Changes and Clinical Utility of a Novel Test for Preeclampsia
A study testing Experimental Arm in people with Pre-Eclampsia, run by Qure Healthcare, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pre-Eclampsia
- What is being tested?
- Experimental Arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2019to 23 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- 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.
- Provider survey: Once providers are enrolled in the study, they will be asked to complete a questionnaire describing their practice and professional background.
- Randomization: The 110 OB/GYNs will be randomized into equally-sized (55) control and intervention arms.
- 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.
- 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
- Pre-Eclampsia
- Being tested
- Experimental Arm
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental ArmOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Experimental-arm providers will complete four simulated patient cases (CPVs) with two additions described in the next column: Receives: Other: Experimental Arm |
| Control | No intervention | These providers will complete four simulated patient cases (CPVs) only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: 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).
Measured: One week
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start22 Nov 2019
- Primary completion23 Dec 2019
- Study completion23 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qure Healthcare, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Progenity, Inc.
- Responsible party
- Sponsor
- Investigators
- John Peabody, MD PhD, Principal investigator, President, QURE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04204018
- Sponsor's protocol ID
- 01PRO2019
- Status last verified
- Feb 2020
- First submitted
- 15 Nov 2019
- Last updated
- 10 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared.
Publications
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.
PubMed 15545677Peabody 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.
PubMed 23667587Peabody 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.
PubMed 28036350Solon 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.
PubMed 19224955
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Practice Pattern Changes and Clinical Utility of a Novel Test for Preeclampsia
- ClinicalTrials.gov ID
- NCT04204018
- Acronym / sponsor ID
- 01PRO2019
- Conditions
- Pre-Eclampsia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Qure Healthcare, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Progenity, Inc.
- Study start
- 22 Nov 2019 (actual)
- Primary completion
- 23 Dec 2019 (actual)
- Study completion
- 23 Dec 2019 (actual)
- First posted
- 18 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- Provider survey: Once providers are enrolled in the study, they will be asked to complete a questionnaire describing their practice and professional background.
- Randomization: The 110 OB/GYNs will be randomized into equally-sized (55) control and intervention arms.
- 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.
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Experimental ArmExperimental-arm providers will complete four simulated patient cases (CPVs) with two additions described in the next column: |
| Control | No intervention | –These providers will complete four simulated patient cases (CPVs) only. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Experimental |
Primary outcome
CPV-measured cost difference
Time frame: One week
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.)
CPV-measured clinical score difference
Time frame: One week
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).
3 secondary outcomes
CPV-measured cost differences by use case
Time frame: One week
CPV-measured clinical score differences by use case
Time frame: One week
CPV-calculated baseline variation
Time frame: One week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2020.
- Background: PubMed 15545677Peabody 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.
- Background: PubMed 23667587Peabody 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.
- Background: PubMed 28036350Peabody 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.
- Background: PubMed 19224955Solon 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.
- Individual participant dataSharing planned: No. No IPD will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Peabody, MD PhD principal investigator
President, QURE Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Arm in people with Pre-Eclampsia, run by Qure Healthcare, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CPV-measured cost difference (time frame: One week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04204018, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2020.