Ignite Creation Date:
2024-05-06 @ 2:16 PM
Last Modification Date:
2024-10-26 @ 1:28 PM
Study NCT ID:
NCT04266860
Status:
COMPLETED
Last Update Posted:
2020-09-16
First Post:
2020-02-07
Brief Title:
Establishing Clinical Utility of a New Diagnostic Test for Rheumatology Patients
Sponsor:
Qure Healthcare LLC
Organization:
Qure Healthcare LLC
Study Overview
Official Title:
Establishing Clinical Utility of a New Diagnostic Test for Rheumatology Patients A CPV Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will collect high-quality randomized controlled data from a nationally representative sample of practicing rheumatologists to determine how they currently manage patients with SLE systemic lupus erythematosus and how the results of DxTeritys IFN-1 interferon type I test change clinical decision making
Detailed Description:
This study will collect high-quality randomized controlled data from a nationally representative sample of practicing rheumatologists to determine how they currently manage patients with SLE and how the results of the IFN-1 test change clinical decision making Data from this study will better illuminate the clinical use cases in which the IFN-1 test has the most significant impact on clinical decision making and thus the largest clinical utility and the associated physician characteristics eg 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 CPVs have been validated and used effectively in rheumatology 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 six steps
1 Enrollment The study will enroll an estimated 166 practicing rheumatologists who practice in the US and 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 166 rheumatologists will be randomized into equally-sized control and intervention arms
4 CPVs First Round Physicians will complete three randomly-assigned CPV patient simulations Cases will be identical across the intervention and control arms All interactive cases are presented on an online platform and are accessible via unique weblinks and any internet-connected computer
5 Intervention education Intervention-arm rheumatologists will receive educational materials describing the clinical validation and use cases of the IFN-1 test This material will replicate what physicians would receive as part of an actual marketing push introducing them to the IFN-1 test These materials may be comprised of a slide deck fact sheet webinar andor case studies
6 CPVs Second Round Physicians will then complete three additional CPV patient simulations in random order Cases will be identical across the intervention and control arms except that the intervention arm will receive IFN-1 test results at an appropriate point in each simulated case in the post-intervention round Control arm physicians will continue to have access to standard of care diagnostic tools only
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 CPVs have been validated and used effectively in rheumatology 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 six steps
1 Enrollment The study will enroll an estimated 166 practicing rheumatologists who practice in the US and 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 166 rheumatologists will be randomized into equally-sized control and intervention arms
4 CPVs First Round Physicians will complete three randomly-assigned CPV patient simulations Cases will be identical across the intervention and control arms All interactive cases are presented on an online platform and are accessible via unique weblinks and any internet-connected computer
5 Intervention education Intervention-arm rheumatologists will receive educational materials describing the clinical validation and use cases of the IFN-1 test This material will replicate what physicians would receive as part of an actual marketing push introducing them to the IFN-1 test These materials may be comprised of a slide deck fact sheet webinar andor case studies
6 CPVs Second Round Physicians will then complete three additional CPV patient simulations in random order Cases will be identical across the intervention and control arms except that the intervention arm will receive IFN-1 test results at an appropriate point in each simulated case in the post-intervention round Control arm physicians will continue to have access to standard of care diagnostic tools only
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None