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Establishing Clinical Utility of a New Diagnostic Test for Rheumatology Patients

Primary Purpose

Lupus Nephritis, Lupus Erythematosus, Systemic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Experimental - Test Results and Education
Sponsored by
Qure Healthcare, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lupus Nephritis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Board-certified in rheumatology for at least two years
  2. Averaging at least 20 hours per week of clinical and patient care duties over the last six months
  3. Practicing in the U.S.
  4. English speaking
  5. Access to the internet
  6. Informed, signed and voluntarily consented to be in the study

Exclusion Criteria:

  1. Non-English speaking
  2. Practicing in an academic setting
  3. Unable to access the internet
  4. Not practicing in the U.S.
  5. Not averaging at least 20 hours per week of clinical or patient care duties over the last six months
  6. Do not voluntarily consent to be in the study

Sites / Locations

  • QURE Healthcare

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental

Control

Arm Description

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

These providers will complete two rounds of three simulated patient cases (CPVs) only.

Outcomes

Primary Outcome Measures

CPV-measured pre-/post-score difference
Doctors receive scores on their simulated cases, or CPVs, based upon their quality of care. This measure will assess the pre- vs post-difference in the overall and the diagnostic and treatment quality scores between control physicians using standard of care diagnostic tools and intervention physicians with access to DxTerity test results, including by use case types.
CPV-measured value of care
Doctors make decisions in their simulated cases, or CPVs, including which tests and/or treatments to order for their virtual patients. This measure will model whether using IFN-1 results in higher-value care decisions in these CPV cases, including more appropriate use of disease modifying agents, for lupus-related care in different use cases.

Secondary Outcome Measures

CPV-measured baseline variation
Doctors receive scores on their simulated cases, or CPVs, based upon their quality of care. This measure will assess the baseline levels of score variation in the work-up and management of lupus patients among all participants, including by use case types

Full Information

First Posted
February 7, 2020
Last Updated
September 14, 2020
Sponsor
Qure Healthcare, LLC
Collaborators
DxTerity Diagnostics
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1. Study Identification

Unique Protocol Identification Number
NCT04266860
Brief Title
Establishing Clinical Utility of a New Diagnostic Test for Rheumatology Patients
Official Title
Establishing Clinical Utility of a New Diagnostic Test for Rheumatology Patients: A CPV® Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2012 (Actual)
Primary Completion Date
June 1, 2012 (Actual)
Study Completion Date
March 1, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qure Healthcare, LLC
Collaborators
DxTerity Diagnostics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 DxTerity's 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 (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. 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: Enrollment: The study will enroll an estimated 166 practicing rheumatologists who practice in the U.S. and 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 166 rheumatologists will be randomized into equally-sized control and intervention arms. 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. 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, and/or case studies. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Nephritis, Lupus Erythematosus, Systemic

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The study will enroll practicing rheumatologists in the US, who will be randomly assigned to either an intervention or control arm. All eligible and consented participants will complete two rounds of three patient simulations. The intervention arm only will receive educational material about the DxTerity test in between these two rounds, and be provided simulated DxTerity test results in the second round of simulated cases.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
166 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Experimental-arm providers will complete two rounds of three simulated patient cases (CPVs) with two additions described in the next column:
Arm Title
Control
Arm Type
No Intervention
Arm Description
These providers will complete two rounds of three simulated patient cases (CPVs) only.
Intervention Type
Other
Intervention Name(s)
Experimental - Test Results and Education
Intervention Description
First, these providers will receive educational materials (e.g. a slide deck, mock test result and one-page fact sheet) meant to mimic what physicians will receive in the real-world market as they learn about the DxTerity test. Second, within each of their second-round cases, intervention-arm physicians only will receive simulated test results from the DxTerity test at the clinically-appropriate point in each case.
Primary Outcome Measure Information:
Title
CPV-measured pre-/post-score difference
Description
Doctors receive scores on their simulated cases, or CPVs, based upon their quality of care. This measure will assess the pre- vs post-difference in the overall and the diagnostic and treatment quality scores between control physicians using standard of care diagnostic tools and intervention physicians with access to DxTerity test results, including by use case types.
Time Frame
2-4 weeks
Title
CPV-measured value of care
Description
Doctors make decisions in their simulated cases, or CPVs, including which tests and/or treatments to order for their virtual patients. This measure will model whether using IFN-1 results in higher-value care decisions in these CPV cases, including more appropriate use of disease modifying agents, for lupus-related care in different use cases.
Time Frame
2-4 weeks
Secondary Outcome Measure Information:
Title
CPV-measured baseline variation
Description
Doctors receive scores on their simulated cases, or CPVs, based upon their quality of care. This measure will assess the baseline levels of score variation in the work-up and management of lupus patients among all participants, including by use case types
Time Frame
1 week

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Board-certified in rheumatology for at least two years Averaging at least 20 hours per week of clinical and patient care duties over the last six months Practicing in the U.S. English speaking Access to the internet Informed, signed and voluntarily consented to be in the study Exclusion Criteria: Non-English speaking Practicing in an academic setting Unable to access the internet Not practicing in the U.S. Not averaging at least 20 hours per week of clinical or patient care duties over the last six months Do not voluntarily consent to be in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Peabody, MD, PhD
Organizational Affiliation
President, QURE Healthcare
Official's Role
Principal Investigator
Facility Information:
Facility Name
QURE Healthcare
City
San Francisco
State/Province
California
ZIP/Postal Code
94133
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30328782
Citation
Burgon TB, Cox-Chapman J, Czarnecki C, Kropp R, Guerriere R, Paculdo D, Peabody JW. Engaging Primary Care Providers to Reduce Unwanted Clinical Variation and Support ACO Cost and Quality Goals: A Unique Provider-Payer Collaboration. Popul Health Manag. 2019 Aug;22(4):321-329. doi: 10.1089/pop.2018.0111. Epub 2018 Oct 17.
Results Reference
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PubMed Identifier
28036350
Citation
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.
Results Reference
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PubMed Identifier
23667587
Citation
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.
Results Reference
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PubMed Identifier
19224955
Citation
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.
Results Reference
background
PubMed Identifier
24561410
Citation
DeMaria L, Acelajado MC, Luck J, Ta H, Chernoff D, Florentino J, Peabody JW. Variations and practice in the care of patients with rheumatoid arthritis: quality and cost of care. J Clin Rheumatol. 2014 Mar;20(2):79-86. doi: 10.1097/RHU.0000000000000076.
Results Reference
background
PubMed Identifier
15545677
Citation
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.
Results Reference
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Establishing Clinical Utility of a New Diagnostic Test for Rheumatology Patients

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