Establishing Clinical Utility of a New Diagnostic Test for Rheumatology Patients

NCT04266860 | Completed

• 1 other identifier: 01DXT2019
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

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.

Conditions

Lupus Nephritis; Lupus Erythematosus, Systemic

Outcome Measures

Primary Outcomes (2)

• 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.

  2-4 weeks

• 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.

  2-4 weeks

Secondary Outcomes (1)

• CPV-measured baseline variation

  1 week

Study Arms (2)

Experimental

EXPERIMENTAL

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

Other: Experimental - Test Results and Education

Control

NO INTERVENTION

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

Interventions

Experimental - Test Results and Education OTHER

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.

Experimental

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qure Healthcare, LLC: lead
• DxTerity Diagnostics: collaborator

Study Sites (1)

QURE Healthcare

San Francisco, California, 94133, United States

Location

Related Publications (6)

• 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.

  PMID: 30328782 BACKGROUND

• 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.

  PMID: 28036350 BACKGROUND

• 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.

  PMID: 23667587 BACKGROUND

• 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.

  PMID: 19224955 BACKGROUND

• 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.

  PMID: 24561410 BACKGROUND

• 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.

  PMID: 15545677 BACKGROUND

MeSH Terms

Conditions

Lupus Nephritis; Lupus Erythematosus, Systemic

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• John Peabody, MD, PhD

  President, QURE Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: February 12, 2020
• Study Start: March 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: March 1, 2013
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)