Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-03-10 @ 11:37 PM
Study NCT ID:
NCT04266860
Status:
COMPLETED
Last Update Posted:
2020-09-16
First Post:
2020-02-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Establishing Clinical Utility of a New Diagnostic Test for Rheumatology Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008181', 'term': 'Lupus Nephritis'}, {'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}], 'ancestors': [{'id': 'D005921', 'term': 'Glomerulonephritis'}, {'id': 'D009393', 'term': 'Nephritis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The study will enroll practicing rheumatologists in the US, who will be randomly assigned to either an intervention or control arm.\n\nAll eligible and consented participants will complete two rounds of three patient simulations.\n\nThe 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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 166}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2013-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-14', 'studyFirstSubmitDate': '2020-02-07', 'studyFirstSubmitQcDate': '2020-02-10', 'lastUpdatePostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CPV-measured pre-/post-score difference', 'timeFrame': '2-4 weeks', '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.'}, {'measure': 'CPV-measured value of care', 'timeFrame': '2-4 weeks', '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.'}], 'secondaryOutcomes': [{'measure': 'CPV-measured baseline variation', 'timeFrame': '1 week', '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lupus Nephritis', 'Lupus Erythematosus, Systemic']}, 'referencesModule': {'references': [{'pmid': '30328782', 'type': 'BACKGROUND', '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.'}, {'pmid': '28036350', 'type': 'BACKGROUND', '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.'}, {'pmid': '23667587', 'type': 'BACKGROUND', '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.'}, {'pmid': '19224955', 'type': 'BACKGROUND', '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.'}, {'pmid': '24561410', 'type': 'BACKGROUND', '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.'}, {'pmid': '15545677', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.\n\nThis 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.\n\nThe study is a prospective cohort trial with six steps:\n\n1. 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.\n2. Provider survey: Once providers are enrolled in the study, they will be asked to complete a questionnaire describing their practice and professional background.\n3. Randomization: The 166 rheumatologists will be randomized into equally-sized control and intervention arms.\n4. 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.\n5. 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.\n6. 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Board-certified in rheumatology for at least two years\n2. Averaging at least 20 hours per week of clinical and patient care duties over the last six months\n3. Practicing in the U.S.\n4. English speaking\n5. Access to the internet\n6. Informed, signed and voluntarily consented to be in the study\n\nExclusion Criteria:\n\n1. Non-English speaking\n2. Practicing in an academic setting\n3. Unable to access the internet\n4. Not practicing in the U.S.\n5. Not averaging at least 20 hours per week of clinical or patient care duties over the last six months\n6. Do not voluntarily consent to be in the study'}, 'identificationModule': {'nctId': 'NCT04266860', 'briefTitle': 'Establishing Clinical Utility of a New Diagnostic Test for Rheumatology Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Qure Healthcare, LLC'}, 'officialTitle': 'Establishing Clinical Utility of a New Diagnostic Test for Rheumatology Patients: A CPV® Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '01DXT2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Experimental-arm providers will complete two rounds of three simulated patient cases (CPVs) with two additions described in the next column:', 'interventionNames': ['Other: Experimental - Test Results and Education']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'These providers will complete two rounds of three simulated patient cases (CPVs) only.'}], 'interventions': [{'name': 'Experimental - Test Results and Education', 'type': 'OTHER', '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.\n\nSecond, 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.', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94133', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'QURE Healthcare', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'John Peabody, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'President, QURE Healthcare'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qure Healthcare, LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'DxTerity Diagnostics', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}