Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2025-12-25 @ 10:35 PM
Study NCT ID:
NCT03501667
Status:
UNKNOWN
Last Update Posted:
2020-07-07
First Post:
2018-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Testing Pediatric Rheumatology Diagnostic Decision Support in Clinical Use
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Data collected by an RA, PI and outcome assessment (I.e., data analyst) are blinded to which arm the participant was assigned to. Given use of software, the participant cannot be blinded to the arm he/she was assigned'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Comparing use of deision support group (intervention group) to use of common literature (control group) among pediatric trainees treating patients with possible rheumatologic disorder'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 900}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-02', 'studyFirstSubmitDate': '2018-04-04', 'studyFirstSubmitQcDate': '2018-04-10', 'lastUpdatePostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparing DDx with that of the attending physician (gold standard)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Comparing DDx provided by the trainee with that of the attending physician (gold standard)'}, {'measure': 'Comparing evaluation plan with that of the attending physician (gold standard)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Comparing evaluation plan laid out by the trainee with that of the attending physician (gold standard)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Pediatric Rheumatological Condition (i.e., Arthritis, SLE, Kawasaki's Disaese)"]}, 'referencesModule': {'references': [{'pmid': '27964737', 'type': 'BACKGROUND', 'citation': 'Segal MM, Athreya B, Son MB, Tirosh I, Hausmann JS, Ang EY, Zurakowski D, Feldman LK, Sundel RP. Evidence-based decision support for pediatric rheumatology reduces diagnostic errors. Pediatr Rheumatol Online J. 2016 Dec 13;14(1):67. doi: 10.1186/s12969-016-0127-z.'}]}, 'descriptionModule': {'briefSummary': "Boston Children's Hospital resources include SimulConsult which is a decision support tool available for use of BCH provider through the library portal. It is offered along other resources on that webpage (UpToDate, Micromedex, and VisualDx). See addendum 1.\n\nRecently, a pediatric rheumatology arm was added to the expertise of SimulConsult, guided by our co-PI, Dr. Robert Sundel. As this tool is being offered and used, the investigators would like to assess metric of performance of this tool in enhancing participant trainees knowledge about the work up of patients with a potential rheumatologic disorder. See also www.ncbi.nlm.gov/pubmed/27964737 The investigators are conducting a clinical research to assess improvement in the clinical performance of study participants evaluating patients with a potential rheumatologic disorder. The intervention involved in using a computerized decision support tool already available in the Boston Children's Hospital domain. The outcome will be comparing this performance to that of an attending physician as the gold standard. We will assess the study participants performance across two locations: Emergency Department and Rheumatology clinic. Care to patients remains unchanged, as the workup plan and care is provided by an attending across both domains.\n\nThe investigators main hypothesis is that using a decision support tool will result in a higher agreement rate between study participants' differential diagnosis and work up plan compared with the gold standard (attending differential diagnosis and research plan).", 'detailedDescription': "Boston Children's Hospital resources include SimulConsult which is a decision support tool available for use of BCH provider through the library portal. It is offered along other resources on that webpage (UpToDate, Micromedex, and VisualDx). See addendum 1.\n\nRecently, a pediatric rheumatology arm was added to the expertise of SimulConsult, guided by our co-PI, Dr. Robert Sundel. As this tool is being offered and used, the investigators would like to assess metric of performance of this tool in enhancing study participants (trainees) knowledge about the work up of patients with a potential rheumatologic disorder. See also www.ncbi.nlm.gov/pubmed/27964737 The investigators are conducting a clinical research to assess improvement in the clinical performance of trainees evaluating patients with a potential rheumatologic disorder. The intervention involved in using a computerized decision support tool already available in the Boston Children's Hospital domain. The outcome will be comparing this performance to that of an attending physician as the gold standard. The investigators will assess the study participants performance across two locations: Emergency Department and Rheumatology clinic. Care to patients remains unchanged, as the workup plan and care is provided by an attending across both domains.\n\nOur main hypothesis is that using a decision support tool will result in a higher agreement rate between study participants' differential diagnosis and work up plan compared with the gold standard (attending differential diagnosis and research plan)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nA trainee at Boston Children's residency program (pediatrics, emergency medicine, pediatric emergency medicine, pediatric rheumatology)\n\nExclusion Criteria:\n\nOpting out of the study (optional at any stage)"}, 'identificationModule': {'nctId': 'NCT03501667', 'briefTitle': 'Testing Pediatric Rheumatology Diagnostic Decision Support in Clinical Use', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': "Boston Children's Hospital", 'orgStudyIdInfo': {'id': 'IRB-P00027105'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Use of decision support tool', 'description': 'Trainee using decision support tool while assessing a clinical case. This intervention will affect the study participant fund of knowledge on the case.', 'interventionNames': ['Other: Use of decision support tool']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Use of UpToDate', 'description': 'Control group, participants using current literature prior to assessing a clinical case. Allowing 10 minutes to read on a topic during clinical care is an active intervention in the study participant fund of knowledge.', 'interventionNames': ['Other: Use of UpToDate']}], 'interventions': [{'name': 'Use of decision support tool', 'type': 'OTHER', 'otherNames': ['Use of SimulConsult'], 'description': 'use of a decision support software during clinical assessment of a case', 'armGroupLabels': ['Use of decision support tool']}, {'name': 'Use of UpToDate', 'type': 'OTHER', 'otherNames': ['Use of current literature'], 'description': 'Control group, participants using current literature prior to assessing a clinical case. Allowing 10 minutes to read on a topic during clinical care is an active intervention in the study participant fund of knowledge.', 'armGroupLabels': ['Use of UpToDate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lauren Robertson', 'role': 'CONTACT', 'email': 'lauren.robertson@childrens.harvard.edu', 'phone': '617-919-1526'}, {'name': 'Lindsey Rice', 'role': 'CONTACT', 'email': 'lindsey.rice@childrens.harvard.edu', 'phone': '6179196160'}], 'facility': "Boston Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Lauren Robertson', 'role': 'CONTACT', 'email': 'lauren.robertson@childrens.harvard.edu', 'phone': '(617)-919-6160'}, {'name': 'Lindsey Rice', 'role': 'CONTACT', 'email': 'Lindsey.Rice@childrens.harvard.edu', 'phone': '6179196160'}], 'overallOfficials': [{'name': 'Amir A Kimia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Boston Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Boston Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Amir Kimia', 'investigatorAffiliation': "Boston Children's Hospital"}}}}