Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2026-01-01 @ 4:23 PM
Study NCT ID:
NCT06993805
Status:
RECRUITING
Last Update Posted:
2025-05-29
First Post:
2025-04-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating a Our Practice Advisory (OPA) to Optimize Hemoglobin A1c (A1c) and Thyroid-Stimulating Hormone (TSH) Test Orders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 384}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-22', 'studyFirstSubmitDate': '2025-04-30', 'studyFirstSubmitQcDate': '2025-05-22', 'lastUpdatePostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Frequency of Hemoglobin A1c (A1c) and Thyroid-Stimulating Hormone (TSH) Ordered within 30 days of Prior Results', 'timeFrame': 'Study month 6', 'description': 'This measure evaluates the impact of a randomized Our Practice Advisory (OPA) intervention on the frequency of Hemoglobin A1c (A1c) and Thyroid-Stimulating Hormone (TSH) tests ordered within 30 days of prior results. Data will be extracted from the UCLA Health Electronic Health Record (EHR) system using a structured query to identify qualifying test orders. Logistic regression will be used to compare the likelihood of A1c or TSH orders within the 30 days between the intervention and control group, adjusting for patient age, sex, and comorbidities. Clustering by providers will be accounted for.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Clinical Decision Support', 'Laboratory Test Optimization', 'Resource Utilization', 'Our Practice Advisory (OPA)'], 'conditions': ['Physician Workflow', 'Resource Utilization']}, 'descriptionModule': {'briefSummary': 'Our Practice Advisory (OPA) are essential tools in clinical decision-making. The alerts are designed to guide providers towards evidence-based practices and improve patient outcomes. The focus of this initiative is on Hemoglobin A1c (A1c) and Thyroid-Stimulating Hormone (TSH) testing, with the goal of addressing unnecessary repeat testing within a 30-day timeframe, which rarely yields significant new insights. Although randomization occurs at the patient level, the primary outcome of this study focuses on provider behavior and decision-making.\n\nBy focusing on this specific intervention, the study aims to optimize resource use, align test ordering with evidence-based guidelines, and support improved patient outcomes. The results of this evaluation will help refine OPAs and guide broader strategies for implementing clinical decision support tools across healthcare systems.', 'detailedDescription': 'The purpose of this Quality Improvement (QI) initiative is to evaluate the impact of a randomized Our Practice Advisory (OPA) intervention on physician ordering behavior of Hemoglobin A1c (A1c) and Thyroid-Stimulating Hormone (TSH) tests within a 30-day interval from the prior test. The OPA will fire when an A1c or TSH are ordered within 30 days of a prior result (these short-interval tests are widely considered unnecessary) and will ask providers to reconsider the order. This study will evaluate the effectiveness of this intervention by randomizing patients 1:1 such that physicians caring for the patient will either (1) receive the OPA or (2) not receive the OPA if the providers order a short-interval test. This study is being conducted for a primary QI intent, as the results will (1) dictate if the short-interval OPA should be implemented across all patients, and (2) if this short-interval OPA should be applied to other labs aside from A1c and TSH. In these ways, the purpose of this study is to directly inform health system operations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Inpatient or observation stays within UCLA Health System hospitals\n* Hemoglobin A1c (A1c) and Thyroid-Stimulating Hormone (TSH) ordered, AND this lab was ordered and resulted within the prior 30 days\n\nExclusion Criteria:\n\n* Have an A1c or TSH ordered and do not have a result for one of these labs in the prior 30 days'}, 'identificationModule': {'nctId': 'NCT06993805', 'briefTitle': 'Evaluating a Our Practice Advisory (OPA) to Optimize Hemoglobin A1c (A1c) and Thyroid-Stimulating Hormone (TSH) Test Orders', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'Evaluation of Our Practice Advisory (OPA) Interventions on Hemoglobin A1c (A1c) and Thyroid-Stimulating Hormone (TSH) Short Interval Ordering', 'orgStudyIdInfo': {'id': 'IRB-25-0120'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OPA Intervention Group', 'description': 'Providers in this group will receive a Our Practice Advisory (OPA) through the electronic health record (EHR) system when ordering Hemoglobin A1c (A1c) and Thyroid-Stimulating Hormone (TSH) tests. The OPA will prompt providers to reconsider the test if it was ordered within the previous 30 days, aligning with evidence-based guidelines to reduce unnecessary testing.', 'interventionNames': ['Behavioral: OPA']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Providers in this group will not receive a Our Practice Advisory (OPA) through the Electronic Health Record (EHR) system when ordering Hemoglobin A1c (A1c) and Thyroid-Stimulating Hormone (TSH) tests. This group represents the current standard of care, with no additional prompts or alerts implemented.'}], 'interventions': [{'name': 'OPA', 'type': 'BEHAVIORAL', 'description': 'The Our Practice Advisory (OPA) intervention is a behavioral nudge integrated into the electronic health record system. It is designed to prompt providers to reconsider ordering Hemoglobin A1c (A1c) and Thyroid-Stimulating Hormone (TSH) tests if a similar test was performed within the previous 30 days. The OPA aligns with evidence-based guidelines to reduce unnecessary testing, improve resource utilization, and optimize patient care by enhancing clinical decision-making at the point of order entry.', 'armGroupLabels': ['OPA Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90024', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Katelyn Clinical Research Coodinator', 'role': 'CONTACT', 'email': 'katenguyen@mednet.ucla.edu', 'phone': '310-267-5250'}], 'facility': 'UCLA Health System', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'centralContacts': [{'name': 'Katelyn Clinical Research Coordinator', 'role': 'CONTACT', 'email': 'katenguyen@mednet.ucla.edu', 'phone': '310-267-5250'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Catherine A. Sarkisian', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}