Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT04927351
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2021-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nudges for Opioid Reduction After Major Surgery Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-06-01', 'size': 353298, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-10-03T12:16', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '2 arm parallel, cluster-randomized trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 484}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-03', 'studyFirstSubmitDate': '2021-06-04', 'studyFirstSubmitQcDate': '2021-06-14', 'lastUpdatePostDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Discharge Opioid Burden', 'timeFrame': 'Immediately after study intervention', 'description': 'Morphine milligram equivalents in the initial discharge prescription after index surgery'}], 'secondaryOutcomes': [{'measure': 'Additional Opioid Burden within 30 days', 'timeFrame': 'Within 30 Days', 'description': 'Morphine milligram equivalents on any additional opioid prescription within 30 days of discharge'}, {'measure': 'Proportion of cases with Phone Calls to Surgery Department', 'timeFrame': 'Within 30 Days', 'description': 'Phone calls to surgery department within 30 days of discharge'}, {'measure': 'Proportion of Cases with Emergency Room Visits', 'timeFrame': 'Within 30 Days', 'description': 'ER visits within 30 days of discharge'}, {'measure': 'Proportion of Cases with Hospital Readmissions to a Surgical Service', 'timeFrame': 'Within 30 Days', 'description': 'Readmissions to surgical service within 30 days of discharge'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Surgery', 'Discharge', 'Hospital Systems', 'Electronic Medical Record', 'Opioids', 'Prescription'], 'conditions': ['Surgery']}, 'descriptionModule': {'briefSummary': 'This is a prospective pilot trial to evaluate a new electronic medical record based intervention to improve discharges after surgery. The investigators hypothesize that standard discharge medications after surgery will help to optimize opioid prescribing and potentially decrease healthcare utilization in the first 30 days after surgery.', 'detailedDescription': 'This is a 2-arm parallel randomized trial comparing a new electronic medical record (EMR)-based intervention to usual care after surgery. All patients will receive their usual peri- and intraoperative care. Then, upon discharge, their providers will see the new EMR-based discharge order set (intervention arm) or not (usual care). The investigators hypothesize that standard discharge medication order sets after surgery will help to optimize opioid prescribing and potentially decrease healthcare utilization in the first 30 days after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients\n* Aged 18 and over\n* Undergo selected general surgical procedures\n\nExclusion Criteria:\n\n* Less than 18 years of age'}, 'identificationModule': {'nctId': 'NCT04927351', 'acronym': 'NORMS', 'briefTitle': 'Nudges for Opioid Reduction After Major Surgery Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Nudges for Opioid Reduction After Major Surgery', 'orgStudyIdInfo': {'id': 'STUDY00013382'}, 'secondaryIdInfos': [{'id': '2T32DK070555-06', 'link': 'https://reporter.nih.gov/quickSearch/2T32DK070555-06', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'New electronic medical record based discharge medication order set.', 'interventionNames': ['Behavioral: Electronic Medical Record Based Discharge Medication Order Set']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Usual Care'}], 'interventions': [{'name': 'Electronic Medical Record Based Discharge Medication Order Set', 'type': 'BEHAVIORAL', 'description': 'New medication discharge order set including recommended opioid quantities, adjunct pain medication', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'David Flum, MD, MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Washington'}, {'name': 'Irene Zhang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Surgery', 'investigatorFullName': 'David Flum', 'investigatorAffiliation': 'University of Washington'}}}}