Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2026-04-17 @ 12:05 AM
Study NCT ID:
NCT03110692
Status:
COMPLETED
Last Update Posted:
2019-12-09
First Post:
2017-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Default Options to Reduce Unnecessary Daily Imaging During Palliative Radiation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mpatel@pennmedicine.upenn.edu', 'phone': '215-898-3367', 'title': 'Dr. Mitesh S. Patel', 'organization': 'Perelman School of Medicine, University of Pennsylvania'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Through study completion (1 year from study start)', 'eventGroups': [{'id': 'EG000', 'title': 'Usual Practice (Control)', 'description': 'The usual practice group will rollover to the intervention arm 3 months after the start of the default intervention group in Feb. 2017', 'otherNumAtRisk': 679, 'deathsNumAtRisk': 679, 'otherNumAffected': 0, 'seriousNumAtRisk': 679, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Intervention', 'description': 'Default initiation: Introduce a default prescription template in the palliative setting in order to reduce unnecessary daily image guided radiation.\n\nDefault initiation: A default prescription template will be introduced in the palliative setting in order to reduce unnecessary daily image guided radiation.\n\nTo start in Feb 2017 and continue in the intervention through Feb 2018', 'otherNumAtRisk': 509, 'deathsNumAtRisk': 509, 'otherNumAffected': 0, 'seriousNumAtRisk': 509, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent of Patients Receiving Daily Imaging', 'denoms': [{'units': 'Participants', 'counts': [{'value': '679', 'groupId': 'OG000'}, {'value': '509', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Practice (Control)', 'description': 'The usual practice group will rollover to the intervention arm after 3 months from start of the default intervention in Feb 2017.'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Default initiation: Introduce a default prescription template in the palliative setting in order to reduce unnecessary daily image guided radiation.\n\nDefault initiation: A default prescription template will be introduced in the palliative setting in order to reduce unnecessary daily image guided radiation.\n\nTo start in Feb 2017 and continue in the intervention through Feb 2018'}], 'classes': [{'categories': [{'measurements': [{'value': '679', 'groupId': 'OG000'}, {'value': '509', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months post arm crossover', 'description': 'Radiology tests including x-rays and CT scans', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Usual Practice (Control)', 'description': 'The usual practice group will rollover to the intervention arm 3 months after the start of the default intervention group in Feb. 2017'}, {'id': 'FG001', 'title': 'Intervention', 'description': 'Default initiation: Introduce a default prescription template in the palliative setting in order to reduce unnecessary daily image guided radiation.\n\nDefault initiation: A default prescription template will be introduced in the palliative setting in order to reduce unnecessary daily image guided radiation.\n\nTo start in Feb 2017 and continue in the intervention through Feb 2018'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '679'}, {'groupId': 'FG001', 'numSubjects': '509'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '679'}, {'groupId': 'FG001', 'numSubjects': '509'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '679', 'groupId': 'BG000'}, {'value': '509', 'groupId': 'BG001'}, {'value': '1188', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Usual Practice (Control)', 'description': 'The usual practice group will rollover to the intervention arm after 3 months following the start of the default intervention in Feb 2017.'}, {'id': 'BG001', 'title': 'Intervention', 'description': 'Default initiation: Introduce a default prescription template in the palliative setting in order to reduce unnecessary daily image guided radiation.\n\nDefault initiation: A default prescription template will be introduced in the palliative setting in order to reduce unnecessary daily image guided radiation.\n\nTo start in Feb 2017 and continue in the intervention through Feb 2018'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '341', 'groupId': 'BG000'}, {'value': '259', 'groupId': 'BG001'}, {'value': '600', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '338', 'groupId': 'BG000'}, {'value': '250', 'groupId': 'BG001'}, {'value': '588', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '347', 'groupId': 'BG000'}, {'value': '268', 'groupId': 'BG001'}, {'value': '615', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '332', 'groupId': 'BG000'}, {'value': '241', 'groupId': 'BG001'}, {'value': '573', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race/Ethnicity', 'categories': [{'title': 'White non-hispanic', 'measurements': [{'value': '470', 'groupId': 'BG000'}, {'value': '333', 'groupId': 'BG001'}, {'value': '803', 'groupId': 'BG002'}]}, {'title': 'Black non-hispanic', 'measurements': [{'value': '147', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '261', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'ECOG Performance Status', 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '200', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '345', 'groupId': 'BG002'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '206', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '339', 'groupId': 'BG002'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '151', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '272', 'groupId': 'BG002'}]}]}, {'title': '4', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'The ECOG (Eastern Cooperative Oncology Group) Performance Status is used to classify a patient according to their functional status. It assesses how the disease affects the daily living abilities of the patient, and to help determine treatment and prognosis.\n\nScale Ranking 0- Fully active, able to carry on all pre-disease performance without restriction\n\n1 2 3- 4-Completely disabled, cannot carry on any selfcare, totally confined to bed or chair', 'unitOfMeasure': 'participants'}, {'title': 'Insurance', 'classes': [{'title': 'Medicaid', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}, {'title': 'Medicare', 'categories': [{'measurements': [{'value': '337', 'groupId': 'BG000'}, {'value': '226', 'groupId': 'BG001'}, {'value': '563', 'groupId': 'BG002'}]}]}, {'title': 'Commercial', 'categories': [{'measurements': [{'value': '296', 'groupId': 'BG000'}, {'value': '229', 'groupId': 'BG001'}, {'value': '525', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Target Type', 'classes': [{'title': 'Bone', 'categories': [{'measurements': [{'value': '345', 'groupId': 'BG000'}, {'value': '275', 'groupId': 'BG001'}, {'value': '620', 'groupId': 'BG002'}]}]}, {'title': 'Brain', 'categories': [{'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '186', 'groupId': 'BG002'}]}]}, {'title': 'Soft Tissue', 'categories': [{'measurements': [{'value': '133', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '236', 'groupId': 'BG002'}]}]}, {'title': 'Multiple Sites', 'categories': [{'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior Radiation', 'classes': [{'categories': [{'measurements': [{'value': '381', 'groupId': 'BG000'}, {'value': '268', 'groupId': 'BG001'}, {'value': '649', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Patients Receiving Fractions', 'classes': [{'title': '2-5 total fractions per course', 'categories': [{'measurements': [{'value': '156', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '318', 'groupId': 'BG002'}]}]}, {'title': '6-10 total fractions per course', 'categories': [{'measurements': [{'value': '403', 'groupId': 'BG000'}, {'value': '277', 'groupId': 'BG001'}, {'value': '680', 'groupId': 'BG002'}]}]}, {'title': '11-15 total fractions per course', 'categories': [{'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}]}]}, {'title': '15+ total fractions per course', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The measure shows the proportion of patients that received X number of fractions per course', 'unitOfMeasure': 'Participants'}, {'title': 'Number of patients receiving dose per fraction', 'classes': [{'title': 'Less than or equal to 200 doses per fraction', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}, {'title': '201-300 doses per fraction', 'categories': [{'measurements': [{'value': '509', 'groupId': 'BG000'}, {'value': '308', 'groupId': 'BG001'}, {'value': '817', 'groupId': 'BG002'}]}]}, {'title': '301-400 doses per fraction', 'categories': [{'measurements': [{'value': '137', 'groupId': 'BG000'}, {'value': '154', 'groupId': 'BG001'}, {'value': '291', 'groupId': 'BG002'}]}]}, {'title': 'Greater than 400 doses per fraction', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The total radiation dose is divided up into several fractions. Each fraction contains a small amount of radiation that gradually accumulates to form the total dose. The measure displayed shows the proportion of patients that received the dose per fraction.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-10-17', 'size': 578784, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-10-14T11:11', 'hasProtocol': False}, {'date': '2017-01-25', 'size': 658251, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-11-19T16:24', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1188}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2018-02-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-20', 'studyFirstSubmitDate': '2017-03-29', 'resultsFirstSubmitDate': '2019-07-29', 'studyFirstSubmitQcDate': '2017-04-05', 'lastUpdatePostDateStruct': {'date': '2019-12-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-20', 'studyFirstPostDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of Patients Receiving Daily Imaging', 'timeFrame': '3 months post arm crossover', 'description': 'Radiology tests including x-rays and CT scans'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer']}, 'referencesModule': {'references': [{'pmid': '31246224', 'type': 'BACKGROUND', 'citation': 'Sharma S, Guttmann D, Small DS, Rareshide CAL, Jones J, Patel MS, Bekelman JE. Effect of Introducing a Default Order in the Electronic Medical Record on Unnecessary Daily Imaging During Palliative Radiotherapy for Adults With Cancer: A Stepped-Wedge Cluster Randomized Clinical Trial. JAMA Oncol. 2019 Aug 1;5(8):1220-1222. doi: 10.1001/jamaoncol.2019.1432.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to reduce preference sensitive, unnecessary daily imaging during radiation treatment in which a pre-planned quality improvement default option for radiation treatment prescriptions will be introduced throughout the network of Penn Radiation Oncology.', 'detailedDescription': 'The goal of this study is to reduce preference sensitive, unnecessary daily imaging during radiation treatment in which a pre-planned quality improvement default option for radiation treatment prescriptions will be introduced throughout the network of Penn Radiation Oncology. This study is a prospectively designed, observational trial with two comparison groups: (1) a usual practice group (control group) and (2) a default radiation treatment prescription group (intervention group), in which the usual practice group will subsequently rollover from control to intervention so that all sites and physicians in the practice network of Penn Radiation Oncology are exposed to intervention. The purpose of this study is to reduce preference sensitive, unnecessary daily imaging during radiation treatment with the implementation of a quality improvement initiative within 5 sites of Penn Radiation Oncology. We aim to leverage the introduction of a default prescription option to reduce the use of daily imaging in palliative intent cases where it has limited clinical benefit and adds to cost burden. Our objective is to encourage more patient-centric clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Radiation treatment courses with palliative intent\n* Palliative treatment of bone, soft tissue, and intracranial metastases\n* Photon radiation with 3D conformal therapy (3DCRT) only\n\nExclusion Criteria:\n\n* Use of intensity modulated radiation (IMRT) or stereotactic body radiation (SBRT) as radiation treatment modality\n* Retreatment to same site\n* Proton radiation'}, 'identificationModule': {'nctId': 'NCT03110692', 'briefTitle': 'Default Options to Reduce Unnecessary Daily Imaging During Palliative Radiation', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Health System Initiative to Reduce Unnecessary Daily X-Ray Image Guidance During Palliative Radiation Treatment', 'orgStudyIdInfo': {'id': '826810'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual practice (control)', 'description': 'The usual practice group will rollover to the intervention arm after 3 months.'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Default initiation: Introduce a default prescription template in the palliative setting in order to reduce unnecessary daily image guided radiation.', 'interventionNames': ['Behavioral: Default initiation']}], 'interventions': [{'name': 'Default initiation', 'type': 'BEHAVIORAL', 'description': 'A default prescription template will be introduced in the palliative setting in order to reduce unnecessary daily image guided radiation.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania Health System', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Justin Bekelman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}, {'name': 'Mitesh Patel, MD, MBA, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}