Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-27 @ 11:20 PM
Study NCT ID:
NCT05711134
Status:
COMPLETED
Last Update Posted:
2023-11-09
First Post:
2023-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CT C-spine Audit and Feedback
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004630', 'term': 'Emergencies'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-06', 'studyFirstSubmitDate': '2023-01-24', 'studyFirstSubmitQcDate': '2023-01-24', 'lastUpdatePostDateStruct': {'date': '2023-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent NEXUS-Negative', 'timeFrame': '6 months', 'description': 'Percentage of CT C-spine studies that an individual provider ordered on NEXUS-negative patients'}], 'secondaryOutcomes': [{'measure': 'Number of Fractures', 'timeFrame': '6 months', 'description': 'Number of cervical spine fractures identified on CT for patients who are NEXUS-negative'}, {'measure': 'Clinically Significant Fractures', 'timeFrame': '6 months', 'description': 'Number of cervical spine fractures identified on CT for patients who are NEXUS-negative that required procedural intervention, hospitalization, or prolonged immobilization'}, {'measure': 'Number of CTs', 'timeFrame': '6 months', 'description': 'Number of CT scans of the cervical spine ordered by each provider'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['computed tomography', 'resource utilization', 'NEXUS', 'emergency medicine'], 'conditions': ['Cervical Spine Injury', 'Emergencies', 'Trauma']}, 'descriptionModule': {'briefSummary': 'This is a prospective quality improvement study to assess the effect of using an audit-and-feedback process for emergency providers on utilization of computed tomography of the cervical spine. The objective of this study is to determine whether providing repeated individualized feedback on CT C-spine utilization to emergency providers alters their practice pattern and reduces overutilization. The investigators hypothesize that emergency providers who receive individualized feedback regarding their CT C-spine utilization on a regular basis will alter their practice pattern to reduce overutilization of this imaging study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Emergency medicine physician, nurse practitioner, or physician assistant\n* Ordered at least 5 CT scans of the cervical spine on adult patients in the two-month pre-intervention period\n\nExclusion Criteria:\n\n* Non-emergency providers\n* Ordered few than 5 studies in the pre-intervention period'}, 'identificationModule': {'nctId': 'NCT05711134', 'briefTitle': 'CT C-spine Audit and Feedback', 'organization': {'class': 'OTHER', 'fullName': 'University of Massachusetts, Worcester'}, 'officialTitle': 'Audit and Feedback for Computed Tomography of the Cervical Spine in the Emergency Department', 'orgStudyIdInfo': {'id': 'STUDY00000533'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Serial In-Person Feedback', 'description': 'Providers are given recurring individualized in-person feedback on their practice patterns.', 'interventionNames': ['Behavioral: Audit and Feedback on Individual Practice Patterns']}, {'type': 'EXPERIMENTAL', 'label': 'In-Person Feedback with Serial Electronic Feedback', 'description': 'Providers are given one-time individualized in-person feedback on their practice patterns, followed by recurrent individualized electronic feedback.', 'interventionNames': ['Behavioral: Audit and Feedback on Individual Practice Patterns']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Providers are not given any feedback on their practice patterns.'}], 'interventions': [{'name': 'Audit and Feedback on Individual Practice Patterns', 'type': 'BEHAVIORAL', 'description': 'Providers are given feedback on their practice patterns of ordering computed tomography of the cervical spine.', 'armGroupLabels': ['In-Person Feedback with Serial Electronic Feedback', 'Serial In-Person Feedback']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'University of Massachusetts Chan Medical School', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}], 'overallOfficials': [{'name': 'Karl T Chamberlin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Massachusetts Chan Medical School'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Massachusetts, Worcester', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professsor', 'investigatorFullName': 'Karl Chamberlin', 'investigatorAffiliation': 'University of Massachusetts, Worcester'}}}}