Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-01-28 @ 11:35 PM
Study NCT ID:
NCT01944202
Status:
COMPLETED
Last Update Posted:
2013-09-17
First Post:
2013-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Educational Intervention to Reduce Outpatient Inappropriate Transthoracic Echocardiograms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D018479', 'term': 'Early Intervention, Educational'}], 'ancestors': [{'id': 'D002662', 'term': 'Child Health Services'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-12', 'studyFirstSubmitDate': '2013-09-10', 'studyFirstSubmitQcDate': '2013-09-12', 'lastUpdatePostDateStruct': {'date': '2013-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Clinical reasons for appropriate and inappropriate transthoracic echocardiograms', 'timeFrame': '9 months', 'description': 'All echocardiograms will be classifed according to the Appropriate Use Criteria (AUC). This will allow for determination of the most common clinical indications for both appropriate and inappopriate TTEs.'}], 'primaryOutcomes': [{'measure': 'Rate of Inappropriate transthoracic echocardiograms', 'timeFrame': '9 months', 'description': 'Rate of inappropriate echocardiograms determined from a review of the electronic medical record.'}], 'secondaryOutcomes': [{'measure': 'Rate of Appropriate Transthoracic Echocardiograms', 'timeFrame': '9 months', 'description': 'Rate of appropriate transthoracic echocardiograms determined from a review of the electronic medical record.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Echocardiography', 'Appropriate Use Criteria', 'Educational Intervention'], 'conditions': ['Inappropriate Use of Echocardiography']}, 'referencesModule': {'references': [{'pmid': '25129520', 'type': 'DERIVED', 'citation': 'Bhatia RS, Dudzinski DM, Malhotra R, Milford CE, Yoerger Sanborn DM, Picard MH, Weiner RB. Educational intervention to reduce outpatient inappropriate echocardiograms: a randomized control trial. JACC Cardiovasc Imaging. 2014 Sep;7(9):857-66. doi: 10.1016/j.jcmg.2014.04.014. Epub 2014 Aug 13.'}]}, 'descriptionModule': {'briefSummary': 'It is well documented that the proportion of inappropriate transthoracic echocardiograms (TTEs) is highest in the ambulatory environment, where it has been reported as high as 30%. Therefore, the potential to improve TTE utilization may be greatest in the outpatient setting. However, no study to date has evaluated whether an Appropriate Use Criteria (AUC)-based educational intervention can reduce inappropriate TTEs in this setting. The investigators therefore designed the first randomized control trial of an AUC-based educational and feedback intervention aimed at reducing inappropriate outpatient TTEs ordered by cardiology and internal medicine physicians in training.', 'detailedDescription': 'The investigators designed a randomized, control trial of an AUC-based educational and feedback intervention designed to reduce the proportion of inappropriate TTEs in the cardiology and internal medicine outpatient practices at Massachusetts General Hospital. A random number generator divided 24 cardiology fellows and 88 internal medicine residents into control and intervention arms.\n\nDuring the study, physicians in the intervention arm receive the following multi-faceted educational intervention on TTE appropriateness: 1) a lecture at the beginning of the study period, which describes the AUC for echocardiography and highlights common clinical scenarios for which outpatient TTEs are ordered, 2) an electronic "pocket card" via email that provides tips on appropriate ordering of TTEs, and 3) an individualized monthly feedback report that categorizes TTEs ordered over the preceding month. The feedback reports contain the number of TTEs ordered during the month and how many are classified as appropriate, inappropriate, or uncertain based on the 2011 AUC. A description of all inappropriate TTEs and the rationale for the inappropriate classification is provided. The physicians in the control arm have their TTE orders tracked and classified, but do not receive any feedback on their ordering behavior. While study participants are not blinded to which arm of the study they are in, they were blinded to which arm of the study their colleagues are in.\n\nPrior to the start of the intervention, all study participants receive a knowledge assessment survey. The survey includes five case-based questions designed to assess knowledge of the AUC for TTE and also questions regarding attitudes toward diagnostic testing. Each participant also receives a post-study knowledge assessment survey.\n\nThe primary outcome measures in this study are the rate of inappropriate and appropriate TTEs. Secondary outcome measures include the number of TTEs ordered, common appropriate and inappropriate TTE indications, and pre- and post-study knowledge assessment scores among the study physicians.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cardiovascular Medicine fellows at Massachusetts General Hospital\n* Internal Medicine residents at Massachusetts General Hospital\n\nExclusion Criteria:\n\n* Attending physicians'}, 'identificationModule': {'nctId': 'NCT01944202', 'briefTitle': 'Educational Intervention to Reduce Outpatient Inappropriate Transthoracic Echocardiograms', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Reducing Outpatient Inappropriate Transthoracic Echocardiograms With An Educational Intervention: A Randomized Control Trial', 'orgStudyIdInfo': {'id': '2011P001779CR1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Educational Intervention', 'description': 'Physicians in the intervention arm receive the following multi-faceted educational intervention on transthoracic echocardiogram appropriateness: 1) a lecture at the beginning of the study period, which describes the Appropriate Use Criteria (AUC) for echocardiography and highlights common clinical scenarios for which outpatient TTEs are ordered, 2) an electronic "pocket card" via email that provides tips on appropriate ordering of TTEs, and 3) an individualized monthly feedback report that categorized TTEs ordered over the preceding month. The feedback reports contains the number of TTEs ordered during the month and how many are classified as appropriate, inappropriate, or uncertain based on the 2011 AUC.', 'interventionNames': ['Behavioral: Educational intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Physicians in the control arm have their TTE orders tracked and classified, but do not receive any feedback on their ordering behavior.'}], 'interventions': [{'name': 'Educational intervention', 'type': 'BEHAVIORAL', 'description': 'Educational and feedback intervention, as described in the Arm Description.', 'armGroupLabels': ['Educational Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Rory B Weiner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor Medicine', 'investigatorFullName': 'Rory Weiner, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}