Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT03036358
Status:
COMPLETED
Last Update Posted:
2018-04-05
First Post:
2016-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Teledermatology on Length of Hospital Admission, Length of Stay, 30 Day Readmission Rate, and Antibiotic Use in Patients Presenting With Cellulitis vs Pseudocellulitis in an Academic ED Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002481', 'term': 'Cellulitis'}], 'ancestors': [{'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007249', 'term': 'Inflammation'}, {'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', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-03', 'studyFirstSubmitDate': '2016-06-04', 'studyFirstSubmitQcDate': '2017-01-26', 'lastUpdatePostDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Admission to the hospital', 'timeFrame': '30 days', 'description': 'To determine the benefit of teledermatology to differentiate cellulitis from pseudocellulitis in emergency departments through the analysis of time spent in the emergency department (ED), admission to the inpatient hospital, antibiotic use, time to improvement, We anticipate a high rate of pseudocellulitis, and this aim will determine if there is a difference in patient admissions among those who receive a dermatologic assessment'}], 'secondaryOutcomes': [{'measure': 'Length of stay in the hospital', 'timeFrame': '30 days post admission', 'description': 'Will assess time spent in the hospital for those that were admitted'}, {'measure': '30 day readmission rate', 'timeFrame': '30 days post admission', 'description': 'Will assess hospitalization/emergency department readmission in the following 30 days'}, {'measure': 'Antibiotic use', 'timeFrame': '30 days post admission', 'description': 'Will assess the frequency of antibiotic use between groups'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cellulitis']}, 'descriptionModule': {'briefSummary': 'The effect of teledermatology on length of hospital admission, length of stay, 30 day readmission rate, and antibiotic use in patients presenting with cellulitis vs pseudocellulitis in an academic emergency department setting.', 'detailedDescription': 'The Investigator hope to determine if the implementation of teledermatology in the emergency department (ED) at The Ohio State University Wexner Medical Center is beneficial in diagnosing cases of cellulitis and pseudocellulitis conditions. Prior studies have indicated that misdiagnosis may occur in up to 28% of patients in the ED with these conditions. Additionally, dermatological consults have been shown to change diagnosis or management of these conditions in more than 60% of the patients examined. Without the use of teledermatology, however, a dermatological consult would be prohibitively expensive and take time to obtain. The investigator proposes that by utilizing teledermatology in emergency rooms, the investigator can make faster, yet just as accurate, dermatological diagnoses in patients presenting with cellulitis-like symptoms. Subsequently, by reducing the number of misdiagnoses, unnecessary use of antibiotics and hospitalizations will also decrease, lowering health care costs and simultaneously providing patients with faster treatment of the actual dermatologic condition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 18\n* Present to the ED with cellulitis-like symptoms, including but not limited to the following: tenderness, redness, swelling, expansive lesion\n\nExclusion Criteria:\n\n* pregnant\n* prisoner'}, 'identificationModule': {'nctId': 'NCT03036358', 'briefTitle': 'Effect of Teledermatology on Length of Hospital Admission, Length of Stay, 30 Day Readmission Rate, and Antibiotic Use in Patients Presenting With Cellulitis vs Pseudocellulitis in an Academic ED Setting', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'The Effect of Teledermatology on Length of Hospital Admission, Length of Stay, 30 Day Readmission Rate, and Antibiotic Use in Patients Presenting With Cellulitis vs Pseudocellulitis in an Academic Emergency Department Setting.', 'orgStudyIdInfo': {'id': '2015H0134'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Teledermatology consult', 'description': 'To determine the benefit of teledermatology to differentiate cellulitis from pseudocellulitis in emergency departments through the analysis of time spent in the emergency department (ED), admission to the inpatient hospital, antibiotic use, time to improvement, and 30-day remission rate. This arm will undergo imaging, a dermatologic assessment will be performed, AND this assessment will be entered into the patients chart.', 'interventionNames': ['Other: teledermatology consult']}, {'type': 'OTHER', 'label': 'Routine Care', 'description': 'To determine the benefit of teledermatology to differentiate cellulitis from pseudocellulitis in emergency departments through the analysis of time spent in the emergency department (ED), admission to the inpatient hospital, antibiotic use, time to improvement, and 30-day remission rate. This arm will undergo imaging, a dermatologic assessment will be performed, AND this assessment WILL NOT be entered into the patients chart', 'interventionNames': ['Other: Routine Care']}], 'interventions': [{'name': 'teledermatology consult', 'type': 'OTHER', 'description': 'Information from the dermatologic assessment will be entered into the patients chart.', 'armGroupLabels': ['Teledermatology consult']}, {'name': 'Routine Care', 'type': 'OTHER', 'description': 'The dermatologic assessment will occur but not added to the patients medical record. Dermatology may still be consulted but will be at the prerogative of the treating hospitalist.', 'armGroupLabels': ['Routine Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University Wexner Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Benjamin H Kaffenberger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OSU Dermatology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Benjamin Kaffenberger', 'investigatorAffiliation': 'Ohio State University'}}}}