Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2025-12-25 @ 5:35 PM
Study NCT ID:
NCT07164404
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-08-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nicotine Replacement Therapy Prescribing and Lung Cancer Screening in Hospitalized Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2025-08-28', 'studyFirstSubmitQcDate': '2025-09-07', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nicotine Replacement Therapy (NRT) prescribing rates during hospitalization', 'timeFrame': 'During hospitalization, assessed from admission to discharge (average of 3-7 days)'}, {'measure': 'Nicotine Replacement Therapy (NRT) prescribing rates at discharge', 'timeFrame': 'During hospitalization, assessed from admission to discharge (average of 3-7 days)'}, {'measure': 'Rate of referral to outpatient tobacco cessation clinic', 'timeFrame': 'During hospitalization, assessed from admission to discharge (average of 3-7 days)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tobacco Use Disorder']}, 'descriptionModule': {'briefSummary': 'Investigators are evaluating an EHR-based, non-interruptive alert to increase NRT prescribing in the hospital and at discharge for hospitalized patients. Investigators will investigate two randomized groups of resident physicians to evaluate their prescribing behaviors when the tool is introduced.', 'detailedDescription': 'Efforts to decrease cancer-related morbidity and mortality include increasing smoking cessation, however smoking remains prevalent. Classically, alerts within the electronic health record (EHR) are implemented to address gaps in care, yet studies suggest typical EHR alerts are often overridden and ignored. In this study, the investigators aim to decrease the incidence and burden of disease by including hospitalists as part of the multidisciplinary care team by implementing and evaluating a novel non-interruptive EHR alert embedded within a provider note as a tool to increase prescription of nicotine replacement therapy to patients who smoke upon admission to and discharge from the hospital. Investigators will investigate two randomized groups of resident physicians to evaluate their prescribing behaviors when the tool is introduced.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Patients\n\nInclusion Criteria:\n\n* Hospitalized patients admitted to a General Medicine Service at MUSC Charleston\n* Identified as actively smoking tobacco via nursing admission screening\n* Admitted by a resident physician participating in the study (as indicated by the H\\&P note)\n\nExclusion Criteria:\n\n• None\n\nResident Physicians:\n\nInclusion Criteria:\n\n• Internal medicine resident physicians rotating on the hospitalist service at MUSC Health Charleston\n\nExclusion Criteria:\n\n• None'}, 'identificationModule': {'nctId': 'NCT07164404', 'briefTitle': 'Nicotine Replacement Therapy Prescribing and Lung Cancer Screening in Hospitalized Patients', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'Increasing Nicotine Replacement Therapy Prescribing and Lung Cancer Screening in Hospitalized Patients Using an Innovative Non-Interruptive Alert Within the Electronic Health Record Provider Note', 'orgStudyIdInfo': {'id': 'Pro00146588'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EHR alert', 'description': 'Group will have access to the EHR embedded alert into the admission note template, where it automatically inserts smoking history, prompts NRT prescribing in the hospital, and offers referral to outpatient follow up.', 'interventionNames': ['Other: EHR alert']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Routine care, no access to the EHR embedded alert'}], 'interventions': [{'name': 'EHR alert', 'type': 'OTHER', 'description': 'EHR embedded alert into the admission note template, where it automatically inserts smoking history, prompts NRT prescribing in the hospital, and offers referral to outpatient follow up.', 'armGroupLabels': ['EHR alert']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29407', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'overallOfficials': [{'name': 'Ellen Esposito, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'South Carolina Clinical & Translational Research Institute (SCTR)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor-Faculty', 'investigatorFullName': 'Ellen Esposito', 'investigatorAffiliation': 'Medical University of South Carolina'}}}}