Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2026-01-02 @ 1:16 PM
Study NCT ID:
NCT04107857
Status:
COMPLETED
Last Update Posted:
2024-12-20
First Post:
2019-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electronic Health Record-Enabled Evidence-Based Smoking Cessation Quality Improvement Implementation Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-18', 'studyFirstSubmitDate': '2019-09-25', 'studyFirstSubmitQcDate': '2019-09-26', 'lastUpdatePostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinic level percentage of patients receiving brief counseling', 'timeFrame': 'From 6 months pre-intervention through 6 months post-intervention'}, {'measure': 'Clinic level percentage of smokers offered referral to additional counseling', 'timeFrame': 'From 6 months pre-intervention through 6 months post-intervention'}, {'measure': 'Clinic level percentage of smokers offered medication', 'timeFrame': 'From 6 months pre-intervention through 6 months post-intervention'}], 'secondaryOutcomes': [{'measure': 'Clinic level percentage of patients receiving brief counseling', 'timeFrame': 'Estimated to be 12 months pre-intervention and 12, 24, 36, and 48 months post-intervention'}, {'measure': 'Clinic level percentage of smokers offered referral to additional counseling', 'timeFrame': 'Estimated to be 12 months pre-intervention and 12, 24, 36, and 48 months post-intervention'}, {'measure': 'Clinic level percentage of smokers offered medication', 'timeFrame': 'Estimated to be 12 months pre-intervention and 12, 24, 36, and 48 months post-intervention'}, {'measure': 'Clinic level percentage of smokers receiving smoking assessment', 'timeFrame': 'Estimated to be 12 months pre-intervention and 12, 24, 36, and 48 months post-intervention'}, {'measure': 'Clinic level percentage of smokers receiving cessation medication', 'timeFrame': 'Estimated to be 12 months pre-intervention and 12, 24, 36, and 48 months post-intervention'}, {'measure': 'Number of patients who have abstained from smoking', 'timeFrame': 'Estimated to be 6 months post-intervention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Smoking Cessation']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.siteman.wustl.edu', 'label': 'Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine'}, {'url': 'https://siteman.wustl.edu/prevention/smoking-cessation-program/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The goal of this quality improvement program is to implement, evaluate, and sustain an evidence-based smoking cessation treatment program with a population-based approach so that all patients at the Siteman Cancer Center, Washington University, Barnes-Jewish Hospital, BJC Healthcare, and satellite locations receive assessment of smoking and all smokers receive treatment support.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients 18 years of age or older', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Patients seen at Siteman Cancer Center, Washington University, Barnes-Jewish Hospital, BJC Healthcare, or any of the satellite locations\n\nExclusion Criteria:\n\n-None'}, 'identificationModule': {'nctId': 'NCT04107857', 'briefTitle': 'Electronic Health Record-Enabled Evidence-Based Smoking Cessation Quality Improvement Implementation Program', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Electronic Health Record-Enabled Evidence-based Smoking Cessation Quality Improvement Program', 'orgStudyIdInfo': {'id': '89276'}, 'secondaryIdInfos': [{'id': 'P30CA091842', 'link': 'https://reporter.nih.gov/quickSearch/P30CA091842', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Smoking Cessation', 'description': "* Patients enter the program through clinic appointments or community outreach programs.\n* Patients will be given brief advice to quit smoking and referral options to receive evidence-based treatment through Missouri/Illinois Quitlines, Smokefree.TXT, or smokefree.gov dependent on the patient's preference for counseling\n* Patient can also be prescribed smoking cessation pharmacotherapy", 'interventionNames': ['Behavioral: ELEVATE enhancement to electronic health record (EHR) to improve cessation counseling offer', 'Behavioral: ELEVATE enhancement to electronic health record (EHR) to improve smoking cessation medication offer', 'Behavioral: Data Driven Feedback reports']}], 'interventions': [{'name': 'ELEVATE enhancement to electronic health record (EHR) to improve cessation counseling offer', 'type': 'BEHAVIORAL', 'description': '* Brief advise to quit smoking\n* Referral to Missouri/Illinois Quitlines, Smokefree.TXT, or smokefree.gov', 'armGroupLabels': ['Smoking Cessation']}, {'name': 'ELEVATE enhancement to electronic health record (EHR) to improve smoking cessation medication offer', 'type': 'BEHAVIORAL', 'description': '-Nicotine replacement therapy, varenicline, bupropion, or combination therapy (not provided by study)', 'armGroupLabels': ['Smoking Cessation']}, {'name': 'Data Driven Feedback reports', 'type': 'BEHAVIORAL', 'description': '-Feedback reports will be based on data', 'armGroupLabels': ['Smoking Cessation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Li-Shiun Chen, M.D., ScD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}