Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2026-02-25 @ 9:47 PM
Study NCT ID:
NCT03900767
Status:
UNKNOWN
Last Update Posted:
2023-08-03
First Post:
2019-03-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Strategies to Connect Patients at Federally Qualified Health Clinics With Evidence Based Tobacco Cessation Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073869', 'term': 'Tobacco Smoking'}, {'id': 'D064424', 'term': 'Tobacco Use'}, {'id': 'D020340', 'term': 'Tobacco Use Cessation'}], 'ancestors': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D015438', 'term': 'Health Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000074602', 'term': 'Smoking Devices'}], 'ancestors': [{'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-09-24', 'size': 274600, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-09-26T15:50', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12009}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-01', 'studyFirstSubmitDate': '2019-03-11', 'studyFirstSubmitQcDate': '2019-04-01', 'lastUpdatePostDateStruct': {'date': '2023-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reach', 'timeFrame': 'Up to 12 months', 'description': 'Defined as the proportion of tobacco users who enter Quitline treatment.'}, {'measure': 'Impact', 'timeFrame': 'At 12 months', 'description': 'Defined as reach x efficacy. Efficacy is defined as the proportion of tobacco users entering Quitline treatment who quit (i.e., achieve abstinence).'}, {'measure': 'Abstinence from tobacco use', 'timeFrame': 'At 12 months', 'description': 'Abstinence assessments are based on recommendations for cessation induction trials (i.e., 7 and 30 day point prevalence abstinence).'}, {'measure': 'Health-related quality of life', 'timeFrame': 'At 12 months', 'description': 'Assessed with the Short Form Health Survey (SF-12)'}], 'secondaryOutcomes': [{'measure': 'Abstinence from tobacco use (biochemical validation)', 'timeFrame': 'At 12 months', 'description': 'We will randomly select a subset of participants who report abstinence at 12 months follow-up survey to complete biochemical validation of abstinence via saliva samples. The saliva sample will be used to test for cotinine, a metabolite of nicotine.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Text Messaging', 'Underserved Population', 'Underserved', 'Utah', 'Tobacco Cessation'], 'conditions': ['Current Smoker', 'Tobacco Smoking', 'Tobacco Use']}, 'referencesModule': {'references': [{'pmid': '32000812', 'type': 'DERIVED', 'citation': 'Fernandez ME, Schlechter CR, Del Fiol G, Gibson B, Kawamoto K, Siaperas T, Pruhs A, Greene T, Nahum-Shani I, Schulthies S, Nelson M, Bohner C, Kramer H, Borbolla D, Austin S, Weir C, Walker TW, Lam CY, Wetter DW. QuitSMART Utah: an implementation study protocol for a cluster-randomized, multi-level Sequential Multiple Assignment Randomized Trial to increase Reach and Impact of tobacco cessation treatment in Community Health Centers. Implement Sci. 2020 Jan 30;15(1):9. doi: 10.1186/s13012-020-0967-2.'}]}, 'descriptionModule': {'briefSummary': 'This trial aims to connect tobacco using patients of Community Health Centers (CHCs) and Federally Qualified Health Centers (FQHCs) with evidence-based treatment to help them quit. The trial will evaluate multiple strategies, that target both clinics and for patients, to increase the number of patients who enroll in Utah Tobacco Quit Line treatment.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To evaluate clinic and patient level interventions with respect to increasing the reach of evidence-based treatment for tobacco use (delivered via the Utah Quitline).\n\nII. To evaluate clinic and patient level interventions with respect to increasing the impact of Quitline treatment. Impact is defined as Reach X Efficacy. In calculating impact, efficacy is defined as the proportion of smokers who enroll in Quitline delivered treatment that successfully quit.\n\nIII. To evaluate characteristics of both clinics and patients that may influence tobacco use outcomes.\n\nOUTLINE:\n\nCLINIC-LEVEL INTERVENTION\n\nAll clinics will receive a clinic-level intervention of Ask Advise Connect (AAC). AAC consists of an electronic health record (EHR) intervention that utilizes the EHR to facilitate clinic staff to Ask patients about tobacco use, Advise patients to quit using tobacco, and directly and electronically Connect patients to the Utah Tobacco Quit Line.\n\nPHASE I (PATIENT-LEVEL): Patients who do not enroll in the Quit Line following the clinic visit will be eligible for Phase 1 randomization to receive either TM or continue with the EHR Condition Only (CO).\n\nGROUP I: Patients receive a Text Message (TM) weekly for one month followed by a monthly text message with a one-touch response to connect to the Quit Line over the next 5 months (i.e., 6 months of text messages following the clinic visit).\n\nGROUP II: Patients receive continued clinic level EHR intervention only (CO).\n\nPHASE II (Patient-level): Nonresponders (i.e., did not enroll in Quit Line treatment at 6 months) in Group 1 of Phase I (TM/CO) will be randomized to 1 of 2 groups:\n\nGROUP I: Patients will continue to receive text messages (motivational messaging with simple touch response to connect directly to the Quit Line) plus 2 brief telephone calls from health coaches for 6-12 months following the clinic visit. Brief telephone coaching calls will be conducted using Motivation and Problem Solving (MAPS) for a TM+MAPS condition.\n\nGROUP II: Patients continue to receive a monthly text message with a one-touch response to directly connect to the Quit Line during months 6-12 following the clinic visit, i.e., text message continued (TM-Cont).\n\nRoughly twelve months after the clinic visit, eligible patients will be invited to complete a 12-month survey on quality of life and abstinence assessments.\n\nA saliva kit will be sent to 300 randomly selected patients who indicate abstinence at the 12-month follow-up and agree to the saliva sample.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants will be current tobacco users.\n* Participants who speak English or Spanish.\n* Participants will have a working cellphone that can accept texts and calls.\n* Participants who present at participating community health center (CHC) clinics.'}, 'identificationModule': {'nctId': 'NCT03900767', 'briefTitle': 'Strategies to Connect Patients at Federally Qualified Health Clinics With Evidence Based Tobacco Cessation Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Multi-Level Interventions for Increasing Tobacco Cessation at Federally Qualified Health Clinics (FQHCs)', 'orgStudyIdInfo': {'id': 'HCI111985'}, 'secondaryIdInfos': [{'id': 'NCI-2019-00502', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'HCI111985', 'type': 'OTHER', 'domain': 'Huntsman Cancer Institute/University of Utah'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clinic-Level', 'description': 'Clinics will receive the AAC intervention consisting of an EHR-based point of care alert that prompts clinic staff to Ask every patient about tobacco use, Advise tobacco using patients to quit, and Connect interested tobacco users to the Utah Tobacco Quit Line\n\nAssigned Interventions = Electronic Health Record intervention AAC', 'interventionNames': ['Other: Electronic Health Record intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Phase I Group I (Continued EHR and text messages)', 'description': "Patients receive a weekly text message for one month followed by a monthly text message over the next 5 months (i.e., 6 months of text messages following each tobacco users' clinic visit). All messages will include a motivational message, the Quit Line website, the Quit Line phone number, and simple two-touch response that directly connects interested tobacco users to the Quit Line.", 'interventionNames': ['Other: Electronic Health Record intervention', 'Behavioral: Smoking Cessation Intervention', 'Behavioral: Telephone-Based Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Phase I Group II (Continued clinic-level EHR intervention only)', 'description': 'Patients receive continued clinic level EHR intervention only (CO).', 'interventionNames': ['Other: Electronic Health Record intervention', 'Behavioral: Smoking Cessation Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Phase II Group I (Text messages, Counseling call)', 'description': "Patients receive a monthly text message plus 2 brief telephone calls from patient navigators/health educators for 6-12 months following each tobacco user's clinic visit.", 'interventionNames': ['Other: Electronic Health Record intervention', 'Behavioral: Smoking Cessation Intervention', 'Behavioral: Telephone-Based Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Phase II Group II (Text messages continued)', 'description': "Patients receive a monthly text message for 6-12 months following each tobacco user's clinic visit that includes a simple one-touch response to directly connect to the Quitline.", 'interventionNames': ['Other: Electronic Health Record intervention', 'Behavioral: Smoking Cessation Intervention', 'Behavioral: Telephone-Based Intervention']}], 'interventions': [{'name': 'Electronic Health Record intervention', 'type': 'OTHER', 'description': 'AAC', 'armGroupLabels': ['Clinic-Level', 'Phase I Group I (Continued EHR and text messages)', 'Phase I Group II (Continued clinic-level EHR intervention only)', 'Phase II Group I (Text messages, Counseling call)', 'Phase II Group II (Text messages continued)']}, {'name': 'Smoking Cessation Intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Smoking and Tobacco Use Cessation Interventions'], 'description': 'Receive standard Utah Quitline treatment', 'armGroupLabels': ['Phase I Group I (Continued EHR and text messages)', 'Phase I Group II (Continued clinic-level EHR intervention only)', 'Phase II Group I (Text messages, Counseling call)', 'Phase II Group II (Text messages continued)']}, {'name': 'Telephone-Based Intervention', 'type': 'BEHAVIORAL', 'description': 'Receive text messages', 'armGroupLabels': ['Phase I Group I (Continued EHR and text messages)', 'Phase II Group I (Text messages, Counseling call)', 'Phase II Group II (Text messages continued)']}, {'name': 'Telephone-Based Intervention', 'type': 'BEHAVIORAL', 'description': 'Receive phone calls', 'armGroupLabels': ['Phase II Group I (Text messages, Counseling call)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Huntsman Cancer Institute/University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'David Wetter', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Huntsman Cancer Institute/ University of Utah'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'collaborators': [{'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'David Wetter', 'investigatorAffiliation': 'University of Utah'}}}}