Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2026-01-27 @ 7:00 PM
Study NCT ID:
NCT03477435
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-10
First Post:
2018-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing an Opt-out to an opt-in Approach for Smoking Cessation in VA Primary Care Clinics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064424', 'term': 'Tobacco Use'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D015438', 'term': 'Health Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Type 1 hybrid effectiveness/implementation study to evaluate two population-based approaches'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1365}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-05', 'studyFirstSubmitDate': '2018-03-19', 'studyFirstSubmitQcDate': '2018-03-19', 'lastUpdatePostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of smokers who accept referral to treatment (Quitline or text messaging)', 'timeFrame': '2-year intervention period', 'description': 'This outcome will be based on intervention process data. Note that we will measure both offering and accepting referral, but our outcome will be accepting referral.'}, {'measure': 'Proportion of smokers who engage in treatment with the Quitline or text messaging service', 'timeFrame': '2-year intervention period', 'description': 'This outcome will be based on data from the Quitline and SmokefreeTXT.'}, {'measure': 'Abstinence at the end of the 2-year intervention period', 'timeFrame': '7-day abstinence', 'description': 'Abstinence will be based on self-report, as is recommended for population-level studies'}], 'secondaryOutcomes': [{'measure': 'Cost-effectiveness of the two approaches (opt-out vs opt-in)', 'timeFrame': '2-year intervention period', 'description': 'This outcome will be based on cost data at the end of the intervention'}, {'measure': 'Use of smoking cessation medications', 'timeFrame': '2-year intervention period', 'description': 'This outcome will be based on VA administrative data'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['smoking', 'tobacco dependence', 'quitline', 'smoking cessation'], 'conditions': ['Tobacco Use']}, 'referencesModule': {'references': [{'pmid': '35276337', 'type': 'DERIVED', 'citation': 'Haber Y, Fu SS, Rogers E, Richter K, Tenner C, Dognin J, Goldfeld K, Gold HT, Sherman SE. A novel opt-in vs opt-out approach to referral-based treatment of tobacco use in Veterans Affairs (VA) primary care clinics: A provider-level randomized controlled trial protocol. Contemp Clin Trials. 2022 May;116:106716. doi: 10.1016/j.cct.2022.106716. Epub 2022 Mar 8.'}]}, 'descriptionModule': {'briefSummary': 'The investigators propose a Type I hybrid effectiveness/implementation study to evaluate two population-based approaches for increasing use of Quitlines and text messaging at two VA sites. Specifically, the investigators will test the default bias, examining whether an opt-out approach to referral is more effective than an opt-in approach. The investigators will randomly assign teams to either an opt-out or opt-in approach to referring smokers to treatment. In the opt-out approach, the default is that everyone is referred to treatment unless they actively choose not to be. In the opt-in approach, people are offered treatment but must actively choose to enroll in it.', 'detailedDescription': 'This project is a Type 1 hybrid effectiveness/implementation study to evaluate two population-based approaches for increasing use of specific evidence-based approaches for behavioral tobacco dependence treatment, Quitlines and text messaging, at the Manhattan and Brooklyn campuses of the VA New York Harbor Healthcare System (NYHHS). The project will test the default bias, examining whether an opt-out approach to referral is more effective than an opt-in approach. Researchers will randomly assign clinical care teams at each VA campus to either an opt-out or an opt-in approach to referring smokers to treatment. In the opt-out approach, the default is that everyone is referred to treatment unless they actively choose not to be. In the opt-in approach, people are offered treatment but must actively choose to enroll in it.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Survey Cohort -- Have been seen by an NA on the PACT team in the past 12 months at the Manhattan or Brooklyn VA campus AND Current smoker\n* Nursing Assistants/Registered Nurses -- Work on a PACT at the Manhattan or Brooklyn VA campus\n* Administrative Cohort -- Have been seen by a PACT team at the Manhattan or Brooklyn VA campus AND Current smoker\n* Patient Post-Visit Survey Population -- Had a visit with an NA/RN included in the study AND Current smoker\n\nExclusion Criteria:\n\n* Survey Cohort -- Non-English speaking\n* Nursing Assistants/Registered Nurses -- None\n* Administrative Cohort -- None\n* Patient Post-Visit Survey Population -- Non-English speaking'}, 'identificationModule': {'nctId': 'NCT03477435', 'briefTitle': 'Comparing an Opt-out to an opt-in Approach for Smoking Cessation in VA Primary Care Clinics', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Comparing an Opt-out to an opt-in Approach for Smoking Cessation in VA Primary Care Clinics', 'orgStudyIdInfo': {'id': 'IIR 17-056'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Opt-in clinical reminder', 'description': 'As the investigators have done previously, the reminder will be self-explanatory, and will walk staff through each step of referral. The reminder will include the following domains: normative advice, referral to treatment, handout', 'interventionNames': ['Behavioral: Staff training and academic detailing']}, {'type': 'EXPERIMENTAL', 'label': 'Opt-out tobacco treatment', 'description': 'The investigators will directly change the treatment status quo by implementing a clinical reminder that automatically initiates tobacco treatment referral at the time the reminder is activated.', 'interventionNames': ['Behavioral: Staff training and academic detailing']}], 'interventions': [{'name': 'Staff training and academic detailing', 'type': 'BEHAVIORAL', 'description': 'Both arms will receive training at baseline to help their patients quit smoking. The training will be a mix of content and process education. We will provide brief updates to staff every 6 months throughout the intervention period, which will focus primarily on process education. We will monitor which staff attend and reach out separately to staff who did not. During the month after implementation of the clinical reminders, two study investigators will make a brief outreach visit to each staff member. We will follow a script, using the seven steps recommended by the National Resource Center for Academic Detailing: 1) Introduction; 2) Needs Assessment; 3) Key Messages/Features/Benefits; 4) Understanding Barriers and Enablers; 5) Identifying and Handling Objections; 6) Summary; and 7) Close. The key message (Step 3) will include demonstration of the clinical reminder, review of the evidence for telephone counseling and text messaging and how to refer patients.', 'armGroupLabels': ['Opt-in clinical reminder', 'Opt-out tobacco treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10010-5011', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'VA NY Harbor Healthcare System, New York, NY', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Scott E. Sherman, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA NY Harbor Healthcare System, New York, NY'}, {'name': 'Steven S. Fu, MD MSCE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Minneapolis VA Health Care System, Minneapolis, MN'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}