Ignite Creation Date:
2025-12-24 @ 1:14 PM
Ignite Modification Date:
2026-01-08 @ 8:09 PM
Study NCT ID:
NCT04071795
Status:
COMPLETED
Last Update Posted:
2023-04-28
First Post:
2019-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Reminder Changes to Increase Smoking Cessation Treatment in Outpatient Psychiatry
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Erin.Rogers@nyulangone.org', 'phone': '6465012544', 'title': 'Erin Rogers', 'organization': 'NYU Langone Health'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 Months', 'description': 'Adverse Event/Serious Adverse Events/All-Cause Mortality data were collected only for participating psychiatrists. AE/SAE/All-Cause Mortality data were not collected for Participants with extracted outcome measure data who visited the participating psychiatrists. Thus, the number of participants analyzed for AEs/SAEs/All-Cause Mortality in the Opt-Out Reminder and Opt-In Reminder arms is 34 and 55, respectively (equal to the number of psychiatrists who completed the trial in each arm).', 'eventGroups': [{'id': 'EG000', 'title': 'Opt Out Reminder', 'description': 'Psychiatrists in the Opt-Out Reminder group received a clinical reminder that included a standing nicotine replacement therapy (NRT) order and a referral to cessation counseling that automatically generated unless the provider actively opted-out.', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Opt In Reminder', 'description': 'Psychiatrists in the Opt-In Reminder group received a reminder that encouraged the psychiatrist to offer cessation medications and referral to cessation counseling to patients interested in quitting.', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 0, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients Screened for Smoking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Opt-Out Reminder - Patients of Participating Psychiatrists', 'description': 'Mental health patients with documented current smoking in the medical record who visited a psychiatrist randomized to receive the Opt-Out reminder.'}, {'id': 'OG001', 'title': 'Opt-In Reminder - Patients of Participating Psychiatrists', 'description': 'Mental health patients with documented current smoking in the medical record who visited a psychiatrist randomized to receive the Opt-In reminder.'}], 'classes': [{'categories': [{'measurements': [{'value': '240', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Month 6', 'description': 'Number of patients with documented current smoking in the medical record who were screened for tobacco use during their psychiatry visit. Data derived from medial records.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A waiver of HIPAA authorization was granted to abstract patient electronic health record (EHR) data from VA administrative data for the purposes of analysis of the primary outcomes. The overall number of participants analyzed represents patients (Participants) with available EHR data (Opt-Out Reminder Group, n = 240; Opt-In Reminder Group = 303) who visited a participating psychiatrist.'}, {'type': 'PRIMARY', 'title': 'Number of Smokers Prescribed a Cessation Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Opt-Out Reminder - Patients of Participating Psychiatrists', 'description': 'Mental health patients with documented current smoking in the medical record who visited a psychiatrist randomized to receive the Opt-Out reminder.'}, {'id': 'OG001', 'title': 'Opt-In Reminder - Patients of Participating Psychiatrists', 'description': 'Mental health patients with documented current smoking in the medical record who visited a psychiatrist randomized to receive the Opt-In reminder.'}], 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Month 6', 'description': 'Number of people with documented current smoking in the medical record who were prescribed cessation medication.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A waiver of HIPAA authorization was granted to abstract patient electronic health record (EHR) data from VA administrative data for the purposes of analysis of the primary outcomes. The overall number of participants analyzed represents patients (Participants) with available EHR data (Opt-Out Reminder Group, n = 240; Opt-In Reminder Group = 303) who visited a participating psychiatrist.'}, {'type': 'PRIMARY', 'title': 'Number of Smokers Referred to Counseling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Opt-Out Reminder - Patients of Participating Psychiatrists', 'description': 'Mental health patients with documented current smoking in the medical record who visited a psychiatrist randomized to receive the Opt-Out reminder.'}, {'id': 'OG001', 'title': 'Opt-In Reminder - Patients of Participating Psychiatrists', 'description': 'Mental health patients with documented current smoking in the medical record who visited a psychiatrist randomized to receive the Opt-In reminder.'}], 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Month 6', 'description': 'Number of people with documented current smoking in the medical record for whom counseling referrals were ordered.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A waiver of HIPAA authorization was granted to abstract patient electronic health record (EHR) data from VA administrative data for the purposes of analysis of the primary outcomes. The overall number of participants analyzed represents patients (Participants) with available EHR data (Opt-Out Reminder Group, n = 240; Opt-In Reminder Group = 303) who visited a participating psychiatrist.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Opt Out Reminder - Psychiatrists', 'description': 'Psychiatrists in the Opt-Out Reminder group received a clinical reminder that included a standing nicotine replacement therapy (NRT) order and a referral to cessation counseling that automatically generated unless the provider actively opted-out.'}, {'id': 'FG001', 'title': 'Opt-Out Reminder - Patients', 'description': 'Patients of psychiatrists randomized to the opt-out reminder arm.'}, {'id': 'FG002', 'title': 'Opt In Reminder - Psychiatrists', 'description': 'Psychiatrists in the Opt-In Reminder group received a reminder that encouraged the psychiatrist to offer cessation medications and referral to cessation counseling to patients interested in quitting.'}, {'id': 'FG003', 'title': 'Opt In Reminder - Patients', 'description': 'Patients of psychiatrists randomized to the opt-in reminder arm.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '240'}, {'groupId': 'FG002', 'numSubjects': '82'}, {'groupId': 'FG003', 'numSubjects': '303'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '240'}, {'groupId': 'FG002', 'numSubjects': '55'}, {'groupId': 'FG003', 'numSubjects': '303'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '27'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'In this study, psychiatrists practicing at the VA New York Harbor Healthcare System were enrolled and randomized to either the Opt-Out Reminder group (n=58) or Opt-In Reminder group (n=82).\n\nA waiver of informed consent was granted to extract data on patients (Opt-Out Reminder, n=240; Opt-In Reminder, n=303) who were seen by the participating psychiatrists. These patients were not considered to be enrolled participants'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Opt Out Reminder', 'description': 'Psychiatrists in the Opt-Out Reminder group received a clinical reminder that included a standing nicotine replacement therapy (NRT) order and a referral to cessation counseling that automatically generated unless the provider actively opted-out.'}, {'id': 'BG001', 'title': 'Opt In Reminder', 'description': 'Psychiatrists in the Opt-In Reminder group received a reminder that encouraged the psychiatrist to offer cessation medications and referral to cessation counseling to patients interested in quitting.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.6', 'spread': '16.8', 'groupId': 'BG000'}, {'value': '66.6', 'spread': '9.23', 'groupId': 'BG001'}, {'value': '64.4', 'spread': '12.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Baseline data were only collected from participating psychiatrists. A waiver of informed consent was granted to extract data on patients who were seen by the participating psychiatrists. No baseline data were collected for these patients.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-07-11', 'size': 519224, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-02-10T12:27', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '2 arm cluster randomized study design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-06', 'studyFirstSubmitDate': '2019-08-23', 'resultsFirstSubmitDate': '2023-02-10', 'studyFirstSubmitQcDate': '2019-08-26', 'lastUpdatePostDateStruct': {'date': '2023-04-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-04-06', 'studyFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients Screened for Smoking', 'timeFrame': 'Up to Month 6', 'description': 'Number of patients with documented current smoking in the medical record who were screened for tobacco use during their psychiatry visit. Data derived from medial records.'}, {'measure': 'Number of Smokers Prescribed a Cessation Medication', 'timeFrame': 'Up to Month 6', 'description': 'Number of people with documented current smoking in the medical record who were prescribed cessation medication.'}, {'measure': 'Number of Smokers Referred to Counseling', 'timeFrame': 'Up to Month 6', 'description': 'Number of people with documented current smoking in the medical record for whom counseling referrals were ordered.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Smoking Cessation']}, 'referencesModule': {'references': [{'pmid': '32617528', 'type': 'DERIVED', 'citation': 'Rogers ES, Wysota C, Prochaska JJ, Tenner C, Dognin J, Wang B, Sherman SE. A behavioral economic intervention to increase psychiatrist adherence to tobacco treatment guidelines: a provider-randomized study protocol. Implement Sci Commun. 2020;1:32. doi: 10.1186/s43058-020-00011-x. Epub 2020 Feb 25.'}]}, 'descriptionModule': {'briefSummary': 'This study will use a scientifically robust, mixed-methods, two-arm cluster-randomized study design. Investigators will implement a tobacco use clinical reminder for outpatient psychiatrists practicing at the VA New York Harbor Healthcare System (N = 20). Half of the psychiatrists will receive a reminder that encourages the psychiatrist to offer cessation medications and referral to cessation counseling to patients interested in quitting (Opt-In Reminder). The other half will receive a clinical reminder that includes a standing nicotine replacement therapy (NRT) order and a referral to cessation counseling that will automatically generate unless the provider actively opts-out (Opt-Out Reminder). Prior to implementation of the reminders, psychiatrists in both arms will receive a one-hour training on tobacco treatment and individual education outreach to demonstrate the clinical reminder and answer questions (academic detailing).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Psychiatrists\n* Works in outpatient psychiatry at Manhattan or Brooklyn VA campus and has no plans to leave in the next 6 months\n* Patient Post-Visit Survey Population\n* Had a visit with a psychiatrist included in the study Current smoker\n\nExclusion Criteria:\n\n* Outpatient Psychiatrists:\n* None\n* Patient Post-Visit Survey Population:\n* Non-English speaking'}, 'identificationModule': {'nctId': 'NCT04071795', 'briefTitle': 'Clinical Reminder Changes to Increase Smoking Cessation Treatment in Outpatient Psychiatry', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Clinical Reminder Changes to Increase Smoking Cessation Treatment in Outpatient Psychiatry', 'orgStudyIdInfo': {'id': '19-00813'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Opt Out', 'description': 'Training and Academic Detailing', 'interventionNames': ['Behavioral: Opt-Out Reminder']}, {'type': 'EXPERIMENTAL', 'label': 'Opt In', 'description': 'Training and Academic Detailing', 'interventionNames': ['Behavioral: Opt-In Reminder']}], 'interventions': [{'name': 'Opt-Out Reminder', 'type': 'BEHAVIORAL', 'description': 'half will receive a clinical reminder that includes a standing NRT order and a referral to cessation counseling that will automatically generate unless the provider actively opts-out', 'armGroupLabels': ['Opt Out']}, {'name': 'Opt-In Reminder', 'type': 'BEHAVIORAL', 'description': 'Half of the psychiatrists will receive a reminder that encourages the psychiatrist to offer cessation medications and referral to cessation counseling to patients interested in quitting', 'armGroupLabels': ['Opt In']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Erin Rogers, DrPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York Langone Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}