Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-01-25 @ 8:43 PM
Study NCT ID:
NCT06582693
Status:
RECRUITING
Last Update Posted:
2025-08-18
First Post:
2024-08-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Refer2Quit: Evaluating a Proactive, Tailored, Population Health Approach for Tobacco Treatment for Household Smokers Through a Pediatric Care Network
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D015438', 'term': 'Health Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Only adult participants will be blinded during the study. Child participants do not need to be blinded because they will not be engaging in study procedures. Study staff will be aware of the assigned treatment arms. To maintain the blinding of adult participants, study staff will not disclose the treatment assignment to the adult participants at any point during the study. The recruit and consent procedures will describe the study, but not provide the adult participants with details that would reveal their treatment assignment.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-14', 'studyFirstSubmitDate': '2024-08-30', 'studyFirstSubmitQcDate': '2024-08-30', 'lastUpdatePostDateStruct': {'date': '2025-08-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of adult participants who engage in any evidence-based tobacco use treatments', 'timeFrame': 'Baseline, 1 and 6 months', 'description': 'The proportion of adult participants who engage in any evidence-based tobacco use treatments, between the intervention and control arms, by adult participant self-report.'}, {'measure': 'Combustible tobacco quit rate at 1 and 6 months', 'timeFrame': '1 and 6 months', 'description': 'The quit rate, compared between the intervention and control arms, will be assessed by a self-reported 7-day point prevalence smoking abstinence, collected via follow-up survey, and confirmed via breath carbon monoxide (CO) \\<5ppm at the time-point'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Smoking', 'Smoking Cessation', 'Second Hand Tobacco Smoke'], 'conditions': ['Smoking', 'Smoking Cessation', 'Second Hand Tobacco Smoke']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare the reach and effectiveness of the Refer2Quit intervention for increasing tobacco use treatment and quit rates among household members who smoke versus a treatment as usual group. This clinical trial also aims to study household member and pediatric patient characteristics that are associated with reach and effectiveness of Refer2Quit.', 'detailedDescription': "This study aims to evaluate a proactive and population health-based approach that leverages a clinical decision support (CDS) system embedded in the electronic health record (EHR) to identify household members who smoke but did not complete the smoking survey at the visit, and remotely engage them in tobacco use treatment.\n\nParticipants will be recruited through up to 32 outpatient primary care practice from the Children's Hospital of Philadelphia's (CHOP) Pediatric Research Consortium (PeRC). Potential participants will be identified from the cohort of referrals for tobacco cessation treatment. Randomization of adult participants into either the intervention or control group will occur after the participants have consented to partake in the study and completed enrollment. The investigators will deploy a remote recruitment strategy (via phone and/or text) to outreach to eligible adult participants to maximize recruitment efforts.\n\nAfter the initial referral of the household member who smokes, a study team member will reach out to them, explain the reason they are being contacted and confirm their smoking status and age. All participants will complete the enrollment step with data collection including: adult participant demographics, nicotine dependence and quitting motivation.\n\nOnly the intervention arm will receive the opportunity to be automatically connected by the study team to four evidence-based tobacco treatment options: varenicline, nicotine replacement therapy (NRT), quitline, and/or smokefreeTXT. Adult intervention arm participants will also receive brief motivational counseling by the study team.\n\nAdult control arm participants will receive treatment as usual which consistent of a handout of evidence tobacco treatment resources which the adult participant must connect with on their own\n\nEnrolled adult participants in both the intervention and control arms will be followed-up via surveys at approximately 1 and 6-month time intervals. Adult participants who self-report 7-day abstinence at the 1 and 6-month surveys will be asked to confirm smoking cessation through carbon monoxide testing."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Adult Intervention Subject Inclusion Criteria\n\n* Males or females ages ≥18 years in age\n* Self-identify as a current combustible tobacco user\n* Have a valid cell phone number\n\nChild Intervention Subject Inclusion Criteria\n\n* Must be a CHOP patient\n\nAdult Intervention Subject Exclusion Criteria\n\n* \\<18 years in age.\n* Indicates no combustible tobacco smoking\n\nChild Intervention Subject Exclusion Criteria\n\n* Not a CHOP patient\n\nAdult Control Subject Inclusion Criteria\n\n* Males or females ages ≥18 years in age\n* Self-identify as a current combustible tobacco user\n* Have a valid cell phone number\n\nChild Control Subject Inclusion Criteria\n\n* Must be a CHOP patient\n\nAdult Control Subject Exclusion Criteria\n\n* \\<18 years in age.\n* Indicates no combustible tobacco smoking\n\nChild Control Subject Exclusion Criteria\n\n* Not a CHOP patient'}, 'identificationModule': {'nctId': 'NCT06582693', 'briefTitle': 'Refer2Quit: Evaluating a Proactive, Tailored, Population Health Approach for Tobacco Treatment for Household Smokers Through a Pediatric Care Network', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Philadelphia"}, 'officialTitle': 'Refer2Quit: Evaluating a Proactive, Tailored, Population Health Approach for Tobacco Treatment for Household Smokers Through a Pediatric Care Network', 'orgStudyIdInfo': {'id': '23-021075'}, 'secondaryIdInfos': [{'id': '1R37CA282153-01', 'link': 'https://reporter.nih.gov/quickSearch/1R37CA282153-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Arm', 'description': 'Adult intervention arm participants will receive motivational counseling provided by the study staff member enrolling them. The study team member will offer 4 evidence-based treatment options (varenicline, NRT, quitline, and/or smokefreeTXT), emphasizing that the combination is often more effective than one treatment alone, and that they could start treatment even if they are not ready to quit.', 'interventionNames': ['Other: Refer2Quit']}, {'type': 'NO_INTERVENTION', 'label': 'Control Arm', 'description': 'Adult control arm participants will receive a handout listing tobacco treatment options that they can connect to on their own'}], 'interventions': [{'name': 'Refer2Quit', 'type': 'OTHER', 'description': "The Refer2Quit intervention consists of automatic connection to the adult participant's choice of any or all of four evidence-based tobacco treatment options (varenicline, NRT, quitline, and/or smokefreeTXT), as well as motivational counseling provided by the study team. Supportive and motivational text messaging is also included in the intervention to connect or reconnect adult participants to treatments as needed. Text messaging and support would also focus on supporting appropriate use of NRT and/or varenicline if indicated.", 'armGroupLabels': ['Intervention Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19146', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Brian P Jenssen, MD, MSHP', 'role': 'CONTACT', 'email': 'jenssenb@chop.edu', 'phone': '267-559-1566'}], 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'centralContacts': [{'name': 'Brian P Jenssen, MD, MSHP', 'role': 'CONTACT', 'email': 'jenssenb@chop.edu', 'phone': '267-559-1566'}], 'overallOfficials': [{'name': 'Brian P Jenssen, MD, MSHP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Philadelphia"}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will be shared with key stakeholders throughout the duration of the study.', 'ipdSharing': 'YES', 'description': "For adult participants who sign up for the Quitline, the generated reports that contain participant names and contact information will be stored on a secure HIPAA-compliant server managed by CHOP. The reports will contain adult participants' identifiable information (e.g., name, phone number).\n\nFor adult participants who sign up for SmokefreeTXT, their contact information and preference to enroll into the SmokefreeTXT program will be stored on a secure HIPAA-compliant server managed by CHOP. These reports will contain adult participants' identifiable information (e.g., name, phone number).\n\nFor adult participants who sign up for varenicline and/or NRT, their contact information and preference to get the varenicline and/or NRT medication will be stored on a secure HIPAA-compliant server managed by CHOP. These reports will contain adult participants' identifiable information (e.g., name, phone number).", 'accessCriteria': 'Data will be restricted to appropriately authorized members of the study team.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Philadelphia", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}