Refer2Quit: Evaluating a Proactive, Tailored, Population Health Approach for Tobacco Treatment for Household Smokers Through a Pediatric Care Network
2 other identifiers
interventional
3,200
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2024
CompletedFirst Posted
Study publicly available on registry
September 3, 2024
CompletedStudy Start
First participant enrolled
September 6, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
August 18, 2025
August 1, 2025
2.5 years
August 30, 2024
August 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The proportion of adult participants who engage in any evidence-based tobacco use treatments
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.
Baseline, 1 and 6 months
Combustible tobacco quit rate at 1 and 6 months
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
1 and 6 months
Study Arms (2)
Intervention Arm
EXPERIMENTALAdult 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.
Control Arm
NO INTERVENTIONAdult control arm participants will receive a handout listing tobacco treatment options that they can connect to on their own
Interventions
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.
Eligibility Criteria
You may qualify if:
- Males or females ages ≥18 years in age
- Self-identify as a current combustible tobacco user
- Have a valid cell phone number
- Must be a CHOP patient
You may not qualify if:
- \<18 years in age.
- Indicates no combustible tobacco smoking
- Not a CHOP patient
- Males or females ages ≥18 years in age
- Self-identify as a current combustible tobacco user
- Have a valid cell phone number
- Must be a CHOP patient
- \<18 years in age.
- Indicates no combustible tobacco smoking
- Not a CHOP patient
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Hospital of Philadelphialead
- National Institutes of Health (NIH)collaborator
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19146, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brian P Jenssen, MD, MSHP
Children's Hospital of Philadelphia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- 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.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2024
First Posted
September 3, 2024
Study Start
September 6, 2024
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
August 18, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will be shared with key stakeholders throughout the duration of the study.
- Access Criteria
- Data will be restricted to appropriately authorized members of the study team.
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). For 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). For 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).