SmokingNCT06582693
Refer2Quit: Evaluating a Proactive, Tailored, Population Health Approach for Tobacco Treatment for Household Smokers Through a Pediatric Care Network
A study testing Refer2Quit in people with Smoking and Smoking Cessation, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking, Smoking Cessation, Second Hand Tobacco Smoke
- What is being tested?
- Refer2Quit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,200 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2024to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Adult Intervention Subject Inclusion Criteria
- Males or females ages ≥18 years in age
- Self-identify as a current combustible tobacco user
- Have a valid cell phone number
Child Intervention Subject Inclusion Criteria
- Must be a CHOP patient
Adult Intervention Subject Exclusion Criteria
- <18 years in age.
- Indicates no combustible tobacco smoking
Child Intervention Subject Exclusion Criteria
- Not a CHOP patient
Adult Control Subject Inclusion Criteria
- Males or females ages ≥18 years in age
- Self-identify as a current combustible tobacco user
- Have a valid cell phone number
Child Control Subject Inclusion Criteria
- Must be a CHOP patient
Adult Control Subject Exclusion Criteria
- <18 years in age.
- Indicates no combustible tobacco smoking
Child Control Subject Exclusion Criteria
- Not a CHOP patient
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19146
Brian P Jenssen, MD, MSHP, 267-559-1566, jenssenb@chop.edu
About this study
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.
Read the detailed description
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.
Participants 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.
After 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.
Only 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.
Adult 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
Enrolled 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.
- Conditions
- Smoking, Smoking Cessation, Second Hand Tobacco Smoke
- Being tested
- Refer2Quit
- Keywords
- Smoking, Smoking Cessation, Second Hand Tobacco Smoke
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Refer2QuitOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | 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. Receives: Other: Refer2Quit |
| Control Arm | No intervention | Adult control arm participants will receive a handout listing tobacco treatment options that they can connect to on their own |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 1 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start6 Sep 2024
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Brian P Jenssen, MD, MSHP, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06582693
- Sponsor's protocol ID
- 23-021075
- Other IDs
- 1R37CA282153-01
- Status last verified
- Aug 2026
- First submitted
- 30 Aug 2024
- Last updated
- 6 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refer2Quit: Evaluating a Proactive, Tailored, Population Health Approach for Tobacco Treatment for Household Smokers Through a Pediatric Care Network
- ClinicalTrials.gov ID
- NCT06582693
- Acronym / sponsor ID
- 23-021075
- Conditions
- Smoking, Smoking Cessation, Second Hand Tobacco Smoke
- Keywords
- Smoking, Smoking Cessation, Second Hand Tobacco Smoke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,200 participants (estimated)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 6 Sep 2024 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Participants 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.
After 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.
Only 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.
Adult 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
Enrolled 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: Refer2QuitAdult 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 intervention | –Adult control arm participants will receive a handout listing tobacco treatment options that they can connect to on their own |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Refer2QuitThe 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. | Other | Intervention Arm |
Primary outcome
The proportion of adult participants who engage in any evidence-based tobacco use treatments
Time frame: Baseline, 1 and 6 months
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.
Combustible tobacco quit rate at 1 and 6 months
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brian P Jenssen, MD, MSHP principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Refer2Quit in people with Smoking and Smoking Cessation, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brian P Jenssen, MD, MSHP (267-559-1566, jenssenb@chop.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of adult participants who engage in any evidence-based tobacco use treatments (time frame: Baseline, 1 and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.