Refer2Quit for Smoking Cessation

Overseen By Brian P Jenssen, MD, MSHP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital of Philadelphia

Disqualifiers: Non-smokers, Under 18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 6 months

3200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called Refer2Quit, which helps people stop smoking by comparing it to standard advice. The trial aims to evaluate the program's effectiveness for smokers living in the same household and to learn more about the individuals it benefits. Participants will either receive motivational counseling and support options, such as nicotine patches, or a list of resources to explore independently. Ideal candidates are adults who smoke tobacco and have a cell phone. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new methods for quitting smoking.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Refer2Quit intervention is safe?

Research shows that the treatments in the Refer2Quit program are generally safe for those trying to quit smoking. Varenicline, one option, is effective and usually well-tolerated, though some may experience side effects like nausea or trouble sleeping. Nicotine Replacement Therapy (NRT), another option, helps ease withdrawal symptoms and is safe for most users.

Studies have found that combining these treatments can be more effective without adding major safety concerns. Counseling, also part of the Refer2Quit program, is a safe and supportive method that has helped many quit smoking. Overall, these treatments are well-researched and have been safely used by many trying to quit tobacco. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Refer2Quit approach for smoking cessation because it combines multiple evidence-based treatments, offering a personalized plan that can be more effective than using a single method. Unlike standard treatments like varenicline, nicotine replacement therapy (NRT), or quitlines, Refer2Quit integrates these options and includes smokefreeTXT, an innovative text-based support system. This comprehensive strategy not only supports individuals when they're ready to quit but also encourages action even if they're not quite there yet, potentially increasing overall success rates.

What evidence suggests that the Refer2Quit intervention is effective for smoking cessation?

The Refer2Quit program, available to participants in this trial, has been shown in studies to help people stop smoking. Past research found that about 46% of participants used the treatment options offered, and 13% successfully quit smoking. The program includes motivational counseling and proven treatments such as varenicline (a medication to help quit smoking), nicotine replacement therapy (NRT), phone support through quitlines, and text message support. Combining these treatments typically proves more effective than using just one. Overall, Refer2Quit aims to increase quit rates and improve access to helpful resources for people who smoke. ^{6 7 8 9 10}

Who Is on the Research Team?

Brian P Jenssen, MD

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

This trial is for household members who smoke and are interested in quitting. It's designed to see if a new approach, Refer2Quit, helps more people stop smoking compared to usual treatments. Specific characteristics of the participants and their families will also be studied.

Inclusion Criteria

Child Control Subject: Must be a CHOP patient

Child Intervention Subject: Must be a CHOP patient

I am 18 or older, smoke tobacco, and have a cell phone.

Exclusion Criteria

Child Control Subject: Not a CHOP patient

Child Intervention Subject: Not a CHOP patient

I am under 18 and do not smoke.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment

Participants are enrolled and randomized into intervention or control groups

1 week

Treatment

Intervention arm participants receive motivational counseling and access to tobacco treatment options; control arm receives a handout of resources

6 months

Remote engagement via phone and/or text

Follow-up

Participants are monitored for smoking cessation and treatment engagement at 1 and 6 months

6 months

Surveys at 1 and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Refer2Quit

Trial Overview The study tests the Refer2Quit intervention against standard quit-smoking strategies. Participants will either receive this new method or continue with the typical support available, allowing researchers to compare success rates between the two groups.

How Is the Trial Designed?

Group I: Intervention Arm Experimental Treatment 1 Intervention

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.

Group II: Control Arm Active Control 1 Intervention

Adult control arm participants will receive a handout listing tobacco treatment options that they can connect to on their own

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

This study is the first randomized controlled trial assessing the effectiveness of combining brief smoking cessation advice with active referral to cessation services, involving 1291 smokers across 66 clusters.

The primary goal is to evaluate the impact of this intervention on smoking cessation rates at 3 and 6 months, which could provide valuable insights for improving smoking cessation practices in the community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief advice and active referral for smoking cessation services among community smokers: a study protocol for randomized controlled trial. Suen, YN., Wang, MP., Li, WH., et al.[2018]

In a study involving 8144 participants, varenicline and bupropion were associated with specific adverse events (AEs) like nausea and insomnia compared to the nicotine patch, but overall, these treatments were well tolerated with less than 1.5% of participants experiencing severe AEs.

Most reported AEs were manageable and not clinically significant, allowing healthcare providers to reassure patients about the safety of these smoking cessation pharmacotherapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frequently Reported Adverse Events With Smoking Cessation Medications: Post Hoc Analysis of a Randomized Trial. Ebbert, J., Jimenez-Ruiz, C., Dutro, MP., et al.[2021]

A new referral aid is being tested to help practice nurses provide better smoking cessation guidance to patients willing to quit, with the goal of increasing adherence to Dutch smoking cessation guidelines.

The study will evaluate the effectiveness of this intervention by comparing outcomes between patients receiving guidance with the aid and those without, using various statistical analyses to assess cessation rates and cost-effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A referral aid for smoking cessation interventions in primary care: study protocol for a randomized controlled trial. Zijlstra, DN., Muris, JWM., Bolman, C., et al.[2023]

Smoking is the leading cause of premature death in Western countries, highlighting the urgent need for effective cessation methods to help smokers quit early.

Current and emerging therapies, including novel medications and vaccines, show promise in improving the efficacy and safety of smoking cessation treatments, with many in advanced stages of development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation: present status and future perspectives. Caponnetto, P., Russo, C., Polosa, R.[2018]

In a study of 904 smokers using nicotine replacement therapy (NRT), bupropion, or a combination of both, adverse effects were reported by a significant number of participants, particularly in those using bupropion or combined therapy, but most effects were mild and not severe.

Despite the mild nature of most adverse effects, 4.5% of participants discontinued treatment indefinitely due to these effects, highlighting the importance of clinician supervision and patient education in managing treatment for smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse effects of pharmacological therapy for nicotine addiction in smokers following a smoking cessation program. Barrueco, M., Otero, MJ., Palomo, L., et al.[2015]

The Committed Quitters Program (CQP) significantly improved quit rates among smokers who actively used the program materials, with 38.8% abstinence at 6 weeks and 18.2% at 12 weeks, compared to 30.7% and 11.1% in the standard User's Guide (UG) group.

Overall abstinence rates did not differ significantly between the CQP and UG groups, indicating that the effectiveness of CQP is particularly notable among those who engage with the tailored materials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of computer-tailored smoking cessation material as a supplement to nicotine patch therapy. Shiffman, S., Paty, JA., Rohay, JM., et al.[2019]

The Refer2Quit (R2Q) online training program significantly increased fax referral rates to tobacco quitlines among healthcare providers, with an odds ratio of 2.86, indicating a strong improvement in referral practices after training.

Providers who completed the R2Q training reported enhanced self-efficacy and more positive attitudes towards delivering tobacco cessation interventions, although barriers like lack of reimbursement and patient reluctance still hindered referral rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Refer2Quit: impact of Web-based skills training on tobacco interventions and quitline referrals. Carpenter, KM., Carlini, BH., Painter, I., et al.[2012]

In a phase II clinical trial with 346 adult smokers, the combination of reduced-nicotine cigarettes (Quest) and nicotine replacement therapy (NRT) led to a higher rate of continuous abstinence (32.8%) compared to conventional cigarettes with NRT (21.9%).

The study found no serious adverse events linked to the reduced-nicotine cigarettes, suggesting they are a safe option for smokers looking to quit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of nicotine replacement therapy in combination with reduced-nicotine cigarettes for smoking cessation. Becker, KM., Rose, JE., Albino, AP.[2022]

This study is a cluster randomized controlled trial comparing high-intensity and low-intensity smoking cessation (SC) referrals among smokers in Hong Kong, aiming to determine which method is more effective in achieving smoking abstinence.

The primary outcome will be the self-reported 7-day point prevalence abstinence at 3 and 6 months, with secondary outcomes including smoking cessation service use and smoking reduction rates, providing a comprehensive evaluation of the referral methods' efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing different intensities of active referral to smoking cessation services in promoting smoking cessation among community smokers: a study protocol of a cluster randomized controlled trial. Weng, X., Wang, MP., Suen, YN., et al.[2019]

This ongoing trial aims to enroll 1134 daily smokers in Hong Kong to assess the effectiveness of active referral combined with a financial incentive on smoking cessation, with follow-ups at 1, 2, 3, and 6 months.

Participants in the intervention group receive a referral to smoking cessation services and a financial incentive of approximately US$38 for using these services, with primary outcomes measured by bioverified abstinence at 3 and 6 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of active referral combined with a small financial incentive on smoking cessation: study protocol for a cluster randomised controlled trial. Weng, X., Wang, MP., Li, HCW., et al.[2021]

The integration of the Ask, Advise, Refer (AAR) strategy by nursing staff in a VHA outpatient surgery clinic effectively promoted smoking cessation, with 19% of smokers using the provided resources after their visit.

This approach highlights the importance of utilizing every clinical encounter as an opportunity to encourage smoking cessation, demonstrating that simple strategies can be effective even in busy healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Connecting veterans with smoking cessation services in less than 3 minutes. Boe, R., Ridner, SL.[2021]

The introduction of Best Practice Advisory and Population Outreach referral methods significantly increased the utilization of the Duke Smoking Cessation Program, with the number of smokers referred rising from 129 to 329 in Primary Care clinics and from 206 to 401 in Disadvantaged Care clinics over one year.

This increase in referrals is projected to result in substantial health benefits, including 967 life-years gained and 408 quality-adjusted life-years saved, along with an estimated total healthcare cost savings of over $46 million.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health benefits and economic advantages associated with increased utilization of a smoking cessation program. Datta, SK., Dennis, PA., Davis, JM.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11910067/

Refer2Quit: A pilot referral approach to promote treatment ... Our preliminary results suggest that, for adults who smoke who are referred to our team, our system performed better than this patient-reported data. An ...

2. naquitline.org naquitline.org/news/696494/Refer2Quit-A-Pilot-Referral-Approach-to-Promote-Treatment-for-Parents-Who-Smoke-Tobacco-Through-Ped.htm

A Pilot Referral Approach to Promote Treatment for Parents ... At follow-up, 54 (59 %) completed the survey; 42 (46 %) reported treatment use, and 12 (13 %) reported smoking cessation. Conclusions: This EHR ...

3. withpower.com withpower.com/trial/phase-smoking-8-2024-eed36

Refer2Quit for Smoking Cessation The primary outcome will be the self-reported 7-day point prevalence abstinence at 3 and 6 months, with secondary outcomes including smoking cessation service ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40092286/

Refer2Quit: A pilot referral approach to promote treatment ... At follow-up, 54 (59 %) completed the survey; 42 (46 %) reported treatment use, and 12 (13 %) reported smoking cessation. Conclusions: This EHR- ...

5. researchgate.net researchgate.net/publication/389141968_Refer2Quit_A_Pilot_Referral_Approach_to_Promote_Treatment_for_Parents_who_Smoke_Tobacco_through_Pediatric_Primary_Care

A Pilot Referral Approach to Promote Treatment for Parents ... At follow-up, 54 (59 %) completed the survey; 42 (46 %) reported treatment use, and 12 (13 %) reported smoking cessation. Conclusions This EHR-linked ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10077936/

Proactive Referral to Behavioral Smoking Cessation ... Research has shown that smokers who are passively referred to behavioral smoking cessation programs often fail to enroll in treatment. A study ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10858725/

A Review of Smoking Cessation Interventions - PubMed Central This review commences by highlighting the burden of smoking as a public health concern, exploring various smoking cessation interventions, and assessing their ...

8. cdph.ca.gov cdph.ca.gov/Programs/CCDPHP/DCDIC/CTCB/Pages/CessationServicesAndResources.aspx

Cessation Services and Resources - CDPH - CA.gov Kick It California is a telephone, text, app, and chat-based tobacco cessation program. Services are free, evidence-based, and are offered in many languages.

9. cdc.gov cdc.gov/pcd/issues/2023/23_0033.htm

A Safety Net Tobacco Use Cessation Resource: Quitline ... Intake data are self-reported data collected from quitline participants during registration for services. Quitline programs in all 50 states, ...

10. ahajournals.org ahajournals.org/doi/10.1161/CIRCOUTCOMES.115.002458

Efficacy and Safety of Smoking Cessation Interventions in ... Our meta-analysis suggests varenicline and bupropion, as well as individual and telephone counseling, are efficacious for smoking cessation in CVD patients.