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

Trial Summary

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 data supports the effectiveness of the treatment Refer2Quit for smoking cessation?

The Refer2Quit program includes web-based training for healthcare providers to improve their skills in referring patients to tobacco quitlines, which are known to provide effective counseling for quitting smoking. This approach addresses barriers like lack of provider knowledge and confidence, potentially increasing the use of these proven cessation resources. ^{1 2 3 4 5}

Is Refer2Quit safe for humans?

Refer2Quit is a web-based training program for healthcare providers to improve tobacco intervention skills and does not involve direct treatment of patients, so there is no safety data specific to it. However, smoking cessation treatments like nicotine replacement therapy and bupropion are generally safe when prescribed and monitored by healthcare professionals, with most side effects being mild. ^{2 6 7 8 9}

How is the Refer2Quit treatment different from other smoking cessation treatments?

Refer2Quit is unique because it is an online training program designed to educate healthcare providers about tobacco quitlines and improve their skills in referring patients to these services. It includes tailored training for different provider types and settings, as well as motivational enhancement strategies, which is not a common feature in other smoking cessation treatments. ^{2 4 10 11 12}

What is the purpose of this trial?

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.

Research Team

Brian P Jenssen, MD

Principal Investigator

Children's Hospital of Philadelphia

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Health benefits and economic advantages associated with increased utilization of a smoking cessation program. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Refer2Quit: impact of Web-based skills training on tobacco interventions and quitline referrals. [2012]

3. United States pubmed.ncbi.nlm.nih.gov

Connecting veterans with smoking cessation services in less than 3 minutes. [2021]

4. England 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. [2021]

5. England pubmed.ncbi.nlm.nih.gov

A referral aid for smoking cessation interventions in primary care: study protocol for a randomized controlled trial. [2023]

6. England pubmed.ncbi.nlm.nih.gov

A randomized trial of nicotine replacement therapy in combination with reduced-nicotine cigarettes for smoking cessation. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Smoking cessation: present status and future perspectives. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Adverse effects of pharmacological therapy for nicotine addiction in smokers following a smoking cessation program. [2015]

9. England pubmed.ncbi.nlm.nih.gov

Frequently Reported Adverse Events With Smoking Cessation Medications: Post Hoc Analysis of a Randomized Trial. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Brief advice and active referral for smoking cessation services among community smokers: a study protocol for randomized controlled trial. [2018]

11. England 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. [2019]

12. Ireland pubmed.ncbi.nlm.nih.gov

The efficacy of computer-tailored smoking cessation material as a supplement to nicotine patch therapy. [2019]