Referral Approaches for Tobacco Use

Not currently recruiting at 1 trial location

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Non-English speaking

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods to help smokers use Quitlines and text messaging to quit smoking. One method automatically enrolls smokers for help unless they opt out, while the other requires smokers to enroll themselves. The trial aims to determine which method encourages more people to use these services. It seeks current smokers who have visited specific VA clinics in Manhattan or Brooklyn. As an unphased trial, this study offers a unique opportunity to contribute to research that may enhance smoking cessation support services.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on smoking cessation methods, so it's best to ask the trial coordinators for more details.

What prior data suggests that these referral approaches are safe for increasing use of Quitlines and text messaging?

Studies have shown that training healthcare staff and educating them through academic detailing are generally safe and well-tolerated. Teaching healthcare providers how to help people quit smoking has produced positive results without serious issues. Academic detailing, which involves educating healthcare providers in detail, also ensures that smoking treatments remain safe and effective.

These methods have succeeded in other locations, with no major safety concerns reported. This indicates that the treatments are safe for individuals who want to quit smoking, with a strong record of helping people without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative methods to enhance tobacco cessation efforts. Unlike current standard treatments that often require active participation from patients, the "Opt-in clinical reminder" and "Opt-out tobacco treatment" approaches streamline the referral process for tobacco treatment directly within clinical settings. The "Opt-in" strategy guides staff through each step with clear reminders, while the "Opt-out" method automatically initiates treatment referrals, minimizing the chance for patients to miss out on support. These methods aim to make the referral process more efficient and accessible, potentially increasing patient engagement in tobacco cessation programs.

What evidence suggests that this trial's approaches could be effective for increasing tobacco treatment referrals?

Research has shown that automatically enrolling people in tobacco treatment, unless they opt out, is generally more effective than requiring them to sign up. In this trial, one arm will use an "Opt-out tobacco treatment" approach, where a clinical reminder automatically initiates a tobacco treatment referral. One study found that this automatic enrollment method doubled the number of people who engaged in treatment and increased quit attempts among smokers. Specifically, about 22% of participants in the automatic enrollment group quit smoking after one month, compared to just 16% in the group that had to sign up. These findings suggest that automatic enrollment can significantly improve the chances of quitting tobacco. ^{6 7 8 9 10}

Who Is on the Research Team?

Steven S. Fu, MD MSCE

Principal Investigator

Minneapolis VA Health Care System, Minneapolis, MN

Scott E. Sherman, MD MPH

Principal Investigator

VA NY Harbor Healthcare System, New York, NY

Are You a Good Fit for This Trial?

This trial is for current smokers who have been seen by a nursing assistant on the PACT team at the Manhattan or Brooklyn VA campus within the last year. It's also open to those nurses and administrative staff who smoke. Non-English speakers cannot participate.

Inclusion Criteria

Survey Cohort - Have been seen by an NA on the PACT team in the past 12 months at the Manhattan or Brooklyn VA campus AND Current smoker

Patient Post-Visit Survey Population - Had a visit with an NA/RN included in the study AND Current smoker

Nursing Assistants/Registered Nurses - Work on a PACT at the Manhattan or Brooklyn VA campus

Exclusion Criteria

Nursing Assistants/Registered Nurses - None

Survey Cohort - Non-English speaking

Administrative Cohort - None

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants are randomly assigned to either an opt-out or opt-in approach for smoking cessation treatment referral

2 years

Follow-up

Participants are monitored for smoking cessation outcomes and cost-effectiveness of the approaches

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Staff training and academic detailing

Trial Overview The study is comparing two methods of encouraging smoking cessation: an 'opt-out' where smokers are automatically referred to treatment unless they decline, and an 'opt-in' where smokers must actively choose to enroll in treatment programs.

How Is the Trial Designed?

Group I: Opt-out tobacco treatment Experimental Treatment 1 Intervention

The investigators will directly change the treatment status quo by implementing a clinical reminder that automatically initiates tobacco treatment referral at the time the reminder is activated.

Group II: Opt-in clinical reminder Experimental Treatment 1 Intervention

As the investigators have done previously, the reminder will be self-explanatory, and will walk staff through each step of referral. The reminder will include the following domains: normative advice, referral to treatment, handout

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

Tobacco smoking is the leading cause of preventable death in the U.S., but there are now more evidence-based resources available for physicians to help patients quit, including new pharmacotherapies and community programs.

Electronic nicotine delivery systems may offer potential benefits as treatment tools for smoking cessation, but their safety and efficacy still require further investigation, especially for high-priority groups like cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking Cessation. Patel, MS., Patel, SB., Steinberg, MB.[2022]

Health professionals can significantly improve patient outcomes related to tobacco use by implementing ten practical recommendations that enhance the delivery of tobacco interventions in clinical settings.

These recommendations focus on integrating tobacco treatment into routine clinical workflows, emphasizing the importance of evidence-based treatments, and ensuring that every patient encounter is an opportunity for intervention, ultimately aiming to reduce social disparities among tobacco users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing consumer demand for tobacco treatments: Ten design recommendations for clinicians and healthcare systems. Woods, SS., Jaén, CR.[2010]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9972241/

The Effects of Opt-out vs Opt-in Tobacco Treatment on ... In this randomized clinical trial, opt-out care doubled treatment engagement and increased quit attempts, while enhancing patients' sense of ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1551714422000428

A novel opt-in vs opt-out approach to referral-based ... Our primary aim for this trial is to determine whether an opt-out approach is more effective than an opt-in approach to tobacco cessation treatment referrals.

3. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2801751

The Effects of Opt-out vs Opt-in Tobacco Treatment on ... This randomized clinical trial evaluates the efficacy of opt-out care vs opt-in care for people who use tobacco.

4. researchgate.net researchgate.net/publication/359104921_A_novel_opt-in_vs_opt-out_approach_to_referral-based_treatment_of_tobacco_use_in_Veterans_Affairs_VA_primary_care_clinics_A_provider-level_randomized_controlled_trial_protocol

A novel opt-in vs opt-out approach to referral-based ... If OPT OUT proves to be more effective, it will expand the population eligible for cessation treatment by over 300%. It will also simplify the ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11255176/

Effectiveness of Very Brief Advice on Tobacco Cessation VBA delivered in a clinical setting is effective in increasing self-reported tobacco abstinence, which provides support for wider adoption in clinical practice.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7501381/

Impact of comprehensive smoking cessation training ... Training of HCPs to provide tobacco dependence treatment has demonstrated clinically significant effects on patient smoking cessation outcomes (Carson et al.

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/40/NCT02845440/Prot_SAP_001.pdf

Integrated Smoking Cessation Treatment for Smokers with ... Academic detailing to educate providers about the safety and tolerability of smoking cessation treatment and the risk to benefit ratio of ...

8. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.ps.20220187

A Pragmatic Cluster-Randomized Trial of Provider ... Conclusions: Combined PE and CHW tobacco cessation support increased tobacco abstinence rates among adults with serious mental illness.

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

A Safety Net Tobacco Use Cessation Resource: Quitline ... Our study found that quitlines primarily served as a resource for low-SES populations in 2019, providing cessation services to many people who ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4590019/

Academic Detailing Interventions Improve Tobacco Use ... This study demonstrates the feasibility and potential effectiveness of a low-cost and highly disseminable intervention to improve clinician behavior.