1365 Participants Needed

Referral Approaches for Tobacco Use

Recruiting at 1 trial location
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

The investigators propose a Type I hybrid effectiveness/implementation study to evaluate two population-based approaches for increasing use of Quitlines and text messaging at two VA sites. Specifically, the investigators will test the default bias, examining whether an opt-out approach to referral is more effective than an opt-in approach. The investigators will randomly assign teams to either an opt-out or opt-in approach to referring smokers to treatment. In the opt-out approach, the default is that everyone is referred to treatment unless they actively choose not to be. In the opt-in approach, people are offered treatment but must actively choose to enroll in it.

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 data supports the effectiveness of the treatment involving staff training and academic detailing for tobacco use?

Research shows that healthcare providers can play a crucial role in helping people quit smoking by using evidence-based treatments like counseling and follow-up. However, there are gaps in the guidance provided to them, suggesting that better training and detailed information could improve their effectiveness in supporting tobacco cessation.12345

Is the referral approach for tobacco use treatment safe for humans?

The articles do not provide specific safety data for the referral approach for tobacco use treatment, but they emphasize the importance of evidence-based treatments and interventions in clinical settings, which generally prioritize patient safety.678910

How does the treatment in the Referral Approaches for Tobacco Use trial differ from other treatments for tobacco use?

This treatment is unique because it focuses on referral approaches, which may involve directing patients to specialized programs or resources for tobacco cessation, rather than solely relying on direct counseling or medication. This approach can help overcome barriers to accessing effective tobacco cessation support, making it different from traditional methods that primarily focus on direct interventions.1112131415

Research Team

SS

Steven S. Fu, MD MSCE

Principal Investigator

Minneapolis VA Health Care System, Minneapolis, MN

SE

Scott E. Sherman, MD MPH

Principal Investigator

VA NY Harbor Healthcare System, New York, NY

Eligibility Criteria

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
See 1 more

Exclusion Criteria

Nursing Assistants/Registered Nurses - None
Survey Cohort - Non-English speaking
Administrative Cohort - None
See 1 more

Timeline

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

Treatment Details

Interventions

  • Staff training and academic detailing
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Opt-out tobacco treatmentExperimental Treatment1 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 reminderExperimental Treatment1 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

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Findings from Research

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

References

Availability and content of clinical guidance for tobacco use and dependence treatment - United States, 2000-2019. [2022]
Is some provider advice on smoking cessation better than no advice? An instrumental variable analysis of the 2001 National Health Interview Survey. [2018]
Physician and patient concordance of report of tobacco cessation intervention in primary care in India. [2022]
Tobacco Treatment Guideline Use and Predictors Among U.S. Physicians by Specialty. [2023]
Increasing the efficacy of physician-delivered smoking interventions: a randomized clinical trial. [2019]
A Clinical Decision Support System for Motivational Messaging and Tobacco Cessation Treatment for Parents: Pilot Evaluation of Use and Acceptance. [2023]
Smoking Cessation. [2022]
Increasing consumer demand for tobacco treatments: Ten design recommendations for clinicians and healthcare systems. [2010]
Tobacco use screening and counseling during physician office visits among adults--National Ambulatory Medical Care Survey and National Health Interview Survey, United States, 2005-2009. [2022]
Stakeholder perceptions of using "opt-out" for tobacco use treatment in a cancer care setting: a qualitative evaluation of patients, providers, and desk staff. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
US public health service clinical practice guideline: treating tobacco use and dependence. [2022]
Increasing clinician participation in tobacco cessation by an implementation science-based tobacco cessation champion program. [2023]
Educating Substance Use Treatment Center Providers on Tobacco Use Treatments Is Associated with Increased Provision of Counseling and Medication to Patients Who Use Tobacco. [2023]
14.United Statespubmed.ncbi.nlm.nih.gov
A Pilot Clinical Trial of Smoking Cessation Services Implemented in the Workplace for Service Industry Employees. [2020]
15.United Statespubmed.ncbi.nlm.nih.gov
Healthcare provider training in tobacco treatment: building competency. [2019]