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Completed

NCT Number: NCT05683821

BREATHE 2 Clinic Stop-Smoking Treatment Outreach Study

The purpose of this research study is to see if offering adult primary care patients who smoke combustible cigarettes more frequent outreach, more choices about how they receive that outreach, and more smoking treatment options will increase the use of smoking treatments and help more people quit smoking, when compared against a standard outreach approach. Only patients at participating adult primary care clinics will be eligible for the study. Five clinic sites will be randomized to an enhanced outreach approach, while another 5 will be randomly assigned to standard smoking treatment outreach. Eligible patients at these clinics will be in this study for up to 18 months.

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Key information

Conditions

Quitting Smoking Behavior Cigarette Smoking Health Behavior Smoking Smoking Cessation Smoking, Cigarette Tobacco Smoking Tobacco Use

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Wisconsin Center for Tobacco Research and Intervention

Madison, Wisconsin, 53711, United States

About this study

This 2-arm cluster-randomized clinical trial will compare a standard approach to smoking cessation treatment outreach in adult primary care to an enhanced approach offering more frequent outreach, multiple ways to request treatment, and a broader array of treatment options.

The researchers hypothesize that enhanced outreach comprising quarterly messages offering both standard, person-to-person treatment options (quitline services, care from a primary care provider, phone coaching and medication through a clinical trial) and self-guided treatment options (nicotine replacement therapy sampling (2 week supplies of nicotine replacement therapies and/or enrollment in text-message based cessation support via Smokefree.gov text-message programs) will attract more adult primary care patients who smoke to treatment, and will help more participants achieve abstinence from smoking, as indicated by a change in their smoking status from current to former smoking in their electronic health records. The comparison condition is a standard outreach approach comprising a mailed letter informing participants of person-to-person treatment options (quitline services, care from a primary care provider, and/or phone coaching and medication through a clinical trial).

Up to 12,000 adult participants who receive primary care at 10 participating clinic sites and whose electronic health records suggest they smoke will receive smoking cessation treatment outreach for up to 18 months, unless they opt out of participation. Randomization will occur at the clinic site level rather than at the participant level, and an opt-out approach to recruitment will be adopted.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult age 18 years or older
  • Meet criteria for inclusion on a smoking registry (based on current smoking status and/or recent diagnosis of nicotine dependence or treatment of nicotine dependence)
  • Being seen in a participating clinic in the past 1-3 years, as documented in the EHR
  • Having a valid address
  • Not having a language other than English listed as preferred language

Exclusion criteria

  • Invalid address
  • Participant opted out of the study within 18 months of initial outreach letter (or were opted out of the study by a legally authorized representative or an activated power of attorney for health care)
  • Participant clarification that they did not meet criteria for the smoking registry at the time of initial outreach

Treatment and study plan

Text message smoking treatment

Behavioral

Facilitated enrollment in an NCI-sponsored text messaging program:

  • SmokefreeTXT (if ready to set a quit date in the next 14 days)
  • Practice Quit (if ready to practice quitting 1-5 days but not ready to quit permanently)
  • Daily Challenges (if not ready to quit, but willing to make some changes)

Nicotine replacement therapy sampling

Drug

Participants may request:

  • Nicotine patches that release nicotine slowly over 24 hours, in either 7 mg, 14 mg, or 21 mg doses
  • Nicotine gum or lozenges that release medication quickly and can be used every 1-2 hours to prevent and cope with cravings to smoke, in either 2 mg or 4 mg doses

Other names: Nicoderm, Nicorette

Wisconsin Tobacco QuitLine Referral

Combination Product

Patients will be offered referral to the Wisconsin Tobacco QuitLine that offers phone counseling and nicotine replacement starter kits (2 week supplies) to people ready to quit smoking, in addition to web-based, text messaging, and mailed support, at no cost to Wisconsin residents.

Referral to Primary Care Provider

Combination Product

Patients who want to talk to their Primary Care Providers about quitting smoking will be encouraged to make an appointment with their provider to receive smoking cessation counseling and to discuss pharmacotherapy options.

BREATHE 2 Cessation Study

Combination Product

Patients who are interested in participating in a separate randomized controlled trial of smoking cessation treatment will be invited to learn about and complete an eligibility screening and consent process for the trial. Those who enter the study receive both counseling and pharmacotherapy.

Additional modalities to learn about and request treatment

Behavioral

Participants in Enhanced Outreach arm clinics will have the option to request e-mail and/or text message communication regarding their smoking treatment options, and to initiate treatment via phone or online survey.

Primary outcomes

  1. Smoking Treatment Initiation Within 12 Months of Enrollment

    Time frame: Up to 12 months

    The proportion of study participants who initiate smoking treatment, as recorded in the electronic health record. Rates of smoking treatment initiation will be compared in the Enhanced Outreach and Standard Outreach arms.

Secondary outcomes

  1. Smoking Treatment Initiation Within 18 Months of Enrollment

    Time frame: Up to 18 months

    The proportion of study participants who initiate smoking treatment, as recorded in the electronic health record. Rates of smoking treatment initiation will be compared in the Enhanced Outreach and Standard Outreach arms.

  2. Conversion From Current Smoking to Former Smoking

    Time frame: 12 and 18 months after study enrollment

    Quitting smoking as indicated by a change in smoking status from current to former smoking, as recorded in the electronic health record.

  3. Cost Per Quit Attempt

    Time frame: Up to 18 months

    Estimated costs per assisted quit attempt initiated were computed. Total costs were computed as the sum of costs of outreach materials, digital outreach, and mailings; tobacco quitline counseling; nicotine medications ordered for patients; smoking cessation counseling provided by healthcare providers; text message support programs; and treatment navigation support. Costs were calculated based on prices or reimbursement rates as of May 6, 2025 for each outreach or treatment component, multiplied by the volume of patients who received each component within study arms. Cost per quit attempt was computed by dividing total costs by the number of patients who entered treatment to quit within each arm.

  4. Cost Per Quit

    Time frame: Up to 18 months

    Estimated costs per successful quit attempt (conversion to former smoking status) were computed. Total costs were computed as the sum of costs of outreach materials, digital outreach, and mailings; tobacco quitline counseling; nicotine medications ordered for patients; smoking cessation counseling provided by healthcare providers; text message support programs; and treatment navigation support. Costs were calculated based on prices or reimbursement rates as of May 6, 2025 for each outreach or treatment component, multiplied by the volume of patients who received each component within study arms. Cost per quit was computed by dividing total costs by the number of patients who converted from current to former smoking within each arm.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

BREATHE 2 Cluster-randomized Trial of Health System Changes to Increase Reach of Smoking Cessation Treatments

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 13, 2023
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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