BREATHE 2 Clinic Stop-Smoking Treatment Outreach Study

NCT ID: NCT05683821

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12376 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-24
• Study Completion Date: 2025-05-07

Brief Summary

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.

Detailed Description

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.

Conditions

Quitting Smoking; Smoking Cessation; Smoking, Cigarette

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Enhanced outreach

Quarterly outreach via letter and applicable patient-preferred modalities, including e-mail and/or text messaging, offering both standard person-to-person treatment options (quitline referral, primary care provider referral, cessation counseling and treatment in a randomized clinical trial) and self-guided, remote treatment options (mailed nicotine replacement therapy samples and/or facilitated enrollment in a Smokefree.gov texting program). Patients in clinics assigned to this arm will also have the option to initiate treatment by phone or online. Patients may also receive outreach calls from Tobacco Care Managers offering the person-to-person treatments at their health systems 1-30 days following a visit to a participating clinic.

Group Type: EXPERIMENTAL

Text message smoking treatment

Intervention Type: 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

Intervention Type: 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

Wisconsin Tobacco QuitLine Referral

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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.

Standard outreach

One mailed letter at study initiation outlining available person-to-person treatment options (quitline referral, primary care provider referral, cessation counseling and treatment in a randomized clinical trial) and how to initiate treatment by phone. Patients may also receive outreach calls from Tobacco Care Managers offering the person-to-person treatments at their health systems 1-30 days following a visit to a participating clinic.

Group Type: ACTIVE_COMPARATOR

Wisconsin Tobacco QuitLine Referral

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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.

Interventions

Text message smoking treatment

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)

Intervention Type: BEHAVIORAL

Nicotine replacement therapy sampling

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

Intervention Type: DRUG

Wisconsin Tobacco QuitLine Referral

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.

Intervention Type: COMBINATION_PRODUCT

Referral to Primary Care Provider

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.

Intervention Type: COMBINATION_PRODUCT

BREATHE 2 Cessation Study

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.

Intervention Type: COMBINATION_PRODUCT

Additional modalities to learn about and request treatment

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Nicoderm, Nicorette

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Danielle E McCarthy, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin Center for Tobacco Research and Intervention

Madison, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

2P01CA180945-06

Identifier Type: NIH

Identifier Source: secondary_id

View Link

A534253

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/MEDICINE/GEN INT MD

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 07/11/2022

Identifier Type: OTHER

Identifier Source: secondary_id

2022-0973

Identifier Type: -

Identifier Source: org_study_id