At a glance
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BREATHE 2 Cluster-randomized Trial of Health System Changes to Increase Reach of Smoking Cessation Treatments
In Brief
A Phase 4 clinical trial evaluating Text message smoking treatment, Nicotine replacement therapy sampling, and 4 other interventions for Quitting Smoking and 2 related conditions. Completed, enrolled 12,376 participants across 1 site.
Signals
Detailed 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.
Study Details
Timeline
Arms & Interventions
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.
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.
Interventions
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)
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
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.
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.
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.
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.