BREATHE 2 Clinic Stop-Smoking Treatment Outreach Study
- Conditions
- Quitting SmokingSmoking CessationSmoking, Cigarette
- Interventions
- Behavioral: Text message smoking treatmentCombination Product: Wisconsin Tobacco QuitLine ReferralCombination Product: Referral to Primary Care ProviderCombination Product: BREATHE 2 Cessation StudyBehavioral: Additional modalities to learn about and request treatment
- Registration Number
- NCT05683821
- Lead Sponsor
- University of Wisconsin, Madison
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 12376
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Enhanced outreach Nicotine replacement therapy sampling 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. Enhanced outreach Text message smoking treatment 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. Enhanced outreach Wisconsin Tobacco QuitLine Referral 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. Enhanced outreach Referral to Primary Care Provider 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. Enhanced outreach BREATHE 2 Cessation Study 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. Enhanced outreach Additional modalities to learn about and request treatment 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. Standard outreach Wisconsin Tobacco QuitLine Referral 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. Standard outreach Referral to Primary Care Provider 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. Standard outreach BREATHE 2 Cessation Study 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.
- Primary Outcome Measures
Name Time Method Smoking treatment initiation within 12 months of enrollment 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 Outcome Measures
Name Time Method Smoking treatment initiation within 18 months of enrollment 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.
Conversion from current smoking to former smoking 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.
Cost per quit attempt Up to 18 months Estimated costs per assisted quit attempt initiated will be computed.
Cost per quit Up to 18 months Estimated costs per successful attempt (conversion to former smoking status) will be computed.
Trial Locations
- Locations (1)
University of Wisconsin Center for Tobacco Research and Intervention
🇺🇸Madison, Wisconsin, United States