Quitting Smoking, Smoking Cessation, Smoking, Cigarette
Conditions
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.
Interventions
BEHAVIORALText 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)
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
COMBINATION_PRODUCTWisconsin 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.
COMBINATION_PRODUCTReferral 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.
COMBINATION_PRODUCTBREATHE 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.
BEHAVIORALAdditional 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.
Sponsors
University of Wisconsin, Madison
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Cluster-randomized controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| Cost Per Quit | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDanielle E McCarthy, PhD
University of Wisconsin, Madison
Participant flow
Recruitment details
Prospective participants were identified based on a review of electronic health record data to ensure they met inclusion criteria and did not meet exclusion criteria. All eligible participants who did not opt out of participation after being mailed a letter with information about the study and instructions about how to decline participation were considered enrolled. Those who contacted their health system to decline participation or note they were ineligible were no longer considered enrolled.
Pre-assignment details
Ten clinics were randomized to either Standard Outreach (n=5) or Enhanced Outreach (n=5). To enhance balance across arms, clinics were stratified in successive pairs by number of patients from minoritized racial or ethnic groups (a function of clinic size and diversity) and then randomized 1:1 within pairs to study arm. Patients received outreach as assigned to the clinic they visited. Patients seen in both Standard and Enhanced clinics were only assigned Enhanced Outreach (not double counted).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized Age 18-25 years old | 217 Participants |
| Age, Customized Age 26-35 years old | 1221 Participants |
| Age, Customized Age 36-45 years old | 2091 Participants |
| Age, Customized Age 46-55 years old | 2120 Participants |
| Age, Customized Age 56-65 years old | 2443 Participants |
| Age, Customized Age 66-75 years old | 1889 Participants |
| Age, Customized Age 75 years or older | 491 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 508 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4103 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 22 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 57 Participants |
| Race (NIH/OMB) Asian | 138 Participants |
| Race (NIH/OMB) Black or African American | 1953 Participants |
| Race (NIH/OMB) More than one race | 145 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 17 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 28 Participants |
| Race (NIH/OMB) White | 5896 Participants |
| Region of Enrollment United States | 6221 participants |
| Sex/Gender, Customized Female | 5266 Participants |
| Sex/Gender, Customized Male | 2056 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4,251 | 0 / 6,221 |
| other Total, other adverse events | 0 / 4,251 | 0 / 6,221 |
| serious Total, serious adverse events | 0 / 4,251 | 0 / 6,221 |
Outcome results
None listed