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| ID | Type | Description | Link |
|---|---|---|---|
| 2P01CA180945-06 | U.S. NIH Grant/Contract | View source | |
| A534253 | Other Identifier | UW Madison | |
| SMPH/MEDICINE/GEN INT MD | Other Identifier | UW Madison | |
| Protocol Version 07/11/2022 | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced outreach | Experimental | 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. |
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| Standard outreach | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Text message smoking treatment | Behavioral | Facilitated enrollment in an NCI-sponsored text messaging program:
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| Measure | Description | Time Frame |
|---|---|---|
| Smoking Treatment Initiation Within 12 Months of Enrollment | 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. | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Smoking Treatment Initiation Within 18 Months of Enrollment | 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. | Up to 18 months |
| Conversion From Current Smoking to Former Smoking |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Danielle E McCarthy, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Center for Tobacco Research and Intervention | Madison | Wisconsin | 53711 | United States |
Data for this study will be extracted from electronic health records at health systems participating in this research. These data belong to the health systems and not to the research team. As such, individual participant data will not be available to other researchers until and unless the participating health systems authorize such sharing.
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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).
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.
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 23, 2024 |
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Cluster-randomized controlled
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| Nicotine replacement therapy sampling | Drug | Participants may request:
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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Quitting smoking as indicated by a change in smoking status from current to former smoking, as recorded in the electronic health record. |
| 12 and 18 months after study enrollment |
| Cost Per Quit Attempt | 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. | Up to 18 months |
| Cost Per Quit | 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. | Up to 18 months |
| FG001 | Standard Outreach | Eligible patients affiliated with a clinic assigned to Standard Outreach received 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. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Customized | Count of Participants | Participants |
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| Sex/Gender, Customized | Sex was missing or other for 1 participant in the Enhanced outreach arm | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Smoking Treatment Initiation Within 12 Months of Enrollment | 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. | Posted | Count of Participants | Participants | Up to 12 months |
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| Secondary | Smoking Treatment Initiation Within 18 Months of Enrollment | 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. | Posted | Count of Participants | Participants | Up to 18 months |
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| Secondary | Conversion From Current Smoking to Former Smoking | Quitting smoking as indicated by a change in smoking status from current to former smoking, as recorded in the electronic health record. | Posted | Count of Participants | Participants | 12 and 18 months after study enrollment |
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| Secondary | Cost Per Quit Attempt | 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. | Posted | Number | Cost in US dollars per quit attempt | Up to 18 months |
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| Secondary | Cost Per Quit | 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. | Posted | Number | Cost in US dollars per quit | Up to 18 months |
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From enrollment in enhanced treatment through the end of outreach up to 18 months later.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 4,251 | 0 | 4,251 | 0 | 4,251 |
| EG001 | 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. | 0 | 6,221 | 0 | 6,221 | 0 | 6,221 |
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Determining the timing of medication orders for nicotine replacement therapy and varenicline in one participating health system was approximate because medication order data could be linked only to a calendar year and not a month year. Not all quit attempts, treatment use, or successful quitting may be captured by the data sources in this study (e.g., quitting on own without treatment or with support from sources other than participating clinics, the participating quitline, and the study).
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Danielle McCarthy | University of Wisconsin School of Medicine and Public Health | 6082655949 | demccarthy@ctri.wisc.edu |
| Apr 6, 2026 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 22, 2024 | Jun 3, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D000073865 | Cigarette Smoking |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D064424 | Tobacco Use |
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| ID | Term |
|---|---|
| D009538 | Nicotine |
| D000074164 | Nicotine Chewing Gum |
| ID | Term |
|---|---|
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D002638 | Chewing Gum |
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D061485 | Tobacco Use Cessation Devices |
| D013812 | Therapeutics |
| D002182 | Candy |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Age 26-35 years old |
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| Age 36-45 years old |
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| Age 46-55 years old |
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| Age 56-65 years old |
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| Age 66-75 years old |
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| Age 75 years or older |
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| Male |
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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. |
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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. |
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