Trial Outcomes & Findings for BREATHE 2 Clinic Stop-Smoking Treatment Outreach Study (NCT NCT05683821)

Last Updated: 2026-06-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

12376 participants

Primary outcome timeframe

Up to 12 months

Results posted on

2026-06-26

Participant Flow

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.

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).

Unit of analysis: Clinics

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	5058 5	7318 5
Overall Study COMPLETED	4251 5	6221 5
Overall Study NOT COMPLETED	807 0	1097 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sex was missing or other for 1 participant in the Enhanced outreach arm

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Enhanced Outreach n=4251 Participants 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 n=6221 Participants 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.	Total n=10472 Participants Total of all reporting groups
Age, Customized Age 18-25 years old	85 Participants n=4251 Participants	132 Participants n=6221 Participants	217 Participants n=10472 Participants
Age, Customized Age 26-35 years old	482 Participants n=4251 Participants	739 Participants n=6221 Participants	1221 Participants n=10472 Participants
Age, Customized Age 36-45 years old	777 Participants n=4251 Participants	1314 Participants n=6221 Participants	2091 Participants n=10472 Participants
Age, Customized Age 46-55 years old	829 Participants n=4251 Participants	1291 Participants n=6221 Participants	2120 Participants n=10472 Participants
Age, Customized Age 56-65 years old	994 Participants n=4251 Participants	1449 Participants n=6221 Participants	2443 Participants n=10472 Participants
Age, Customized Age 66-75 years old	834 Participants n=4251 Participants	1055 Participants n=6221 Participants	1889 Participants n=10472 Participants
Age, Customized Age 75 years or older	250 Participants n=4251 Participants	241 Participants n=6221 Participants	491 Participants n=10472 Participants
Sex/Gender, Customized Female	2194 Participants n=4250 Participants • Sex was missing or other for 1 participant in the Enhanced outreach arm	3072 Participants n=6221 Participants • Sex was missing or other for 1 participant in the Enhanced outreach arm	5266 Participants n=10471 Participants • Sex was missing or other for 1 participant in the Enhanced outreach arm
Sex/Gender, Customized Male	2056 Participants n=4250 Participants • Sex was missing or other for 1 participant in the Enhanced outreach arm	3149 Participants n=6221 Participants • Sex was missing or other for 1 participant in the Enhanced outreach arm	5205 Participants n=10471 Participants • Sex was missing or other for 1 participant in the Enhanced outreach arm
Ethnicity (NIH/OMB) Hispanic or Latino	130 Participants n=4251 Participants	508 Participants n=6221 Participants	638 Participants n=10472 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4103 Participants n=4251 Participants	5691 Participants n=6221 Participants	9794 Participants n=10472 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	18 Participants n=4251 Participants	22 Participants n=6221 Participants	40 Participants n=10472 Participants
Race (NIH/OMB) American Indian or Alaska Native	22 Participants n=4251 Participants	35 Participants n=6221 Participants	57 Participants n=10472 Participants
Race (NIH/OMB) Asian	68 Participants n=4251 Participants	138 Participants n=6221 Participants	206 Participants n=10472 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=4251 Participants	14 Participants n=6221 Participants	17 Participants n=10472 Participants
Race (NIH/OMB) Black or African American	2152 Participants n=4251 Participants	1953 Participants n=6221 Participants	4105 Participants n=10472 Participants
Race (NIH/OMB) White	1935 Participants n=4251 Participants	3961 Participants n=6221 Participants	5896 Participants n=10472 Participants
Race (NIH/OMB) More than one race	53 Participants n=4251 Participants	92 Participants n=6221 Participants	145 Participants n=10472 Participants
Race (NIH/OMB) Unknown or Not Reported	18 Participants n=4251 Participants	28 Participants n=6221 Participants	46 Participants n=10472 Participants
Region of Enrollment United States	4251 participants n=4251 Participants	6221 participants n=6221 Participants	10472 participants n=10472 Participants

PRIMARY outcome

Timeframe: Up to 12 months

Outcome measures

Outcome measures
Measure	Enhanced Outreach n=4251 Participants 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 n=6221 Participants 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.
Smoking Treatment Initiation Within 12 Months of Enrollment	330 Participants	454 Participants

SECONDARY outcome

Timeframe: Up to 18 months

Outcome measures

Outcome measures
Measure	Enhanced Outreach n=4251 Participants 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 n=6221 Participants 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.
Smoking Treatment Initiation Within 18 Months of Enrollment	419 Participants	531 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Enhanced Outreach n=4251 Participants 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 n=6221 Participants 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.
Conversion From Current Smoking to Former Smoking Converted to former smoking 12 full months after outreach began	241 Participants	302 Participants
Conversion From Current Smoking to Former Smoking Converted to former smoking 18 full months after outreach began	273 Participants	347 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Enhanced Outreach n=4251 Participants 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 n=6221 Participants 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.
Cost Per Quit Attempt	389.10 Cost in US dollars per quit attempt	58.27 Cost in US dollars per quit attempt

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Enhanced Outreach n=4251 Participants 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 n=6221 Participants 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.
Cost Per Quit	597.19 Cost in US dollars per quit	89.17 Cost in US dollars per quit

Adverse Events

Enhanced Outreach

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Outreach

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Danielle McCarthy

University of Wisconsin School of Medicine and Public Health

Phone: 6082655949

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place