Smoking Cessation Outreach Methods for Quitting Smoking

Overseen By Kari Giacalone, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Invalid address, Opted out, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 18 months

12376 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Danielle E McCarthy, PhD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

The BREATHE 2 study is for adults over 18 who smoke and have visited participating primary care clinics in the last 1-3 years. They must be on a smoking registry, speak English, and have a valid address. Those with invalid addresses or who opted out of the study are excluded.

Inclusion Criteria

Being seen in a participating clinic in the past 1-3 years, as documented in the EHR

My preferred language for medical care is English.

Meets criteria for inclusion on a smoking registry (based on current smoking status and/or recent diagnosis of nicotine dependence or treatment of nicotine dependence)

Exclusion Criteria

Invalid address

I chose to leave the study within 18 months of being contacted, or my legal representative did.

Participant clarification that they did not meet criteria for the smoking registry at the time of initial outreach

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive smoking cessation treatment outreach, including standard and enhanced outreach approaches

18 months

Quarterly outreach via letter, email, or text messaging

Follow-up

Participants are monitored for smoking cessation success and treatment initiation

18 months

Treatment Details

Interventions

• Nicotine replacement therapy sampling
• Text message smoking treatment

Trial Overview This trial tests if more frequent outreach, varied outreach methods (like texts), and multiple treatment options help smokers quit better than standard approaches. Participants will experience this at certain clinics for up to 18 months.

Participant Groups

Group I: Enhanced outreach Experimental Treatment 6 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.

Group II: Standard outreach Active Control 3 Interventions

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.

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+