BREATHE 2 Clinic Stop-Smoking Treatment Outreach Study

University of Wisconsin (UW)

Status: Active, not recruiting

Conditions: Quitting Smoking; Smoking, Cigarette; Smoking Cessation

Treatments: Combination Product: Wisconsin Tobacco QuitLine Referral; Combination Product: BREATHE 2 Cessation Study; Combination Product: Referral to Primary Care Provider; Behavioral: Additional modalities to learn about and request treatment; Drug: Nicotine replacement therapy sampling; Behavioral: Text message smoking treatment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05683821

2022-0973

SMPH/MEDICINE/GEN INT MD (Other Identifier)

A534253 (Other Identifier)

Protocol Version 07/11/2022 (Other Identifier)

2P01CA180945-06 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12,376 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12,376 participants in 2 patient groups

Enhanced outreach

Experimental group

Description:

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.

Treatment:

Behavioral: Text message smoking treatment

Behavioral: Additional modalities to learn about and request treatment

Drug: Nicotine replacement therapy sampling

Combination Product: Referral to Primary Care Provider

Combination Product: BREATHE 2 Cessation Study

Combination Product: Wisconsin Tobacco QuitLine Referral

Standard outreach

Active Comparator group

Description:

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.

Treatment:

Combination Product: Referral to Primary Care Provider

Combination Product: BREATHE 2 Cessation Study

Combination Product: Wisconsin Tobacco QuitLine Referral