Clinical trial NCT05683821: BREATHE 2 Clinic Stop-Smoking Treatment Outreach Study
Official title: BREATHE 2 Cluster-randomized Trial of Health System Changes to Increase Reach of Smoking Cessation Treatments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quitting Smoking
Smoking Cessation
Smoking, Cigarette
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-01-13
Enrollment: 12376
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster-randomized controlled
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Smoking treatment initiation within 12 months of enrollment
timeFrame: Up to 12 months
Secondary outcomes:
measure: Smoking treatment initiation within 18 months of enrollment
timeFrame: Up to 18 months
measure: Conversion from current smoking to former smoking
timeFrame: 12 and 18 months after study enrollment
measure: Cost per quit attempt
timeFrame: Up to 18 months
measure: Cost per quit
timeFrame: Up to 18 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Center for Tobacco Research and Intervention
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Danielle E McCarthy, PhD
role: PRINCIPAL_INVESTIGATOR
References: