BREATHE 2 Clinic Stop-Smoking Treatment Outreach Study

Smoking Cessation Clinical Trial

Official title:

BREATHE 2 Cluster-randomized Trial of Health System Changes to Increase Reach of Smoking Cessation Treatments

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05683821
• Other study ID #: 2022-0973
• Secondary ID: 2P01CA180945-06A
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 24, 2023
• Est. completion date: April 2025

Study information

• Verified date: July 2023
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 13000
• Est. completion date: April 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Quitting Smoking
• Smoking Cessation
• Smoking, Cigarette

Intervention

Behavioral:
• Text message smoking treatment
Facilitated enrollment in an NCI-sponsored text messaging program: SmokefreeTXT (if ready to set a quit date in the next 14 days) Practice Quit (if ready to practice quitting 1-5 days but not ready to quit permanently) Daily Challenges (if not ready to quit, but willing to make some changes)

Drug:
• Nicotine replacement therapy sampling
Participants may request: Nicotine patches that release nicotine slowly over 24 hours, in either 7 mg, 14 mg, or 21 mg doses Nicotine gum or lozenges that release medication quickly and can be used every 1-2 hours to prevent and cope with cravings to smoke, in either 2 mg or 4 mg doses

Combination Product:
• Wisconsin Tobacco QuitLine Referral
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.
• Referral to Primary Care Provider
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.
• BREATHE 2 Cessation Study
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.

Behavioral:
• Additional modalities to learn about and request treatment
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.

Locations

Country	Name	City	State
United States	University of Wisconsin Center for Tobacco Research and Intervention	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Up to 12 months
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.	Up to 18 months
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.	12 and 18 months after study enrollment
Secondary	Cost per quit attempt	Estimated costs per assisted quit attempt initiated will be computed.	Up to 18 months
Secondary	Cost per quit	Estimated costs per successful attempt (conversion to former smoking status) will be computed.	Up to 18 months