BREATHE 2 Clinic Stop-Smoking Treatment Outreach Study

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Smoking Cessation; Smoking, Cigarette; Quitting Smoking
• Intervention / Treatment: Behavioral: Text message smoking treatment; Drug: Nicotine replacement therapy sampling; Combination product: Wisconsin Tobacco QuitLine Referral; Combination product: Referral to Primary Care Provider; Combination product: BREATHE 2 Cessation Study; Behavioral: Additional modalities to learn about and request treatment

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.

• Study Type: Interventional
• Enrollment (Estimated): 13000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Danielle E McCarthy, PhD; Phone Number: 6082655949; Email: demccarthy@ctri.wisc.edu
• Study Contact Backup: Name: Kari Giacalone, MPH; Phone Number: 6082644992; Email: kgiacalone@ctri.wisc.edu

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53711
      • University of Wisconsin Center for Tobacco Research and Intervention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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; Other Names: Nicoderm, Nicorette; 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.; Combination product: 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.; Combination product: 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.
Active Comparator: Standard outreach; 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.	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.; Combination product: 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.; Combination product: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Cost per quit attempt	Estimated costs per assisted quit attempt initiated will be computed.	Up to 18 months
Cost per quit	Estimated costs per successful attempt (conversion to former smoking status) will be computed.	Up to 18 months

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Danielle E McCarthy, PhD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: January 4, 2023
• First Submitted That Met QC Criteria: January 4, 2023
• First Posted (Actual): January 13, 2023

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 2022-0973; A534253 (Other Identifier: UW Madison); SMPH/MEDICINE/GEN INT MD (Other Identifier: UW Madison); 2P01CA180945-06 (U.S. NIH Grant/Contract); Protocol Version 07/11/2022 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data for this study will be extracted from electronic health records at health systems participating in this research. These data belong to the health systems and not to the research team. As such, individual participant data will not be available to other researchers until and unless the participating health systems authorize such sharing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No