Health Systems Reach Interventions Project

Completed · Phase 4

Conditions studied: Smoking, Cigarette, Smoking Cessation

In brief

This project seeks to identify ways to enhance the reach of evidence-based smoking cessation treatments among adult primary care patients who smoke daily and are not ready to start treatment at study enrollment. The 2x2x2x2 factorial experiment will evaluate the extent to which 4 intervention components promote the use of evidence-based treatments to help smokers not initially ready to quit to cease smoking over 2 years. The intervention components tested include: modest financial incentives for completing an initial counseling session in a smoking cessation treatment (vs. none); automated semi-annual outreach materials sent via patients' preferred communication modality using data in the electronic health record to tailor and personalize invitations to use available treatments to quit smoking (vs. untailored letters); direct, proactive telephone outreach from a tobacco care manager who will promote treatment use and deliver motivational intervention twice per year (vs. none); and access to 3 no-cost telephone smoking cessation counseling calls with combination nicotine replacement therapy (C-NRT) or varenicline (vs. state tobacco quitline and primary care provider referral). Proactive treatment offers will be made up to 22 months after enrollment. Smoking status and use of any smoking cessation treatments will be assessed every 6 months through 2 years of study enrollment. Data from 1664 adult primary care patients meeting inclusion/exclusion criteria will be analyzed to see whether the intervention components have an effect on the use of treatment (primary outcome) and smoking status after 2 years of treatment access (secondary outcome). The project will evaluate the manipulated intervention components first in terms of treatment initiation (defined as rates of completing at least 1 smoking cessation counseling session prior to a target stop-smoking date), and then in terms of end-of-study (2 year post-enrollment) abstinence rates (secondary outcome), and cost-effectiveness in promoting reach (tertiary outcome). This experiment will help to identify health system reach interventions that effectively enhance utilization of stop smoking treatments in an effort to help more smokers quit and to prevent tobacco-induced cancer morbidity and mortality.

Key facts

Study ID

NCT04199117

Run by

University of Wisconsin, Madison

People needed

210

Starts

2020-03-11

Expected to finish

2024-10-16

Last updated by the study team

2025-09-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Primary care patient who receives care at one of the host family medicine or internal medicine clinics
• >17 years old
• Report smoking 7 of the last 7 days at enrollment
• Report smoking at least five cigarettes per day for at least 6 months at enrollment
• Able to speak and read English

You may not qualify if…

• Opted out of Care Manager outreach at the most recent clinic visit or by phone
• Willing to quit smoking within 30 days (these patients will be referred for immediate treatment rather than enrolled in this study)
• Inability to use both C-NRT and varenicline due to a contraindication to both treatments at enrollment (allergic reactions, severe renal disease)
• Current treatment for schizophrenia or a psychotic disorder at enrollment
• History of suicide attempt in the past 10 years at enrollment

Where it is running

• UW Center for Tobacco Research and Intervention — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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