Health Systems Reach Interventions Project

Summary

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.

Conditions

• Smoking, Cigarette
• Smoking Cessation

Interventions

DRUG

Varenicline

Participants randomized to intensive treatment who choose to use this intervention will receive one 0.5 mg pill for the first 3 days, starting 7 days prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 11 weeks post-TQD. This will not be used at the same time as combination nicotine replacement therapy.

DRUG

Combination nicotine patch and nicotine mini-lozenge treatment

Participants randomized to intensive treatment who choose to use this intervention will receive 12 weeks of nicotine patches and nicotine mini-lozenges starting on the target quit day (TQD). Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges for use starting on the target quit date and the following 12 weeks. Participants will be instructed to use 9-20 mini-lozenges per day (one every 1-2 hours) for the first 6 weeks, then reduce to a mini-lozenge every 2-4 hours for 3 weeks, and then a mini-lozenge every 4-8 hours for 3 weeks. Combination nicotine patch and nicotine mini-lozenge treatment will not be used at the same time as varenicline.

BEHAVIORAL

Monetary incentives for initiating treatment

Participants randomized to this intervention will earn an incentive each time they complete a first counseling session in an available treatment, up to 2 rounds of counseling per year, and up to 4 rounds of counseling over 2 years of enrollment.

BEHAVIORAL

Automated tailored outreach

Participants randomized to this intervention will receive 5 tailored letters delivered every 4-6 months. Letter content will be tailored to participant demographics and use of study treatment, and personalized with references to their primary care teams and tobacco care manager. Letters offer encouragement to quit and information about how to access available treatments.

BEHAVIORAL

Care management

Participants randomized to this intervention will receive 5 live, proactive phone calls lasting 10-15 minutes from as assigned Tobacco Care Manager who will provide manualized support and motivational encouragement, discuss available treatment options, and inform the participant how to initiate treatment when ready to quit.

OTHER

Wisconsin Tobacco Quit Line referral

This is recommended standard care that will be offered to participants who are not medically eligible for varenicline or combination nicotine patch or who are randomized to standard treatment access. The Wisconsin Tobacco Quit Line (WTQL) offers a single 20-minute counseling session to all Wisconsin residents ready to set a date to stop smoking in the next month, at no charge, and offers those who meet their medical eligibility criteria a 2-week supply of either nicotine patches, lozenges, or gums, at no charge. The WTQL assumes full clinical responsibility for participants' use of cessation medications dispensed by the WTQL.

OTHER

Primary care provider referral

This is a form of recommended standard care that will be offered to participants who are not medically eligible for varenicline or combination nicotine patch or who are randomized to standard treatment access. Participants who choose to use this intervention will be referred electronically to their primary care provider for counseling and/or medication if they express an interest in quitting in the next 30 days and agree to this referral.

BEHAVIORAL

Untailored outreach

Participants randomized to this intervention will receive 5 untailored letters delivered every 4-6 months. Letter content will not be tailored or personalized. Letters will offer information about how to access available treatments.

BEHAVIORAL

Multiple smoking cessation coaching calls

Participants randomized to intensive treatment access who choose to quit will receive three 15-20-minute quit coaching calls from a trained smoking cessation health counselor. Calls will be scheduled for one week pre-quit, one day after the target quit day, and one week after the target quit day.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• University of Wisconsin, Madison

  lead OTHER

Principal Investigators

• Michael C Fiore, MD,MPH,MBA · University of Wisconsin, Madison

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-03-11

Primary Completion

2024-10-16

Completion

2024-10-16

FDA Drug

Yes

Countries

• United States

Study Locations