Clinical trial NCT04199117: Health Systems Reach Interventions Project
Official title: Centralized Health System Interventions to Enhance Reach: A Factorial Screening Experiment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking, Cigarette
Smoking Cessation
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-12-13
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2 x 2 x 2 x 2 factorial experiment
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: Design and Objective: This 2-year experimental study will evaluate the effectiveness, costs, and cost-effectiveness of four interventions designed to connect primary care patients who smoke with evidence-based stop-smoking treatment. The interventions to be tested are healthcare system interventions intended to better attract patients who smoke to stop-smoking treatments that work. Participants enrolled in the study will be randomized to 1 level of each of the following 4 intervention components: 1) to receive financial incentive each time they complete a first counseling telephone call in a new round of stop-smoking treatment (for up to 4 rounds of treatment) or no incentives for starting treatment; 2) to receive tailored letters encouraging use of evidence-based stop-smoking treatment every 4-6 months for 2 years, or non-tailored letters every 4-6 months for 2 years; 3) to receive calls every 4-6 months from a Tobacco Care Manager who will provide motivational counseling to patients to encourage them to use stop-smoking treatment, and will connect patients willing to quit with available treatments, or no Tobacco Care Manager calls; and 4) access to intensive treatment (standard 12-week regimens of 2 nicotine medications used together, also called combination nicotine replacement therapy, or varenicline, a non-nicotine pill), with 3 telephone counseling sessions, all of which improve stop-smoking success rates), or standard care (referral to a quitline offering telephone counseling and 2 weeks of one nicotine medication provided by the quitline, and referral to the patient's primary care provider). The objective is to identify the intervention components and combination of components that best promote use of smoking cessation treatment and tobacco abstinence.

Recruitment and Participants: Participants will be 1664 primary care patients recruited through their primary care clinics in 2 healthcare systems in central and eastern Wisconsin. At the launch of recruitment in a clinic, all patients known to smoke at that clinic will receive notice that a new tobacco specialist, a Tobacco Care Manager, is available to help them quit smoking and given information about how to contact them. At healthcare visits, patients will be asked if they smoke, and if they do, told that the clinic has a new program for smokers that will start with a phone call from a Tobacco Care Manager within the next few days. Patients will be able to opt out of receiving such calls if they do not want them. The Tobacco Care Manager will offer information to all patients who smoke about resources available to help them quit smoking, and will ask them if they are interested in a research study. For those not willing to quit within a month and interested in the study, the Tobacco Care Manager will describe this study and ask them if they want to be screened for eligibility for the study. Those who assent to and pass the screening will then be given detailed information about the study and asked to provide informed consent for participation. For those who consent to participation, the Tobacco Care Manager will administer a 10-15-minute baseline interview over the phone, randomize patients to experimental condition, and inform them of the types of stop-smoking information and resources they will receive over the course of the 2-year study. Everyone in the study will receive a letter about their randomly assigned smoking cessation resources and study information by mail after enrollment and 4 more times over the next 2 years. Follow-up assessments will occur every 6 months over 2 years to see if participants are still smoking, if they have tried to quit, and if they have used any stop-smoking treatment. One and two years after enrollment, some participants will be asked to come to their clinic for breath and urine tests to determine if they are still smoking. Patients may be asked to complete additional follow-up calls if they start stop-smoking treatment, to see if they are smoking, using treatment, experiencing withdrawal, and are still motivated and confident about quitting and treatment at 3, 12, and 26 weeks after trying to quit smoking.

Outcomes and Analyses. The primary outcome of interest in this study is whether or not participants use the stop-smoking treatments available to them. The primary research question of interest is the extent to which each intervention improves the reach of stop-smoking treatments (i.e., how many people use the treatment), and whether particular packages of interventions do this particularly well. A second important research question is whether the study interventions help more people stop smoking during the 2-year study, and which packages of interventions do this well. A third question of importance to healthcare systems that may adopt these interventions is whether the interventions are affordable and whether or not they improve treatment use rates and tobacco abstinence rates in a manner that is cost-effective. Total costs of each intervention component will be estimated and used to compute costs per reach (initiating treatment), per quit (achieving abstinence), and per quality-adjusted life-year gained, and to estimate the net monetary benefit and incremental cost effectiveness ratio for each intervention component and combination of components.

Knowledge to be Gained. This study will assess the effectiveness, costs, and cost-effectiveness of 4 promising strategies to connect more primary care patients who smoke with evidence-based treatment to help them quit smoking. Results will be used to select an optimized package of interventions that seems to work especially well. The results of this research have the potential to suggest effective and efficient ways to reduce smoking prevalence by connecting more primary care patients who smoke to evidence-based care.

Eligibility criteria: Inclusion criteria:

* 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

Exclusion criteria:

* 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

Primary outcomes:
measure: Number of participants who initiate treatment over 1 year of study enrollment
timeFrame: 1 year
measure: Number of participants who initiate treatment over 2 years of study enrollment
timeFrame: 2 years
Secondary outcomes:
measure: Number of participants who achieve biochemically verified seven-day point prevalence abstinence 2 years post-enrollment
timeFrame: 2 years from enrollment
Other outcomes:
measure: First year intervention costs from healthcare and societal perspectives
timeFrame: 1 year
measure: Second year intervention costs from healthcare and societal perspectives
timeFrame: 2 years
measure: Number of participants who complete intensive treatment
timeFrame: 2 years
measure: Number of participants who report short-term abstinence following smoking cessation treatment initiation
timeFrame: 3, 12, and 26 weeks post-target quit day
Locations:
city: Madison
country: United States
facility: UW Center for Tobacco Research and Intervention
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Michael C Fiore, MD,MPH,MBA
role: PRINCIPAL_INVESTIGATOR
References: