UW-CTRI has 8 active studies and 3 new studies. Here are the active studies.
1) Quitting Using Intensive Treatments Study (QUITS). (Status: Recruitment complete, seeing patients in follow-up) UW-CTRI is partnering with the UW Department of Medicine Cardiology Division on the study. Participants in Madison and Milwaukee get free medication and coaching. All patients get three months of varenicline pills and coaching; some patients also get nicotine patches and extended medications regimens. The study is designed to answer two key questions: 1) whether adding the nicotine patch to varenicline (Chantix) can boost quit rates; and 2) whether extending varenicline or varenicline + nicotine patch treatment for six months (rather than the standard three months) can boost quit rates. Researchers expect both treatment enhancements (either adding the nicotine patch or extending treatment for 6 months) will yield higher cessation rates among people trying to quit. Smokers and their clinicians are calling for cessation treatment options that can substantially increase current modest quit rates, and the goal of this study is to produce such an enhancement. June 2017-May 2021, $7 million. Funded by NHLBI. Drs. Timothy Baker and James Stein, PIs.
2) Transforming the Treatment of Tobacco Use in Health Care: Seizing the Potential of the Electronic Health Record (EHR) to Deliver Comprehensive Chronic Care Treatment for Smoking. (Status: Several projects ongoing) This R35 grant to Dr. Michael Fiore is designed to offer flexibility to researchers in the quest to overcome barriers in helping primary-care patients quit smoking. In other words, it sparks innovation to translate efficacious treatments into clinical use. Projects have included:
- Tobacco Cessation Quitline eReferral. This study is a two-group, non-blinded, randomized, controlled trial to assess the impact of an EHR-based eReferral system relative to the current standard Fax referral method concluded in Year 3. UW-CTRI partnered with Ascension WI-Wheaton Franciscan Healthcare and Gundersen Health System on the clinical trial to test eReferrals versus fax referrals. The trial, known as the Quit Line Referral Method Study, included 23 clinics, a dozen from Wheaton Franciscan Healthcare and 11 from Gundersen Health System. In each system, half of the clinics tested the closed-loop, HIPAA-compliant eReferral to the Quit Line, while the others operated the Fax to Quit program. Across both healthcare systems, eReferral produced referral rates that were 3-4 times higher than those produced by Fax to Quit. While the rates improved, challenges include increasing enrollment rates as well as sustaining use outside of a research study.
- SmokefreeTXT Pilot. This pilot project integrates NCI’s SmokefreeTXT program that sends text messages to participants’ phone to inspire and support an attempt to quit smoking. At two participating Gundersen Health System clinics, if a patient was ready to quit smoking, the “best practice alert” in the EHR prompted clinicians to refer to SmokefreeTXT via an eReferral order. Data from this small pilot study indicated feasibility of the approach, and present questions on which members of a care team may be best suited to intervene with this approach.
- Tolerability of 3 Medications for Smoking Cessation. A single-group, open-label, pilot study of 37 patients explored the tolerability and feasibility of combining varenicline with combination nicotine-replacement medications. An innovative “triple therapy” of three FDA-approved medications taken together—along with coaching on how to quit smoking—appears safe and shows promise, according to a UW-CTRI research paper published in the Journal of Smoking Cessation.
- Comprehensive Chronic Care Smoking Treatment System. Given that only about half of smokers in America are advised to quit during clinic visits, UW-CTRI has teamed with Epic and GHC-SCW in a program designed to reach out to all GHC patients who smoke. GHC Tobacco Cessation Outreach Specialists Katherine Coates and Hannah Wallenkamp are ensuring their patients have the tools they need to quit smoking for good. All six GHC primary-care sites are actively participating in this project.
- Tablet Technology Pilot Project with Low-Income Smokers. In order to continue to test the integration and scalability of technology-assisted interventions and to reach out to potential treatment delivery sites that serve populations who smoke at a higher rate, IRB approval was obtained for a tablet-based smoking-cessation intervention for clients at two Salvation Army sites. Following the intervention, staff and clients were interviewed about their experiences, receiving the intervention via a tablet.
August 2015-July 2022. $6.1 million. Funded by the National Cancer Institute of the National Institutes of Health. Dr. Michael Fiore, PI.
3) Exhale Study. (Status: Retention and long-term follow-up) As the federal government considers how to regulate electronic cigarettes (e-cigs), the University of Wisconsin was awarded a $3.7 million, 5-year grant from the National Cancer Institute as well as the Food and Drug Administration to study them over five years. This research is providing in-depth, longitudinal information, based on real-time reports, which addresses key priorities that may inform regulatory and health concerns, including understanding the relations between vaping and nicotine dependence; changes in rates of smoking conventional cigarettes; health outcomes such as evidence of exposure to carcinogens, as well as acute and long-term pulmonary health; attempts to quit smoking and the success of those attempts. Specifically, researchers have identified and are tracking over time 150 participants who exclusively smoke cigarettes and 250 participants who both smoke and vape. Researchers have used smart phones and other tools to collect information on patterns of use of these products, levels of addiction, withdrawal symptoms, success quitting versus relapse, lifestyle factors, carcinogen exposure, and how one group of participants compares to the other over time. This research is providing essential information to inform regulatory bodies, as well as researchers, clinicians, and tobacco users, about the patterns of real-world e-cig use and how such use is related to conventional smoking and the health risks caused by it. March 2015–February 2020, $3.7 million. Funded by the National Cancer Institute of the National Institutes of Health, and the Food and Drug Administration. Dr. Megan Piper and Dr. Douglas Jorenby, PIs.
4) Breaking Addiction to Tobacco for Health (BREATHE). (Status: Recruitment complete; in long-term follow-up) This project tests new phased-based treatments to help patients in the Milwaukee and Madison areas quit smoking. Partners in this research include colleagues from Penn State University and the University of Illinois-Chicago, as well as Aurora Health Care, Dean Health System, and Epic. Under the BREATHE project, any smoker who visits a participating clinic, regardless of the initial reason for the visit, is invited to get treatment through BREATHE. This study has implemented both an electronic health records (EHR) system that increases smokers’ recruitment into treatment as well as a highly effective chronic-care treatment with intervention components for all smokers. First, the EHR system was implemented in 18 clinics in two health-care systems and experimentally evaluated on its ability to increase the recruitment of smokers into chronic-care treatment (Project 1). Then, using highly efficient research methods, researchers have experimentally compared multiple intervention components and identified especially effective interventions for every phase of smoking treatment. This includes motivating smokers initially unwilling to quit and preparing them for cessation (Project 2), enhancing quitting success and preventing relapse when smokers are ready to quit (Project 3), and re-engaging relapsed smokers in treatment and restoring their abstinence (Project 4). BREATHE researchers hope this will produce an optimized, comprehensive, chronic-care treatment for smoking that can be readily implemented in primary care settings by project end. June 2014-July 2019, $12 million. Funded by the National Cancer Institute of the National Institutes of Health. Michael Fiore and Tim Baker, PIs.
5) PTSD and Veterans Merit Award. (Status: Recruitment complete) UW-CTRI Researcher Dr. Jessica Cook had led this merit award research at the William S. Middleton Memorial Veterans Hospital in Madison, Wisconsin. The primary objective of this research has been to produce an empirically validated treatment that increases smoking cessation in veterans with posttraumatic stress disorder (PTSD), one that can be easily integrated into smoking cessation clinics and/or mental health clinics within VA facilities. Recent evidence shows that behavioral activation therapy (BA), a behavioral treatment that increases engagement in reinforcing activities, significantly reduces PTSD symptoms and may aid in quitting smoking. The research was designed to determine whether BA, as an adjunct to standard smoking-cessation treatment, (ST+BA) is superior to a comparably intense combination of standard smoking cessation treatment + health and smoking education (ST+HSE) in improving smoking cessation outcomes among veterans with PTSD. The HSE intervention is intended to constitute a credible intervention that controls for contact time. Secondary objectives are to determine if BA improves PTSD symptomatology and associated affective distress, and to identify potential mediators of BA on smoking outcomes. A total of 120 veterans with PTSD who were motivated to quit smoking have attended an initial diagnostic and baseline assessment session. All participants will receive 8 weeks of the nicotine patch. Smoking-cessation outcomes are being assessed 2, 4, 8, 16, and 26 weeks after the quit date. Jan. 2014-Sept. 2019, $770,500. Funded by the United States Department of Veterans Affairs. Jessica Cook, PI.
6) Improving Quitline Support Study (IQS). (Status: Recruiting participants) This project will evaluate promising strategies to enhance quit-smoking success among low-income smokers. Researchers are enrolling 1,408 Medicaid-eligible or uninsured smokers who continued smoking four months after engaging in standard services from the Wisconsin Tobacco Quit Line. These smokers are invited to participate in an experiment to evaluate the value of augmenting standard Quit Line treatment with more intensive counseling, more intensive nicotine replacement, NCI’s SmokefreeTXT text support program, and/or financial incentives for using Quit Line and SmokefreeTXT support. Analyses will examine the main and interactive effects of these four treatment components at 26 weeks, as well as other quit-smoking outcomes in this at-risk population. August 2017-July 2022, $3 million. Funded by the National Cancer Institute of the National Institutes of Health. Drs. Danielle McCarthy and Michael Fiore, PIs.
7) First Breath Families: Helping Low-Income Moms Quit Smoking and Babies Grow Up Smoke-Free. (Status: Assisting with implementation) The Wisconsin Women’s Health Foundation (WWHF) has received a $1 million grant from the Wisconsin Partnership Program to significantly expand efforts to bring quit-smoking services to high-risk individuals, families and communities across Wisconsin. UW-CTRI is collaborating with WWHF on this project, to be provided during five years to First Breath Families. The group will also seek systems changes that will provide sustainable funding for these services. The First Breath Families team will collaborate with local agencies that serve pregnant and postpartum women and their families, provide statewide access to local WWHF Quit Coaches, and develop participant-informed services. January 2018-December 2022. $1,000,000. Funded by the Wisconsin Partnership Program/Oversight & Advisory Committee (WPP/OAC). Drs. Bruce Christiansen and Michael Fiore, Academic Partners. Lisette Kahlil, Wisconsin Women’s Health Foundation Community Lead.
8) Smoking Cessation – Bucket Approach Training Module Development. (Status: Developing online training) UW-CTRI Researcher Dr. Bruce Christiansen is collaborating with UW-CTRI colleagues to create videos for an online training based on his brief “Bucket Approach” to help patients with serious or significant mental illness to quit smoking. This online training will offer continuing education credits via the same UW training site that already offers a general training for behavioral health providers on how to help behavioral health patients quit smoking. The focus for the new training is on reaching out to Wisconsin Community Support Programs (CSP) and Comprehensive Community Services (CCS) Systems. CSPs work with patients with serious mental illness typically at discrete treatment sites. CCSs generally treat patients with less-serious but still significant mental illness using network models. Both types of programs are county-based. The Bucket Approach is designed to tailor the intervention to various motivational statuses of patients with serious mental illness. October 2018-September 2019. $112,000. Funded by the State of Wisconsin Department of Health Services. Dr. Bruce Christiansen, PI.