UW-CTRI has 5 active studies and 4 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. (Status: Primary outcomes paper published; secondary outcomes under analyses) 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. 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. (Status: Primary outcomes paper published) 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 the patient to SmokefreeTXT via an eReferral order. Data from this small pilot study indicated feasibility of the approach and information on which members of a care team may be best suited to intervene with this approach.
- Tolerability of 3 Medications for Smoking Cessation. (Status: Primary outcomes paper published) 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. (Status: intervention ongoing; intermediate analyses underway) 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. EHR tools prompted physicians to talk to their patients about quitting smoking. It also facilitated referrals to follow-up support by GHC Tobacco Cessation Outreach Specialists Katherine Coates, Hannah Wallenkamp and Maggie Nolan. The aim was to ensure patients have the tools they need to quit smoking for good. All six GHC primary-care sites are actively participating in this project in which every GHC-SCW patient with a history of current smoking in their health record is offered treatment through routine care, follow-up care, or annual telephone outreach. Additionally, the program has promoted program awareness and quit readiness through quarterly, mailed promotions/communications direct to the patients’ home/EHR patient portal. All clinics have adopted the program for more than a year. The first wave of clinics have done so for nearly two years. Preliminary data suggest that more than 1,000 patients have quit smoking.
- Learn, Connect, & Quit Pilot. (Status: project complete) UW-CTRI researchers partnered with app developers to create and pilot a tablet app for tobacco users sitting in clinic waiting rooms. Patients watched educational videos regarding how to quit tobacco use, treatment options, and modifiable plans. Patients could discuss clear action steps with providers. While patients liked the app, clinical implementation was a challenge.
- Tablet Technology Pilot Project with Low-Income Smokers. (Status: project complete) UW-CTRI researchers designed a tablet-based smoking-cessation intervention for clients and piloted it at two Salvation Army sites. This project was intended to continue testing the integration and scalability of technology-assisted interventions and to reach out to potential treatment-delivery sites that serve populations who smoke at higher rate. After clients received the information about quitting tobacco use via a tablet, researchers interviewed these patients as well as clinic staff about their experiences. They unanimously endorsed it.
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) 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.
5) 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.