UW-CTRI has recently completed 7 studies, with data under analysis for dissemination.
1. COVID EHR Cohort at the University of Wisconsin (CEC-UW). The National Cancer Institute asked UW-CTRI researchers to reach out to health systems associated with the Cancer Center Cessation Initiative (C3I), coordinated at UW, to help better understand COVID-19. The goal was to explore whether patient demographics or other electronic health record (EHR) variables—including smoking status and cancer—in patients diagnosed with COVID-19 were associated with disease severity, complications and/or mortality. Twenty-one health systems across the nation participated in the project, most of which were also C3I sites. Data collection for the project concluded at the end of January 2022. EHR data on approximately 1.6 million patients who tested positive for, or were diagnosed with, COVID-19 was collected, including 149,989 hospitalized patients. May 2020-September 2022, $3 million. Funded by NCI. Dr. Michael Fiore, PI.
2. Options Study. The Options Study was conducted by UW-CTRI in the Madison and Milwaukee areas. Participants temporarily switched from just smoking to alternative products. These products included Juul e-cigarettes or cigarettes with very low nicotine content. Participants were paid up to $380. All study participants didn’t want to quit smoking, but were willing to switch from their cigarettes to something new for a week. The four weeks of the study had different goals:
- Week 1: Try out the study product they were randomly assigned to use: Juul e-cigarettes, VLN cigarettes or no alternative product. They could smoke their own cigarettes as usual.
- Week 2 (Switch Week): Don’t smoke their own cigarettes but use a patch (active or placebo) and their assigned study product.
- Week 3: Smoke their own cigarettes and use their study product as much as they want.
- Week 4 (Switch Week): Don’t smoke their own cigarettes but use a patch (if they had an active patch with nicotine in Week 2 they now had a placebo patch with no nicotine or vice versa) and their assigned study product.
3. Transforming the Treatment of Tobacco Use in Healthcare: Seizing the Potential of the Electronic Health Record (EHR) to Deliver Comprehensive Chronic Care Treatment for Smoking. This R35 grant to Dr. Michael Fiore was designed to offer flexibility to researchers in the quest to overcome barriers in helping primary-care patients quit smoking. In other words, it sparked innovation to translate efficacious treatments into clinical use. Projects have included:
- Tobacco Cessation Quitline eReferral. This study was 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. A main outcomes paper was published in the Journal of the American Medical Informatics Association.
- SmokefreeTXT Pilot. This pilot project integrated 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 electronic health records (EHR) prompted clinicians to refer to SmokefreeTXT via an eReferral order. Data from this small pilot study indicated feasibility of the approach, and presented questions on which members of a care team may be best suited to intervene with this approach. Based on study findings, researchers reported in a paper in Translational Behavioral Medicine that interoperable eReferral via outpatient EHR to SmokefreeTXT was feasible and acceptable to clinic staff, enrolled roughly 3% of people who smoke, and the individual clinic context and implementation approach may influence reach.
- 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—appeared to be safe and showed 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 people who smoke in America are advised to quit during clinic visits, UW-CTRI teamed with Epic and GHC-SCW in a program designed to reach out to all GHC patients who smoke. GHC Tobacco Cessation Outreach Specialists ensured patients had the tools they needed to quit smoking for good. All six GHC primary-care sites were actively participating in this project.
- Financial Incentives for Smoking Treatment Engagement. Building upon the robust treatment program implemented at Group Health Cooperative-South Central Wisconsin (GHC), this project evaluated modest financial incentives to people who smoke who engaged in quit planning with the GHC Tobacco Cessation Outreach Specialists. More than 500 patients who smoked were randomized to three different incentive levels to encourage engagement in quit-smoking treatment planning over the phone.
- Tablet Technology Pilot Project with Low-Income People Who Smoke. A tablet-based smoking-cessation intervention for clients was pilot tested at two Salvation Army sites. The goals were to gauge 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. Following the intervention, researchers interviewed staff and clients about their experiences, affirming acceptability of the tablet intervention.
- Learn, Connect, and Quit. Researchers conducted a pilot of a tablet app featuring videos for people who smoke visiting one primary-care clinic. Unfortunately, clinic staff gave the tablet to patients much less frequently than researchers anticipated. Of the 30 patients who engaged with the app, 15 watched at least 1 video: 10 watched 1 video, 3 watched 2 videos and 2 watched 3 videos.
August 2015-July 2022, $6.1 million. Funded by the National Cancer Institute of the National Institutes of Health. Dr. Michael Fiore, PI.
4. Quit Line eReferral with Feedback and Nicotine Patch Sampling. UW-CTRI partnered with Ascension Wisconsin to develop strategies to enhance system-wide implementation of electronic referral (eReferral) to the Wisconsin Tobacco Quit Line for adult primary care patients who smoke. UW-CTRI continues to work with 32 Ascension clinics to evaluate the effectiveness of monthly implementation feedback and provision of free nicotine patch samples in an ongoing experiment to identify strategies that increase the reach of Quit Line treatment. November 2019-February 2022, $150,000. Funded by the UW Institute for Clinical and Translational Research. Dr. Danielle McCarthy, PI.
5. Withdraw from Tobacco Study. This study recruited more than 200 people to quit without medication for the first week. All participants received eight weeks of combination nicotine-replacement medication (nicotine patch and mini lozenge). Study staff provided coaching to help participants quit smoking and confirm their smoking status 9 weeks after the quit date. One of the important products of our research at UW-CTRI is the Wisconsin Smoking Withdrawal Scale (WSWS) and a recently revised version (WSWS2). The UW Withdraw from Tobacco Study, led by Dr. Tim Baker and Dr. Jesse Kaye, will be critical to validating the revised scale, making it congruent with recent research on the nature of smoking withdrawal. July 2021-September 2022, $1.2 Million. Funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health. Drs. Timothy Baker and Jesse Kaye, PIs.
6. First Breath Families: Helping Low-Income Moms Quit Smoking and Babies Grow Up Smoke-Free. The Wisconsin Women’s Health Foundation (WWHF) received a $1 million grant from the Wisconsin Partnership Program and expanded efforts to bring quit-smoking services to high-risk individuals, families and communities across Wisconsin. UW-CTRI collaborated with WWHF on this project. The group sparked systems changes that will provide sustainable funding for these services. The First Breath Families team partnered with local agencies to 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). Karen Conner and Dr. Michael Fiore, Academic Partners. Lisette Kahlil, Wisconsin Women’s Health Foundation Community Lead.
7. Cardiac and LUng E-cigarette smoking Study (CLUES). The UW Atherosclerosis Imaging Research Program (UW AIRP) and UW-CTRI collaborated on a study on the acute and chronic effects of vaping and dual use of cigarettes and e-cigarettes. UW AIRP Director and Cardiologist Dr. James Stein and UW-CTRI Director of Research Dr. Tim Baker led the team that enrolled 440 participants representing four groups: people who vape, smoke, vape and smoke, or never used. Participants received $200 for two study visits. The study used an array of tests to explore relations between:
- Acute smoking and/or vaping with possible cardiovascular and pulmonary disease mechanisms.
- Longer-term patterns of smoking and/or vaping with measures of cardiovascular and pulmonary dysfunction and injury.
These outcome biomarkers will predict future disease risk and measure injury to arteries and lungs. For cardiovascular disease (CVD), the primary biomarkers are brachial artery flow-mediated dilation (FMD, a measure of endothelial function that predicts CVD) and carotid intima-media thickness (IMT, a measure of subclinical arterial injury and atherosclerosis that also predicts CVD events). For pulmonary disease, the primary biomarkers are predicted lung volumes and flow rates obtained by spirometry. In secondary analyses, researchers will:
- Characterize carotid artery echogenicity (a novel measure of arterial injury).
- Perform treadmill exercise stress testing (to measure exercise capacity, heart rate recovery, heart rate reserve, and rate-pressure product).
- Electrocardiography (to measure heart rate variability).
- Measure blood pressure, fasting lipids, HbA1c, markers of inflammation and oxidation (leukocyte count, C-reactive protein, F2 isoprostanes), and exhaled nitric oxide. These tests index the degree of dysfunction, injury mechanisms, and future risks of cardiovascular and pulmonary disease.
UW-AIRP Manager Dr. Claudia Korcarz coordinated the study and UW-CTRI Director of Clinical Services Dr. Doug Jorenby served as the on-site and operational scientific lead. Dr. Nathan Sando oversaw all pulmonary measurements. UW-AIRP Research Specialist Kristin Hansen assisted with tests. Holly Prince of UW-CTRI managed study visits in Madison. September 2018-August 2022, $1.8 million. Funded by NIH. Drs. Timothy Baker and James Stein, PIs.