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Randomized Controlled Trial Multicenter Study Comparative Study Pragmatic Clinical Trial
A Pragmatic Trial of E-Cigarettes, Incentives, and Drugs for Smoking Cessation.
- Scott D Halpern, Michael O Harhay, Kathryn Saulsgiver, Christine Brophy, Andrea B Troxel, and Kevin G Volpp.
- From the Departments of Medicine (S.D.H., K.G.V.), Medical Ethics and Health Policy (S.D.H., K.G.V.), and Biostatistics, Epidemiology, and Informatics (S.D.H., M.O.H., K.S.), University of Pennsylvania Perelman School of Medicine, the Center for Health Incentives and Behavioral Economics at the Leonard Davis Institute of Health Economics (S.D.H., M.O.H., K.S., A.B.T., K.G.V.), the Palliative and Advanced Illness Research Center (S.D.H., M.O.H.), and the Department of Health Care Management, Wharton School (K.G.V.), University of Pennsylvania, and the Center for Health Equity Research and Promotion, Philadelphia Veterans Affairs Medical Center (M.O.H., K.G.V.) - all in Philadelphia; and the Vitality Institute (C.B.) and the Division of Biostatistics, New York University Langone Medical Center (A.B.T.) - both in New York.
- N. Engl. J. Med. 2018 Jun 14; 378 (24): 2302-2310.
BackgroundWhether financial incentives, pharmacologic therapies, and electronic cigarettes (e-cigarettes) promote smoking cessation among unselected smokers is unknown.MethodsWe randomly assigned smokers employed by 54 companies to one of four smoking-cessation interventions or to usual care. Usual care consisted of access to information regarding the benefits of smoking cessation and to a motivational text-messaging service. The four interventions consisted of usual care plus one of the following: free cessation aids (nicotine-replacement therapy or pharmacotherapy, with e-cigarettes if standard therapies failed); free e-cigarettes, without a requirement that standard therapies had been tried; free cessation aids plus $600 in rewards for sustained abstinence; or free cessation aids plus $600 in redeemable funds, deposited in a separate account for each participant, with money removed from the account if cessation milestones were not met. The primary outcome was sustained smoking abstinence for 6 months after the target quit date.ResultsAmong 6131 smokers who were invited to enroll, 125 opted out and 6006 underwent randomization. Sustained abstinence rates through 6 months were 0.1% in the usual-care group, 0.5% in the free cessation aids group, 1.0% in the free e-cigarettes group, 2.0% in the rewards group, and 2.9% in the redeemable deposit group. With respect to sustained abstinence rates, redeemable deposits and rewards were superior to free cessation aids (P<0.001 and P=0.006, respectively, with significance levels adjusted for multiple comparisons). Redeemable deposits were superior to free e-cigarettes (P=0.008). Free e-cigarettes were not superior to usual care (P=0.20) or to free cessation aids (P=0.43). Among the 1191 employees (19.8%) who actively participated in the trial (the "engaged" cohort), sustained abstinence rates were four to six times as high as those among participants who did not actively engage in the trial, with similar relative effectiveness.ConclusionsIn this pragmatic trial of smoking cessation, financial incentives added to free cessation aids resulted in a higher rate of sustained smoking abstinence than free cessation aids alone. Among smokers who received usual care (information and motivational text messages), the addition of free cessation aids or e-cigarettes did not provide a benefit. (Funded by the Vitality Institute; ClinicalTrials.gov number, NCT02328794 .).
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