D ATA D R I V E N . P O L I C Y F O C U S E D LDI ResearchBRIEF Research to Improve the Nation’s Health System 2018 . No. 11 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 New England Journal of Medicine – May 23, 2018 KEYFINDINGS In a trial examining five approaches to smoking cessation among over 6,000 U.S. employees, financial incentives combined with free cessation aids were more effective at getting employees to stop smoking than free cessation aids alone. Specifically, the most effective intervention (free cessation aids plus $600 in redeemable funds) helped 2.9% of participants stop smoking through six months after their target quit date; this rate jumped to 12.7% among participants who actively engaged in the trial and were more motivated to quit. For employees with access to usual care (information and a free motivational text messaging service), offering free cessation aids or electronic cigarettes (e-cigarettes) did not help them quit smoking. THE QUESTION e-cigarettes if standard therapies failed); free e-cigarettes, without a requirement that standard therapies had been tried; free cessation aids Recognizing the health and economic costs of employees who smoke, plus $600 in rewards for sustained abstinence, and; free cessation aids most large U.S. companies offer smoking-cessation programs, nearly plus $600 in redeemable funds, deposited in a separate account for half of which are paired with financial incentives for employees who each participant, with money removed from the account if cessation successfully stop smoking. However, the benefits offered by workplace milestones were not met. They compared quit rates between groups smoking-cessation programs vary considerably, and there is limited and the costs associated with each intervention. evidence about the optimal design of smoking cessation interventions. The authors conducted a five-group randomized, controlled trial to compare usual care (access to information regarding the benefits of THE FINDINGS smoking cessation and a motivational text-messaging service) with four Among 6,131 smokers from 54 companies invited to enroll, 6,006 enrolled smoking-cessation interventions to determine which is most effective and were randomized to usual care or one of the four intervention groups at helping employees stop smoking. The four interventions were free (125 opted out). Of the enrollees, 1,191 (19.8%) were “engaged,” meaning cessation aids (nicotine-replacement therapy or pharmacotherapy, with they logged into the trial website at least once during the program. Engaged participants were more educated, more motivated to quit, more likely to be female, and more often past or present users of e-cigarettes than participants who did not actively engage in the trial. COLONIAL PENN CENTER | 3641 LOCUST WALK | PHILADELPHIA, PA 19104-6218 | LDI.UPENN.EDU | P: 215-898-5611 | F: 215-898-0229 | @PENNLDI ResearchBRIEF LDI THE IMPLICATIONS Figure 1. Previous randomized, controlled trials included employees who were Sustained Smoking Abstinence at 6 Months after the interested in quitting smoking. This trial examined the success of Target Quit Date smoking cessation interventions when offered to all smokers, not just those interested in quitting. This study design produced lower cessation rates overall compared to previous workplace studies on employees who were motivated to quit (though found comparable results among engaged participants). Despite low rates overall, incentive programs may still be useful for employers, as most costs are incurred only if employees successfully quit, and overall costs are lower than the extra cost of employing smokers. An important finding is that free cessation aids, a cornerstone of many employer wellness programs, did not significantly improve quit rates. This trial also provided robust evidence that offering free e-cigarettes did not result in higher quit rates than traditional smoking cessation aids, nor improve quit rates among employees offered information and access to a motivational text messaging service. The authors did not assess efficacy of the use of these products, or the possibility that e-cigarettes reduce the harms associated with conventional smoking. However, a recent expert report suggests that e-cigarettes would only reduce short-term adverse health effects of smoking if they lead to complete smoking cessation. Source: New England Journal of Medicine This trial showed that financial incentives promoted smoking cessation even when free cessation aids were routinely available. These results, considered alongside those from previous trials, suggest that incentives Overall, 80 (1.3%) participants stopped smoking through six months after at least triple cessation rates regardless of whether free cessation aids their target quit date. The rate of sustained smoking abstinence was 0.1% are offered. The authors found that redeemable deposit contracts, in in the group that received usual care, 0.5% in the free cessation aids group, which participants would lose incentives if they continued smoking, 1.0% in the free e-cigarettes group, 2.0% in the rewards group, and 2.9% were not significantly better than incentive programs structured as pure in the redeemable deposit group (Figure 1). The authors found three rewards. Nonetheless, the observation that this loss framing produced meaningful comparisons between groups: redeemable deposits combined nominally higher rates of quitting at nominally lower costs per quit may with free cessation aids were more effective than either free cessation aids motivate employers that are planning incentive programs to consider or free e-cigarettes alone, and rewards combined with free cessation aids the use of loss framing. were more effective than free cessation aids alone. Important to note are the negative findings: free cessation aids and free e-cigarettes were no more effective than usual care. About half of the participants who stopped THE STUDY smoking for six months after their target quit date were also smoke-free at 12 months (six months after interventions ended). This study was done in partnership with the Vitality group, a health and wellness company (a subsidiary of Discovery, the South African Engaged participants had sustained smoking abstinence rates that were Insurance Company). Eligible participants were employees and their four to six times as those who did not actively engage: 2.9% in the free spouses at 54 companies that used Vitality as part of their wellness cessation aids group, 4.8% in the free e-cigarettes group, 9.5% in the rewards programs, were at least 18 years old, and reported current smoking on group, and 12.7% in the redeemable deposit group (Figure 1). The relative health risk assessment within the previous year. Enrollment proceeded effectiveness of the interventions also applied to engaged participants. in two phases: 2,229 eligible participants were identified from nine companies in the first phase, and 3,902 eligible participants from 45 The average cost per participant was lowest in the usual care group companies were identified in the second phase. (<$1) and highest in the redeemable deposit group ($101). The cost per successful quit was lower in the rewards ($3,623) and redeemable deposit Potential participants were notified by email on at least four occasions ($3,461) groups than in the free e-cigarettes ($5,416) or free cessation aids that they had been selected to participate. If participants didn’t opt ($7,798) group. out, they were enrolled and randomly assigned to usual care or to 2 ResearchBRIEF LDI an intervention. All participants were informed of usual care resources (information and access to a free motivational text-messaging program); those randomized to ABOUT PENN LDI intervention groups were also offered one of four additional programs. Since 1967, the Leonard Davis Institute of Health Economics at the University of The authors measured the rate of sustained smoking abstinence at six months after Pennsylvania (Penn LDI) has been the leading the target quit date for each group. Successful smoking abstinence required that university institute dedicated to data-driven, participants report smoking cessation on a survey at 1, 3, and 6 months, which was policy-focused research that improves our biochemically confirmed with a urine or blood sample. Participants assigned to the nation’s health and health care. Originally rewards and redeemable deposit groups were eligible to earn $100, $200, and $300 at founded to bridge the gap between scholars 1, 3, and 6 months after the quit date, respectively, if their samples were negative for in business (Wharton) and medicine, Penn nicotine metabolites. The authors compared quit rates between groups, designating LDI now connects all of Penn’s schools and the Children’s Hospital of Philadelphia through the free cessation aids group as the primary comparator against which the other four its more than 250 Senior Fellows. groups were compared. Four other between-group contrasts were done, resulting in eight total comparisons. They calculated and compared each intervention’s cost LDI Research Briefs are produced by (including incentives disbursed, evaluation and payment for blood and urine samples, LDI’s policy team. For more information and cessation aids). please contact Janet Weiner at weinerja@pennmedicine.upenn.edu COLONIAL PENN CENTER 3641 LOCUST WALK PHILADELPHIA, PA 19104-6218 LDI.UPENN.EDU P: 215-898-5611 F: 215-898-0229 @PENNLDI Halpern, SD, Harhay MO, Saulsgiver K, LEAD AUTHORS Brophy C, Troxel AB, & Volpp KG. A Pragmatic Trial of E-Cigarettes, Incentives, DR. SCOTT D. HALPERN and Drugs for Smoking Cessation. New Scott Halpern MD, PhD, MBE is Associate Professor of Medicine, England Journal of Medicine, May 2018. Epidemiology, and Medical Ethics and Health Policy at the Perelman doi:10.1056/NEJMsa1715757 School of Medicine at the University of Pennsylvania. His research focuses on improving the efficient and ethical distribution of health care resources, particularly for acutely and seriously ill patients. He is the founding Director of the Palliative and Advanced Illness Research (PAIR) Center and the Fostering Improvement in End-of-Life Decision Science (FIELDS) program. DR. KEVIN G. VOLPP Kevin G. Volpp, MD, PhD is the Founders President’s Distinguished Professor of Medicine and Medical Ethics and Policy at the Perelman School of Medicine and Health Care Management at the Wharton School. He is also Director of the Center for Health Incentives and Behavioral Economics, Vice Chairman for Health Policy for the Department of Medical Ethics and Policy, and Director (with Karen Glanz) of the Penn CDC Prevention Research Center. His research focuses on developing and testing innovative ways of applying behavioral economics insights to improve patient health behavior and provider performance. 3