A Pragmatic Trial of E-Cigarettes, Incentives, and Drugs for Smoking Cessation

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

Preference-Adaptive Randomization in Comparative Effectiveness Studies

Background Determination of comparative effectiveness in a randomized controlled trial requires consideration of an intervention’s comparative uptake (or acceptance) among randomized participants and the intervention’s comparative efficacy among participants who use their assigned intervention. If acceptance differs across interventions, then simple randomization of participants can result in post-randomization losses that introduce bias and limit statistical power. Methods We develop a novel preference-adaptive randomization procedure in which the allocation probabilities are updated based on the inverse of the relative acceptance rates among randomized participants in each arm. In simulation studies, we determine the optimal frequency with which to update the allocation probabilities based on the number of participants randomized. We illustrate the development and application of preference-adaptive randomization using a randomized controlled trial comparing the effectiveness of different financial incentive structures on prolonged smoking cessation. Results Simulation studies indicated that preference-adaptive randomization performed best with frequent updating, accommodated differences in acceptance across arms, and performed well even if the initial values for the allocation probabilities were not equal to their true values. Updating the allocation probabilities after randomizing each participant minimized imbalances in the number of accepting participants across arms over time. In the smoking cessation trial, unexpectedly large differences in acceptance among arms required us to limit the allocation of participants to less acceptable interventions. Nonetheless, the procedure achieved equal numbers of accepting participants in the more acceptable arms, and balanced the characteristics of participants across assigned interventions. Conclusions Preference-adaptive randomization, coupled with analysis methods based on instrumental variables, can enhance the validity and generalizability of comparative effectiveness studies. In particular, preference-adaptive randomization augments statistical power by maintaining balanced sample sizes in efficacy analyses, while retaining the ability of randomization to balance covariates across arms in effectiveness analyses

Randomized Trial of Four Financial-Incentive Programs for Smoking Cessation

Background Financial incentives promote many health behaviors, but effective ways to deliver health incentives remain uncertain. Methods We randomly assigned CVS Caremark employees and their relatives and friends to one of four incentive programs or to usual care for smoking cessation. Two of the incentive programs targeted individuals, and two targeted groups of six participants. One of the individual-oriented programs and one of the group-oriented programs entailed rewards of approximately $800 for smoking cessation; the others entailed refundable deposits of$150 plus $650 in reward payments for successful participants. Usual care included informational resources and free smoking-cessation aids. Results Overall, 2538 participants were enrolled. Of those assigned to reward-based programs, 90.0% accepted this assignment, as compared with 13.7% of those assigned to deposit-based programs (P Conclusions Reward-based programs were much more commonly accepted than deposit-based programs, leading to higher rates of sustained abstinence from smoking. Group-oriented incentive programs were no more effective than individual-oriented programs

Remote Patient Monitoring and Incentives to Support Smoking Cessation Among Pregnant and Postpartum Medicaid Members: Three Randomized Controlled Pilot Studies

BackgroundSmoking rates among low-income individuals, including those eligible for Medicaid, have not shown the same decrease that is observed among high-income individuals. The rate of smoking among pregnant women enrolled in Medicaid is almost twice that among privately insured women, which leads to significant disparities in birth outcomes and a disproportionate cost burden placed on Medicaid. Several states have identified maternal smoking as a key target for improving birth outcomes and reducing health care expenditures; however, efficacious, cost-effective, and feasible cessation programs have been elusive. ObjectiveThis study aims to examine the feasibility, acceptability, and effectiveness of a smartwatch-enabled, incentive-based smoking cessation program for Medicaid-eligible pregnant smokers. MethodsPilot 1 included a randomized pilot study of smartwatch-enabled remote monitoring versus no remote monitoring for 12 weeks. Those in the intervention group also received the SmokeBeat program. Pilot 2 included a randomized pilot study of pay-to-wear versus pay-to-quit for 4 weeks. Those in a pay-to-wear program could earn daily incentives for wearing the smartwatch, whereas those in pay-to-quit program could earn daily incentives if they wore the smartwatch and abstained from smoking. Pilot 3, similar to pilot 2, had higher incentives and a duration of 3 weeks. ResultsFor pilot 1 (N=27), self-reported cigarettes per week among the intervention group declined by 15.1 (SD 27) cigarettes over the study; a similar reduction was observed in the control group with a decrease of 17.2 (SD 19) cigarettes. For pilot 2 (N=8), self-reported cigarettes per week among the pay-to-wear group decreased by 43 cigarettes (SD 12.6); a similar reduction was seen in the pay-to-quit group, with an average of 31 (SD 45.6) fewer cigarettes smoked per week. For pilot 3 (N=4), one participant in the pay-to-quit group abstained from smoking for the full study duration and received full incentives. ConclusionsDecreases in smoking were observed in both the control and intervention groups during all pilots. The use of the SmokeBeat program did not significantly improve cessation. The SmokeBeat program, remote cotinine testing, and remote delivery of financial incentives were considered feasible and acceptable. Implementation challenges remain for providing evidence-based cessation incentives to low-income pregnant smokers. The feasibility and acceptability of the SmokeBeat program were moderately high. Moreover, the feasibility and acceptability of remote cotinine testing and the remotely delivered contingent financial incentives were successful. Trial RegistrationClinicalTrials.gov NCT03209557; https://clinicaltrials.gov/ct2/show/NCT03209557

Disruptive Effects of Stimulus Intensity on Two Variations of a Temporal Discrimination Procedure

Previous reports using stimulus intensity changes to disrupt temporal discrimination have shown shifts in the psychophysical curve for time, while studies using other disruptors have shown a flattening of the curve. The current study investigated the impact of increases and decreases in stimulus intensity on temporal discrimination in pigeons, to determine if a flattening of the curve could be extended to this disruptor. The brightness of the sample to be timed was manipulated under two procedural variations, in which the response alternatives were differentiated by color or location. Results showed that all subjects in the color procedure, and one in the location procedure, showed a flattening of the psychophysical curve when they experienced increased stimulus intensity in descending order. No subjects exposed to an ascending order of stimulus intensities, and none of the other subjects in the location procedure, showed any impact of changed stimulus intensity. Minimal disruption was found when test sessions presented decreased stimulus intensity levels in a second series. These results, together with those using other types of disruptors, add to the evidence of a flattening of the psychophysical curve when temporal discrimination is disrupted