Dataset Information

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

ABSTRACT:

Background

Smoking 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.

Objective

This study aims to examine the feasibility, acceptability, and effectiveness of a smartwatch-enabled, incentive-based smoking cessation program for Medicaid-eligible pregnant smokers.

Methods

Pilot 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.

Results

For 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.

Conclusions

Decreases 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 registration

ClinicalTrials.gov NCT03209557; https://clinicaltrials.gov/ct2/show/NCT03209557.

SUBMITTER: Joyce CM

PROVIDER: S-EPMC8517817 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:Low-income populations are especially likely to smoke and have difficulty quitting. This study evaluated a monetary incentive intended to increase smoking treatment engagement and abstinence among Medicaid recipients who smoke.Two-group randomized clinical trial of Incentive (n=948) and Control interventions (n=952) for smoking.Medicaid recipients recruited from primary care patients (n=920) and callers to the Wisconsin Tobacco Quit Line (n=980).Participants were offered five quitline cessation calls and were encouraged to obtain cessation medication (covered by Medicaid). All participants received payment for completing a baseline assessment and a 6-month smoking test. Only Incentive condition participants received compensation for taking counseling calls ($30 per call) and for biochemically verified abstinence at the 6-month visit ($40).Seven-day point-prevalence smoking abstinence 6-months post study entry and cost/quit.Incentive condition participants had significantly higher biochemically determined 7-day point-prevalence smoking abstinence rates 6 months after study induction than did Controls (21.6% vs 13.8%, respectively, p<0.0001). A positive treatment effect of incentives was present across other abstinence indices, but the size of effects and levels of abstinence varied considerably across indices. Incentive condition participants were also significantly more likely than non-incentivized Control participants to accept Wisconsin Tobacco Quit Line treatment calls and their acceptance of calls mediated their attainment of higher abstinence rates at 6-month follow-up. The cost/quit/participant averaged $4,268.26 for the Control participants and $3,601.37 for the Incentive participants.This study shows that fairly moderate levels of incentive payments for treatment engagement and abstinence (a total possible payment of $190) increased very low-income smokers' engagement and success in smoking cessation treatment.This study is registered at www.clinicaltrials.gov: NCT02713594.

Project description:We report results from a single-blinded randomized controlled trial examining financial incentives for smoking cessation among 249 pregnant and newly postpartum women. Participants included 169 women assigned to best practices (BP) or BP plus financial incentives (BP + FI) for smoking cessation available through 12-weeks postpartum. A third condition included 80 never-smokers (NS) sociodemographically-matched to women who smoked. Trial setting was Burlington, Vermont, USA, January, 2014 through January, 2020. Outcomes included 7-day point-prevalence abstinence antepartum and postpartum, and birth and other infant outcomes during 1st year of life. Reliability and external validity of results were assessed using pooled results from the current and four prior controlled trials coupled with data on maternal-smoking status and birth outcomes for all 2019 singleton live births in Vermont. Compared to BP, BP + FI significantly increased abstinence early- (AOR = 9.97; 95%CI, 3.32-29.93) and late-pregnancy (primary outcome, AOR = 5.61; 95%CI, 2.37-13.28) and through 12-weeks postpartum (AOR = 2.46; CI,1.05-5.75) although not 24- (AOR = 1.31; CI,0.54-3.17) or 48-weeks postpartum (AOR = 1.33; CI,0.55-3.25). There was a significant effect of trial condition on small-for-gestational-age (SGA) deliveries (χ2 [2] = 9.01, P = .01), with percent SGA deliveries (+SEM) greatest in BP, intermediate in BP + FI, and lowest in NS (17.65 + 4.13, 10.81 + 3.61, and 2.53 + 1.77, respectively). Reliability analyses supported the efficacy of financial incentives for increasing abstinence antepartum and postpartum and decreasing SGA deliveries; external-validity analyses supported relationships between antepartum cessation and SGA risk. Adding financial incentives to Best Practice increases smoking cessation among antepartum and postpartum women and improves other maternal-infant outcomes. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02210832.

Project description:BackgroundSmoking tobacco remains the most significant modifiable cause of adverse pregnancy outcomes and contributor to ongoing maternal and infant ill-health. Pregnancy for many is a time of heightened health focus, with the primary motivation being the well-being of the unborn child. Yet, many women continue to smoke throughout their pregnancy. Despite this heightened motivation and known health risks, interventions to date have not effectively curbed the rate of smoking during pregnancy and they remain as high as rates among the general population. One promising strategy has been to incentivize these women to quit. However, incentives-based studies have not shown or reported long-term efficacy. Here, we present the protocol of a trial exploring the effect of incentivized partner support on pre- and postpartum smoking cessation.ObjectiveThe aim of this study is to determine whether providing incentives to both the expectant mother and her support person in promoting short- and long-term smoking cessation during pregnancy is more effective than incentives to the expectant mother alone.MethodsThis protocol is designed as a non-randomized, single-blinded trial to determine the efficacy of incentivized partner support, compared to participant incentive only, in promoting smoking cessation during pregnancy and postpartum. All eligible pregnant women receiving antenatal care via the Tasmanian Health Service (Australia) will be invited to participate. Participants will be eligible for monthly quit-contingent shopping vouchers if they verify, via carbon monoxide breath sample, as being abstinent from smoking. Participating women will be eligible for vouchers until 6-months postpartum and will be followed up at 12-months postpartum.ResultsThe recruitment phase of this study has concluded. Results are expected to be published by the end of 2018.ConclusionsThis study protocol extends the current literature on incentivized smoking cessation interventions for pregnant women by assessing the influence of incentivizing a support partner on short- and long-term abstinence. Key ethical considerations are discussed including potential for receipt (or not) of quit-contingent vouchers impacting negatively on the participant's relationship with their partner. The findings of the study may have important implications for the role support partners are assigned in smoking cessation programs targeting pregnant women.Trial registrationAustralian New Zealand Clinical Trials Registry (ACTRN): 12615001158550; https://www.anzctr.org.au/ Trial/Registration/TrialReview.aspx?id=367981 (Archived by WebCite at http://www.webcitation.org/6tGKO28uh).

Project description:BACKGROUND:Limited research exists on interest in and use of smoking cessation support in pregnancy and postpartum. METHODS:A longitudinal cohort of pregnant smokers and recent ex-smokers were recruited in Nottinghamshire, United Kingdom (N = 850). Data were collected at 8-26 weeks gestation, 34-36 weeks gestation, and 3 months postpartum and used as three cross-sectional surveys. Interest and use of cessation support and belief and behavior measures were collected at all waves. Key data were adjusted for nonresponse and analyzed descriptively, and multiple regression was used to identify associations. RESULTS:In early and late pregnancy, 44% (95% CI 40% to 48%) and 43% (95% CI 37% to 49%) of smokers, respectively, were interested in cessation support with 33% (95% CI 27% to 39%) interested postpartum. In early pregnancy, 43% of smokers reported discussing cessation with a midwife and, in late pregnancy, 27% did so. Over one-third (38%) did not report discussing quitting with a health professional during pregnancy. Twenty-seven percent of smokers reported using any National Health Service (NHS) cessation support and 12% accessed NHS Stop Smoking Services during pregnancy. Lower quitting confidence (self-efficacy), higher confidence in stopping with support, higher quitting motivation, and higher age were associated with higher interest in support (ps ? .001). A recent quit attempt and greater interest in support was associated with speaking to a health professional about quitting and use of NHS cessation support (ps ? .001). CONCLUSIONS:When asked in early or late pregnancy, about half of pregnant smokers were interested in cessation support, though most did not engage. Cessation support should be offered throughout pregnancy and after delivery. IMPLICATIONS:There is relatively high interest in cessation support in early and late pregnancy and postpartum among smokers; however, a much smaller proportion of pregnant or postpartum women access any cessation support, highlighting a gap between interest and engagement. Reflecting women's interest, offers of cessation support should be provided throughout pregnancy and after delivery. Increasing motivation to quit and confidence in quitting with assistance may enhance interest in support, and promoting the discussion of stopping smoking between women and health practitioners may contribute to higher support engagement rates.

Project description:IntroductionSmoking during pregnancy increases the risk of morbidity and mortality of the mother and child. The inability of the unborn child to protect itself, raises the social and academic responsibility to protect the child from the harmful effects of smoking. Interventions including rewards (incentives) for lifestyle changes are an upcoming trend and can encourage women to quit smoking. However, these incentives can, as we will argue, also have negative consequences, for example the restriction of personal autonomy and encouragement of smoking to become eligible for participation. To prevent these negative consequences, we developed an ethical framework that enables to assess and address unwanted consequences of incentive-based interventions whereby moral permissibility can be evaluated.Aims and methodsThe possible adverse consequences of incentives were identified through an extensive literature search. Subsequently, we developed ethical criteria to identify these consequences based on the biomedical ethical principles of Beauchamp and Childress.ResultsOur framework consists of 12 criteria. These criteria concern (1) effectiveness, (2) support of a healthy lifestyle, (3) motivational for the target population, (4) stimulating unhealthy behavior, (5) negative attitudes, (6) personal autonomy, (7) intrinsic motivation, (8) privacy, (9) fairness, (10) allocation of incentives, (11) cost-effectiveness, and (12) health inequity. Based on these criteria, the moral permissibility of potential interventions can be evaluated.ConclusionsIncentives for smoking cessation are a response to the responsibility to protect the unborn child. But these interventions might have possible adverse effects. This ethical framework aims to identify and address ethical pitfalls in order to avoid these adverse effects.ImplicationsAlthough various interventions to promote smoking cessation during pregnancy exist, many women still smoke during pregnancy. Interventions using incentives for smoking cessation during pregnancy are a promising and upcoming trend but can have unwanted consequences. This ethical framework helps to identify and address ethical pitfalls in order to avoid these adverse effects.It can be a practical tool in the development and evaluation of these interventions and in evaluating the moral permissibility of interventions using incentives for smoking cessation during pregnancy.