Dataset Information

Treatment Satisfaction in a Randomized Clinical Trial of mHealth Smoking Abstinence Reinforcement.

ABSTRACT: The importance of patient satisfaction in modern healthcare is widely recognized, but research on satisfaction in the context of smoking cessation has not kept pace. The purpose of this study was to explore treatment satisfaction in a sample of smokers (N=84) randomized to one of two smoking cessation treatment interventions (mHealth reinforcement and mHealth monitoring) that used cell phone-based procedures to monitor smoking status in individuals' natural environments for 4 weeks. Starting on the target quit date, participants received usual care smoking cessation treatment consisting of 8 weeks of transdermal nicotine and 4 weeks of twice-weekly telephone counseling were also prompted 1 to 3 times daily (with exact number and timing not disclosed beforehand) to use a study cell phone and CO monitor to complete a CO self-test, video-record the process, and submit videos using multimedia messaging within 2 hours. mHealth reinforcement participants could earn prizes for smoking-negative on-time CO tests. A treatment satisfaction survey was completed at the end of the 4-week monitoring/reinforcement phase. Results indicate that participants overwhelmingly endorsed high levels of overall satisfaction in both conditions. Treatment adherence did not differ between conditions, but was positively associated with endorsing the highest satisfaction with help quitting with the intervention (p<.01 to .03). mHealth reinforcement was associated with increased longest duration of abstinence (p<.01). Controlling for relevant participant characteristics and treatment adherence, longest duration of abstinence robustly predicted highest satisfaction with help quitting and mediated the effect of treatment condition on that satisfaction. Further research on treatment satisfaction may aid the development of effective abstinence reinforcement and other smoking cessation interventions.

SUBMITTER: Alessi SM

PROVIDER: S-EPMC5154906 | biostudies-literature | 2017 Jan

REPOSITORIES: biostudies-literature

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Treatment Satisfaction in a Randomized Clinical Trial of mHealth Smoking Abstinence Reinforcement.

Alessi Sheila M SM Rash Carla J CJ

Journal of substance abuse treatment 20160704

The importance of patient satisfaction in modern healthcare is widely recognized, but research on satisfaction in the context of smoking cessation has not kept pace. The purpose of this study was to explore treatment satisfaction in a sample of smokers (N=84) randomized to one of two smoking cessation treatment interventions (mHealth reinforcement and mHealth monitoring) that used cell phone-based procedures to monitor smoking status in individuals' natural environments for 4 weeks. Starting on ...[more]

PMID: 27449226

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Project description:Abstinence reinforcement is efficacious for improving smoking treatment outcomes, but practical constraints related to the need for multiple in-person carbon monoxide (CO) breath tests daily to verify smoking abstinence have limited its use. This study tested an mHealth procedure to remotely monitor and reinforce smoking abstinence in individuals' natural environment.Eligible treatment-seeking smokers (N = 90) were randomized to (1) usual care and ecological monitoring with abstinence reinforcement (mHealth reinforcement) or (2) without reinforcement (mHealth monitoring). Usual care was 8 weeks of transdermal nicotine and twice-weekly telephone counseling. Following training, an interactive voice response system prompted participants to conduct CO tests 1-3 daily at pseudorandom times (7 am to 10 pm) for 4 weeks. When prompted, participants used a study cell phone and CO monitor to complete a CO self-test, video record the process, and submit videos using multimedia messaging. mHealth reinforcement participants could earn prizes for smoking-negative on-time CO tests. The interactive voice response generated preliminary earnings immediately. Earnings were finalized by comparing video records against participants' self-reports.mHealth reinforcement was associated with a greater proportion of smoking-negative CO tests, longest duration of prolonged abstinence, and point-prevalence abstinence during the monitoring/reinforcement phase compared to mHealth monitoring (p < .01, d = 0.8-1.3). Follow-up (weeks 4-24) analyses indicated main effects of reinforcement on point-prevalence abstinence and proportion of days smoked (p ? .05); values were comparable by week 24.mHealth reinforcement has short-term efficacy. Research on methods to enhance and sustain benefits is needed.This study suggests that mHealth abstinence reinforcement is efficacious and may present temporal and spatial opportunities to research, engage, and support smokers trying to quit that do not exist with conventional (not technology-based) reinforcement interventions.

Project description:Introduction:Three-quarters of homeless people smoke cigarettes. Financial incentives for smoking abstinence have appeared promising in nonexperimental studies of homeless smokers, but randomized controlled trial (RCT) data are lacking. Methods:We conducted a pilot RCT of financial incentives for homeless smokers. Incentive arm participants (N = 25) could earn escalating $15-$35 rewards for brief smoking abstinence (exhaled carbon monoxide <8 parts per million) assessed 14 times over 8 weeks. Control arm participants (N = 25) were given $10 at each assessment regardless of abstinence. All participants were offered nicotine patches and counseling. The primary outcome was a repeated measure of brief smoking abstinence across 14 assessments. The secondary outcome was brief abstinence at 8 weeks. Exploratory outcomes were self-reported 1-day and 7-day abstinence from (1) any cigarette and (2) any puff of a cigarette. Other outcomes included 24-hour quit attempts, nicotine patch use, counseling attendance, and changes in alcohol and drug use. Results:Compared to control, incentive arm participants were more likely to achieve brief abstinence overall (odds ratio 7.28, 95% confidence interval 2.89 to 18.3) and at 8 weeks (48% vs. 8%, p = .004). Similar effects were seen for 1-day abstinence, but 7-day puff abstinence was negligible in both arms. Incentive arm participants made more quit attempts (p = .03). Nicotine patch use and counseling attendance were not significantly different between the groups. Alcohol and drug use did not change significantly in either group. Conclusions:Among homeless smokers, financial incentives increased brief smoking abstinence and quit attempts without worsening substance use. This approach merits further development focused on promoting sustained abstinence. Registration:ClinicalTrials.gov (NCT02565381). Implications:Smoking is common among homeless people, and conventional tobacco treatment strategies have yielded modest results in this population. This pilot RCT suggests that financial incentives may be a safe way to promote brief smoking abstinence and quit attempts in this vulnerable group of smokers. However, further development is necessary to translate this approach into real-world settings and to promote sustained periods of smoking abstinence.

Project description:Prior studies by our group demonstrated the efficacy of a brief but intensive behavioral intervention for producing initial smoking abstinence among opioid-dependent patients. In the present study, our aim was to promote longer-duration abstinence in this population. Following an initial 2-week incentive intervention for smoking abstinence, we examined whether a 10-week maintenance arm involving continuation of contingent reinforcement will produce greater smoking abstinence than a similar duration of noncontingent reinforcement.Randomized, 12-week, parallel-group study.Out-patient research clinic in Burlington, Vermont, USA.Opioid-maintained smokers (n = 88) who provided breath carbon monoxide and urinary cotinine specimens and received contingent reinforcement for smoking abstinence during weeks 1-2 (phase 1), with 63 randomized on day 14 to an extended contingent (EC; n = 31) or extended noncontingent (EN; n = 32) experimental condition for weeks 3-12 (phase 2).The EC condition consisted of voucher values that escalated across consecutive negative samples until they reached $30, after which they remained at $30 per negative sample. A positive or a missing sample resulted in no vouchers for that day and reset the value of the next negative same to $9. Two consecutive negatives returned the schedule to the pre-reset value. The EN control condition consisted of vouchers delivered for providing scheduled samples, but independent of smoking status.The primary outcome was percentage of biochemically abstinent samples during phase 2. Secondary measures included abstinence status at final study visit, complete abstinence, participants' longest duration of continuous abstinence, cotinine and carbon monoxide (CO) levels and self-reported cigarettes per day.EC participants achieved greater smoking abstinence during phase 2 than EN participants [46.7 versus 23.5% negative samples, respectively; odds ratio (OR) = 2.98, 95% confidence interval (CI) = 1.16-7.65, ?(2) 1 (=) 5.0, P = 0.02]. When longest duration of continuous abstinence was compared between experimental groups, EC participants achieved twice the mean duration of continuous abstinence compared with EN participants (3.31 versus 1.68 weeks; t61 = 1.83, P = 0.07). An effect of experimental condition was also seen on mean cotinine levels (42.5 versus 210.6 ng/ml, respectively; F1,61 =5.9, P = 0.02).Among opioid-maintained smokers receiving an initial period of daily contingent incentives, a contingent reinforcement intervention appears to be more effective at extending smoking abstinence than noncontingent reinforcement over 10 weeks.

Project description:In utero exposure to drugs of abuse can lead to neonatal abstinence syndrome, a condition that is associated with prolonged hospitalization. Buprenorphine is a partial mu-opioid agonist used for treatment of adult detoxification and maintenance but has never been administered to neonates with opioid abstinence syndrome. The primary objective of this study was to demonstrate the feasibility and, to the extent possible in this size of study, the safety of sublingual buprenorphine in the treatment of neonatal abstinence syndrome. Secondary goals were to evaluate efficacy relative to standard therapy and to characterize buprenorphine pharmacokinetics when sublingually administered.We conducted a randomized, open-label, active-control study of sublingual buprenorphine for the treatment of opiate withdrawal. Thirteen term infants were allocated to receive sublingual buprenorphine 13.2 to 39.0 mug/kg per day administered in 3 divided doses and 13 to receive standard-of-care oral neonatal opium solution. Dose decisions were made by using a modified Finnegan scoring system.Sublingual buprenorphine was largely effective in controlling neonatal abstinence syndrome. Greater than 98% of plasma concentrations ranged from undetectable to approximately 0.60 ng/mL, which is less than needed to control abstinence symptoms in adults. The ratio of buprenorphine to norbuprenorphine was larger than that seen in adults, suggesting a relative impairment of N-dealkylation. Three infants who received buprenorphine and 1 infant who received standard of care reached protocol-specified maximum doses and required adjuvant therapy with phenobarbital. The mean length of treatment for those in the neonatal-opium-solution group was 32 compared with 22 days for the buprenorphine group. The mean length of stay for the neonatal-opium-solution group was 38 days compared with 27 days for those in the buprenorphine group. Treatment with buprenorphine was well tolerated.Buprenorphine administered via the sublingual route is feasible and apparently safe and may represent a novel treatment for neonatal abstinence syndrome.

Project description:Randomized controlled trials (RCTs) have long been considered the primary research study design capable of eliciting causal relationships between health interventions and consequent outcomes. However, with a prolonged duration from recruitment to publication, high-cost trial implementation, and a rigid trial protocol, RCTs are perceived as an impractical evaluation methodology for most mHealth apps.Given the recent development of alternative evaluation methodologies and tools to automate mHealth research, we sought to determine the breadth of these methods and the extent that they were being used in clinical trials.We conducted a review of the ClinicalTrials.gov registry to identify and examine current clinical trials involving mHealth apps and retrieved relevant trials registered between November 2014 and November 2015.Of the 137 trials identified, 71 were found to meet inclusion criteria. The majority used a randomized controlled trial design (80%, 57/71). Study designs included 36 two-group pretest-posttest control group comparisons (51%, 36/71), 16 posttest-only control group comparisons (23%, 16/71), 7 one-group pretest-posttest designs (10%, 7/71), 2 one-shot case study designs (3%, 2/71), and 2 static-group comparisons (3%, 2/71). A total of 17 trials included a qualitative component to their methodology (24%, 17/71). Complete trial data collection required 20 months on average to complete (mean 21, SD 12). For trials with a total duration of 2 years or more (31%, 22/71), the average time from recruitment to complete data collection (mean 35 months, SD 10) was 2 years longer than the average time required to collect primary data (mean 11, SD 8). Trials had a moderate sample size of 112 participants. Two trials were conducted online (3%, 2/71) and 7 trials collected data continuously (10%, 7/68). Onsite study implementation was heavily favored (97%, 69/71). Trials with four data collection points had a longer study duration than trials with two data collection points: F4,56=3.2, P=.021, ?(2)=0.18. Single-blinded trials had a longer data collection period compared to open trials: F2,58=3.8, P=.028, ?(2)=0.12. Academic sponsorship was the most common form of trial funding (73%, 52/71). Trials with academic sponsorship had a longer study duration compared to industry sponsorship: F2,61=3.7, P=.030, ?(2)=0.11. Combined, data collection frequency, study masking, sample size, and study sponsorship accounted for 32.6% of the variance in study duration: F4,55=6.6, P<.01, adjusted r(2)=.33. Only 7 trials had been completed at the time this retrospective review was conducted (10%, 7/71).mHealth evaluation methodology has not deviated from common methods, despite the need for more relevant and timely evaluations. There is a need for clinical evaluation to keep pace with the level of innovation of mHealth if it is to have meaningful impact in informing payers, providers, policy makers, and patients.

Dataset Information

Treatment Satisfaction in a Randomized Clinical Trial of mHealth Smoking Abstinence Reinforcement.

Publications

Treatment Satisfaction in a Randomized Clinical Trial of mHealth Smoking Abstinence Reinforcement.

Similar Datasets

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