Dataset Information

Helping Hospitalized Smokers: A Factorial RCT of Nicotine Patches and Counseling.

ABSTRACT: Most smokers abstain from smoking during hospitalization but relapse upon discharge. This study tests the effectiveness of two proven treatments (i.e., nicotine patches and telephone counseling) in helping these patients stay quit after discharge from the hospital, and assesses a model of hospital-quitline partnership.This study had a 2×2 factorial design in which participants were stratified by recruitment site and smoking rate and randomly assigned to usual care, nicotine patches only, counseling only, or patches plus counseling. They were evaluated at 2 and 6 months post-randomization.A total of 1,270 hospitalized adult smokers were recruited from August 2011 to November 2013 from five hospitals within three healthcare systems.Participants in the patch condition were provided 8 weeks of nicotine patches at discharge (or were mailed them post-discharge). Quitline staff started proactively calling participants in the counseling condition 3 days post-discharge to provide standard quitline counseling.The primary outcome measure was self-reported 30-day abstinence at 6 months using an intention-to-treat analysis. Data were analyzed from September 2015 to May 2016.The 30-day abstinence rate at 6 months was 22.8% for the nicotine patch condition and 18.3% for the no-patch condition (p=0.051). Nearly all participants (99%) in the patch condition were provided nicotine patches, although 36% were sent post-discharge. The abstinence rates were 20.0% and 21.1% for counseling and no counseling conditions, respectively (p=0.651). Fewer than half of the participants in the counseling condition (47%) received counseling (mean follow-up sessions, 3.6).Provision of nicotine patches proved feasible, although their effectiveness in helping discharged patients stay quit was not significant. Telephone counseling was not effective, in large part because of low rates of engagement. Future interventions will need to be more immediate to be effective.This study is registered at www.clinicaltrials.gov NCT01289275.

SUBMITTER: Cummins SE

PROVIDER: S-EPMC5031241 | biostudies-literature | 2016 Oct

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Helping Hospitalized Smokers: A Factorial RCT of Nicotine Patches and Counseling.

Cummins Sharon E SE Gamst Anthony C AC Brandstein Kendra K Seymann Gregory B GB Klonoff-Cohen Hillary H Kirby Carrie A CA Tong Elisa K EK Chaplin Edward E Tedeschi Gary J GJ Zhu Shu-Hong SH

American journal of preventive medicine 20161001 4

<h4>Introduction</h4>Most smokers abstain from smoking during hospitalization but relapse upon discharge. This study tests the effectiveness of two proven treatments (i.e., nicotine patches and telephone counseling) in helping these patients stay quit after discharge from the hospital, and assesses a model of hospital-quitline partnership.<h4>Study design</h4>This study had a 2×2 factorial design in which participants were stratified by recruitment site and smoking rate and randomly assigned to ...[more]

PMID: 27647058

Similar Datasets

Project description:ObjectiveTo determine the efficacy of 16 hour nicotine patches among pregnant smokers, with the dose individually adjusted according to saliva cotinine levels (potential range 10-30 mg/day).DesignRandomised, double blind, placebo controlled, parallel group, multicentre trial (Study of Nicotine Patch in Pregnancy, SNIPP) between October 2007 and January 2013.Setting23 maternity wards in France.Participants476 pregnant smokers aged more than 18 years and between 12 and 20 weeks' gestation, who smoked at least five cigarettes a day. After exclusions, 402 women were randomised: 203 to nicotine patches and 199 to placebo patches. Data were available on 192 live births in each group.InterventionsNicotine and identical placebo patches were administered from quit day up to the time of delivery. Doses were adjusted to saliva cotinine levels when smoking to yield a substitution rate of 100%. Participants were assessed monthly and received behavioural smoking cessation support.Main outcome measuresThe primary outcomes were complete abstinence (self report confirmed by carbon monoxide level in expired air ≤ 8 ppm) from quit date to delivery, and birth weight. The secondary outcomes were point prevalence of abstinence, time to lapse (a few puffs) or relapse, and delivery and birth characteristics. All data were analysed on an intention to treat basis.ResultsComplete abstinence was achieved by 5.5% (n=11) of women in the nicotine patch group and 5.1% (n=10) in the placebo patch group (odds ratio 1.08, 95% confidence interval 0.45 to 2.60). The median time to the first cigarette smoked after target quit day was 15 days in both groups (interquartile range 13-18 in the nicotine patch group, 13-20 in the placebo patch group). The point prevalence abstinence ranged from 8% to 12.5% in the nicotine patch group and 8% to 9.5% in the placebo patch group without statistically significant differences. The nicotine substitution rate did not differ from 100%, and the self reported median compliance rate was 85% (interquartile range 56-99%) in the nicotine patch group and 83% (56-95%) in the placebo patch group, assessed at 1016 visits. The mean birth weight was 3065 g (SE 44 g) in the nicotine patch group and 3015 g (SE 44 g) in the placebo patch group (P=0.41). Diastolic blood pressure was significantly higher in the nicotine patch group than in the placebo patch group. The frequency of serious adverse events was similar between the groups, although more non-serious adverse reactions, mainly of skin, occurred in the nicotine patch group.ConclusionThe nicotine patch did not increase either smoking cessation rates or birth weights despite adjustment of nicotine dose to match levels attained when smoking, and higher than usual doses.Trial registrationClinicalTrials.gov NCT00507975.

Project description:BackgroundThe potential of electronic nicotine delivery systems (ENDS) to reduce the cardiovascular and other disease risks of smoking is of great interest. While many smokers report using ENDS for cessation, their impact under real-world use patterns and conditions on adult smokers' quitting behavior is uncertain. The objective of this study was to generate more recent and comprehensive evidence on the effect of "real world" ENDS use on the population quit rates of adult smokers while taking account of frequency and duration of use, device type, e-liquid flavor, and reasons for use.Methods and findingsWe conducted a population-based, prospective cohort study of a random probability sample of 1284 U.S. adult smokers recruited in August/September 2015 and re-contacted one-year later (September 2016) from GfK's KnowledgePanel, a national, probability-based web-panel designed to be representative of non-institutionalized U.S. adults. Among the 1081 baseline smokers who remained members of KnowledgePanel, 858 completed the follow-up survey. The primary outcome was smoking abstinence for at least 30 days prior to follow-up. Secondary outcomes were making a quit attempt during the 12-month study period and number of cigarettes smoked per day at follow-up. The adjusted odds of quitting smoking were lower for those that used ENDS at baseline (9.4%, 95% CI = 5.22%-16.38%; AOR = 0.30, 95% CI = 0.13-0.72) compared to smokers who did not use at ENDS (18.9%, 95% CI = 14.24%-24.68%). Smokers who used ENDS daily at some point during the study period were also less likely to quit smoking than nonusers (AOR = 0.17; 95% CI = 0.04-0.82). Limited ability to draw causal inferences from the observational design and a lack of biochemical verification of quitting smoking or ENDS use are limitations of this study.ConclusionsWe found no evidence that ENDS use, within context of the 2015-2016 US regulatory and tobacco/vaping market landscape, helped adult smokers quit at rates higher than smokers who did not use these products. Absent any meaningful changes, ENDS use among adult smokers is unlikely to be a sufficient solution to obtaining a meaningful increase in population quit rates. Additional research is needed to reconcile the divergent literature and monitor the impact of ENDS in an environment of rapidly evolving markets and regulatory policies.

Project description:BackgroundSmoking cessation interventions for hospitalized smokers are effective in promoting smoking cessation, but only if the tobacco dependence treatment continues after the patient leaves the hospital. Sustaining tobacco dependence treatment after hospital discharge is a challenge for health care systems. Our previous single-site randomized controlled trial demonstrated the effectiveness of an intervention that facilitated the delivery of comprehensive tobacco cessation treatment, including both medication and counseling, after hospital discharge. We subsequently streamlined the intervention model to increase its potential for dissemination. This new model is being tested in a larger multi-site trial with broader eligibility criteria in order to enroll a more representative sample of hospitalized smokers. This paper describes the trial design and contrasts it with the earlier study.Methods/designA 2-arm, 3-site randomized controlled trial is testing the hypothesis that a multi-component Sustained Care intervention is more effective than Standard Care in helping hospitalized cigarette smokers stop smoking after hospital discharge. The trial enrolls adult daily cigarette smokers who are admitted to 1 of 3 participating hospitals in Massachusetts or Pennsylvania. Participants receive the same smoking cessation intervention in the hospital. They are randomly assigned to receive either Standard Care or Sustained Care after hospital discharge. Participants in the Sustained Care arm receive a free 3-month supply of FDA-approved smoking cessation medication and 5 interactive voice response calls that provide tailored motivational messages, medication refills, and access to a live tobacco treatment counselor. Participants in the Standard Care arm receive a smoking cessation medication recommendation and information about community resources. Outcomes are assessed at 1, 3, and 6 months after discharge. The primary outcome is biochemically-validated tobacco abstinence for the past 7 days at 6-month follow-up. Other outcome measures include self-reported tobacco abstinence measures, use of medication and counseling after discharge, hospital readmissions, and program cost-effectiveness.DiscussionWe adapted a proven intervention for hospitalized smokers to enhance its potential for dissemination and are testing it in a multi-site trial. Study enrollment data suggests that the trial achieved the goal of recruiting a broader sample of hospitalized smokers.Trial registrationComparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers (Helping HAND2) NCT01714323. Registered October 22, 2012.

Project description:BackgroundTobacco smoking remains the leading preventable cause of death in the US. A hospital admission provides smokers with a unique opportunity to stop smoking because it requires temporary tobacco abstinence while illness may enhance motivation to quit. Hospital interventions must continue post-discharge to increase tobacco abstinence long-term, but how best to accomplish this remains unclear. Building on two previous randomized controlled trials, each of which tested smoking cessation interventions that began in hospital and continued after discharge, this trial compares two interventions that provide sustained smoking cessation treatment after hospital discharge with the goal of improving long-term smoking cessation rates among hospitalized smokers.Methods/designHelping HAND 4 is a three-site randomized controlled trial that compares the effectiveness of two active interventions for producing validated past 7-day tobacco abstinence 6 months after hospital discharge. Smokers who are admitted to three hospitals receive a standard in-hospital smoking intervention, and those who plan to quit smoking after discharge are recruited and randomly assigned to two interventions that begin at discharge, Personalized Tobacco Care Management (PTCM) or Quitline eReferral. Each lasts 3 months. At discharge, PTCM provides 8 weeks of free nicotine replacement (NRT; a participant's choice of patch, gum, lozenge, or a combination) and then proactive smoking cessation support using an automated communication platform and live contact with a tobacco treatment specialist who is based in the health care system. In the eReferral condition, a direct referral is made from the hospital electronic health record to a community-based resource, the state's telephone quitline. The quitline provides up to 8 weeks of free NRT and offers behavioral support via a series of phone calls from a trained coach. Outcomes are assessed at 1, 3, and 6 months after discharge. The study hypothesis is that PTCM will produce higher quit rates than eReferral.DiscussionHelping HAND 4 is a pragmatic trial that aims to evaluate interventions in real-world conditions. This project will give hospital systems critical evidence-based tools for meeting National Hospital Quality Measures for tobacco treatment and maximizing their ability to improve cessation rates and overall health for the millions of smokers hospitalized annually in the US.Trial registrationProspectively registered prior to start of enrollment at Clinicaltrials.gov, NCT03603496 (July 27, 2018). https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S00084MJ&selectaction=Edit&uid=U00002G7&ts=2&cx=ff0oxn.

Project description:IntroductionNetwork theories of psychopathology highlight that, rather than being indicators of a latent disorder, symptoms of disorders can causally interact with one another in a network. This study examined tobacco withdrawal from a network perspective.MethodsParticipants (n = 525, 50.67% female) completed the Minnesota Tobacco Withdrawal Scale four times (2 weeks prior to a target quit day, on the target quit day, and 4 and 8 weeks after the target quit day) over the course of 8 weeks of treatment with nicotine patch and behavioral counseling within a randomized clinical trial testing long-term nicotine patch therapy in treatment-seeking smokers. The conditional dependence among seven withdrawal symptoms was estimated at each of the four measurement occasions. Influential symptoms of withdrawal were identified using centrality indices. Changes in network structure were examined using the Network Comparison Test.ResultsFindings indicated many associations among the individual symptoms of withdrawal. The strongest associations that emerged were between sleep problems and restlessness, and associations among affective symptoms. Restlessness and affective symptoms emerged as the most central symptoms in the withdrawal networks. Minimal differences in the structure of the withdrawal networks emerged across time.ConclusionsThe cooccurrence of withdrawal symptoms may result from interactions among symptoms of withdrawal rather than simply reflecting passive indicators of a latent disorder. Findings encourage greater consideration of individual withdrawal symptoms and their potential interactions and may be used to generate hypotheses that may be tested in future intensive longitudinal studies.ImplicationsThis study provides a novel, network perspective on tobacco withdrawal. Drawing on network theories of psychopathology, we suggest that the cooccurrence of withdrawal symptoms may result from interactions among symptoms of withdrawal over time, rather than simply reflecting passive indicators of a latent disorder. Results indicating many associations among individual symptoms of withdrawal are consistent with a network perspective. Other results of interest include minimal changes in the network structure of withdrawal across four measurement occasions prior to and during treatment with nicotine patch and behavioral counseling.

Dataset Information

Helping Hospitalized Smokers: A Factorial RCT of Nicotine Patches and Counseling.

Publications

Helping Hospitalized Smokers: A Factorial RCT of Nicotine Patches and Counseling.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets