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BackgroundSmoking rates among people living with behavioral health conditions (BHC) range from 30 to 65% and are 2-4 times higher than rates found in the general population. Starting tobacco treatment during a hospital stay is effective for smoking cessation, but little is known regarding treatment response among inpatients with BHC.ObjectiveThis study pooled data across multiple clinical trials to determine the relative success in quitting among participants with BHC compared to other study participants.ParticipantsAdults who smoke (≥ 18 years old) from five hospital-based smoking cessation randomized clinical trials.DesignA retrospective analysis using data from the electronic health record to identify participants with primary diagnoses related to BHC. Recruitment and data analysis were conducted from 2011 to 2016. We used propensity score matching to pair patients with BHC to those with similar characteristics and logistic regression to determine differences between groups.MeasuresThe main outcome was self-reported 30-day abstinence 6 months post-discharge.ResultsOf 6612 participants, 798 patients had a BHC-related primary diagnosis. The matched sample included 642 pairs. Nearly 1 in 3 reported using tobacco medications after hospitalization, with no significant difference between patients with and without BHC (29.3% vs. 31.5%; OR (95% CI) = 0.90 (0.71, 1.14), p = 0.40). Nearly 1 in 5 patients with BHC reported abstinence at 6 months; however, their odds of abstinence were 30% lower than among people without BHC (OR (95% CI) = 0.70 (0.53,0.92), p = 0.01).ConclusionWhen offered tobacco treatment, hospitalized patients with BHC were as likely as people without BHC to accept and engage in treatment. However, patients with BHC were less likely to report abstinence compared to those without BHC. Hospitals are a feasible and promising venue for tobacco treatment among inpatients with BHC. More studies are needed to identify treatment approaches that help people with BHC achieve long-term abstinence.

Abstract Introduction As access to effective antiretroviral therapy (ART) has improved globally, tobacco‐related illnesses, including cardiovascular disease, cancer and chronic respiratory conditions, account for a growing proportion of deaths among people with HIV (PWH). We estimated the impact of tobacco smoking and smoking cessation on life expectancy among PWH in South Africa. Methods In a microsimulation model, we simulated 18 cohorts of PWH with virologic suppression, each homogenous by sex, initial age (35y/45y/55y) and smoking status (current/former/never). Input parameters were from data sources published between 2008 and 2022. We used South African data to estimate age‐stratified mortality hazard ratios: 1.2−2.3 (females)/1.1−1.9 (males) for people with current versus never smoking status; and 1.0−1.3 (females)/1.0−1.5 (males) for people with former versus never smoking status, depending on age at cessation. We assumed smoking status remains unchanged during the simulation; people who formerly smoked quit at model start. Simulated PWH face a monthly probability of disengagement from care and virologic non‐suppression. In sensitivity analysis, we varied smoking‐associated and HIV‐associated mortality risks. Additionally, we estimated the total life‐years gained if a proportion of all virologically suppressed PWH stopped smoking. Results Forty‐five‐year‐old females/males with HIV with virologic suppression who smoke lose 5.3/3.7 life‐years compared to PWH who never smoke. Smoking cessation at age 45y adds 3.4/2.4 life‐years. Simulated PWH who continue smoking lose more life‐years from smoking than from HIV (females, 5.3 vs. 3.0 life‐years; males, 3.7 vs. 2.6 life‐years). The impact of smoking and smoking cessation increase as smoking‐associated mortality risks increase and HIV‐associated mortality risks, including disengagement from care, decrease. Model results are most sensitive to the smoking‐associated mortality hazard ratio; varying this parameter results in 1.0−5.1 life‐years gained from cessation at age 45y. If 10−25% of virologically suppressed PWH aged 30−59y in South Africa stopped smoking now, 190,000−460,000 life‐years would be gained. Conclusions Among virologically suppressed PWH in South Africa, tobacco smoking decreases life expectancy more than HIV. Integrating tobacco cessation interventions into HIV care, as endorsed by the World Health Organization, could substantially improve life expectancy.

Tobacco use is the leading preventable cause of death worldwide and is a major risk factor for cardiovascular disease (CVD). Both prevention of smoking initiation among youth and smoking cessation among established smokers are key for reducing smoking prevalence and the associated negative health consequences. Proven tobacco cessation treatment includes pharmacotherapy and behavioral support, which are most effective when provided together. First-line medications (varenicline, bupropion, and nicotine replacement) are effective and safe for patients with CVD. Clinicians who care for patients with CVD should give as high a priority to treating tobacco use as to managing other CVD risk factors. Broader tobacco control efforts to raise tobacco taxes, adopt smoke-free laws, conduct mass media campaigns, and restrict tobacco marketing enhance clinicians' actions working with individual smokers.

Tobacco use is the leading preventable cause of death worldwide and is a major risk factor for cardiovascular disease (CVD). Both prevention of smoking initiation among youth and smoking cessation among established smokers are key for reducing smoking prevalence and the associated negative health consequences. Proven tobacco cessation treatment includes pharmacotherapy and behavioral support, which are most effective when provided together. First-line medications (varenicline, bupropion, and nicotine replacement) are effective and safe for patients with CVD. Clinicians who care for patients with CVD should give as high a priority to treating tobacco use as to managing other CVD risk factors. Broader tobacco control efforts to raise tobacco taxes, adopt smoke-free laws, conduct mass media campaigns, and restrict tobacco marketing enhance clinicians' actions working with individual smokers.

AimsTo estimate the prevalence and predictors of failed biochemical verification of self-reported abstinence among participants enrolled in trials of hospital-initiated smoking cessation interventions.DesignComparison of characteristics between participants who verified and those who failed to verify self-reported abstinence.SettingsMulti-site randomized clinical trials conducted between 2010 and 2014 in hospitals throughout the United States.ParticipantsRecently hospitalized smokers who reported tobacco abstinence 6 months post-randomization and provided a saliva sample for verification purposes (n = 822).MeasurementsOutcomes were salivary cotinine-verified smoking abstinence at 10 and 15 ng/ml cut-points. Predictors and correlates included participant demographics and tobacco use; hospital diagnoses and treatment; and study characteristics collected via surveys and electronic medical records.FindingsUsable samples were returned by 69.8% of the 1178 eligible trial participants who reported 7-day point prevalence abstinence. The proportion of participants verified as quit was 57.8% [95% confidence interval (CI) = 54.4, 61.2; 10 ng/ml cut-off] or 60.6% (95% CI = 57.2, 63.9; 15 ng/ml). Factors associated independently with verification at 10 ng/ml were education beyond high school education [odds ratio (OR) = 1.51; 95% CI = 1.07, 2.11], continuous abstinence since hospitalization (OR = 2.82; 95% CI = 2.02, 3.94), mailed versus in-person sample (OR = 3.20; 95% CI = 1.96, 5.21) and race. African American participants were less likely to verify abstinence than white participants (OR = 0.64; 95% CI = 0.44, 0.93). Findings were similar for verification at 15 ng/ml. Verification rates did not differ by treatment group.ConclusionsIn the United States, high rates (40%) of recently hospitalized smokers enrolled in smoking cessation trials fail biochemical verification of their self-reported abstinence.

Introduction: The National Cancer Institute Smoking Cessation at Lung Examination (SCALE) Collaboration includes eight clinical trials testing smoking cessation interventions delivered with lung cancer screening (LCS). This investigation compared pooled participant baseline demographic and smoking characteristics of seven SCALE trials to LCS-eligible smokers in three U.S. nationally representative surveys. Methods: Baseline variables (age, sex, race, ethnicity, education, income, cigarettes per day, and time to the first cigarette) from 3614 smokers enrolled in SCALE trials as of September 2020 were compared with pooled data from the Tobacco Use Supplement–Current Population Survey (2018–2019), National Health Interview Survey (2017–2018), and Population Assessment of Tobacco and Health (wave 4, 2016–2017) using the U.S. Preventive Services Task Force 2013 (N = 4803) and 2021 (N = 8604) LCS eligibility criteria. Results: SCALE participants have similar average age as the U.S. LCS–eligible smokers using the 2013 criteria but are 2.8 years older using the 2021 criteria (p < 0.001). SCALE has a lower proportion of men, a higher proportion of Blacks, and slightly higher education and income levels than national surveys (p < 0.001). SCALE participants smoke an average of 17.9 cigarettes per day (SD 9.2) compared with 22.4 (SD 9.3) using the 2013 criteria and 19.6 (SD 9.7) using the 2021 criteria (p < 0.001). The distribution of time to the first cigarette differs between SCALE and the national surveys (p < 0.001), but both indicate high levels of nicotine dependence. Conclusions: SCALE participants smoke slightly less than the LCS-eligible smokers in the general population, perhaps related to socioeconomic status or race. Other demographic variables reveal small but statistically significant differences, likely of limited clinical relevance with respect to tobacco treatment outcomes. SCALE trial results should be applicable to LCS-eligible smokers from the U.S. population.

Abstract Background Tobacco 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/design Helping 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. Discussion Helping 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 registration Prospectively 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

Introduction: Cancer patients who smoke report more stress and psychological distress than patients who do not smoke. It is unclear how these emotional symptoms may modify smoking behavior in cancer patients. We examined the influence of a smoking cessation intervention for cancer patients on stress and distress, and the effects of these symptoms on smoking abstinence. Methods: Mixed-methods secondary analysis of data from the Smokefree Support Study, a two-site randomized controlled trial examining the efficacy of Intensive (IT; n = 153) vs. Standard Treatment (ST; n = 150) for smoking cessation in newly diagnosed cancer patients. Stress coping, perceived stress, distress, and anxiety were self-reported at baseline, 3, and 6 months. Abstinence was biochemically-confirmed at 6 months. A subset of patients (n = 72) completed qualitative exit-interviews. Results: Patients were on average, 58 years old, 56% female, and smoked a median of 10 cigarettes/day. There were no significant treatment group × time interactions or main effects of treatment group on stress or distress measures (p’s > 0.05), however there were significant main effects of time suggesting symptom improvements on each measure in both study groups (p’s

We conducted a longitudinal study of tobacco use among adults initiating antiretroviral therapy (ART) in Mbarara, Uganda where 11 % of men and 3 % of women use tobacco according to the 2011 Demographic and Health Survey. In a prospective cohort, self-reported tobacco use was assessed before starting ART and reassessed every 3-4 months. Plasma cotinine, a nicotine metabolite, was measured in a subset of adults pre-ART to verify self-report. Among 496 subjects, 50 (10 %) reported current tobacco use (20 % of men, 6 % of women). Most (53 %) adults with elevated cotinine levels (>15 ng/mL) reported no tobacco use. By 6 months after ART initiation, 33 % of tobacco users had quit (95 % CI 20-46 %). By 5 years, 64 % quit (95 % CI 47-77 %). Self-reported tobacco use among rural Ugandans starting ART was twice as common as among the local background population and use may be underreported. ART initiation could be an opportunity for tobacco cessation interventions.

NicVAX, a nicotine vaccine (3'AmNic-rEPA), has been clinically evaluated to determine whether higher antibody (Ab) concentrations are associated with higher smoking abstinence rates and whether dosages and frequency of administration are associated with increased Ab response. This randomized, double-blinded, placebo-controlled multicenter clinical trial (N = 301 smokers) tested the results of 200- and 400-µg doses administered four or five times over a period of 6 months, as compared with placebo. 3'AmNic-rEPA recipients with the highest serum antinicotine Ab response (top 30% by area under the curve (AUC)) were significantly more likely than the placebo recipients (24.6% vs. 12.0%, P = 0.024, odds ratio (OR) = 2.69, 95% confidence interval (CI), 1.14-6.37) to attain 8 weeks of continuous abstinence from weeks 19 through 26. The five-injection, 400-µg dose regimen elicited the greatest Ab response and resulted in significantly higher abstinence rates than placebo. This study demonstrates, as proof of concept, that 3'AmNic-rEPA elicits Abs to nicotine and is associated with higher continuous abstinence rates (CAR). Its further development as a treatment for nicotine dependence is therefore justified.

Abstract Background Three-quarters of homeless people smoke cigarettes. Competing priorities for shelter, food, and other subsistence needs may be one explanation for low smoking cessation rates in this population. We analyzed data from two samples of homeless smokers to examine the associations between subsistence difficulties and 1) smoking cessation readiness, confidence, and barriers in a cross-sectional study, and 2) smoking abstinence during follow-up in a longitudinal study. Methods We conducted a survey of homeless smokers (N = 306) in 4/2014–7/2014 and a pilot randomized controlled trial (RCT) for homeless smokers (N = 75) in 10/2015–6/2016 at Boston Health Care for the Homeless Program. In both studies, subsistence difficulties were characterized as none, low, or high based on responses to a 5-item scale assessing the frequency of past-month difficulty finding shelter, food, clothing, a place to wash, and a place to go to the bathroom. Among survey participants, we used linear regression to assess the associations between subsistence difficulty level and readiness to quit, confidence to quit, and a composite measure of perceived barriers to quitting. Among RCT participants, we used repeated-measures logistic regression to examine the association between baseline subsistence difficulty level and carbon monoxide-defined brief smoking abstinence assessed 14 times over 8 weeks of follow-up. Analyses adjusted for demographic characteristics, substance use, mental illness, and nicotine dependence. Results Subsistence difficulties were common in both study samples. Among survey participants, greater subsistence difficulties were associated with more perceived barriers to quitting (p

Abstract Background Every U.S. state has a free telephone quitline that tobacco users can access to receive cessation assistance, yet referral rates for parents in the pediatric setting remain low. This study evaluates, within pediatric offices, the impact of proactive enrollment of parents to quitlines compared to provider suggestion to use the quitline and identifies other factors associated with parental quitline use. Methods As part of a cluster randomized controlled trial (Clinical Effort Against Secondhand Smoke Exposure), research assistants completed post-visit exit interviews with parents in 20 practices in 16 states. Parents’ quitline use was assessed at a 12-month follow-up interview. A multivariable analysis was conducted for quitline use at 12 months using a logistic regression model with generalized estimating equations to account for provider clustering. Self-reported cessation rates were also compared among quitline users based on the type of referral they received at their child’s doctor’s office. Results Of the 1980 parents enrolled in the study, 1355 (68 %) completed a 12-month telephone interview and of those 139 (10 %) reported talking with a quitline (15 % intervention versus 6 % control; p

Importance: Smoking among individuals with serious mental illness (SMI) represents a major public health problem. Intervening during a psychiatric hospital stay may provide an opportunity to aid engagement in smoking cessation treatment and facilitate success in quitting.Objective: To examine the effectiveness of a multicomponent, sustained care (SusC) smoking cessation intervention in adults with SMI receiving inpatient psychiatric care.Design, Setting, and Participants: The Helping HAND 3 randomized clinical trial compared SusC with usual care (UC) among individuals with SMI who smoked daily and were receiving inpatient psychiatric care in Austin, Texas, in a single hospital. The study was conducted from July 2015 through August 2019.Interventions: The UC intervention involved brief smoking cessation information, self-help materials and advice from the admitting nurse, and an offer to provide nicotine replacement therapy during hospitalization. The SusC intervention included 4 main components designed to facilitate patient engagement with postdischarge smoking cessation resources: (1) inpatient motivational counseling; (2) free transdermal nicotine patches on discharge; (3) an offer of free postdischarge telephone quitline, text-based, and/or web-based smoking cessation counseling, and (4) postdischarge automated interactive voice response calls or text messages.Main Outcomes and Measures: The primary outcome was biochemically verified 7-day point-prevalence abstinence at 6-month follow-up. A secondary outcome was self-reported smoking cessation treatment use at 1, 3, and 6 months after discharge.Results: A total of 353 participants were randomized, of whom 342 were included in analyses (mean [SD] age, 35.8 [12.3] years; 268 White individuals [78.4%]; 280 non-Hispanic individuals [81.9%]; 169 women [49.4%]). They reported smoking a mean (SD) of 16.9 (10.4) cigarettes per day. Participants in the SusC group evidenced significantly higher 6-month follow-up point-prevalence abstinence rates than those in the UC group (8.9% vs 3.5%; adjusted odds ratio, 2.95 [95% CI, 1.24-6.99]; P = .01). The number needed to treat was 18.5 (95% CI, 9.6-306.4). A series of sensitivity analyses confirmed effectiveness. Finally, participants in the SusC group were significantly more likely to report using smoking cessation treatment over the 6 months postdischarge compared with participants in the UC group (74.6% vs 40.5%; relative risk, 1.8 [95% CI, 1.51-2.25]; P < .001).Conclusions and Relevance: The findings of this randomized clinical trial provide evidence for the effectiveness of a scalable, multicomponent intervention in promoting smoking cessation treatment use and smoking abstinence in individuals with SMI following hospital discharge.Trial Registration: ClinicalTrials.gov Identifier: NCT02204956. [ABSTRACT FROM AUTHOR]

Abstract Background A hospital admission offers smokers an opportunity to quit. Smoking cessation counseling provided in the hospital is effective, but only if it continues for more than one month after discharge. Providing smoking cessation medication at discharge may add benefit to counseling. A major barrier to translating this research into clinical practice is sustaining treatment during the transition to outpatient care. An evidence-based, practical, cost-effective model that facilitates the continuation of tobacco treatment after discharge is needed. This paper describes the design of a comparative effectiveness trial testing a hospital-initiated intervention against standard care. Methods/design A two-arm randomized controlled trial compares the effectiveness of standard post-discharge care with a multi-component smoking cessation intervention provided for three months after discharge. Current smokers admitted to Massachusetts General Hospital who receive bedside smoking cessation counseling, intend to quit after discharge and are willing to consider smoking cessation medication are eligible. Study participants are recruited following the hospital counseling visit and randomly assigned to receive Standard Care or Extended Care after hospital discharge. Standard Care includes a recommendation for a smoking cessation medication and information about community resources. Extended Care includes up to three months of free FDA-approved smoking cessation medication and five proactive computerized telephone calls that use interactive voice response technology to provide tailored motivational messages, offer additional live telephone counseling calls from a smoking cessation counselor, and facilitate medication refills. Outcomes are assessed at one, three, and six months after hospital discharge. The primary outcomes are self-reported and validated seven-day point prevalence tobacco abstinence at six months. Other outcomes include short-term and sustained smoking cessation, post-discharge utilization of smoking cessation treatment, hospital readmissions and emergency room visits, and program cost per quit. Discussion This study tests a disseminable smoking intervention model for hospitalized smokers. If effective and widely adopted, it could help to reduce population smoking rates and thereby reduce tobacco-related mortality, morbidity, and health care costs. Trial registration United States Clinical Trials Registry NCT01177176.

E-cigarettes are growing in popularity. Dual use of e-cigarettes and cigarettes is an increasingly common practice, but little is known about patterns of dual use in parents. We sought to describe smoking-related behaviors among dual-users. Parent exit surveys were conducted following their child's visit in 5 control pediatric practices in 5 states participating in the Clinical Effort Against Secondhand Smoke Exposure trial. We examined factors associated with dual use of e-cigarettes and cigarettes versus cigarette-only smokers, assessed by self-report. Of 1382 smokers or recent quitters screened after their child's visit between April and October 2017, 943 (68%) completed the survey. Of these, 727 parents reported current use of cigarettes; of those, 81 (11.1%) also reported e-cigarette use, meeting the definition of dual use. Compared with cigarette-only smokers, dual users were more likely to have a child younger than 1 year old, planned to quit in the next 6 months, and had tried to quit in the past (had a quit attempt in the past 3 months, called the quitline, or used medicine to quit in the past 2 years; P <.05 for each). Parents who use both e-cigarettes and cigarettes may have greater rates of contemplating smoking cessation than parents who only smoke cigarettes. These parents may be using e-cigarettes for harm reduction or as a step toward cessation. Identification of these parents may provide an opportunity to deliver effective treatment, including nicotine-replacement therapies that do not expose infants and children to e-cigarette aerosol. [ABSTRACT FROM AUTHOR]

Background: Every U.S. state has a free telephone quitline that tobacco users can access to receive cessation assistance, yet referral rates for parents in the pediatric setting remain low. This study evaluates, within pediatric offices, the impact of proactive enrollment of parents to quitlines compared to provider suggestion to use the quitline and identifies other factors associated with parental quitline use. Methods: As part of a cluster randomized controlled trial (Clinical Effort Against Secondhand Smoke Exposure), research assistants completed post-visit exit interviews with parents in 20 practices in 16 states. Parents’ quitline use was assessed at a 12-month follow-up interview. A multivariable analysis was conducted for quitline use at 12 months using a logistic regression model with generalized estimating equations to account for provider clustering. Self-reported cessation rates were also compared among quitline users based on the type of referral they received at their child’s doctor’s office. Results: Of the 1980 parents enrolled in the study, 1355 (68 %) completed a 12-month telephone interview and of those 139 (10 %) reported talking with a quitline (15 % intervention versus 6 % control; p < .0001). Parents who were Hispanic (aOR 2.12 (1.22, 3.70)), black (aOR 1.57 (1.14, 2.16)), planned to quit smoking in the next 30 days (aOR 2.32 (1.47, 3.64)), and had attended an intervention practice (aOR 2.37 (1.31, 4.29)) were more likely to have talked with a quitline. Parents who only received a suggestion from a healthcare provider to use the quitline (aOR 0.45 (0.23, 0.90)) and those who were not enrolled and did not receive a suggestion (aOR 0.33 (0.17, 0.64)) were less likely to talk with a quitline than those who were enrolled in the quitline during the baseline visit. Self-reported cessation rates among quitline users were similar regardless of being proactively enrolled (19 %), receiving only a suggestion (25 %), or receiving neither a suggestion nor an enrollment (17 %) during a visit (p = 0.47). Conclusions: These results highlight the enhanced clinical effectiveness of not just recommending the quitline to parents but also offering them enrollment in the quitline at the time of their child's visit to the pediatric office. Trial registration ClinicalTrials.gov, Identifier: NCT00664261

Summary: Tobacco use is a leading cause of preventable death worldwide. Respiratory diseases, including chronic obstructive pulmonary disease (COPD) and lung cancer, account for a large proportion of tobacco-related deaths. Smoking cessation benefits almost all smokers, irrespective of the age at which they quit, making smoking cessation a core component of prevention and treatment of respiratory diseases. Evidence shows that psychosocial counselling and pharmacotherapy are effective smoking cessation methods and are most effective when used together. The first-line drugs licensed to aid smoking cessation (nicotine replacement therapy, bupropion, and varenicline) are effective in patients with COPD. Efforts are underway to improve the efficacy of existing treatments and increase the proportion of smokers who try to quit, and who use treatment when doing so. However, existing smoking cessation counselling and drugs are among the most cost-effective clinical preventive services available. Incorporation of such treatment into routine clinical practice is essential for provision of high-quality care to all patients, especially those with respiratory disease. [ABSTRACT FROM AUTHOR]

Background: Smoking 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/Design A 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. Discussion We 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 registration Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers (Helping HAND2) NCT01714323. Registered October 22, 2012.