A Post-Discharge Smoking-Cessation Intervention for Hospital Patients: Helping Hand 2 Randomized Clinical Trial.

INTRODUCTION: Hospitalization provides an opportunity for smokers to quit, but tobacco-cessation interventions started in hospital must continue after discharge to be effective. This study aimed to improve the scalability of a proven effective post-discharge intervention by incorporating referral to a telephone quitline, a nationally available cessation resource. STUDY DESIGN: A three-site RCT compared Sustained Care, a post-discharge tobacco-cessation intervention, with Standard Care among hospitalized adult smokers who wanted to quit smoking and received in-hospital tobacco-cessation counseling. SETTING/PARTICIPANTS: A total of 1,357 daily smokers admitted to three hospitals were enrolled from December 2012 to July 2014. INTERVENTION: Sustained Care started at discharge and included automated interactive voice response telephone calls and the patient's choice of cessation medication for 3 months. Each automated call advised cessation, supported medication adherence, and triaged smokers seeking additional counseling or medication support directly to a telephone quitline. Standard Care provided only medication and counseling recommendations at discharge. MAIN OUTCOME MEASURES: Biochemically confirmed past 7-day tobacco abstinence 6 months after discharge (primary outcome) and self-reported tobacco abstinence and tobacco-cessation treatment use at 1, 3, and 6 months and overall (0-6 months). Analyses were done in 2015-2016. RESULTS: Smokers offered Sustained Care (n=680), versus those offered Standard Care (n=677), did not have greater biochemically confirmed abstinence at 6 months (17% vs 16%, p=0.58). However, the Sustained Care group reported more tobacco-cessation counseling and medication use at each follow-up and higher rates of self-reported past 7-day tobacco abstinence at 1 month (43% vs 32%, p<0.0001) and 3 months (37% vs 30%, p=0.008). At 6 months, the difference narrowed (31% vs 27%, p=0.09). Overall, the intervention increased self-reported 7-day abstinence over the 6-month follow-up (relative risk, 1.25; 95% CI=1.10, 1.40; p=0.0006). CONCLUSIONS: A 3-month post-discharge smoking-cessation intervention for hospitalized smokers who wanted to quit did not increase confirmed tobacco abstinence at 6 months but did increase self-reported abstinence during the treatment period (3 months). Real-time linkage of interactive voice response calls to a quitline, done in this trial to increase scalability of a previously proven cessation intervention, demonstrated short-term promise but did not sustain long-term intervention effectiveness. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.gov NCT01714323.

Smoking Status Confirmation by Proxy: Validation in a Smoking Cessation Trial.

INTRODUCTION: Biochemical confirmation (BC) of self-report is the gold standard of evidence for abstinence in smoking cessation research, but difficulty in obtaining samples may bias estimates of quit rates. Proxy confirmation (PC) has not been validated in cessation trials. We assessed the feasibility and validity of PC in a cessation trial for hospitalized smokers. METHODS: We enrolled 402 daily cigarette smokers during a hospital admission. At enrollment, participants provided demographics, smoking history, and named proxies to confirm their smoking status at follow-up. Participants provided self-reported (SR) 7-day tobacco abstinence by telephone at 6 months post-discharge. SR quitters were asked to mail a saliva sample for BC. Incentives were offered for survey completion ($20) and returned samples ($50). We called proxies for all those with SR to obtain PC. Quit rates were calculated with missing data indicating smoking. We assessed associations of nonresponse with baseline characteristics using chi-squared tests and logistic regression. We calculated the sensitivity and specificity of PC in detecting smokers as determined by BC. RESULTS: All patients named at least one proxy. Response rates were 82% for SR, 84% for PC, and 69% for BC. Observed participant characteristics were unrelated to provision of sample for BC. Estimated quit rates were 35% for SR, 27% for SR + PC, 21% for SR + BC and 27% for SR + BC or PC. Sensitivity of PC was not higher than SR (73% vs. 77%); specificity was lower (84% vs. 100%). CONCLUSION: PC was feasible but not superior to self-report in a cessation trial.

Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers: study protocol for the Helping HAND 2 randomized controlled trial.

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.

Sustained care intervention and postdischarge smoking cessation among hospitalized adults: a randomized clinical trial.

IMPORTANCE: Health care systems need effective models to manage chronic diseases like tobacco dependence across transitions in care. Hospitalizations provide opportunities for smokers to quit, but research suggests that hospital-delivered interventions are effective only if treatment continues after discharge. OBJECTIVE: To determine whether an intervention to sustain tobacco treatment after hospital discharge increases smoking cessation rates compared with standard care. DESIGN, SETTING, AND PARTICIPANTS: A randomized clinical trial compared sustained care (a postdischarge tobacco cessation intervention) with standard care among 397 hospitalized daily smokers (mean age, 53 years; 48% were males; 81% were non-Hispanic whites) who wanted to quit smoking after discharge and received a tobacco dependence intervention in the hospital; 92% of eligible patients and 44% of screened patients enrolled. The study was conducted from August 2010 through November 2012 at Massachusetts General Hospital. INTERVENTIONS: Sustained care participants received automated interactive voice response telephone calls and their choice of free smoking cessation medication (any type approved by the US Food and Drug Administration) for up to 90 days. The automated telephone calls promoted cessation, provided medication management, and triaged smokers for additional counseling. Standard care participants received recommendations for postdischarge pharmacotherapy and counseling. MAIN OUTCOMES AND MEASURES: The primary outcome was biochemically confirmed past 7-day tobacco abstinence at 6-month follow-up after discharge from the hospital; secondary outcomes included self-reported tobacco abstinence. RESULTS: Smokers randomly assigned to sustained care (n = 198) used more counseling and more pharmacotherapy at each follow-up assessment than those assigned to standard care (n = 199). Biochemically validated 7-day tobacco abstinence at 6 months was higher with sustained care (26%) than with standard care (15%) (relative risk [RR], 1.71 [95% CI, 1.14-2.56], P = .009; number needed to treat, 9.4 [95% CI, 5.4-35.5]). Using multiple imputation for missing outcomes, the RR for 7-day tobacco abstinence was 1.55 (95% CI, 1.03-2.21; P = .04). Sustained care also resulted in higher self-reported continuous abstinence rates for 6 months after discharge (27% vs 16% for standard care; RR, 1.70 [95% CI, 1.15-2.51]; P = .007). CONCLUSIONS AND RELEVANCE: Among hospitalized adult smokers who wanted to quit smoking, a postdischarge intervention providing automated telephone calls and free medication resulted in higher rates of smoking cessation at 6 months compared with a standard recommendation to use counseling and medication after discharge. These findings, if replicated, suggest an approach to help achieve sustained smoking cessation after a hospital stay. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01177176.

An intervention to address secondhand tobacco smoke exposure among nonsmokers hospitalized with coronary heart disease.

Secondhand tobacco smoke (SHS) exposure increases nonsmokers' risk of coronary heart disease and worsens outcomes after hospitalization for acute coronary syndrome, but it is rarely addressed in inpatient cardiac care. We developed and assessed a hospital-based intervention to increase nonsmokers' awareness of SHS as a cardiovascular risk factor. Nonsmokers admitted to 2 cardiac units of a large Boston, Massachusetts, hospital were surveyed before (May 2010 to January 2011) and after (November 2011 to March 2012) a system-level nurse-delivered intervention was implemented in October 2011. It consisted of a revised admission form that prompted nurses to document SHS exposure at admission, provide a pamphlet about SHS risks, and advise nonsmokers to make their home and car smoke free. The primary outcome was patients' short-term recall of advice to keep their home and car smoke free. The secondary outcome was patients' awareness of the cardiovascular risk of SHS exposure. We enrolled 190 nonsmokers before and 142 nonsmokers after implementation. Adjusting for group differences, patients admitted after the system change were more likely to recall being asked if a household member smokes (24% vs 10%, adjusted odds ratio [AOR] 3.6, 95% confidence interval [CI] 1.8 to 7.1, p=0.0002) and being advised to keep their home and car smoke free (28% vs 2%, AOR 27.3, 95% CI 7.8 to 95.7, p<0.0001). After the intervention, more patients believed that SHS exposure increased cardiovascular risk for nonsmokers (42% vs 21%, AOR 2.6, 95% CI 1.6 to 4.4) and for themselves (39% vs 22%, AOR 2.2, 95% CI 1.3 to 3.8). In conclusion, a system-level intervention in cardiac units successfully increased hospitalized nonsmokers' awareness of the cardiovascular risk of SHS exposure.

Prevalence and predictors of smoking by inpatients during a hospital stay.

BACKGROUND: Accredited US hospitals prohibit smoking inside hospital buildings. Patients are expected to abstain from smoking throughout their hospitalization, but how many do so is unclear. Smoking by inpatients may compromise patient safety, clinical outcomes, and hospital efficiency. METHODS: We conducted an observational study of adult cigarette smokers visited by a tobacco counselor while hospitalized and reached for telephone follow-up in the 2 weeks after discharge. We assessed smoking during the hospital stay at the time of counseling for all patients and at follow-up for those reached. We used generalized linear models to estimate adjusted relative risk (ARR) for smoking while hospitalized, adjusted by patient and admission characteristics. RESULTS: From May 1, 2007, through April 31, 2010, counselors visited 5399 smokers, of whom 14.9% had smoked between admission and the visit. Of 3555 eligible smokers who consented to follow-up, 2185 were reached. Smoking at any time during the hospitalization was reported by 18.4%, less often during winter months than the rest of the year (14.4% vs 19.7%, P = .007). Smoking at any time while hospitalized was less common among those 50 years or older (ARR, 0.74; 95% CI, 0.62-0.88), those admitted to a cardiac unit (0.64; 0.51-0.81), and those intending to quit after discharge (0.46; 0.34-0.63) and more common among those with longer stays (1.36; 1.14-1.62) and those experiencing cigarette cravings (moderate: 1.23; 1.14-1.33; severe: 1.25; 1.18-1.34). Nicotine replacement therapy ordered the day of admission was associated with less smoking before the counselor's visit (ARR, 0.83; 95% CI, 0.72-0.96) but not for the entire hospital stay. CONCLUSIONS: Nearly one-fifth of smokers admitted to a smoke-free hospital smoked during their hospital stay. Ordering nicotine replacement therapy routinely at admission and ongoing monitoring of patients' cigarette cravings might reduce smoking among admitted patients.

Comparative effectiveness of post-discharge interventions for hospitalized smokers: study protocol for a randomized controlled trial.

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.

Nicotine replacement therapy use at home after use during a hospitalization.

INTRODUCTION: We assessed whether providing inpatient smokers with nicotine replacement therapy (NRT) to relieve withdrawal symptoms while hospitalized was associated with self-initiated NRT use soon after hospital discharge. METHODS: We conducted an observational study of 1,895 cigarette smokers admitted to a large hospital over 24 months (July 2007 through June 2009) and seen by a tobacco counselor during hospitalization. Participants were surveyed at 2 weeks after discharge to assess postdischarge NRT use. We calculated adjusted rate ratios (ARRs) for the effect of NRT use in the hospital on the rate of NRT use after discharge, adjusting for gender, age, hospital service, intention to quit, baseline smoking level, length of stay, and counseling duration. RESULTS: 62 percent (1,166/1,895) of enrolled participants received NRT during hospitalization. The survey response rate was 72%. 42 percent (544/1,293) of survey respondents reported initiating postdischarge NRT use within 2 weeks of discharge. NRT use after discharge was more likely to be reported by those who used it in hospital whether they had ever used it prior to hospitalization (ARR: 5.64, 95% CI: 3.95-8.05) or had never used it before (ARR: 4.68, 95% CI: 3.25-6.73). CONCLUSIONS: Smokers who received NRT during a hospitalization were more likely to use it after discharge compared with those who did not use NRT in hospital. By encouraging use of this effective cessation aid, supplementing counseling with NRT for hospitalized smokers may promote smoking cessation efforts after discharge.

An interactive voice response system to continue a hospital-based smoking cessation intervention after discharge.

INTRODUCTION: Hospitalized smokers benefit from tobacco counseling received in hospital only if it continues after discharge. Interactive voice response (IVR) technology may be useful in delivering this care. METHODS: We conducted a randomized controlled trial testing two intensities of follow-up contact using an IVR system; 738 cigarette smokers who received inpatient counseling at an academic medical center were enrolled. Participants were randomized to receive four IVR calls during the first month postdischarge that included the offer of a call back (CB) from a smoking counselor (IVR + CB, N = 368) or 1 IVR call at 2 weeks postdischarge that assessed smoking outcomes without offering any counseling support (IVR, N = 370). All were assessed by human telephone call at 12 weeks. Postdischarge counseling and medication utilization rates and self-reported smoking cessation were assessed at 2 and 12 weeks postdischarge. RESULTS: Of those randomized to IVR + CB, 59% received a CB offer and 34% of those receiving offers accepted. Cessation rates did not differ between IVR + CB and IVR at 2 weeks (39% vs. 39%, rate ratio: 1.02, 95% CI: 0.85-1.22) or 12 weeks (29% vs. 26%, rate ratio: 1.11, 95% CI: 0.90-1.41). Medication use did not differ by group but was higher among those accepting versus declining CB offers (69% vs. 52%, p < .05). CONCLUSIONS: An IVR system is feasible for postdischarge follow-up and support for hospitalized smokers. Participants, especially pharmacotherapy users, took advantage of postdischarge counseling offers, although offers were not associated with increased smoking cessation.

An international survey of training programs for treating tobacco dependence.

AIMS: The World Health Organization (WHO) Framework Convention on Tobacco Control (FCTC) requires countries to implement tobacco dependence treatment programs. To provide treatment effectively, a country needs trained individuals to deliver these services. We report on the global status of programs that train individuals to provide tobacco dependence treatment. DESIGN: Cross-sectional web-based survey of tobacco treatment training programs in a stratified convenience sample of countries chosen to vary by WHO geographic region and World Bank income level. PARTICIPANTS: Key informants in 48 countries; 70% of 69 countries who were sent surveys responded. MEASUREMENTS: Program prevalence, frequency, duration and size; background of trainees; content (adherence to pre-defined core competencies); funding sources; challenges. FINDINGS: We identified 61 current tobacco treatment training programs in 37 (77%) of 48 countries responding to the survey. Three-quarters of them began in 2000 or later, and 40% began after 2003, when the FCTC was adopted. Programs estimated training 14,194 individuals in 2007. Training was offered to a variety of professionals and paraprofessionals, but most often to physicians and nurses. Median program duration was 16 hours, but programs' duration, intensity and size varied widely. Most programs used evidence-based guidelines and reported adherence to core tobacco treatment competencies. Training programs were less frequent in low-income countries and in Africa. Securing funding was the major challenge for most programs; current funding sources were government (58%), non-government organizations (23%), pharmaceutical companies (17%) and, in one case, the tobacco industry. CONCLUSION: Training programs for tobacco treatment providers are diverse and growing. Most upper- and middle-income countries have programs, and most programs appear to be evidence-based. However, funding is a major challenge. In particular, more programs are needed for non-physicians and for low-income countries.