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); 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. Clinical trial registration NCT01714323

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.