Abstract
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.
Highlights
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
Study design Helping HAND 2 (HH2) is a multi-center randomized controlled trial testing the hypothesis that the Sustained Care intervention is more effective than Standard Care in helping hospitalized cigarette smokers quit smoking long-term
The Helping Helping Hospital-initiated Assistance for Nicotine Dependence study (HAND) 2 trial tests whether a coordinated system to sustain smoking cessation treatment initiated during a hospitalization increases the proportion of hospitalized smokers who are tobacco abstinent 6 months after discharge
Summary
The Helping HAND 2 trial tests whether a coordinated system to sustain smoking cessation treatment initiated during a hospitalization increases the proportion of hospitalized smokers who are tobacco abstinent 6 months after discharge. It resembles the intervention that was effective in the single-site HH1 trial [12] but extends this earlier work It tests the intervention’s effectiveness in three hospitals in two states, and the intervention provides a new real-time direct transfer from the automated call to a live smoking cessation counselor when smokers request additional assistance. Analysis of outcome data, which is still being collected, will determine whether the intervention will retain its effectiveness If effective, this model could be adopted by U.S hospitals to help reduce population smoking rates, thereby decreasing tobacco-related mortality, morbidity, and health care costs. Authors’ information During the first 2.5 years of this study, HAT was on faculty at the University of Pittsburgh and founded and directed the inpatient Tobacco Treatment Services that served as standard care in this trial
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