Abstract
BackgroundA 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/designA 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.DiscussionThis 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 registrationUnited States Clinical Trials Registry NCT01177176.
Highlights
A hospital admission offers smokers an opportunity to quit
Translation of this research into clinical practice was facilitated in 2004 when tobacco items were included in National Hospital Quality Measures (NHQM) adopted by the Joint Commission (JC) and the US federal government’s Centers for Medicare and Medicaid Services
Outcome assessment Participants are contacted by study staff via telephone at one, three and six months after discharge to collect outcome measures, including: smoking status, use of smoking cessation medication and counseling, hospital readmissions, emergency room visits and, in the intervention group, satisfaction with the interactive voice response (IVR) system
Summary
We considered whether to target all hospitalized smokers or only those who state an intention to quit smoking after discharge We chose the latter approach, reasoning that less motivated smokers were unlikely to use the interventions, that the intervention would be most cost-effective for those intending to quit, and a more targeted intervention would have the best chance of being adopted into clinical practice. Our study design assesses the combined effect of an intervention package consisting of two components (IVR + medication provision) compared to standard care (counseling information and medication recommendation). An evidence-based, cost-effective intervention model that is readily adoptable by US hospitals is needed in order to realize the potential impact of hospital-initiated smoking interventions and to meet new hospital quality measures under review This trial is testing an intervention designed to meet this need.
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