Nicotine patches and quitline counseling to help hospitalized smokers stay quit: study protocol for a randomized controlled trial

Abstract

BackgroundHospitalized smokers often quit smoking, voluntarily or involuntarily; most relapse soon after discharge. Extended follow-up counseling can help prevent relapse. However, it is difficult for hospitals to provide follow-up and smokers rarely leave the hospital with quitting aids (for example, nicotine patches). This study aims to test a practical model in which hospitals work with a state cessation quitline. Hospital staff briefly intervene with smokers at bedside and refer them to the quitline. Depending on assigned condition, smokers may receive nicotine patches at discharge or extended quitline telephone counseling post-discharge. This project establishes a practical model that lends itself to broader dissemination, while testing the effectiveness of the interventions in a rigorous randomized trial.Methods/designThis randomized clinical trial (N = 1,640) tests the effect of two interventions on long-term quit rates of hospitalized smokers in a 2 x 2 factorial design. The interventions are (1) nicotine patches (eight-week, step down program) dispensed at discharge and (2) proactive telephone counseling provided by the state quitline after discharge. Subjects are randomly assigned into: usual care, nicotine patches, telephone counseling, or both patches and counseling. It is hypothesized that patches and counseling have independent effects and their combined effect is greater than either alone. The primary outcome measure is thirty-day abstinence at six months; a secondary outcome is biochemically validated smoking status. Cost-effectiveness analysis is conducted to compare each intervention condition (patch alone, counseling alone, and combined interventions) against the usual care condition. Further, this study examines whether smokers’ medical diagnosis is a moderator of treatment effect. Generalized linear (binomial) mixed models will be used to study the effect of treatment on abstinence rates. Clustering is accounted for with hospital-specific random effects.DiscussionIf this model is effective, quitlines across the U.S. could work with interested hospitals to set up similar systems. Hospital accreditation standards related to tobacco cessation performance measures require follow-up after discharge and provide additional incentive for hospitals to work with quitlines. The ubiquity of quitlines, combined with the consistency of quitline counseling delivery as centralized state operations, make this partnership attractive.Trial registrationSmoking cessation in hospitalized smokers NCT01289275. Date of registration February 1, 2011; date of first patient August 3, 2011.

Helping Hospitalized Smokers

“…The study protocol was previously reported 25 but a brief overview is provided here. Subjects who provided consent were stratified by recruitment site and cigarettes per day (CPD; six to ten or ≥11) and randomly assigned by computer to one of four groups: usual care, nicotine patches at discharge, proactive quitline counseling, or both.…”

“…23,25 Randomization into the nicotine patch condition triggered a flag in the EMR indicating that the patient was to be given a package at discharge that included 8 weeks of patches, with dosing that varied by the number of cigarettes smoked prior to hospitalization. Those who smoked six to ten CPD were provided 6 weeks of 14-mg patches and 2 weeks of 7-mg patches.…”

Preventing Postpartum Smoking Relapse

“…Women also received written information at each session. Cognitive behavioral strategies, including preparation for high-risk periods, management of slips, and creation of a relapse plan, successfully have decreased smoking relapse risk in general [41][42][43] and during the postpartum period. 17,20 Therefore, in both interventions women were asked to monitor urges to smoke and discussed strategies to address cravings and high-risk situations.…”

CHARTing a Path to Pragmatic Tobacco Treatment Research

“…Five of the projects were two-arm RCTs comparing active interventions to usual care 6-10 ; one used a factorial design to test the effects of two different interventions alone and in combination 11 ; and the last used group randomization procedures to assign hospitals to intervention and control conditions. 12 Some interventions were initiated during hospitalization, 6,12 but most were delivered post-discharge.…”

“…12 Some interventions were initiated during hospitalization, 6,12 but most were delivered post-discharge. 10,11 Table 1 provides study details. 12 …”