Helping Hospitalized Smokers: A Factorial RCT of Nicotine Patches and Counseling.

INTRODUCTION: Most smokers abstain from smoking during hospitalization but relapse upon discharge. This study tests the effectiveness of two proven treatments (i.e., nicotine patches and telephone counseling) in helping these patients stay quit after discharge from the hospital, and assesses a model of hospital-quitline partnership. STUDY DESIGN: This study had a 2×2 factorial design in which participants were stratified by recruitment site and smoking rate and randomly assigned to usual care, nicotine patches only, counseling only, or patches plus counseling. They were evaluated at 2 and 6 months post-randomization. SETTING/PARTICIPANTS: A total of 1,270 hospitalized adult smokers were recruited from August 2011 to November 2013 from five hospitals within three healthcare systems. INTERVENTION: Participants in the patch condition were provided 8 weeks of nicotine patches at discharge (or were mailed them post-discharge). Quitline staff started proactively calling participants in the counseling condition 3 days post-discharge to provide standard quitline counseling. MAIN OUTCOME MEASURES: The primary outcome measure was self-reported 30-day abstinence at 6 months using an intention-to-treat analysis. Data were analyzed from September 2015 to May 2016. RESULTS: The 30-day abstinence rate at 6 months was 22.8% for the nicotine patch condition and 18.3% for the no-patch condition (p=0.051). Nearly all participants (99%) in the patch condition were provided nicotine patches, although 36% were sent post-discharge. The abstinence rates were 20.0% and 21.1% for counseling and no counseling conditions, respectively (p=0.651). Fewer than half of the participants in the counseling condition (47%) received counseling (mean follow-up sessions, 3.6). CONCLUSIONS: Provision of nicotine patches proved feasible, although their effectiveness in helping discharged patients stay quit was not significant. Telephone counseling was not effective, in large part because of low rates of engagement. Future interventions will need to be more immediate to be effective. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.gov NCT01289275.

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

BACKGROUND: Hospitalized 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/DESIGN: This 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. DISCUSSION: If 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 REGISTRATION: Smoking cessation in hospitalized smokers NCT01289275. Date of registration February 1, 2011; date of first patient August 3, 2011.

Forensic aspects in people with intellectual disabilities.

PURPOSE OF REVIEW: The past few years have seen a growth in research of forensic issues relating to people with intellectual disabilities. This review examines a broad spectrum covering 2005 and 2006, for which articles are already available. Given the diversity of publications, reference will also be made to some of the main articles of 2004 to provide a context. RECENT FINDINGS: We are now at the stage where people are questioning the existing forensic psychiatry evidence base for people with intellectual disabilities. This review examines the assessment and treatment of three different groups, that is, fire setters, sexual offenders and those with problems of anger and aggression along with service outcome research, the criminal justice system, and a round up of other related research. SUMMARY: The growth of research in this area has aided the development of assessment and treatment instruments and treatment models for people with intellectual disabilities. This has helped to highlight the specialist and complex nature of this group. The review also looks at services from the point of delivery and the difficulty in research methodology and quantifying outcomes that take into account a changing society and current health inequalities.