Effectiveness of intensive practice nurse counselling versus brief general practitioner advice, both combined with varenicline, for smoking cessation: a randomized pragmatic trial in primary care

Aims To study the effectiveness of intensive counselling by a practice nurse (PN) versus brief advice by a general practitioner (GP), each combined with pharmacotherapy, for 6 months' tobacco abstinence (primary outcome). Secondary outcomes included 12-month abstinence, medication adherence and incremental costs per life-year gained. Design A multi-site (n=10), two-group, parallel, pragmatic randomized controlled trial. Setting A network of primary health-care centres in the Netherlands. Participants A total of 295 adult daily smokers (mean age=48 years; mean cigarettes/day=19). Intervention and comparator Patients were randomized to receive individual counselling by a practice nurse (PN) (n=149) or brief advice by a general practitioner (GP) (146). All patients received 12 weeks of open-label varenicline. Measurements The primary outcome was prolonged biochemically validated abstinence from weeks 9 to 26 after treatment initiation. Secondary outcomes included abstinence from weeks 9 to 52, good dosing adherence (&gt;80%days taken) and incremental costs per life-year gained. Findings Abstinence rates in the PN versus GP groups were 32.2% (n=48) versus 39.0% [n=57; odds ratio (OR)=0.71; 95% confidence interval (CI)=0.44-1.16] from weeks 9 to 26 and 25.5% (n=38) versus 28.8% (n=42; OR=0.84, 95% CI=0.50-1.43) from weeks 9 to 52, respectively. Values of the Bayes factor indicated that the PN and GP were equally effective. Good dosing adherence was significantly lower in the PN (45.5%, n=56/123) than in the GP group (62.0%, n=75/121; OR=0.45, 95% CI=0.26-0.77), and the incremental costs per life-year gained were -(sic) 416.10. Conclusions Among people seeking help to stop smoking from their general practice, one-off brief advice from a general practitioner appears to be as effective as several sessions of behavioural support from a practice nurse when smoking cessation medication is provided.</p

A randomized controlled trial of a smoking cessation intervention conducted among prisoners

Aim: To evaluate the efficacy of nortriptyline (NOR) added to a multi-component smoking cessation intervention, which included cognitive-behavioural therapy (CBT) and provision of nicotine replacement therapy (NRT). Design: Randomized controlled trial (RCT) comparing two study groups with blinded follow-up at 3, 6 and 12 months. Both groups received a multi-component smoking cessation intervention comprising two half-hour individual sessions of CBT and NRT with either active NOR or placebo. Setting: Prisons in New South Wales (17) and Queensland (one), Australia. Participants: A total of 425 male prisoners met inclusion criteria and were allocated to either treatment (n=206) or control group (n=219). Measurements: Primary end-points at 3, 6 and 12 months were continuous abstinence, point prevalence abstinence and reporting a 50% reduction in smoking. Smoking status was confirmed by expired carbon monoxide, using a cut-point of =10 parts per million. Findings: Participants' demographics and baseline tobacco use were similar in treatment and control groups. Based on an intention-to-treat analysis, continuous abstinence between the treatment and control groups was not significantly different at 3 months (23.8 versus 16.4%), 6 months (17.5 versus 12.3%) and 12 months (11.7 versus 11.9%). Conclusion: Adding nortriptyline to a smoking cessation treatment package consisting of behavioural support and nicotine replacement therapy does not appear to improve long-term abstinence rates in male prisoners. © 2012 The Authors, Addiction © 2012 Society for the Study of Addiction

Web-based smoking cessation intervention that transitions from inpatient to outpatient: study protocol for a randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>E-health tools are a new mechanism to expand patient care, allowing supplemental resources to usual care, including enhanced patient-provider communication. These applications to smoking cessation have yet to be tested in a hospitalized patient sample. This project aims to evaluate the effectiveness and cost-effectiveness of a tailored web-based and e-message smoking cessation program for current smokers that, upon hospital discharge, transitions the patient to continue a quit attempt when home (Decide2Quit).</p> <p>Design</p> <p>A randomized two-arm follow-up design will test the effectiveness of an evidence- and theoretically-based smoking cessation program designed for post-hospitalization.</p> <p>Methods</p> <p>A total of 1,488 patients aged 19 or older, who smoked cigarettes in the previous 30 days, are being recruited from 27 patient care areas of a large urban university hospital. Study-eligible hospitalized patients receiving usual tobacco cessation usual care are offered study referral. Trained hospital staff assist the 744 patients who are being randomized to the intervention arm with registration and orientation to the intervention website. This e-mail and web-based program offers tailored messages as well as education, self-assessment and planning aids, and social support to promote tobacco use cessation. Condition-blind study staff assess participants for tobacco use history and behaviors, tobacco use cost-related information, co-morbidities and psychosocial factors at 0, 3, 6, and 12 months. The primary outcome is self-reported 30-day tobacco abstinence at 6 months follow-up. Secondary outcomes include 7-day point prevalence quit rates at 3-, 6-, and 12-month follow-up, 30-day point prevalence quit rates at 3 and 12 months, biologically confirmed tobacco abstinence at 6-month follow-up, and multiple point-prevalence quit rates based on self-reported tobacco abstinence rates at each follow-up time period. Healthcare utilization and quality of life are assessed at baseline, and 6- and 12-month follow-up to measure program cost-effectiveness from the hospital, healthcare payer, patient, and societal perspectives.</p> <p>Discussion</p> <p>Given the impact of tobacco use on medical resources, establishing feasible, cost-effective methods for reducing tobacco use is imperative. Given the minimal hospital staff burden and the automated transition to a post-hospitalization tailored intervention, this program could be an easily disseminated approach.</p> <p>Trial registration</p> <p>Current Intervention Trial NCT01277250</p