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 (>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