title: Combining intensive practice nurse counselling or brief general practitioner advice with varenicline for smoking cessation in primary care: study protocol of a pragmatic randomized controlled trial.
abstract: BACKGROUND
  Combining behavioural support and pharmacotherapy is most effective for smoking cessation and recommended in clinical guidelines. Despite that smoking cessation assistance from the general practitioner can be effective, dissemination of clinical practice guidelines and efforts on upskilling has not lead to the routine provision of smoking cessation advice among general practitioners. Intensive counselling from the practice nurse could contribute to better smoking cessation rates in primary care. However, the effectiveness of intensive counselling from a practice nurse versus usual care from a general practitioner in combination with varenicline is still unknown.
  
  
  METHODS
  A pragmatic randomized controlled trial was conducted comparing: (a) intensive individual counselling delivered by a practice nurse and (b) brief advice delivered by a general practitioner; both groups received 12-weeks of open-label varenicline. A minimum of 272 adult daily smoking participants were recruited and treated in their routine primary care setting. The primary outcome was defined as prolonged abstinence from weeks 9 to 26, biochemically validated by exhaled carbon monoxide. Data was analysed blinded according to the intention-to-treat principle and participants with missing data on their smoking status at follow-up were counted as smokers. Secondary outcomes included: one-year prolonged abstinence, short-term incremental cost-effectiveness, medication adherence, and baseline predictors of successful smoking cessation.
  
  
  CONCLUSIONS
  This trial is the first to provide scientific evidence on the effectiveness, cost-effectiveness, and potential mechanisms of action of intensive practice nurse counselling combined with varenicline under real-life conditions. This paper explains the methodology of the trial and discusses the pragmatic and/or explanatory design aspects.
  
  
  BACKGROUND
  Dutch Trial Register NTR3067.
authors: CAPHRI School for Public Health and Primary Care, Department of Family Medicine, Maastricht University, Maastricht, The Netherlands. Electronic address: carolien.vanrossem@maastrichtuniversity.nl.
authors: C
authors: C
authors: van Rossem
authors: CAPHRI School for Public Health and Primary Care, Department of Family Medicine, Maastricht University, Maastricht, The Netherlands; General Practice Research Unit, Department of Community Medicine, The Arctic University of Norway, Tromsø, Norway. Electronic address: m.spigt@maastrichtuniversity.nl.
authors: M
authors: M
authors: Spigt
authors: CAPHRI School for Public Health and Primary Care, Department of Health Promotion, Maastricht University, Maastricht, The Netherlands; Amsterdam School of Communication Research/ASCoR, Department of Communication Science, University of Amsterdam, Amsterdam, The Netherlands. Electronic address: e.s.smit@uva.nl.
authors: E S
authors: ES
authors: Smit
authors: MHeNS School for Mental Health and Neuroscience, Department of Psychiatry and Psychology, Maastricht University, Maastricht, The Netherlands. Electronic address: wolfgang.viechtbauer@maastrichtuniversity.nl.
authors: W
authors: W
authors: Viechtbauer
authors: Eindhoven Corporation of Primary Health Care Centres (SGE), Eindhoven, The Netherlands. Electronic address: k.mijnheer@sge.nl.
authors: K K
authors: KK
authors: Mijnheer
authors: CAPHRI School for Public Health and Primary Care, Department of Family Medicine, Maastricht University, Maastricht, The Netherlands. Electronic address: o.vanschayck@maastrichtuniversity.nl.
authors: C P
authors: CP
authors: van Schayck
authors: CAPHRI School for Public Health and Primary Care, Department of Family Medicine, Maastricht University, Maastricht, The Netherlands. Electronic address: d.kotz@maastrichtuniversity.nl.
authors: D
authors: D
authors: Kotz
mesh_terms: D057179:Advanced Practice Nursing / Q000379:methods*; D003376:Counseling / Q000379:methods; D058006:General Practice / Q000379:methods*; D006801:Humans; D018722:Nicotinic Agonists / Q000627:therapeutic use*; D011320:Primary Health Care; D012907:Smoking / Q000628:therapy*; D016540:Smoking Cessation / Q000379:methods*; D016896:Treatment Outcome; D000068580:Varenicline / Q000627:therapeutic use*
chemical_list: D018722:Nicotinic Agonists; D000068580:Varenicline
keywords: Brief advice; Intensive counselling; Practice nurse; Pragmatic design; Primary care; Smoking cessation; Varenicline