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

Dutch Trial Register NTR3067.

Nursing approach to tobacco users in primary health care

“…The study pointed out that the main expectation of nurses is to support tobacco users in the smoking cessation process. A qualitative study conducted in the Netherlands with 14 smokers and 9 PHC health professionals showed nurses were the preferred providers of intensive behavioral support with a focus on smoking cessation (23) .…”

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

“…This study was a multi-site two-group parallel randomized controlled trial evaluating intensive counselling from a PN versus usual care from a GP, both combined with openlabel varenicline for smoking cessation. A detailed description of the protocol has been published previously [19]. Ethical approval had been obtained (NL30057.068.09/ METC 09-03-075), and the study had been registered in the Dutch Trial Register (NTR3067).…”

“…Abstinence rates from weeks 9 to 26 were expected to be 35% in the PN group and 20% in the GP group [19]. The estimated quit rates derived from the results of previous varenicline trials when using varenicline only [11,12] and from one of our own smoking cessation trials that combined individual counselling with nortriptyline [21].…”

“…PNs had received training in delivering counselling for their routine clinical work according to Dutch guidelines prior to the start of the trial. The counselling protocol was developed through an intensive innovation process involving GPs, PNs and patients [19]. Counselling included the following evidence-based behaviour change techniques: planning a target quit date; advice on abrupt quitting and the 'not a puff rule'; strengthening motivation and self-efficacy; and enhancing a non-smoker identity [22].…”

“…All patients received a prescription of 12 weeks' open-label varenicline during an initial visit with the PN or GP. The usual dosage was recommended, but health-care professionals were allowed to change the dosage when they believed this would be more appropriate for their patient [19]. The starting dose of varenicline was dispensed in the original packaging, and subsequent medication was offered in Medication Event Monitoring System (MEMS ® ) vials from week 3 until the end of treatment.…”