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OBJECTIVE To assess the effectiveness of a 3.5h-training for general practitioners (GPs) in two different methods of giving brief stop-smoking advice – 5A (ask, advice, assess, assist, arrange) or ABC (ask, brief advice, cessation support) – during routine consultations with smoking patients. DESIGN Pragmatic 2-arm cluster randomised controlled trial with a pre-post-design for the primary outcome and cluster randomisation for secondary outcomes. SETTING General practices (cluster) in the Rhine-Ruhr Metropolitan Region of the German federal state of North Rhine-Westphalia. The study opened to recruitment in June 2017 and closed in July 2019, with final follow-up in February 2020. PARTICIPANTS General practices with their GPs were randomised (1:1) to receive training in either 5A or ABC. Tobacco smoking patients aged > 18 years, who routinely consulted these GPs six weeks prior or six six following the training were eligible to participate. Non-smokers, those with limited literacy or incapability to provide informed consent, or who did not see their GP in person were ineligible. INTERVENTIONS Two different standardised 3.5h-trainings (ABC or 5A), in small groups of ~8 GPs, in delivering brief stop-smoking advice, moderated by a senior researcher and an experienced GP peer-trainer and including role-plays with professional actors. MAIN OUTCOME MEASURES Primary outcome: patient-reported receipt of GP advice to quit, measured during a face-to-face interview directly following the consultation in the GP practice. Secondary outcomes included patient-reported receipt of GP delivered recommendation/prescription of evidence-based behavioural counselling; nicotine replacement therapy (NRT); varenicline or bupropion; any pharmacotherapy (NRT, varenicline or bupropion); or a combination of behavioural support and pharmacotherapy. A further aim was to compare the effectiveness of the two methods (ABC vs. 5A) against each other regarding all outcomes. All analyses were adjusted for a priori defined potentially relevant confounders and by using imputed patient data for missing data on confounding variables. Main analyses were double-checked using complete cases patient data. RANDOMISATION AND MASKING Two different methods of randomisation were applied, depending on how many GPs were available for the scheduled training dates (six training cycles over the course of two years, with two trainings – 5A and ABC – per cycle): computer-generated block randomisation, or randomisation by virtue of the GPs temporal availability. GPs could not be fully blinded with respect to their training allocation. Patients were blinded to the nature and aim of the study until the end of the data collection. RESULTS 52 GP practices (with 69 GPs) participated in the training and data collection (ABC training: 27 GP practices, 5A training: 25 GP practices). Of 5,406 unique patients who routinely consulted their GP within 5 weeks prior/post training and provided informed consent to participate, 1,937 (35.9%) were current tobacco smokers. Of these, 1,039 were interviewed prior to, and 898 following, the training. The rates of stop-smoking advice delivered by GPs (primary outcome) increased from 13.1% (n=136/1,039) to 33.1% (n=297/898) following the training (adjusted odds ratio (aOR)=3.25, 95% confidence interval (CI)=2.34 to 4.51). Overall, recommendation/prescription rates of cessation treatment were low a priori ( |
