ABSTRACTOBJECTIVETo assess the effectiveness of a 3.5h-training for general practitioners (GPs) in two different methods (ABC, 5As) of giving brief stop-smoking advice during routine consultations.DESIGNPragmatic two-arm cluster randomised controlled trial with pre-post-design for the primary outcome and cluster randomisation for secondary outcomes.SETTINGGeneral practices, North Rhine-Westphalia (German federal state), recruited 2017-2019.PARTICIPANTSPractices were randomised (1:1) to an ABC or 5As training. Tobacco smoking, adult patients, who consulted trained GPs in these practices in the 6 weeks prior to or following the training were eligible to participate. Ineligible were: non-smokers, patients who did not meet the GP in person, or could not provide informed consent.INTERVENTIONSTwo different standardised 3.5h-trainings (ABC or 5As) for GPs in delivering brief stop-smoking advice were carried out per study cycle (six cycles in total). Trainings were moderated by a senior researcher and an experienced GP, and included role-plays with professional actors.MAIN OUTCOME MEASURESPrimary outcome: patient-reported rates of GP-delivered stop-smoking advice prior and following the training, irrespective of the training method. Secondary outcomes: patient-reported receipt of recommendation/prescription of evidence-based smoking cessation treatment: including behavioural support, any pharmacotherapy (nicotine replacement therapy (NRT), varenicline, or bupropion), or a combination therapy; and the effectiveness of ABC versus 5As regarding all outcomes.RANDOMISATION AND MASKINGComputer-generated block randomisation or, if not feasible, randomisation based on the GPs’ temporal availability at training dates. GPs were not fully blinded. Patients were blinded to the nature of the study until data collection ended.RESULTS52 GP practices (27 ABC, 25 5As) with 69 GPs were included. Of 5,406 patients who provided informed consent, 1,937 (35.9%) were current smokers, of whom 1,039 were interviewed prior to and 898 following the training. GP-delivered stop-smoking advice increased from 13.1% (n=136/1,039) to 33.1% (n=297/898) following the training (adjusted odds ratio (aOR)=3.25, 95%CI=2.34 to 4.51). Recommendation/prescription rates of treatment were low (<2%) pre-training, but had increased after the training (e.g., behavioural support: aOR=7.15, 95%CI=4.02 to 12.74; any pharmacotherapy: aOR=7.99, 95%CI=4.11 to 15.52). GP-delivered stop-smoking advice increased non-significantly (p=0.08) stronger in the ABC vs. 5As group (aOR=1.71, 95%CI=0.94 to 3.12).CONCLUSIONSIn GPs in Germany, a single session of training in stop-smoking advice was associated with a three-fold increase in rates of advice giving and a seven-fold increase in offer of support. The ABC method may lead to higher rates of GP-delivered stop-smoking advice during routine consultations. Approaches to further increase the delivery of such advice, and upscaling implementation strategies for the training in general practice, should be evaluated.TRIAL REGISTRATIONGerman Clinical Trials Register: DRKS00012786.WHAT IS ALREADY KNOWN ON THIS TOPICThe implementation of clinical guideline recommendations stating that general practitioners (GPs) should routinely deliver brief stop-smoking advice and offer evidence-based smoking cessation treatment is low in Germany, a country with a smoking prevalence of ∼28%.A strategy is needed to overcome barriers (e.g., lack in knowledge and skills) preventing GPs from routinely delivering stop-smoking advice. No experimental study has evaluated such a strategy in German general practice so far.Two different methods of delivering such advice are recommended in the national guidelines – ABC and 5As – but it is unclear which method can be more effectively implemented by trained GPs.WHAT THIS STUDY ADDSThis cluster randomised controlled trial evaluated the effectiveness of a 3.5h-training for GPs in delivering brief stop-smoking advice and compared two different methods (ABC vs. 5As) regarding the rates of delivery of such advice and recommendations of evidence-based cessation treatment in 1,937 smoking patients from 52 GP practices in Germany.The training, irrespective of the method, was associated with a three-fold increase in rates of advice giving and a seven-fold increase in the offer of support.The data indicate that training according to ABC may be more effective than 5As in increasing the rates of GP-delivered stop-smoking advice.
Effectiveness of training general practitioners to improve the implementation of brief stop-smoking advice in German primary care: study protocol of a pragmatic, 2-arm cluster randomised controlled trial (the ABCII trial)
