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)

Abstract

Background The German clinical guideline on tobacco addiction recommends that general practitioners (GPs) provide brief stop-smoking advice to their patients according to the “5A” or the much briefer “ABC” method, but its implementation is insufficient. A lack of training is one barrier for GPs to provide such advice. Moreover, the respective effectiveness of a 5A or ABC training regarding subsequent delivery of stop-smoking advice has not been investigated. We developed a training for GPs according to both methods, and conducted a pilot study with process evaluation to optimize the trainings according to the needs of GPs. This study aims at evaluating the effectiveness of both trainings. Methods A pragmatic 2-arm cluster randomised controlled trial with a pre-post data collection will be conducted in 48 GP practices in North Rhine-Westphalia (Germany). GPs will be randomised to receive a 3.5-h-training in delivering either 5A or ABC, including peer coaching and intensive role plays with professional actors. The patient-reported primary outcome (receipt of GP advice to quit: yes/no) and secondary outcomes (recommendation rates of smoking cessation treatments, group comparison (5A versus ABC): receipt of GP advice to quit) will be collected in smoking patients routinely consulting their GP within 4 weeks prior, and 4 weeks following the training. Additional secondary outcomes will be collected at 4, 12 and 26 weeks following the consultation: use of cessation treatments during the last quit attempt (if so) since the GP consultation, and point-prevalence abstinence rates. The primary data analysis will be conducted using a mixed-effects logistic regression model with random effects for the cluster variable. Discussion If the training increases the rates of delivery of stop-smoking advice, it would offer a low-threshold strategy for the guideline implementation in German primary care. Should one method prove superior, a more specific guideline recommendation can be proposed. Trial registration German Clinical Trials Register ( DRKS00012786 ); registered on 22th August 2017, prior to the first patient in. Electronic supplementary material The online version of this article (10.1186/s12875-019-0986-8) contains supplementary material, which is available to authorized users.

Training general practitioners in the ABC versus 5As method of delivering stop-smoking advice: a pragmatic, two-arm cluster randomised controlled trial

“…The power calculation was informed by current rates of GP-delivered stop-smoking advice in Germany (~18%) [7], and from projections of the pilot study [27], showing that recruitment of 48 GP practices would be feasible within 2 years. Training GPs was assumed to have a clinically relevant effect if it increases rates of advice by at least 10% (odds ratio of 1.77).…”

“…Rhine-Westphalia, and from the practice network of the Institute of General Practice (HHU) [27]. All GPs were eligible, except for those specialised in treating substance abuse, or those who have been trained in providing smoking cessation support within the last 5 years [27]. Many GPs in Germany provide psychosomatic or psychotherapeutic care.…”

“…GPs had to register for at least two of the proposed training dates. Depending on how many GPs were available at these dates, two different randomisation methods were applied [27]:  > 8 GPs: computer-generated block randomisation with permuted blocks of sizes two or four, prepared by an independent statistician (WV).  < 8 GPs: randomisation by virtue of the GPs temporal availability.…”

“…All proposals requesting data access will need to specify how it is planned to use the data, and all proposals will need approval of the trial investigator team before data release. The study protocol [27], the statistical analysis plan and code have been published (osf.io/36kpc/, osf.io/zurfq/). Supplementary Table 1 Changes in capability, opportunity and motivation to deliver brief stop-smoking advice to smoking patients from prior to following the training reported by 69 general practitioners (GPs) of 52 GP practices.…”

Effectiveness of training general practitioners in the ABC versus 5As method of delivering brief stop-smoking advice: a pragmatic, two-arm cluster randomised controlled trial

“…Since it may be assumed that the ABC method is more convenient to apply for GPs in daily practice, we developed and pre-tested two 3.5h-trainings for GPs in delivering such advice during routine consultations: one based on the 5As and one based on the ABC method. 27 The aim of the present study was to assess whether these trainings provide an effective strategy to improve the implementation of the clinical guideline recommendations for the treatment of tobacco addiction by increasing patient-reported rates of GP-delivered brief stop-smoking advice (primary outcome) and the recommendation/prescription rates for evidence-based smoking cessation treatment (secondary outcomes). A secondary aim was to compare the effectiveness of ABC and 5As against each other.…”