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.

Keywords: Brief smoking cessation advice; General practitioner; National practice guideline; Primary care; Tobacco addiction.

Fig. 1

Gantt chart of the study illustrating the schedule of the total study, including the preparation period, pilot testing of the intervention, the distribution of the six study cycles (intervention) over the total duration of the study, and all periods of data collection. P0 Process evaluation pilot study, finalisation of training and manual, ethical approval, study registration. P1-P6 Preparations study cycles 1 to 6: practice recruitment, material, application for CME certification, scheduling of trainings. B1-B6 Pre- (7 days) and post-baseline (7 days) data collection of primary and secondary outcomes (S1-S3) in 8 GP practices per study cycle. T1-T6 Intervention: 3.5-h training of GPs in delivering brief stop-smoking advice according to either 5A or ABC. F1-F6 Postal follow-up data collection of secondary outcomes (S4-S9) corresponding to study cycle 1–6

Fig. 2

Consolidated Standards of Reporting Trials (CONSORT) flow chart illustrating all steps in the study from enrolment to training allocation and follow-ups. Inclusion and exclusion criteria are also specified as well as outcome measures