Dataset Information

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.

SUBMITTER: Kastaun S

PROVIDER: S-EPMC6660716 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Publications

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).

Kastaun Sabrina S Leve Verena V Hildebrandt Jaqueline J Funke Christian C Becker Stephanie S Lubisch Diana D Viechtbauer Wolfgang W Reddemann Olaf O Hempel Linn L McRobbie Hayden H Raupach Tobias T West Robert R Kotz Daniel D

BMC family practice 20190727 1

<h4>Background</h4>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 G ...[more]

PMID: 31351460

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Project description:Importance:Most smoking cessation (SC) clinics are costly, passive, and underused. Objective:To compare the SC effect of a combined intervention involving brief, model-guided SC advice plus active referral to SC services (active referral group) with those of brief, model-guided SC advice only (brief advice group) and general SC advice only (control group). Design, Setting, and Participants:A single-blind, 3-arm, pragmatic cluster randomized clinical trial was conducted including 1226 adult daily smokers in the general Hong Kong community proactively recruited to participate in the Quit-to-Win Contest held in 2015. The study was conducted from June 20 to September 24, 2015. Participants were randomly allocated to the active referral (n = 402), brief advice (n = 416), and control (n = 408) groups. Intention-to-treat analysis was used. Interventions:Brief telephone counseling was offered to the active referral and brief advice groups at 1 and 2 months. Interventions were delivered by SC ambassadors who had undergone a short training period. Main Outcomes and Measures:The primary outcome was the self-reported past 7-day point prevalence of abstinence (PPA) at 6 months. The secondary outcomes were carbon monoxide level-validated abstinence, smoking reduction, and SC service use. Results:Participants included 991 (80.8%) men; mean (SD) age was 42.0 (14.8) years. The response rate was 68.2% at 3 and 72.3% at 6 months. The corresponding PPAs were 18.9% and 17.2% in the active referral group-higher than in the brief advice (8.9% and 9.4%; both P ≤ .001) or control (14.0% and 11.5%; P = .03 at 6 months) groups. Compared with the other 2 groups, the active referral group had significantly higher validated abstinence rates (10.2% at 3 months and 9.0% at 6 months, all P < .05) with odds ratios of 2.84 (95% CI, 1.57-5.15) and 2.61 (95% CI, 1.46-4.68) at 3 months, and 1.85 (95% CI, 1.06-3.23) and 1.81 (95% CI, 1.04-3.16) at 6 months in the brief advice and control groups, respectively. The SC service use rate was significantly higher in the active referral group (25.1%) than in either brief advice (2.4%) or control (3.4%) groups at 6 months (P < .001). Conclusions and Relevance:An intervention involving brief advice and active referral delivered to smokers in the community by volunteers can increase quitting in places where SC services are available but underused. Trial Registration:clinicaltrials.gov Identifier: NCT02539875.

Project description:BackgroundMany young people report they want to stop smoking and have tried to do so, but most of their quit attempts fail. For adult smokers, there is strong evidence that group behavioural support enhances quit rates. However, it is uncertain whether group behavioural support enhances abstinence in young smokers trying to quit.FindingsA cluster randomised trial for young people trying to stop smoking to compare the efficacy of a school-based 9 week intensive group behavioural support course versus a school-based 7 week brief advice only course. Participants were assessed for evidence of tobacco addiction and nicotine replacement therapy (NRT) was used if it was deemed appropriate by the therapist. Both types of course aimed to recruit approximately one hundred participants from approximately ten schools.The primary outcome was successful quitting at 4 weeks after quit day judged according to the Russell standard. Had the trial been completed, abstinence at 6 months after quit day and the relationships between successful quit attempts and 1) psychological assessments of dependence prior to quitting 2) salivary cotinine concentration prior to quitting and 3) sociodemographic characteristics would also have been assessed. The proportion of participants who stopped smoking in each arm of the trial were compared using Chi square tests.The trial was stopped shortly after it had started because funding to support the therapists running the stop smoking group behavioural support programme was withdrawn. Only three stop smoking courses were completed (two group support courses and one brief advice pharmacotherapy course). Seventeen participants in total entered the trial. At the end of the courses, one participant (10%) attending the group support programme had stopped smoking and no participant attending the brief advice programme had stopped smoking.DiscussionThe trial was stopped so we were unable to determine whether group support helped more young people to stop smoking than brief advice. Engagement and recruitment of participants proved much more difficult than had been anticipated. Fifteen of the seventeen participants reported that quitting smoking was either pretty important or very important to them. Thus, the stop smoking success rate could, nevertheless, be considered disappointing.Trial registrationCurrent Controlled Trials ISRCTN25181936.

Project description:ObjectiveTo examine the effectiveness of a nicotine patch worn for four weeks before a quit attempt.DesignRandomised controlled open label trial.SettingPrimary care and smoking cessation clinics in England, 2012-15.Participants1792 adults who were daily smokers with tobacco dependence. 899 were allocated to the preloading arm and 893 to the control arm.InterventionsParticipants were randomised 1:1, using concealed randomly permuted blocks stratified by centre, to either standard smoking cessation pharmacotherapy and behavioural support or the same treatment supplemented by four weeks of 21 mg nicotine patch use before quitting: "preloading."Main outcome measuresThe primary outcome was biochemically confirmed prolonged abstinence at six months. Secondary outcomes were prolonged abstinence at four weeks and 12 months.ResultsBiochemically validated abstinence at six months was achieved by 157/899 (17.5%) participants in the preloading arm and 129/893 (14.4%) in the control arm: difference 3.0% (95% confidence interval -0.4% to 6.4%), odds ratio 1.25 (95% confidence interval 0.97 to 1.62), P=0.08 in the primary analysis. There was an imbalance between arms in the frequency of varenicline use as post-cessation treatment, and planned adjustment for this gave an odds ratio for the effect of preloading of 1.34 (95% confidence interval 1.03 to 1.73), P=0.03: difference 3.8% (0.4% to 7.2%). At four weeks, the difference in prolonged abstinence unadjusted for varenicline use was odds ratio 1.21 (1.00 to 1.48), difference 4.3% (0.0% to 8.7%), P=0.05, and adjusted for varenicline use was 1.32 (1.08 to 1.62) P=0.007. At 12 months the odds ratio was 1.28 (0.97 to 1.69), difference 2.7% (-0.4% to 5.8%), P=0.09 unadjusted for varenicline use and after adjustment was 1.36 (1.02 to 1.80) P=0.04. 5.9% of participants discontinued preloading owing to intolerance. Gastrointestinal symptoms-chiefly nausea-occurred in 4.0% (2.2% to 5.9%) more people in the preloading arm than control arm. Eight serious adverse events occurred in the preloading arm and eight in the control arm (odds ratio 0.99, 0.36 to 2.75).ConclusionsEvidence was insufficient to confidently show that nicotine preloading increases subsequent smoking abstinence. The beneficial effect seems to have been masked by a concurrent reduction in the use of varenicline in people using nicotine preloading, and future studies should explore ways to mitigate this unintended effect.Trial registrationCurrent Controlled Trials ISRCTN33031001.

Project description:Implementation research is concerned with bridging the gap between evidence and practice through the study of methods to promote the uptake of research into routine practice. Good quality evidence has been summarised into guideline recommendations to show that peri-operative fasting times could be considerably shorter than patients currently experience. The objective of this trial was to evaluate the effectiveness of three strategies for the implementation of recommendations about peri-operative fasting.A pragmatic cluster randomised trial underpinned by the PARIHS framework was conducted during 2006 to 2009 with a national sample of UK hospitals using time series with mixed methods process evaluation and cost analysis. Hospitals were randomised to one of three interventions: standard dissemination (SD) of a guideline package, SD plus a web-based resource championed by an opinion leader, and SD plus plan-do-study-act (PDSA). The primary outcome was duration of fluid fast prior to induction of anaesthesia. Secondary outcomes included duration of food fast, patients' experiences, and stakeholders' experiences of implementation, including influences. ANOVA was used to test differences over time and interventions.Nineteen acute NHS hospitals participated. Across timepoints, 3,505 duration of fasting observations were recorded. No significant effect of the interventions was observed for either fluid or food fasting times. The effect size was 0.33 for the web-based intervention compared to SD alone for the change in fluid fasting and was 0.12 for PDSA compared to SD alone. The process evaluation showed different types of impact, including changes to practices, policies, and attitudes. A rich picture of the implementation challenges emerged, including inter-professional tensions and a lack of clarity for decision-making authority and responsibility.This was a large, complex study and one of the first national randomised controlled trials conducted within acute care in implementation research. The evidence base for fasting practice was accepted by those participating in this study and the messages from it simple; however, implementation and practical challenges influenced the interventions' impact. A set of conditions for implementation emerges from the findings of this study, which are presented as theoretically transferable propositions that have international relevance.ISRCTN18046709--Peri-operative Implementation Study Evaluation (POISE).

Project description:BackgroundStatins are widely used to prevent cardiovascular disease (CVD). With advancing age, the risks of statins might outweigh the potential benefits. It is unclear which factors influence general practitioners' (GPs) advice to stop statins in oldest-old patients.ObjectiveTo investigate the influence of a history of CVD, statin-related side effects, frailty and short life expectancy, on GPs' advice to stop statins in oldest-old patients.DesignWe invited GPs to participate in this case-based survey. GPs were presented with 8 case vignettes describing patients > 80 years using a statin, and asked whether they would advise stopping statin treatment.Main measuresCases varied in history of CVD, statin-related side effects and frailty, with and without shortened life expectancy (< 1 year) in the context of metastatic, non-curable cancer. Odds ratios adjusted for GP characteristics (ORadj) were calculated for GPs' advice to stop.Key resultsTwo thousand two hundred fifty GPs from 30 countries participated (median response rate 36%). Overall, GPs advised stopping statin treatment in 46% (95%CI 45-47) of the case vignettes; with shortened life expectancy, this proportion increased to 90% (95CI% 89-90). Advice to stop was more frequent in case vignettes without CVD compared to those with CVD (ORadj 13.8, 95%CI 12.6-15.1), with side effects compared to without ORadj 1.62 (95%CI 1.5-1.7) and with frailty (ORadj 4.1, 95%CI 3.8-4.4) compared to without. Shortened life expectancy increased advice to stop (ORadj 50.7, 95%CI 45.5-56.4) and was the strongest predictor for GP advice to stop, ranging across countries from 30% (95%CI 19-42) to 98% (95% CI 96-99).ConclusionsThe absence of CVD, the presence of statin-related side effects, and frailty were all independently associated with GPs' advice to stop statins in patients aged > 80 years. Overall, and within all countries, cancer-related short life expectancy was the strongest independent predictor of GPs' advice to stop statins.

Project description:IntroductionIn 2019, smoking prevalence in North Macedonia was one of the world's highest at around 46% in adults. However, access to smoking cessation treatment is limited and no co-ordinated smoking cessation programmes are provided in primary care.MethodsWe conducted a three parallel-armed randomised controlled trial (n = 1368) to investigate effectiveness and cost-effectiveness of lung age (LA) or exhaled carbon monoxide (CO) feedback combined with very brief advice (VBA) to prompt smoking cessation compared with VBA alone, delivered by GPs in primary care in North Macedonia. All participants who decided to attempt to quit smoking were advised about accessing smoking cessation medications and were also offered behavioural support as part of the "ACT" component of VBA. Participants were aged ≥ 35 years, smoked ≥ 10 cigarettes per day, were recruited from 31 GP practices regardless of motivation to quit and were randomised (1:1:1) using a sequence generated before the start of recruitment. The primary outcome was biochemically validated 7-day point prevalence abstinence at 4 weeks (wks). Participants and GPs were not blinded to allocation after randomisation, however outcome assessors were blind to treatment allocation.ResultsThere was no evidence of a difference in biochemically confirmed quitting between intervention and control at 4wks (VBA + LA RR 0.90 (97.5%CI: 0.35, 2.27); VBA + CO RR 1.04 (97.5%CI: 0.44, 2.44)), however the absolute number of quitters was small (VBA + LA 1.6%, VBA + CO 1.8%, VBA 1.8%). A similar lack of effect was observed at 12 and 26wks, apart from in the VBA + LA arm where the point estimate was significant but the confidence intervals were very wide. In both treatment arms, a larger proportion reported a reduction in cigarettes smoked per day at 4wks (VBA + LA 1.30 (1.10, 1.54); VBA + CO 1.23 (1.03, 1.49)) compared with VBA. The point estimates indicated a similar direction of effect at 12wks and 26wks, but differences were not statistically significant. Quantitative process measures indicated high fidelity to the intervention delivery protocols, but low uptake of behavioural and pharmacological support. VBA was the dominant intervention in the health economic analyses.ConclusionOverall, there was no evidence that adding LA or CO to VBA increased quit rates. However, a small effect cannot be ruled out as the proportion quitting was low and therefore estimates were imprecise. There was some evidence that participants in the intervention arms were more likely to reduce the amount smoked, at least in the short term. More research is needed to find effective ways to support quitting in settings like North Macedonia where a strong smoking culture persists.Trial registrationThe trial was registered at http://www.isrctn.com (ISRCTN54228638) on the 07/09/2018.

Dataset Information

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).

Background

Methods

Discussion

Trial registration

Publications

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).

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