Iterative delivery of an implementation support package to increase and sustain the routine provision of antenatal care addressing alcohol consumption during pregnancy: study protocol for a stepped-wedge cluster trial.

INTRODUCTION: Antenatal care addressing alcohol consumption during pregnancy is not routinely delivered in maternity services. Although a number of implementation trials have reported significant increases in such care, the majority of women still did not receive all recommended care elements, and improvements dissipated over time. This study aims to assess the effectiveness of an iteratively developed and delivered implementation support package in: (1) increasing the proportion of pregnant women who receive antenatal care addressing alcohol consumption and (2) sustaining the rate of care over time. METHODS AND ANALYSIS: A stepped-wedge cluster trial will be conducted as a second phase of a previous trial. All public maternity services within three sectors of a local health district in Australia will receive an implementation support package that was developed based on an assessment of outcomes and learnings following the initial trial. The package will consist of evidence-based strategies to support increases in care provision (remind clinicians; facilitation; conduct educational meetings) and sustainment (develop a formal implementation blueprint; purposely re-examine the implementation; conduct ongoing training). Measurement of outcomes will occur via surveys with women who attend antenatal appointments each week. Primary outcomes will be the proportion of women who report being asked about alcohol consumption at subsequent antenatal appointments; and receiving complete care (advice and referral) relative to alcohol risk at initial and subsequent antenatal appointments. Economic and process evaluation measures will also be reported. ETHICS AND DISSEMINATION: Ethical approval was obtained through the Hunter New England (16/11/16/4.07, 16/10/19/5.15) and University of Newcastle Human Research Ethics Committees (H-2017-0032, H-2016-0422) and the Aboriginal Health and Medical Research Council (1236/16). Trial findings will be disseminated to health service decision makers to inform the feasibility of conducting additional cycles to further improve antenatal care addressing alcohol consumption as well as at scientific conferences and in peer-reviewed journals. TRIAL REGISTRATION NUMBER: Australian and New Zealand Clinical Trials Registry (ACTRN12622000295741).

Real-time video counselling for smoking cessation.

BACKGROUND: Real-time video communication software such as Skype and FaceTime transmits live video and audio over the Internet, allowing counsellors to provide support to help people quit smoking. There are more than four billion Internet users worldwide, and Internet users can download free video communication software, rendering a video counselling approach both feasible and scalable for helping people to quit smoking. OBJECTIVES: To assess the effectiveness of real-time video counselling delivered individually or to a group in increasing smoking cessation, quit attempts, intervention adherence, satisfaction and therapeutic alliance, and to provide an economic evaluation regarding real-time video counselling. SEARCH METHODS: We searched the Cochrane Tobacco Addiction Group Specialised Register, CENTRAL, MEDLINE, PubMed, PsycINFO and Embase to identify eligible studies on 13 August 2019. We searched the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov to identify ongoing trials registered by 13 August 2019. We checked the reference lists of included articles and contacted smoking cessation researchers for any additional studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs), randomised trials, cluster RCTs or cluster randomised trials of real-time video counselling for current tobacco smokers from any setting that measured smoking cessation at least six months following baseline. The real-time video counselling intervention could be compared with a no intervention control group or another smoking cessation intervention, or both. DATA COLLECTION AND ANALYSIS: Two authors independently extracted data from included trials, assessed the risk of bias and rated the certainty of the evidence using the GRADE approach. We performed a random-effects meta-analysis for the primary outcome of smoking cessation, using the most stringent measure of smoking cessation measured at the longest follow-up. Analysis was based on the intention-to-treat principle. We considered participants with missing data at follow-up for the primary outcome of smoking cessation to be smokers. MAIN RESULTS: We included two randomised trials with 615 participants. Both studies delivered real-time video counselling for smoking cessation individually, compared with telephone counselling. We judged one study at unclear risk of bias and one study at high risk of bias. There was no statistically significant treatment effect for smoking cessation (using the strictest definition and longest follow-up) across the two included studies when real-time video counselling was compared to telephone counselling (risk ratio (RR) 2.15, 95% confidence interval (CI) 0.38 to 12.04; 2 studies, 608 participants; I2 = 66%). We judged the overall certainty of the evidence for smoking cessation as very low due to methodological limitations, imprecision in the effect estimate reflected by the wide 95% CIs and inconsistency of cessation rates. There were no significant differences between real-time video counselling and telephone counselling reported for number of quit attempts among people who continued to smoke (mean difference (MD) 0.50, 95% CI -0.60 to 1.60; 1 study, 499 participants), mean number of counselling sessions completed (MD -0.20, 95% CI -0.45 to 0.05; 1 study, 566 participants), completion of all sessions (RR 1.13, 95% CI 0.71 to 1.79; 1 study, 43 participants) or therapeutic alliance (MD 1.13, 95% CI -0.24 to 2.50; 1 study, 398 participants). Participants in the video counselling arm were more likely than their telephone counselling counterparts to recommend the programme to a friend or family member (RR 1.06, 95% CI 1.01 to 1.11; 1 study, 398 participants); however, there were no between-group differences on satisfaction score (MD 0.70, 95% CI -1.16 to 2.56; 1 study, 29 participants). AUTHORS' CONCLUSIONS: There is very little evidence about the effectiveness of real-time video counselling for smoking cessation. The existing research does not suggest a difference between video counselling and telephone counselling for assisting people to quit smoking. However, given the very low GRADE rating due to methodological limitations in the design, imprecision of the effect estimate and inconsistency of cessation rates, the smoking cessation results should be interpreted cautiously. High-quality randomised trials comparing real-time video counselling to telephone counselling are needed to increase the confidence of the effect estimate. Furthermore, there is currently no evidence comparing real-time video counselling to a control group. Such research is needed to determine whether video counselling increases smoking cessation.

Strategies to improve the implementation of policies, practices or programmes in sporting organisations targeting poor diet, physical inactivity, obesity, risky alcohol use or tobacco use: a systematic review.

OBJECTIVES: The primary aim for this review is to determine the effectiveness of strategies to improve the implementation of policies, practices or programmes in sporting organisations. The secondary aims are to describe the cost or cost-effectiveness and adverse effects of such strategies and to examine the effects of those implementation strategies on individual's diet, physical activity, obesity, alcohol use or tobacco use. METHODS: We conducted searches of academic databases (eg, MEDLINE, EMBASE and CENTRAL), trial registers and hand searches of selected journals. Studies were included if they were conducted at a sporting venue; described a strategy to improve implementation of policies, practices or programmes focusing on one or more health risks (diet, physical inactivity, obesity, alcohol or tobacco use), and included a parallel control group. Two authors independently screened citations and extracted data. The results of included studies were synthesised narratively. RESULTS: Of the 5926 citations screened three studies met the inclusion criteria. Two studies were randomised controlled trials. Two studies sought to improve the implementation of nutrition-related policy and practices and one study sought to improve implementation of alcohol-related policy and practices. Each study reported improvement in at least one measure of policy or practice implementation. Two studies reported individual-level outcomes and found a reduction in excessive alcohol consumption and an increase in purchase of fruits and vegetables at the sports club ground. Two studies assessed club revenue as a potential adverse effect, neither reported significant between-group differences on these measures. CONCLUSION: There is a sparse evidence base regarding the effectiveness of strategies to improve the implementation of policies, practices or programmes targeting chronic disease risk factors in sporting clubs. While all studies reported some improvements in implementation, for some multistrategic implementation strategies it is difficult to determine the extent to which such effects are generalisable. PROSPERO REGISTRATION NUMBER: CRD42016039490.