Abstract

BackgroundDespite clinical guideline recommendations, implementation of antenatal care addressing alcohol consumption by pregnant women is limited. Implementation strategies addressing barriers to such care may be effective in increasing care provision. The aim of this study is to examine the effectiveness, cost and cost-effectiveness of a multi-strategy practice change intervention in increasing antenatal care addressing the consumption of alcohol by pregnant women.MethodsThe study will be a randomised, stepped-wedge controlled trial conducted in three sectors in a health district in New South Wales, Australia. Stepped implementation of a practice change intervention will be delivered to sectors in a random order to support the introduction of a model of care for addressing alcohol consumption by pregnant women. A staged process was undertaken to develop the implementation strategies, which comprise of: leadership support, local clinical practice guidelines, electronic prompts and reminders, opinion leaders, academic detailing (audit and feedback), educational meetings and educational materials, and performance monitoring. Repeated cross-sectional outcome data will be gathered weekly across all sectors for the study duration. The primary outcome measures are the proportion of antenatal appointments at ‘booking in’, 27–28 weeks gestation and 35–36 weeks gestation for which women report (1) being assessed for alcohol consumption, (2) being provided with brief advice related to alcohol consumption during pregnancy, (3) receiving relevant care for addressing alcohol consumption during pregnancy, and (4) being assessed for alcohol consumption and receiving relevant care. Data on resources expended during intervention development and implementation will be collected. The proportion of women who report consuming alcohol since knowing they were pregnant will be measured as a secondary outcome.DiscussionThis will be the first randomised controlled trial to evaluate the effectiveness, cost and cost-effectiveness of implementation strategies in improving antenatal care that addresses alcohol consumption by pregnant women. If positive changes in clinical practice are found, this evidence will support health service adoption of implementation strategies to support improved antenatal care for this recognised risk to the health and wellbeing of the mother and child.Trial registrationsAustralian and New Zealand Clinical Trials Registry, No. ACTRN12617000882325 (date registered: 16/06/2017).

Highlights

  • Despite clinical guideline recommendations, implementation of antenatal care addressing alcohol consumption by pregnant women is limited

  • No safe level of prenatal alcohol exposure has been established for the foetus and many countries, including Australia, have national guidelines recommending that the safest option is for women to abstain from alcohol consumption when trying to conceive, during conception and during pregnancy [1,2,3]

  • In Australia, national surveys and prospective cohort studies report the prevalence of maternal alcohol consumption at any time during pregnancy to be between 35 and 72% [5,6,7,8,9,10]

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Summary

Introduction

Implementation of antenatal care addressing alcohol consumption by pregnant women is limited. No safe level of prenatal alcohol exposure has been established for the foetus and many countries, including Australia, have national guidelines recommending that the safest option is for women to abstain from alcohol consumption when trying to conceive, during conception and during pregnancy [1,2,3]. A prospective cohort study of 1403 women attending antenatal clinics in the Australian states of New South Wales and Western Australia found that 61% of women consumed alcohol between conception and pregnancy recognition, often at risky levels Of these women, approximately 30% continued to drink alcohol once they were aware they were pregnant [10]. A study of 1570 women attending public antenatal clinics in Melbourne, Australia, found that just over half (54%) of women consumed alcohol in the first trimester, and half of these women continued to consume alcohol throughout the remainder of their pregnancy [8]

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