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Type: Journal article
Title: A practice change intervention to improve antenatal care addressing alcohol consumption by women during pregnancy: research protocol for a randomised stepped-wedge cluster trial
Author: Kingsland, M.
Doherty, E.
Anderson, A.
Crooks, K.
Tully, B.
Tremain, D.
Tsang, T.
Attia, J.
Wolfenden, L.
Dunlop, A.
Bennett, N.
Hunter, M.
Ward, S.
Reeves, P.
Symonds, I.
Rissel, C.
Azzopardi, C.
Searles, A.
Gillham, K.
Elliott, E.
et al.
Citation: Implementation Science, 2018; 13(1):112-1-112-14
Publisher: BioMed Central
Issue Date: 2018
ISSN: 1748-5908
Statement of
Melanie Kingsland, Emma Doherty, Amy E. Anderson, Kristy Crooks, Belinda Tully, Danika Tremain, Tracey W. Tsang, John Attia, Luke Wolfenden, Adrian J. Dunlop, Nicole Bennett, Mandy Hunter, Sarah Ward, Penny Reeves, Ian Symonds, Chris Rissel, Carol Azzopardi, Andrew Searles, Karen Gillham, Elizabeth J. Elliott, and John Wiggers
Abstract: Background: Despite 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. Methods: The 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. Discussion: This 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.
Keywords: Maternal; alcohol consumption; pregnancy; antenatal care; implementation; clinical practice change; stepped-wedge trial; protocol
Rights: © The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (, which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( applies to the data made available in this article, unless otherwise stated.
RMID: 0030097277
DOI: 10.1186/s13012-018-0806-x
Grant ID:
Appears in Collections:Medicine publications

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