A practice change intervention to improve antenatal care addressing alcohol consumption by women during pregnancy: research protocol for a randomised stepped-wedge cluster trial

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.

Trial registrations: Australian and New Zealand Clinical Trials Registry, No. ACTRN12617000882325 (date registered: 16/06/2017).

Keywords: Alcohol consumption; Antenatal care; Clinical practice change; Implementation; Maternal; Pregnancy; Protocol; Stepped-wedge trial.

Fig. 1

Study design. Figure 1 shows the trial design and implementation of the trial data collection and intervention components over the course of the 34 months trial period. Repeated cross-sectional outcome data from surveys of pregnant women will be gathered on a weekly basis across all three sectors for the duration of the study. Baseline data will be collected for each of the three sectors from 7 months prior to the commencement of the intervention in the first sector to the start of the intervention in each sector. Stepped implementation of a 7-month practice change intervention will be delivered in a randomly selected order at six monthly intervals. Follow-up data will continue to be collected for all three sectors 7 months following completion of the practice change intervention in the third sector

Fig. 2

Model of care for addressing maternal alcohol consumption during pregnancy. Figure 2 shows the model of care for addressing maternal alcohol consumption during pregnancy. This model of care will consist of three key elements—assessment, advice and referral—which will be delivered to women who attend an antenatal clinic appointment booking in, 27–29 weeks gestation and 35–37 weeks gestation. The Alcohol Use Disorders Identification Test Consumption (AUDIT-C) tool will be used to assess the alcohol consumption of pregnant women. All women, regardless of their Alcohol Risk of Harm category, will be provided with advice by their maternity clinician that it is best not to consume alcohol at any time during pregnancy and that alcohol consumption during pregnancy can increase risk of harm to the foetus and the woman. Women will be provided with additional advice based on their Alcohol Risk of Harm category. Women with a Medium AUDIT-C risk level will be offered a referral to the Get Healthy in Pregnancy telephone-based coaching service. Aboriginal women with a Medium AUDIT-C risk level will also be offered the option of referral to counselling services at a local Aboriginal Community Controlled Health Service (ACCHS) (if available). For women with a High AUDIT-C risk level, direct referral to Hunter New England Local Health District Drug and Alcohol Clinical Services will be provided. Care from such services will involve ongoing clinical support from a multidisciplinary Drug and Alcohol team throughout pregnancy, including assessment, brief intervention, counselling and withdrawal and post-withdrawal support as clinically indicated