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

All public antenatal services in the three sectors will receive the practice change intervention, including midwifery group practices, midwifery clinics, specialist medical services, Aboriginal Maternal Infant Health Services (AMIHS), and multi-disciplinary teams caring for women with complex pregnancies or identified vulnerabilities. The practice change intervention will be provided to all maternity clinicians providing antenatal care in participating services: registered midwives (clinical midwife educators, clinical midwife specialists, clinical midwife consultants, community liaison midwives), medical practitioners (staff specialists in obstetrics, fellows, registrars, resident medical officers, general practice obstetricians), Aboriginal health practitioners, Aboriginal health workers and students. All such clinicians who worked in participating antenatal services for at least one of the 7 months during which the practice change intervention was implemented in their sector will be invited to participate in a post intervention survey.

It is intended that all pregnant women who attend participating services from the start of the practice change intervention in their health sector will receive the intervention. During the 34-month data collection period, women who attend an individual face-to-face antenatal appointment at three time points (i) the time of the first public antenatal service visit (from this point referred to as the ‘booking in’ visit), (ii) 27–28 weeks gestation, or (iii) 35–36 weeks gestation, will be eligible to participate in data collection surveys. To be eligible for participation in such surveys, women need to: be aged 18 years or older, be currently pregnant at more than 12 weeks gestation and less than 37 weeks gestation, have a sufficient level of English language proficiency to complete the survey unaided, and be mentally and physically capable of completing the survey. Women will be ineligible to participate in data collection surveys if they: are determined by clinical discretion to be inappropriate to contact for the survey (e.g. due to medical or social issues); and/or are receiving the majority of their antenatal care via a private obstetrician; and/or have given birth or had a negative pregnancy outcome; and/or had already been selected to participate in the survey for that care time point in the past 4 weeks; and/or had previously declined participation in the survey. The number of women deemed ineligible for the above-listed reasons will be recorded and reported.

Each week, a sample of eligible women who attended an antenatal appointment in the past week (for booking in, 27–28 weeks gestation or 35–36 weeks gestation care) will be randomly selected via a computerised random number generator by members of the research team not involved in delivering care to women. Selected women will be mailed a participant information statement explaining the purpose of the survey 1 week prior to receiving a phone call inviting them to participate in the survey. Study posters will be displayed in antenatal clinics and pamphlets distributed in antenatal information packs provided to all women at the time of their booking in appointment. Women identified via the medical record data as being of Aboriginal or Torres Strait Islander origin and/or women who are attending or enrolled to attend an AMIHS will be first contacted by text message and invited to participate. If they do not respond, they will be followed up with a telephone call 4 days later. All women will have the opportunity to decline participation at any point, including opting out during the clinic visit or when they receive information in the antenatal booking in pack, when they receive the study information letter in the mail, at the time of the phone call or text message, or partway through survey completion. On the morning of the day that a woman is to be contacted via phone call or text message, medical record data will be checked and any women who are identified as having given birth or having had a negative pregnancy outcome will be deemed ineligible and not contacted.

A model of care for addressing alcohol consumption in pregnancy will be implemented in antenatal services across the three participating sectors. The model of care is consistent with international [20] and Australian national [21, 22], and state [23, 24] antenatal clinical practice guidelines and is based on models of assessment and brief intervention that have been shown to reduce the risk of an alcohol-exposed pregnancy [11, 13‐18].

As shown in Fig. 2, the 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 the 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. The tool has shown to be a valid tool for use with pregnant women [53]. Maternity clinicians will ask all women the first AUDIT-C question: ‘How often do you have a drink containing alcohol?’. Those women who provide a response other than ‘Never’, will be asked the remaining two AUDIT-C items: ‘How many standard drinks of alcohol do you have on a typical day when you are drinking?’ and ‘How often do you have five or more alcohol drinks on one occasion?’. These responses will be used to calculate an ‘Alcohol Risk Score’ and ‘Alcohol Risk of Harm’ category (No Risk, Low Risk, Medium Risk, High Risk).

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. Get Healthy in Pregnancy is a free, state-wide, government-funded telephone coaching service that supports women to make positive health and lifestyle changes [54]. Women can set a goal of alcohol abstinence throughout pregnancy and receive up to ten tailored calls by qualified health coaches. The coaching is based on behaviour change principles designed to assist with goal setting, maintaining motivation and overcoming barriers [54]. 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). This latter referral pathway was established through consultation with Aboriginal community members and the ACCHS’s that provide care for Aboriginal pregnant women in the study region.

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. Referral may also be made to residential drug and alcohol treatment services if required (provided by non-government services).

A series of organisational and individual clinician focused strategies will be used to support clinician implementation of the model of care.

Prior to implementation of the practice change intervention in each of the three sectors, usual antenatal care for addressing maternal alcohol consumption during pregnancy will be provided. Such care is likely to vary by antenatal service and clinician as no existing health sector-wide guideline or procedure specifies the provision of routine care for addressing alcohol consumption during pregnancy.

As the research team will control the initiation and delivery of all the intervention elements, the intervention strategies will not be accessible to antenatal clinicians during the baseline (control) phase. Although potential for contamination during this phase from staff movement between sectors is possible, it is considered to be limited due to the structural and systemic nature of the implementation strategies. Information on movement of clinicians between participating sectors will be collected throughout the study.

There are four primary outcomes for this trial. They are the proportion of all antenatal clinic appointments (at ‘booking in’, 27-28 weeks gestation and 35–36 weeks gestation) for which women report:

For women attending antenatal appointments at ‘booking in’, 27–28 weeks gestation and 35–36 weeks gestation, alcohol consumption since pregnancy recognition as measured by total AUDIT-C score will be collected based on self-report of women. AUDIT-C is a validated tool for assessing risk of harm due to alcohol consumption [53].

The acceptability, appropriateness, feasibility, intervention fidelity and reach of the model of care for addressing maternal alcohol consumption in pregnancy and the implementation strategies will be assessed via surveys of women and clinicians and project records. These process measures will be based on an implementation evaluation framework [61] and use validated measures where available [62]. Measures to assess implementation intervention reach will include participation of antenatal clinical staff in educational meetings, interaction with local opinion leaders, involvement in academic detailing/ audit and feedback sessions, and receipts of clinical practice guidelines. To determine reach of the implementation intervention strategies across different groups of clinicians, data will be collected from clinicians on position/profession, level of training, and length of time working in current antenatal service and in antenatal services generally. To assess delivery of the model of care across different demographic groups of women, the following information will be collected from pregnant women: age, gender, highest level of education, employment status, geographical location, Aboriginal or Torres Strait Islander status of woman and baby, household composition, current gestation, gestation at first antenatal clinic visit, whether attending care for first or subsequent pregnancy and alcohol consumption prior pregnancy (via AUDIT-C).

To provide a measure of the investment required to develop, implement and maintain the effect of the implementation strategies, resource use will be prospectively measured and valued from a public finance perspective. The outcomes from the cost analysis will be (i) an estimate of the cost required to develop the intervention strategies, (ii) the net cost of delivering the implementation intervention (including labour costs for the CME and the clinicians to conduct/participate in each of the implementation strategies, undertaking quality assurance processes, providing managerial oversight), and (iii) assuming a positive trial outcome, the expected incremental cost to maintain effect. Additionally, the cost-effectiveness of the implementation strategies will be assessed relative to the baseline (current practice) phase in each of the three sectors. The incremental cost-effectiveness ratio (ICER) will be calculated as the difference in average cost between the intervention and baseline phases, divided by the difference in the primary outcome. Sensitivity analyses will test the robustness of results to selected issues and assumptions.

Each week a sample of women who in the past week attended an antenatal clinic for a ‘booking in’ visit, a visit when they were 27–28 weeks gestation, or a visit when they were 35–36 weeks gestation will be sent a letter providing information about the study and inviting them to participate in a computer assisted telephone interview (CATI) survey. Telephone contact will be attempted with women up to ten times over a 2-week period, including at different times of the day and on weekdays and weekends, in order to elicit consent and completion of the survey. If a woman declines to participate in the CATI, they will be invited to complete the survey online. If they consent to participate in the online survey, they will be sent a survey link via text message. Women who are of Aboriginal or Torres Strait Islander origin and/or are attending or enrolled to attend an AMIHS will be offered via text message the choice of participating in the survey via either CATI or online mode.

The CATI survey will be conducted by experienced female interviewers who will receive specific training and undertake practice interviews. The CATI and online survey script are identical in the wording of questions, response options and help provided. Both surveys will be pilot tested prior to starting the study to test comprehension, logic flow and survey length.

Data for the aforementioned process evaluation measures will be collected via surveys with women (as per procedure described above) and clinicians. Online surveys of clinicians will be conducted at the completion of the intervention in each sector. All eligible clinicians in antenatal services in the participating sectors will be sent a link to an online survey via email, and also given the option to complete the survey on tablet computers/laptops in regular in-services and clinic meetings. Surveys will be completed anonymously. Additional process data to assess intervention fidelity and reach will be collected using project management logs completed by project staff.

Project management logs, including a cost capture template, will be used to prospectively collect data regarding the resources expended during intervention development and implementation.

Management of trial data will be in accordance with a data management protocol, which has been developed and approved by the project’s advisory group. Data will be stored securely as per the requirements of the Hunter New England Human Research Ethics Committee, The University of Newcastle Human Research Ethics Committee and the Aboriginal Health and Medical Research Council. Data will only be accessible to primary researchers and statisticians. Confidential participant data will be stored securely and not linked to survey responses.