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The effectiveness of a practice change intervention to increase the provision of recommended care for addressing maternal alcohol consumption during pregnancy.

The effectiveness of a practice change intervention to increase the provision of recommended care for addressing maternal alcohol consumption during pregnancy: a stepped-wedge trial.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000882325
Enrollment
6942
Registered
2017-06-16
Start date
2017-07-03
Completion date
2020-05-18
Last updated
2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to determine the effectiveness of a practice change intervention in increasing the provision of best practice care for alcohol consumption during pregnancy. The study will be conducted as a stepped-wedge controlled trial, with staggered (random order) implementation of the intervention across antenatal services in three health sectors within the Hunter New England Local Health District, New South Wales, Australia. The intervention will consist of evidence-based practice change strategies including leadership support, training, performance feedback, and system prompts. The prevalence of alcohol-related best practice care at three time points in pregnancy (booking in visit, 28 week visit and 36 week visit) will be the outcomes of interest. Repeated, weekly cross-sectional measurement of these outcomes will occur for 34 months via telephone or online surveys with a random sample of women who attended the services in the previous week. An intervention effect will be demonstrated by a cumulative increase in recommended care delivery across combined sites.

Interventions

A seven month multi-component clinical practice change intervention will be implemented across three health sectors, which will include a one month wash-in period introducing the practice change and a six month intensive practice change intervention. Practice changes implemented will include the routine provision to all pregnant women of recommended care for addressing alcohol use in pregnancy including: 1) alcohol screening with a validated instrument (i.e. AUDIT-C), 2) provision of brief advic

A seven month multi-component clinical practice change intervention will be implemented across three health sectors, which will include a one month wash-in period introducing the practice change and a six month intensive practice change intervention. Practice changes implemented will include the routine provision to all pregnant women of recommended care for addressing alcohol use in pregnancy including: 1) alcohol screening with a validated instrument (i.e. AUDIT-C), 2) provision of brief advice in-line with national guidelines for alcohol consumption in pregnancy, and 3) offer of referral to specialist services for ongoing care if screened to be consuming alcohol at medium or high risk levels. To facilitate these practice changes the following intervention strategies will be implemented: Leadership and consensus support: Existing clinical networks and antenatal clinical leaders will be engaged prior to and during the intervention to facilitate ongoing leadership support for the initiative. A clinical expert group will provide clinical guidance across all components of the intervention. To increase intervention adherence, consensus for the model of care will be sought from clinical stakeholders and formalised through the development of service level guidelines and procedures. Aboriginal health staff will provide oversight regarding cultural appropriateness of the intervention, and specific cultural task groups will be formed. At the service level, antenatal clinicians and service managers will be consulted prior to the intervention to identify potential barriers to clinical practice change and resources required to support practice change. Educational outreach visits and academic detailing: Clinical Midwife Educators (CMEs) will be allocated to the three health sectors for each of the seven month intervention phases to facilitate the implementation of practice change strategies and clinician provision of recommended care for addressing alcohol use in pregnancy. CMEs will advise, train, monitor and provide feedback to antenatal clinicians and service managers, and support local care improvement initiatives. Services will be supported to set practice change goals, monitor progress and develop action plans in response to such feedback. Enabling systems and procedures: Modifications will be made to medical record systems used by antenatal clinicians to prompt standardised point of care assessment of alcohol use using the validated AUDIT-C alcohol screening tool, tailored brief advice based on the AUDIT-C risk score, and referral (if required) for clients requiring further support for alcohol use. Clinician training and resources: Multi-mode training will be provided to clinicians in service with the support of a CME in each of the health sectors. Face-to-face training sessions will be rostered into the health sectors’ routine educational sessions. These sessions vary per sector due to size, geographical dispersion of services within the sectors, and standard training procedures per sector for implementing changes to routine practice. Therefore, the number, frequency and duration of sessions will be tailored to the different sectors to fit within standard procedures for implementing practice change within maternity services. Based on partnership agreements for this project, three hours per clinician has been dedicated through in-kind support from Hunter New England Local Health District Clinical Services Nursing and Midwifery. At least one face-to-face 30-60 minute presentation to introduce the practice change to a number of clinicians (e.g. midwives, staff specialists) will occur within each sector. Additional introductory sessions will be scheduled as needed in health sectors with a larger number of staff or dispersed services. These introductory sessions will be delivered jointly by both senior health promotion staff and a Clinical Midwife Educator. One off expert presentations by an investigator specialising in Fetal Alcohol Spectrum Disorder, and an expert specialising in addressing alcohol and drug use with pregnant clients will be scheduled for each health sector. Face-to-face training will then be delivered to each service within each sector by a CME who is a registered senior midwife with training in antenatal staff education and professional development. Each service has an individual training procedure, of which this training will be incorporated into (e.g. half hour morning briefing). Training will be scheduled in consultation with maternity service managers to mitigate burden on their services. The CME will also provide individual support and feedback to clinicians as they provide antenatal care. The training will relate to the practicalities of providing the new model of care for addressing alcohol use in pregnancy (i.e. assess alcohol use with the AUDIT-C, provide brief advice and refer to specialist services for support if required) at three time points in antenatal care (ie. Booking in visit, 28 week visit, 36 week visit). Clinicians will also complete a 20 minute online learning module delivered via the local health district clinician online learning platform. Training content will be adapted from the nationally accredited ‘Women Want to Know’ course developed by the Foundation for Alcohol Research and Education in partnership with the Australian Government Department of Health. Training will improve clinician knowledge and skills in addressing alcohol use in pregnancy, and will cover content including: * Recommendations for alcohol consumption in pregnancy based on The National Health and Medical Research Council Alcohol Guidelines. *Recommended care for addressing alcohol use in pregnancy based on the Australian Antenatal Care Clinical Practice Guidelines and New South Wales Guidelines for the Management of Substance Use During Pregnancy, Birth and the Postnatal Period. *Effects of alcohol consumption in pregnancy and associated adverse health outcomes for the fetus and child. *Providing recommended care for addressing alcohol use in pregnancy in-line with clinical practice guidelines including 1) alcohol use assessment, 2) brief advice and 3) referral for ongoing care. Monitoring and feedback: Antenatal service managers will be supported to build capacity in accessing, interpreting and monitoring performance measures for clinician provision of recommended care for addressing alcohol use in pregnancy. Performance measures will be built into antenatal services’ existing monitoring and accountability frameworks including Operational Plans, formal performance measures, Sector Performance Report, 90 day action plans, and Monthly Accountability Meetings.

Sponsors

University of Newcastle
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

All pregnant women who have had attended at least one face-to-face antenatal appointment with an obstetrics focus for a booking in visit, 28 week visit, or 36 week visit within three health sectors of the Hunter New England Local Health District (HNELHD) of New South Wales, Australia who meet the following inclusion criteria will be eligible for participation: • Attending HNELHD maternity service for antenatal care in Greater Newcastle, Peel or Lower Mid North Coast Sectors. • Aged 18 years or older. • More than 12 weeks gestation and less than 37 weeks gestation at time of the appointment. • English proficient to complete a survey. • Mentally and physically capable of completing a survey. • Attended the appointment of interest in the previous week.

Exclusion criteria

Pregnant women will be excluded if they are determined by clinical discretion to be inappropriate to contact for the telephone/online survey (e.g. medical or social issues). Women will not be sampled if they are less than 18 years of age, are under 12 weeks or over 37 weeks gestation, are receiving antenatal care via a private provider, or have already given birth or had a negative pregnancy outcome (e.g. miscarriage).

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 5, 2026