RecruitingACTRN12622000295741

Can a successive implementation intervention that is informed by learnings from an initial trial further increase and sustain the routine provision of antenatal care addressing alcohol consumption during pregnancy?

The efficacy of successive implementation intervention on routine provision of antenatal care addressing alcohol consumption during pregnancy: a stepped-wedge controlled trial


Sponsor

University of Newcastle

Enrollment

6,525 participants

Start Date

Apr 1, 2022

Study Type

Interventional

Conditions

Summary

In line with iterative improvement approaches, a successive implementation intervention will be delivered in the same maternity services that participated in an initial practice change intervention trial in 2018-2019. The trial has two aims: 1) to increase the proportion of pregnant women who receive the recommended model of antenatal care addressing alcohol consumption; and 2) sustain the rate of care provision over time. A three-month implementation intervention will be delivered. Three strategies will be used to support increases in the proportion of pregnant women who receive the recommended model of antenatal care addressing alcohol consumption: remind clinicians; facilitation; and conduct educational meetings. Three strategies will be implemented to support sustain the rate of care provision over time: develop a formal implementation blueprint; purposely re-examine the implementation and conduct ongoing training. Cross-sectional data will be collected via telephone and online interviews with a random sample of women who attend the participating maternity services each week. The primary outcomes of the trial include: i) proportion of women that report being asked about alcohol consumption at subsequent antenatal visits; ii) proportion of women that report receiving complete care (advice and referral) relative to their level of alcohol risk at subsequent antenatal visits; and iii) proportion of women that report receiving complete care (advice and referral) relative to their level of alcohol risk at the initial antenatal visit. Intervention fidelity, penetration, acceptability and costs will be measured as secondary outcomes. A stepped-wedge controlled study design will be used to assess aim 1. It will determine whether the average proportion of women who received the recommended model of antenatal care for all three primary outcomes is higher post-intervention compared to pre-intervention. Aim 2 will use a multiple baseline design to assess whether the proportion of women who receive the recommended model of antenatal care increases and sustains following delivery of the implementation intervention.


Eligibility

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Drinking alcohol during pregnancy carries risks for both mother and baby, yet many pregnant women are not being asked about their alcohol use at prenatal appointments or given appropriate advice. This Australian study is working to change that by improving how maternity services routinely address alcohol during antenatal care. Building on an earlier trial, this study delivers a fresh round of implementation support to maternity clinics — including reminders, training, and facilitation — to help staff consistently ask about alcohol, give advice, and refer women who need further support. Researchers will measure whether these efforts lead to lasting improvements in care. You may be eligible to participate in the survey component if you are a pregnant woman aged 18 or older, between 12 and 37 weeks pregnant, who has recently attended an antenatal appointment at one of the participating maternity services. Women who are under 18, very early or late in pregnancy, receiving only private care, or have had a pregnancy loss are not eligible.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

A seven-month practice change intervention was implemented in all maternity services across three sectors in the Hunter New England Local Health District in 2018-2019 to support the introduction of a

A seven-month practice change intervention was implemented in all maternity services across three sectors in the Hunter New England Local Health District in 2018-2019 to support the introduction of a recommended model of care for addressing alcohol consumption during pregnancy. The model of care consisted of three key elements: i) assessment of alcohol consumption; ii) advice not to consume alcohol during pregnancy and explanation of the potential risks; and iii) referral to specialist support if required. The model of care was to be implemented as part of routine practice at three antenatal visits: i) initial antenatal visit; ii) 28 weeks gestation; and iii) 36 weeks gestation. The practice change intervention was found to be effective in increasing pregnant women’s receipt of all elements of the recommended model of care at all antenatal visit types. There was a significant decline in care receipt post the intervention. In line with iterative improvement approaches, such as continuous quality improvement commonly used in healthcare settings, a successive implementation intervention will be delivered in the same maternity services that participated in the initial trial. The development of the intervention has been informed by data and learnings from the initial trial. The trial has two aims: 1. to increase the proportion of pregnant women who receive the recommended model of antenatal care addressing alcohol consumption; and 2. to sustain the rate of care provision over time. A three-month intervention that consists of the following implementation and sustainability strategies will be delivered to the participating maternity services. Strategies to support increases in the proportion of pregnant women who receive recommended antenatal care addressing alcohol consumption • Remind clinicians: Point of care prompts for assessment of alcohol consumption at subsequent antenatal visits and advice on the risks of alcohol consumption in pregnancy will be included on women’s medical records. There will be three prompts in total, one for each antenatal visit (initial antenatal visit, 28 weeks gestation and 36 weeks gestation). The placement of the prompts will be tailored to fit with each service’s usual clinical workflow. The prompts will include a place to record that action was taken in the visit. To support the ongoing availability of this strategy, staff who are usually responsible for ordering resources and managing medical record files in each of the services will receive instruction in the ordering and placement of the prompts in the women’s medical records. This strategy will be implemented in month one of the intervention. • Conduct educational meetings: A 15-minute educational meeting will be conducted with antenatal providers. The meeting will include persuasive education on the harms of alcohol consumption during pregnancy delivered by a Paediatrician with clinical expertise in Fetal Alcohol Spectrum Disorder. A Clinical Midwife Educator will guide a discussion on the purpose of providing assessment and care for alcohol consumption in multiple antenatal visits. The discussion will focus on reasons women’s responses to the alcohol questions may change between visits and the consequences of not providing care to all women regardless of disclosure. Maternity services will be supported to incorporate this education into existing resources and schedules. This strategy will be implemented in month one of the intervention. • Facilitation: A Clinical Midwife Educator will facilitate a process of interactive problem solving with antenatal providers to identify behavioural cues for providing assessment and care within antenatal visit clinical workflow. Individual action plans that document the identified cues will be developed. Facilitation will occur in individual face-to-face meetings using a guide and action plan template developed by the project team. Each session will take approximately 15 minutes. Examples of identified behavioural cues will be included in existing training and resources for new antenatal providers. This strategy will be implemented in month two of the intervention. Strategies to support sustainment of the rate of care provision over time • Conduct ongoing training: Existing Clinical Midwife Educators in each of the services will receive resources to conduct and schedule training for new staff and top-up training for existing staff. Resources provided will include training slides, videos and educational handouts that will be saved on an online platform used by Clinical Midwife Educators. An example schedule for providing training opportunities to new and existing staff will also be saved. All resources will be developed by the project team specifically for this study. This strategy will be implemented in month two of the intervention. • Develop a formal implementation blueprint: A formal implementation blueprint that plans for sustainability will be developed and agreed to by maternity service leads in consultation with the supporting agency (Population Health Unit within the same Local Health District as the maternity services) during the intervention. The plan will define the roles and responsibilities of maternity services in the continued provision of the model of care as part of routine practice. It will also define the roles and responsibilities of key maternity service groups/positions and the supporting agency in ensuring the ongoing availability, use and maintenance of the strategies that have been implemented to support practice. The implementation blueprint will be finalised during a one hour face-to-face leadership meeting between maternity service leads and the supporting agency. This strategy will be implemented in month three of the intervention. • Purposely re-examine the implementation: A process for reviewing the formal implementation blueprint will be developed and agreed to by maternity service leads in consultation with the supporting agency during the intervention. The review will provide a mechanism to identify whether adaptions to the model of care and strategies supporting practice need to be made. The review will be conducted using a template developed by the project team that will be completed by maternity service leads in consultation with the supporting agency. The first review will occur within 12 months from the commencement of the intervention in each maternity service and will take approximately two hours. This strategy will be implemented in month three of the intervention.


Locations(6)

John Hunter Hospital - New Lambton

NSW, Australia

Belmont Hospital - Belmont

NSW, Australia

Manning Rural Referral Hospital (Taree) - Taree

NSW, Australia

Tamworth Rural Referral Hospital - Tamworth

NSW, Australia

Gunnedah District Hospital - Gunnedah

NSW, Australia

Quirindi Community Hospital - Quirindi

NSW, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12622000295741


Related Trials