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Trial registered on ANZCTR


Registration number
ACTRN12622000295741
Ethics application status
Approved
Date submitted
10/02/2022
Date registered
16/02/2022
Date last updated
7/02/2023
Date data sharing statement initially provided
16/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
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?
Scientific title
The efficacy of successive implementation intervention on routine provision of antenatal care addressing alcohol consumption during pregnancy: a stepped-wedge controlled trial
Secondary ID [1] 306392 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol consumption in pregnancy 325219 0
Harmful alcohol consumption 325220 0
Fetal alcohol exposure 325221 0
Condition category
Condition code
Public Health 322622 322622 0 0
Health service research
Public Health 322623 322623 0 0
Health promotion/education
Reproductive Health and Childbirth 322624 322624 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 322827 0
Prevention
Intervention code [2] 322828 0
Behaviour
Comparator / control treatment
In the baseline data collection phase, usual antenatal care for addressing alcohol consumption during pregnancy will be provided as per the services’ uptake of the recommended model of care following the initial practice change intervention. The baseline period will serve as the control for the intervention periods, with each sector acting as its own control. Due to the stepped-wedge study design, the baseline phase will be of varying lengths for the three sectors (Sector One: 6 months; Sector Two: 10 months; and Sector Three: 14 months).
Control group
Active

Outcomes
Primary outcome [1] 330416 0
The proportion of women that report being asked about alcohol consumption at subsequent antenatal visits.

Self-reported data will be collected through telephone or online surveys with pregnant women receiving antenatal care from the maternity services within the three sectors involved in the trial. The survey instrument was designed specifically for the study and used in the previous trial.
Timepoint [1] 330416 0
Continuous cross-sectional data collection on a weekly basis for 23 months for two antenatal visit time-points: 28 weeks gestation visit and 36 weeks gestation visit.

Baseline data will be gathered for 6, 10 and 14 months prior to the intervention (sectors one, two and three respectively). Post-intervention data will be gathered for 14, 10 and 6 months (sectors one, two and three respectively).
Primary outcome [2] 330417 0
The proportion of women that report receiving complete care (advice and referral) relative to their level of alcohol risk at subsequent antenatal visits.

Self-reported data will be collected through telephone or online surveys with pregnant women receiving antenatal care from the maternity services within the three sectors involved in the trial. The survey instrument was designed specifically for the study and used in the previous trial.
Timepoint [2] 330417 0
Continuous cross-sectional data collection on a weekly basis for 23 months for two antenatal visit time-points: 28 weeks gestation visit and 36 weeks gestation visit.

Baseline data will be gathered for 6, 10 and 14 months prior to the intervention (sectors one, two and three respectively). Post-intervention data will be gathered for 14, 10 and 6 months (sectors one, two and three respectively).
Primary outcome [3] 330418 0
The proportion of women that report receiving complete care (advice and referral) relative to their level of alcohol risk at the initial antenatal visit.

Self-reported data will be collected through telephone or online surveys with pregnant women receiving antenatal care from the maternity services within the three sectors involved in the trial. The survey instrument was designed specifically for the study and used in the previous trial.
Timepoint [3] 330418 0
Continuous cross-sectional data collection on a weekly basis for 23 months for the initial antenatal visit.

Baseline data will be gathered for 6, 10 and 14 months prior to the intervention (sectors one, two and three respectively). Post-intervention data will be gathered for 14, 10 and 6 months (sectors one, two and three respectively).
Secondary outcome [1] 406139 0
Fidelity, penetration and acceptability of the implementation intervention will be collected using project management logs and validated measures where available.
Timepoint [1] 406139 0
Project management logs, audit of files and cross-sectional surveys with maternity service staff within three months post-intervention.
Secondary outcome [2] 406140 0
A cost analysis will measure and value resources used in the delivery of the intervention. Data regarding resources expended on materials, labour and other expenses will be recorded in project management logs. Research costs will be excluded.
Timepoint [2] 406140 0
Data will be entered into project management logs on a weekly basis throughout the entire study period.

Eligibility
Key inclusion criteria
All maternity service staff will participate in the implementation intervention as part of routine service improvement and will be offered the opportunity to participate in surveys post the intervention.

All pregnant women who attended an initial antenatal visit, 28 weeks gestation visit or 36 weeks gestation visit in the past week with a participating maternity service will be eligible for participation in study surveys based on the following criteria:
- Aged 18 years or older.
- More than 12 weeks and less than 37 weeks’ gestation at time of the appointment.
- English sufficiently proficient to complete a survey.
- Mentally and physically capable of completing a survey.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key 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, less than 12 weeks or over 37 weeks’ gestation, are receiving antenatal care via a private provider, or have given birth or had a negative pregnancy outcome (e.g. miscarriage).

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
A stepped-wedge controlled trial will be used to assess aim 1 and 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.

For aim 2 the data collected from the stepped wedge trial with an additional 4 months of post-intervention data from all 3 sectors will be re-analysed using a multiple baseline design. This design will assess whether the proportion of women who receive the recommended model of antenatal care increases and sustains over time, following the implementation intervention.

For aim 1 data will be gathered across all three sectors continuously for a period of 23 months. Baseline data will be gathered for 6, 10 and 14 months prior to the intervention (sectors one, two and three respectively). Post-intervention data will be gathered for 14, 10 and 6 months (sectors one, two and three respectively). For aim 2 an additional 6 months of post-intervention data will be collected for all 3 sectors to allow for a more prolonged assessment of sustainment.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Assuming that 225 women will complete a survey per month (approximately 150 for subsequent antenatal visit time points and 75 for the initial antenatal visit time point), we will have 80% power to detect an absolute increase of approximately (i) 15% in being asked about alcohol consumption at subsequent antenatal visits (baseline prevalence of 42%); (ii) 13% in complete care at subsequent antenatal visits (baseline prevalence of 23%); and (iii) 21% in complete care at initial antenatal visits (baseline prevalence of 45%). This is assuming an ICC of 0.01 and an alpha level of 1.67% (Bonferroni adjusted for the 3 primary outcomes).

To address the first aim pre-post differences in the proportion of women reporting receipt of care for each of the three primary outcomes will be compared using generalised linear models with a binomial distribution and logit link function. These models will compare the odds of receiving care at post the implementation intervention versus pre-intervention. Each model will contain a term for period (pre or post intervention), sector (one, two, three), antenatal visit for the outcomes on subsequent antenatal visits (28 weeks gestation, 36 weeks gestation) and time (in months). An alpha level of 1.67% (Bonferroni adjusted for 3 primary outcomes) will be used to determine statistical significance. The odds ratio and 95% confidence limit from the term for period will be presented as the intervention effect.

For the second aim, segmented regression within an interrupted time-series framework will be used to assess women’s receipt of care over time, and whether this improves and sustains following the delivery of the implementation intervention. These analyses will be on the same three primary outcomes assessed in the pre-post difference analyses and will be conducted separately for each of the three health sectors. Following a multiple baseline design replication of findings across the three sectors will lend greater confidence in the intervention effect Three segments will be specified in each segmented regression, one for each of the study phases (i.e. pre-intervention, intervention and post-intervention). The trend in the delivery of care will be estimated for each of the three segments.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2022
Actual
1/04/2022
Date of last participant enrolment
Anticipated
13/02/2023
Actual
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
6525
Accrual to date
4000
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 21695 0
John Hunter Hospital - New Lambton
Recruitment hospital [2] 21696 0
Belmont Hospital - Belmont
Recruitment hospital [3] 21697 0
Manning Rural Referral Hospital (Taree) - Taree
Recruitment hospital [4] 21698 0
Tamworth Rural Referral Hospital - Tamworth
Recruitment hospital [5] 21699 0
Gunnedah District Hospital - Gunnedah
Recruitment hospital [6] 21700 0
Quirindi Community Hospital - Quirindi
Recruitment postcode(s) [1] 36740 0
2305 - New Lambton
Recruitment postcode(s) [2] 36741 0
2280 - Belmont
Recruitment postcode(s) [3] 36742 0
2430 - Taree
Recruitment postcode(s) [4] 36743 0
2340 - Tamworth
Recruitment postcode(s) [5] 36744 0
2380 - Gunnedah
Recruitment postcode(s) [6] 36745 0
2343 - Quirindi

Funding & Sponsors
Funding source category [1] 310745 0
Government body
Name [1] 310745 0
Hunter New England Local Health District – Clinical Services, Nursing and Midwifery
Country [1] 310745 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive, Callaghan, NSW, 2308
Country
Australia
Secondary sponsor category [1] 311969 0
None
Name [1] 311969 0
Address [1] 311969 0
Country [1] 311969 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310320 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 310320 0
Ethics committee country [1] 310320 0
Australia
Date submitted for ethics approval [1] 310320 0
31/10/2016
Approval date [1] 310320 0
14/12/2016
Ethics approval number [1] 310320 0
16/11/16/4.07
Ethics committee name [2] 310322 0
Aboriginal Health and Medical Research Council Ethics Committee
Ethics committee address [2] 310322 0
Ethics committee country [2] 310322 0
Australia
Date submitted for ethics approval [2] 310322 0
21/11/2016
Approval date [2] 310322 0
03/02/2017
Ethics approval number [2] 310322 0
1236/16
Ethics committee name [3] 310323 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [3] 310323 0
Ethics committee country [3] 310323 0
Australia
Date submitted for ethics approval [3] 310323 0
01/02/2017
Approval date [3] 310323 0
09/02/2017
Ethics approval number [3] 310323 0
H-2017-0032

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117242 0
Ms Emma Doherty
Address 117242 0
Population Health, Hunter New England Local Health District
Locked Bag 10, Wallsend, NSW, 2287
Country 117242 0
Australia
Phone 117242 0
+61 2 49246374
Fax 117242 0
+61 2 49246048
Email 117242 0
[email protected]
Contact person for public queries
Name 117243 0
Emma Doherty
Address 117243 0
Population Health, Hunter New England Local Health District
Locked Bag 10, Wallsend, NSW, 2287
Country 117243 0
Australia
Phone 117243 0
+61 2 49246374
Fax 117243 0
+61 2 49246048
Email 117243 0
[email protected]
Contact person for scientific queries
Name 117244 0
Emma Doherty
Address 117244 0
Population Health, Hunter New England Local Health District
Locked Bag 10, Wallsend, NSW, 2287
Country 117244 0
Australia
Phone 117244 0
+61 2 49246374
Fax 117244 0
+61 2 49246048
Email 117244 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
There is no ethical approval to share individual participant data


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseIterative delivery of an implementation support package to increase and sustain the routine provision of antenatal care addressing alcohol consumption during pregnancy: Study protocol for a stepped-wedge cluster trial.2022https://dx.doi.org/10.1136/bmjopen-2022-063486
N.B. These documents automatically identified may not have been verified by the study sponsor.