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Trial registered on ANZCTR


Registration number
ACTRN12617000882325
Ethics application status
Approved
Date submitted
21/05/2017
Date registered
16/06/2017
Date last updated
9/12/2020
Date data sharing statement initially provided
26/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of a practice change intervention to increase the provision of recommended care for addressing maternal alcohol consumption during pregnancy.
Scientific title
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.
Secondary ID [1] 292004 0
'Nil'
Universal Trial Number (UTN)
U1111-1197-2949
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol consumption in pregnancy 303388 0
Harmful alcohol consumption
 303389 0
Fetal alcohol exposure

 303390 0
Fetal Alcohol Spectrum Disorder (FASD)
 303391 0
Condition category
Condition code
Public Health 302802 302802 0 0
Health service research
Public Health 302803 302803 0 0
Health promotion/education
Reproductive Health and Childbirth 302804 302804 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 298136 0
Prevention
Intervention code [2] 298277 0
Behaviour
Comparator / control treatment
Continuous data collected during the baseline period will measure usual antenatal care (i.e. standard care) for addressing alcohol in pregnancy and will serve as the control for the intervention periods, with each health sector serving as its own control. Baseline data will be collected for each of the three sectors from seven months prior to the commencement of the intervention in the first sector to the start of the intervention in each sector.
Control group
Active

Outcomes
Primary outcome [1] 302183 0
Client reported receipt of guideline recommended antenatal care for addressing alcohol use in pregnancy. Recommended antenatal care for addressing alcohol use is defined as the client having received either: 1) assessment of alcohol consumption and provision of brief advice (for all pregnant clients), and 2) referral to specialist services for clients screening at medium or high risk from alcohol consumption.

Self-reported data will be collected through undertaking telephone or online surveys with pregnant women receiving care from antenatal services within three health sectors involved in the intervention. The survey instrument was designed specifically for the current study, and includes the validated AUDIT-C alcohol screening tool. For the purposes of participant information statements, the survey is referred to as "Survey for pregnant women having antenatal care with Hunter New England Local Health District maternity services – Regarding alcohol and pregnancy." To enhance cultural safety and appropriateness of proposed data collection methods, Aboriginal women and/or women receiving antenatal care from an AMIHS (Aboriginal Maternal and Infant Health Service) will be offered the choice of doing the survey via computer-assisted telephone interview (CATI) or online.
Timepoint [1] 302183 0
Continuous cross-sectional data collection on a weekly basis for 34 months for three antenatal appointment time-points: booking in visit, 28 week visit and 36 week visit. Data will be gathered across all three health sectors from seven months prior to the commencement of the intervention in the first sector to the start of the intervention in each sector and continued until seven months post intervention in the third sector.
Primary outcome [2] 302184 0
Additional primary outcomes gathered will include the proportion of client's reporting that they received each recommended element of care: 1) alcohol assessment, 2) brief advice, and 3) brief advice and referral to specialist services (for those screened at medium or high risk alcohol consumption). This will be collected via the study specific survey: "Survey for pregnant women having antenatal care with Hunter New England Local Health District maternity services – Regarding alcohol and pregnancy," which includes the validated AUDIT-C alcohol assessment tool.
Timepoint [2] 302184 0
Continuous cross-sectional data collection on a weekly basis for 34 months for three antenatal appointment time-points: booking in visit, 28 week visit and 36 week visit. Data will be gathered across all three health sectors from seven months prior to the commencement of the intervention in the first sector to the start of the intervention in each sector and continued until seven months post intervention in the third sector.
Secondary outcome [1] 335117 0
Client reported alcohol use since pregnancy recognition will be obtained using the validated AUDIT-C alcohol screening tool. This will be collected via the study specific survey: "Survey for pregnant women having antenatal care with Hunter New England Local Health District maternity services – Regarding alcohol and pregnancy."
Timepoint [1] 335117 0
Continuous cross-sectional data collection on a weekly basis for 34 months for three antenatal appointment time-points: booking in visit, 28 week visit and 36 week visit. Data will be gathered across all three health sectors from seven months prior to the commencement of the intervention in the first sector to the start of the intervention in each sector and continued until seven months post intervention in the third sector.
Secondary outcome [2] 335118 0
Clinician self-reported acceptability of the model of care and of the intervention implementation strategies will be assessed by a survey designed specifically for the current study at the completion of the intervention in each service. All clinicians that provide antenatal care within the three intervention health sectors will be invited to participate in the survey.
Timepoint [2] 335118 0
Post intervention measurement directly following intervention in each sector.
Secondary outcome [3] 335119 0
Cost analysis will be examined based on the resources expended by the research team in terms of materials, labour and other related expenses associated with achieving practice change. The main outcome from the cost analysis will be an estimate of the annual net cost of implementing the practice change intervention. These resources will be recorded in project management logs. Labour costs regarding training, quality assurance processes, managerial oversight and the activities undertaken by the clinical midwife educators will be recorded.
Timepoint [3] 335119 0
Data will be entered into project management logs on a fortnightly basis throughout the entire study period.
Secondary outcome [4] 335819 0
Client reported acceptability of alcohol care received during antenatal consultations, and of referrals (where relevant) will be collected in the telephone/online surveys using study specific questions.
Timepoint [4] 335819 0
Continuous cross-sectional data collection on a weekly basis for 34 months for three antenatal appointment time-points: booking in visit, 28 week visit and 36 week visit. Data will be gathered across all three health sectors from seven months prior to the commencement of the intervention in the first sector to the start of the intervention in each sector and continued until seven months post intervention in the third sector.

Eligibility
Key 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.
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, 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).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The three health sectors will be randomly allocated to the stepped order of the intervention implementation (first, second, third). The services within these three sectors will be aware of the allocated order of the intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation of the three health sectors will be completed by a statistician independent of the study, using simple randomisation with a computer random number generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Other
Other design features
Stepped-wedge controlled trial. Data will be gathered across all three health sectors from seven months prior to the commencement of the intervention in the first sector to the start of the intervention in each sector and continued until seven months post intervention in the third sector. The 7 month long intervention will be delivered to the three participating sectors sequentially in a random order at six-monthly intervals.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
It is expected that 70% of invited clients will consent to participate in the surveys (based on previous work by the research team). Assuming 48 working weeks a year, a sample of 200 women per month (approximately 67 women per each of the three time points: booking in visit, 28 week visit, 36 week visit) will give the study 80% power to detect an absolute increase in care provision of 15% in the intervention period (based on a conservative 50% estimate of prevalence of care provision pre-intervention) in at least one of the four primary outcomes at a 1.25% significance threshold. Assuming there are approximately 190 women eligible per week, a weekly sample of 72 women (i.e. 24 women per time point) with a 70% survey completion rate (n=50) will result in the required number of women needed per month.

Pre and post-intervention primary outcomes data will be analysed using logistic regression to detect change in the reported receipt of recommended antenatal care for addressing alcohol use in pregnancy. The model will include fixed effects for client group and health sector. The main predictor of interest will be a before/after intervention indicator variable which, after adjusting for health sector, will provide a weighted average of the effect within each health sector.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/06/2017
Actual
3/07/2017
Date of last participant enrolment
Anticipated
16/03/2020
Actual
18/05/2020
Date of last data collection
Anticipated
31/03/2020
Actual
6/06/2020
Sample size
Target
6800
Accrual to date
Final
6942
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 8069 0
John Hunter Hospital - New Lambton
Recruitment hospital [2] 8070 0
Belmont Hospital - Belmont
Recruitment hospital [3] 8071 0
Manning Rural Referral Hospital (Taree) - Taree
Recruitment hospital [4] 8072 0
Tamworth Rural Referral Hospital - Tamworth
Recruitment hospital [5] 8073 0
Gunnedah District Hospital - Gunnedah
Recruitment hospital [6] 8074 0
Quirindi Community Hospital - Quirindi
Recruitment postcode(s) [1] 16112 0
2305 - New Lambton
Recruitment postcode(s) [2] 16113 0
2280 - Belmont
Recruitment postcode(s) [3] 16114 0
2430 - Taree
Recruitment postcode(s) [4] 16115 0
2340 - Tamworth
Recruitment postcode(s) [5] 16116 0
2380 - Gunnedah
Recruitment postcode(s) [6] 16117 0
2343 - Quirindi

Funding & Sponsors
Funding source category [1] 296525 0
Government body
Name [1] 296525 0
National Health and Medical Research Council - Partnership Grant
Country [1] 296525 0
Australia
Funding source category [2] 296526 0
Government body
Name [2] 296526 0
Hunter New England Local Health District (Drug and Alcohol Clinical Services)
Country [2] 296526 0
Australia
Funding source category [3] 296527 0
Government body
Name [3] 296527 0
NSW Office of Preventive Health
Country [3] 296527 0
Australia
Funding source category [4] 296528 0
Government body
Name [4] 296528 0
Hunter New England Local Health District (Clinical Services Nursing and Midwifery)
Country [4] 296528 0
Australia
Funding source category [5] 296529 0
Charities/Societies/Foundations
Name [5] 296529 0
Foundation of Alcohol Research and Education (FARE)
Country [5] 296529 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive,
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 295484 0
None
Name [1] 295484 0
Address [1] 295484 0
Country [1] 295484 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297743 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 297743 0
Ethics committee country [1] 297743 0
Australia
Date submitted for ethics approval [1] 297743 0
31/10/2016
Approval date [1] 297743 0
14/12/2016
Ethics approval number [1] 297743 0
16/11/16/4.07
Ethics committee name [2] 297744 0
Aboriginal Health and Medical Research Council
Ethics committee address [2] 297744 0
Ethics committee country [2] 297744 0
Australia
Date submitted for ethics approval [2] 297744 0
21/11/2016
Approval date [2] 297744 0
03/02/2017
Ethics approval number [2] 297744 0
1236/16
Ethics committee name [3] 297745 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [3] 297745 0
Ethics committee country [3] 297745 0
Australia
Date submitted for ethics approval [3] 297745 0
01/02/2017
Approval date [3] 297745 0
09/02/2017
Ethics approval number [3] 297745 0
H-2017-0032

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

Contacts
Principal investigator
Name 74998 0
Prof John Wiggers
Address 74998 0
Hunter New England Population Health
Locked Bag 10
Wallsend, NSW 2287
Country 74998 0
Australia
Phone 74998 0
+61 2 4924 6247
Fax 74998 0
+61 2 4924 6048
Email 74998 0
John.Wiggers@hnehealth.nsw.gov.au
Contact person for public queries
Name 74999 0
John Wiggers
Address 74999 0
Hunter New England Population Health
Locked Bag 10
Wallsend, NSW 2287
Country 74999 0
Australia
Phone 74999 0
+61 2 4924 6247
Fax 74999 0
+61 2 4924 6048
Email 74999 0
John.Wiggers@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 75000 0
John Wiggers
Address 75000 0
Hunter New England Population Health
Locked Bag 10
Wallsend, NSW 2287
Country 75000 0
Australia
Phone 75000 0
+61 2 4924 6247
Fax 75000 0
+61 2 4924 6048
Email 75000 0
John.Wiggers@hnehealth.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10015Study protocolKingsland, M., Doherty, E., Anderson, A.E. et al. A practice change intervention to improve antenatal care addressing alcohol consumption by women during pregnancy: research protocol for a randomised stepped-wedge cluster trial. Implementation Sci 13, 112 (2018). https://doi.org/10.1186/s13012-018-0806-x melanie.kingsland@health.nsw.gov.au



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA practice change intervention to improve antenatal care addressing alcohol consumption by women during pregnancy: research protocol for a randomised stepped-wedge cluster trial.2018https://dx.doi.org/10.1186/s13012-018-0806-x
EmbasePractice change intervention to improve antenatal care addressing alcohol consumption during pregnancy: a randomised stepped-wedge controlled trial.2022https://dx.doi.org/10.1186/s12884-022-04646-7
N.B. These documents automatically identified may not have been verified by the study sponsor.