ANZCTR - Registration

Registration number

ACTRN12621000054819

Ethics application status

Approved

Date submitted

30/09/2020

Date registered

22/01/2021

Date last updated

5/07/2024

Date data sharing statement initially provided

22/01/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

Can we increase the routine provision of antenatal care addressing gestational weight gain for pregnant women through a clinical practice change intervention?

Scientific title

A practice change intervention to increase the routine provision of antenatal care addressing gestational weight gain: a stepped-wedge controlled trial

Secondary ID [1]

NIL

Universal Trial Number (UTN)

U1111-1257-2702

Trial acronym

NA

Linked study record

NA

Health condition

Health condition(s) or problem(s) studied:

Gestational weight gain

Nutrition in pregnancy

Physical activity in pregnancy

Condition category

Condition code

Public Health

Health service research

Public Health

Health promotion/education

Reproductive Health and Childbirth

Antenatal care

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

A 5 1/2-month multi-component clinical practice change intervention will be implemented across Maternity Services in three health sectors. The practice change intervention will involve two components:

1. Best practice care pathway: Implementation support strategies will be used to support the routine implementation of the following best practice care pathway for gestational weight gain during existing antenatal appointments for all pregnant women. Care will be delivered within existing timing for antenatal appointments, with no additional time added, and the time taken on additional components will be monitored. The intervention will support the delivery of recommended antenatal care through the usual mode of providing antenatal care at each maternity service, and can include face-to-face, telephone and/or video conference consultations. The best practice pathway is consistent with clinical guidelines and based on a condensed version of the recommended ‘5A’s’ behavioural counselling framework:
i. Assess gestational weight gain, using objective measures of weight, and compare against recommended weight gain targets (based on pre-pregnancy BMI);
ii. Advise/Discuss gestational weight gain and nutrition and physical activity; and,
iii. Offer to Arrange a referral to the NSW Get Healthy in Pregnancy (GHiP) Service, a free evidence-based state-wide telephone coaching service for all pregnant women and, for all women who are gaining weight outside their recommended weight gain target, a referral to local dietetics services. For all Aboriginal women and/or those having Aboriginal babies, offer culturally appropriate support pathway for dietetics services where available. For women who have previously been referred to one of these services, discuss progress.

2. Implementation support strategies: The following organisational and clinician-focused strategies will support clinician implementation of the above care pathway.

Leadership: Existing clinical networks and antenatal clinical leaders will be engaged prior to and during the intervention period to facilitate ongoing authorisation and endorsement of the initiative. This will include the presence of clinical leaders at training and through communication of performance and feedback. A clinical expert group will provide clinical guidance across all components of the intervention. Aboriginal Health staff will provide oversight on cultural appropriateness of the intervention.

Prompts and reminders: The electronic maternity medical record used by antenatal clinicians at point of care will be modified to prompt standardised assessment, brief advice and referral for gestational weight gain. Physical point of care prompts will also be provided, including stickers in the antenatal care record, and a clinic room flip chart, to prompt recommended care delivery.

Local guidelines and procedures: Will be developed to outline the care pathway elements, including local service referral options and procedures for each maternity service site.

Service champion: A Clinical Midwife Educator (CME) will be allocated to each of the three health sectors for the five-and-a-half month intervention phase to facilitate the implementation of the practice change intervention in each service. They will train and advise staff, monitor performance and provide feedback to antenatal clinicians and service managers.

Clinician training and resources: Multi-mode (online and face-to-face) training will be provided to clinicians in each maternity service, facilitated by the CMEs. Staff will participate in a 35 minute face-to-face training session during the intervention. Face-to-face training sessions will be rostered into the routine educational sessions, with the delivery of the training sessions (e.g. timing and number of repeat training sessions) decided by each maternity service as per local need. The training will focus on addressing identified barriers to care delivery and use evidence-based training elements including interactive components and case studies. The online GWG training module is estimated to take 20 minutes to complete. Printed resources to support clinician delivery of recommended care will be provided to each maternity service.

Care delivery monitoring and feedback (including academic detailing): Data on patient-reported receipt of care and from electronic medical records will be used to compile monthly reports of guideline recommended care delivery. Antenatal clinic managers will be supported to access, interpret and monitor performance measures. Services will be supported to set care delivery goals, monitor progress and develop action plans in response to feedback. Performance measures will be built into maternity services’ existing monitoring accountability frameworks, including operational plans and Monthly Accountability Meetings.

To finalise the local tailoring of the above practice change strategies, a formative survey will be undertaken with antenatal clinicians to elicit care delivery barriers. The survey will be based on the based on the Theoretical Domains Framework (TDF) to prioritise barriers and strategies and provide an intervention investment hierarchy.

The implementation support strategies will be delivered to participating maternity services at the same time as they will commence delivering the ‘best practice care pathway’ - at the commencement of the 5 1/2 month intervention period in each maternity service.

All implementation support strategies have been co-developed and approved to be implemented at all participating maternity services by the executive leadership group. All strategies will be implemented in each maternity service, however the concentration of time and effort on individual strategies will be dependent on the results of formative staff survey which will ask staff to rank their key barriers to providing recommended care. These key barriers will be mapped to Behaviour Change Techniques and implementation strategies to identify the priority strategies to support practice change at that site.

Launch of the implementation support strategies will commence on day 1 of the 5 1/2-month intervention period, starting with training sessions and a memo from operational management with staff encouraged to uptake the new best practice care pathway from that point onwards, with all implementation strategies provided across the 5 1/2 month intervention period.

The study will involve continuous outcome data collection over 31 months. The 5 1/2 month intervention will be delivered sequentially in three services at 5 1/2-monthly intervals. Outcome data will be collected from 4 months prior to intervention delivery in the first service, to 12 months following intervention completion in the last service.

eMaternity data (electronic medical record system) and women’s self-reported care receipt following antenatal appointments (collected through telephone interviews and online surveys) will be used to monitor clinician provision of care adherent to the best practice care pathway. Adherence to implementation strategies (i.e. log of delivery of each implementation support strategy, including training completion and resource logs) will also be monitored.

Intervention code [1]

Prevention

Intervention code [2]

Behaviour

Comparator / control treatment

During the pre-intervention (control) phase for each participating service, usual antenatal care for addressing gestational weight gain (i.e. standard care) will be provided to patients according to existing care pathways, including any quality improvement strategies being implemented according to local practice.

Data collected during the baseline periods for each of the three sectors will measure usual antenatal care (i.e. standard care) for addressing gestational weight gain in pregnancy and will serve as the control for the intervention periods, with each health sector serving as its own control.

Control group

Active

Outcomes

Primary outcome [1]

The proportion of participants that report receiving an assessment of gestational weight gain using objective measures of weight against recommended weight gain targets.

Self-reported data will be collected through telephone or online surveys with pregnant women receiving antenatal care from the maternity services within the three health sectors involved in the trial. The survey instrument was designed specifically for the study. To enhance cultural safety and appropriateness of 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]

Continuous cross-sectional data collection on a weekly basis for 31 months for three antenatal appointment time-points: first/booking in appointment, 28 week gestation appointment and 36 week gestation appointment. Baseline data will be gathered for all three health sectors from 4 months prior to the intervention in the first health sector and data collection will continue until 12 months post intervention in the third health sector.

Primary outcome [2]

The proportion of participants that report receiving advice on gestational weight gain, nutrition and physical activity.

Self-reported data will be collected through telephone or online surveys with pregnant women receiving antenatal care from the maternity services within the three health sectors involved in the trial. The survey instrument was designed specifically for the study. To enhance cultural safety and appropriateness of 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 [2]

Continuous cross-sectional data collection on a weekly basis for 31 months for three antenatal appointment time-points: first/booking in appointment, 28 week gestation appointment and 36 week gestation appointment. Baseline data will be gathered for all three health sectors from 4 months prior to the intervention in the first health sector and data collection will continue until 12 months post intervention in the third health sector.

Primary outcome [3]

The proportion of participants that report offer of a referral to the NSW Get Healthy in Pregnancy (GHiP) Service, and, for all women who are gaining weight above or below their recommended weight gain target, report of offer of a referral to local dietetics services. For all Aboriginal women and/or those having Aboriginal babies, report of offer of culturally appropriate support pathway for dietetics services where available. Self-reported data will be collected through telephone or online surveys with pregnant women receiving antenatal care from the maternity services within the three health sectors involved in the trial. The survey instrument was designed specifically for the study. To enhance cultural safety and appropriateness of 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 [3]

Continuous cross-sectional data collection on a weekly basis for 31 months for three antenatal appointment time-points: first/booking in appointment, 28 week gestation appointment and 36 week gestation appointment. Baseline data will be gathered for all three health sectors from 4 months prior to the intervention in the first health sector and data collection will continue until 12 months post intervention in the third health sector.

Secondary outcome [1]

The proportion of participants that report receiving complete recommended care, as defined as: i. receiving an assessment of gestational weight gain using objective measures of weight against recommended weight gain targets; and ii. receiving advice on gestational weight gain, nutrition and physical activity; and, iii. offer of a referral to the NSW Get Healthy in Pregnancy (GHiP) Service, and, for all women who are gaining weight above or below their recommended weight gain target, offer of a referral to local dietetics services. For all Aboriginal women and/or those having Aboriginal babies, offer of culturally appropriate support pathway for dietetics services where available.

Timepoint [1]

Continuous cross-sectional data collection on a weekly basis for 31 months for three antenatal appointment time-points: first/booking in appointment, 28 week gestation appointment and 36 week gestation appointment. Baseline data will be gathered for all three health sectors from 4 months prior to the intervention in the first health sector and data collection will continue until 12 months post intervention in the third health sector.

Secondary outcome [2]

Proportion of participants that report accepting a referral to the NSW GHiP Service and, for women who are gaining weight above or below their recommended weight gain target, accepting a referral to a local dietetics service. For all Aboriginal women and/or those having Aboriginal babies, accepting a referral to culturally appropriate support pathway for dietetics services where available. Self-reported data will be collected through telephone or online surveys with pregnant women receiving antenatal care from the maternity services within the three health sectors involved in the trial. The survey instrument was designed specifically for the study. To enhance cultural safety and appropriateness of 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 [2]

Continuous cross-sectional data collection on a weekly basis for 31 months for three antenatal appointment time-points: first/booking in appointment, 28 week gestation appointment and 36 week gestation appointment. Baseline data will be gathered for all three health sectors from 4 months prior to the intervention in the first health sector and data collection will continue until 12 months post intervention in the third health sector.

Secondary outcome [3]

Proportion of participants that report gestational weight gain within recommended ranges at 28 weeks and 36 weeks gestation based on the Institute of Medicine Guidelines according to the four categories of pre-pregnancy body mass index (BMI); underweight, healthy weight, overweight and obese. Pre-pregnancy weight, height and current weight will be self-reported by participants in the study specific survey.

Timepoint [3]

Continuous cross-sectional data collection on a weekly basis for 31 months via the study specific survey for women who attend: 28 week gestation appointment and 36 week gestation appointment. Baseline data will be gathered for all three health sectors from 4 months prior to the intervention in the first health sector and data collection will continue until 12 months post intervention in the third health sector.

Secondary outcome [4]

Estimated average rate of weekly gestational weight gain at 28 weeks and 36 weeks gestation, according to the four categories of pre-pregnancy body mass index (BMI); underweight, healthy weight, overweight and obese. Estimated average rate of weekly weight gain will be calculated by subtracting pre-pregnancy weight from current weight at 28 weeks and 36 weeks gestation, dividing by week’s gestation. Pre-pregnancy weight, height and current weight will be self-reported by participants in the study specific survey.

Timepoint [4]

Continuous cross-sectional data collection on a weekly basis for 31 months via the study specific survey for women who attend: 28 week gestation appointment and 36 week gestation appointment. Baseline data will be gathered for all three health sectors from 4 months prior to the intervention in the first health sector and data collection will continue until 12 months post intervention in the third health sector.

Secondary outcome [5]

Mean maternal diet quality score at 28 weeks and 36 weeks. An 11-item food frequency questionnaire based on the Australian Guide to Healthy Eating will be used to calculate the diet quality score.

Timepoint [5]

Continuous cross-sectional data collection on a weekly basis for 31 months via the study specific survey for women who attend: 28 week gestation appointment and 36 week gestation appointment. Baseline data will be gathered for all three health sectors from 4 months prior to the intervention in the first health sector and data collection will continue until 12 months post intervention in the third health sector.

Secondary outcome [6]

Mean total maternal physical activity levels (minutes/week) at 28 weeks and 36 weeks. This will be assessed using the 7-item International Physical Activity Questionnaire (IPAQ) short form, which has been found to be both reliable and valid in assessing physical activity in adults.

Timepoint [6]

Continuous cross-sectional data collection on a weekly basis for 31 months via the study specific survey for women who attend: 28 week gestation appointment and 36 week gestation appointment. Baseline data will be gathered for all three health sectors from 4 months prior to the intervention in the first health sector and data collection will continue until 12 months post intervention in the third health sector.

Secondary outcome [7]

Participant reported acceptability of each of the elements of the best practice care pathway will be assessed through the patient telephone survey/online survey at each time point. The telephone/online surveys were designed specifically for this study.

Timepoint [7]

Continuous cross-sectional data collection on a weekly basis for 31 months via the study specific survey for women who attend: 28 week gestation appointment and 36 week gestation appointment. Baseline data will be gathered for all three health sectors from 4 months prior to the intervention in the first health sector and data collection will continue until 12 months post intervention in the third health sector.

Secondary outcome [8]

An assessment of clinician barriers and facilitators (using the theoretical domains framework) to provision of care will be undertaken through pre and post implementation surveys at each maternity service to determine theoretical mediators of intervention effect. The surveys were designed specifically for this study, using the theoretical domains framework as a basis.

Timepoint [8]

Cross-sectional data collection pre- and post-implementation at each maternity service.

Secondary outcome [9]

The clinician reported acceptability of the best practice care pathway and implementation support strategies for addressing gestational weight gain will be assessed via surveys with clinicians. Clinician exposure to the implementation strategies will be assessed using surveys and project records designed specifically for this study. These process measures will use validated instruments where available (including the Acceptability of Intervention Measure (AIM).

Timepoint [9]

Cross-sectional data collection post-implementation at each maternity service.

Secondary outcome [10]

Cost analysis: A cost analysis will measure and value resources used in the development and delivery of the intervention from the perspective of the antenatal service provider. Delivery of the intervention strategies and data regarding resources expended on materials, labour and other expenses incurred in developing and executing the intervention will be recorded in project management logs. Labour costs for training, quality assurance processes, managerial oversight and activities undertaken by the midwife educators will be recorded prospectively. Research and data collection and analysis costs will be excluded. Sensitivity analysis will be conducted on variables with uncertain values.

Timepoint [10]

Data will be entered into project management logs on a fortnightly basis throughout the entire study period.

Secondary outcome [11]

Cost effectiveness, budget and equity impact: The incremental costs and outcomes of the practice change intervention will be presented as a cost effectiveness analysis. The analysis will adhere to cost and economic analysis guidelines. Budget impact assessment will be conducted to inform affordability of the intervention from the perspective of the public health service. In addition to measuring the efficiency of the practice change intervention, an analysis of equity impact will be conducted to assess whether any observed impacts/gains are equitably shared amongst the target population.

Delivery of the intervention strategies and data regarding resources expended on materials, labour and other expenses incurred in developing and executing the intervention will be recorded in project management logs, as has occurred in previous trials conducted by the research team. Labour costs for training, quality assurance processes, managerial oversight and activities undertaken by the midwife educators will be recorded prospectively. Research and data collection and analysis costs will be excluded.

Timepoint [11]

Data will be entered into project management logs on a fortnightly basis throughout the entire study period.

Eligibility

Key inclusion criteria

The best practice care pathways will be implemented as routine care for all women attending antenatal clinics within the participating sectors. All health professionals providing antenatal care will participate in the implementation intervention as part of routine service improvement and all will be offered to opportunity to participate in clinician surveys pre and post intervention.

All pregnant women who have had attended at least one face-to-face antenatal appointment with an obstetrics focus for a booking in appointment, 28 week appointment, or 36 week appointment 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 in study surveys:
- Had an antenatal care appointment with an HNELHD maternity service in Greater Newcastle, Peel or Lower Mid North Coast Sector.
- Aged 18 years or older.
- More than 12 weeks 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?

No

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

Statistical methods / analysis

Based on recruitment outcomes of previous trials conducted by the research team in clinical settings and maternity services specifically, it is expected that 70% of invited clients, or 15 clients (average of 5 per service), will consent to participate in each of the weekly surveys for women at each of the three gestation time periods (‘~12-18’, ‘27-29’ or ’35-37’ weeks). This will yield 5600 data points over the course of the data collection period, sufficient to detect (with 80% power and with a Bonferoni adjusted alpha of 0.0167): i) a 15% absolute increase in receipt of recommended assessment of gestational weight gain (baseline prevalence of 40%); ii) a 14% absolute increase in recommended advice (baseline prevalence of 30%); and, iii) a 9% absolute increase in offer of recommended referral (baseline prevalence of 10%).

Pre and post intervention primary outcome data will be analysed using mixed effects logistic regression models to detect change in reported receipt of the three recommended elements of gestational weight gain care for all three services combined. Separate models will be fitted for each outcome.

The main predictor of interest will be a before/after intervention indicator variable as well as a fixed effect for time, and a random intercept for client group. The intervention will be declared effective if the coefficient for the intervention period variable is below the threshold of .0167 for any of the outcomes. Time-series analysis will be performed over the post intervention periods to determine if slope changes occur, as an indicator of sustainability.

The cost analysis and practice change cost effectiveness results will be incorporated into an economic model to project the expected costs and outcomes that would be associated with broader scale-up of the practice change intervention to antenatal services across NSW.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/02/2021

Actual

1/07/2021

Date of last participant enrolment

Anticipated

31/01/2024

Actual

31/01/2024

Date of last data collection

Anticipated

31/01/2024

Actual

1/02/2024

Sample size

Target

5600

Accrual to date

Final

7014

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

John Hunter Hospital - New Lambton

Recruitment hospital [2]

Belmont Hospital - Belmont

Recruitment hospital [3]

Manning Rural Referral Hospital (Taree) - Taree

Recruitment hospital [4]

Tamworth Rural Referral Hospital - Tamworth

Recruitment hospital [5]

Gunnedah District Hospital - Gunnedah

Recruitment hospital [6]

Quirindi Community Hospital - Quirindi

Recruitment postcode(s) [1]

2305 - New Lambton

Recruitment postcode(s) [2]

2280 - Belmont

Recruitment postcode(s) [3]

2430 - Taree

Recruitment postcode(s) [4]

2340 - Tamworth

Recruitment postcode(s) [5]

2380 - Gunnedah

Recruitment postcode(s) [6]

2343 - Quirindi

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council – Partnership Grant

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

NSW Office of Preventive Health

Country [2]

Australia

Funding source category [3]

Government body

Name [3]

Hunter New England Local Health District – Clinical Services, Nursing and Midwifery

Country [3]

Australia

Primary sponsor type

University

Name

University of Newcastle

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hunter New England Human Research Ethics Committee

Ethics committee address [1]

Level 3, Pod, HMRI, Lot 1, Kookaburra Circuit, New Lambton Heights NSW 2305

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

14/07/2020

Approval date [1]

16/07/2020

Ethics approval number [1]

16/11/16/4.07

Ethics committee name [2]

Aboriginal Health and Medical Research Council

Ethics committee address [2]

35 Harvey Street, Little Bay, NSW, 2036

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

21/07/2020

Approval date [2]

31/07/2020

Ethics approval number [2]

1236/16

Ethics committee name [3]

University of Newcastle Human Research Ethics Committee

Ethics committee address [3]

University Drive, Callaghan, NSW, 2308

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

05/08/2020

Approval date [3]

03/09/2020

Ethics approval number [3]

H-2017-0032

Summary

Brief summary

This study aims to determine the effectiveness of a practice change intervention in increasing the provision of recommended gestational weight gain care by antenatal services. Relative to usual antenatal appointments, it is hypothesised that the intervention will achieve increases in the proportion of post intervention appointments in which gestational weight gain care is consistent with guideline recommendations: assessment (predicted 15% increase); brief advice (predicted 14% increase); referral (predicted 9% increase). The study will be conducted as a stepped-wedge controlled trial, with staggered implementation of the intervention across maternity services in three health sectors within Hunter New England Local Health District, New South Wales, Australia. The intervention will consist of evidence-based, locally tailored practice change strategies including guidelines and procedures, system prompts, leadership support, training, and audit and feedback. The prevalence of woman-reported assessment, advice and referral for gestational weight gain will be the primary outcomes of interest. Cross-sectional measurement of outcomes will occur via telephone interviews with a random sample of women who attend the services each week. An intervention effect will be determined by an increase in recommended care delivery across the sites. Economic analyses will be undertaken to assess the cost, cost effectiveness and budget impact of the practice change intervention. Women’s weight gain during pregnancy, diet, physical activity and intervention acceptability will also be measured.

Trial website

NA

Public notes

NA

Contacts

Principal investigator

Name

Prof John Wiggers

Address

Hunter New England Population Health
Locked Bag 10
Wallsend, NSW, 2287

Country

Australia

Phone

+61 2 4924 6247

Email

John.Wiggers@health.nsw.gov.au

Contact person for public queries

Name

John Wiggers

Address

Hunter New England Population Health
Locked Bag 10
Wallsend, NSW, 2287

Country

Australia

Phone

+61 2 4924 6247

Email

John.Wiggers@health.nsw.gov.au

Contact person for scientific queries

Name

John Wiggers

Address

Hunter New England Population Health
Locked Bag 10
Wallsend, NSW, 2287

Country

Australia

Phone

+61 2 4924 6247

Email

John.Wiggers@health.nsw.gov.au

Doc. No.	Type	Citation	Link	Attachment
9340	Informed consent form			380680-(Uploaded-30-09-2020-15-44-59)-Study-related document.pdf
9341	Ethical approval			380680-(Uploaded-30-09-2020-15-49-08)-Study-related document.pdf
19035	Study protocol	Kingsland, M., Hollis, J., Farragher, E. et al. An implementation intervention to increase the routine provision of antenatal care addressing gestational weight gain: study protocol for a stepped-wedge cluster trial. Implement Sci Commun 2, 118 (2021).	https://doi.org/10.1186/s43058-021-00220-y	380680-(Uploaded-12-04-2023-10-36-26)-Study-related document.pdf

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