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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000054819
Acronym
NA
Enrollment
7014
Registered
2021-01-22
Start date
2021-07-01
Completion date
2024-01-31
Last updated
2024-07-15

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 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.

Interventions

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 f

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.

Sponsors

University of Newcastle
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

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

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.

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).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 21, 2026