Authors: Ailsa Borbolla Foster, Jennifer Haxton, Nicole Bennett, Jon Hyett, Felicity Park
Categories: Original Article, implementation science, prenatal care, prenatal diagnosis, pre‐eclampsia
Source: The Australian & New Zealand Journal of Obstetrics & Gynaecology
Doi: 10.1111/ajo.13837
Australian rates of adverse obstetric outcomes have improved little despite guidelines recommending history‐based screening and intervention. The first trimester provides a unique opportunity to predict and prevent complications, yet population‐based screening has failed to be translated into broad clinical practice.
This study aimed to redesign antenatal care within an Australian public healthcare centre to align with evidence‐based maternity care, including population‐based first‐trimester screening with early initiation of preventative strategies in high‐risk pregnancies.
A five‐phase action‐process model, sharing key elements with implementation science theory, was used to explore barriers to change in antenatal care, co‐design a novel service with consumers and establish a population‐based antenatal pathway commencing with a multidisciplinary first‐trimester screening, assessment and planning visit.
The case for change and associated barriers were defined from the perspective of antenatal care stakeholders. Key needs of each group were established, and solutions were created using co‐design methodology, allowing the team to create a novel approach to antenatal care which directly addressed identified barriers. Implementation of the service was associated with a fall in the median gestation at first specialist maternity care provider visit from 20 to 13 weeks.
This study confirms the feasibility of establishing a comprehensive first‐trimester screening program within a public Australian healthcare setting and highlights a co‐design process which places individualised assessment at the forefront of antenatal care. This framework may be applicable to most public maternity settings in Australia, with expansion aimed at providing equity of care, including in rural and remote settings.
Keywords: implementation science, pre‐eclampsia, prenatal care, prenatal diagnosis
Little progress has been made to improve key Australian obstetric outcomes with fairly static rates of stillbirth, preterm birth and pre‐eclampsia in New South Wales over the past 20 years. ^1^ Traditional maternity care has focused care on the second half of the pregnancy, but there is growing evidence that the first trimester provides a unique window of opportunity to predict pregnancy complications and intervene to reduce adverse outcomes. ^2^ , ^3^ , ^4^ Although the efficacy of first‐trimester prediction and prevention of preterm pre‐eclampsia has been well demonstrated, ^5^ , ^6^ , ^7^ screening algorithms specific for other common adverse obstetric conditions remain elusive. Pre‐eclampsia prediction algorithms have demonstrated superior predictive performance for fetal growth restriction, ^8^ , ^9^ , ^10^ a major risk factor for stillbirth, with demonstrated reductions in small‐for‐gestational‐age infants and stillbirth rates in centres where pre‐eclampsia screening has been introduced. ^11^ , ^12^ International guidelines increasingly recommend first‐trimester prediction and prevention of pre‐eclampsia13, 14, 15, 16 and an updated RANZCOG (Royal Australian and New Zealand College of Obstetricians and Gynaecologists) clinical statement is awaited.
Current Australian guidelines favour history‐based screening for pre‐eclampsia, fetal growth restriction, stillbirth and preterm birth. ^17^ , ^18^ , ^19^ However, performance is limited within traditional antenatal care ^20^ , ^21^ , ^22^ despite efficacy of preventative strategies being dependent on accurate risk assessment and initiation in early pregnancy. ^18^ , ^23^ , ^24^ A recent systematic review confirms the clinical benefits of implementation of population‐based first‐trimester screening services for pre‐eclampsia,^6^ and outcomes are anticipated following Canadian implementation. ^25^ Although service feasibility is implied within these studies, implementation research methods, defined as ‘the scientific study of methods to promote the systematic uptake of evidence‐based practice into routine practice’, ^26^ have not yet been published to describe the process by which implementation barriers are identified and navigated.
This study aims to describe the prospective use of an implementation framework to design and establish a novel approach to antenatal care incorporating a population‐based multidisciplinary first‐trimester maternity screening, assessment and prevention service.
Action‐process models, which prescribe a series of stages or steps that should be followed in the process of translating research into practice, ^26^ have been described for use in implementation research, with no clear evidence to suggest superiority of any one framework. ^26^ , ^27^ The Australian Agency for Clinical Innovation (ACI) provides leadership for the implementation of innovative models of patient care and supports a specific action‐process model methodology which shares key processes with the knowledge‐to‐action implementation science framework (Fig. 1). This conceptual framework was selected for this study due to staff familiarity and ready access to supportive materials.
Figure 1 Steps of ACI (Australian Agency for Clinical Innovation) framework for clinical redesign (inner circle) aligned with knowledge‐to‐saction‐process model (outer circle): adapted from Nilsen ^26^ and Atkins et al. ^30^
This study was undertaken within a single tertiary public Australian hospital with existing maternity care pathways and an established obstetric ultrasound service previously focused on diagnostic evaluation of complex maternofetal conditions. A project working group comprising key stakeholders from healthcare providers (obstetricians, midwives, sonographers, general practitioners (GP)), allied healthcare staff (administrative staff, social workers, Aboriginal health workers) and service consumers was established within an agreed governance structure. Participation was voluntary, with no additional funding provided, and the study was approved by the Hunter New England Health Human Research Ethics Committee (AU202305‐13).
The sections that follow describe the process of design and establishment of the novel service using the phases of the ACI redesign model demonstrated in Figure 1.
Although the Initial Maternity Assessment and Planning (IMAP) clinical redesign team was initially tasked with implementation of population‐based first‐trimester screening for pre‐eclampsia, the expanding evidence for early prediction and prevention of other adverse outcomes necessitated a broader approach. The project was further shaped by the arrival of the COVID‐19 global pandemic and the need to continue to provide safe women‐centred maternity care while minimising exposure risk. The IMAP service aimed to provide a comprehensive assessment of pregnancy risk as early as possible in pregnancy such that women at low risk of complications could reduce routine visit frequency and women at high risk were provided optimal access to preventative care, with equity of access to optimal evidence‐based maternity information and care for all.
At a local level, the need for change was demonstrated by a long‐standing median gestational age at first hospital visit of 20 weeks, beyond the effective gestation at which most evidence‐based preventative maternity care strategies can be successfully implemented. ^18^ , ^23^ , ^24^ Rates of pre‐eclampsia screening and prevention within traditional care pathways were low (only 12.9% of women assessed as high risk on history‐based assessment were prescribed aspirin ^28^ ), with a cost‐effectiveness analysis based on our local population predicting potential annual cost savings of 715 000 AUD if first‐trimester pre‐eclampsia screening and prevention alone could be implemented. ^28^
Routine data collection systems indicated no significant reduction in rates of other significant adverse pregnancy outcomes, with stillbirth and preterm birth rates at the study centre fluctuating between 0.8–1.7% and 13–15.9%, respectively, between 2012 and 2020. This is not unique to this centre, with similar trends demonstrated across level 6 centres in New South Wales. ^1^
A range of diagnostic tools were used ^29^ to understand existing antenatal care from a range of perspectives, identify barriers to change and address needs and challenges in the design of a novel care approach. Methods of data capture and analysis and issues identified are summarised in Figure 2.
Figure 2 Phase two summary of methods, key issues and core aims in diagnostics phase.
In keeping with established implementation science frameworks, ^30^ barriers to change for each stakeholder group fell into several recognised domains, including lack of knowledge or skills, challenges to existing professional roles and identities, beliefs about the consequences of the intervention and the environmental context, including resource requirements. Each identified barrier was addressed by establishing the key needs of each stakeholder group to support successful implementation. Six core aims for the IMAP project, built around the identified needs of each key stakeholder group, were defined. A central principle was that the service should not deviate from locally applicable maternity care guidelines but rather re‐frame antenatal care to incorporate early multidisciplinary specialist maternity care provider assessments for all pregnancies within our tertiary public sector catchment. A review of applicable maternity care guidelines was undertaken by the project working group to guide the specific conditions to be incorporated in to standardised screening, assessment, and interventions within the IMAP first visit.
In line with ACI co‐design methodology ^31^ , a full‐day solutions workshop brought together staff and consumers to generate ideas and create prototype model of care solutions. Solutions were prioritised by workshop participants, with the top two solutions further refined to establish feasible pilot studies. The blueprint for two pilot studies was shared with all key stakeholders and tested in clinical practice for one week prior to completion of a vote on the preferred solution.
A structured blueprint of the novel IMAP service is shown in Figure 3, which also outlines the woman's journey through the process. A list of conditions for which multidisciplinary assessment or screening is undertaken within the IMAP first visit, the current evidence or guidelines which guide the method of assessment or screening and the associated detection rate are provided in Table 1.
Figure 3 IMAP (Initial Maternity Assessment and Planning) solution blueprint, woman's journey and implementation steps.
Building on the key needs for each stakeholder group identified within the diagnostics phase, implementation strategies were applied to each of the six steps proposed within the IMAP visit solution blueprint and are summarised in Figure 3.
In view of the significant practice change required, relevant stakeholder representatives within the working group focused on the following key aspects of implementation.
Information sharing about the IMAP service incorporating care providers, women and GPs was identified as key to supporting successful implementation. A co‐design process was undertaken to redesign antenatal care information provided to local GPs and develop consumer information on the service for women and families. Increasing reliance on technology to access healthcare information was highlighted, and the working group established digital solutions to optimise information sharing, including updating local online GP resources and ensuring families were able to access information about visits via the Maternity Service website as well as email and SMS links in the days leading up to the visit. Additional education was provided to GPs about the novel service through meetings, information videos and letters provided to clinicians routinely referring women beyond 14 weeks’ gestation.
The maternity referral process required redesign to meet the time‐sensitive nature of the initial visit, and this included two main actions. Firstly, the maternity service transitioned to sole use of the hospital's established electronic referral system. This provided not only immediate feedback to GPs on the successful receipt of maternity referrals but also maternity service with additional transparency about the number and status of pending referrals. Although many local GP practices had electronic referral systems integrated within existing practice software, the hospital referral system also supported digitisation of faxed referrals. Secondly, a dedicated full‐time administration role was successfully established to support ‘real‐time’ processing of all maternity referrals, a role which had previously been shared across many administration staff. Clinical support for referrals was provided by an existing triage midwife role, which ensured that whereas most women were scheduled a first visit at 11 + 0 to 13 + 6 weeks, women with particularly complex needs were identified and offered earlier review.
Total anticipated demand for the service was established based on a birth rate within the catchment population of 3200 per year. To ensure flexibility to respond to fluctuations in demand, total required capacity was calculated as 4000 visits per year, whereby the anticipated demand of 3200 women represented 80% of the total clinic capacity. This capacity could be achieved by 16 visits per day, five days per week across 50 weeks per year. Feasible alternative visit and clinic structures had been tested within the phase three pilot studies prior to voting on the successful design.
Based on the total required capacity, multidisciplinary staffing requirements were calculated as shown in Figure 3.
Based on existing Australian healthcare funding arrangements, required sonographer and obstetrician staffing enhancements were funded by Medicare billings generated within the first visit. Midwifery staffing of the initial visit was supported through redefining the established ‘booking‐in’ midwife role to operate within the novel multidisciplinary IMAP service. Phase three pilot studies were invaluable in identifying that 30% of women screened positive for significant psychosocial vulnerability when recommended screening ^17^ was routinely carried out in early pregnancy during the height of the COVID‐19 pandemic. Given the sensitive nature of these disclosures by women and the need for careful evaluation and support, the project team established an additional midwifery role within the final implementation design to provide immediate assessment and referrals for women with significant vulnerabilities. ^32^ , ^33^ Funding for this role was achieved through the reallocation of midwifery hours saved through reduced routine antenatal visits for women within low‐risk pathways.
Systematic protocols were established for all IMAP staff groups to ensure consistent screening, assessment and interventions for the key health conditions outlined previously in Table 1. Consent to each element of antenatal screening was established verbally prior to the ultrasound component of the visit, and all families were provided the opportunity to decline specific aspects of screening. A standardised reporting blueprint was designed to reduce the potential for elements of assessment to be inadvertently omitted. Quality assurance processes were built into the service design, including RANZCOG nuchal translucency accreditation (including uterine artery Doppler accreditation for pre‐eclampsia prediction), for all staff involved in ultrasound and algorithm‐based risk assessments.
Staff communication was optimised through comprehensive orientation documents for specific staff groups, face‐to‐face and online education programs for both IMAP clinicians and the wider maternity service, daily IMAP team huddles and monthly update meetings for obstetricians and midwives working within the service.
The diagnostics phase highlighted that acceptance of women into specific models of care was a complex process. A novel solution was established through a maternity allocation database managed by a specific administration team member, allowing every woman to be scheduled a follow‐up within an agreed model of care prior to completion of the initial IMAP visit. This aspect of implementation aimed to limit over‐subscription to individual models of care, optimise continuity of care and ensure that women have access to their selected model for the duration of pregnancy.
Optimal frequency of antenatal visits in pregnancy remains a source of debate,^34^ with current Australian guidelines acknowledging the need for individualised care. Based on individualised assessment within the comprehensive IMAP first visit, women at low risk of pregnancy complications were scheduled fewer routine visits than those at increased risk. The total number of antenatal visits required within each model of care per year was calculated based on the total anticipated pregnancies requiring antenatal care, the historical proportions of women accepted into low‐risk or high‐risk care pathways and the number of routine visits within each care pathway. These figures were used to create appropriate and achievable daily visit schedules within each model of care setting.
Locally applicable maternity care guidelines ^16^ , ^17^ , ^18^ , ^19^ , ^32^ were reviewed by members of the working group to create a unifying document for all staff, which recommends specific elements of care at each scheduled visit within low‐risk and high‐risk care pathways. This framework was introduced through a range of face‐to‐face and online education sessions and forms part of the orientation package for all new staff providing care. It remains readily available in clinical settings in both paper and digital formats.
For women in both high‐ and low‐risk routine visit schedules, a range of national and locally endorsed patient information resources were drawn together, which aligned not only with standard visit schedule gestation but also with the elements of care recommended for staff at each scheduled antenatal visit. These education bundles were provided to women during visits in the form of QR codes aligned with each scheduled antenatal visit.
The sustainability phase includes service embedding, and the IMAP process is well established within this tertiary centre. In 2022, the first calendar year of operation, more than 3600 local women received care through IMAP, with 71% of women being seen prior to 14 weeks’ gestation compared with 27% prior to implementation. Median gestation at booking also fell from 20 weeks (Interquartile range (IQR) 10) to 13 weeks (IQR 8) after implementation. As we enter the service evaluation and knowledge sharing phases of sustainability and pregnancy outcomes after implementation becomes available, publications are planned on a range of clinical, service and implementation outcomes. An updated cost‐effectiveness analysis founded on the post‐implementation performance of IMAP and a budget impact assessment will inform on the relative value and the financial implications of the service, with a view to sustainability and potential generalisation.
This study is the first to describe the prospective use of implementation science methodology to successfully design and establish a population‐based first‐trimester screening program linked to ongoing antenatal care pathways. Although successful establishment of screening programs for pre‐eclampsia has been reported in alternative healthcare settings, ^6^ , ^25^ processes of design and implementation have not been well described. Use of an established implementation framework allows this study to identify barriers to change in antenatal care and describe a co‐design process which may support wider implementation of evidence‐based preventative maternity care.
Strengths of this study include demonstration of the feasibility of establishing a population‐based first‐trimester screening program which provides greater alignment of care with evidence‐based practice and international care guidelines. This study highlights a focus on patient engagement within the co‐design process, allowing individualised care to be at the forefront of the new service design. Lack of healthcare responsiveness to evidence‐based practice is well recognised with known barriers, including organisational resources, access to care and staff and consumer education. It is feasible that translation of knowledge into practice within preventative maternity care may be streamlined once a population‐based first‐trimester service is established. Adaptability of the IMAP service to emerging evidence may support future evaluation of the impact of screening strategies outside of the research setting.
A disadvantage of this study is its context of a single tertiary centre; however, the underlying co‐design methods described within an implementation framework could be applied to alternative healthcare settings. Within our research group, efforts are underway to apply a modified form of this process to establish an IMAP service within a remote Australian setting.
Use of an implementation action‐process model allowed redesign of a large Australian public maternity service to align with the principle of first‐trimester screening and treatment of high‐risk pregnancies to reduce adverse pregnancy outcomes. This framework is anticipated to be applicable to many maternity settings, with expansion within Australia aimed at providing equity of pregnancy care, including within rural and remote settings.
Dr Ailsa Borbolla Foster received funding from the Hunter New England Local Health District through JHH Charitable Trust Clinical Research Fellowship.
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