Improving systems of antenatal and postpartum care for hyperglycemia in pregnancy: A process evaluation

SYNOPSIS A complex health systems intervention resulted in perceived improvements in systems of care for women with hyperglycemia in pregnancy in regional and


INTRODUCTION
Hyperglycemia in pregnancy, encompassing pre-existing diabetes (diagnosed prior to pregnancy), gestational diabetes (GDM), and overt diabetes in pregnancy (blood glucose levels during pregnancy meeting diagnostic criteria for diabetes outside of pregnancy), is associated with adverse pregnancy and long-term health outcomes for mothers and children [1][2][3].Internationally, Indigenous populations are disproportionately affected; in Australia, Aboriginal and Torres Strait Islander women are 11 and 1.3 times as likely to have pre-existing diabetes and GDM, respectively, compared to non-Indigenous women [4,5].Rates of pre-existing diabetes and GDM among Aboriginal women in Australia's Northern Territory (NT) have dramatically increased over recent decades, from 0.6% and 3.4% respectively in 1987 to 5.7% and 13% in 2016 [6].
The time during and after pregnancy is an ideal opportunity to improve the health of women and their children.However, care provided for hyperglycemia during pregnancy and postpartum often falls short of recommendations [7,8].In the NT in 2013-2014 only 54% of remote-dwelling Aboriginal women with GDM had glucose testing performed within 12 months postpartum [9].Multiple barriers to providing care for women with hyperglycemia in pregnancy in remote and regional Australia exist, including limited clinician confidence and a lack of clarity around clinician roles This article is protected by copyright.All rights reserved relating to service provision [10][11][12].These barriers apply across the spectrum of hyperglycemia in pregnancy (including GDM, overt diabetes in pregnancy and preexisting diabetes).Improving antenatal and postpartum systems of care for women with hyperglycemia in pregnancy is a priority of the International Federation of Gynecology and Obstetrics (FIGO) [7].
The Diabetes Across the Lifecourse: Northern Australia Partnership (formerly the Northern Territory (NT) and Far North Queensland (FNQ) Diabetes in Pregnancy Partnership, "the Partnership") was established in 2012 in the NT as a collaboration between clinicians, researchers, health services and policymakers.The Partnership expanded to include FNQ in 2015.Between 2016 and 2020, the Partnership implemented a complex health systems intervention to improve antenatal and postpartum care for women across the spectrum of hyperglycemia in pregnancy through addressing identified barriers to care and opportunities for improvement [10,11].Here we report an interim process evaluation of this health systems intervention.

Setting
The NT and FNQ is home to 500,000 inhabitants, speaking over 200 languages, across 1.6 million square kilometres [13][14][15].Approximately 22.5% of the population identify as Aboriginal and/or Torres Strait Islander, compared with 3.2% across Australia [13][14][15][16].There are approximately 7,000 births across NT and FNQ annually [13,14,17].In the NT in 2016, 11.4% of births to all women were complicated by GDM and 2.1% by pre-existing diabetes; for Aboriginal women, these rates were 12.1% and 5.6% respectively [4].An audit of births to Aboriginal and Torres Strait Islander women in FNQ showed the prevalence of GDM and T2DM in 2008 to be 14.2% and 2.3% respectively [18].In FNQ more recently 20% of all pregnancies between January 2019 and June 2020 were complicated by hyperglycemia (Cairns and Hinterland Hospital and Health Service, Casemix Report: Pregnancies complicated by diabetes, 2020; unpublished).
Healthcare for women with hyperglycemia in pregnancy in the NT and FNQ is provided by a complex network of services, including Aboriginal Community Controlled Health Organisations, private primary care services, and government This article is protected by copyright.All rights reserved services at the primary, secondary and tertiary levels.Clinicians in the study regions use multiple guidelines to inform practice, including those published by the Australasian Diabetes in Pregnancy Society [19] and World Health Organisation [20], and local guidelines such as the Queensland Clinical Guidelines [21] and Central Australian Remote Practitioners Association Women's Business Manual [22].

Health Systems Intervention Design
Methods for this health systems intervention have been described in detail previously [23].Five key components were identified through health professional focus groups in 2016-17: 1.
Increasing workforce capacity, skills and knowledge and improving the health literacy of clinicians and women.

2.
Improving access to healthcare through culturally and clinically appropriate pathways.

3.
Improving information management and communication.

4.
Enhancing policies and guidelines.

5.
Embedding a clinical register for women with hyperglycemia in pregnancy [24] within the models of care.
Implementation activities were developed in consultation with health professionals and other stakeholders, guided by the above components (Figure 1; Supplementary

Design
This interim evaluation was designed by NF, an evaluation officer with extensive experience working in the remote Australian context, in consultation with investigators and the implementation team.Design focused on identifying and exploring enablers and barriers to implementation.Evaluation indicators were underpinned by the RE-AIM framework (reach, effectiveness, adoption, implementation and maintenance) [25] (Table 1).
Six primary healthcare services participated as evaluation sites; these primary care services included one government and one Aboriginal community-controlled service in each study region, to facilitate diversity of the services represented.Clinicians involved in the care of women with hyperglycemia in pregnancy at each evaluation site, as well as at the major referral hospital within each region, were invited to participate.Participants also included the intervention implementation team (implementers), and policymakers and managers at the regional health service level.
Individuals who had played key roles in promoting and implementing the health systems intervention were considered 'champions'.Potential participants were recruited by email or opportunistically in person at evaluation sites.
Interviews were conducted by NF in person at participant workplaces (e.g.clinic, hospital, research institution) (n=39), or by phone if in person was not feasible (n=4).
Interviews were guided by a social constructionist epistemological perspective, utilising a descriptive phenomenological approach [26].Interview topics were guided by evaluation indicators (

Use of Evaluation Findings
Findings were discussed with investigators and implementers in a series of meetings and workshops, both across the Partnership as a whole and within each study region, in late 2018 -early 2019 to identify opportunities for improvements to implementation of intervention activities.

RESULTS
NF interviewed 45 informants in 43 semi-structured interviews (Table 2).Seven participants publicly identify as Aboriginal and Torres Strait Islander people, although participants were not specifically asked about their identification so we acknowledge there may be others where this is not known.An additional 11 potential participants were invited; nine of these individuals declined to participate due to being unavailable while two did not respond.Key findings are summarised in Table 3 according to the RE-AIM framework.The first theme detailed below, improvements in the clinical management of hyperglycemia in pregnancy, related to effectiveness; other themes explored recurred across the RE-AIM constructs, with the relevant constructs identified in bold.
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Improvements in the clinical management of hyperglycemia in pregnancy
Several improvements in management of hyperglycemia in pregnancy were described by clinicians, including earlier referral for specialist care, improved postpartum follow-up and greater consistency in practice.These were attributed to Partnership activities including clinician education and the promotion of relevant guidelines: "I find that it's better [postpartum]  The creation of networking opportunities, particularly face-to-face, was a highly valued outcome of the intervention (effectiveness), again emphasising the importance of relationships: "I think just knowing there's a supportive network out there, that we're all trying to achieve the same goal" (Clinician).These networks enabled the identification of issues and solutions, and the sharing of information and resources: "So you know it [request for more education] came from the local teams who identified their needs and it … went up through the group and then back down to provide that service" (Clinician).

Essential role of champions
Champions in each region throughout all phases of the health systems intervention were seen as instrumental.These champions varied in their clinical backgrounds and contributions to the intervention, but all had worked as clinicians and/or policymakers in the respective region for years, were widely recognised as advocates and were influential in impacting the practice of other clinicians, using both grassroots and top-down approaches (reach, adoption): "She [champion] was able to direct really practical solutions.She was also able to listen, and she was able to make changes… she had the ear of the right people, and then that filtered down to the workforce."(Implementer) The trust with which champions were viewed across their networks made them an effective means of promoting the health systems intervention, expanding the reach beyond existing Partnership networks.Champions in the NT were in positions enabling them to influence regional health service priorities, policies and guidelines, regarded as an important avenue to ensure adoption of recommended changes to practice: "But 'cause it has to just go in policy.And once it's there you [clinician] just have to do what your policy is." (Clinician).

Alignment with health service priorities
This article is protected by copyright.All rights reserved There was a broad perception that activities of the health systems intervention aligned with clinical priorities (adoption, implementation): "Our goals [Partnership and health service] are the same so you work together to meet them" (Clinician).
This alignment was enhanced by the responsiveness of implementers to the requests and concerns of health services: "Anything we ever need or having problems with she [implementer]'s always very supportive in helping us" (Clinician).
Champions anticipated that data from the DIP Clinical Register would inform future decision-making regarding service delivery issues highly important to local communities, for example, enabling women to birth closer to home rather than requiring transfer to the tertiary centre if the data supported revisions to birth risk stratification.

Integration of DIP Clinical Register with existing systems
Clinician adoption of aspects of the DIP Clinical Register varied depending on integration with their own clinical processes.Clinicians did not access the DIP Clinical Register for individual patient care, largely because it was not integrated with existing clinical systems: "And do you want to get on a standalone register that really just has two women that you're actually looking at… people didn't want to use it as a day-to-day working tool" (Implementer).However, clinicians reported receiving aggregate data from the DIP Clinical Register as "really good, because I even used that a little bit in my six-monthly report" (Champion).Clinicians in primary care reported there were already so many tasks to complete during a clinical encounter with a woman that there was insufficient time to also discuss the DIP Clinical Register, obtain consent and complete a registration form.This contrasted with champions in a referral centre who had adopted the DIP Clinical Register registration form as an efficient way to collect required clinical information.Notably, an implementer was embedded at this referral centre, potentially influencing DIP Clinical Register use.

Aboriginal and Torres Strait Islander representation
Given the importance of hyperglycemia in pregnancy as a health issue for Aboriginal and

Overlap between barriers to care and implementation barriers
Existing barriers to care were also barriers to implementation and adoption of health systems improvements.The most pervasive of these was high clinician turnover, which was consistently reported across all regions: "The turnover of staff in the primary care setting is so much, whatever you do, you have to redo it again and again and again…" (Champion).Although generally viewed as having negative consequences, staff turnover was reported as a potential antidote to clinician inertia, as clinicians new to the area were potentially more receptive to adopting recommended practices compared to those who were "stuck in their ways" (Champion).
Adopting recommended clinical practices for women with hyperglycemia in pregnancy "easily go by the wayside" (Implementer) due to limitations on clinician capacity.Geographic remoteness was also a barrier; delivering education locally in remote FNQ had met with some success, but was difficult to coordinate: "A lot of the clinicians are based in Cairns and are travelling all over the place, so it's hard to get a particular time to meet with everyone that works."(Implementer).
Clinicians in Top End and FNQ reported the health systems intervention had highlighted the importance of hyperglycemia in pregnancy and prompted them to spend more time with women to communicate relevant health messages (effectiveness): "I probably focus more, spend more educational time … really try to get that message across."(Clinician).However, language and cultural differences This article is protected by copyright.All rights reserved were reported as barriers to adoption and implementation of guideline-based care, with clinicians raising concerns about the effectiveness of information transfer between themselves and women.
The broader context in which care is being provided, where a substantial proportion of women have pressing priorities associated with the social determinants of health, such as housing and food insecurity, was also identified in all regions as being a significant barrier to the adoption of recommended practices.Champions reported changes being needed at a social level to address determinants of health while expressing "we can't do everything" (Champion).

Opportunities for Improvements
Proposed modifications to intervention implementation (Table 4), as identified by

DISCUSSION
This interim evaluation of a complex health systems intervention to improve antenatal and postpartum care for women with hyperglycemia in pregnancy identified several early successes.Highly valued among these was the establishment of a network of clinicians.Collaborative healthcare networks have been previously reported to enhance care coordination and improve quality and safety [27].Access to such a network is of particular importance for clinicians practicing in the remote setting, who are at risk of becoming professionally as well as geographically isolated [28].The sustainability of such a network in a setting with high clinician turnover may prove challenging, and will thus be of interest in the final evaluation.
The high value placed on establishing a network exemplified the recurring theme of the importance of relationships in achieving health systems improvements.This finding is in line with Sheikh's conceptual framework of health policy and systems, in This article is protected by copyright.All rights reserved which 'hardware' components of health systems, such as information systems and human resources, interact with 'software' components including ideas and interests, relationships and power, and values and norms [29].Our findings suggest that enhancements in 'hardware' such as policies and guidelines or the DIP Clinical Register are most likely to contribute to meaningful health systems improvement if adequate attention is also paid to 'software' elements.
An additional success of the health systems intervention was perceived change in practice, including clinician reports of earlier referral of women to specialist services.
While positive, this observation requires verification with objective data.This is of particular interest, with previous studies suggesting an inverse relationship between early access to specialist care and adverse outcomes including macrosomia and large for gestational age [30,31].
A number of challenges to implementation were identified.Maintaining stakeholder relationships and the DIP Clinical Register both required large investments in implementer time, limiting their capacity to conduct other health system improvement activities.Face-to-face contact between implementers and clinicians, while highly valued, was not always practical due to the large geographic areas spanned and capacity limitations of both implementers and clinicians.The paradox whereby geographically remote communities most in need of support to implement health system improvements, are by virtue of their remoteness the same communities where achieving strong engagement to implement such measures is most difficult, has been highlighted in other settings [32].The position of implementers in relation to health services had a substantial impact on their ability to enact systems changes, with those holding a dual implementer/clinician role having greater influence, exemplifying the importance of peers in influencing health professional adoption of practice innovations [33].
Challenges in cross-cultural communication reported by clinicians in this evaluation have been described previously [34].The final evaluation will provide a valuable opportunity to explore the influence that the Indigenous Reference Group has had on the activities and implementation of the intervention.
The social determinants of health, including housing and food insecurity, were identified as significant barriers to health services engaging with women during and after a pregnancy complicated by diabetes.High staff turnover and limitations on clinician capacity, widely reported previously as barriers to improving health services for Indigenous peoples in Australia and elsewhere [10,11,[39][40][41][42], were also identified in our evaluation.Approaches on the part of health services to overcome the impacts of these social determinants on access to care essential, and indeed the need to prioritise health equity in implementation science has recently been highlighted [43].In line with this, while beyond the scope of the current health This article is protected by copyright.All rights reserved systems intervention, a priority of current and future work of the Partnership is exploring and enhancing supports beyond health services for Aboriginal and Torres Strait Islander women with a pregnancy complicated by diabetes, and identifying opportunities for integration of health services with such supports.
This evaluation is impacted by several limitations.There are challenges in attributing perceived changes in systems or clinical practice to the intervention due to the study design lacking a control group.A control group was not feasible as implementation activities included changes to systems, such as electronic health records, in use across entire study regions.This interim evaluation did not include objective data to confirm reports of practice changes.It is unknown whether the views expressed by those at evaluation case study sites would be shared by clinicians at other healthcare services within the study regions, although this evaluation provided an opportunity to reflect deeply about impacts of the project and enabled changes to implementation strategies.These latter limitations will be addressed in the final evaluation utilising mixed methods including surveys and interviews, facilitating capture of both a breadth and depth of views, as well as objective audit data from the DIP Clinical Register and primary care electronic health records.A pre-and postanalysis to further determine impacts of the intervention will be conducted using the quantitative data sources (survey and audit).
Strengths of this evaluation include the use of purposive sampling, ensuring inclusion of a diverse range of perspectives across all study regions and enabling thematic saturation.The use of the RE-AIM framework facilitated the exploration of a wide range of factors, while hybrid inductive-deductive coding ensured that interviewee responses falling outside RE-AIM constructs were not disregarded.
Interviews were conducted by a non-clinician, which may have allowed interviewees to be more comfortable when discussing potentially contentious issues.This interim evaluation was well-timed to ensure findings could be translated to modifications to maximise the impact of this health systems intervention.

CONCLUSION
The early phase of a complex health systems intervention to improve systems of care for women with hyperglycemia in pregnancy has resulted in the development of This article is protected by copyright.All rights reserved a strong network of clinicians and changes to clinical practice.Project champions and stakeholder relationships have been instrumental in achieving these early successes.
implementers and stakeholders in response to evaluation findings, included: the development of a communication and engagement strategy; shifting the focus of the DIP Clinical Register to providing epidemiological and quality improvement data and assistance with patient recall rather than being a web-based clinical tool; and development of culturally appropriate education resources for Aboriginal and Torres Strait Islander women.
Encouragingly, clinicians' reports of investing more time in communication indicates a recognition of this as being essential in empowering Aboriginal and Torres Strait Islander women in optimising their health.Development of culturally appropriate resources will be a priority in the remainingThis article is protected by copyright.All rights reserved phase of this health systems intervention based on the findings of this interim evaluation.Important opportunities to improve communication and cultural safety which have been emphasised by others include providing messages in Aboriginal and Torres Strait Islander languages and the involvement of families in these conversations[35, 36], with the latter embracing family networks as a key strength of Aboriginal and Torres Strait Islander culture.Implementation of the health systems intervention in the NT was facilitated by previous work of the Partnership, contrasting with FNQ where the Partnership did not have an established profile.This difference was partly offset by the pre-existing relationships of key champions in FNQ, demonstrating the value of time invested in relationship-building[37].However, there was some confusion in the NT between other projects and the current study, highlighting the need for effective communication strategies with partner organisations and clinicians.A clear understanding of the Partnership's program of work among stakeholders will aid in empowering partners to be involved in setting program priorities.This is of high importance, as translation of research findings to practice is heavily dependent on the key users of such findings initiating and developing research priorities[38].The Partnership to date has emphasised stakeholder involvement in priority-setting, contributing to alignment of this intervention with health service priorities, although confusion about the Partnership's work suggests improvements can still be made.

Figure 1 .TABLE 1 .
Figure 1.Logic model for a health systems intervention to improve care for women during and after a pregnancy complicated by diabetes (licensed under CC BY 4.0 by MacKay D et al.) Focus of DIP Clinical Register shifted to providing epidemiological and quality improvement data rather than as a hands-on clinical tool, given low clinician engagement with this register function I think we've all agreed that use is not logging suppose use is just being aware of the data a your practice to reflect that, or supporting cha Champion We initially did try to promote the clinical regis very early days of the Partnership, and we we Implementer Maintenance Maintaining a Diabetes In Pregnancy Clinical Register Hyperglycemia in pregnancy recognised as a growing problem, and value of the DIP Clinical Register perceived to increase over the long-term with the ability to identify and monitor Factors required to maintain the register included integration with existing electronic health records and adequate resourcing I would just love to see it [DIP Clinical Registe I'd love to see it continue and to grow more, a now …And unfortunately they're not going aw I think it [DIP Clinical Register] could be some beyond the life of the project because I think what numbers of we were talking about and w think beyond the life of the project it's still wor … so they might like something that links dire example.That would make the most sense t Yeah, that's tricky because you'd probably ne managing it.Clinician Well I'd love to think that there's a pool of mo This article is protected by copyright.All rights reserved somebody to-like [implementer], to be carry everything going.Clinician Embedding health systems intervention activities in clinical practice … unless there's someone sort of driving the clearly embedded in the current practices.Ch DIP -Diabetes in Pregnancy; FNQ -Far North Queensland; the Partnership -Diabetes Across the Lifecourse: Northern Au

TABLE 4 .
Actions to address identified challenges in implementation of a complex health systems intervention, by RE-AIM componentChallengeProposed actionReachClinician engagement highest in regional centres and within some professional streams (midwives, diabetes educators), with limited engagement beyond these groups Flexible education delivery -online, pre-recorded, "train-the-trainer" model Communication strategy with partner organisations Regional champions Specific engagement strategies for Aboriginal health practitioners, including invitations as presenters/participants at education sessions, financial incentives for attending meetings/forums, and integration of messages relating to hyperglycemia in pregnancy in training curriculum Seek feedback from clinicians regarding most effective methods for engagement Adoption Low utility of web-based individual patient clinical tool aspect of Diabetes In Pregnancy Clinical Register Focus shifted to providing epidemiological and quality improvement data (grouped de-identified data) Siloed approach to managing women's health Engagement of child health nurses and general practitioners to promote opportunistic screening and diabetes care, such as during mother's attendance for child's health review Ineffective information sharing with women Development of culturally appropriate resources, in consultation with Partnership Indigenous Reference Group Inability to address social determinants impacting on women's competing priorities and health management Promote awareness of broader social determinants through intervention education/engagement activities Implementation Loss of momentum between large annual educational symposium Communication strategy to maintain engagement between annual symposia This article is protected by copyright.All rights reserved Complexity and inconsistency of educational messages being delivered Dissemination of consistent and accurate messaging, with assistance of content area experts Maintenance Maintaining Diabetes In Pregnancy Clinical Register in current form is labour-intensive Explore potential of direct data extraction from existing electronic health records

Figure 1 -
Figure 1 -Logic model for a health systems intervention to improve care for women during and after a pregnancy complicated by diabetes (by MacKay D et al, licensed under CC BY 4.0)

table 1
This article is protected by copyright.All rights reserved Activities have been implemented across primary, secondary and tertiary health services throughout three study regions, being Top End and Central Australia in the NT, and FNQ.

The importance of relationships in implementing health system change
Aboriginal and Torres Strait Islander voices are prominent in decision-making included partnerships with Aboriginal Community Controlled Health Organisations, initiation of an Indigenous Reference Group (IRG) and employment of Aboriginal and Torres Strait Islander staff.Membership of the IRG comprises female clinicians and community members, and is chaired by a project implementer who has a lived experience of hyperglycemia in pregnancy.Improving processes across the Partnership to ensure research aligns with community concerns and that findings are communicated to and benefit community members is an identified priority.
Torres Strait Islander women, it was seen as essential to highlight "the importance of Aboriginal and Torres Strait Islander leadership within the project" (Implementer) (implementation).An Aboriginal implementer stated "I feel I have to This article is protected by copyright.All rights reserved be an advocate for my people and for Indigenous researchers as well, and ensuring that our research is done appropriately" (Implementer).Strategies to ensure

TABLE 2 .
Participants in the interim evaluation of a complex health systems intervention to improve systems of care for hyperglycemia in pregnancy a Ten total medical practitioners; includes four general practitioners/general practitioner-obstetricians

TABLE 3 .
Findings of an interim evaluation using the RE-AIM framework A lot of clinics won't let them go unless it's forThis article is protected by copyright.All rights reserved Everyone needs to give the same message a are out there … otherwise it's confusing… so This article is protected by copyright.All rights reserved our own work here in Alice Springs.Champio And those reports, like I said, they [health ser the value in them, and I think if it's able to pro their models, 'cause if they've got high rates o that sort of timely information on what you're Prior to that I guess everybody came with the it whereas this has made a much more consiUpdating clinical guidelines and ensuring updatesCause some of that stuff, you know it's transfThis article is protected by copyright.All rights reserved

communicated to clinicians (Central Australia and Top End) now
, which is what we work by, that's our bus education around that change, and then that that's solid....And it's been really good, really This article is protected by copyright.All rights reserved the form, and kill two birds with one stone.Ch And I also think that, I guess having the posit with the hub and spoke model that the Diabe So I'm hearing -so I'm actually having discus This article is protected by copyright.All rights reserved I think that's one of the things I struggle with, breastfeeding, and I can talk about diabetes, the preconception counselling is not my area This article is protected by copyright.All rights reserved