Award Title: An Integrated Primary Care-based Programme of Pre-pregnancy Care to Improve Pregnancy Outcomes in Women with Type 2 diabetes: A Multi-method Study of Implementation, System Adaptation and Performance
Funder: Department of Health and Social Care

Abstract: Aims_x000D_
This research will assess new ways to improve access to pre-pregnancy care for women living with Type 2 diabetes and reduce pregnancy complications and costs._x000D_
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Background_x000D_
Women with Type 2 diabetes account for over 50% of pregnancies in those with established diabetes. Diabetes pregnancies are risky for both mother and baby - especially if unplanned. If the mother has high sugar levels or is taking medications that are unsafe in pregnancy, the baby may be harmed. The risk of a miscarriage is four times higher and the risks of birth defects and stillbirths are doubled compared to those without diabetes. Half of these women have a caesarean delivery; a quarter of the women have large babies and many babies require special care. Such outcomes are distressing for mothers and result in higher care costs. _x000D_
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Most women with Type 2 diabetes do not know these risks. Only 10% of women with Type 2 diabetes receive pre-pregnancy care, which reduces risks by improving blood sugar levels, stopping harmful medications and giving high dose folic acid. Therefore, improving access to pre-pregnancy care for women with Type 2 diabetes is a high priority.  _x000D_
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We reviewed previous studies on pre-pregnancy care uptake and talked to women and health professionals. A key barrier is the location of pre-pregnancy care in hospitals, rather than in primary care where most women with Type 2 diabetes are seen. Pre-pregnancy care access should improve if it is delivered in a primary care setting. _x000D_
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Intervention_x000D_
We have developed a package of primary care-based interventions to ensure that women receive regular reproductive support. The intervention includes:_x000D_
• A clear set of instructions about what care women should receive_x000D_
• Training for health professionals who usually care for women with Type 2 diabetes including clear guidance on what to do and when_x000D_
• Information for women_x000D_
• Recording information about the health of the women and baby at birth (in those who become pregnant) to see if the help made a difference_x000D_
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Methods_x000D_
We will assess the impact of the intervention by doing an audit of pre-pregnancy care uptake and pregnancy outcomes at regular intervals in 30 General Practices in areas with high deprivation and with women from different ethnic backgrounds.  Using multiple types of data collection, we will audit the uptake of pre-pregnancy care and ask women and health professionals about their experiences in the study.  As the study progresses, we will identify how to improve the interventions and how best to implement the interventions in the NHS._x000D_
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Patient and Public Involvement_x000D_
Involvement from patients and professionals is central to our work. We have a strong PPI and advisory group with women with Type 2 diabetes, health professionals and representatives from women’s and patient organisations. Our PPI group guided the design of this study and will be part of the study advisory board which will be co-led by our patient co-applicant. _x000D_
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We will hold an event with women, health professionals and managers to share what we have learnt and identify if there are any further changes needed, and to make a plan of how our package of care could be used by others who care for women _x000D_
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Study outputs and impact_x000D_
At the end of the study we will share our findings widely (including with patients).  If successful we will make the interventions and an implementation plan available to the NHS, to improve pregnancy outcomes for this growing population.

Lay Abstract: Background_x000D_
Women with Type 2 diabetes (T2DM) account over 50% of pregnancies in women with diabetes. These are high risk pregnancies. NICE criteria for diabetes pre-pregnancy care include intensifying glucose control; using high dose folic acid; and stopping medications not safe during pregnancy. Currently less than 10% of T2DM pregnancies achieve these criteria. Effective care models are needed to improve pre-pregnancy care uptake, to reduce adverse pregnancy outcomes and NHS costs._x000D_
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Following a review of prior interventions and work with women and health professionals, we have identified an integrated primary-care based programme of intervention to increase pre-pregnancy care uptake. These include practice staff training; electronic decision supports and prompts; care planning tools; a care-pathway; pregnancy awareness materials for women with T2DM; resources for women; and performance monitoring._x000D_
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Objectives_x000D_
• Study the impact of intervention components and iteratively optimise their effect on care outcomes._x000D_
• Assess intervention feasibility._x000D_
• Understand organisational factors that mediate intervention implementation and performance._x000D_
• Study behavioural impacts of intervention components on health professionals and women with T2DM._x000D_
• Generate theoretical models for implementing pre-pregnancy care._x000D_
• Undertake preliminary modelling of intervention costs and benefits._x000D_
• Produce an implementation plan for enhancing pre-pregnancy care uptake._x000D_
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Methods_x000D_
We will use a multi-method approach based on Complex Adaptive Systems theory to iteratively optimise the intervention’s impact during the study period. We will recruit 30 GP practices with more than 25 women with T2DM of reproductive age (18-45 years) from 2 South London Clinical Commissioning Groups for intervention exposure. This will provide more than 750 women to study, with an estimated incidence of 80-100 pregnancies per year. _x000D_
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The study is organised into 4 work-packages:_x000D_
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Work-package 1 - Optimising intervention components and preparing them for implementation._x000D_
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Work-package 2 - Implementation and optimisation of intervention components using: a clinical audit of processes and outcomes to monitor performance; and a process evaluation considering feasibility and implementation. Performance data will be collected via audits of GP systems, hospital antenatal clinics and pregnancy outcomes. We will use repeat measures to monitor the impact on pre-pregnancy care performance at monthly intervals over 18 months. Performance measures and feasibility data will be reviewed quarterly and interventions boosted or adjusted accordingly. The target for performance is 30% of women meeting NICE pre-pregnancy care criteria. The process evaluation will assess reach, fidelity, delivery and receipt of intervention components; women and health professionals’ experiences; and mechanisms of action._x000D_
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Work-package 3 - Findings from work-package 2 will be used to optimise the intervention components and develop an implementation plan._x000D_
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Work-package 4 - Study data will be used to estimate intervention cost-benefits; effect uncertainty; and cost-effectiveness._x000D_
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Timeline_x000D_
WP1-Months 0-6_x000D_
WP2-Months 7-24_x000D_
WP3-Months 25-30_x000D_
WP4-Months 3-25_x000D_
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Impact_x000D_
The primary output from the study will be development of an integrated programme of interventions to improve pre-pregnancy care uptake and reduce the number of costly adverse pregnancy outcomes in women with T2DM.

Research Activity Codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES
Health Categories: METABOLIC AND ENDOCRINE;REPRODUCTIVE HEALTH AND CHILDBIRTH