Pre-pregnancy Care for Women with Type 2 Diabetes
The PREPARED study is an integrated primary care-based study of pre-pregnancy care to improve pregnancy outcomes in women with type 2 diabetes. It is a multi-method study of implementation, system adaptation and performance.
National audit data show that 90% of women with Type 2 Diabetes do not meet the National Institute for Health and Care Excellence (NICE) pre-pregnancy care criteria of intensifying glucose, starting high dose folic acid, and stopping teratogenic medicines. Women with Type 2 Diabetes Mellitus (T2DM) now account for over half of the pregnancies in women with pre-existing diabetes in the UK. Diabetes pregnancies without adequate preparation are high risk. Compared to women without diabetes, women with diabetes have a quadrupled risk of fetal death; and double the risks of congenital abnormality or stillbirth. Diabetes pregnancy risks can be significantly reduced with adequate pre-pregnancy care; therefore, it is imperative to improve access to this care for women living with Type 2 diabetes.
We have systematically reviewed previous interventions and worked with women and health professionals to identify novel interventions to address this care deficit. The interventions have been theoretically modelled using Capability, Opportunity, Motivation to perform a Behaviour (COM-B); the Behaviour Change Wheel (BCT) and Normalisation Process Theory (NPT). An important feature of our approach is that it is centred in primary care as part of routine diabetes management, rather than hospitals where most pre-pregnancy care is currently provided. In this study we will optimise these interventions by assessing their impact on women’s access to pre-pregnancy care (or contraception) and pregnancy outcomes.
Aims
The project aims to answer the following research questions:
- What are the optimal interventional strategies for increasing the uptake of pre-pregnancy care (PPC) and reducing unplanned pregnancies in women with Type 2 diabetes mellitus (T2DM)?
- What behavioural (woman with T2DM / health professional), and system level factors mediate the implementation of interventions to enhance the uptake of PPC in women with T2DM?
Methods
We will use a multi-method research approach based on Complex Adaptive Systems (CAS) theory to address the inherent complexity of the interventions and the implementation context (primary care). The study is comprised of four work-packages:
- integration of intervention components
- implementation and optimisation of intervention components
- intervention optimisation and implementation
- health economics
Impact
The primary output from the study will be the development of an integrated programme of interventions to improve the uptake of pre-pregnancy care for women living with Type 2 diabetes and reduce the number of adverse pregnancy outcomes in in this group.
Project Team
Senior Research Fellow in Medical Statistics
Professor of Diabetes Nursing
Lecturer in Long-term Conditions and Reproductive Health
Lecturer in Health Economics
Reader in Diabetes & Primary Care
Effective start/end date: 01/10/2021 - 31/03/2024
The PREPARED study is comprised of four interconnected work packages
Work package 1: Integration of intervention components
Working with our multidisciplinary advisory group and Patient and Public Involvement (PPI) group we will develop and install intervention components into 30 GP practices in the boroughs of Lambeth and Southwark in Southeast London.
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The PREPARED study is comprised of four interconnected work packages
Work package 1: Integration of intervention components Working with our multidisciplinary advisory group and Patient and Public Involvement (PPI) group we will develop and install intervention components into 30 GP practices in the boroughs of Lambeth and Southwark in Southeast London.
Work package 2: Implementation and optimisation of intervention components We will conduct audits of processes and outcomes; and a process evaluation informing intervention feasibility, implementation, and behaviour change. Performance data will be collected via audits of GP systems, hospital antenatal clinics and pregnancy outcomes – using established data collection procedures. Using these data, we will iteratively refine the intervention components in line with the complex adaptive systems theory approach.
Work package 3: Intervention optimisation and implementation We will use the findings of work package 2 to optimise the intervention components and develop an implementation plan. This will also include a stakeholder event that brings together the participants from the previous work packages, The PPI group, the advisory board, and the research team.
Work package 4: Health Economics We will undertake an economic evaluation of the intervention in the form of a cost-consequence analysis. A health economic evaluation of the intervention will be undertaken in the form of a cost-consequence analysis. |
Publications
Forde R, Collin J, Brackenridge A, Chamley M, Hunt K, Forbes A. An integrated pre pregnancy care programme framework theoretically modelled from the perspectives of women with Type 2 diabetes and healthcare professionals. Midwifery. 2021; DOI: 10.1016/j.midw.2021.103130
Forde R, Collin J, Brackenridge A, Chamley M, K. Hunt K, Forbes A. A qualitative study exploring the factors that influence the uptake of pre-pregnancy care among women with Type 2 diabetes. Diabetic Medicine. 2020; 37:1038–1048. https://doi.org/10.1111/dme.14040
Forde R, Patelarou E, Forbes A. A meta-synthesis of the experiences of pre-pregnancy care from the perspectives of women with type 2 diabetes mellitus and healthcare professionals. International Journal of Women’s Health. 2016; 8:691–703. https://doi.org/10.2147/IJWH.S115955
Forde R, Abiola O, Anderson J, Bick D, Brackenridge A, Banerjee A, Chamley M, Chua K-C, Hopkins L, Hunt K, Murphy HR, Rogers H, Romeo R, Shearer J, Winkley K, Angus Forbes A. An integrated primary care‑based programme of PRE‑Pregnancy cARE to improve pregnancy outcomes in women with type 2 Diabetes (The PREPARED study): protocol for a multi‑method study of implementation, system adaptation and performance. DOI: https://doi.org/10.1186/s12875-022-01683-1
The publication feed is not currently available.
Project Team
Senior Research Fellow in Medical Statistics
Professor of Diabetes Nursing
Lecturer in Long-term Conditions and Reproductive Health
Lecturer in Health Economics
Reader in Diabetes & Primary Care
Effective start/end date: 01/10/2021 - 31/03/2024
The PREPARED study is comprised of four interconnected work packages
Work package 1: Integration of intervention components
Working with our multidisciplinary advisory group and Patient and Public Involvement (PPI) group we will develop and install intervention components into 30 GP practices in the boroughs of Lambeth and Southwark in Southeast London.
|
The PREPARED study is comprised of four interconnected work packages
Work package 1: Integration of intervention components Working with our multidisciplinary advisory group and Patient and Public Involvement (PPI) group we will develop and install intervention components into 30 GP practices in the boroughs of Lambeth and Southwark in Southeast London.
Work package 2: Implementation and optimisation of intervention components We will conduct audits of processes and outcomes; and a process evaluation informing intervention feasibility, implementation, and behaviour change. Performance data will be collected via audits of GP systems, hospital antenatal clinics and pregnancy outcomes – using established data collection procedures. Using these data, we will iteratively refine the intervention components in line with the complex adaptive systems theory approach.
Work package 3: Intervention optimisation and implementation We will use the findings of work package 2 to optimise the intervention components and develop an implementation plan. This will also include a stakeholder event that brings together the participants from the previous work packages, The PPI group, the advisory board, and the research team.
Work package 4: Health Economics We will undertake an economic evaluation of the intervention in the form of a cost-consequence analysis. A health economic evaluation of the intervention will be undertaken in the form of a cost-consequence analysis. |
Publications
Forde R, Collin J, Brackenridge A, Chamley M, Hunt K, Forbes A. An integrated pre pregnancy care programme framework theoretically modelled from the perspectives of women with Type 2 diabetes and healthcare professionals. Midwifery. 2021; DOI: 10.1016/j.midw.2021.103130
Forde R, Collin J, Brackenridge A, Chamley M, K. Hunt K, Forbes A. A qualitative study exploring the factors that influence the uptake of pre-pregnancy care among women with Type 2 diabetes. Diabetic Medicine. 2020; 37:1038–1048. https://doi.org/10.1111/dme.14040
Forde R, Patelarou E, Forbes A. A meta-synthesis of the experiences of pre-pregnancy care from the perspectives of women with type 2 diabetes mellitus and healthcare professionals. International Journal of Women’s Health. 2016; 8:691–703. https://doi.org/10.2147/IJWH.S115955
Forde R, Abiola O, Anderson J, Bick D, Brackenridge A, Banerjee A, Chamley M, Chua K-C, Hopkins L, Hunt K, Murphy HR, Rogers H, Romeo R, Shearer J, Winkley K, Angus Forbes A. An integrated primary care‑based programme of PRE‑Pregnancy cARE to improve pregnancy outcomes in women with type 2 Diabetes (The PREPARED study): protocol for a multi‑method study of implementation, system adaptation and performance. DOI: https://doi.org/10.1186/s12875-022-01683-1
The publication feed is not currently available.
Principal Investigator
Professor of Diabetes Nursing
Funding
Funding Body: National Institute for Health Research (NIHR)
Amount: £692,937.64
Period: October 2021 - March 2025