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

Abstract

Background The number of women of childbearing age with Type 2 diabetes(T2DM) is increasing, and they now account for > 50% of pregnancies in women with pre-existing diabetes. Diabetes pregnancies without adequate pre-pregnancy care have higher risk for poor outcomes (miscarriages, birth-defects, stillbirths) and are associated with increased complications (caesarean deliveries, macrosomic babies, neonatal intensive-care admissions). The risks and costs of these pregnancies can be reduced with pregnancy preparation (HbA1c, ≤ 6.5%, 5 mg folic acid and stopping potentially harmful medicines). However, 90% of women with T2DM, most of whom are based in primary care, are not adequately prepared for pregnancy. This study will evaluate a programme of primary care-based interventions (decision-support systems; pre-pregnancy care-pathways; pregnancy-awareness resources; professional training; and performance monitoring) to improve pregnancy preparation in women with T2DM. Methods The study aims to optimise the programme interventions and estimate their impact on pregnancy preparation, pre-pregnancy care uptake and pregnancy outcomes. To evaluate this multimodal intervention, we will use a multi-method research design following Complex Adaptive Systems (CAS) theory, refining the interventions iteratively during the study. Thirty GP practices with ≥ 25 women with T2DM of reproductive age (18–45 years) from two South London boroughs will be exposed to the intervention. This will provide > 750 women with an estimated pregnancy incidence of 80–100 to study. The research involves: a clinical audit of processes and outcomes; a process evaluation informing intervention feasibility, implementation, and behaviour change; and a cost-consequences analysis informing future economic evaluation. Performance data will be collected via audits of GP systems, hospital antenatal clinics and pregnancy outcomes. Following CAS theory, we will use repeated measurements to monitor intervention impact on pregnancy preparation markers at 4-monthly intervals over 18-months. We will use performance and feasibility data to optimise intervention effects iteratively. The target performance for the intervention is a 30% increase in the proportion of women meeting pre-pregnancy care criteria. Discussion The primary output will be development of an integrated programme of interventions to improve pregnancy preparation, pre-pregnancy care uptake, and reduce adverse pregnancy outcomes in women with T2DM. We will also develop an implementation plan to support the introduction of the interventions across the NHS. Trial registration ISRCTN47576591; February 8, 2022.

Meta-Analysis of the Effect of Nursing Intervention on Children with Type 2 Diabetes

“…Some studies have pointed out that nursing intervention can effectively control the blood glucose of children with type 2 diabetes and improve their compliance with treatment, so as to delay the progress of the disease and improve patients' life experience [15][16][17], but there is still a lack of relevant medical evidence. Therefore, we systematically evaluated the effect of nursing intervention in children with type 2 diabetes by retrieving relevant literature and applying meta-analysis method, so as to provide medical evidence for the clinical promotion and application of nursing intervention.…”

Interventions to enhance pre‐pregnancy care for women with type 2 diabetes: A systematic review of the literature

“…These studies both aim to integrate pre‐pregnancy care for women with type 2 diabetes into primary care. The proposed interventions components for these studies include: modified electronic health record technology to promote pre‐pregnancy care discussions 28,29 ; health professional education 28 ; education resources for women with type 2 diabetes 28,29 ; and text message prompts to promote health behaviours 29 . Both of these studies address many of the limitations identified in the previous studies as they are theoretically grounded and focused on primary care settings.…”

“…26,27 However, to the authors knowledge, no studies assessing the effectiveness of the PADI app have yet been published. There are two ongoing studies of relevance, with one based in the UK (the PREPARED study), 28 while the other is based in the US. 29 These studies both aim to integrate pre-pregnancy care for women with type 2 diabetes into primary care.…”