SAFE@HOME: Cost analysis of a new care pathway including a digital health platform for women at increased risk of preeclampsia.

OBJECTIVE: To perform a cost analysis of the use of a new care pathway with a digital health platform for blood pressure telemonitoring for women at risk of preeclampsia. STUDY DESIGN: This is a cost analysis of a case-control study with women with chronic hypertension, history of preeclampsia, maternal cardiac or kidney disease at intake of pregnancy. Antenatal care with a reduced visit schedule and a digital health platform (SAFE@HOME, n = 97) was compared to a retrospective control group (n = 133) with usual care without self-monitoring. MAIN OUTCOME MEASURES: Costs per pregnancy (€) of healthcare consumption of antenatal clinic visits, ultrasound assessments, antenatal admissions, laboratory and other diagnostic tests, and societal costs such as traveling and work absence. RESULTS: Baseline characteristics and perinatal outcomes were similar between both groups. A significant reduction of antenatal visits, ultrasounds and hypertension-related admissions was associated with use of the digital platform. In the SAFE@HOME group, costs of antenatal care, including the costs of the digital platform, were 19.7% lower compared to the control group (median €3616 [IQR 3071 - 5329] vs €4504 [IQR 3515-6923], p = 0.001). Total costs per pregnancy, including societal costs, were also reduced (€7485 [IQR 6338-10,173] vs €9150, [IQR 7546-12,286] p < 0.001). Each euro invested in the platform saved on average €8 of antenatal care resources. CONCLUSION: The use of a digital platform for blood pressure and symptom monitoring in antenatal care for high-risk women is associated with lower costs compared to conventional care, while observed maternal and neonatal outcomes are similar.

HOspital care versus TELemonitoring in high-risk pregnancy (HOTEL): study protocol for a multicentre non-inferiority randomised controlled trial.

INTRODUCTION: Pregnant women faced with complications of pregnancy often require long-term hospital admission for maternal and/or fetal monitoring. Antenatal admissions cause a burden to patients as well as hospital resources and costs. A telemonitoring platform connected to wireless cardiotocography (CTG) and automated blood pressure (BP) devices can be used for telemonitoring in pregnancy. Home telemonitoring might improve autonomy and reduce admissions and thus costs. The aim of this study is to compare the effects on patient safety, satisfaction and cost-effectiveness of hospital care versus telemonitoring (HOTEL) as an obstetric care strategy in high-risk pregnancies requiring daily monitoring. METHODS AND ANALYSIS: The HOTEL trial is an ongoing multicentre randomised controlled clinical trial with a non-inferiority design. Eligible pregnant women are >26+0 weeks of singleton gestation requiring monitoring because of pre-eclampsia (hypertension with proteinuria), fetal growth restriction, preterm rupture of membranes without contractions, recurrent reduced fetal movements or an intrauterine fetal death in a previous pregnancy.Randomisation takes place between traditional hospitalisation (planned n=208) versus telemonitoring (planned n=208) until delivery. Telemonitoring at home is facilitated with Sense4Baby CTG devices, Microlife BP monitor and daily telephone calls with an obstetric healthcare professional as well as weekly hospital visits.Primary outcome is a composite of adverse perinatal outcome, defined as perinatal mortality, 5 min Apgar <7 or arterial cord blood pH <7.05, maternal morbidity (eclampsia, HELLP (hemolysis, elevated liver enzymes, and low platelets) syndrome, thromboembolic event), neonatal intensive care admission and caesarean section rate. Patient satisfaction and preference of care will be assessed using validated questionnaires. We will perform an economic analysis. Outcomes will be analysed according to the intention to treat principle. ETHICS AND DISSEMINATION: The study protocol was approved by the Ethics Committee of the Utrecht University Medical Center and the boards of all six participating centres. Trial results will be submitted to peer-reviewed journals. TRIAL REGISTRATION NUMBER: NTR6076.