Home telemonitoring versus hospital care in complicated pregnancies in the Netherlands: a randomised, controlled non-inferiority trial (HoTeL).

BACKGROUND: Women with complicated pregnancies often require hospital admission. Telemonitoring at home is a promising alternative that fulfils a worldwide need in obstetric health care. Moreover, the COVID-19 pandemic has accelerated the transformation to digital care. The aim of this study was to evaluate safety, clinical effectiveness, patient satisfaction, and costs of home telemonitoring against hospital care in complicated pregnancies. METHODS: We did a multicentre, randomised, controlled, non-inferiority trial in six hospitals (four general teaching hospitals and two university hospitals) in the Netherlands (located in Utrecht, Amsterdam, and Groningen). Women aged 18 years and older with singleton pregnancies (>26 weeks gestation) requiring monitoring for pre-eclampsia, fetal growth restriction, fetal anomaly, preterm rupture of membranes, reduced fetal movements, or history of fetal death were included in the study. Participants were randomly assigned to either hospital admission or telemonitoring in (1:1), stratified for the six diagnoses for inclusion and the six centres of inclusion, using block randomisation (block sizes of four and six). When assigned to telemonitoring, participants went home with devices for cardiotocography and blood pressure measurements and had daily contact with their care providers after digitally sending their home measurements. When assigned to hospital admission, participants received care as usual on the ward until the postpartum period. The primary outcome was a composite of adverse perinatal outcomes assessed after delivery, including mortality; an Apgar score below 7 after 5 min or an umbilical arterial pH at birth below 7·05; maternal morbidity; admission of the newborn to the neonatal intensive care unit; and rate of caesarean section. The primary outcome was assessed in the intention-to-treat population. The non-inferiority margin for the primary outcome was a 10% absolute increase in composite primary endpoint based on baseline 20% incidence. The study was registered at the Dutch Trial Registration (NL5888) and is now closed to new participants. FINDINGS: From Dec 1, 2016, to Nov 30, 2019, 201 pregnant women were randomly assigned to an intervention procedure. 101 women were allocated to the telemonitoring group and 100 to the hospital admission group. One participant in the telemonitoring group withdrew consent before the intervention was initiated, and 100 participants were analysed for the primary outcome. In the hospital admission group, four participants did not receive the allocated intervention because they did not accept hospital admission. 100 participants in each group were analysed for the primary outcome according to the intention-to-treat principal. No participants were lost to follow-up. The primary outcome occurred in 31 (31%) of 100 participants in the telemonitoring group and in 40 (40%) of 100 participants in the hospital admission group. Adjusted for centre of inclusion, diagnosis, and nulliparity, the risk difference in primary outcome between both groups was 10·3% (95% CI -22·4 to 2·2) lower in the telemonitoring group, below the pre-defined non-inferiority margin of 10% absolute increase. A similar distribution for each of the individual components within the composite primary outcome was seen between groups. Five serious adverse events were reported: one neonatal death in the hospital admission group, in addition to one intra-uterine fetal death, two neonatal deaths, and one case of eclampsia in the telemonitoring group, all unrelated to the study. INTERPRETATION: This non-inferiority trial shows the first evidence that telemonitoring might be as safe as hospital admission for monitoring complicated pregnancies. FUNDING: Stichting Achmea Gezondheidszorg and ICT Healthcare Technology Solutions.

Digital decision aid for prenatal counseling in imminent extreme premature labor: development and pilot testing.

BACKGROUND: In case of extreme premature delivery at 24 weeks of gestation, both early intensive care and palliative comfort care for the neonate are considered treatment options. Prenatal counseling, preferably using shared decision making, is needed to agree on the treatment option in case labor progresses. This article described the development of a digital decision aid (DA) to support pregnant women, partners and clinicians in prenatal counseling for imminent extreme premature labor. METHODS: This DA is developed following the International Patient Decision Aid Standards. The Dutch treatment guideline and the Dutch recommendations for prenatal counseling in extreme prematurity were used as basis. Development of the first prototype was done by expert clinicians and patients, further improvements were done after alpha testing with involved clinicians, patients and other experts (n = 12), and beta testing with non-involved clinicians and patients (n = 15). RESULTS: The final version includes information, probabilities and figures depending on users' preferences. Furthermore, it elicits patient values and provides guidance to aid parents and professionals in making a decision for either early intensive care or palliative comfort care in threatening extreme premature delivery. CONCLUSION: A decision aid was developed to support prenatal counseling regarding the decision on early intensive care versus palliative comfort care in case of extreme premature delivery at 24 weeks gestation. It was well accepted by parents and healthcare professionals. Our multimedia, digital DA is openly available online to support prenatal counseling and personalized, shared decision-making in imminent extreme premature labor.

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.

Home-Based Monitoring and Telemonitoring of Complicated Pregnancies: Nationwide Cross-Sectional Survey of Current Practice in the Netherlands.

BACKGROUND: Daily monitoring of fetal and maternal conditions in complicated pregnancies leads to recurrent outpatient visits or (prolonged) hospitalization. Alternatives for hospital admissions include home-based monitoring with home visits by professionals or telemonitoring with self-measurements performed by pregnant women and uploaded for in-clinic assessment. For both alternatives, cardiotocography and blood pressure measurement can be performed at home. It is unknown to what extent, for which reasons, and for which pregnancy complications these strategies are used. OBJECTIVE: This study aims to assess the current practice and attitudes concerning home-based monitoring (with daily home visits by professionals) and telemonitoring (using devices and the internet for daily self-recorded measurements) in high-risk pregnancies requiring maternal and fetal monitoring in the Netherlands. METHODS: This nationwide cross-sectional study involved sending a web-based survey to the obstetrics departments of all 73 hospitals in the Netherlands to be answered by 1 representative dedicated to pregnancy monitoring per hospital. The primary outcome was the provision of home-based monitoring or telemonitoring using cardiotocography between 1995 and 2018. The survey further addressed perspectives regarding the use of home-based monitoring and telemonitoring, including (contra)indications, advantages, and disadvantages for pregnant women and clinicians. RESULTS: The response rate for the provision of either home-based monitoring or telemonitoring was 100%. In 2018, 38% (28/73) of centers in the Netherlands offered either home-based monitoring or telemonitoring or both to pregnant women with complications. Home-based monitoring was offered in 26% (19/73) of the centers; telemonitoring, in 23% (17/73); and both in 11% (8/73). Telemonitoring was first offered in 2009, increasing from 4% (3/73) of hospitals in 2014 to 23% (17/73) in 2018. Responses were received from 78% (57/73) of the invited hospitals and analyzed. Of all 17 centers using telemonitoring, 59% (10/17) did not investigate perinatal outcomes, safety, and patient satisfaction prior to implementation. Other (6/17, 35%) telemonitoring centers are participating in an ongoing multicenter randomized clinical trial comparing patient safety, satisfaction, and costs of telemonitoring with standard hospital admission. Home-based monitoring and telemonitoring are provided for a wide range of complications, such as fetal growth restriction, pre-eclampsia, and preterm rupture of membranes. The respondents reported advantages of monitoring from home, such as reduced stress and increased rest for patients, and reduction of admission and possible reduction of costs. The stated barriers included lack of insurance reimbursement and possible technical issues. CONCLUSIONS: Home-based monitoring is provided in 26% (19/73) and telemonitoring, in 23% (17/73) of hospitals in the Netherlands to women with pregnancy complications. Altogether, 38% (28/73) of hospitals offer either home-based monitoring or telemonitoring or both as an alternative to hospital admission. Future research is warranted to assess safety and reimbursement issues before more widespread implementation of this practice.

User Experiences With and Recommendations for Mobile Health Technology for Hypertensive Disorders of Pregnancy: Mixed Methods Study.

BACKGROUND: Hypertensive disorders of pregnancy (HDP) are a primary cause of adverse maternal and neonatal outcomes worldwide. For women at risk of hypertensive complications, guidelines recommend frequent surveillance of blood pressure and signs of preeclampsia. Clinic visits range from every 2 weeks to several times a week. Given the wide ubiquity of smartphones and computers in most countries and a growing attention for self-management, digital technologies, including mobile health (mHealth), constitute a promising component of monitoring (self-measured) blood pressure during pregnancy. Currently, little is known about the experiences of women using such platforms and how mHealth can be aligned with their needs and preferences. OBJECTIVE: The objectives were twofold: (1) to explore the experiences of Dutch women who had an increased risk of HDP with a blended care approach (mHealth combined with face-to-face care) for remote self-monitoring of blood pressure and preeclampsia symptoms and (2) to formulate recommendations for the use and integration of mHealth in clinical care. METHODS: Alongside a prospective blended care study (SAFE@home study) that monitors pregnant women at increased risk of HPD with mHealth technology, a mixed methods study was conducted, including questionnaires (n=52) and interviews (n=11). Results were analyzed thematically. RESULTS: Of the 4 themes, 2 themes were related to the technologies themselves (expectations, usability), and 2 themes were related to the interaction and use of mHealth (autonomy and responsibilities of patients, responsibilities of health care professionals). First, the digital platform met the expectations of patients, which contributed to user satisfaction. Second, the platform was considered user-friendly, and patients favored different moments and frequencies for measuring their blood pressure. Third, patient autonomy was mentioned in terms of increased insight about their own condition and being able to influence clinical decision making. Fourth, clinical expertise of health care professionals was considered essential to interpret the data, which translates to subsequent responsibilities for clinical management. Data from the questionnaires and interviews corresponded. CONCLUSIONS: Blended care using an mHealth tool to monitor blood pressure in pregnancy was positively evaluated by its users. Insights from participants led to 7 recommendations for designing and implementing similar interventions and to enhance future, morally sound use of digital technologies in clinical care.

SAFE@HOME: Digital health platform facilitating a new care path for women at increased risk of preeclampsia - A case-control study.

OBJECTIVE: In women at risk of developing preeclampsia, we evaluated the use of a digital health platform for telemonitoring blood pressure and symptoms combined with a minimal antenatal visit schedule. STUDY DESIGN: A case-control study for women with chronic hypertension, history of preeclampsia, or maternal cardiac or kidney disease. A care path was designed with reduced visits enhanced with a digital platform (SAFE@HOME) for daily blood pressure and symptom monitoring starting from 16 weeks of gestation. Home-measurements were monitored in-hospital by obstetric professionals, taking actions upon alarming results. This prospective SAFE@HOME group was compared to a retrospective control group managed without self-monitoring. MAIN OUTCOME MEASURES: Primary: healthcare consumption (number of antenatal visits, ultrasounds, admissions and diagnostics), user experiences of the platform. Secondary: maternal and perinatal outcomes. RESULTS: Baseline characteristics of the SAFE@HOME (n = 103) and control group (n = 133) were comparable. In the SAFE@HOME group, antenatal visits (mean 13.7 vs 16.0, p < 0.001) and ultrasounds (6.3 vs 7.4, p = 0.005) were lower compared to the control group. Admissions for hypertension or suspected preeclampsia were significantly fewer in the SAFE@HOME group (2.9% versus 13.5%, p = 0.004). Telemonitoring participants were highly satisfied using the platform. No differences were observed for maternal and perinatal outcomes. CONCLUSIONS: Our care path including blood pressure telemonitoring for women at risk of preeclampsia allows fewer antenatal visits, ultrasounds and hypertension-related admissions. We observed no differences in perinatal outcomes. These results suggest that telemonitoring of blood pressure is feasible in a high-risk pregnant population and has the potential to profoundly change antenatal care.

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.

SAFE@HOME - Feasibility study of a telemonitoring platform combining blood pressure and preeclampsia symptoms in pregnancy care.

OBJECTIVE: To study the feasibility of a telemonitoring platform for hypertensive disease in pregnancy, consisting of a wireless blood pressure monitor and an app in combination with an integrated preeclampsia symptom checklist. STUDY DESIGN: Prospective observational study with 14 pregnant women during a 15 weekday study period. For feasibility purposes, compliance was measured by evaluating the number of entered BP and symptom checklists. Comparing all the entered values with the threshold values checked the accuracy of the automatic alerts. Usability and patient satisfaction were measured using questionnaires. RESULTS: Compliance rates for blood pressure and symptom checklist were 93% and 85% respectively. No false positive or missing alerts were found in the alarm system. The telemonitoring system alarmed 7 times for BP thresholds (3.8% of all received values), Of 167 returned symptom checklists, 93% of symptom alarms could be handled with expectant management because of concurrent normal blood pressure. The majority of participants were satisfied with the system. CONCLUSIONS: This is the first feasibility study of a telemonitoring platform, combining remote monitoring of BP with preeclampsia symptoms in pregnancy care. Action from health care providers during telemonitoring is only needed in case of alarming combinations of results. This system is potentially very useful in care for women at risk for hypertensive disorders during pregnancy.

Validation of the iHealth Track and Omron HEM-9210T automated blood pressure devices for use in pregnancy.

OBJECTIVE: Self monitoring of blood pressure in pregnancy is increasingly popular with both health care professionals and patients. We assessed the validity of the iHealth Track and Omron HEM-9210T automated blood pressure devices (with Bluetooth connectivity) for the use in telemonitoring of blood pressure in pregnancy. METHODS: In this prospective observational study, the revised 2010 International Protocol of the European Hypertension Society (EHS) was used for the validation of the two devices against auscultatory sphygmomanometry by two independent observers who took 13 same arm measurements in 33 pregnant women, of which 10 were diagnosed with preeclampsia. The measurements were alternated between the test device and a calibrated aneroid sphygmomanometer following the protocol. Both automated devices were assessed sequentially in the same women. RESULTS: In the group of 33 women, the iHealth Track passed the EHS 2010 validation criteria with 86/98/99 of 99 device-observer systolic measurement comparisons and 88/96/98 of 99 device-observer diastolic measurement comparisons within the 5/10/15 mmHg boundaries respectively. The Omron HEM-9210T passed the same criteria with 85/94/99 of 99 device-observer systolic measurement comparisons and 82/95/99 of 99 device-observer diastolic measurement comparisons. CONCLUSIONS: The iHealth Track and Omron HEM-9210T automated blood pressure monitors are validated for use in pregnancy. These two devices can now be added to the short list of validated devices in pregnancy and can be used for self-measurement of blood pressure in a telemonitoring setting of pregnant patients with (a high risk of) hypertensive disease.