Study of Fetal Health Outcomes: Working With a Missouri E-telehealth Platform

The goal of the investigators is to study aspects of the implementation of a new, FDA-approved technology and conduct quantitative analyses to describe reach and patient-centered predictors of use (e.g. transportation barriers), as well as qualitative analyses (i.e. focus groups with patients and providers). Focus groups were previously performed with participants randomly recruited at each institution to inform the pre-implementation questionnaires for the patients.

For this study, participants will be identified through their PIs institution, as someone who is 18 years of age or older, who has been identified by their providers as someone who requires antenatal fetal testing (starting at 32 weeks), and who has a smart device with WIFI access. Participants with Medicaid insurance will have their expenses covered by insurance as currently Medicaid covers the cost of home fetal telehealth. Participants who are self-pay or who have private insurance will be offered to participate but informed that they will have to pay all expenses out of pocket (as currently in Missouri private payers are not reimbursing for the use of home fetal monitors). All participants will be required to sign an informed consent prior to enrollment.

Questionnaires were iteratively designed by the PIs at each institution. Pre-implementation questionnaires will be distributed to eligible patients and provider (including nurses, Medical Assistants, and scheduling Staff)) enrolled at all 3 centers. Patient participants will be approached between 12-28 weeks and must meet the inclusion criteria outlined below. Providers will be approached prior to the start of enrollment at each institution to discuss their desire to read INVU NSTs remotely as part of the study and will be consented at that time. Providers are eligible if they are board certified or eligible in family medicine, obstetrics and gynecology, or maternal-fetal medicine and read NSTs as part of their routine care delivery to obstetrical patients. Nurse practitioners who provide obstetrical care and are qualified to read NST (as part of routine care), Nurses, Medical Assistants, and Scheduling staff are also eligible to participate as a provider. Eligibility will be verified prior to enrollment. Patient eligibility will be verified prior to enrollment. Following, subjects will be asked whether or not they want to participate in the fetal testing portion of the study. For those who desire to perform the in-home fetal monitoring, they will then be randomized in a 1:1 manner to either in office or home monitoring. Although not testing the effectiveness of the device itself, randomization will ensure that investigators prevent inclusion bias (inherit differences that may be present between those who do not choose to participate and those who do participate) by having all those who want to participate randomly assigned to either receive in-home testing or in-office testing. For those in the home monitoring group, a prescription for the device will be given and the equipment will be shipped to the participants home within 6-10 business days. All training on the device use, troubleshooting, and accessing the cloud platform for telehealth (fetal) visits will be done by INVU through the INVU app. INVU provides an effective, easy-to-use chat service within the application for customer support for these training sessions. A number as well as printed instructions for troubleshooting will be provided to each enrolled individual for easy, 24-hour access to INVU at home. For participants who are randomized to the in-office monitoring, they will continue their standard of care monitoring as they would regardless of being part of the study. The testing and frequency itself will not differ between the groups (i.e. all participants will still receive non-stress testing once or twice weekly as determined by their provider) rather just the location (i.e. in home or in office). Participants will be scheduled as they would normally and will have specified times to place the band and start their fetal monitoring session. Since INVU is not part of routine clinical care at any of the current institutions, participants who choose not to be part of the study will not have the opportunity to use INVU outside of the study.

The routine clinical care group will maintain their obstetrical care as prescribed by their provider and will continue their antenatal fetal testing in the office or hospital setting. They will not be asked to provide any additional testing or information (i.e. questionnaires) after randomization. Investigators will be collecting demographic and clinical outcomes information, including costs at the end of study.

For the at-home fetal monitoring portion, this study will be utilizing "INVU" technology designed by Nuvo to perform fetal testing remotely. As the patient will not be in the ambulatory setting and part of routine antenatal testing includes maternal vital signs, investigators will be providing the at-home participants with blood pressure cuffs (through prescription, or as part of the free Cuff Kit project if available at participating institutions) so they can monitor their blood pressure.