About this trial
The goal of this clinical trial is to evaluate the potential benefit to patients and providers from using the remote fetal-monitoring system NUVO along with its app to allow for pregnant patients requiring weekly non-stress testing to do so from their homes. The main questions the investigators are looking to answer are:
What effect does the NUVO remote fetal monitoring system have on patient/provider satisfaction?
What is the cost savings (both direct and indirect) from using a remote fetal monitoring system as opposed to in-person testing for both the patient and the provider?
Researchers will compare the survey responses by both patients and providers for pre and post implementation of the NUVO fetal monitoring system to the survey responses of patients and providers who used the traditional in-clinic method to evaluate satisfaction and cost savings.
Participants will:
Answer pre-implementation surveys before undergoing the trial
Be randomly assigned to do either fetal testing at-home or in-clinic once or twice weekly as up to the provider
Before hospital discharge or within the last office visit participants will be given a post-implementation survey
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
English Speaking
> 18 years of age
Singleton gestation
Missouri Medicaid as primary insurance (paid by study), offered to patients with private insurance for self-pay
Disqualifiers
Multiple gestations
Additional co-morbidities not listed in the inclusion criteria
PPROM or evidence of preterm labor
Oligohydramnios of < 5 cm of polyhydramnios > 30
Trial design
Parallel
Treatments tested in this trial
INVU fetal monitoring system
DeviceINVU fetal monitoring system allows for at-home non-stress testing as opposed to the typical in-clinic testing
Treatment groups
Trial outcomes
Primary outcomes
Evaluate the implementation of a remote fetal-monitoring system through RE-AIM quest framework
Each of the three participating centers and patients will receive access to and training in the INVU telehealth platform with the goal of studying the implementation (through pre and post implementation questionnaires) of this novel telehealth system and its impact on both patients and providers
Secondary outcomes
Assess direct and indirect cost savings for patients, providers, and insurance carriers following implementation of a remote monitoring system
Investigators will evaluate cost savings by numerating averted emergency room, triage, facility fees, and office visits for fetal symptoms (i.e. decreased fetal movement). Furthermore, investigators will assess cost savings for patients by numerating facility fees, transportation costs, and utilization of hospital resources for those utilizing the home monitoring system as compared to participants who received ambulatory evaluation.
Sponsors and contacts
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University of Missouri-Columbia
Lead sponsor
University of Missouri, Kansas City
Collaborator