Study of Fetal Health Outcomes: Working With a Missouri E-telehealth Platform (The SHOW-ME Study)

ConditionPregnancy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Missouri-Columbia

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • INVU fetal monitoring system

    Device

    INVU fetal monitoring system allows for at-home non-stress testing as opposed to the typical in-clinic testing

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: At-home fetal monitoringExperimental treatment 1 intervention
Group B: In-office fetal monitoringNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Participants will be recruited at any time during pregnancy if they meet inclusion criteria and require antenatal fetal testing between 32 and 40 weeks gestation

Secondary outcomes

1

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.

Time frame
Participants will be recruited at any time during pregnancy if they meet inclusion criteria and require antenatal fetal testing between 32 and 40 weeks gestation

Other outcomes

Sponsors and contacts

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University of Missouri-Columbia

Lead sponsor

University of Missouri, Kansas City

Collaborator