Personalized Prenatal Care for Low-Risk Pregnancies Using Telemedicine
Condition: Pregnancy
Study type: Interventional

Summary: 
      Not all pregnant women have the same risks for pregnancy complications. Women at low-risk for
      pregnancy complications may not need the same type of prenatal care. The goal of this study
      is to learn about the use of telemedicine for low-risk pregnant women and improve the
      delivery of prenatal care. Telemedicine is medical care provided using a computer or
      telephone to visit with a doctor for some medical appointments. Participating patients will
      be assigned by a computer to either standard prenatal care, or prenatal care involving a
      combination of standard prenatal visits and telemedicine visits. Both groups will have the
      same number of prenatal care visits.

      In both groups, we will ask about the patients' satisfaction with their care, the amount of
      time they spent visiting with their doctor, and information about time and their expenses. In
      the telemedicine group, we will teach how to measure blood pressure, fetal heart rate, and
      weight from home.

      The goals of this study are to: 1) assess the patient satisfaction, patient experiences and
      preferences, financial impact, clinical outcomes, and provider satisfaction of providing
      personalized prenatal care for low-risk pregnancies using telecommunication and remote
      patient care devices; and 2) measure the reliability of at-home, patient-recorded,
      computer-documented prenatal care measurements. The primary outcome is patient satisfaction
      with prenatal care after delivery.
    

Detailed description: 
      Study procedures and data collection for a woman enrolled to the study are described below:

        1. Randomization Prior to enrollment in the study, eligible participating patients will be
           randomized into the control or remote prenatal care groups. The study coordinator will
           be aware of which group the participant is assigned to and provide training tailored to
           the assigned study group. The telemedicine group will receive all training described
           below. The control group will only receive training on the survey instrument and
           instruction on how to access the message box within MyChart.

        2. Remote Monitoring Devices Remote prenatal care group participants will measure, record,
           and submit their blood pressure, weight, and fetal heart recordings into MyChart
           (described below) no more than 48 hours prior to a scheduled remote prenatal care visit
           (described below).

             -  Weight- Participants will use their home scale or be given one to use if they don't
                have one. For demonstration purposes, a scale will be available during the
                in-person visit with the study coordinator. The patient is required to measure
                weight in pounds to the nearest pound.

             -  Blood Pressure- Participants will be provided one digital blood pressure cuff that
                will measure their blood pressure to be used throughout the pregnancy. They will be
                required to report the systolic and diastolic blood pressure as measured and
                displayed by the device in millimetres of mercury (mmHg).

             -  Fetal Heart Rate- Participants will be provided one digital fetal doppler monitor
                to be used throughout the pregnancy. They will use it to determine the fetus' heart
                rate in beats per minute.

           Patients will be allowed to keep the devices at the conclusion of the study as
           compensation for participating and completing the research.

        3. MyChart Epic MyChart is the personal health record that is linked to the Epic electronic
           health record used by the University of Utah. Participants will use MyChart to record
           information to allow their recordings to integrate within the Epic electronic health
           record and be viewable by the treating clinician. At each time point that requires
           patient recording of health data described above, patient-entered flowsheets will be
           available with the required data fields. Help text will also be available on the form to
           assist proper data entry. Automated data validity checking will assure data are properly
           recorded.

        4. Remote Prenatal Care Visit The remote prenatal care visit will be conducted at a
           predetermined scheduled time using a web-based, Health Insurance Portability and
           Accountability Act (HIPAA-compliant video communication solution provided by the
           University of Utah Department of Telemedicine. A message will be sent to the participant
           within MyChart containing the video link and password prior to the meeting. If the video
           solution does not work, is having difficulties, or if the patient does not prefer using
           video, the prenatal care visit will be conducted by telephone.

        5. Survey Instrument The survey instrument, built using REDCap, will be available
           immediately following a scheduled visit. A link to the survey will be available in
           MyChart as well as emailed to their message box within MyChart. If the survey hasn't
           been completed within 72 hours, the study coordinator will contact the participant to
           remind them to complete the survey. Participants will have one week to complete the
           survey.

        6. Sample Size/Statistical Analysis Plan Sample size is based on non-inferiority test. We
           assume that in the control group that 80% will be satisfied. We are allowing for a
           relative 10% worse-than non-inferiority margin, which equates to the intervention group
           can have a satisfaction percent of 72%.

      A sample size of 100 per group using 80% power and a two-sided 0.05 alpha comparison allows
      for the intervention group to have satisfaction of 85%. It is reasonable to expect this given
      the perceived advantage of not having to travel.

      We will test for superiority only after having demonstrated non-inferiority. In this
      step-wise method, multiple comparisons adjustment is not needed.
    

Intervention name(s): Remote Prenatal Care
Intervention type(s): Other
Intervention description(s): Remote Prenatal Care using a combination of in-person and telemedicine prenatal care visits.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Prenatal care; Pregnancy; Obstetrics; Telemedicine