Mobile App for Prenatal Care to Reduce Visits and Improve Satisfaction Study (SPROUT)

Effectiveness of a Mobile App for Prenatal Care to Safely Reduce In-Person Visits and Improve Patient Satisfaction: Study Protocol for a Multicenter Prospective Quasi-Randomized Trial

Prenatal care is defined as preventive healthcare characterized by regular check-ups by doctors or midwives to treat and prevent potential health problems throughout the course of the pregnancy. The investigators propose that a mobile app for prenatal care has the potential to provide patient-tailored, risk-appropriate prenatal educational content and may facilitate vital sign and weight checks between visits. The investigators describe the methods used to develop and test the effectiveness of a mobile app for prenatal care to safely reduce the number of in-person visits to the obstetrician (OB) compared to standard of care.

Study Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: Device: Babyscripts Prenatal App; Device: Placebo

Detailed Description

This is a protocol for a multi-center quasi-randomized controlled trial to compare an intervention group receiving a prenatal care app, to a control group receiving usual care. The trial is being conducted at two diverse outpatient obstetric practices that are part of a single academic department of obstetrics in Washington, DC. Women who are between 18 and 40, who are visiting their OB for a first trimester routine visit, who have a confirmed desired pregnancy, who are not considered "high-risk," and who have an IOS, Android or Windows-based smart phone that they use regularly will be eligible for enrollment. The Investigators will measure the effect of a mobile app for prenatal care on:

1. the number of in-person OB visits during pregnancy;
2. patient satisfaction with prenatal care;
3. gestational weight gain;
4. maternal and fetal outcomes; and
5. clinician satisfaction.

To capture these outcomes, the investigators will administer patient surveys via telephone every 4 weeks during gestation and the immediate post-partum period, review the electronic medical record, and conduct in-depth interviews with a representative subset of patients after delivery.

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • George Washington University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Eligible participants will be women who are between 18 than 40-years-old, who are visiting the OB for a first-trimester verification of pregnancy visit, new OB visit or follow-up OB visit, who are low-risk per treating OB, who regularly use a smart-phone, who can understand and consent to English-written consent form.
• Eligible clinicians will be attending obstetric physicians who refer the patient to the research assistant for informed consent and full eligibility assessment.

Exclusion Criteria:

• High-risk obstetrical condition*
• Intends midwifery care
• Intends to terminate
• Not Local resident
• Non--English speaker

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Babyscripts Prenatal App; For patients allocated to the experimental group, they will be assisted in downloading the BRx app to their smartphone and set up the connected weight scale and blood pressure cuff. At time of enrollment, research assistant will also collect baseline demographic and clinical data. For patients allocated to this study arm, the clinician will be informed and therefore, will be receiving regular app-based education while the clinician will be receiving regular blood pressure and weight measurements. Following that communication, it will be the physicians' judgement to reduce in-person visits from usual care.	Device: Babyscripts Prenatal App; The use of a mobile digital app to facilitate certain aspects of standard prenatal care.
PLACEBO_COMPARATOR: Placebo; For patients cared for by clinicians allocated to the control (usual care) arm, the clinician will discuss the management options and scheduling procedures with the patient in that clinician's usual fashion. The patient will not be given access to the BRx app but will consent to the study data collection and survey administration. All potential study subjects will receive standard medical care per DoD/VA Clinical Practice Guidelines for Management of the uncomplicated pregnancy (REF) and local preference by board-certified OB/GYN physicians.	Device: Placebo; No Mobile App, Usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Visit Number	In discussions with OBs, it became clear that, patient safety notwithstanding, the advantages and disadvantages of a reduced visit schedule versus usual care were of greatest importance and so total visit number was selected as the primary outcome. We will measure total visit number by reviewing the EHR. All other outcomes will be secondary outcomes.	From first trimester up to postpartum, between 6 and 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gestational Weight Gain	We will assess gestational weight gain following enrollment until delivery. These measures will be obtained by health record review and review of data collected in the app. Data collection will be performed with a standardized data collection sheet and a 10% check for interrater reliability.	From first trimester up to postpartum, between 6 and 9 months

Collaborators and Investigators

• Sponsor: Andrew Meltzer
• Collaborators: 1EQ, Inc.
• Investigators: Principal Investigator: Andrew C Meltzer, MD, MS, The George Washington University

Publications and helpful links

General Publications

• Marko KI, Ganju N, Krapf JM, Gaba ND, Brown JA, Benham JJ, Oh J, Richards LM, Meltzer AC. A Mobile Prenatal Care App to Reduce In-Person Visits: Prospective Controlled Trial. JMIR Mhealth Uhealth. 2019 May 1;7(5):e10520. doi: 10.2196/10520.

Helpful Links

• site for mobile app

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (ACTUAL): March 1, 2016
• Study Completion (ACTUAL): May 1, 2016

Study Registration Dates

• First Submitted: September 8, 2016
• First Submitted That Met QC Criteria: September 23, 2016
• First Posted (ESTIMATE): September 26, 2016

Study Record Updates

• Last Update Posted (ACTUAL): December 16, 2022
• Last Update Submitted That Met QC Criteria: November 21, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: BABYSCRIPTS 1B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Study Data/Documents

1. Informed Consent Form
   Information identifier: FWA00005945
2. Individual Participant Data Set
   Information identifier: Post-Partum Survey
3. Individual Participant Data Set
   Information identifier: Prenatal Participant Data -22