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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pregnancy
- Sponsor
- Andrew Meltzer
- Enrollment
- 118
- Locations
- 1
- Primary Endpoint
- Total Visit Number
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
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.
Investigators
Andrew Meltzer
Principal Investigator
George Washington University
Eligibility Criteria
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
Outcomes
Primary Outcomes
Total Visit Number
Time Frame: From first trimester up to postpartum, between 6 and 9 months
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.
Secondary Outcomes
- Gestational Weight Gain(From first trimester up to postpartum, between 6 and 9 months)