Telehealth Multi-Component Optional Model (MOM) Study

Study Overview
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Brief Summary
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The aim of this study is to conduct a comparative effectiveness evaluation using a randomized control trail design among diverse women to compare two postpartum care models: 1) Telehealth Multicomponent Optimal Model (Telehealth MOM) and 2) enhanced standard of care (ESoC). This study will address critical gaps in knowledge about how best to deliver comprehensive postpartum care that ensures timely identification and treatment of complications and meets the needs and preferences of diverse patients, including disproportionately-impacted racial groups and rural residents.

Official Title
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Comparative Evaluation of Telehealth Multi-Component Optional Model (MOM) of Postpartum Care Among Rural, Low-income, and Diverse Women

Conditions
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Maternal Health

Intervention / Treatment
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* Behavioral: Telehealth MOM
* Other: Enhanced Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women between 16-35 weeks gestation Age 18-44 years Ability to speak English, Spanish, or Marshallese Participants may have either a vaginal birth or cesarean section birth Have a smartphone with active service Exclusion Criteria: Type 1 diabetes on an insulin pump followed closely by endocrinology Uncontrolled Type 2 diabetes End stage renal disease followed closely by nephrology ICU admission at any point during pregnancy or delivery hospitalization Other maternal conditions requiring additional surgeries (i.e. cesarean hysterectomy or intrapartum or postpartum oophorectomy/appendectomy) Incarceration Mental disability limiting decision-making capacity Uncontrolled hypertension during pregnancy HELLP syndrome or pre-eclampsia during pregnancy Sickle cell disease Maternal heart condition or heart disease Opioid use disorder Lupus Thrombophilia or blood clots Need for blood transfusion during delivery hospitalization Other maternal conditions or complications, known during pregnancy or delivery hospitalization, requiring prolonged hospitalization postpartum

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telehealth MOM<br>Telehealth MOM. Each patient will receive ESoC which includes: education on the symptoms to watch for and when to call their healthcare provider, an in-person comprehensive postpartum visit around 6 weeks postpartum, and any additional care deemed necessary by their health care providers. Patients in the Telehealth MOM arm will be also provided with a remote monitoring blood pressure cuff and thermometer and will be instructed to take their blood pressure and temperature twice a day for 14 days after discharge from the hospital. A Registered Nurse will monitor blood pressure and temperature readings over the 14-day period and will contact the patient if the readings are out of range to discuss symptoms and the recommend a course of action. A Registered Nurse will conduct an early postpartum telehealth visit between 10-14 days postpartum. | Behavioral: Telehealth MOM<br>* Patients will receive enhanced standard of care plus remote blood pressure monitoring, remote thermometer, and a 10- to 14-day post-partum telehealth visit.<br>|
| Active Comparator: Enhanced Standard of Care<br>Enhanced standard of care (ESoC). Each patient will be provided education on the symptoms to watch for and when to call their healthcare provider. Patients will be scheduled for a comprehensive postpartum visit around 6 weeks postpartum and any additional care deemed necessary by their health care providers. | Other: Enhanced Standard of Care<br>* Patients will receive enhanced standard of care which includes: education on symptoms and when to call their healthcare provider, comprehensive 6-week post-partum visit, and any healthcare deemed necessary by providers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of post-partum 6-week comprehensive visit | Binary measure (yes/no) of visit completion | Baseline to 6 weeks post-partum |