Telehealth Multi-Component Optional Model (MOM) Study

University of Arkansas

Status: Enrolling

Conditions: Maternal Health

Treatments: Behavioral: Telehealth MOM; Other: Enhanced Standard of Care

Study type: Interventional

Funder types: Other

Identifiers

NCT06095960

276311

Details and patient eligibility

About

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.

Enrollment: 1,500 estimated patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: Accepts Healthy Volunteers

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

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 chronic hypertension
• HELLP syndrome 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,500 participants in 2 patient groups

Telehealth MOM

Experimental group

Description:

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.

Treatment:

Behavioral: Telehealth MOM

Enhanced Standard of Care

Active Comparator group

Description:

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.

Treatment:

Other: Enhanced Standard of Care