Telehealth Multi-Component Optional Model (MOM) Study

University of Arkansas1,500 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

1,500

Conditions

Maternal Health

Interventions

Telehealth MOMBEHAVIORAL

Patients will receive enhanced standard of care plus remote blood pressure monitoring, remote thermometer, and a 10- to 14-day post-partum telehealth visit.

Enhanced Standard of CareOTHER

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 44 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (6)

UAMS El Dorado FMC

El Dorado, Arkansas, United States

NOT_YET_RECRUITING

UAMS Fayetteville FMC

Fayetteville, Arkansas, United States

RECRUITING

UAMS Fort Smith FMC

Fort Smith, Arkansas, United States

Outcomes

Primary Outcomes

Completion of post-partum 6-week comprehensive visit

Binary measure (yes/no) of visit completion

Time frame: Baseline to 6 weeks post-partum

Central Contacts

Brett Rowland, MA

CONTACT

4797138661 mbrowland@uams.edu

Kacie Simpson, BS

CONTACT

4797138661 klsimpson@uams.edu

Data from ClinicalTrials.gov

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