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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 44 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Telehealth MOM 		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
    Patients will receive enhanced standard of care plus remote blood pressure monitoring, remote thermometer, and a 10- to 14-day post-partum telehealth visit.
Active Comparator
Enhanced Standard of Care 		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
    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.

Recruiting Locations

UAMS Fayetteville FMC
Fayetteville, Arkansas 72703
Contact:
Kenny Halloran
KHalloran@uams.edu

UAMS Fort Smith FMC
Fort Smith, Arkansas 72901
Contact:
Kenny Halloran
KHalloran@uams.edu

UAMS Health Women's Center
Little Rock, Arkansas 72205
Contact:
Kenny Halloran
KHalloran@uams.edu

UAMS Springdale FMC
Springdale, Arkansas 72764
Contact:
Kenny Halloran
KHalloran@uams.edu

More Details

NCT ID
NCT06095960
Status
Recruiting
Sponsor
University of Arkansas

Study Contact

Brett Rowland, MA
4797138661
mbrowland@uams.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.