Telehealth Multi-Component Optional Model (MOM) Study

Sponsor

University of Arkansas (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06095960

Collaborator

Patient-Centered Outcomes Research Institute (Other)

1,500

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Maternal Health	Behavioral: Telehealth MOM Other: Enhanced Standard of Care	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Feb 29, 2024

Anticipated Primary Completion Date :

Jan 30, 2027

Anticipated Study Completion Date :

Dec 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Completion of post-partum 6-week comprehensive visit [Baseline to 6 weeks post-partum]
Binary measure (yes/no) of visit completion

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 44 Years

Sexes Eligible for Study:

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
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Arkansas
Patient-Centered Outcomes Research Institute

Investigators

Principal Investigator: Jennifer Callaghan-Koru, PhD, University of Arkansas
Principal Investigator: Pearl McElfish, PhD, University of Arkansas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Arkansas

ClinicalTrials.gov Identifier:

NCT06095960

Other Study ID Numbers:

276311

First Posted:

Oct 23, 2023

Last Update Posted:

Oct 23, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Oct 23, 2023