Community Health Worker Assessment for Postpartum Health (CAREPATH)

May 1, 2026 updated by: University of Arkansas

Community Health Worker Assessment for Postpartum Health (CAREPATH)

The goal of this randomized controlled trial is to compare the CAREPATH intervention with standard of care on postpartum outcomes among up to 500 postpartum individuals. The CAREPATH includes 3 postpartum telehealth visits from a perinatal CHW.

The study will address the following aims:

Aim 1: Compare: A) CARE PATH and B) standard of care among postpartum individuals on:

Aim 1.A: postpartum visit completion.

  • Hypothesis 1.A: Patients assigned to the CARE PATH will have higher completion of their postpartum visit compared to those receiving standard of care.

Aim 1.B: early detection of postpartum complications.

  • Hypothesis 1.B: Patients assigned to the CARE PATH will be more likely to experience early detection of postpartum complications that arise compared to those receiving standard of care.

Aim 1.C: hospital readmission and ED visits postpartum.

  • Hypothesis 1.C: Patients assigned to the CARE PATH will be less likely to have hospital readmission or an ED visit compared to those receiving standard of care.

Aim 2: Explore the impact of A) CARE PATH and B) standard of care on reproductive life planning/contraceptive counseling.

  • Hypothesis 2: Patients assigned to the CARE PATH will be more likely to report reproductive life planning/contraceptive counseling.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 16-44 years old
  • ≤ 38 weeks pregnant
  • Ability to speak English, Spanish or Marshallese

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
  • Other maternal conditions or complications, known during pregnancy or delivery hospitalization, requiring prolonged hospitalization postpartum

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CAREPATH
Participants in the CAREPATH arm will receive standard of care plus three telehealth visits from a perinatal community health worker during the first six weeks of the postpartum period. During the visits, participants will be screened for postpartum complications using a symptom monitoring checklist that covers urgent maternal warning signs, as well as anxiety and depression.
Patients will received standard of care plus three telehealth visits with a perinatal community health worker.
Active Comparator: Standard of Care (SoC)
Participants in the SoC arm will receive education on symptoms of postpartum complications and assistance scheduling their postpartum visit with their healthcare provider.
Patients will receive standard of care which includes: education on postpartum complications symptoms and when to call their healthcare provider, assistance scheduling their postpartum visit, and any healthcare deemed necessary by providers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postpartum visit completion
Time Frame: 6 weeks postpartum
Binary measure (yes/no) of visit completion
6 weeks postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Pearl McElfish, PhD, University of Arkansas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

August 31, 2029

Study Completion (Estimated)

August 31, 2029

Study Registration Dates

First Submitted

May 1, 2026

First Submitted That Met QC Criteria

May 1, 2026

First Posted (Actual)

May 7, 2026

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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