- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07572604
Community Health Worker Assessment for Postpartum Health (CAREPATH)
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
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Brett Rowland, MA
- Phone Number: 4797138661
- Email: mbrowland@uams.edu
Study Contact Backup
- Name: Kenny Halloran
- Phone Number: 4797138661
- Email: khalloran@uams.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Pearl McElfish, PhD, University of Arkansas
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 299245
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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