Community Health Worker Assessment for Postpartum Health
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age16-44
SponsorUniversity of Arkansas
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 16-44 years old
≤ 38 weeks pregnant
Ability to speak English, Spanish or Marshallese
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
CAREPATH
BehavioralPatients will received standard of care plus three telehealth visits with a perinatal community health worker.
Standard of Care
Other interventionPatients 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.
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: CAREPATHExperimental treatment 1 intervention
Group B: Standard of Care (SoC)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Postpartum visit completion
Binary measure (yes/no) of visit completion
Time frame
6 weeks postpartumLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Arkansas
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: