RECRUITING

Enriched Holistic Care to Eradicate Disparities in Maternal Morbidity

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this randomized controlled intervention trial is to evaluate an integrated, interdisciplinary, multi-level maternity care home model (MCHM) aimed at reducing severe maternal morbidity (SMM) among a group of Black indigenous and people of color (BIPOC) patients. The main question it aims to answer is whether a patient-centered MCHM will address the gap in social, structural, and health system factors that contribute to disparities for the most vulnerable patients, thereby reducing SMM. Participants will be randomized to a MCHM (office-based prenatal care that is integrated with social services within the MCHM) or standard of care (office-based prenatal care with individually outsourced social services referrals) and followed during pregnancy through 1 year postpartum.

Official Title

The ENHANCED Trial: Enriched Holistic Care to Eradicate Disparities in Maternal Morbidity

Quick Facts

Study Start:2024-01-30
Study Completion:2028-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06245057

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.

Ages Eligible for Study:16 Years to 55 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pregnant patients who self-identify as Black, Indigenous, Asian, or Latina (BIPOC)
  2. * Ages 16-55
  3. * Presentation to the hospital in pregnancy - this includes prenatal care or the emergency department
  4. * Plan to deliver at the 2 Penn hospital sites
  5. * Patients must be able to read and understand English or Spanish
  6. * Participants must be willing and able to sign the informed consent form
  1. * Unable to provide written consent by being unable to read or sign informed consent.
  2. * Enrolled in ENHANCED Trial in a prior pregnancy
  3. * Already participating in Maternity Care Home Model (MCHM)

Contacts and Locations

Study Contact

Sindhu K Srinivas, MD, MSCE
CONTACT
215-662-2982
ssrinivas@pennmedicine.upenn.edu
Elizabeth Norton, MPH, MBE
CONTACT
215-349-5277
elizabeth.norton@pennmedicine.upenn.edu

Principal Investigator

Sindhu K Srinivas, MD, MSCE
PRINCIPAL_INVESTIGATOR
University of Pennsylvania

Study Locations (Sites)

Hospital of the University of Pennsylvania
Phialdelphia, Pennsylvania, 19104
United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107
United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

  • Sindhu K Srinivas, MD, MSCE, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

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 Registration Dates

Study Start Date2024-01-30
Study Completion Date2028-01-31

Study Record Updates

Study Start Date2024-01-30
Study Completion Date2028-01-31

Terms related to this study

Keywords Provided by Researchers

  • Prenatal care
  • Disparity
  • Maternity care home model
  • Pregnancy home
  • Severe maternal morbidity

Additional Relevant MeSH Terms

  • Morbidity;Perinatal