- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06245057
Enriched Holistic Care to Eradicate Disparities in Maternal Morbidity (ENHANCED)
The ENHANCED Trial: Enriched Holistic Care to Eradicate Disparities in Maternal Morbidity
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This randomized controlled trial addresses social and structural inequities to reduce severe maternal morbidity (SMM) and maternal mortality in the most at-risk patients - those that self-identify as Black, indigenous and people of color (BIPOC). Specifically, the intervention will implement and evaluate an integrated, multi-level maternity care home model (MCHM) that incorporates maternity care navigation, benefits navigation, social work, doula and mental health resources all within one care-delivery model. While previous studies have evaluated single social determinants (e.g. education and insurance) or single solutions (e.g. care navigator), these approaches lack a comprehensive, integrated approach that is responsive to all patient needs.
The study will test the central hypothesis that a patient-centered MCHM will address the gap in social, structural, and health system factors that contribute to disparities for the most vulnerable BIPOC patients, thereby reducing SMM. To test the effectiveness of this MCHM and ensure timely uptake of the results, the investigators propose a type 1 hybrid effectiveness-implementation trial to evaluate the effectiveness and implementation of an integrated MCHM that provides a comprehensive approach by partnering a unified model of social and structural service delivery with medical service delivery in all prenatal offices affiliated with the two largest birthing hospitals in Philadelphia.
Within this study, the investigators will determine the effectiveness of an integrated MCHM in reducing SMM among BIPOC patients (Aim 1). Patients will be randomized (n=2300) 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 throughout pregnancy and for 1 year postpartum. To determine mechanisms by which this integrated MCHM impacts SMM (Sub-Aim 1a), the investigators will evaluate numerous factors that could plausibly mitigate the effects of health system failures, provider bias and adverse social conditions (e.g. improved health system access, care coordination). The investigators will also characterize patient, provider and organizational implementation determinants relevant to an integrated MCHM and identify barriers and facilitators to implementation and sustainability (Aim 2) as well as determine resource utilization and total cost/cost savings associated with the MCHM (Sub-Aim 2a) by partnering with commercial and Medicaid payers.
Importantly, the results of the proposed study will provide actionable evidence to support effective maternity care delivery that results in optimal and equitable outcomes, thereby revolutionizing the way in which prenatal, intrapartum and postpartum care is delivered and experienced. Additionally, even if the trial is negative in reducing SMM, there are still numerous other potential benefits to an integrated MCHM (including many of the secondary outcomes being evaluated) and the investigators will have therefore collected valuable information to inform the implementation of this model into clinical practice.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sindhu K Srinivas, MD, MSCE
- Phone Number: 215-662-2982
- Email: ssrinivas@pennmedicine.upenn.edu
Study Contact Backup
- Name: Elizabeth Norton, MPH, MBE
- Phone Number: 215-349-5277
- Email: elizabeth.norton@pennmedicine.upenn.edu
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- Hospital of the University of Pennsylvania
-
Contact:
- Meaghan McCabe, MPH
- Phone Number: 215-349-5277
- Email: meaghan.mccabe@pennmedicine.upenn.edu
-
Contact:
- Elizabeth Norton, MPH, MBE
- Phone Number: 215-349-5277
- Email: elizabeth.norton@pennmedicine.upenn.edu
-
Principal Investigator:
- Sindhu K Srinivas, MD, MSCE
-
Principal Investigator:
- Lisa D Levine, MD, MSCE
-
Philadelphia, Pennsylvania, United States, 19107
- Not yet recruiting
- Pennsylvania Hospital
-
Contact:
- Meaghan McCabe, MPH
- Phone Number: 215-349-5277
- Email: meaghan.mccabe@pennmedicine.upenn.edu
-
Contact:
- Elizabeth Norton, MPH, MBE
- Phone Number: 215-349-5277
- Email: elizabeth.norton@pennmedicine.upenn.edu
-
Principal Investigator:
- Sindhu K Srinivas, MD, MSCE
-
Principal Investigator:
- Lisa D Levine, MD, MSCE
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Pregnant patients who self-identify as Black, Indigenous, Asian, or Latina (BIPOC)
- Ages 16-55
- Presentation to the hospital in pregnancy - this includes prenatal care or the emergency department
- Plan to deliver at the 2 Penn hospital sites
- Patients must be able to read and understand English or Spanish
- Participants must be willing and able to sign the informed consent form
Exclusion Criteria:
- Unable to provide written consent by being unable to read or sign informed consent.
- Enrolled in ENHANCED Trial in a prior pregnancy
- Already participating in Maternity Care Home Model (MCHM)
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: Maternity care home model (MCHM)
Office based prenatal care integrated with comprehensive social services within the maternity care home model.
|
The maternity care home model is defined as office based prenatal care integrated with comprehensive social services.
|
No Intervention: Usual care arm
Office based prenatal care with individually outsourced social service referrals.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Severe Maternal Morbidity (SMM)
Time Frame: Delivery to one year postpartum
|
The CDC definition of SMM.
We will also include postpartum hemorrhage, infection, thrombosis, readmission and maternal mortality within this definition
|
Delivery to one year postpartum
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Obstetric outcomes: Mode of delivery
Time Frame: At delivery
|
Vaginal or cesarean
|
At delivery
|
Obstetric outcomes: Preterm birth less than 37 weeks
Time Frame: At delivery
|
Preterm delivery defined as less than 37 weeks
|
At delivery
|
Obstetric outcomes: Preterm birth less than 34 weeks
Time Frame: At delivery
|
Preterm delivery defined as less than 34 weeks.
|
At delivery
|
Obstetric outcomes: Hypertensive disorders of pregnancy
Time Frame: During pregnancy through 6 weeks postpartum
|
Diagnosis of Gestational hypertension, preeclampsia with or without severe features
|
During pregnancy through 6 weeks postpartum
|
Composite adverse neonatal outcome
Time Frame: From birth until 4 months after birth
|
Made up of one or more of the following: severe respiratory distress syndrome, Culture proven/presumed neonatal sepsis, Neonatal blood transfusion, Hypoxic ischemic encephalopathy, Intraventricular hemorrhage grade 3 or 4, Necrotizing enterocolitis, Need for head cooling,
|
From birth until 4 months after birth
|
Postpartum visit attendance
Time Frame: From delivery discharge up to 12 weeks postpartum
|
Whether or not the patient attended their routine postpartum visit up to 12 weeks postpartum mark.
|
From delivery discharge up to 12 weeks postpartum
|
Edinburgh Postnatal Depression Scale (EPDS) Screening
Time Frame: At delivery and at 3-6 months postpartum
|
Scores from the validated EPDS screening tool will be calculated using standard scoring criteria for each of the 10 items.
A score of 9 or greater or indication of suicide ideation will be used to indicate a positive depression screen
|
At delivery and at 3-6 months postpartum
|
Unscheduled Emergency room/pregnancy triage visits
Time Frame: Post-randomization to 1 year postpartum
|
Record number of unscheduled visits, reason for visit, whether or not patient was admitted to hospital.
|
Post-randomization to 1 year postpartum
|
Perceived stress scale
Time Frame: Post-randomization to 1 year postpartum
|
Scores from the validated Perceived Stress Scale (PSS-4) will be calculated using standard scoring criteria for each of the 4 items. Higher scores are correlated with more perceived stress. Survey to be completed at randomization, at delivery, at 3 months post partum, and at 1 year post partum. |
Post-randomization to 1 year postpartum
|
Person centered prenatal care survey for people of color
Time Frame: After delivery up to 6 weeks postpartum
|
Scores from this 34-item scale will be calculated using standard scoring criteria.
This scale measures person-centered prenatal care that reflects the experiences of people of color.
|
After delivery up to 6 weeks postpartum
|
Rate of Lactation initiation and continuation
Time Frame: From delivery through 1 year postpartum
|
Initiation of breastfeeding; Continuation of breastfeeding through 1 year postpartum.
To be assessed by EMR documentation and patient report at 3-months and 1 year postpartum.
|
From delivery through 1 year postpartum
|
Perceived discrimination
Time Frame: At randomization
|
Perceived discrimination will be assessed using the Experiences of Discrimination measure (Krieger et al, 2005).
The measure lists 9 situations in which respondent may have experienced racial discrimination.
Responses options are Yes/No.
It is scored by counting the number of situations in which participant reported experiencing racial discrimination.
Score ranges from 0 to 9, higher being more experiences of discrimination.
|
At randomization
|
Birth satisfaction (BSS-R survey)
Time Frame: After delivery up to 6 weeks postpartum
|
Patient satisfaction as measured by the BSS-R with a possible score of 0-40 with 0 equaling the least birth satisfaction
|
After delivery up to 6 weeks postpartum
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sindhu K Srinivas, MD, MSCE, University of Pennsylvania
Study record dates
Study Major Dates
Study Start (Actual)
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
Other Study ID Numbers
- 853430
- 1R01NR020975-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Morbidity;Perinatal
-
University Tunis El ManarCompleted
-
University Hospital, Clermont-FerrandCompletedPregnancy Related | Sedentary Behavior | Sedentary Time | Perinatal Problems | Morbidity;PerinatalFrance
-
Hospital Civil de GuadalajaraActive, not recruitingMaternal-Fetal Relations | Anesthesia | Perinatal MorbidityMexico
-
Corporacion Parc TauliHospital Sant Joan de Deu; Hospital Clínic Sede MaternitatRecruitingStillbirth | ICD | Perinatal Morbidity | Morbidity;PerinatalSpain
-
Hospital San Juan de Dios GuatemalaWorld Health OrganizationUnknown¨Maternal Morbidity¨ | ¨Perinatal Mortality¨Guatemala
-
University of California, San FranciscoCompletedBreastfeeding | Breastfeeding, Exclusive | Feeding, Bottle | Morbidity;PerinatalUnited States
-
University of British ColumbiaWomen's Health Research Institute of British ColumbiaActive, not recruitingPregnancy Complications | Pregnancy Related | Morbidity;Perinatal
-
Johns Hopkins UniversityCompletedPregnancy Complications | Cesarean Section Complications | Morbidity;Perinatal
-
Begona Martinez de TejadaHospital Italiano de Buenos Aires; University of Zurich; University Hospital... and other collaboratorsTerminatedPreterm Delivery | Morbidity | Perinatal MortalitySwitzerland, Argentina
-
Aga Khan UniversityThe Hospital for Sick Children; Bill and Melinda Gates FoundationActive, not recruitingNewborn Morbidity | Maternal Complication of Pregnancy | Perinatal ProblemsPakistan
Clinical Trials on Maternity care home model (MCHM)
-
Boston UniversityUniversity of Michigan; Bill and Melinda Gates Foundation; Right to Care; Merck...Completed
-
Kwame Nkrumah University of Science and TechnologyUniversity of MichiganCompletedBehavior ProblemGhana
-
London School of Hygiene and Tropical MedicineAga Khan University; University of KarachiRecruitingBehavior | RespectPakistan
-
The Scientific and Technological Research Council...Akdeniz UniversityCompleted
-
University of Illinois at Urbana-ChampaignNational Institute of Mental Health (NIMH); University of DenverUnknownDepressionUnited States
-
Boston Medical CenterCompleted
-
Children's National Research InstitutePatient-Centered Outcomes Research Institute; George Washington UniversityRecruitingPerinatal Depression | Prenatal Stress | Perinatal AnxietyUnited States
-
Harvard School of Public Health (HSPH)RecruitingCardiovascular Diseases (CVD)Argentina
-
timklSanoiaRecruitingDiabetes Mellitus, Type 1France
-
Mustafa Kemal UniversityCompleted