The Mom and Infant Outcomes (MOMI) Study

Official title

The Mom and Infant Outcomes (MOMI) Study: A Trial of Perinatal Outpatient Delivery Systems

Overview

The investigator's long-term goal is to mitigate pregnancy-related mortality (PRM) risk by systematically delivering scalable integrated clinical and supportive care that is effective for all. The investigator's central hypothesis is that the Multi-modal Maternal Infant Perinatal Outpatient Delivery System (MOMI PODS) will mitigate postpartum (PP) risk for all by increasing patient engagement with evidence-based cilnical and supportive care, thus improving biopsychosocial profiles that drive clinical risk. To test this hypothesis, the investigators will conduct a hybrid type 1 randomized controlled trial (RCT) of MOMI PODS versus enhanced usual care (EUC, which we will term MOMI CARE) among a total sample of up to 384 mother-infant dyads (192/group) following pregnancy affected by a cardiometabolic and/or mental health condition. The investigators will enroll participants during late pregnancy and collect data at baseline and 6 months and 1 year PP. The investigators will collect implementation and service data across sites.

Detailed description

Using this data, the investigators will address the following Specific Aims:

Specific Aim 1: To evaluate the effectiveness of MOMI PODS versus EUC in mitigating cardiometabolic and mental health risk across the PP year. Hypotheses: MOMI PODS (vs. EUC) recipients will show better cardiometabolic and mental health (Primary Outcomes: higher Life's Essential 8 scores, fewer depressive and anxiety symptoms, Secondary Outcomes: fewer emergency visits and hospital readmissions).

Specific Aim 2: To identify the biopsychosocial mechanisms through which MOMI PODS affects PP cardiometabolic and mental health at the individual patient level. Hypotheses: MOMI PODS (vs. EUC) recipients will report better patient-provider relationships and less psychosocial stress and show better stress-responsive endocrine and immune profiles, which will be critical drivers of cardiometabolic and mental health.

Specific Aim 3: To determine if MOMI PODS promosed longitudinal delivery of evidence-based PP care and identify strategies to improve implementation and service outcomes. Hypotheses: MOMI PODS (vs. EUC) recipients will receive clinical and supportive care that is more adherent to evidence-based guidelines. Objective: Identify strategies to improve implementation and service outcomes by evaluating fidelity and timeliness of clinical and supportive care across MOMI PODS sites.

Interventions

• Behavioral MOMI PODS
  MOMI PODS is an innovative, dyadic model of PP primary care. Informed by the Chronic Care Model (CCM) and extensive stakeholder engagement, the MOMI PODS suite of services addresses four primary domains, with a focus on preventing PRM and eliminating SES, racial, and ethnic disparities in PRM. First, MOMI PODS is a dyadic model of care, with mothers and infants cared for in tandem throughout the PP year, and beyond. Second, MOMI PODS was strategically designed to facilitate a coordinated obstetr
• Behavioral Enhanced Usual Care (EUC)
  Usual care will be enhanced in by implementing an enhanced PP care handoff as an adaptation of typical institutional discharge procedures. Specifically, under current processes, birthing parents are asked to provide the name of their infant's pediatrician during the L\&D admission, must provide the name of their infant's pediatrician prior to discharge, and are assisted with identifying a pediatrician throughout this process as needed. Alternatively, under current processes, mothers are reminded

Primary outcome measures

• Change in Life's Essential 8 (LE8) Composite Score [Time frame: Baseline (T1) to 6 months postpartum (T2)]
• Change in Life's Essential 8 (LE8) Composite Score [Time frame: 6 months postpartum (T2) to 12 months postpartum (T3)]
• Change in Life's Essential 8 (LE8) Composite Score [Time frame: Baseline (T1) to 12 months postpartum (T3)]
• Change in Patient Health Questionnaire-9 (PHQ-9) Score [Time frame: Baseline (T1) to 6 months postpartum (T2)]
• Change in Patient Health Questionnaire-9 (PHQ-9) Score [Time frame: 6 months postpartum (T2) to 12 months postpartum (T3)]
• Change in Patient Health Questionnaire-9 (PHQ-9) Score [Time frame: Baseline (T1) to 12 months postpartum (T3)]
• Change in Generalized Anxiety Disorder-7 (GAD-7) Score [Time frame: Baseline (T1) to 6 months postpartum (T2)]
• Change in Generalized Anxiety Disorder-7 (GAD-7) Score [Time frame: 6 months postpartum (T2) to 12 months postpartum (T3)]
• Change in Generalized Anxiety Disorder-7 (GAD-7) Score [Time frame: Baseline (T1) to 12 months postpartum (T3)]

Eligibility criteria

Inclusion criteria

To be eligible for the MOMI PODS RCT, individuals will be required to be pregnant, with a current diagnosis or history of one or more of the following reflected in the medical record or by self-report - chronic hypertension (with or without super-imposed preeclampsia); gestational hypertension; preeclampsia; eclampsia; hemolysis, elevated liver enzymes and low platelets (HELLP) syndrome; type 1 diabetes mellitus; type 2 diabetes mellitus; gestational diabetes mellitus (GDM); a depressive disorder (e.g., major depressive disorder, persistent depressive disorder) or anxiety disorder (e.g., generalized anxiety disorder, panic disorder).43-48 Inclusion criteria will also include a singleton pregnancy and medical record documentation or self-report of private or government-sponsored health insurance at the time of enrollment.

Exclusion criteria

Exclusion criteria will include the presence of a pre-existing, community driven MOMI PODS referral and enrollment into the program, maternal history of a seizure disorder, medical record documentation or self-report of a major complication of the infant that would be expected to preclude them from receiving or significantly delay their ability to receive outpatient pediatric care during the first year of life. Examples include but are not limited to anencephaly, myelomeningocele, esophageal atresia, gastroschisis, hypoplastic left heart syndrome, transposition of the great arteries, or tetralogy of Fallot. Exclusion criteria will also include the presence of a major genetic disorder among the infant that would be expected to preclude them from receiving or significantly delay their ability to receive outpatient pediatric care during the first year of life. Examples include but are not limited to trisomy 13, or trisomy 18 (trisomy 21 is not an exclusion criteria).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 1 center

• The Ohio State University — Columbus

Identifiers

NCT: NCT06277661 · 2023H0305

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗