The Mom and Infant Outcomes (MOMI) Study

Postpartum Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06277661
• Other study ID #: 2023H0305
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: May 30, 2028

Study information

• Verified date: April 2024
• Source: Ohio State University
• Contact: Shannon L. Gillespie, PhD, RN
• Phone: 6142924589
• Email: gillespie.175[@]osu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigator's long-term goal is to mitigate pregnancy-related mortality (PRM) risk by systematically delivering integrated clinical and supportive care that is effective, equitable, and scalable. The investigator's central hypothesis is that the Multi-modal Maternal Infant Perinatal Outpatient Delivery System (MOMI PODS) will mitigate postpartum (PP) risk and reduce disparities in PP risk by improving biopsychosocial profiles and facilitating access to evidence-based clinical and supportive care. 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 384 mother-infant dyads (192/group) following pregnancy affected by a cardiometabolic and/or mental health condition. The investigators will enroll participants on PP day 1 and collect data at baseline and 6 months and 1 year PP. The investigators will collect implementation and service data across sites.

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 reduces socioeconomic (SES), racial, and ethnic disparities in evidence-based PP care delivery 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, which will reduce SES, racial, and ethnic disparities in evidence-based care. Objective: Identify strategies to improve implementation and service outcomes by evaluating fidelity, timeliness, and equity of clinical and supportive care across MOMI PODS sites.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 384
• Est. completion date: May 30, 2028
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• index pregnancy affected by one or more of the following that is reflected in the medical record - 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 pre-existing or newly diagnosed depressive disorder (e.g., major depressive disorder, persistent depressive disorder) or anxiety disorder (e.g., generalized anxiety disorder, panic disorder); or undiagnosed depression or anxiety identified by prenatal screening [i.e., PHQ-9 score of >10, GAD-7 score of >10, Edinburgh Postnatal Depression Scale (EPDS) score of >12, or Center for Epidemiological Studies Depression Inventory (CES-D) score of >16).

Exclusion Criteria:

• presence of a pre-existing, community driven MOMI PODS referral that has already been scheduled;
• maternal history of syncope during venipuncture;
• a seizure disorder;
• determination of maternal diminished capacity without a legally authorized representative present at enrollment;
• maternal age <18 without a parent or legal guardian present at enrollment.

Related Conditions & MeSH terms

• Cardiometabolic Syndrome
• Depression, Postpartum
• Metabolic Syndrome
• Postpartum Anxiety
• Postpartum Depression

Intervention

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 obstetric to PP primary care transition. Third, MOMI PODS is delivered in a way that promotes tailored, evidence-based care informed by the obstetric history. Fourth, MOMI PODS systematically integrates clinical and supportive care to concurrently address clinical and psychosocial needs, with MOMI PODS engagement extending beyond the typical referral process to facilitate direct access to needed resources and empower patients.
• 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 to seek PP care but not required to identify the location of care or assisted with doing so. As a component of EUC, we'll provide participants with information about our 7 EUC sites and actively assist with identifying their preferred location of care and scheduling PP care. Our research team will also engage with EUC recipients throughout the study period to encourage engagement and study retention through small care packages and hand-written notes, as well as data collection.

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Life's Essential 8 (LE8) Composite Score	Higher scores=better health (0-100). 0-100 points for each domain. Total divided by 8. Diet (Mediterranean Eating Pattern for Americans score): 100=15-16; 80=12-14; 50=8-11; 25=4-7; 0=0-3; Physical Activity (min. moderate+/week): 100=>=150; 90=120-149; 80=90-119; 60=60-89; 40=30-59; 20=1-29; 0=0; Nicotine: 100=Never; 75=Former, quit >=5y; 50=Former, quit 1-<5y; 25=Former, quit <1y or vaping; 0=Current; -20 living with indoor smoker; Sleep (avg. hrs./night): 100=7<9; 90=9-<10; 70=6-<7; 40=5-<6 or >=10; 20=4-<5; 0=<4; body mass index (kg/m2): 100=<25; 70=25-29.9; 30=30-34.9; 15=35-39.9; 0=>=40; Non-HDL mg/dL: 100=<130; 60=130-159; 40=160-189; 20=190-219; 0=>=220; -20 if treated; Glucose (Diabetes/HbA1c): 100=No/<5.7; 60=No/5.7-6.4; 40=Yes/<7; 30=Yes/7-7.9; 20=Yes/8-8.9; 10=Yes/9-9.9; 0=Yes/>=10; Blood pressure: 100=<120/<80; 75=120-129/<80; 50=130-139 or 80-89; 25=140-159 or 90-99; 0=>=160 or >=100; -20 if treated	Baseline (T1) to 6 months post-baseline (T2)
Primary	Change in Life's Essential 8 (LE8) Composite Score	Higher scores=better health (0-100). 0-100 points for each domain. Total divided by 8. Diet (Mediterranean Eating Pattern for Americans score): 100=15-16; 80=12-14; 50=8-11; 25=4-7; 0=0-3; Physical Activity (min. moderate+/week): 100=>=150; 90=120-149; 80=90-119; 60=60-89; 40=30-59; 20=1-29; 0=0; Nicotine: 100=Never; 75=Former, quit >=5y; 50=Former, quit 1-<5y; 25=Former, quit <1y or vaping; 0=Current; -20 living with indoor smoker; Sleep (avg. hrs./night): 100=7<9; 90=9-<10; 70=6-<7; 40=5-<6 or >=10; 20=4-<5; 0=<4; body mass index (kg/m2): 100=<25; 70=25-29.9; 30=30-34.9; 15=35-39.9; 0=>=40; Non-HDL mg/dL: 100=<130; 60=130-159; 40=160-189; 20=190-219; 0=>=220; -20 if treated; Glucose (Diabetes/HbA1c): 100=No/<5.7; 60=No/5.7-6.4; 40=Yes/<7; 30=Yes/7-7.9; 20=Yes/8-8.9; 10=Yes/9-9.9; 0=Yes/>=10; Blood pressure: 100=<120/<80; 75=120-129/<80; 50=130-139 or 80-89; 25=140-159 or 90-99; 0=>=160 or >=100; -20 if treated	6 months post-baseline (T2) to 12 months post-baseline (T3)
Primary	Change in Life's Essential 8 (LE8) Composite Score	Higher scores=better health (0-100). 0-100 points for each domain. Total divided by 8. Diet (Mediterranean Eating Pattern for Americans score): 100=15-16; 80=12-14; 50=8-11; 25=4-7; 0=0-3; Physical Activity (min. moderate+/week): 100=>=150; 90=120-149; 80=90-119; 60=60-89; 40=30-59; 20=1-29; 0=0; Nicotine: 100=Never; 75=Former, quit >=5y; 50=Former, quit 1-<5y; 25=Former, quit <1y or vaping; 0=Current; -20 living with indoor smoker; Sleep (avg. hrs./night): 100=7<9; 90=9-<10; 70=6-<7; 40=5-<6 or >=10; 20=4-<5; 0=<4; body mass index (kg/m2): 100=<25; 70=25-29.9; 30=30-34.9; 15=35-39.9; 0=>=40; Non-HDL mg/dL: 100=<130; 60=130-159; 40=160-189; 20=190-219; 0=>=220; -20 if treated; Glucose (Diabetes/HbA1c): 100=No/<5.7; 60=No/5.7-6.4; 40=Yes/<7; 30=Yes/7-7.9; 20=Yes/8-8.9; 10=Yes/9-9.9; 0=Yes/>=10; Blood pressure: 100=<120/<80; 75=120-129/<80; 50=130-139 or 80-89; 25=140-159 or 90-99; 0=>=160 or >=100; -20 if treated	Baseline (T1) to 12 months post-baseline (T3)
Primary	Change in Patient Health Questionnaire-9 (PHQ-9) Score	We will assess mental health by self-report using the Patient Health Questionnaire-9 (PHQ-9), with higher scores indicative of more depressive symptoms (range 0-27).	Baseline (T1) to 6 months post-baseline (T2)
Primary	Change in Patient Health Questionnaire-9 (PHQ-9) Score	We will assess mental health by self-report using the Patient Health Questionnaire-9 (PHQ-9), with higher scores indicative of more depressive symptoms (range 0-27).	6 months post-baseline (T2) to 12 months post-baseline (T3)
Primary	Change in Patient Health Questionnaire-9 (PHQ-9) Score	We will assess mental health by self-report using the Patient Health Questionnaire-9 (PHQ-9), with higher scores indicative of more depressive symptoms (range 0-27).	Baseline (T1) to 12 months post-baseline (T3)
Primary	Change in Generalized Anxiety Disorder-7 (GAD-7) Score	We will assess mental health by self-report using the Generalized Anxiety Disorder-7 (GAD-7), with higher scores indicative of more anxiety symptoms (range 0-21).	Baseline (T1) to 6 months post-baseline (T2)
Primary	Change in Generalized Anxiety Disorder-7 (GAD-7) Score	We will assess mental health by self-report using the Generalized Anxiety Disorder-7 (GAD-7), with higher scores indicative of more anxiety symptoms (range 0-21).	6 months post-baseline (T2) to 12 months post-baseline (T3)
Primary	Change in Generalized Anxiety Disorder-7 (GAD-7) Score	We will assess mental health by self-report using the Generalized Anxiety Disorder-7 (GAD-7), with higher scores indicative of more anxiety symptoms (range 0-21).	Baseline (T1) to 12 months post-baseline (T3)