The Mom and Infant Outcomes (MOMI) Study: A Trial of Perinatal Outpatient Delivery Systems
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 384
- 试验地点
- 1
- 主要终点
- Change in Life's Essential 8 (LE8) Composite Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Intervention
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.
干预措施: MOMI PODS (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 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.
干预措施: Enhanced Usual Care (EUC) (Behavioral)
结局指标
主要结局
Change in Life's Essential 8 (LE8) Composite Score
时间窗: Baseline (T1) to 12 months postpartum (T3)
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
Change in Patient Health Questionnaire-9 (PHQ-9) Score
时间窗: Baseline (T1) to 12 months postpartum (T3)
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).
Change in Generalized Anxiety Disorder-7 (GAD-7) Score
时间窗: Baseline (T1) to 12 months postpartum (T3)
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).
Change in Life's Essential 8 (LE8) Composite Score
时间窗: Baseline (T1) to 6 months postpartum (T2)
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
Change in Life's Essential 8 (LE8) Composite Score
时间窗: 6 months postpartum (T2) to 12 months postpartum (T3)
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
Change in Patient Health Questionnaire-9 (PHQ-9) Score
时间窗: Baseline (T1) to 6 months postpartum (T2)
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).
Change in Patient Health Questionnaire-9 (PHQ-9) Score
时间窗: 6 months postpartum (T2) to 12 months postpartum (T3)
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).
Change in Generalized Anxiety Disorder-7 (GAD-7) Score
时间窗: Baseline (T1) to 6 months postpartum (T2)
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).
Change in Generalized Anxiety Disorder-7 (GAD-7) Score
时间窗: 6 months postpartum (T2) to 12 months postpartum (T3)
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).
次要结局
未报告次要终点
研究者
Shannon Gillespie
Assistant Professor
Ohio State University