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Development of a Nationally Scalable Model of Group Prenatal Care to Improve Birth Outcomes: "Expect With Me"

27. května 2020 aktualizováno: Yale University

This study addresses the intractable challenges of adverse birth outcomes, including preterm delivery and low birthweight, by proposing the development, implementation and evaluation of a model of group prenatal care that could be scaled nationally. Group prenatal care models have been demonstrated through rigorous research to provide significantly improved birth outcomes with implications for maternal-child health and substantial cost savings. However, group prenatal care is currently available to only a small fraction of the more than four million women who give birth annually in the US. Through the development, implementation and evaluation of a new model of group prenatal care, we will create an outcomes-focused model of group prenatal care that will be scalable nationally with an eye toward improving US birth outcomes.

The long-term objective of the proposed study is to reduce the risk for adverse perinatal outcomes during and after pregnancy among women and families receiving prenatal care in health centers in 3 geographic locations serving vulnerable populations: Hidalgo County Texas, Nashville Tennessee, and Detroit Michigan. We will develop, disseminate, and evaluate a new and improved model of group prenatal care, "Expect with Me," based on our previous research on group models of prenatal care, which has already yielded favorable behavioral and biological results in two randomized controlled trials.

We hypothesize that, relative to women who receive standard individual prenatal care, the women who receive "Expect with Me" group prenatal care will be significantly more likely to:

  1. have better perinatal outcomes, including better health behaviors during pregnancy (e.g., nutrition, physical activity), better birth outcomes (e.g., decreased preterm labor, low birthweight, Neonatal Intensive Care Unit stays), and better postpartum indicators (e.g., increased breastfeeding);
  2. report greater change in risk-related behaviors and psychosocial characteristics that could be considered potential mechanisms for the program's effectiveness;
  3. have lower rates of sexually transmitted diseases and rapid repeat pregnancy one year postpartum;
  4. have lower healthcare costs through improved outcomes (e.g., appropriate care utilization, fewer complications, reduced NICU admissions/length of stays)

Comparisons based on propensity-score matched sample of women receiving standard individual prenatal care at the same clinical sites.

Přehled studie

Detailní popis

This study addresses the intractable challenges of adverse birth outcomes, including preterm delivery and low birthweight, by proposing the development, implementation and evaluation of a model of group prenatal care that could be scaled nationally. Group prenatal care models have been demonstrated through rigorous research to provide significantly improved birth outcomes with implications for maternal-child health and substantial cost savings. However, group prenatal care is currently available to only a small fraction of the more than four million women who give birth annually in the US. Through the development, implementation and evaluation of a new model of group prenatal care, we will create an outcomes-focused model of group prenatal care that will be scalable nationally with an eye toward improving US birth outcomes.

Specific Aims:

The long-term objective of the proposed study is to reduce the risk for adverse perinatal outcomes during and after pregnancy among women and families receiving prenatal care in health centers in 3 geographic locations serving vulnerable populations: Hidalgo County Texas, Nashville Tennessee, and Detroit Michigan. We will develop, disseminate, and evaluate a new and improved model of group prenatal care, "Expect with Me," based on our previous research on group models of prenatal care, which has already yielded favorable behavioral and biological results in two randomized controlled trials. The overall objective of this project is to improve maternal health and reduce adverse birth outcomes. We will meet this objective by achieving three specific goals:

  1. Develop a new and improved model of group prenatal care, including curriculum, training materials, IT infrastructure and marketing materials to support broad adoption of group prenatal care, enhance consumer experience, monitor patient outcomes, and ensure national scalability.
  2. Implement group prenatal care in three communities at high risk for adverse perinatal outcomes (Hidalgo County TX, Nashville TN, Detroit MI), engaging and training providers in group facilitation and the established curriculum, engaging patients through improved in-reach and outreach strategies, and implementing IT infrastructure to improve uptake, patient experience, and sustainability through the monitoring of patient outcomes.
  3. Evaluate the effect of implementing group prenatal care through a rigorous process and outcome evaluation that identifies any barriers to national scalability and examines maternal health and birth outcomes and resultant cost implications.

Specific Study Hypotheses

We hypothesize that, relative to women who receive standard individual prenatal care, the women who receive "Expect with Me" group prenatal care will be significantly more likely to:

  1. have better perinatal outcomes, including better health behaviors during pregnancy (e.g., nutrition, physical activity), better birth outcomes (e.g., decreased preterm labor, low birthweight, Neonatal Intensive Care Unit stays), and better postpartum indicators (e.g., increased breastfeeding);
  2. report greater change in risk-related behaviors and psychosocial characteristics that could be considered potential mechanisms for the program's effectiveness;
  3. have lower rates of sexually transmitted diseases and rapid repeat pregnancy one year postpartum;
  4. have lower healthcare costs through improved outcomes (e.g., appropriate care utilization, fewer complications, reduced NICU admissions/length of stays)

Typ studie

Intervenční

Zápis (Aktuální)

2402

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

    • Michigan
      • Detroit, Michigan, Spojené státy, 48201
        • Wayne State University
    • Tennessee
      • Nashville, Tennessee, Spojené státy, 37232
        • Vanderbilt University Medical Center

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě
  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Ženský

Popis

Inclusion Criteria:

  • less than 24 weeks pregnant
  • able to attend groups conducted in English or Spanish
  • consent to share their data with the study

Exclusion Criteria:

  • severe medical problem requiring individual care only, as determined by the participating clinical practice

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Nerandomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Expect With Me group prenatal care
receiving prenatal care through an Expect With Me group
Expect With Me group prenatal care was designed based on: principles of group care; evidence from RCTs demonstrating improved birth outcomes; ACOG clinical guidelines; and research on patient and provider engagement through technology. Designed with national dissemination as a primary consideration, Expect With Me incorporates best evidence-based aspects of existing models of group care, with a novel IT platform to improve patient engagement and support, enhance health behaviors and decision making, connect providers and patients, and improve health service delivery. Expect With Me provides care to groups of 8-12 women of the same gestational age, implemented after initial individual assessment through delivery. Group visits are 90-120 minutes each, and follow a structured curriculum that incorporates standard content of prenatal care, and emphasizes critical health issues relevant to pregnancy, such as nutrition, physical activity, stress/mental health and sexual health.
Ostatní jména:
  • group prenatal care
Aktivní komparátor: Individual Care Only
Standard of Care- individual prenatal care
Standard of care- individual prenatal care
Ostatní jména:
  • Individual Care Only

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Risk of preterm birth incidence
Časové okno: up to 37 weeks gestation
Incidence risk of delivery before 37 weeks gestation
up to 37 weeks gestation
Risk of low birth weight incidence
Časové okno: delivery
Incidence risk of infant weight at birth < 2500 grams
delivery
Risk of small for gestational age incidence
Časové okno: delivery
Incidence risk of infant weight below the 10th percentile for the gestational age at birth
delivery
Risk of neonatal intensive care unit (NICU) admission incidence
Časové okno: birth
Incidence risk of being admitted to the neonatal intensive care unit (NICU) at birth
birth

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
breastfeeding
Časové okno: 6 and 12 months postpartum
initiation and duration of breastfeeding
6 and 12 months postpartum
nutrition
Časové okno: 2nd and 3rd trimester of pregnancy and 6 and 12 months postpartum
nutritional choices, food security, and use of mindful eating practices
2nd and 3rd trimester of pregnancy and 6 and 12 months postpartum
physical activity
Časové okno: 2nd and 3rd trimester and 6 and 12 months postpartum
level of physical activity in a typical week
2nd and 3rd trimester and 6 and 12 months postpartum
readiness for labor and delivery
Časové okno: measured at 2nd and third trimester
readiness for labor and delivery
measured at 2nd and third trimester
readiness for taking care of baby
Časové okno: 2nd and 3rd trimester of pregnancy
readiness for taking care of baby
2nd and 3rd trimester of pregnancy
social support
Časové okno: 2nd and 3rd trimester and 6 and 12 months postpartum
multidimensional scale of perceived social support subscale
2nd and 3rd trimester and 6 and 12 months postpartum
condom use self-efficacy
Časové okno: 2nd and 3rd trimester and 6 and 12 months postpartum
condom use self efficacy scale
2nd and 3rd trimester and 6 and 12 months postpartum
substance use
Časové okno: 2nd and 3rd trimester and 6 and 12 months postpartum
use of cigarettes, alcohol, and drugs
2nd and 3rd trimester and 6 and 12 months postpartum
care satisfaction
Časové okno: 3rd trimester
satisfaction with Expect With Me group prenatal care and use of program components
3rd trimester
adherence to medical recommendations
Časové okno: 6 & 12 months postpartum
adherence to medical recommendations (e.g., 6-week postpartum check, pediatric visits, vaccinations, infant feeding)
6 & 12 months postpartum
postpartum body mass index
Časové okno: measured at 6 and 12 months postpartum
individual's body weight divided by the square of their height (kg/m2)
measured at 6 and 12 months postpartum
maternal weight gain
Časové okno: measured at 2nd and 3rd trimester and birth
weight gain as compared to medical recommendations
measured at 2nd and 3rd trimester and birth
mode of delivery
Časové okno: delivery
mode of delivery (e.g., cesarean, vaginal)
delivery
sexual risk: condom use
Časové okno: measured at 2nd and 3rd trimester and 6 and 12 months postpartum
condom use percent (0-100%)
measured at 2nd and 3rd trimester and 6 and 12 months postpartum
sexual risk: contraceptive use (LARC)
Časové okno: measured at 2nd and 3rd trimester and 6 and 12 months postpartum
use of other contraceptives to prevent pregnancy (no/yes)
measured at 2nd and 3rd trimester and 6 and 12 months postpartum
sexual risk: number of sexual partners
Časové okno: measured at 2nd and 3rd trimester and 6 and 12 months postpartum
number of partners
measured at 2nd and 3rd trimester and 6 and 12 months postpartum
sexual risk: sexually transmitted infection
Časové okno: measured at 2nd and 3rd trimester and 6 and 12 months postpartum
sexually transmitted infection (no/yes, during pregnancy or incident postpartum)
measured at 2nd and 3rd trimester and 6 and 12 months postpartum

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
nurse visitation
Časové okno: 2nd and 3rd trimester of pregnancy
participation in a nurse visitation program
2nd and 3rd trimester of pregnancy
sexual debut
Časové okno: 2nd trimester pregnancy
age at first intercourse
2nd trimester pregnancy
living situation
Časové okno: 2nd and 3rd trimester and 6 and 12 months postpartum
where and with whom they live with and the stability of their housing
2nd and 3rd trimester and 6 and 12 months postpartum
transfer of motivation
Časové okno: 2nd and3rd trimester and 6 and 12 months postpartum
relation of motivation for self and baby's health
2nd and3rd trimester and 6 and 12 months postpartum
confidence in parenting skills
Časové okno: 6 and 12 months postpartum
confidence in parenting skills
6 and 12 months postpartum
intimate partner violence
Časové okno: measured at 2nd and 3rd trimester and 6 and 12 months postpartum
perpetration and victimization of violence by an intimate partner
measured at 2nd and 3rd trimester and 6 and 12 months postpartum
perceived stress
Časové okno: 2nd and 3rd trimester and 6 and 12 months postpartum
stress level as reported by patient
2nd and 3rd trimester and 6 and 12 months postpartum
depressive symptomatology
Časové okno: 2nd and 3rd trimester of pregnancy
patient endorsement of depressive symptoms
2nd and 3rd trimester of pregnancy
perceived discrimination
Časové okno: 2nd and 3rd trimester of pregnancy and 6 and 12 months postpartum
patient experiences of discrimination
2nd and 3rd trimester of pregnancy and 6 and 12 months postpartum
resilience
Časové okno: 2nd and 3rd trimester of pregnancy and 6 and 12 months postpartum
shift and persist scale
2nd and 3rd trimester of pregnancy and 6 and 12 months postpartum

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Spolupracovníci

Vyšetřovatelé

  • Vrchní vyšetřovatel: Jeannette R Ickovics, Ph.D., Yale School of Public Health
  • Ředitel studie: Jessica B Lewis, PhD, MFT, Yale School of Public Health

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. února 2014

Primární dokončení (Aktuální)

1. prosince 2016

Dokončení studie (Aktuální)

1. prosince 2017

Termíny zápisu do studia

První předloženo

18. června 2014

První předloženo, které splnilo kritéria kontroly kvality

19. června 2014

První zveřejněno (Odhad)

20. června 2014

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

29. května 2020

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

27. května 2020

Naposledy ověřeno

1. května 2020

Více informací

Termíny související s touto studií

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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