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

27 de mayo de 2020 actualizado por: 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.

Descripción general del estudio

Descripción detallada

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)

Tipo de estudio

Intervencionista

Inscripción (Actual)

2402

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Michigan
      • Detroit, Michigan, Estados Unidos, 48201
        • Wayne State University
    • Tennessee
      • Nashville, Tennessee, Estados Unidos, 37232
        • Vanderbilt University Medical Center

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Femenino

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Otros nombres:
  • group prenatal care
Comparador activo: Individual Care Only
Standard of Care- individual prenatal care
Standard of care- individual prenatal care
Otros nombres:
  • Individual Care Only

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Risk of preterm birth incidence
Periodo de tiempo: up to 37 weeks gestation
Incidence risk of delivery before 37 weeks gestation
up to 37 weeks gestation
Risk of low birth weight incidence
Periodo de tiempo: delivery
Incidence risk of infant weight at birth < 2500 grams
delivery
Risk of small for gestational age incidence
Periodo de tiempo: 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
Periodo de tiempo: birth
Incidence risk of being admitted to the neonatal intensive care unit (NICU) at birth
birth

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
breastfeeding
Periodo de tiempo: 6 and 12 months postpartum
initiation and duration of breastfeeding
6 and 12 months postpartum
nutrition
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: measured at 2nd and third trimester
readiness for labor and delivery
measured at 2nd and third trimester
readiness for taking care of baby
Periodo de tiempo: 2nd and 3rd trimester of pregnancy
readiness for taking care of baby
2nd and 3rd trimester of pregnancy
social support
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 3rd trimester
satisfaction with Expect With Me group prenatal care and use of program components
3rd trimester
adherence to medical recommendations
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: delivery
mode of delivery (e.g., cesarean, vaginal)
delivery
sexual risk: condom use
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
nurse visitation
Periodo de tiempo: 2nd and 3rd trimester of pregnancy
participation in a nurse visitation program
2nd and 3rd trimester of pregnancy
sexual debut
Periodo de tiempo: 2nd trimester pregnancy
age at first intercourse
2nd trimester pregnancy
living situation
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 6 and 12 months postpartum
confidence in parenting skills
6 and 12 months postpartum
intimate partner violence
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 2nd and 3rd trimester of pregnancy
patient endorsement of depressive symptoms
2nd and 3rd trimester of pregnancy
perceived discrimination
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Colaboradores

Investigadores

  • Investigador principal: Jeannette R Ickovics, Ph.D., Yale School of Public Health
  • Director de estudio: Jessica B Lewis, PhD, MFT, Yale School of Public Health

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de febrero de 2014

Finalización primaria (Actual)

1 de diciembre de 2016

Finalización del estudio (Actual)

1 de diciembre de 2017

Fechas de registro del estudio

Enviado por primera vez

18 de junio de 2014

Primero enviado que cumplió con los criterios de control de calidad

19 de junio de 2014

Publicado por primera vez (Estimar)

20 de junio de 2014

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

29 de mayo de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

27 de mayo de 2020

Última verificación

1 de mayo de 2020

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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