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

27. mai 2020 oppdatert av: 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.

Studieoversikt

Detaljert beskrivelse

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)

Studietype

Intervensjonell

Registrering (Faktiske)

2402

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Michigan
      • Detroit, Michigan, Forente stater, 48201
        • Wayne State University
    • Tennessee
      • Nashville, Tennessee, Forente stater, 37232
        • Vanderbilt University Medical Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Andre navn:
  • group prenatal care
Aktiv komparator: Individual Care Only
Standard of Care- individual prenatal care
Standard of care- individual prenatal care
Andre navn:
  • Individual Care Only

Hva måler studien?

Primære resultatmål

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

Sekundære resultatmål

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

Andre resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Samarbeidspartnere

Etterforskere

  • Hovedetterforsker: Jeannette R Ickovics, Ph.D., Yale School of Public Health
  • Studieleder: Jessica B Lewis, PhD, MFT, Yale School of Public Health

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. februar 2014

Primær fullføring (Faktiske)

1. desember 2016

Studiet fullført (Faktiske)

1. desember 2017

Datoer for studieregistrering

Først innsendt

18. juni 2014

Først innsendt som oppfylte QC-kriteriene

19. juni 2014

Først lagt ut (Anslag)

20. juni 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. mai 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. mai 2020

Sist bekreftet

1. mai 2020

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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