- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02169024
Development of a Nationally Scalable Model of Group Prenatal Care to Improve Birth Outcomes: "Expect With Me"
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:
- 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);
- report greater change in risk-related behaviors and psychosocial characteristics that could be considered potential mechanisms for the program's effectiveness;
- have lower rates of sexually transmitted diseases and rapid repeat pregnancy one year postpartum;
- 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.
연구 개요
상태
상세 설명
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:
- 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.
- 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.
- 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:
- 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);
- report greater change in risk-related behaviors and psychosocial characteristics that could be considered potential mechanisms for the program's effectiveness;
- have lower rates of sexually transmitted diseases and rapid repeat pregnancy one year postpartum;
- have lower healthcare costs through improved outcomes (e.g., appropriate care utilization, fewer complications, reduced NICU admissions/length of stays)
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Michigan
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Detroit, Michigan, 미국, 48201
- Wayne State University
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Tennessee
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Nashville, Tennessee, 미국, 37232
- Vanderbilt University Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Expect With Me group prenatal care
receiving prenatal care through an Expect With Me group
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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.
다른 이름들:
|
활성 비교기: Individual Care Only
Standard of Care- individual prenatal care
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Standard of care- individual prenatal care
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Risk of preterm birth incidence
기간: up to 37 weeks gestation
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Incidence risk of delivery before 37 weeks gestation
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up to 37 weeks gestation
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Risk of low birth weight incidence
기간: delivery
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Incidence risk of infant weight at birth < 2500 grams
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delivery
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Risk of small for gestational age incidence
기간: delivery
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Incidence risk of infant weight below the 10th percentile for the gestational age at birth
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delivery
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Risk of neonatal intensive care unit (NICU) admission incidence
기간: birth
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Incidence risk of being admitted to the neonatal intensive care unit (NICU) at birth
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birth
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
breastfeeding
기간: 6 and 12 months postpartum
|
initiation and duration of breastfeeding
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6 and 12 months postpartum
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nutrition
기간: 2nd and 3rd trimester of pregnancy and 6 and 12 months postpartum
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nutritional choices, food security, and use of mindful eating practices
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2nd and 3rd trimester of pregnancy and 6 and 12 months postpartum
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physical activity
기간: 2nd and 3rd trimester and 6 and 12 months postpartum
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level of physical activity in a typical week
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2nd and 3rd trimester and 6 and 12 months postpartum
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readiness for labor and delivery
기간: measured at 2nd and third trimester
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readiness for labor and delivery
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measured at 2nd and third trimester
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readiness for taking care of baby
기간: 2nd and 3rd trimester of pregnancy
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readiness for taking care of baby
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2nd and 3rd trimester of pregnancy
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social support
기간: 2nd and 3rd trimester and 6 and 12 months postpartum
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multidimensional scale of perceived social support subscale
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2nd and 3rd trimester and 6 and 12 months postpartum
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condom use self-efficacy
기간: 2nd and 3rd trimester and 6 and 12 months postpartum
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condom use self efficacy scale
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2nd and 3rd trimester and 6 and 12 months postpartum
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substance use
기간: 2nd and 3rd trimester and 6 and 12 months postpartum
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use of cigarettes, alcohol, and drugs
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2nd and 3rd trimester and 6 and 12 months postpartum
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care satisfaction
기간: 3rd trimester
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satisfaction with Expect With Me group prenatal care and use of program components
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3rd trimester
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adherence to medical recommendations
기간: 6 & 12 months postpartum
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adherence to medical recommendations (e.g., 6-week postpartum check, pediatric visits, vaccinations, infant feeding)
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6 & 12 months postpartum
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postpartum body mass index
기간: measured at 6 and 12 months postpartum
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individual's body weight divided by the square of their height (kg/m2)
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measured at 6 and 12 months postpartum
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maternal weight gain
기간: measured at 2nd and 3rd trimester and birth
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weight gain as compared to medical recommendations
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measured at 2nd and 3rd trimester and birth
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mode of delivery
기간: delivery
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mode of delivery (e.g., cesarean, vaginal)
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delivery
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sexual risk: condom use
기간: measured at 2nd and 3rd trimester and 6 and 12 months postpartum
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condom use percent (0-100%)
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measured at 2nd and 3rd trimester and 6 and 12 months postpartum
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sexual risk: contraceptive use (LARC)
기간: measured at 2nd and 3rd trimester and 6 and 12 months postpartum
|
use of other contraceptives to prevent pregnancy (no/yes)
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measured at 2nd and 3rd trimester and 6 and 12 months postpartum
|
sexual risk: number of sexual partners
기간: measured at 2nd and 3rd trimester and 6 and 12 months postpartum
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number of partners
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measured at 2nd and 3rd trimester and 6 and 12 months postpartum
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sexual risk: sexually transmitted infection
기간: measured at 2nd and 3rd trimester and 6 and 12 months postpartum
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sexually transmitted infection (no/yes, during pregnancy or incident postpartum)
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measured at 2nd and 3rd trimester and 6 and 12 months postpartum
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
nurse visitation
기간: 2nd and 3rd trimester of pregnancy
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participation in a nurse visitation program
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2nd and 3rd trimester of pregnancy
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sexual debut
기간: 2nd trimester pregnancy
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age at first intercourse
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2nd trimester pregnancy
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living situation
기간: 2nd and 3rd trimester and 6 and 12 months postpartum
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where and with whom they live with and the stability of their housing
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2nd and 3rd trimester and 6 and 12 months postpartum
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transfer of motivation
기간: 2nd and3rd trimester and 6 and 12 months postpartum
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relation of motivation for self and baby's health
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2nd and3rd trimester and 6 and 12 months postpartum
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confidence in parenting skills
기간: 6 and 12 months postpartum
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confidence in parenting skills
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6 and 12 months postpartum
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intimate partner violence
기간: measured at 2nd and 3rd trimester and 6 and 12 months postpartum
|
perpetration and victimization of violence by an intimate partner
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measured at 2nd and 3rd trimester and 6 and 12 months postpartum
|
perceived stress
기간: 2nd and 3rd trimester and 6 and 12 months postpartum
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stress level as reported by patient
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2nd and 3rd trimester and 6 and 12 months postpartum
|
depressive symptomatology
기간: 2nd and 3rd trimester of pregnancy
|
patient endorsement of depressive symptoms
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2nd and 3rd trimester of pregnancy
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perceived discrimination
기간: 2nd and 3rd trimester of pregnancy and 6 and 12 months postpartum
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patient experiences of discrimination
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2nd and 3rd trimester of pregnancy and 6 and 12 months postpartum
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resilience
기간: 2nd and 3rd trimester of pregnancy and 6 and 12 months postpartum
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shift and persist scale
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2nd and 3rd trimester of pregnancy and 6 and 12 months postpartum
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Jeannette R Ickovics, Ph.D., Yale School of Public Health
- 연구 책임자: Jessica B Lewis, PhD, MFT, Yale School of Public Health
간행물 및 유용한 링크
일반 간행물
- Lewis JB, Cunningham SD, Shabanova V, Hassan SS, Magriples U, Rodriguez MG, Ickovics JR. Group prenatal care and improved birth outcomes: Results from a type 1 hybrid effectiveness-implementation study. Prev Med. 2021 Dec;153:106853. doi: 10.1016/j.ypmed.2021.106853. Epub 2021 Oct 20.
- Cunningham SD, Lewis JB, Thomas JL, Grilo SA, Ickovics JR. Expect With Me: development and evaluation design for an innovative model of group prenatal care to improve perinatal outcomes. BMC Pregnancy Childbirth. 2017 May 18;17(1):147. doi: 10.1186/s12884-017-1327-3.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
성병에 대한 임상 시험
-
University of Pennsylvania완전한Intrntl Classification of Diseases, 9th Revision, (ICD-9-CM) 410의 주진단 또는 이차진단 코드가 있는 환자(5번째 숫자가 2인 경우 제외)미국