跳至主要内容
临床试验/NCT02076204
NCT02076204已完成不适用

Mother and Infant Home Visiting Program Evaluation (MIHOPE) - Strong Start

MDRC1 个研究点 分布在 1 个国家目标入组 1,059 人开始时间: 2014年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
MDRC
入组人数
1,059
试验地点
1
主要终点
Low birth weight

研究概览

简要总结

Adverse birth outcomes result in significant emotional and economic costs for families and communities. Research suggests that poor birth outcomes are influenced by a variety of social, psychological, behavioral, environmental, and biological factors. Home visiting programs represent a promising means of impacting each of these areas.

The Mother and Infant Home Visiting Program Evaluation - Strong Start (MIHOPE-Strong Start) will evaluate the effectiveness of two evidence-based home visiting models at improving birth outcomes for women who are enrolled in Medicaid or CHIP. The two models to be studied - Healthy Families America (HFA) and Nurse-Family Partnership (NFP) - have both shown some evidence of improving birth outcomes in prior research.

The overall goals of the study are to determine whether home visiting programs improve birth outcomes and reduce health care costs in the child's first year. In addition, the evaluation is designed to investigate the features of local programs and of home visitation that lead to greater effects on birth outcomes and health care costs. The study includes an impact analysis to measure what difference home visiting programs make on maternal prenatal health and health care use, preterm birth and other birth outcomes, and infant health and health care use. It also includes an implementation analysis that will describe the families who participate and examine how the program models operate in their local and state contexts. The primary data used in the study are expected to be from surveys completed by families and home visiting staff, Medicaid and CHIP data, vital records, and program service records. Among families who are eligible for the study, random assignment will be used to select families for enrollment in home visiting services. Those selected for home visiting services will form the program group, and those not selected will form a comparison group. The research team will monitor both groups over time to see if differences emerge in the outcome areas mentioned above. Although the study will affect which families can enroll in home visiting services, no fewer families will be served as a result of the study.

详细描述

The study's conceptual framework has three broad aspects: (1) inputs (factors influencing service delivery), (2) outputs (services delivered) and (3) outcomes for families. Each site in MIHOPE-Strong Start will use either the NFP or HFA home visiting model.

Community resources provide a foundation from which programs operate and are considered an input that influence how services are provided to families. In particular, these determine the outside referral services available to home visiting programs and the opportunities available to families in both the program and control groups. By connecting pregnant women with services, home visiting programs can change mothers' health care use, health behaviors, and health status, which in turn can lead to improvements in birth outcomes. In communities where services are limited, however, home visiting programs may have limited capacity to improve mothers' connections to such supports. Furthermore, a program's ability to improve outcomes is influenced by the "treatment differential," or the difference between service receipt among families who receive home visiting and families who do not receive home visiting. The more that control group members receive services that are similar to those provided by HFA and NFP, the smaller the "treatment differential." Community context also includes community characteristics that could affect norms toward use of social services and health care, or other influences on control group help-seeking and program group responses to home visiting programs. These contextual factors can affect program impacts in both positive and negative directions. The service model defines the program plan. It includes information such as the intended goals of the home visiting program; the expected frequency, duration, and content of home visits; and intended linkages with other services.

The MIHOPE-Strong Start implementation study will document the extent to which the two evidence-based models and their local counterparts have defined clear, coherent, and well-specified service plans for helping parents to obtain prenatal care, other services needed to reduce the risk of poor birth outcomes, and infant health care in the first year of life - a critical prerequisite to delivering services that could affect these outcomes.

In MIHOPE-Strong Start, the "service model" can be defined at two levels: the service model is defined by the national evidence-based model and then it may be refined or adapted by the agency that is operating a local program. It is important to clearly understand how HFA and NFP define their models since these models showed efficacy in prior research. At the same time, local programs often deliberately adapt models to fit their local contexts. Given inconsistent impacts on birth outcomes in past studies, in fact, such adaptations could be one path to improvements in program impacts.

There are multiple organizational influences on how a home visiting program defines its service model and its implementation system. These organizations include the local program operator, the purveyor of the evidence-based model that has been adopted (HFA or NFP), the state MIECHV (Maternal, Infant, and Early Childhood Home Visiting Program) grantee (if the site is participating in MIECHV), and community organizations with which the local agency collaborates.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Must be pregnant with at least 8 weeks to expected due date
  • Must be eligible for a home visiting program in MIHOPE-Strong Start
  • Must be at least 15 years old

排除标准

  • Currently enrolled in home visiting
  • Does not speak English or Spanish

研究组 & 干预措施

Home visiting

Experimental

Home visiting group: Women will be randomized so that 60 percent can receive home visiting services and 40 percent are in the control group. Home visiting for low-income, pregnant women - whereby individualized in-home services (including direct education, assessments, and referrals to community resources) are provided to families - has been identified by the Strong Start initiative as one promising method for reaching women who are vulnerable to poor birth outcomes.

干预措施: Home visiting (Behavioral)

Non-Home Visiting

No Intervention

Control group: As described above, women will be randomized so that 60 percent can receive home visiting services and 40 percent are in the control group.The home visiting program will provide control group families with referrals to other appropriate services in the community.

结局指标

主要结局

Low birth weight

时间窗: Time of birth

Birth weight \< 2,500 g

Preterm birth

时间窗: Time of birth

Birth at less than 37 weeks gestation

Infant admitted to the neonatal intensive care unit at birth

时间窗: Time of birth

Proportion of infants admitted to the NICU

Number of well-child visits for infant

时间窗: During the first year of life

Number of well-child visits during the first year of life, measured using Medicaid claims

Infant emergency department visits

时间窗: During the first year of life

Whether the infant was admitted to the emergency in the year after birth, measured from Medicaid claims data

Infant hospital admissions

时间窗: During the first year of life

Whether the infant was admitted to hospital in the year after birth, measured from Medicaid claims data

Any smoking during the 3rd trimester of pregnancy

时间窗: Time of birth

Whether the mother smoked during the 3rd trimester of pregnancy

Breastfeeding rates

时间窗: Time of birth

Infant was breastfed at hospital discharge, based on birth certificate data

次要结局

  • Fetal (intrauterine) growth(Time of birth)
  • Use of prenatal care(Time of birth)
  • Emergency department use(During the first year of life)

研究者

发起方
MDRC
申办方类型
Other
责任方
Principal Investigator
主要研究者

Charles Michalopoulos

Chief Economist

MDRC

研究点 (1)

Loading locations...

相似试验