Pregnancy Clinical Trial
Official title:
Mother and Infant Home Visiting Program Evaluation (MIHOPE) - Strong Start
Verified date | February 2019 |
Source | MDRC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1059 |
Est. completion date | January 2019 |
Est. primary completion date | September 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 15 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - Currently enrolled in home visiting - Does not speak English or Spanish |
Country | Name | City | State |
---|---|---|---|
United States | MDRC | New York | New York |
Lead Sponsor | Collaborator |
---|---|
MDRC | Centers for Medicare and Medicaid Services, James Bell Associates, Johns Hopkins University, Mathematica Policy Research, Inc., Office of Planning, Research, and Evaluation (OPRE) |
United States,
Jill H. Filene, Emily K. Snell, Helen Lee, Virginia Knox, Charles Michalopoulos, and Anne Duggan (2013). The Mother and Infant Home Visiting Program Evaluation-Strong Start: First Annual Report. OPRE Report 2013-54. Washington, DC: Office of Planning, Research and Evaluation, Administration for Children and Families, U.S. Department of Health and Human Services.
Lee, Helen, Anne Warren, Lakhpreet Gill (2015). Cheaper, Faster, Better: Are State Administrative Data the Answer? The Mother and Infant Home Visiting Program Evaluation-Strong Start Second Annual Report. OPRE Report 2015-09. Washington, DC: Office of Planning, Research and Evaluation, Administration for Children and Families, U.S. Department of Health and Human Services.
Lee, Helen, Sarah Crowne, Kristen Faucetta, and Rebecca Hughes. 2016. An Early Look at Families and Local Programs in the Mother and Infant Home Visiting Program Evaluation--Strong Start: Third Annual Report.
Lee, Helen, Sarah Shea Crowne, Melanie Estarziau, Keith Kranker, Charles Michalopoulos, Anne Warren, Tod Mijanovich, Jill H. Filene, Anne Duggan, and Virginia Knox. (2019). The Effects of Home Visiting on Prenatal Health, Birth Outcomes, and Health Care Use in the First Year of Life: Final Implementation and Impact Findings from the Mother and Infant Home Visiting Program Evaluation-Strong Start. OPRE Report 2019-08. Washington, DC: Office of Planning, Research, and Evaluation, Administration for Children and Families, U.S. Department of Health and Human Services.
Michalopoulos C, Lee H, Snell EK, Crowne S, Filene JH, Fox MK, Kranker K, Mijanovich T, Lakhpreet Gill L, and Duggan A. Design for the Mother and Infant Home Visiting Program Evaluation—Strong Start. OPRE Report 2015-63. Washington, DC: Office of Planning, Research and Evaluation, Administration for Children and Families, U.S. Department of Health and Human Services.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Low birth weight | Birth weight < 2,500 g | Time of birth | |
Primary | Preterm birth | Birth at less than 37 weeks gestation | Time of birth | |
Primary | Infant admitted to the neonatal intensive care unit at birth | Proportion of infants admitted to the NICU | Time of birth | |
Primary | Number of well-child visits for infant | Number of well-child visits during the first year of life, measured using Medicaid claims | During the first year of life | |
Primary | Infant emergency department visits | Whether the infant was admitted to the emergency in the year after birth, measured from Medicaid claims data | During the first year of life | |
Primary | Infant hospital admissions | Whether the infant was admitted to hospital in the year after birth, measured from Medicaid claims data | During the first year of life | |
Primary | Any smoking during the 3rd trimester of pregnancy | Whether the mother smoked during the 3rd trimester of pregnancy | Time of birth | |
Primary | Breastfeeding rates | Infant was breastfed at hospital discharge, based on birth certificate data | Time of birth | |
Secondary | Fetal (intrauterine) growth | By combining information on birth weight, gestational age, and the baby's sex, the prevalence of infants who are small for gestational age or large for gestational age will be estimated and examined. | Time of birth | |
Secondary | Use of prenatal care | Birth certificate data will be used to assess the date of the first prenatal care visit and the total number of prenatal care visits. In some states, particularly those with a low concentration of managed care, Medicaid data may also provide information to assess the effect of home visiting programs on prenatal care and the quality of data on prenatal care coming from birth certificates. These data, along with gestational age at birth, can be used to estimate the adequacy of prenatal care. | Time of birth | |
Secondary | Emergency department use | From Medicaid files, number of infant visits to the emergency department | During the first year of life |
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