NCT02076204

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,059

participants targeted

Target at P75+ for not_applicable pregnancy

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 3, 2014

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

February 6, 2019

Status Verified

February 1, 2019

Enrollment Period

4.6 years

First QC Date

February 26, 2014

Last Update Submit

February 4, 2019

Conditions

PregnancyPostpartum CareInfant Development

Keywords

PregnancyPostpartum programsInfant health services

Outcome Measures

Primary Outcomes (8)

  • Low birth weight

    Birth weight \< 2,500 g

    Time of birth

  • Preterm birth

    Birth at less than 37 weeks gestation

    Time of birth

  • Infant admitted to the neonatal intensive care unit at birth

    Proportion of infants admitted to the NICU

    Time of birth

  • 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

  • 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

  • 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

  • Any smoking during the 3rd trimester of pregnancy

    Whether the mother smoked during the 3rd trimester of pregnancy

    Time of birth

  • Breastfeeding rates

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

    Time of birth

Secondary Outcomes (3)

  • Fetal (intrauterine) growth

    Time of birth

  • Use of prenatal care

    Time of birth

  • Emergency department use

    During the first year of life

Study Arms (2)

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.

Behavioral: Home visiting

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.

Interventions

Home visitingBEHAVIORAL

MIHOPE-Strong Start will examine local programs that use either of two home visiting service models that have shown previous evidence of improving birth outcomes: Healthy Families America (HFA) and Nurse-Family Partnership (NFP). HFA and NFP provide disadvantaged expectant mothers with individualized in-home services, including assessment of prenatal and postnatal risks to child well-being; referrals to needed health care or social services; and direct education of parents by home visitors on such topics as healthy prenatal behaviors, parenting, and child development.

Home visiting

Eligibility Criteria

Age15 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MDRC

New York, New York, 10016-4326, United States

Location

Related Publications (5)

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

Related Links

MeSH Terms

Interventions

House Calls

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • Charles Michalopoulos, Ph.D.

    MDRC

    STUDY DIRECTOR

  • Virginia Knox, Ph.D.

    MDRC

    STUDY DIRECTOR

  • Keith Kranker, Ph.D.

    Mathematica Policy Research, Inc.

    PRINCIPAL INVESTIGATOR

  • Anne Duggan, Ph.D.

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Economist

Study Record Dates

First Submitted

February 26, 2014

First Posted

March 3, 2014

Study Start

February 1, 2014

Primary Completion

September 1, 2018

Study Completion

January 1, 2019

Last Updated

February 6, 2019

Record last verified: 2019-02

Locations

US(1)