Nurse-Family Partnership Impact Evaluation in South Carolina (NFP)

President and Fellows of Harvard College

Status: Active, not recruiting

Conditions: Injuries; Maternal Behavior; Preterm Birth

Treatments: Behavioral: Nurse-Family Partnership

Study type: Interventional

Funder types: Other

Identifiers

NCT03360539

IRB15-2939

Details and patient eligibility

About

This study evaluates the effects of the Nurse Family Partnership (NFP), an established home-visiting program, using a scientifically rigorous individual-level randomized controlled trial. The study will be based in South Carolina, where a Medicaid waiver in combination with a pay-for-success contract will allow expansion of the program to women on Medicaid. The study plans to enroll 4000 low-income, first time mothers and their children into the intervention group, and another 2000 into the control group. The study will evaluate the program's impacts on outcomes using administrative records. This study aims to yield new evidence on the effect of NFP in a modern context, applied to a new population, across a broad range of outcomes, and financed by a novel public-private partnership based on accountability for outcomes.

Full description

This study is an individual-level randomized controlled trial, with randomization post-consent. The study will enroll pregnant women who are income-eligible for Medicaid, less than 28 weeks pregnant, and have not had a previous live birth. All eligible applicants who provide written consent will be randomly assigned either to a treatment group that is offered access to NFP or to a control group that is not. Two-thirds of those recruited will be randomized to the treatment group and one-third to the control group. Control group members will have access to the standard of care and whatever other programs and services are available in the community.

The investigators will assess the effect of NFP on a range of short- and long-run maternal and child outcomes using administrative data that will be available for all members of both treatment and control groups. Several of the outcomes the investigators will evaluate are required as part of the Medicaid waiver and pay-for-success financing model.

Enrollment: 5,670 patients

Sex: Female

Ages: 15 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female
• No previous live births
• Currently pregnant
• Gestation period less than 28 weeks (i.e. less than or equal to 27 weeks, 6 days) at time of recruitment
• Ages 15-55
• Income level meets Medicaid eligibility criteria
• Live within an area serviced by a NFP Implementing Agency
• Not currently enrolled in the study
• Not incarcerated or living in lock down facilities

Exclusion criteria

• Men
• Women who have had a previous live birth
• Women who are not currently pregnant
• Women who are past their 28th week of gestation (i.e. greater than or equal to 28 weeks, 0 days) at time of recruitment
• Women who are younger than 15 or older than 55 years of age
• Women whose income level does not meet Medicaid eligibility criteria
• Women who live outside of an area serviced by a NFP Implementing Agency
• Women who are currently enrolled in the study
• Women who are currently incarcerated or living in a lock down facility

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5,670 participants in 2 patient groups

Treatment-NFP

Experimental group

Description:

NFP is a prenatal and infancy home visiting program for low-income, first-time mothers and their families. Registered nurses begin visiting their clients as early in the pregnancy as possible, helping the mother-to-be make informed choices. The nurses continue visiting regularly until the child is two years old.

Treatment:

Behavioral: Nurse-Family Partnership

Control

No Intervention group

Description:

Control group members have access to the standard of care and whatever other programs and services are available in the community.