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Randomized Evaluation of the Nurse Family Partnership in South Carolina
Last registered on May 03, 2019

Pre-Trial

Trial Information
General Information
Title
Randomized Evaluation of the Nurse Family Partnership in South Carolina
RCT ID
AEARCTR-0001039
Initial registration date
February 20, 2016
Last updated
May 03, 2019 5:14 PM EDT
Location(s)

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Primary Investigator
Affiliation
Harvard School of Public Health
Other Primary Investigator(s)
PI Affiliation
J-PAL North America, MIT
PI Affiliation
Harvard T.H. Chan School of Public Health
PI Affiliation
Harvard T.H. Chan School of Public Health
PI Affiliation
J-PAL North America
PI Affiliation
Harvard University
Additional Trial Information
Status
In development
Start date
2016-04-01
End date
2024-03-31
Secondary IDs
Abstract
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. Using data from administrative records, researchers will evaluate the average impact of NFP on pre-term birth, birth spacing, child injury, as well as the long-term health, education, and economic self-sufficiency of the family. From 1978 to 1994, three modest-scale randomized evaluations had suggested that NFP had a positive impact on birth outcomes, maternal and child health, and other measures of social and economic well-being of mothers and their children. 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.
External Link(s)
Registration Citation
Citation
Baicker, Katherine et al. 2019. "Randomized Evaluation of the Nurse Family Partnership in South Carolina." AEA RCT Registry. May 03. https://doi.org/10.1257/rct.1039-4.0.
Former Citation
Baicker, Katherine et al. 2019. "Randomized Evaluation of the Nurse Family Partnership in South Carolina." AEA RCT Registry. May 03. https://www.socialscienceregistry.org/trials/1039/history/45919.
Sponsors & Partners

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Experimental Details
Interventions
Intervention(s)
The Nurse-Family Partnership (NFP) was launched by pediatrician David Olds in the early 1970s in response to the observation that low-income mothers are less likely to engage in positive health and parenting behaviors that are associated with better child development outcomes (Olds et al. 1986). 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.
Intervention Start Date
2016-04-01
Intervention End Date
2022-03-31
Primary Outcomes
Primary Outcomes (end points)
PRIMARY OUTCOMES

We will consider three outcomes for the Medicaid waiver and pay-for-success (PFS) financing model:
• Pre-term birth: proportion of infants born at less than 37 weeks (vital records, collected and maintained by the South Carolina Department of Health and Environmental Control)
• Birth spacing: number of months from birth of the first child to the subsequent birth (vital records, collected and maintained by the South Carolina Department of Health and Environmental Control)
• Child injuries: fraction of infants with emergency department visits and hospitalizations within 24 months post-partum (all-payer encounter database overseen by the South Carolina Data Oversight Council)

In addition to the outcomes relevant for the PFS evaluation, we will consider other indicators of the impact of NFP outlined below.

Additional non-health outcomes:
• Confirmed cases of abuse and neglect for child or mothers under the age of 18 (from data provided by the Department of Social Services)
• Maternal educational attainment: completion of high school (from data provided by the South Carolina Department of Education)
• Child school readiness and achievement: participation in a state-run pre-kindergarten program, test scores in third grade (from data provided by the South Carolina Department of Education)
• Criminal justice involvement: maternal arrests, child arrests (from data provided by South Carolina Law Enforcement Division and the Department of Juvenile Justice)
We will provide additional details on non-health outcomes prior to the conclusion of study enrollment.

Additional health-related outcomes: health outcomes from vital records birth certificate data (VR), Medicaid claims (MC) data or hospital discharge data (HD).
• Very preterm birth (proportion of infants born at less than 32 weeks)
• Extremely preterm birth (proportion of infants born at less than 28 weeks)
• Low birth weight (proportion of infants born with a birth weight of less than 2500 grams)
• Very low birth weight (proportion of infants born with a birth weight of less than 1500 grams)
• Neonatal intensive care unit (NICU) admission
• Length of stay in NICU (days)
• Short birth interval (proportion of subsequent infants born within 24 months of the first birth)
• Very short birth interval (proportion of subsequent infants born within 18 months of the first birth)
• Delivery method (vaginal delivery or cesarean section)
• Tobacco use
• Long-acting reversible contraception (LARC) use
• Neonatal mortality (proportion of infants that die under 28 days of age)
• Infant mortality (proportion of infants that die under 1 year of age)
• Child mortality (proportion of infants that die under 5 years of age)
• Exceeding recommended pregnancy weight gain (proportion of mothers that exceed recommended pregnancy weight gain)
• Stillbirth
• Gestational diabetes
• Gestational hypertension
• Preeclampsia
Primary Outcomes (explanation)
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
This study is an individual-level randomized controlled trial, with randomization post-consent. The study will enroll low-income, first-time, Medicaid-eligible pregnant women at less than 28 weeks gestation. 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. Study enrollment, on-the-spot randomization, and the baseline survey will be conducted by NFP staff using encrypted tablets and Computer Assisted Personal Interview (CAPI) software.
Experimental Design Details
Not available
Randomization Method
On-the-spot randomization using a tablet (Survey CTO)
Randomization Unit
The unit of randomization is the individual (a pregnant woman who meets the eligibility criteria for program participation).
Was the treatment clustered?
No
Experiment Characteristics
Sample size: planned number of clusters
6,000 women (individual-level randomization without clusters)
Sample size: planned number of observations
6,000 women and their children
Sample size (or number of clusters) by treatment arms
4,000 women in treatment group
2,000 women in control group
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
We have performed power calculations as part of the preparation for the Medicaid waiver and pay-for-success contract specifications. Our power analysis is based on expected effect sizes suggested by previous NFP trials and NFP data on the target population. We use the effect sizes of a 20% drop in pre-term birth (with a baseline mean rate of preterm birth of .12), 18% reduction in birth spacing of less than 2 years (baseline mean of .14), and a 13% reduction in child injury (baseline mean of .18); we assume that 95% or more of women randomized into the treatment group receive any NFP services and at most 5% of the control group that receives a home visiting program that has as much impact as NFP. NFP plans to serve 4,000 families in South Carolina between January 2016 and January 2020. Our power analysis suggests that with 4,000 families in the treatment group, a 2:1 T:C ratio (or 2,000 control group families) will achieve 80% or higher chance of detecting statistically significant effects on two out of the three primary outcomes, with the greatest power to detect child injury and the lowest to detect pre-term birth. We anticipate having substantially greater power for many of the additional outcomes that we will assess for the broader evaluation (e.g. utilization of government benefits or the mother’s subsequent arrests). We will further develop our plans for these measures during the pilot period.
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Harvard Longwood Medical Area IRB
IRB Approval Date
2015-12-09
IRB Approval Number
IRB15-2939