Randomized Evaluation of the Nurse Family Partnership in South Carolina
Last registered on March 18, 2020

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
March 18, 2020 2:00 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 University
PI Affiliation
J-PAL North America
PI Affiliation
Harvard T.H. Chan School of Public Health
PI Affiliation
Harvard T.H. Chan School of Public Health
Additional Trial Information
Status
On going
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. 2020. "Randomized Evaluation of the Nurse Family Partnership in South Carolina." AEA RCT Registry. March 18. https://doi.org/10.1257/rct.1039-5.0.
Former Citation
Baicker, Katherine et al. 2020. "Randomized Evaluation of the Nurse Family Partnership in South Carolina." AEA RCT Registry. March 18. http://www.socialscienceregistry.org/trials/1039/history/64576.
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)
In addition to the outcomes designated by the PFS evaluation, we will consider other indicators of the impact of NFP outlined below.

First, we will consider indicators of the impact of NFP during pregnancy, delivery, and the first two years postpartum in several key domains. We specify a primary outcome in each health related domain. These outcomes come from vital records birth certificate data (VR), mortality records (MR) Medicaid claims (MC) data or hospital discharge data (HD).

Pregnancy, birth, and maternal health outcomes
• Composite of at least one of: small for gestational age, low birthweight, preterm birth, or perinatal mortality (VR, MR, FDR)
Child Health & Development
• Composite of at least one health care encounter or mortality associated with ICD codes indicating major injury, or, concern for abuse or neglect in first 24 months of life (MC, HD, MR)
Maternal Life-Course
• Inter-birth interval of < 21 months (VR)
Primary Outcomes (explanation)
Secondary Outcomes
Secondary Outcomes (end points)
Pregnancy, birth, and maternal health outcomes
• Infant outcomes observed at birth
o Small for gestational age (VR)
o Large for gestational age (VR)
o Low birthweight [<2500 grams] (VR)
o Very low birthweight [<1500 grams] (VR)
o Birthweight [continuous] (VR)
o Preterm birth [<37 weeks’ gestation by obstetric estimate] (VR)
o Extremely preterm birth [<28 weeks’ gestation] (VR)
o Gestational age at birth [continuous] (VR)
o Perinatal mortality [fetal death at or after 20 weeks of gestation or mortality in the first 7 days of life] (MR, FDR)
o Neonatal intensive care unit admission of at least overnight (HD)
o Neonatal morbidity [assisted ventilation immediately after delivery, assisted ventilation for more than six hours, seizure, receipt of surfactant replacement therapy, and receipt of antibiotics for suspected sepsis] (HD)
• Maternal outcomes
o Cesarean delivery (VR)
o Severe acute maternal morbidity [as defined by the CDC] (HD)
o Maternal mortality [up to one year after birth] (MR)
o Neonatal abstinence disorder or maternal drug/substance abuse [2 years post-delivery] (MC, HD)
o Maternal experience of violence or homicide (MC, MR)
o Postpartum visit within the first 12 weeks (MC)
• Utilization and quality of prenatal care
o Adequate prenatal care [Adequacy of Prenatal Care Utilization (APNCU) Index] (VR)
o Number of emergency department visits during pregnancy (HD)
o Dental visit (preventive or treatment) during pregnancy (MC)
o Ultrasound at 18-22 weeks (anatomy scan) (MC)
o Share of recommended prenatal screenings completed (MC)
• Mental health outcomes
o Any mental health diagnosis or outpatient treatment [diagnosis for depression/anxiety/stress reaction or antidepressant prescription or outpatient mental health visit during pregnancy or 60 days postpartum] (MC)
o Diagnosis of depression/anxiety/stress reaction during pregnancy or 60 days postpartum (MC)
o Antidepressant prescription during pregnancy or 60 days postpartum (MC)
o Outpatient mental health visit during pregnancy or 60 days postpartum (MC)
o Mental health treatment follow up [second antidepressant prescription or outpatient mental health visit with 120 days of treatment initiation] (MC)
o Mental health related emergency/inpatient visit during pregnancy or 12 months postpartum (HD)
o Number of mental health related emergency/inpatient visits during pregnancy or 12 months postpartum (HD)

Child Health & Development
• Accidents, suspected abuse and neglect and emergency care utilization
o Health care encounter or mortality associated with ICD codes indicating major injury in first 24 months of life (MC, HD, MR)
o Health care encounter or mortality associated with ICD codes indicating concern for abuse or neglect in first 24 months of life (MC, HD, MR)
o Number of injuries in first 24 months of life (HD)
o Any ED visit during first 24 months of life (HD)
o Number of ED visits first 24 months of life (HD)
o All-cause child mortality in first 24 months of life (MR)
• Outcomes related to preventative care
o Proportion of recommended well-child visits by 15 months (MC)
o At least one lead screening by 15 months (MC)
o At least one developmental screening by 12 months (MC)
o At least one dental visit in the first 24 months (MC)
o Share of recommended fluoride treatments in first 24 months of life (MC)
Maternal Life-Course
• Birth spacing outcomes
o Inter-birth interval of < 24 months (VR)
o Inter-birth interval of < 15 months (VR)
o Inter-birth interval measured at 60 months postpartum [continuous] (VR)
• Postpartum family planning while enrolled in postpartum Medicaid coverage (6 weeks)
o Any family planning related counseling or service (MC, HD)
o Received a highly or moderately effective method of contraception (MC, HD)
o Immediate postpartum long-acting reversible contraception (MC, HD)
• Postpartum family planning within one year
o Any family planning related counseling or service (MC, HD)
o Received a highly or moderately effective method of contraception (MC, HD)
o Postpartum intrauterine device insertion (MC, HD)
• Timing of postpartum family planning take-up
o Time to first take-up of family planning [months from pregnancy] (MC, HD)
o Time to first take-up of highly effective contraception methods [months from discharge] (MC, HD)

Connection to social services
• Enrollment in SNAP, WIC, TANF during pregnancy and first 24 months of child’s life
• Medicaid coverage: continuous enrollment for the child in the first 24 months of child’s life
• Participation in early head start in the first 24 months of child’s life
• Receipt of ABC childcare voucher in the first 24 months of child’s life

We will also examine longer-term indicators of the impact of NFP. We will release additional information about these outcomes in the years after trial enrollment. Examples of anticipated analyses include:
• Longer-term health related outcomes: Inter-birth interval [continuous] (VR), child and adult mortality, intimate partner violence, child health outcomes (ex: asthma, mental health), child and adult health utilization
• 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)
• Service coordination: enrollment in SNAP, WIC, TANF, early childhood intervention, education and childcare opportunities
• Medicaid coverage: continuous enrollment for the child
• Economic wellbeing: credit scores
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
Analysis Plan

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