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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Preterm Birth; Injuries; Maternal Behavior
• Intervention / Treatment: Behavioral: Nurse-Family Partnership

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 5820
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Anderson, South Carolina, United States, 29625
      • Nurse-Family Partnership of Anderson County
    • Charleston, South Carolina, United States, 29405
      • NFP of Berkeley/Charleston/Dorchester Counties
    • Columbia, South Carolina, United States, 29204
      • Nurse-Family Partnership of Lexington-Richland Co.
    • Conway, South Carolina, United States, 29526
      • Nurse-Family Partnership of Horry County
    • Florence, South Carolina, United States, 29506
      • McLeod Health NFP
    • Greenville, South Carolina, United States, 29605
      • Nurse-Family Partnership of Greenville County
    • Greenwood, South Carolina, United States, 29646
      • Carolina Health Centers NFP
    • Orangeburg, South Carolina, United States, 29118
      • Family Solutions of the Lowcountry NFP
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Regional Hospital NFP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment-NFP; 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.	Behavioral: Nurse-Family Partnership
No Intervention: Control; Control group members have access to the standard of care and whatever other programs and services are available in the community.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite birth outcome	Composite of at least one of: small for gestational (SGA), or low birth weight (LBW) less than 2500 grams, preterm birth (PTB) less than 37 weeks' gestation (obstetric estimate), or perinatal mortality (fetal death at or after 20 weeks of gestation or mortality in the first 7 days of life)	0-7 days after birth; vital records, mortality records, and fetal death records
Major injury or concern for abuse or neglect	Composite of at least one health care encounter or mortality associated with ICD codes indicating either major injury, or, concern for abuse or neglect	24 months postpartum; Medicaid claims or hospital discharge data
Inter-birth interval of < 21 months	Having a subsequent birth within the first 21 months of the index birth	21 months postpartum; vital records

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Small for gestational age (SGA)	Infant birth weight below the 10th percentile for infants of the same gestational age	At birth; vital records
Large for gestational age (LGA)	Infant birth weight above the 90th percentile for infants of the same gestational age	At birth; vital records
Low birth weight (LBW)	Infant born with a birth weight of less than 2500 grams	At birth; vital records
Very low birth weight	Infant born with a birth weight of less than 1500 grams	At birth; vital records
Birth weight (continuous)	A continuous measure of infant birth weight (grams)	At birth; vital records
Preterm birth	Infant born before 37 weeks' gestation (obstetric estimate)	At birth; vital records
Extremely preterm birth	Infant born before 28 weeks' gestation	At birth; vital records
Gestational age at birth	Gestational age at birth in weeks (continuous)	At birth; vital records
Perinatal mortality	Fetal death at or after 20 weeks of gestation or mortality in the first 7 days of life	1 month postpartum; mortality records and fetal death records
NICU admission of at least overnight	Infant admitted to the neonatal intensive care unit (NICU) for at least one night	At birth; hospital discharge
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.	At birth; hospital discharge
Cesarean delivery	Cesarean delivery	At birth; vital records
Severe acute maternal morbidity	As defined by the CDC	At birth; hospital discharge
Maternal mortality	Death of mother within one year postpartum	One year postpartum; mortality records
Neonatal abstinence disorder (NAS) or maternal drug/substance abuse	Evidence of NAS or maternal drug or substance abuse in first two years postpartum	Two years postpartum; Medicaid claims, hospital discharge
Maternal experience of violence or homicide	Includes any ICD code for healthcare encounter associated with experiencing violence or mortality associated with homicide based on ICD code	24 months postpartum; Medicaid claims, mortality records
Postpartum visit	Postpartum visit in first 12 weeks after birth	12 weeks postpartum; Medicaid claims
Adequate prenatal care	Adequacy of Prenatal Care Utilization Index (APNCU)	At birth; vital records
Number of emergency department visits during pregnancy	Number of emergency department visits during pregnancy	At birth; hospital discharge
Dental visit during pregnancy	Dental visit during pregnancy (preventive or treatment)	At birth; Medicaid claims and dental records
Ultrasound at 18-22 weeks	Ultrasound at 18-22 weeks (anatomy scan)	At birth; Medicaid claims
Prenatal screenings	Obstetric panel (D (Rh), RBC antibody screen, CBC, urine culture, urinalysis), STI screenings (HIV, Syphilis, Hep B, Chlamydia if <25, gonorrhea if <25), Group B screening, Glucose screening at 24-28 weeks	At birth; Medicaid claims
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; Medicaid claims
Diagnosis of depression/anxiety/stress reaction	Diagnosis of depression/anxiety/stress reaction	During pregnancy or 60 days postpartum; Medicaid claims
Antidepressant prescription	Antidepressant prescription	During pregnancy or 60 days postpartum; Medicaid claims
Outpatient mental health visit	Outpatient mental health visit	During pregnancy or 60 days postpartum; Medicaid claims
Mental health treatment follow up	Second antidepressant prescription or outpatient mental health visit within 120 days of treatment initiation ("acute phase")	120 days of treatment initiation; Medicaid claims
Any mental health related emergency/inpatient visit	Based on all-listed diagnoses (i.e. primary or secondary) for depression/anxiety/stress reaction	During pregnancy or 12 months postpartum; Hospital discharge
Number of mental health related emergency/inpatient visits	Based on all-listed diagnoses (i.e. primary or secondary) for depression/anxiety/stress reaction	During pregnancy or 12 months postpartum; Hospital discharge
Health care encounter or mortality associated with ICD codes indicating major injury	Child experiences a major injury	24 months of life; Medicaid claims, hospital discharge, mortality records
Health care encounter or mortality associated with ICD codes indicating concern for abuse or neglect	Concern for abuse or neglect of child	24 months of life; Medicaid claims, hospital discharge, mortality records
Number of injuries	Number of injuries	24 months of life; hospital discharge
Any emergency department visit for child	Child visit to the emergency department	24 months of life; hospital discharge
Number of emergency department visits	Total number of child visits to the emergency department	24 months of life; hospital discharge
Child mortality	All-cause child mortality in first 24 months of life	24 months; Mortality records
Well-child visits	Proportion of recommended well-child visits	15 months; Medicaid claims
Lead screening	Child receives at least one lead screening	15 months; Medicaid claims
Developmental screening	Child receives at least one developmental screening	12 months; Medicaid claims
Dental visit	Child visits the dentist at least once in first 24 months	24 months; Medicaid claims and dental records
Flouride treatment	Share of recommended fluoride treatments received by child	24 months; Medicaid claims and dental records
Inter-birth interval of < 24 months	Having a subsequent birth within the first 24 months of the index birth	24 months; vital records
Inter-birth interval	Continuous measure of inter-birth interval	60 months; vital records
Family planning visit (6 weeks)	Any family planning-related counseling or service	6 weeks postpartum; Medicaid claims, hospital discharge
Received a highly or moderately effective method of contraception (6 weeks)	Received implant, IPP-LARC, LARC, or sterilization and moderately effective contraception to include path, ring, diaphragm, injectables and contraceptive pills	6 weeks postpartum; Medicaid claims, hospital discharge
Received immediate postpartum long-acting reversible contraception (6 weeks)	Received Immediate postpartum long-acting reversible contraception in first 6 weeks postpartum	6 weeks postpartum; Medicaid claims, hospital discharge
Family planning visit (1 year)	Any family planning-related counseling or service	12 months postpartum; Medicaid claims, hospital discharge
Received a highly or moderately effective method of contraception (1 year)	Received implant, IPP-LARC, LARC, or sterilization and moderately effective contraception to include path, ring, diaphragm, injectables and contraceptive pills	12 months postpartum; Medicaid claims, hospital discharge
Postpartum intrauterine device insertion (1 year)	Postpartum intrauterine device insertion in first 12 months postpartum	12 months postpartum; Medicaid claims, hospital discharge
Time to first take-up of family planning counseling or service	Months from pregnancy to first take up of family planning counseling or service	24 months postpartum; Medicaid claims, hospital discharge
Time to first take-up of highly effective contraceptive method	Months from discharge to first take up of highly effective contraceptive method (include implant, IPP-LARC, LARC, or sterilization)	24 months postpartum; Medicaid claims, hospital discharge
Receipt of SNAP or WIC	Any receipt of Supplemental Nutrition Assistance Program or Special Supplemental Nutrition Program for Women, Infants, and Children during pregnancy	During pregnancy, assessed up to 42 weeks; South Carolina Department of Social Services data and birth certificate data respectively
Number of months receiving SNAP or TANF	Total months receiving Supplemental Nutrition Assistance Program or Temporary Assistance for Needy Families	24 months postpartum; South Carolina Department of Social Services data
Measure of SNAP or TANF benefit churn	Receiving Supplemental Nutrition Assistance Program or Temporary Assistance for Needy Families at any time during a given year and having experienced at least one break in participation of four months or less that started and/or ended during the year	24 months postpartum; South Carolina Department of Social Services data
Inter-birth interval of < 15 months	Having a subsequent birth within the first 15 months of the index birth	15 months; vital records

Collaborators and Investigators

• Sponsor: Harvard School of Public Health (HSPH)
• Collaborators: University of Chicago; Abdul Latif Jameel Poverty Action Lab
• Investigators: Principal Investigator: Margaret McConnell, PhD, Harvard School of Public Health (HSPH)

Publications and helpful links

General Publications

• McConnell MA, Zhou RA, Martin MW, Gourevitch RA, Steenland M, Bates MA, Zera C, Hacker M, Chien A, Baicker K. Protocol for a randomized controlled trial evaluating the impact of the Nurse-Family Partnership's home visiting program in South Carolina on maternal and child health outcomes. Trials. 2020 Dec 4;21(1):997. doi: 10.1186/s13063-020-04916-9.
• McConnell MA, Rokicki S, Ayers S, Allouch F, Perreault N, Gourevitch RA, Martin MW, Zhou RA, Zera C, Hacker MR, Chien A, Bates MA, Baicker K. Effect of an Intensive Nurse Home Visiting Program on Adverse Birth Outcomes in a Medicaid-Eligible Population: A Randomized Clinical Trial. JAMA. 2022 Jul 5;328(1):27-37. doi: 10.1001/jama.2022.9703. Erratum In: JAMA. 2023 Feb 28;329(8):687.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): April 1, 2023
• Study Completion (Estimated): April 1, 2046

Study Registration Dates

• First Submitted: November 28, 2017
• First Submitted That Met QC Criteria: November 28, 2017
• First Posted (Actual): December 4, 2017

Study Record Updates

• Last Update Posted (Actual): May 30, 2023
• Last Update Submitted That Met QC Criteria: May 25, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: IRB15-2939

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No