Nurse-Family Partnership Impact Evaluation in South Carolina

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Nurse-Family Partnership Impact Evaluation in South Carolina

Conditions
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Preterm Birth, Injuries, Maternal Behavior

Intervention / Treatment
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* Behavioral: Nurse-Family Partnership


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment-NFP<br>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<br> <br> |
| No Intervention: Control<br>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?
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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 of < 15 months | Having a subsequent birth within the first 15 months of the index birth | 15 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 |