Nurse-Family Partnership Impact Evaluation in South Carolina
- Conditions
- InjuriesPreterm BirthMaternal Behavior
- Interventions
- Behavioral: Nurse-Family Partnership
- Registration Number
- NCT03360539
- Lead Sponsor
- Harvard School of Public Health (HSPH)
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 5820
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment-NFP Nurse-Family Partnership 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.
- Primary Outcome Measures
Name Time Method Composite birth outcome 0-7 days after birth; vital records, mortality records, and fetal death records 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)
Inter-birth interval of < 21 months 21 months postpartum; vital records Having a subsequent birth within the first 21 months of the index birth
Major injury or concern for abuse or neglect 24 months postpartum; Medicaid claims or hospital discharge data Composite of at least one health care encounter or mortality associated with ICD codes indicating either major injury, or, concern for abuse or neglect
- Secondary Outcome Measures
Name Time Method Time to first take-up of family planning counseling or service 24 months postpartum; Medicaid claims, hospital discharge Months from pregnancy to first take up of family planning counseling or service
Extremely preterm birth At birth; vital records Infant born before 28 weeks' gestation
Number of emergency department visits during pregnancy At birth; hospital discharge Number of emergency department visits during pregnancy
Small for gestational age (SGA) At birth; vital records Infant birth weight below the 10th percentile for infants of the same gestational age
Large for gestational age (LGA) At birth; vital records Infant birth weight above the 90th percentile for infants of the same gestational age
Very low birth weight At birth; vital records Infant born with a birth weight of less than 1500 grams
Gestational age at birth At birth; vital records Gestational age at birth in weeks (continuous)
Perinatal mortality 1 month postpartum; mortality records and fetal death records Fetal death at or after 20 weeks of gestation or mortality in the first 7 days of life
Neonatal abstinence disorder (NAS) or maternal drug/substance abuse Two years postpartum; Medicaid claims, hospital discharge Evidence of NAS or maternal drug or substance abuse in first two years postpartum
Low birth weight (LBW) At birth; vital records Infant born with a birth weight of less than 2500 grams
Maternal mortality One year postpartum; mortality records Death of mother within one year postpartum
Maternal experience of violence or homicide 24 months postpartum; Medicaid claims, mortality records Includes any ICD code for healthcare encounter associated with experiencing violence or mortality associated with homicide based on ICD code
Preterm birth At birth; vital records Infant born before 37 weeks' gestation (obstetric estimate)
Mental health treatment follow up 120 days of treatment initiation; Medicaid claims Second antidepressant prescription or outpatient mental health visit within 120 days of treatment initiation ("acute phase")
Number of mental health related emergency/inpatient visits During pregnancy or 12 months postpartum; Hospital discharge Based on all-listed diagnoses (i.e. primary or secondary) for depression/anxiety/stress reaction
Any emergency department visit for child 24 months of life; hospital discharge Child visit to the emergency department
Developmental screening 12 months; Medicaid claims Child receives at least one developmental screening
Flouride treatment 24 months; Medicaid claims and dental records Share of recommended fluoride treatments received by child
Inter-birth interval of < 24 months 24 months; vital records Having a subsequent birth within the first 24 months of the index birth
Inter-birth interval of < 15 months 15 months; vital records Having a subsequent birth within the first 15 months of the index birth
Inter-birth interval 60 months; vital records Continuous measure of inter-birth interval
Adequate prenatal care At birth; vital records Adequacy of Prenatal Care Utilization Index (APNCU)
Postpartum visit 12 weeks postpartum; Medicaid claims Postpartum visit in first 12 weeks after birth
Birth weight (continuous) At birth; vital records A continuous measure of infant birth weight (grams)
Antidepressant prescription During pregnancy or 60 days postpartum; Medicaid claims Antidepressant prescription
Neonatal morbidity At birth; hospital discharge 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.
Cesarean delivery At birth; vital records Cesarean delivery
Severe acute maternal morbidity At birth; hospital discharge As defined by the CDC
Ultrasound at 18-22 weeks At birth; Medicaid claims Ultrasound at 18-22 weeks (anatomy scan)
Mental health diagnosis or outpatient treatment During pregnancy or 60 days postpartum; Medicaid claims Diagnosis for depression/anxiety/stress reaction or antidepressant prescription or outpatient mental health visit
Diagnosis of depression/anxiety/stress reaction During pregnancy or 60 days postpartum; Medicaid claims Diagnosis of depression/anxiety/stress reaction
Any mental health related emergency/inpatient visit During pregnancy or 12 months postpartum; Hospital discharge Based on all-listed diagnoses (i.e. primary or secondary) for depression/anxiety/stress reaction
Well-child visits 15 months; Medicaid claims Proportion of recommended well-child visits
Lead screening 15 months; Medicaid claims Child receives at least one lead screening
Received a highly or moderately effective method of contraception (6 weeks) 6 weeks postpartum; Medicaid claims, hospital discharge Received implant, IPP-LARC, LARC, or sterilization and moderately effective contraception to include path, ring, diaphragm, injectables and contraceptive pills
NICU admission of at least overnight At birth; hospital discharge Infant admitted to the neonatal intensive care unit (NICU) for at least one night
Number of injuries 24 months of life; hospital discharge Number of injuries
Number of emergency department visits 24 months of life; hospital discharge Total number of child visits to the emergency department
Child mortality 24 months; Mortality records All-cause child mortality in first 24 months of life
Received immediate postpartum long-acting reversible contraception (6 weeks) 6 weeks postpartum; Medicaid claims, hospital discharge Received Immediate postpartum long-acting reversible contraception in first 6 weeks postpartum
Family planning visit (1 year) 12 months postpartum; Medicaid claims, hospital discharge Any family planning-related counseling or service
Received a highly or moderately effective method of contraception (1 year) 12 months postpartum; Medicaid claims, hospital discharge Received implant, IPP-LARC, LARC, or sterilization and moderately effective contraception to include path, ring, diaphragm, injectables and contraceptive pills
Health care encounter or mortality associated with ICD codes indicating concern for abuse or neglect 24 months of life; Medicaid claims, hospital discharge, mortality records Concern for abuse or neglect of child
Dental visit 24 months; Medicaid claims and dental records Child visits the dentist at least once in first 24 months
Family planning visit (6 weeks) 6 weeks postpartum; Medicaid claims, hospital discharge Any family planning-related counseling or service
Dental visit during pregnancy At birth; Medicaid claims and dental records Dental visit during pregnancy (preventive or treatment)
Prenatal screenings At birth; Medicaid claims 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
Outpatient mental health visit During pregnancy or 60 days postpartum; Medicaid claims Outpatient mental health visit
Health care encounter or mortality associated with ICD codes indicating major injury 24 months of life; Medicaid claims, hospital discharge, mortality records Child experiences a major injury
Measure of SNAP or TANF benefit churn 24 months postpartum; South Carolina Department of Social Services data 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
Postpartum intrauterine device insertion (1 year) 12 months postpartum; Medicaid claims, hospital discharge Postpartum intrauterine device insertion in first 12 months postpartum
Time to first take-up of highly effective contraceptive method 24 months postpartum; Medicaid claims, hospital discharge Months from discharge to first take up of highly effective contraceptive method (include implant, IPP-LARC, LARC, or sterilization)
Receipt of SNAP or WIC During pregnancy, assessed up to 42 weeks; South Carolina Department of Social Services data and birth certificate data respectively Any receipt of Supplemental Nutrition Assistance Program or Special Supplemental Nutrition Program for Women, Infants, and Children during pregnancy
Number of months receiving SNAP or TANF 24 months postpartum; South Carolina Department of Social Services data Total months receiving Supplemental Nutrition Assistance Program or Temporary Assistance for Needy Families
Trial Locations
- Locations (9)
Carolina Health Centers NFP
🇺🇸Greenwood, South Carolina, United States
Family Solutions of the Lowcountry NFP
🇺🇸Orangeburg, South Carolina, United States
Nurse-Family Partnership of Greenville County
🇺🇸Greenville, South Carolina, United States
Nurse-Family Partnership of Anderson County
🇺🇸Anderson, South Carolina, United States
Nurse-Family Partnership of Lexington-Richland Co.
🇺🇸Columbia, South Carolina, United States
Spartanburg Regional Hospital NFP
🇺🇸Spartanburg, South Carolina, United States
Nurse-Family Partnership of Horry County
🇺🇸Conway, South Carolina, United States
McLeod Health NFP
🇺🇸Florence, South Carolina, United States
NFP of Berkeley/Charleston/Dorchester Counties
🇺🇸Charleston, South Carolina, United States