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.
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
5,670
Nurse-Family Partnership of Anderson County
Anderson, South Carolina, United States
NFP of Berkeley/Charleston/Dorchester Counties
Charleston, South Carolina, United States
Nurse-Family Partnership of Lexington-Richland Co.
Columbia, South Carolina, United States
Nurse-Family Partnership of Horry County
Conway, South Carolina, United States
McLeod Health NFP
Florence, South Carolina, United States
Nurse-Family Partnership of Greenville County
Greenville, South Carolina, United States
Carolina Health Centers NFP
Greenwood, South Carolina, United States
Family Solutions of the Lowcountry NFP
Orangeburg, South Carolina, United States
Spartanburg Regional Hospital NFP
Spartanburg, South Carolina, United States
Number of Participants With a 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).
Time frame: 0-7 days after index birth; vital records, mortality records, and fetal death records
Number of Participants Whose Child Experienced a Major Injury or Concern for Abuse or Neglect
Composite of at least one health care encounter or mortality associated with International Classification of Diseases (ICD) codes indicating either major injury, or, concern for abuse or neglect for the participant's index child(ren).
Time frame: within 24 months after index birth; Medicaid claims or hospital discharge data
Number of Participants With an Inter-birth Interval of < 21 Months
Having a subsequent birth within the first 21 months of the index birth
Time frame: within 21 months after index birth; vital records
Number of Participants With an Infant Born Small for Gestational Age (SGA)
Infant birth weight below the 10th percentile for infants of the same gestational age
Time frame: At index birth; vital records
Number of Participants With an Infant Born Large for Gestational Age (LGA)
Infant birth weight above the 90th percentile for infants of the same gestational age
Time frame: At index birth birth; vital records
Number of Participants With an Infant Born With Low Birth Weight (LBW)
Number of participants with an infant born with a birth weight of less than 2500 grams.
Time frame: At index birth; vital records
Number of Participants With an Infant With Very Low Birth Weight
Number of participants with an infant born with a birth weight of less than 1500 grams.
Time frame: At index birth; vital records
Birth Weight (Continuous)
A continuous measure of infant birth weight (grams)
Time frame: At index birth; vital records
Number of Participants With a Preterm Birth
Infant born before 37 weeks' gestation (obstetric estimate)
Time frame: At index birth; vital records
Number of Participants With an Extremely Preterm Birth
Number of participants with an infant born before 28 weeks' gestation.
Time frame: At index birth; vital records
Gestational Age at Birth
Gestational age at birth in weeks (continuous)
Time frame: At index birth; vital records
Number of Participants Experiencing Perinatal Mortality
Fetal death at or after 20 weeks of gestation or mortality in the first 7 days of life
Time frame: Within 1 week after index birth; mortality records and fetal death records
Number of Participants With a NICU Admission of at Least Overnight
Infant admitted to the neonatal intensive care unit (NICU) for at least one night
Time frame: At index birth; hospital discharge
Number of Participants Experiencing 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.
Time frame: At index birth; hospital discharge
Number of Participants Experiencing Cesarean Delivery
Number of participants experiencing a cesarean delivery for their index birth.
Time frame: At index birth; vital records
Number of Participants Experiencing Severe Acute Maternal Morbidity
Severe acute maternal morbidity as defined by the Centers for Disease Control and Prevention (CDC).
Time frame: At index birth; hospital discharge
Number of Participants Experiencing Maternal Mortality
Number of participants experiencing all-cause mortality within one year postpartum.
Time frame: Within one year after index birth; mortality records
Number of Participants Experiencing Neonatal Abstinence Disorder (NAS) or Maternal Drug/Substance Abuse
Number of participants experiencing neonatal abstinence disorder (NAS) or maternal drug/substance abuse in the first two years postpartum.
Time frame: Within two years after index birth; Medicaid claims, hospital discharge
Number of Participants Experiencing Violence or Homicide
Includes any ICD code for healthcare encounter associated with experiencing violence or mortality associated with homicide based on ICD code
Time frame: Within 2 years after index birth; Medicaid claims, mortality records
Number of Participants With a Postpartum Visit
Number of participants with a postpartum visit in first 12 weeks after an index birth.
Time frame: Within 12 weeks after index birth; Medicaid claims
Number of Participants Who Received Adequate Prenatal Care
With adequacy defined using the Adequacy of Prenatal Care Utilization Index (APNCU), where prenatal care began by the 4th month and at least 80% of recommended visits were attended
Time frame: At index birth; vital records
Number of Emergency Department Visits During Pregnancy
Number of emergency department visits during pregnancy.
Time frame: At index birth; hospital discharge
Number of Participants With a Dental Visit During Pregnancy
Number of participants with a dental visit during pregnancy (preventive or treatment).
Time frame: At index birth; Medicaid claims and dental records
Number of Participants With an Ultrasound at 18-22 Weeks
Number of participants with an ultrasound (anatomy scan) at 18-22 weeks.
Time frame: 18-22 weeks gestation during index pregnancy. Assessed at index birth using Medicaid claims.
Number of Participants Who Received Prenatal Screens
Our original prenatal screening outcome variable included the obstetric panel: Rhesus-D (DRh), red blood cell (RBC) antibody screen, complete blood count (CBC), urine culture, urinalysis; sexually transmitted infection (STI) screenings (HIV, syphilis, hepatitis B, chlamydia if \<25, gonorrhea if \<25); Group B strep screening, and glucose screening. However, since most participants had already completed their first prenatal visit prior to enrolling in the trial (when many of these tests are performed), it was not appropriate to include first-visit tests as outcomes. We therefore modified the outcome to instead use three clinically relevant measures that could occur after enrollment: glucose screening, Group B strep screening, and Tdap vaccination. These outcomes are reported as they appear in the published papers.
Time frame: At index birth; Medicaid claims
Number of Participants Who Received a Gestational Diabetes Test (24-28 Weeks)
Received a glucose screen at 24-28 weeks' gestation. Note: Our original prenatal screening outcome variable included the obstetric panel (D \[Rh\], RBC antibody screen, CBC, urine culture, urinalysis), STI screenings (HIV, syphilis, hepatitis B, chlamydia if \<25, gonorrhea if \<25), Group B strep screening, and glucose screening. However, since most participants had already completed their first prenatal visit prior to enrolling in the trial (when many of these tests are performed), it was not appropriate to include first-visit tests as outcomes. We therefore modified the outcome to instead use three clinically relevant measures that could occur after enrollment: glucose screening, Group B strep screening, and Tdap vaccination. These outcomes are reported as they appear in the published papers.
Time frame: At 24-28 weeks' gestation of index pregnancy; Medicaid claims
Number of Participants With a Tdap Vaccination (27-36 Weeks)
Received Tdap vaccination at 27-36 weeks' gestation. Our original prenatal screening outcome variable included the obstetric panel (D \[Rh\], RBC antibody screen, CBC, urine culture, urinalysis), STI screenings (HIV, syphilis, hepatitis B, chlamydia if \<25, gonorrhea if \<25), Group B strep screening, and glucose screening. However, since most participants had already completed their first prenatal visit prior to enrolling in the trial (when many of these tests are performed), it was not appropriate to include first-visit tests as outcomes. We therefore modified the outcome to instead use three clinically relevant measures that could occur after enrollment: glucose screening, Group B strep screening, and Tdap vaccination. These outcomes are reported as they appear in the published papers.
Time frame: At 27-36 weeks' gestation of index pregnancy; Medicaid claims
Number of Participants With a Group B Streptococcus Test (35-37 Weeks)
Received Group B streptococcus test at 35-37 weeks' gestation. Note: Our original prenatal screening outcome variable included the obstetric panel (D \[Rh\], RBC antibody screen, CBC, urine culture, urinalysis), STI screenings (HIV, syphilis, hepatitis B, chlamydia if \<25, gonorrhea if \<25), Group B strep screening, and glucose screening. However, since most participants had already completed their first prenatal visit prior to enrolling in the trial (when many of these tests are performed), it was not appropriate to include first-visit tests as outcomes. We therefore modified the outcome to instead use three clinically relevant measures that could occur after enrollment: glucose screening, Group B strep screening, and Tdap vaccination. These outcomes are reported as they appear in the published papers.
Time frame: At 35-37 weeks' gestation of index pregnancy; Medicaid claims
Number of Participants With a Mental Health Diagnosis or Outpatient Treatment
Diagnosis for depression/anxiety/stress reaction or antidepressant prescription or outpatient mental health visit
Time frame: During index pregnancy or 60 days postpartum; Medicaid claims
Number of Participants With a Diagnosis of Depression/Anxiety/Stress Reaction
Number of participants with a diagnosis of depression/anxiety/stress reaction.
Time frame: During index pregnancy or 60 days postpartum; Medicaid claims
Number of Participants With an Antidepressant Prescription
Number of participants with an antidepressant prescription.
Time frame: During index pregnancy or 60 days postpartum; Medicaid claims
Number of Participants With an Outpatient Mental Health Visit
Number of participants with at least one outpatient mental health visit.
Time frame: During index pregnancy or 60 days postpartum; Medicaid claims
Number of Participants With a Mental Health Treatment Follow up
Second antidepressant prescription or outpatient mental health visit within 120 days of treatment initiation ("acute phase")
Time frame: Within 120 days of treatment initiation; Medicaid claims
Number of Participants With a Mental Health Related Emergency/Inpatient Visit
Based on all-listed diagnoses (i.e. primary or secondary) for depression/anxiety/stress reaction
Time frame: During index 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
Time frame: During index pregnancy or 12 months postpartum; Hospital discharge
Number of Participants Whose Child Experienced a Major Injury
Health care encounter or mortality associated with ICD codes indicating major injury
Time frame: Within 24 months after index birth; Medicaid claims, hospital discharge, mortality records
Number of Participants Whose Child Experienced Concern for Abuse or Neglect
Health care encounter or mortality associated with ICD codes indicating concern for abuse or neglect
Time frame: Within 24 months after index birth; Medicaid claims, hospital discharge, mortality records
Number of Injuries
Number of injuries for child
Time frame: Within 24 months after index birth; hospital discharge
Number of Participants Whose Child Had an Emergency Department Visit
Number of participants whose child had at least one visit to the emergency department.
Time frame: Within 24 months after index birth; hospital discharge
Number of Child Emergency Department Visits
Total number of child visits to the emergency department (without admission)
Time frame: Within 24 months after index birth; hospital discharge
Number of Participants Experiencing Child Mortality
All-cause child mortality in first 24 months of life
Time frame: Within 24 months after index birth; Mortality records
Number of Participants With Recommended Number of Well-child Visits
Number of participants that received the recommended number of well-child visits.
Time frame: At 15 months after index birth; Medicaid claims
Number of Participants With Lead Screening
Number of participants whose child received at least one lead screening.
Time frame: At 15 months after index birth; Medicaid claims
Number of Participants With Developmental Screening
Number of participants whose child received at least one developmental screening.
Time frame: At 12 months after index birth; Medicaid claims
Number of Participants With a Dental Visit
Child receives a dental screen at least once in first 24 months
Time frame: Within 24 months after index birth; Medicaid claims and dental records
Number of Participants With Fluoride Treatment
Share with recommended fluoride treatments received by child
Time frame: Within 24 months after index birth; Medicaid claims and dental records
Number of Participants With an Inter-birth Interval of < 24 Months
Having a subsequent birth within the first 24 months of the index birth
Time frame: Within 24 months after index birth; vital records
Number of Participants With an Inter-birth Interval of < 15 Months
Having a subsequent birth within the first 15 months of the index birth
Time frame: Within 15 months after index birth; vital records
Inter-birth Interval
Continuous measure of inter-birth interval
Time frame: 60 months after index birth; vital records
Number of Participants With a Family Planning Visit (6 Weeks)
Number of participants who received any family planning-related counseling or service.
Time frame: Within 6 weeks after index birth; Medicaid claims, hospital discharge
Number of Participants Who Received a Highly or Moderately Effective Method of Contraception (6 Weeks)
Received implant, immediate postpartum long-acting reversible contraception (IPP-LARC), long-acting reversible contraception (LARC), or sterilization and moderately effective contraception to include path, ring, diaphragm, injectables and contraceptive pills
Time frame: Within 6 weeks after index birth; Medicaid claims, hospital discharge
Number of Participants Who Received Immediate Postpartum Long-acting Reversible Contraception (6 Weeks)
Number of participants who received immediate postpartum long-acting reversible contraception in first 6 weeks postpartum.
Time frame: Within 6 weeks after index birth; Medicaid claims, hospital discharge
Number of Participants With a Family Planning Visit (1 Year)
Number of participants who received any family planning-related counseling or service in the first year postpartum.
Time frame: Within 12 months after index birth; Medicaid claims, hospital discharge
Number of Participants Who 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
Time frame: Within 12 months after index birth; Medicaid claims, hospital discharge
Number of Participants Who Received a Postpartum Intrauterine Device Insertion (1 Year)
Number of participants who received a postpartum intrauterine device insertion in first 12 months postpartum.
Time frame: Within 12 months after index birth; 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
Time frame: Within 24 months after index birth; 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)
Time frame: Within 24 months after index birth; Medicaid claims, hospital discharge
Number of Participants Who Received Supplemental Nutrition Assistance Program (SNAP) or Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) Benefits
Number of participants who received Supplemental Nutrition Assistance Program (SNAP) or Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) benefits during pregnancy.
Time frame: During index pregnancy, assessed up to 42 weeks; South Carolina Department of Social Services data and birth certificate data respectively
Number of Months Receiving SNAP or Temporary Assistance for Needy Families (TANF) Benefits
Total months receiving Supplemental Nutrition Assistance Program or Temporary Assistance for Needy Families
Time frame: Within 24 months after index birth; South Carolina Department of Social Services data
Number of Participants With 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
Time frame: Within 24 months after index birth; South Carolina Department of Social Services data
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