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Last Published January 27, 2020 08:52 AM February 07, 2020 11:05 AM
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, or low birthweight or preterm birth (VR) Child Health & Development • Major injury or concern for abuse or neglect in first 24 months of life [composite] (MC, HD) Maternal Life-Course • Inter-birth interval of < 21 months (VR) 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)
Secondary Outcomes (End Points) AEA UPDATES 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 • Small for gestational age (VR) • Large for gestational age (VR) • Low birthweight [<2500 grams] (VR) • Very low birthweight [<1500 grams] (VR) • Birthweight [continuous] (VR) • Preterm birth [<37 weeks’ gestation] (VR) • Extremely preterm birth [<28 weeks’ gestation] (VR) • Gestational age at birth [continuous] (VR) • Cesarean delivery (VR) • Severe acute maternal morbidity [as defined by the CDC] (HD) • 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 mortality [up to one year after birth] (MR) • Infant mortality [up to one year after birth] (MR) • Neonatal abstinence disorder or maternal drug/substance abuse [2 years post-delivery] (MC, HD) • Postpartum visit within the first 12 weeks postpartum (MC) • Adequate prenatal care [Kotlechuck Index] (VR) • Number of emergency department visits during pregnancy (HD) • Dental visit (preventive or treatment) during pregnancy (MC) • Ultrasound at 18-22 weeks (anatomy scan) (MC) • Share of recommended prenatal screenings completed (MC) • 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) • Diagnosis of depression/anxiety/stress reaction during pregnancy or 60 days postpartum (MC) • Antidepressant prescription during pregnancy or 60 days postpartum (MC) • Outpatient mental health visit during pregnancy or 60 days postpartum (MC) • Mental health treatment follow up [second antidepressant prescription or outpatient mental health visit with 120 days of treatment initiation] (MC) • Mental health related emergency/inpatient visit during pregnancy or 12 months postpartum (HD) • Number of mental health related emergency/inpatient visits during pregnancy or 12 months postpartum (HD) • Intimate partner violence in 24 months postpartum (MC) Child Health & Development • Major injury in first 24 months of life (MC, HD) • Concern for abuse or neglect in first 24 months of life (MC, HD) • Number of injuries in first 24 months of life (HD) • Any ED visit during first 24 months of life (HD) • Number of ED visits first 24 months of life (HD) • Proportion of recommended well-child visits by 15 months (MC) • Lead screening by 15 months (MC) • Developmental screening by 12 months (MC) • At least one dental visit in the first 24 months (MC) • Share of recommended fluoride treatments in first 24 months of life (MC) • All-cause child mortality in first 24 months of life or fetal death (MR and fetal death records) Maternal Life-Course • Inter-birth interval of < 24 months (VR) • Inter-birth interval of < 15 months (VR) • Inter-birth interval measured at 60 months postpartum [continuous] (VR) • Any family planning related counseling or service in first six weeks postpartum (MC, HD) • Any family planning related counseling or service in first year postpartum (MC, HD) • Received a highly or moderately effective method of contraception in first six weeks postpartum (MC, HD) • Received a highly or moderately effective method of contraception in first year postpartum (MC, HD) • Immediate postpartum long-acting reversible contraception (LARC) in first six weeks (MC, HD) • Any family planning related counseling service in first six months postpartum (MC, HD) • Postpartum intrauterine device insertion in first year postpartum (MC, HD) • Time to first take-up of family planning [months from pregnancy] (MC, HD) • 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 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 or fetal death (MR, FDR) • 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
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