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Table 1 NFP program objectives and corresponding primary and secondary outcomes

From: 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

  Data source(s) Time at complete outcome observation (time since all pregnancies completed)
Objective 1. Improve pregnancy, birth, and maternal health outcomes
 Primary outcome
  Composite of at least one of:
   • Small for gestational age, or
   • Low birth weight (less than 2500 g), or
   • Preterm birth (less than 37 weeks’ gestation by obstetric estimate), or
   • Perinatal mortality (fetal death at or after 20 weeks of gestation or mortality in the first 7 days of life)
Birth certificates, fetal death records, mortality records 1 months (Feb 2021)
 Secondary outcomes
  Infant outcomes observed at birth
   Small for gestational age Birth certificates 0 months (Jan 2021)
   Large for gestational age Birth certificates 0 months (Jan 2021)
   Low birth weight (< 2500 g) Birth certificates 0 months (Jan 2021)
   Very low birth weight (< 1500 g) Birth certificates 0 months (Jan 2021)
   Birth weight (continuous) Birth certificates 0 months (Jan 2021)
   Preterm birth (< 37 weeks’ gestation by obstetric estimate)1 Birth certificates 0 months (Jan 2021)
   Extremely preterm (< 28 weeks’ gestation) Birth certificates 0 months (Jan 2021)
   Gestational age at birth in weeks (continuous) Birth certificates 0 months (Jan 2021)
   Perinatal mortality (fetal death at or after 20 weeks of gestation or mortality in the first 7 days of life) Fetal death records, mortality records 1 months (Feb 2021)
   NICU admission of at least overnight Hospital discharge 0 months (Jan 2021)
   Neonatal morbidity2 Hospital discharge 0 months (Jan 2021)
  Maternal outcomes
   Cesarean delivery Birth certificates 0 months (Jan 2021)
   Severe acute maternal morbidity3 Hospital discharge 0 months (Jan 2021)
   Maternal mortality (up to 1 year after birth) Mortality records 12 months (Jan 2022)
   Neonatal abstinence disorder or maternal drug/substance abuse Medicaid claims, hospital discharge 24 months (January 2023)
   Maternal experience of violence or homicide4 Medicaid claims, mortality records 24 months (January 2023)
   Postpartum visit within the first 12 weeks postpartum Medicaid claims 2 months (March 2021)
  Utilization and quality of prenatal care
   Adequate prenatal care (Adequacy of Prenatal Care Utilization (APNCU) Index) Birth certificates 0 months (Jan 2021)
   Number of emergency department visits during pregnancy Hospital discharge 0 months (Jan 2021)
   Dental visit (preventive or treatment) during pregnancy Medicaid medical and dental claims 0 months (Jan 2021)
   Ultrasound at 18–22 weeks (anatomy scan) Medicaid claims 0 months (Jan 2021)
   Proportion of recommended prenatal screenings completed5 Medicaid claims 0 months (Jan 2021)
  Mental health outcomes
   Any outpatient treatment or diagnosis6,7 Medicaid claims 2 months (March 2021)
   Diagnosis of depression/anxiety/stress reaction6 Medicaid claims 2 months (March 2021)
   Antidepressant prescription6 Medicaid claims 2 months (March 2021)
   Outpatient mental health visit6 Medicaid claims 2 months (March 2021)
   Treatment follow-up8 Medicaid claims 6 months (July 2021)
   Mental health-related emergency/inpatient visit9 Hospital discharge 12 months (January 2022)
   Number of mental health-related emergency/impatient visits9 Hospital discharge 12 months (January 2022)
Objective 2. Improve child health and development
 Primary outcome
  Composite of at least one health care encounter or mortality associated with ICD codes indicating at least one of the following:
   • Major injury, or
   • Concern for abuse or neglect
Medicaid claims, hospital discharge, mortality files (defined in Tables 2 and 3) 24 months (January 2023)
 Secondary outcomes
  Accidents, suspected abuse and neglect and emergency care utilization
   Health care encounter or mortality associated with ICD codes indicating major injury Medicaid claims, hospital discharge, mortality files (defined in Table 2) 24 months (January 2023)
   Health care encounter or mortality associated with ICD codes indicating concern for abuse or neglect Medicaid claims, hospital discharge, mortality files (defined in Table 3) 24 months (January 2023)
   Number of injuries10 Hospital discharge 24 months (February 2023)
   Any emergency department visit Hospital discharge 24 months (January 2023)
   Number of emergency department visits Hospital discharge 24 months (January 2023)
   All-cause child mortality in first 24 months of life or fetal death Fetal death records, mortality records 24 months (January 2023)
  Outcomes related to preventative care
   Proportion of recommended well-child visits Medicaid claims 15 months (April 2022)
   At least one lead screening Medicaid claims 15 months (April 2022)
   At least one developmental screening11 Medicaid claims 12 months (January 2022)
   At least one dental visit12 Medicaid medical and dental claims 24 months (January 2023)
   Share of recommended fluoride treatments13 Medicaid medical and dental claims 24 months (January 2023)
Objective 3. Alter maternal life course
 Primary outcome
  Inter-birth interval of < 21 months Birth certificates 21 months (October 2022)
 Secondary outcomes
  Birth spacing outcomes
   Inter-birth interval of < 24 months14 Birth certificates 24 months (January 2023)
   Inter-birth interval of < 15 months Birth certificates 15 months (April 2022)
   Inter-birth interval (continuous) Birth certificates 60 months (January 2026)
  Postpartum family planning while enrolled in postpartum Medicaid coverage (6 weeks)
   Any family planning related counseling or service Medicaid claims, hospital discharge15 6 weeks (March 2021)
   Received a highly or moderately effective method of contraception16 Medicaid claims, hospital discharge 6 weeks (March 2021)
   Immediate postpartum long-acting reversible contraception Medicaid claims, hospital discharge 6 weeks (March 2021)
  Postpartum family planning within 1 year
   Any family planning related counseling or service Medicaid claims, hospital discharge 12 months (January 2022)
   Received a highly or moderately effective method of contraception16 Medicaid claims, hospital discharge 12 months (January 2022)
   Postpartum intrauterine device insertion Medicaid claims, hospital discharge 12 months (January 2022)
  Timing of postpartum family planning take-up
   Time to first family planning counseling or service (months from pregnancy) Medicaid claims, hospital discharge 24 months (January 2023)
   Time to first utilization of highly effective contraceptive methods (months from discharge) Medicaid claims, hospital discharge 24 months (January 2023)
  1. 1Outcome included in Pay for Success contract
  2. 2Assisted ventilation immediately after delivery, assisted ventilation for more than 6 h, seizure, receipt of surfactant replacement therapy, and receipt of antibiotics for suspected sepsis
  3. 3As defined by the Centers for Disease Control and Prevention (CDC)
  4. 4Includes any ICD code for healthcare encounter associated with experiencing violence (codes related to intimate partner violence adapted from Schafer et al. 2008) or mortality associated with homicide based on ICD code
  5. 5Obstetric panel (D (Rhesus), red blood cell antibody screen, complete blood count, urine culture, urinalysis), Sexually Transmitted Infection screenings (HIV, Syphilis, Hepatitis B, Chlamydia if age < 25 years, gonorrhea if age < 25 years), Group B screening, Glucose screening at 24–28 weeks
  6. 6During pregnancy or 60 days postpartum
  7. 7Diagnosis for depression/anxiety/stress reaction or antidepressant prescription or outpatient mental health visit
  8. 8Second antidepressant prescription or outpatient mental health visit within 120 days of treatment initiation (“acute phase”)
  9. 9During pregnancy or 12 months postpartum; based on all-listed diagnoses (i.e., primary or secondary) for depression/anxiety/stress reaction
  10. 10Based on ICD codes designated in the Pay for Success (PFS) contract. Outcome included in PFS contract
  11. 11Recommended at 9 months
  12. 12Recommended by American Academy of Pediatrics (AAP) / American Academy of Pediatric Dentistry (AAP/AAPD)
  13. 13AAP/AAPD recommends 4 treatments (one every 6 months). These are covered by Medicaid
  14. 14Outcome included in Pay for Success (PFS) contract
  15. 15National Drug Codes/ICD codes derived from OPA and supplemented by ICD any codes indicating family planning counseling
  16. 16CDC defines highly effective contraception to include implant, immediate postpartum long-acting reversible contraception, long-acting reversible contraception, or sterilization and moderately effective contraception to include path, ring, diaphragm, injectables, and contraceptive pills
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