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NCT Number: NCT03360539

Nurse-Family Partnership Impact Evaluation in South Carolina

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.

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Key information

Conditions

Preterm Birth Female Urogenital Diseases and Pregnancy Complications Injuries Maternal Behavior Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases Wounds and Injuries

Age range

15 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Nurse-Family Partnership of Anderson County, Anderson, South Carolina, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nurse-Family Partnership

Behavioral

Primary outcomes

  1. Number of Participants With a Composite Birth Outcome

    Time frame: 0-7 days after index 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).

  2. Number of Participants Whose Child Experienced a Major Injury or Concern for Abuse or Neglect

    Time frame: within 24 months after index birth; Medicaid claims or hospital discharge data

    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).

  3. Number of Participants With an Inter-birth Interval of < 21 Months

    Time frame: within 21 months after index birth; vital records

    Having a subsequent birth within the first 21 months of the index birth

Secondary outcomes

  1. Number of Participants With an Infant Born Small for Gestational Age (SGA)

    Time frame: At index birth; vital records

    Infant birth weight below the 10th percentile for infants of the same gestational age

  2. Number of Participants With an Infant Born Large for Gestational Age (LGA)

    Time frame: At index birth birth; vital records

    Infant birth weight above the 90th percentile for infants of the same gestational age

  3. Number of Participants With an Infant Born With Low Birth Weight (LBW)

    Time frame: At index birth; vital records

    Number of participants with an infant born with a birth weight of less than 2500 grams.

  4. Number of Participants With an Infant With Very Low Birth Weight

    Time frame: At index birth; vital records

    Number of participants with an infant born with a birth weight of less than 1500 grams.

  5. Birth Weight (Continuous)

    Time frame: At index birth; vital records

    A continuous measure of infant birth weight (grams)

  6. Number of Participants With a Preterm Birth

    Time frame: At index birth; vital records

    Infant born before 37 weeks' gestation (obstetric estimate)

  7. Number of Participants With an Extremely Preterm Birth

    Time frame: At index birth; vital records

    Number of participants with an infant born before 28 weeks' gestation.

  8. Gestational Age at Birth

    Time frame: At index birth; vital records

    Gestational age at birth in weeks (continuous)

  9. Number of Participants Experiencing Perinatal Mortality

    Time frame: Within 1 week after index birth; mortality records and fetal death records

    Fetal death at or after 20 weeks of gestation or mortality in the first 7 days of life

  10. Number of Participants With a NICU Admission of at Least Overnight

    Time frame: At index birth; hospital discharge

    Infant admitted to the neonatal intensive care unit (NICU) for at least one night

  11. Number of Participants Experiencing Neonatal Morbidity

    Time frame: At index 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.

  12. Number of Participants Experiencing Cesarean Delivery

    Time frame: At index birth; vital records

    Number of participants experiencing a cesarean delivery for their index birth.

  13. Number of Participants Experiencing Severe Acute Maternal Morbidity

    Time frame: At index birth; hospital discharge

    Severe acute maternal morbidity as defined by the Centers for Disease Control and Prevention (CDC).

  14. Number of Participants Experiencing Maternal Mortality

    Time frame: Within one year after index birth; mortality records

    Number of participants experiencing all-cause mortality within one year postpartum.

  15. Number of Participants Experiencing Neonatal Abstinence Disorder (NAS) or Maternal Drug/Substance Abuse

    Time frame: Within two years after index birth; Medicaid claims, hospital discharge

    Number of participants experiencing neonatal abstinence disorder (NAS) or maternal drug/substance abuse in the first two years postpartum.

  16. Number of Participants Experiencing Violence or Homicide

    Time frame: Within 2 years after index birth; Medicaid claims, mortality records

    Includes any ICD code for healthcare encounter associated with experiencing violence or mortality associated with homicide based on ICD code

  17. Number of Participants With a Postpartum Visit

    Time frame: Within 12 weeks after index birth; Medicaid claims

    Number of participants with a postpartum visit in first 12 weeks after an index birth.

  18. Number of Participants Who Received Adequate Prenatal Care

    Time frame: At index birth; vital records

    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

  19. Number of Emergency Department Visits During Pregnancy

    Time frame: At index birth; hospital discharge

    Number of emergency department visits during pregnancy.

  20. Number of Participants With a Dental Visit During Pregnancy

    Time frame: At index birth; Medicaid claims and dental records

    Number of participants with a dental visit during pregnancy (preventive or treatment).

  21. Number of Participants With an Ultrasound at 18-22 Weeks

    Time frame: 18-22 weeks gestation during index pregnancy. Assessed at index birth using Medicaid claims.

    Number of participants with an ultrasound (anatomy scan) at 18-22 weeks.

  22. Number of Participants Who Received Prenatal Screens

    Time frame: At index birth; Medicaid claims

    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.

  23. Number of Participants Who Received a Gestational Diabetes Test (24-28 Weeks)

    Time frame: At 24-28 weeks' gestation of index pregnancy; Medicaid claims

    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.

  24. Number of Participants With a Tdap Vaccination (27-36 Weeks)

    Time frame: At 27-36 weeks' gestation of index pregnancy; Medicaid claims

    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.

  25. Number of Participants With a Group B Streptococcus Test (35-37 Weeks)

    Time frame: At 35-37 weeks' gestation of index pregnancy; Medicaid claims

    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.

  26. Number of Participants With a Mental Health Diagnosis or Outpatient Treatment

    Time frame: During index pregnancy or 60 days postpartum; Medicaid claims

    Diagnosis for depression/anxiety/stress reaction or antidepressant prescription or outpatient mental health visit

  27. 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 a diagnosis of depression/anxiety/stress reaction.

  28. Number of Participants With an Antidepressant Prescription

    Time frame: During index pregnancy or 60 days postpartum; Medicaid claims

    Number of participants with an antidepressant prescription.

  29. Number of Participants With an Outpatient Mental Health Visit

    Time frame: During index pregnancy or 60 days postpartum; Medicaid claims

    Number of participants with at least one outpatient mental health visit.

  30. Number of Participants With a Mental Health Treatment Follow up

    Time frame: Within 120 days of treatment initiation; Medicaid claims

    Second antidepressant prescription or outpatient mental health visit within 120 days of treatment initiation ("acute phase")

  31. Number of Participants With a Mental Health Related Emergency/Inpatient Visit

    Time frame: During index pregnancy or 12 months postpartum; Hospital discharge

    Based on all-listed diagnoses (i.e. primary or secondary) for depression/anxiety/stress reaction

  32. Number of Mental Health Related Emergency/Inpatient Visits

    Time frame: During index pregnancy or 12 months postpartum; Hospital discharge

    Based on all-listed diagnoses (i.e. primary or secondary) for depression/anxiety/stress reaction

  33. Number of Participants Whose Child Experienced a Major Injury

    Time frame: Within 24 months after index birth; Medicaid claims, hospital discharge, mortality records

    Health care encounter or mortality associated with ICD codes indicating major injury

  34. Number of Participants Whose Child Experienced Concern for Abuse or Neglect

    Time frame: Within 24 months after index birth; Medicaid claims, hospital discharge, mortality records

    Health care encounter or mortality associated with ICD codes indicating concern for abuse or neglect

  35. Number of Injuries

    Time frame: Within 24 months after index birth; hospital discharge

    Number of injuries for child

  36. Number of Participants Whose Child Had an Emergency Department Visit

    Time frame: Within 24 months after index birth; hospital discharge

    Number of participants whose child had at least one visit to the emergency department.

  37. Number of Child Emergency Department Visits

    Time frame: Within 24 months after index birth; hospital discharge

    Total number of child visits to the emergency department (without admission)

  38. Number of Participants Experiencing Child Mortality

    Time frame: Within 24 months after index birth; Mortality records

    All-cause child mortality in first 24 months of life

  39. Number of Participants With Recommended Number of Well-child Visits

    Time frame: At 15 months after index birth; Medicaid claims

    Number of participants that received the recommended number of well-child visits.

  40. Number of Participants With Lead Screening

    Time frame: At 15 months after index birth; Medicaid claims

    Number of participants whose child received at least one lead screening.

  41. Number of Participants With Developmental Screening

    Time frame: At 12 months after index birth; Medicaid claims

    Number of participants whose child received at least one developmental screening.

  42. Number of Participants With a Dental Visit

    Time frame: Within 24 months after index birth; Medicaid claims and dental records

    Child receives a dental screen at least once in first 24 months

  43. Number of Participants With Fluoride Treatment

    Time frame: Within 24 months after index birth; Medicaid claims and dental records

    Share with recommended fluoride treatments received by child

  44. Number of Participants With an Inter-birth Interval of < 24 Months

    Time frame: Within 24 months after index birth; vital records

    Having a subsequent birth within the first 24 months of the index birth

  45. Number of Participants With an Inter-birth Interval of < 15 Months

    Time frame: Within 15 months after index birth; vital records

    Having a subsequent birth within the first 15 months of the index birth

  46. Inter-birth Interval

    Time frame: 60 months after index birth; vital records

    Continuous measure of inter-birth interval

  47. Number of Participants With a Family Planning Visit (6 Weeks)

    Time frame: Within 6 weeks after index birth; Medicaid claims, hospital discharge

    Number of participants who received any family planning-related counseling or service.

  48. Number of Participants Who Received a Highly or Moderately Effective Method of Contraception (6 Weeks)

    Time frame: Within 6 weeks after index birth; Medicaid claims, hospital discharge

    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

  49. Number of Participants Who Received Immediate Postpartum Long-acting Reversible Contraception (6 Weeks)

    Time frame: Within 6 weeks after index birth; Medicaid claims, hospital discharge

    Number of participants who received immediate postpartum long-acting reversible contraception in first 6 weeks postpartum.

  50. Number of Participants With a Family Planning Visit (1 Year)

    Time frame: Within 12 months after index birth; Medicaid claims, hospital discharge

    Number of participants who received any family planning-related counseling or service in the first year postpartum.

  51. Number of Participants Who Received a Highly or Moderately Effective Method of Contraception (1 Year)

    Time frame: Within 12 months after index birth; Medicaid claims, hospital discharge

    Received implant, IPP-LARC, LARC, or sterilization and moderately effective contraception to include path, ring, diaphragm, injectables and contraceptive pills

  52. Number of Participants Who Received a Postpartum Intrauterine Device Insertion (1 Year)

    Time frame: Within 12 months after index birth; Medicaid claims, hospital discharge

    Number of participants who received a postpartum intrauterine device insertion in first 12 months postpartum.

  53. Time to First Take-up of Family Planning Counseling or Service

    Time frame: Within 24 months after index birth; Medicaid claims, hospital discharge

    Months from pregnancy to first take up of family planning counseling or service

  54. Time to First Take-up of Highly Effective Contraceptive Method

    Time frame: Within 24 months after index birth; Medicaid claims, hospital discharge

    Months from discharge to first take up of highly effective contraceptive method (include implant, IPP-LARC, LARC, or sterilization)

  55. Number of Participants Who Received Supplemental Nutrition Assistance Program (SNAP) or Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) Benefits

    Time frame: During index pregnancy, assessed up to 42 weeks; South Carolina Department of Social Services data and birth certificate data respectively

    Number of participants who received Supplemental Nutrition Assistance Program (SNAP) or Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) benefits during pregnancy.

  56. Number of Months Receiving SNAP or Temporary Assistance for Needy Families (TANF) Benefits

    Time frame: Within 24 months after index birth; South Carolina Department of Social Services data

    Total months receiving Supplemental Nutrition Assistance Program or Temporary Assistance for Needy Families

  57. Number of Participants With SNAP or TANF Benefit Churn

    Time frame: Within 24 months after index birth; 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

Sponsors and collaborators

Lead sponsor

Harvard School of Public Health (HSPH)

Other

Collaborators

  • Abdul Latif Jameel Poverty Action Lab
  • University of Chicago

Registry information

Acronym: NFP

Important dates

Study start
2016
Primary completion
2023
Study completion
2046
First posted
Dec 4, 2017
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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