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Nurse-Family Partnership Impact Evaluation in South Carolina

Nurse-Family Partnership Impact Evaluation in South Carolina

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03360539
Acronym
NFP
Enrollment
5670
Registered
2017-12-04
Start date
2016-04-01
Completion date
2046-04-01
Last updated
2025-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Injuries, Maternal Behavior, Preterm Birth

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.

Interventions

Sponsors

Abdul Latif Jameel Poverty Action Lab
CollaboratorOTHER
University of Chicago
CollaboratorOTHER
Harvard School of Public Health (HSPH)
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

The Nurse-Family Partnership (NFP) was launched by pediatrician David Olds in the early 1970s in response to the observation that low-income mothers are less likely to engage in positive health and parenting behaviors that are associated with better child development outcomes (Olds et al. 1986). 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.

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With a Composite Birth Outcome0-7 days after index birth; vital records, mortality records, and fetal death recordsComposite 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).
Number of Participants Whose Child Experienced a Major Injury or Concern for Abuse or Neglectwithin 24 months after index birth; Medicaid claims or hospital discharge dataComposite 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).
Number of Participants With an Inter-birth Interval of < 21 Monthswithin 21 months after index birth; vital recordsHaving a subsequent birth within the first 21 months of the index birth

Secondary

MeasureTime frameDescription
Number of Participants With an Infant Born Large for Gestational Age (LGA)At index birth birth; vital recordsInfant birth weight above the 90th percentile for infants of the same gestational age
Number of Participants With an Infant Born With Low Birth Weight (LBW)At index birth; vital recordsNumber of participants with an infant born with a birth weight of less than 2500 grams.
Number of Participants With an Infant With Very Low Birth WeightAt index birth; vital recordsNumber of participants with an infant born with a birth weight of less than 1500 grams.
Birth Weight (Continuous)At index birth; vital recordsA continuous measure of infant birth weight (grams)
Number of Participants With a Preterm BirthAt index birth; vital recordsInfant born before 37 weeks' gestation (obstetric estimate)
Number of Participants With an Extremely Preterm BirthAt index birth; vital recordsNumber of participants with an infant born before 28 weeks' gestation.
Gestational Age at BirthAt index birth; vital recordsGestational age at birth in weeks (continuous)
Number of Participants Experiencing Perinatal MortalityWithin 1 week after index birth; mortality records and fetal death recordsFetal death at or after 20 weeks of gestation or mortality in the first 7 days of life
Number of Participants With a NICU Admission of at Least OvernightAt index birth; hospital dischargeInfant admitted to the neonatal intensive care unit (NICU) for at least one night
Number of Participants Experiencing Neonatal MorbidityAt index birth; hospital dischargeAssisted ventilation immediately after delivery, assisted ventilation for more than six hours, seizure, receipt of surfactant replacement therapy, and receipt of antibiotics for suspected sepsis.
Number of Participants Experiencing Cesarean DeliveryAt index birth; vital recordsNumber of participants experiencing a cesarean delivery for their index birth.
Number of Participants Experiencing Severe Acute Maternal MorbidityAt index birth; hospital dischargeSevere acute maternal morbidity as defined by the Centers for Disease Control and Prevention (CDC).
Number of Participants Experiencing Maternal MortalityWithin one year after index birth; mortality recordsNumber of participants experiencing all-cause mortality within one year postpartum.
Number of Participants Experiencing Neonatal Abstinence Disorder (NAS) or Maternal Drug/Substance AbuseWithin two years after index birth; Medicaid claims, hospital dischargeNumber of participants experiencing neonatal abstinence disorder (NAS) or maternal drug/substance abuse in the first two years postpartum.
Number of Participants Experiencing Violence or HomicideWithin 2 years after index birth; Medicaid claims, mortality recordsIncludes any ICD code for healthcare encounter associated with experiencing violence or mortality associated with homicide based on ICD code
Number of Participants Who Received Adequate Prenatal CareAt index birth; vital recordsWith 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
Number of Emergency Department Visits During PregnancyAt index birth; hospital dischargeNumber of emergency department visits during pregnancy.
Number of Participants With a Dental Visit During PregnancyAt index birth; Medicaid claims and dental recordsNumber of participants with a dental visit during pregnancy (preventive or treatment).
Number of Participants With an Ultrasound at 18-22 Weeks18-22 weeks gestation during index pregnancy. Assessed at index birth using Medicaid claims.Number of participants with an ultrasound (anatomy scan) at 18-22 weeks.
Number of Participants Who Received Prenatal ScreensAt index birth; Medicaid claimsOur 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.
Number of Participants Who Received a Gestational Diabetes Test (24-28 Weeks)At 24-28 weeks' gestation of index pregnancy; Medicaid claimsReceived 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.
Number of Participants With a Tdap Vaccination (27-36 Weeks)At 27-36 weeks' gestation of index pregnancy; Medicaid claimsReceived 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.
Number of Participants With a Group B Streptococcus Test (35-37 Weeks)At 35-37 weeks' gestation of index pregnancy; Medicaid claimsReceived 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.
Number of Participants With a Mental Health Diagnosis or Outpatient TreatmentDuring index pregnancy or 60 days postpartum; Medicaid claimsDiagnosis for depression/anxiety/stress reaction or antidepressant prescription or outpatient mental health visit
Number of Participants With a Diagnosis of Depression/Anxiety/Stress ReactionDuring index pregnancy or 60 days postpartum; Medicaid claimsNumber of participants with a diagnosis of depression/anxiety/stress reaction.
Number of Participants With an Antidepressant PrescriptionDuring index pregnancy or 60 days postpartum; Medicaid claimsNumber of participants with an antidepressant prescription.
Number of Participants With an Outpatient Mental Health VisitDuring index pregnancy or 60 days postpartum; Medicaid claimsNumber of participants with at least one outpatient mental health visit.
Number of Participants With a Mental Health Treatment Follow upWithin 120 days of treatment initiation; Medicaid claimsSecond antidepressant prescription or outpatient mental health visit within 120 days of treatment initiation (acute phase)
Number of Participants With a Mental Health Related Emergency/Inpatient VisitDuring index pregnancy or 12 months postpartum; Hospital dischargeBased on all-listed diagnoses (i.e. primary or secondary) for depression/anxiety/stress reaction
Number of Mental Health Related Emergency/Inpatient VisitsDuring index pregnancy or 12 months postpartum; Hospital dischargeBased on all-listed diagnoses (i.e. primary or secondary) for depression/anxiety/stress reaction
Number of Participants Whose Child Experienced a Major InjuryWithin 24 months after index birth; Medicaid claims, hospital discharge, mortality recordsHealth care encounter or mortality associated with ICD codes indicating major injury
Number of Participants Whose Child Experienced Concern for Abuse or NeglectWithin 24 months after index birth; Medicaid claims, hospital discharge, mortality recordsHealth care encounter or mortality associated with ICD codes indicating concern for abuse or neglect
Number of InjuriesWithin 24 months after index birth; hospital dischargeNumber of injuries for child
Number of Participants Whose Child Had an Emergency Department VisitWithin 24 months after index birth; hospital dischargeNumber of participants whose child had at least one visit to the emergency department.
Number of Child Emergency Department VisitsWithin 24 months after index birth; hospital dischargeTotal number of child visits to the emergency department (without admission)
Number of Participants Experiencing Child MortalityWithin 24 months after index birth; Mortality recordsAll-cause child mortality in first 24 months of life
Number of Participants With Recommended Number of Well-child VisitsAt 15 months after index birth; Medicaid claimsNumber of participants that received the recommended number of well-child visits.
Number of Participants With Lead ScreeningAt 15 months after index birth; Medicaid claimsNumber of participants whose child received at least one lead screening.
Number of Participants With Developmental ScreeningAt 12 months after index birth; Medicaid claimsNumber of participants whose child received at least one developmental screening.
Number of Participants With a Dental VisitWithin 24 months after index birth; Medicaid claims and dental recordsChild receives a dental screen at least once in first 24 months
Number of Participants With Fluoride TreatmentWithin 24 months after index birth; Medicaid claims and dental recordsShare with recommended fluoride treatments received by child
Number of Participants With an Inter-birth Interval of < 24 MonthsWithin 24 months after index birth; vital recordsHaving a subsequent birth within the first 24 months of the index birth
Number of Participants With an Inter-birth Interval of < 15 MonthsWithin 15 months after index birth; vital recordsHaving a subsequent birth within the first 15 months of the index birth
Number of Participants With a Family Planning Visit (6 Weeks)Within 6 weeks after index birth; Medicaid claims, hospital dischargeNumber of participants who received any family planning-related counseling or service.
Number of Participants Who Received a Highly or Moderately Effective Method of Contraception (6 Weeks)Within 6 weeks after index birth; Medicaid claims, hospital dischargeReceived 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
Number of Participants Who Received Immediate Postpartum Long-acting Reversible Contraception (6 Weeks)Within 6 weeks after index birth; Medicaid claims, hospital dischargeNumber of participants who received immediate postpartum long-acting reversible contraception in first 6 weeks postpartum.
Number of Participants With a Family Planning Visit (1 Year)Within 12 months after index birth; Medicaid claims, hospital dischargeNumber of participants who received any family planning-related counseling or service in the first year postpartum.
Number of Participants Who Received a Highly or Moderately Effective Method of Contraception (1 Year)Within 12 months after index birth; Medicaid claims, hospital dischargeReceived implant, IPP-LARC, LARC, or sterilization and moderately effective contraception to include path, ring, diaphragm, injectables and contraceptive pills
Number of Participants Who Received a Postpartum Intrauterine Device Insertion (1 Year)Within 12 months after index birth; Medicaid claims, hospital dischargeNumber of participants who received a postpartum intrauterine device insertion in first 12 months postpartum.
Number of Participants With a Postpartum VisitWithin 12 weeks after index birth; Medicaid claimsNumber of participants with a postpartum visit in first 12 weeks after an index birth.
Time to First Take-up of Highly Effective Contraceptive MethodWithin 24 months after index birth; Medicaid claims, hospital dischargeMonths from discharge to first take up of highly effective contraceptive method (include implant, IPP-LARC, LARC, or sterilization)
Number of Participants Who Received Supplemental Nutrition Assistance Program (SNAP) or Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) BenefitsDuring index pregnancy, assessed up to 42 weeks; South Carolina Department of Social Services data and birth certificate data respectivelyNumber of participants who received Supplemental Nutrition Assistance Program (SNAP) or Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) benefits during pregnancy.
Number of Months Receiving SNAP or Temporary Assistance for Needy Families (TANF) BenefitsWithin 24 months after index birth; South Carolina Department of Social Services dataTotal months receiving Supplemental Nutrition Assistance Program or Temporary Assistance for Needy Families
Number of Participants With SNAP or TANF Benefit ChurnWithin 24 months after index birth; South Carolina Department of Social Services dataReceiving 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 to First Take-up of Family Planning Counseling or ServiceWithin 24 months after index birth; Medicaid claims, hospital dischargeMonths from pregnancy to first take up of family planning counseling or service
Inter-birth Interval60 months after index birth; vital recordsContinuous measure of inter-birth interval
Number of Participants With an Infant Born Small for Gestational Age (SGA)At index birth; vital recordsInfant birth weight below the 10th percentile for infants of the same gestational age

Countries

United States

Participant flow

Participants by arm

ArmCount
Treatment - Participation in 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.
3,319
Control
Control group members have access to the standard of care and whatever other programs and services are available in the community.
1,647
Total4,966

Baseline characteristics

CharacteristicTreatment - Participation in Nurse Family PartnershipControlTotal
Age, Customized
Age in years
15-18 years
605 Participants290 Participants895 Participants
Age, Customized
Age in years
19-24
1814 Participants905 Participants2719 Participants
Age, Customized
Age in years
25-34
806 Participants418 Participants1224 Participants
Age, Customized
Age in years
35+
94 Participants34 Participants128 Participants
Depressive symptoms635 Participants305 Participants940 Participants
Economic conditions at time of enrollment
Experienced housing insecurity
549 Participants287 Participants836 Participants
Economic conditions at time of enrollment
Lived with parents
1439 Participants729 Participants2168 Participants
Economic conditions at time of enrollment
Received at least one social service program
2133 Participants1076 Participants3209 Participants
Economic conditions at time of enrollment
Worked for pay
1753 Participants867 Participants2620 Participants
Highest education level
Bachelor's degree or higher
247 Participants130 Participants377 Participants
Highest education level
High school diploma or equivalent
1187 Participants561 Participants1748 Participants
Highest education level
Less than high school diploma
750 Participants358 Participants1108 Participants
Highest education level
Some college, less than bachelor's degree
1121 Participants592 Participants1713 Participants
High stress2161 Participants1073 Participants3234 Participants
Race/Ethnicity, Customized
Race and Ethnicity
Asian, Indigenous, Native Hawaiian and Pacific Islander, non-Hispanic
44 Participants12 Participants56 Participants
Race/Ethnicity, Customized
Race and Ethnicity
Hispanic
173 Participants95 Participants268 Participants
Race/Ethnicity, Customized
Race and Ethnicity
More than once race reported, non-Hispanic
97 Participants45 Participants142 Participants
Race/Ethnicity, Customized
Race and Ethnicity
Non-Hispanic Black
1713 Participants852 Participants2565 Participants
Race/Ethnicity, Customized
Race and Ethnicity
Non-Hispanic White
1091 Participants526 Participants1617 Participants
Received mental health treatment in last year458 Participants221 Participants679 Participants
Region of Enrollment
United States
3319 participants1647 participants4966 participants
Sex: Female, Male
Female
3319 Participants1647 Participants4966 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
5 / 3,3192 / 1,647
other
Total, other adverse events
0 / 3,3190 / 1,647
serious
Total, serious adverse events
0 / 3,3190 / 1,647

Outcome results

Primary

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

Population: Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants Whose Child Experienced a Major Injury or Concern for Abuse or Neglect901 Participants
ControlNumber of Participants Whose Child Experienced a Major Injury or Concern for Abuse or Neglect438 Participants
95% CI: [-2.3, 3]
Primary

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

Population: Differs from randomized sample as it excludes participants who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants With a Composite Birth Outcome892 Participants
ControlNumber of Participants With a Composite Birth Outcome430 Participants
95% CI: [-2.1, 3.1]
Primary

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

Population: Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants With an Inter-birth Interval of < 21 Months363 Participants
ControlNumber of Participants With an Inter-birth Interval of < 21 Months199 Participants
95% CI: [-2.9, 0.8]
Secondary

Birth Weight (Continuous)

A continuous measure of infant birth weight (grams)

Time frame: At index birth; vital records

Population: Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (MEAN)Dispersion
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipBirth Weight (Continuous)3085.2 gramsStandard Deviation 609.6
ControlBirth Weight (Continuous)3095.7 gramsStandard Deviation 38.1
95% CI: [-43.7, 28]
Secondary

Gestational Age at Birth

Gestational age at birth in weeks (continuous)

Time frame: At index birth; vital records

Population: Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (MEAN)Dispersion
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipGestational Age at Birth38.2 weeksStandard Deviation 2.3
ControlGestational Age at Birth38.1 weeksStandard Deviation 2.3
95% CI: [0, 0.2]
Secondary

Inter-birth Interval

Continuous measure of inter-birth interval

Time frame: 60 months after index birth; vital records

Secondary

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

Population: Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (MEAN)Dispersion
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Child Emergency Department Visits2.3 number of visitsStandard Deviation 2.8
ControlNumber of Child Emergency Department Visits2.4 number of visitsStandard Deviation 2.8
95% CI: [-0.7, 0.1]
Secondary

Number of Emergency Department Visits During Pregnancy

Number of emergency department visits during pregnancy.

Time frame: At index birth; hospital discharge

Population: Differs from randomized sample as it excludes participants with missing outcome data, an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (MEAN)Dispersion
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Emergency Department Visits During Pregnancy2.1 number of visitsStandard Deviation 2.5
ControlNumber of Emergency Department Visits During Pregnancy2.0 number of visitsStandard Deviation 2.5
95% CI: [0.95, 1.08]
Secondary

Number of Injuries

Number of injuries for child

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

Population: Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (MEAN)Dispersion
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Injuries0.2 number of injuriesStandard Deviation 0.6
ControlNumber of Injuries0.3 number of injuriesStandard Deviation 0.6
95% CI: [-0.1, 0.1]
Secondary

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

Population: Differs from randomized sample as it excludes participants with missing outcome data, an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (MEAN)Dispersion
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Mental Health Related Emergency/Inpatient Visits.24 number of visitsStandard Deviation 0.89
ControlNumber of Mental Health Related Emergency/Inpatient Visits.21 number of visitsStandard Deviation 0.83
Secondary

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

Population: Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (MEAN)Dispersion
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Months Receiving SNAP or Temporary Assistance for Needy Families (TANF) Benefits10.4 number of monthsStandard Deviation 9.4
ControlNumber of Months Receiving SNAP or Temporary Assistance for Needy Families (TANF) Benefits9.8 number of monthsStandard Deviation 9.2
95% CI: [0.1, 1.1]
Secondary

Number of Participants Experiencing Cesarean Delivery

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

Time frame: At index birth; vital records

Population: Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants Experiencing Cesarean Delivery1015 Participants
ControlNumber of Participants Experiencing Cesarean Delivery530 Participants
95% CI: [-4.7, 0.7]
Secondary

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

Population: Differs from randomized sample as it excludes participants who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants Experiencing Child Mortality49 Participants
ControlNumber of Participants Experiencing Child Mortality21 Participants
95% CI: [-0.4, 1]
Secondary

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

Population: Differs from randomized sample as it excludes participants with missing outcome data, an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants Experiencing Maternal Mortality5 Participants
ControlNumber of Participants Experiencing Maternal Mortality1 Participants
Secondary

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

Population: Differs from randomized sample as it excludes participants with missing outcome data, an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants Experiencing Neonatal Abstinence Disorder (NAS) or Maternal Drug/Substance Abuse708 Participants
ControlNumber of Participants Experiencing Neonatal Abstinence Disorder (NAS) or Maternal Drug/Substance Abuse367 Participants
Secondary

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

Population: Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants Experiencing Neonatal Morbidity328 Participants
ControlNumber of Participants Experiencing Neonatal Morbidity144 Participants
95% CI: [-1.1, 2.4]
Secondary

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

Population: Differs from randomized sample as it excludes participants who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants Experiencing Perinatal Mortality27 Participants
ControlNumber of Participants Experiencing Perinatal Mortality10 Participants
95% CI: [-0.3, 0.8]
Secondary

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

Population: The analysis population for this outcome includes participants who matched to an index birth in claims data.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants Experiencing Severe Acute Maternal Morbidity56 Participants
ControlNumber of Participants Experiencing Severe Acute Maternal Morbidity23 Participants
95% CI: [-0.5, 0.9]
Secondary

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

Population: Differs from randomized sample as it excludes participants with missing outcome data, an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants Experiencing Violence or Homicide55 Participants
ControlNumber of Participants Experiencing Violence or Homicide27 Participants
Secondary

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

Population: Differs from randomized sample as it excludes participants with missing outcome data, an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants Who Received Adequate Prenatal Care2572 Participants
ControlNumber of Participants Who Received Adequate Prenatal Care1283 Participants
95% CI: [-3, 1.7]
Secondary

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

Population: Differs from randomized sample as it excludes participants with missing outcome data, an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants Who Received a Gestational Diabetes Test (24-28 Weeks)1747 Participants
ControlNumber of Participants Who Received a Gestational Diabetes Test (24-28 Weeks)869 Participants
95% CI: [-3.1, 2.9]
Secondary

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

Population: Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants Who Received a Highly or Moderately Effective Method of Contraception (1 Year)2165 Participants
ControlNumber of Participants Who Received a Highly or Moderately Effective Method of Contraception (1 Year)1075 Participants
95% CI: [-2.6, 2.9]
Secondary

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

Population: Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants Who Received a Highly or Moderately Effective Method of Contraception (6 Weeks)1013 Participants
ControlNumber of Participants Who Received a Highly or Moderately Effective Method of Contraception (6 Weeks)512 Participants
95% CI: [-3.4, 2]
Secondary

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

Population: Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants Who Received a Postpartum Intrauterine Device Insertion (1 Year)476 Participants
ControlNumber of Participants Who Received a Postpartum Intrauterine Device Insertion (1 Year)227 Participants
95% CI: [-1.5, 2.6]
Secondary

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

Population: Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants Who Received Immediate Postpartum Long-acting Reversible Contraception (6 Weeks)384 Participants
ControlNumber of Participants Who Received Immediate Postpartum Long-acting Reversible Contraception (6 Weeks)176 Participants
95% CI: [-1, 2.7]
Secondary

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

Secondary

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

Population: Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants Who Received Supplemental Nutrition Assistance Program (SNAP) or Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) Benefits2892 Participants
ControlNumber of Participants Who Received Supplemental Nutrition Assistance Program (SNAP) or Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) Benefits1408 Participants
95% CI: [0.3, 4]
Secondary

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

Population: Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants Whose Child Experienced a Major Injury878 Participants
ControlNumber of Participants Whose Child Experienced a Major Injury430 Participants
95% CI: [-2.4, 2.8]
Secondary

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

Population: Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants Whose Child Experienced Concern for Abuse or Neglect137 Participants
ControlNumber of Participants Whose Child Experienced Concern for Abuse or Neglect66 Participants
95% CI: [-1.1, 1.3]
Secondary

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

Population: Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants Whose Child Had an Emergency Department Visit2306 Participants
ControlNumber of Participants Whose Child Had an Emergency Department Visit1192 Participants
95% CI: [-5.3, -0.1]
Secondary

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

Population: Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants With a Dental Visit1096 Participants
ControlNumber of Participants With a Dental Visit509 Participants
95% CI: [-1, 4.5]
Secondary

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

Population: Differs from randomized sample as it excludes participants with missing outcome data, an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants With a Dental Visit During Pregnancy625 Participants
ControlNumber of Participants With a Dental Visit During Pregnancy275 Participants
95% CI: [0.1, 4.9]
Secondary

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

Population: Differs from randomized sample as it excludes participants with missing outcome data, an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants With a Diagnosis of Depression/Anxiety/Stress Reaction937 Participants
ControlNumber of Participants With a Diagnosis of Depression/Anxiety/Stress Reaction491 Participants
Secondary

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

Population: Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants With a Family Planning Visit (1 Year)2378 Participants
ControlNumber of Participants With a Family Planning Visit (1 Year)1188 Participants
95% CI: [-3, 2.2]
Secondary

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

Population: Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants With a Family Planning Visit (6 Weeks)1303 Participants
ControlNumber of Participants With a Family Planning Visit (6 Weeks)669 Participants
95% CI: [-4.3, 1.3]
Secondary

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

Population: Differs from randomized sample as it excludes participants with missing outcome data, an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants With a Group B Streptococcus Test (35-37 Weeks)1150 Participants
ControlNumber of Participants With a Group B Streptococcus Test (35-37 Weeks)602 Participants
95% CI: [-8, -0.4]
Secondary

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

Population: Differs from randomized sample as it excludes participants with missing outcome data, an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants With a Mental Health Diagnosis or Outpatient Treatment1048 Participants
ControlNumber of Participants With a Mental Health Diagnosis or Outpatient Treatment543 Participants
Secondary

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

Population: Differs from randomized sample as it excludes participants with missing outcome data, an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants With a Mental Health Related Emergency/Inpatient Visit459 Participants
ControlNumber of Participants With a Mental Health Related Emergency/Inpatient Visit202 Participants
Secondary

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

Population: Differs from randomized sample as it excludes participants with missing outcome data, an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants With a Mental Health Treatment Follow up292 Participants
ControlNumber of Participants With a Mental Health Treatment Follow up142 Participants
Secondary

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

Population: Differs from randomized sample as it excludes participants with missing outcome data, an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants With an Antidepressant Prescription435 Participants
ControlNumber of Participants With an Antidepressant Prescription216 Participants
Secondary

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

Population: Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants With an Extremely Preterm Birth32 Participants
ControlNumber of Participants With an Extremely Preterm Birth16 Participants
95% CI: [-0.6, 0.5]
Secondary

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

Population: Differs from randomized sample as it excludes participants with missing outcome data, those who experienced an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants With a NICU Admission of at Least Overnight241 Participants
ControlNumber of Participants With a NICU Admission of at Least Overnight128 Participants
95% CI: [-2.5, 0.9]
Secondary

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

Population: Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants With an Infant Born Large for Gestational Age (LGA)166 Participants
ControlNumber of Participants With an Infant Born Large for Gestational Age (LGA)95 Participants
95% CI: [-2.3, 0.4]
Secondary

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

Population: Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants With an Infant Born Small for Gestational Age (SGA)553 Participants
ControlNumber of Participants With an Infant Born Small for Gestational Age (SGA)265 Participants
95% CI: [-1.5, 2.9]
Secondary

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

Population: Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants With an Infant Born With Low Birth Weight (LBW)436 Participants
ControlNumber of Participants With an Infant Born With Low Birth Weight (LBW)219 Participants
95% CI: [-2.4, 1.6]
Secondary

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

Population: Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants With an Infant With Very Low Birth Weight78 Participants
ControlNumber of Participants With an Infant With Very Low Birth Weight48 Participants
95% CI: [-1.6, 0.3]
Secondary

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

Population: Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants With an Inter-birth Interval of < 15 Months148 Participants
ControlNumber of Participants With an Inter-birth Interval of < 15 Months85 Participants
95% CI: [-1.9, 0.6]
Secondary

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

Population: Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants With an Inter-birth Interval of < 24 Months474 Participants
ControlNumber of Participants With an Inter-birth Interval of < 24 Months244 Participants
95% CI: [-2.4, 1.7]
Secondary

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

Population: Differs from randomized sample as it excludes participants with missing outcome data, an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants With an Outpatient Mental Health Visit165 Participants
ControlNumber of Participants With an Outpatient Mental Health Visit76 Participants
Secondary

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.

Population: Differs from randomized sample as it excludes participants with missing outcome data, an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants With an Ultrasound at 18-22 Weeks2293 Participants
ControlNumber of Participants With an Ultrasound at 18-22 Weeks1134 Participants
95% CI: [-2.1, 3]
Secondary

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

Population: Differs from randomized sample as it excludes participants with missing outcome data, an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants With a Postpartum Visit2079 Participants
ControlNumber of Participants With a Postpartum Visit1038 Participants
95% CI: [-3.2, 2.5]
Secondary

Number of Participants With a Preterm Birth

Infant born before 37 weeks' gestation (obstetric estimate)

Time frame: At index birth; vital records

Population: Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants With a Preterm Birth379 Participants
ControlNumber of Participants With a Preterm Birth190 Participants
95% CI: [-2.4, 1.3]
Secondary

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

Population: Differs from randomized sample as it excludes participants with missing outcome data, an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants With a Tdap Vaccination (27-36 Weeks)914 Participants
ControlNumber of Participants With a Tdap Vaccination (27-36 Weeks)446 Participants
95% CI: [-2.4, 3.7]
Secondary

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

Population: Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants With Developmental Screening1070 Participants
ControlNumber of Participants With Developmental Screening540 Participants
95% CI: [-3.4, 2]
Secondary

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

Population: Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants With Fluoride Treatment1146 Participants
ControlNumber of Participants With Fluoride Treatment570 Participants
95% CI: [-2.6, 3.1]
Secondary

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

Population: Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants With Lead Screening2093 Participants
ControlNumber of Participants With Lead Screening1030 Participants
95% CI: [-2.3, 3.2]
Secondary

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

Population: Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants With Recommended Number of Well-child Visits1150 Participants
ControlNumber of Participants With Recommended Number of Well-child Visits537 Participants
95% CI: [-0.4, 5]
Secondary

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

Population: Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipNumber of Participants With SNAP or TANF Benefit Churn382 Participants
ControlNumber of Participants With SNAP or TANF Benefit Churn174 Participants
95% CI: [-0.7, 3]
Secondary

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

Population: Differs from randomized sample as it excludes participants with missing outcome data, an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (MEAN)Dispersion
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipTime to First Take-up of Family Planning Counseling or Service2 monthsStandard Error 3.6
ControlTime to First Take-up of Family Planning Counseling or Service1.9 monthsStandard Error 3.3
95% CI: [-0.1, 0.37]
Secondary

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

Population: Differs from randomized sample as it excludes participants with missing outcome data, an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.

ArmMeasureValue (MEAN)Dispersion
Treatment - Participation in Nurse Family Partnership Nurse-Family PartnershipTime to First Take-up of Highly Effective Contraceptive Method2.5 monthsStandard Deviation 4.3
ControlTime to First Take-up of Highly Effective Contraceptive Method2.6 monthsStandard Deviation 4.5
95% CI: [-0.45, 0.5]

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026