Injuries, Maternal Behavior, Preterm Birth
Conditions
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
Study design
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
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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Composite Birth Outcome | 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). |
| Number of Participants Whose Child Experienced a Major Injury or Concern for Abuse or Neglect | 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). |
| Number of Participants With an Inter-birth Interval of < 21 Months | within 21 months after index birth; vital records | Having a subsequent birth within the first 21 months of the index birth |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With an Infant Born Large for Gestational Age (LGA) | At index birth birth; vital records | Infant 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 records | Number 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 Weight | At index birth; vital records | Number of participants with an infant born with a birth weight of less than 1500 grams. |
| Birth Weight (Continuous) | At index birth; vital records | A continuous measure of infant birth weight (grams) |
| Number of Participants With a Preterm Birth | At index birth; vital records | Infant born before 37 weeks' gestation (obstetric estimate) |
| Number of Participants With an Extremely Preterm Birth | At index birth; vital records | Number of participants with an infant born before 28 weeks' gestation. |
| Gestational Age at Birth | At index birth; vital records | Gestational age at birth in weeks (continuous) |
| Number of Participants Experiencing Perinatal Mortality | 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 |
| Number of Participants With a NICU Admission of at Least Overnight | At index birth; hospital discharge | Infant admitted to the neonatal intensive care unit (NICU) for at least one night |
| Number of Participants Experiencing Neonatal Morbidity | 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. |
| Number of Participants Experiencing Cesarean Delivery | At index birth; vital records | Number of participants experiencing a cesarean delivery for their index birth. |
| Number of Participants Experiencing Severe Acute Maternal Morbidity | At index birth; hospital discharge | Severe acute maternal morbidity as defined by the Centers for Disease Control and Prevention (CDC). |
| Number of Participants Experiencing Maternal Mortality | Within one year after index birth; mortality records | Number of participants experiencing all-cause mortality within one year postpartum. |
| Number of Participants Experiencing Neonatal Abstinence Disorder (NAS) or Maternal Drug/Substance Abuse | 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. |
| Number of Participants Experiencing Violence or Homicide | 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 |
| Number of Participants Who Received Adequate Prenatal Care | 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 |
| Number of Emergency Department Visits During Pregnancy | At index birth; hospital discharge | Number of emergency department visits during pregnancy. |
| Number of Participants With a Dental Visit During Pregnancy | At index birth; Medicaid claims and dental records | Number of participants with a dental visit during pregnancy (preventive or treatment). |
| Number of Participants With an Ultrasound at 18-22 Weeks | 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. |
| Number of Participants Who Received Prenatal Screens | 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. |
| Number of Participants Who Received a Gestational Diabetes Test (24-28 Weeks) | 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. |
| Number of Participants With a Tdap Vaccination (27-36 Weeks) | 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. |
| Number of Participants With a Group B Streptococcus Test (35-37 Weeks) | 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. |
| Number of Participants With a Mental Health Diagnosis or Outpatient Treatment | During index pregnancy or 60 days postpartum; Medicaid claims | Diagnosis for depression/anxiety/stress reaction or antidepressant prescription or outpatient mental health visit |
| Number of Participants With a Diagnosis of Depression/Anxiety/Stress Reaction | During index pregnancy or 60 days postpartum; Medicaid claims | Number of participants with a diagnosis of depression/anxiety/stress reaction. |
| Number of Participants With an Antidepressant Prescription | During index pregnancy or 60 days postpartum; Medicaid claims | Number of participants with an antidepressant prescription. |
| Number of Participants With an Outpatient Mental Health Visit | During index pregnancy or 60 days postpartum; Medicaid claims | Number of participants with at least one outpatient mental health visit. |
| Number of Participants With a Mental Health Treatment Follow up | Within 120 days of treatment initiation; Medicaid claims | Second 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 Visit | During index pregnancy or 12 months postpartum; Hospital discharge | Based on all-listed diagnoses (i.e. primary or secondary) for depression/anxiety/stress reaction |
| Number of Mental Health Related Emergency/Inpatient Visits | During index pregnancy or 12 months postpartum; Hospital discharge | Based on all-listed diagnoses (i.e. primary or secondary) for depression/anxiety/stress reaction |
| Number of Participants Whose Child Experienced a Major Injury | Within 24 months after index birth; Medicaid claims, hospital discharge, mortality records | Health care encounter or mortality associated with ICD codes indicating major injury |
| Number of Participants Whose Child Experienced Concern for Abuse or Neglect | 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 |
| Number of Injuries | Within 24 months after index birth; hospital discharge | Number of injuries for child |
| Number of Participants Whose Child Had an Emergency Department Visit | Within 24 months after index birth; hospital discharge | Number of participants whose child had at least one visit to the emergency department. |
| Number of Child Emergency Department Visits | Within 24 months after index birth; hospital discharge | Total number of child visits to the emergency department (without admission) |
| Number of Participants Experiencing Child Mortality | Within 24 months after index birth; Mortality records | All-cause child mortality in first 24 months of life |
| Number of Participants With Recommended Number of Well-child Visits | At 15 months after index birth; Medicaid claims | Number of participants that received the recommended number of well-child visits. |
| Number of Participants With Lead Screening | At 15 months after index birth; Medicaid claims | Number of participants whose child received at least one lead screening. |
| Number of Participants With Developmental Screening | At 12 months after index birth; Medicaid claims | Number of participants whose child received at least one developmental screening. |
| Number of Participants With a Dental Visit | Within 24 months after index birth; Medicaid claims and dental records | Child receives a dental screen at least once in first 24 months |
| Number of Participants With Fluoride Treatment | Within 24 months after index birth; Medicaid claims and dental records | Share with recommended fluoride treatments received by child |
| Number of Participants With an Inter-birth Interval of < 24 Months | Within 24 months after index birth; vital records | Having a subsequent birth within the first 24 months of the index birth |
| Number of Participants With an Inter-birth Interval of < 15 Months | Within 15 months after index birth; vital records | Having 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 discharge | Number 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 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 |
| Number of Participants Who Received Immediate Postpartum Long-acting Reversible Contraception (6 Weeks) | 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. |
| Number of Participants With a Family Planning Visit (1 Year) | 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. |
| Number of Participants Who Received a Highly or Moderately Effective Method of Contraception (1 Year) | 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 |
| Number of Participants Who Received a Postpartum Intrauterine Device Insertion (1 Year) | 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. |
| Number of Participants With a Postpartum Visit | Within 12 weeks after index birth; Medicaid claims | Number of participants with a postpartum visit in first 12 weeks after an index birth. |
| Time to First Take-up of Highly Effective Contraceptive Method | 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) |
| Number of Participants Who Received Supplemental Nutrition Assistance Program (SNAP) or Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) Benefits | 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. |
| Number of Months Receiving SNAP or Temporary Assistance for Needy Families (TANF) Benefits | 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 |
| Number of Participants With SNAP or TANF Benefit Churn | 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 |
| Time to First Take-up of Family Planning Counseling or Service | Within 24 months after index birth; Medicaid claims, hospital discharge | Months from pregnancy to first take up of family planning counseling or service |
| Inter-birth Interval | 60 months after index birth; vital records | Continuous measure of inter-birth interval |
| Number of Participants With an Infant Born Small for Gestational Age (SGA) | At index birth; vital records | Infant birth weight below the 10th percentile for infants of the same gestational age |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 4,966 |
Baseline characteristics
| Characteristic | Treatment - Participation in Nurse Family Partnership | Control | Total |
|---|---|---|---|
| Age, Customized Age in years 15-18 years | 605 Participants | 290 Participants | 895 Participants |
| Age, Customized Age in years 19-24 | 1814 Participants | 905 Participants | 2719 Participants |
| Age, Customized Age in years 25-34 | 806 Participants | 418 Participants | 1224 Participants |
| Age, Customized Age in years 35+ | 94 Participants | 34 Participants | 128 Participants |
| Depressive symptoms | 635 Participants | 305 Participants | 940 Participants |
| Economic conditions at time of enrollment Experienced housing insecurity | 549 Participants | 287 Participants | 836 Participants |
| Economic conditions at time of enrollment Lived with parents | 1439 Participants | 729 Participants | 2168 Participants |
| Economic conditions at time of enrollment Received at least one social service program | 2133 Participants | 1076 Participants | 3209 Participants |
| Economic conditions at time of enrollment Worked for pay | 1753 Participants | 867 Participants | 2620 Participants |
| Highest education level Bachelor's degree or higher | 247 Participants | 130 Participants | 377 Participants |
| Highest education level High school diploma or equivalent | 1187 Participants | 561 Participants | 1748 Participants |
| Highest education level Less than high school diploma | 750 Participants | 358 Participants | 1108 Participants |
| Highest education level Some college, less than bachelor's degree | 1121 Participants | 592 Participants | 1713 Participants |
| High stress | 2161 Participants | 1073 Participants | 3234 Participants |
| Race/Ethnicity, Customized Race and Ethnicity Asian, Indigenous, Native Hawaiian and Pacific Islander, non-Hispanic | 44 Participants | 12 Participants | 56 Participants |
| Race/Ethnicity, Customized Race and Ethnicity Hispanic | 173 Participants | 95 Participants | 268 Participants |
| Race/Ethnicity, Customized Race and Ethnicity More than once race reported, non-Hispanic | 97 Participants | 45 Participants | 142 Participants |
| Race/Ethnicity, Customized Race and Ethnicity Non-Hispanic Black | 1713 Participants | 852 Participants | 2565 Participants |
| Race/Ethnicity, Customized Race and Ethnicity Non-Hispanic White | 1091 Participants | 526 Participants | 1617 Participants |
| Received mental health treatment in last year | 458 Participants | 221 Participants | 679 Participants |
| Region of Enrollment United States | 3319 participants | 1647 participants | 4966 participants |
| Sex: Female, Male Female | 3319 Participants | 1647 Participants | 4966 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5 / 3,319 | 2 / 1,647 |
| other Total, other adverse events | 0 / 3,319 | 0 / 1,647 |
| serious Total, serious adverse events | 0 / 3,319 | 0 / 1,647 |
Outcome results
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants Whose Child Experienced a Major Injury or Concern for Abuse or Neglect | 901 Participants |
| Control | Number of Participants Whose Child Experienced a Major Injury or Concern for Abuse or Neglect | 438 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants With a Composite Birth Outcome | 892 Participants |
| Control | Number of Participants With a Composite Birth Outcome | 430 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants With an Inter-birth Interval of < 21 Months | 363 Participants |
| Control | Number of Participants With an Inter-birth Interval of < 21 Months | 199 Participants |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Birth Weight (Continuous) | 3085.2 grams | Standard Deviation 609.6 |
| Control | Birth Weight (Continuous) | 3095.7 grams | Standard Deviation 38.1 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Gestational Age at Birth | 38.2 weeks | Standard Deviation 2.3 |
| Control | Gestational Age at Birth | 38.1 weeks | Standard Deviation 2.3 |
Inter-birth Interval
Continuous measure of inter-birth interval
Time frame: 60 months after index birth; vital records
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Child Emergency Department Visits | 2.3 number of visits | Standard Deviation 2.8 |
| Control | Number of Child Emergency Department Visits | 2.4 number of visits | Standard Deviation 2.8 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Emergency Department Visits During Pregnancy | 2.1 number of visits | Standard Deviation 2.5 |
| Control | Number of Emergency Department Visits During Pregnancy | 2.0 number of visits | Standard Deviation 2.5 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Injuries | 0.2 number of injuries | Standard Deviation 0.6 |
| Control | Number of Injuries | 0.3 number of injuries | Standard Deviation 0.6 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Mental Health Related Emergency/Inpatient Visits | .24 number of visits | Standard Deviation 0.89 |
| Control | Number of Mental Health Related Emergency/Inpatient Visits | .21 number of visits | Standard Deviation 0.83 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Months Receiving SNAP or Temporary Assistance for Needy Families (TANF) Benefits | 10.4 number of months | Standard Deviation 9.4 |
| Control | Number of Months Receiving SNAP or Temporary Assistance for Needy Families (TANF) Benefits | 9.8 number of months | Standard Deviation 9.2 |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants Experiencing Cesarean Delivery | 1015 Participants |
| Control | Number of Participants Experiencing Cesarean Delivery | 530 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants Experiencing Child Mortality | 49 Participants |
| Control | Number of Participants Experiencing Child Mortality | 21 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants Experiencing Maternal Mortality | 5 Participants |
| Control | Number of Participants Experiencing Maternal Mortality | 1 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants Experiencing Neonatal Abstinence Disorder (NAS) or Maternal Drug/Substance Abuse | 708 Participants |
| Control | Number of Participants Experiencing Neonatal Abstinence Disorder (NAS) or Maternal Drug/Substance Abuse | 367 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants Experiencing Neonatal Morbidity | 328 Participants |
| Control | Number of Participants Experiencing Neonatal Morbidity | 144 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants Experiencing Perinatal Mortality | 27 Participants |
| Control | Number of Participants Experiencing Perinatal Mortality | 10 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants Experiencing Severe Acute Maternal Morbidity | 56 Participants |
| Control | Number of Participants Experiencing Severe Acute Maternal Morbidity | 23 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants Experiencing Violence or Homicide | 55 Participants |
| Control | Number of Participants Experiencing Violence or Homicide | 27 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants Who Received Adequate Prenatal Care | 2572 Participants |
| Control | Number of Participants Who Received Adequate Prenatal Care | 1283 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants Who Received a Gestational Diabetes Test (24-28 Weeks) | 1747 Participants |
| Control | Number of Participants Who Received a Gestational Diabetes Test (24-28 Weeks) | 869 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants Who Received a Highly or Moderately Effective Method of Contraception (1 Year) | 2165 Participants |
| Control | Number of Participants Who Received a Highly or Moderately Effective Method of Contraception (1 Year) | 1075 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants Who Received a Highly or Moderately Effective Method of Contraception (6 Weeks) | 1013 Participants |
| Control | Number of Participants Who Received a Highly or Moderately Effective Method of Contraception (6 Weeks) | 512 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants Who Received a Postpartum Intrauterine Device Insertion (1 Year) | 476 Participants |
| Control | Number of Participants Who Received a Postpartum Intrauterine Device Insertion (1 Year) | 227 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants Who Received Immediate Postpartum Long-acting Reversible Contraception (6 Weeks) | 384 Participants |
| Control | Number of Participants Who Received Immediate Postpartum Long-acting Reversible Contraception (6 Weeks) | 176 Participants |
Number of Participants Who Received Prenatal Screens
Our original prenatal screening outcome variable included the obstetric panel: Rhesus-D (DRh), red blood cell (RBC) antibody screen, complete blood count (CBC), urine culture, urinalysis; sexually transmitted infection (STI) screenings (HIV, syphilis, hepatitis B, chlamydia if \<25, gonorrhea if \<25); Group B strep screening, and glucose screening. However, since most participants had already completed their first prenatal visit prior to enrolling in the trial (when many of these tests are performed), it was not appropriate to include first-visit tests as outcomes. We therefore modified the outcome to instead use three clinically relevant measures that could occur after enrollment: glucose screening, Group B strep screening, and Tdap vaccination. These outcomes are reported as they appear in the published papers.
Time frame: At index birth; Medicaid claims
Number of Participants Who Received 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants Who Received Supplemental Nutrition Assistance Program (SNAP) or Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) Benefits | 2892 Participants |
| Control | Number of Participants Who Received Supplemental Nutrition Assistance Program (SNAP) or Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) Benefits | 1408 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants Whose Child Experienced a Major Injury | 878 Participants |
| Control | Number of Participants Whose Child Experienced a Major Injury | 430 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants Whose Child Experienced Concern for Abuse or Neglect | 137 Participants |
| Control | Number of Participants Whose Child Experienced Concern for Abuse or Neglect | 66 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants Whose Child Had an Emergency Department Visit | 2306 Participants |
| Control | Number of Participants Whose Child Had an Emergency Department Visit | 1192 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants With a Dental Visit | 1096 Participants |
| Control | Number of Participants With a Dental Visit | 509 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants With a Dental Visit During Pregnancy | 625 Participants |
| Control | Number of Participants With a Dental Visit During Pregnancy | 275 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants With a Diagnosis of Depression/Anxiety/Stress Reaction | 937 Participants |
| Control | Number of Participants With a Diagnosis of Depression/Anxiety/Stress Reaction | 491 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants With a Family Planning Visit (1 Year) | 2378 Participants |
| Control | Number of Participants With a Family Planning Visit (1 Year) | 1188 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants With a Family Planning Visit (6 Weeks) | 1303 Participants |
| Control | Number of Participants With a Family Planning Visit (6 Weeks) | 669 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants With a Group B Streptococcus Test (35-37 Weeks) | 1150 Participants |
| Control | Number of Participants With a Group B Streptococcus Test (35-37 Weeks) | 602 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants With a Mental Health Diagnosis or Outpatient Treatment | 1048 Participants |
| Control | Number of Participants With a Mental Health Diagnosis or Outpatient Treatment | 543 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants With a Mental Health Related Emergency/Inpatient Visit | 459 Participants |
| Control | Number of Participants With a Mental Health Related Emergency/Inpatient Visit | 202 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants With a Mental Health Treatment Follow up | 292 Participants |
| Control | Number of Participants With a Mental Health Treatment Follow up | 142 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants With an Antidepressant Prescription | 435 Participants |
| Control | Number of Participants With an Antidepressant Prescription | 216 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants With an Extremely Preterm Birth | 32 Participants |
| Control | Number of Participants With an Extremely Preterm Birth | 16 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants With a NICU Admission of at Least Overnight | 241 Participants |
| Control | Number of Participants With a NICU Admission of at Least Overnight | 128 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants With an Infant Born Large for Gestational Age (LGA) | 166 Participants |
| Control | Number of Participants With an Infant Born Large for Gestational Age (LGA) | 95 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants With an Infant Born Small for Gestational Age (SGA) | 553 Participants |
| Control | Number of Participants With an Infant Born Small for Gestational Age (SGA) | 265 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants With an Infant Born With Low Birth Weight (LBW) | 436 Participants |
| Control | Number of Participants With an Infant Born With Low Birth Weight (LBW) | 219 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants With an Infant With Very Low Birth Weight | 78 Participants |
| Control | Number of Participants With an Infant With Very Low Birth Weight | 48 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants With an Inter-birth Interval of < 15 Months | 148 Participants |
| Control | Number of Participants With an Inter-birth Interval of < 15 Months | 85 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants With an Inter-birth Interval of < 24 Months | 474 Participants |
| Control | Number of Participants With an Inter-birth Interval of < 24 Months | 244 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants With an Outpatient Mental Health Visit | 165 Participants |
| Control | Number of Participants With an Outpatient Mental Health Visit | 76 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants With an Ultrasound at 18-22 Weeks | 2293 Participants |
| Control | Number of Participants With an Ultrasound at 18-22 Weeks | 1134 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants With a Postpartum Visit | 2079 Participants |
| Control | Number of Participants With a Postpartum Visit | 1038 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants With a Preterm Birth | 379 Participants |
| Control | Number of Participants With a Preterm Birth | 190 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants With a Tdap Vaccination (27-36 Weeks) | 914 Participants |
| Control | Number of Participants With a Tdap Vaccination (27-36 Weeks) | 446 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants With Developmental Screening | 1070 Participants |
| Control | Number of Participants With Developmental Screening | 540 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants With Fluoride Treatment | 1146 Participants |
| Control | Number of Participants With Fluoride Treatment | 570 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants With Lead Screening | 2093 Participants |
| Control | Number of Participants With Lead Screening | 1030 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants With Recommended Number of Well-child Visits | 1150 Participants |
| Control | Number of Participants With Recommended Number of Well-child Visits | 537 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Number of Participants With SNAP or TANF Benefit Churn | 382 Participants |
| Control | Number of Participants With SNAP or TANF Benefit Churn | 174 Participants |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Time to First Take-up of Family Planning Counseling or Service | 2 months | Standard Error 3.6 |
| Control | Time to First Take-up of Family Planning Counseling or Service | 1.9 months | Standard Error 3.3 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | Time to First Take-up of Highly Effective Contraceptive Method | 2.5 months | Standard Deviation 4.3 |
| Control | Time to First Take-up of Highly Effective Contraceptive Method | 2.6 months | Standard Deviation 4.5 |