Nurse-Family Partnership Impact Evaluation in South Carolina
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Preterm Birth
- Sponsor
- Harvard School of Public Health (HSPH)
- Enrollment
- 5670
- Locations
- 9
- Primary Endpoint
- Number of Participants With a Composite Birth Outcome
- Status
- Active, not recruiting
- Last Updated
- 4 months ago
Overview
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.
Investigators
Margaret McConnell
Associate Professor of Global Health Economics
Harvard School of Public Health (HSPH)
Eligibility Criteria
Inclusion Criteria
- •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
- •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
Outcomes
Primary Outcomes
Number of Participants With a Composite Birth Outcome
Time Frame: 0-7 days after index birth; vital records, mortality records, and fetal death records
Composite of at least one of: small for gestational (SGA), or low birth weight (LBW) less than 2500 grams, preterm birth (PTB) less than 37 weeks' gestation (obstetric estimate), or perinatal mortality (fetal death at or after 20 weeks of gestation or mortality in the first 7 days of life).
Number of Participants Whose Child Experienced a Major Injury or Concern for Abuse or Neglect
Time Frame: within 24 months after index birth; Medicaid claims or hospital discharge data
Composite of at least one health care encounter or mortality associated with International Classification of Diseases (ICD) codes indicating either major injury, or, concern for abuse or neglect for the participant's index child(ren).
Number of Participants With an Inter-birth Interval of < 21 Months
Time Frame: within 21 months after index birth; vital records
Having a subsequent birth within the first 21 months of the index birth
Secondary Outcomes
- Number of Participants With a Preterm Birth(At index birth; vital records)
- Number of Participants With an Extremely Preterm Birth(At index birth; vital records)
- Gestational Age at Birth(At index birth; vital records)
- Number of Participants Experiencing Perinatal Mortality(Within 1 week after index birth; mortality records and fetal death records)
- Number of Participants With a NICU Admission of at Least Overnight(At index birth; hospital discharge)
- Birth Weight (Continuous)(At index birth; vital records)
- Number of Participants With an Infant Born Small for Gestational Age (SGA)(At index birth; vital records)
- Number of Participants With an Infant Born Large for Gestational Age (LGA)(At index birth birth; vital records)
- Number of Participants With an Infant Born With Low Birth Weight (LBW)(At index birth; vital records)
- Number of Participants With an Infant With Very Low Birth Weight(At index birth; vital records)
- Number of Participants Experiencing Neonatal Morbidity(At index birth; hospital discharge)
- Number of Participants Experiencing Cesarean Delivery(At index birth; vital records)
- Number of Participants Experiencing Severe Acute Maternal Morbidity(At index birth; hospital discharge)
- Number of Participants Experiencing Maternal Mortality(Within one year after index birth; mortality records)
- 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 Violence or Homicide(Within 2 years after index birth; Medicaid claims, mortality records)
- Number of Participants With a Postpartum Visit(Within 12 weeks after index birth; Medicaid claims)
- Number of Participants Who Received Adequate Prenatal Care(At index birth; vital records)
- Number of Emergency Department Visits During Pregnancy(At index birth; hospital discharge)
- Number of Participants With a Dental Visit During Pregnancy(At index birth; Medicaid claims and dental records)
- 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 Who Received Prenatal Screens(At index birth; Medicaid claims)
- Number of Participants Who Received a Gestational Diabetes Test (24-28 Weeks)(At 24-28 weeks' gestation of index pregnancy; Medicaid claims)
- Number of Participants With a Tdap Vaccination (27-36 Weeks)(At 27-36 weeks' gestation of index pregnancy; Medicaid claims)
- Number of Participants With a Group B Streptococcus Test (35-37 Weeks)(At 35-37 weeks' gestation of index pregnancy; Medicaid claims)
- Number of Participants With a Mental Health Diagnosis or Outpatient Treatment(During index pregnancy or 60 days postpartum; Medicaid claims)
- Number of Participants With a Diagnosis of Depression/Anxiety/Stress Reaction(During index pregnancy or 60 days postpartum; Medicaid claims)
- Number of Participants With an Antidepressant Prescription(During index pregnancy or 60 days postpartum; Medicaid claims)
- Number of Participants With an Outpatient Mental Health Visit(During index pregnancy or 60 days postpartum; Medicaid claims)
- Number of Participants With a Mental Health Treatment Follow up(Within 120 days of treatment initiation; Medicaid claims)
- Number of Participants With a Mental Health Related Emergency/Inpatient Visit(During index pregnancy or 12 months postpartum; Hospital discharge)
- Number of Mental Health Related Emergency/Inpatient Visits(During index pregnancy or 12 months postpartum; Hospital discharge)
- Number of Participants Whose Child Experienced a Major Injury(Within 24 months after index birth; Medicaid claims, hospital discharge, mortality records)
- Number of Participants Whose Child Experienced Concern for Abuse or Neglect(Within 24 months after index birth; Medicaid claims, hospital discharge, mortality records)
- Number of Injuries(Within 24 months after index birth; hospital discharge)
- Number of Participants Whose Child Had an Emergency Department Visit(Within 24 months after index birth; hospital discharge)
- Number of Child Emergency Department Visits(Within 24 months after index birth; hospital discharge)
- Number of Participants Experiencing Child Mortality(Within 24 months after index birth; Mortality records)
- Number of Participants With Recommended Number of Well-child Visits(At 15 months after index birth; Medicaid claims)
- Number of Participants With Lead Screening(At 15 months after index birth; Medicaid claims)
- Number of Participants With Developmental Screening(At 12 months after index birth; Medicaid claims)
- Number of Participants With a Dental Visit(Within 24 months after index birth; Medicaid claims and dental records)
- Number of Participants With Fluoride Treatment(Within 24 months after index birth; Medicaid claims and dental records)
- Number of Participants With an Inter-birth Interval of < 24 Months(Within 24 months after index birth; vital records)
- Number of Participants With an Inter-birth Interval of < 15 Months(Within 15 months after index birth; vital records)
- Inter-birth Interval(60 months after index birth; vital records)
- 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 a Highly or Moderately Effective Method of Contraception (6 Weeks)(Within 6 weeks after index birth; Medicaid claims, hospital discharge)
- 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 With a Family Planning Visit (1 Year)(Within 12 months after index birth; Medicaid claims, hospital discharge)
- 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)
- Number of Participants Who Received a Postpartum Intrauterine Device Insertion (1 Year)(Within 12 months after index birth; Medicaid claims, hospital discharge)
- Time to First Take-up of Family Planning Counseling or Service(Within 24 months after index birth; Medicaid claims, hospital discharge)
- Time to First Take-up of Highly Effective Contraceptive Method(Within 24 months after index birth; Medicaid claims, hospital discharge)
- 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 Months Receiving SNAP or Temporary Assistance for Needy Families (TANF) Benefits(Within 24 months after index birth; South Carolina Department of Social Services data)
- Number of Participants With SNAP or TANF Benefit Churn(Within 24 months after index birth; South Carolina Department of Social Services data)