Nurse-Family Partnership Impact Evaluation in South Carolina

Preterm Birth Clinical Trial

— NFP  

Official title:

Nurse-Family Partnership Impact Evaluation in South Carolina

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03360539
• Other study ID #: IRB15-2939
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2016
• Est. completion date: April 1, 2046

Study information

• Verified date: May 2023
• Source: Harvard School of Public Health (HSPH)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5820
• Est. completion date: April 1, 2046
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 55 Years

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

Related Conditions & MeSH terms

• Injuries
• Maternal Behavior
• Premature Birth
• Preterm Birth

Intervention

Behavioral:
• Nurse-Family Partnership

Locations

Country	Name	City	State
United States	Nurse-Family Partnership of Anderson County	Anderson	South Carolina
United States	NFP of Berkeley/Charleston/Dorchester Counties	Charleston	South Carolina
United States	Nurse-Family Partnership of Lexington-Richland Co.	Columbia	South Carolina
United States	Nurse-Family Partnership of Horry County	Conway	South Carolina
United States	McLeod Health NFP	Florence	South Carolina
United States	Nurse-Family Partnership of Greenville County	Greenville	South Carolina
United States	Carolina Health Centers NFP	Greenwood	South Carolina
United States	Family Solutions of the Lowcountry NFP	Orangeburg	South Carolina
United States	Spartanburg Regional Hospital NFP	Spartanburg	South Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Harvard School of Public Health (HSPH)	Abdul Latif Jameel Poverty Action Lab, University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	0-7 days after birth; vital records, mortality records, and fetal death records
Primary	Major injury or concern for abuse or neglect	Composite of at least one health care encounter or mortality associated with ICD codes indicating either major injury, or, concern for abuse or neglect	24 months postpartum; Medicaid claims or hospital discharge data
Primary	Inter-birth interval of < 21 months	Having a subsequent birth within the first 21 months of the index birth	21 months postpartum; vital records
Secondary	Small for gestational age (SGA)	Infant birth weight below the 10th percentile for infants of the same gestational age	At birth; vital records
Secondary	Large for gestational age (LGA)	Infant birth weight above the 90th percentile for infants of the same gestational age	At birth; vital records
Secondary	Low birth weight (LBW)	Infant born with a birth weight of less than 2500 grams	At birth; vital records
Secondary	Very low birth weight	Infant born with a birth weight of less than 1500 grams	At birth; vital records
Secondary	Birth weight (continuous)	A continuous measure of infant birth weight (grams)	At birth; vital records
Secondary	Preterm birth	Infant born before 37 weeks' gestation (obstetric estimate)	At birth; vital records
Secondary	Extremely preterm birth	Infant born before 28 weeks' gestation	At birth; vital records
Secondary	Gestational age at birth	Gestational age at birth in weeks (continuous)	At birth; vital records
Secondary	Perinatal mortality	Fetal death at or after 20 weeks of gestation or mortality in the first 7 days of life	1 month postpartum; mortality records and fetal death records
Secondary	NICU admission of at least overnight	Infant admitted to the neonatal intensive care unit (NICU) for at least one night	At birth; hospital discharge
Secondary	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.	At birth; hospital discharge
Secondary	Cesarean delivery	Cesarean delivery	At birth; vital records
Secondary	Severe acute maternal morbidity	As defined by the CDC	At birth; hospital discharge
Secondary	Maternal mortality	Death of mother within one year postpartum	One year postpartum; mortality records
Secondary	Neonatal abstinence disorder (NAS) or maternal drug/substance abuse	Evidence of NAS or maternal drug or substance abuse in first two years postpartum	Two years postpartum; Medicaid claims, hospital discharge
Secondary	Maternal experience of violence or homicide	Includes any ICD code for healthcare encounter associated with experiencing violence or mortality associated with homicide based on ICD code	24 months postpartum; Medicaid claims, mortality records
Secondary	Postpartum visit	Postpartum visit in first 12 weeks after birth	12 weeks postpartum; Medicaid claims
Secondary	Adequate prenatal care	Adequacy of Prenatal Care Utilization Index (APNCU)	At birth; vital records
Secondary	Number of emergency department visits during pregnancy	Number of emergency department visits during pregnancy	At birth; hospital discharge
Secondary	Dental visit during pregnancy	Dental visit during pregnancy (preventive or treatment)	At birth; Medicaid claims and dental records
Secondary	Ultrasound at 18-22 weeks	Ultrasound at 18-22 weeks (anatomy scan)	At birth; Medicaid claims
Secondary	Prenatal screenings	Obstetric panel (D (Rh), RBC antibody screen, CBC, urine culture, urinalysis), STI screenings (HIV, Syphilis, Hep B, Chlamydia if <25, gonorrhea if <25), Group B screening, Glucose screening at 24-28 weeks	At birth; Medicaid claims
Secondary	Mental health diagnosis or outpatient treatment	Diagnosis for depression/anxiety/stress reaction or antidepressant prescription or outpatient mental health visit	During pregnancy or 60 days postpartum; Medicaid claims
Secondary	Diagnosis of depression/anxiety/stress reaction	Diagnosis of depression/anxiety/stress reaction	During pregnancy or 60 days postpartum; Medicaid claims
Secondary	Antidepressant prescription	Antidepressant prescription	During pregnancy or 60 days postpartum; Medicaid claims
Secondary	Outpatient mental health visit	Outpatient mental health visit	During pregnancy or 60 days postpartum; Medicaid claims
Secondary	Mental health treatment follow up	Second antidepressant prescription or outpatient mental health visit within 120 days of treatment initiation ("acute phase")	120 days of treatment initiation; Medicaid claims
Secondary	Any mental health related emergency/inpatient visit	Based on all-listed diagnoses (i.e. primary or secondary) for depression/anxiety/stress reaction	During pregnancy or 12 months postpartum; Hospital discharge
Secondary	Number of mental health related emergency/inpatient visits	Based on all-listed diagnoses (i.e. primary or secondary) for depression/anxiety/stress reaction	During pregnancy or 12 months postpartum; Hospital discharge
Secondary	Health care encounter or mortality associated with ICD codes indicating major injury	Child experiences a major injury	24 months of life; Medicaid claims, hospital discharge, mortality records
Secondary	Health care encounter or mortality associated with ICD codes indicating concern for abuse or neglect	Concern for abuse or neglect of child	24 months of life; Medicaid claims, hospital discharge, mortality records
Secondary	Number of injuries	Number of injuries	24 months of life; hospital discharge
Secondary	Any emergency department visit for child	Child visit to the emergency department	24 months of life; hospital discharge
Secondary	Number of emergency department visits	Total number of child visits to the emergency department	24 months of life; hospital discharge
Secondary	Child mortality	All-cause child mortality in first 24 months of life	24 months; Mortality records
Secondary	Well-child visits	Proportion of recommended well-child visits	15 months; Medicaid claims
Secondary	Lead screening	Child receives at least one lead screening	15 months; Medicaid claims
Secondary	Developmental screening	Child receives at least one developmental screening	12 months; Medicaid claims
Secondary	Dental visit	Child visits the dentist at least once in first 24 months	24 months; Medicaid claims and dental records
Secondary	Flouride treatment	Share of recommended fluoride treatments received by child	24 months; Medicaid claims and dental records
Secondary	Inter-birth interval of < 24 months	Having a subsequent birth within the first 24 months of the index birth	24 months; vital records
Secondary	Inter-birth interval of < 15 months	Having a subsequent birth within the first 15 months of the index birth	15 months; vital records
Secondary	Inter-birth interval	Continuous measure of inter-birth interval	60 months; vital records
Secondary	Family planning visit (6 weeks)	Any family planning-related counseling or service	6 weeks postpartum; Medicaid claims, hospital discharge
Secondary	Received a highly or moderately effective method of contraception (6 weeks)	Received implant, IPP-LARC, LARC, or sterilization and moderately effective contraception to include path, ring, diaphragm, injectables and contraceptive pills	6 weeks postpartum; Medicaid claims, hospital discharge
Secondary	Received immediate postpartum long-acting reversible contraception (6 weeks)	Received Immediate postpartum long-acting reversible contraception in first 6 weeks postpartum	6 weeks postpartum; Medicaid claims, hospital discharge
Secondary	Family planning visit (1 year)	Any family planning-related counseling or service	12 months postpartum; Medicaid claims, hospital discharge
Secondary	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	12 months postpartum; Medicaid claims, hospital discharge
Secondary	Postpartum intrauterine device insertion (1 year)	Postpartum intrauterine device insertion in first 12 months postpartum	12 months postpartum; Medicaid claims, hospital discharge
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	24 months postpartum; Medicaid claims, hospital discharge
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)	24 months postpartum; Medicaid claims, hospital discharge
Secondary	Receipt of SNAP or WIC	Any receipt of Supplemental Nutrition Assistance Program or Special Supplemental Nutrition Program for Women, Infants, and Children during pregnancy	During pregnancy, assessed up to 42 weeks; South Carolina Department of Social Services data and birth certificate data respectively
Secondary	Number of months receiving SNAP or TANF	Total months receiving Supplemental Nutrition Assistance Program or Temporary Assistance for Needy Families	24 months postpartum; South Carolina Department of Social Services data
Secondary	Measure of 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	24 months postpartum; South Carolina Department of Social Services data