Clinical trial NCT03360539: Nurse-Family Partnership Impact Evaluation in South Carolina
Official title: Nurse-Family Partnership Impact Evaluation in South Carolina
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Preterm Birth
Injuries
Maternal Behavior
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: Abdul Latif Jameel Poverty Action Lab
name: University of Chicago
First posted: 2017-12-04
Enrollment: 5820
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite birth outcome
timeFrame: 0-7 days after birth; vital records, mortality records, and fetal death records
measure: Major injury or concern for abuse or neglect
timeFrame: 24 months postpartum; Medicaid claims or hospital discharge data
measure: Inter-birth interval of < 21 months
timeFrame: 21 months postpartum; vital records
Secondary outcomes:
measure: Small for gestational age (SGA)
timeFrame: At birth; vital records
measure: Large for gestational age (LGA)
timeFrame: At birth; vital records
measure: Low birth weight (LBW)
timeFrame: At birth; vital records
measure: Very low birth weight
timeFrame: At birth; vital records
measure: Birth weight (continuous)
timeFrame: At birth; vital records
measure: Preterm birth
timeFrame: At birth; vital records
measure: Extremely preterm birth
timeFrame: At birth; vital records
measure: Gestational age at birth
timeFrame: At birth; vital records
measure: Perinatal mortality
timeFrame: 1 month postpartum; mortality records and fetal death records
measure: NICU admission of at least overnight
timeFrame: At birth; hospital discharge
measure: Neonatal morbidity
timeFrame: At birth; hospital discharge
measure: Cesarean delivery
timeFrame: At birth; vital records
measure: Severe acute maternal morbidity
timeFrame: At birth; hospital discharge
measure: Maternal mortality
timeFrame: One year postpartum; mortality records
measure: Neonatal abstinence disorder (NAS) or maternal drug/substance abuse
timeFrame: Two years postpartum; Medicaid claims, hospital discharge
measure: Maternal experience of violence or homicide
timeFrame: 24 months postpartum; Medicaid claims, mortality records
measure: Postpartum visit
timeFrame: 12 weeks postpartum; Medicaid claims
measure: Adequate prenatal care
timeFrame: At birth; vital records
measure: Number of emergency department visits during pregnancy
timeFrame: At birth; hospital discharge
measure: Dental visit during pregnancy
timeFrame: At birth; Medicaid claims and dental records
measure: Ultrasound at 18-22 weeks
timeFrame: At birth; Medicaid claims
measure: Prenatal screenings
timeFrame: At birth; Medicaid claims
measure: Mental health diagnosis or outpatient treatment
timeFrame: During pregnancy or 60 days postpartum; Medicaid claims
measure: Diagnosis of depression/anxiety/stress reaction
timeFrame: During pregnancy or 60 days postpartum; Medicaid claims
measure: Antidepressant prescription
timeFrame: During pregnancy or 60 days postpartum; Medicaid claims
measure: Outpatient mental health visit
timeFrame: During pregnancy or 60 days postpartum; Medicaid claims
measure: Mental health treatment follow up
timeFrame: 120 days of treatment initiation; Medicaid claims
measure: Any mental health related emergency/inpatient visit
timeFrame: During pregnancy or 12 months postpartum; Hospital discharge
measure: Number of mental health related emergency/inpatient visits
timeFrame: During pregnancy or 12 months postpartum; Hospital discharge
measure: Health care encounter or mortality associated with ICD codes indicating major injury
timeFrame: 24 months of life; Medicaid claims, hospital discharge, mortality records
measure: Health care encounter or mortality associated with ICD codes indicating concern for abuse or neglect
timeFrame: 24 months of life; Medicaid claims, hospital discharge, mortality records
measure: Number of injuries
timeFrame: 24 months of life; hospital discharge
measure: Any emergency department visit for child
timeFrame: 24 months of life; hospital discharge
measure: Number of emergency department visits
timeFrame: 24 months of life; hospital discharge
measure: Child mortality
timeFrame: 24 months; Mortality records
measure: Well-child visits
timeFrame: 15 months; Medicaid claims
measure: Lead screening
timeFrame: 15 months; Medicaid claims
measure: Developmental screening
timeFrame: 12 months; Medicaid claims
measure: Dental visit
timeFrame: 24 months; Medicaid claims and dental records
measure: Flouride treatment
timeFrame: 24 months; Medicaid claims and dental records
measure: Inter-birth interval of < 24 months
timeFrame: 24 months; vital records
measure: Inter-birth interval of < 15 months
timeFrame: 15 months; vital records
measure: Inter-birth interval
timeFrame: 60 months; vital records
measure: Family planning visit (6 weeks)
timeFrame: 6 weeks postpartum; Medicaid claims, hospital discharge
measure: Received a highly or moderately effective method of contraception (6 weeks)
timeFrame: 6 weeks postpartum; Medicaid claims, hospital discharge
measure: Received immediate postpartum long-acting reversible contraception (6 weeks)
timeFrame: 6 weeks postpartum; Medicaid claims, hospital discharge
measure: Family planning visit (1 year)
timeFrame: 12 months postpartum; Medicaid claims, hospital discharge
measure: Received a highly or moderately effective method of contraception (1 year)
timeFrame: 12 months postpartum; Medicaid claims, hospital discharge
measure: Postpartum intrauterine device insertion (1 year)
timeFrame: 12 months postpartum; Medicaid claims, hospital discharge
measure: Time to first take-up of family planning counseling or service
timeFrame: 24 months postpartum; Medicaid claims, hospital discharge
measure: Time to first take-up of highly effective contraceptive method
timeFrame: 24 months postpartum; Medicaid claims, hospital discharge
measure: Receipt of SNAP or WIC
timeFrame: During pregnancy, assessed up to 42 weeks; South Carolina Department of Social Services data and birth certificate data respectively
measure: Number of months receiving SNAP or TANF
timeFrame: 24 months postpartum; South Carolina Department of Social Services data
measure: Measure of SNAP or TANF benefit churn
timeFrame: 24 months postpartum; South Carolina Department of Social Services data
Other outcomes:
Locations:
city: Anderson
country: United States
facility: Nurse-Family Partnership of Anderson County
state: South Carolina
city: Charleston
country: United States
facility: NFP of Berkeley/Charleston/Dorchester Counties
state: South Carolina
city: Columbia
country: United States
facility: Nurse-Family Partnership of Lexington-Richland Co.
state: South Carolina
city: Conway
country: United States
facility: Nurse-Family Partnership of Horry County
state: South Carolina
city: Florence
country: United States
facility: McLeod Health NFP
state: South Carolina
city: Greenville
country: United States
facility: Nurse-Family Partnership of Greenville County
state: South Carolina
city: Greenwood
country: United States
facility: Carolina Health Centers NFP
state: South Carolina
city: Orangeburg
country: United States
facility: Family Solutions of the Lowcountry NFP
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Regional Hospital NFP
state: South Carolina
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Margaret McConnell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McConnell MA, Rokicki S, Ayers S, Allouch F, Perreault N, Gourevitch RA, Martin MW, Zhou RA, Zera C, Hacker MR, Chien A, Bates MA, Baicker K. Effect of an Intensive Nurse Home Visiting Program on Adverse Birth Outcomes in a Medicaid-Eligible Population: A Randomized Clinical Trial. JAMA. 2022 Jul 5;328(1):27-37. doi: 10.1001/jama.2022.9703.
citation: McConnell MA, Zhou RA, Martin MW, Gourevitch RA, Steenland M, Bates MA, Zera C, Hacker M, Chien A, Baicker K. Protocol for a randomized controlled trial evaluating the impact of the Nurse-Family Partnership's home visiting program in South Carolina on maternal and child health outcomes. Trials. 2020 Dec 4;21(1):997. doi: 10.1186/s13063-020-04916-9.