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

Abstract

Background Policy-makers are increasingly seeking rigorous evidence on the impact of programs that go beyond typical health care settings to improve outcomes for low-income families during the critical period around the transition to parenthood and through early childhood. Methods This study is a randomized controlled trial evaluating the impact of the Nurse-Family Partnership’s expansion in South Carolina. The scientific trial was made possible by a “Pay for Success” program embedded within a 1915(b) Waiver from Medicaid secured by the South Carolina Department of Health and Human Services. This protocol describes study procedures and defines primary and secondary health-related outcomes that can be observed during the intervention period (including pregnancy through the child’s first 2 years of life). Primary study outcomes include (1) a composite indicator for adverse birth outcomes including being born small for gestational age, low birth weight (less than 2500 g), preterm birth (less than 37 weeks’ gestation), or perinatal mortality (fetal death at or after 20 weeks of gestation or mortality in the first 7 days of life), (2) a composite outcome indicating health care utilization or mortality associated with major injury or concern for abuse or neglect occurring during the child’s first 24 months of life, and (3) an indicator for an inter-birth interval of < 21 months. Secondary outcomes are defined similarly in three domains: (1) improving pregnancy and birth outcomes, (2) improving child health and development, and (3) altering the maternal life course through changes in family planning. Discussion Evidence from this trial on the impact of home visiting services delivered at scale as part of a Medicaid benefit can provide policy-makers and stakeholders with crucial information about the effectiveness of home visiting programs in improving health and well-being for low-income mothers and children and about novel financing mechanisms for cross-silo interventions. Trial registration The trial was registered prospectively on the American Economic Association Trial Registry (the primary registry for academic economists doing policy trials) on 16 February 2016 (AEARCTR-0001039). ClinicalTrials.gov NCT03360539. Registered on 28 November 2017.

Effect of an Intensive Nurse Home Visiting Program on Adverse Birth Outcomes in a Medicaid-Eligible Population

“…Additional secondary outcomes not reported in this article include health care utilization, maternal mental health, postpartum maternal health, child health, utilization of family planning, and utilization of social services. 13 The analytical sample for the primary outcome was participants with an "index" live birth or fetal death in matched vital records within 120 days of the expected delivery date reported on the baseline survey (eMethods in Supplement 2, section 5). Outcomes for participants who did not meet this criterion or who withdrew from the study were excluded.…”

“…Pregnant individuals either self-referred to the program or were referred through channels including clinicians, schools, or Medicaid to 1 of 9 program-implementing sites embedded in government agencies and hospital systems throughout South Carolina (eMethods in Supplement 2, section 3). 13 Program staff assessed potential participants' eligibility. Eligible participants provided written informed consent and completed a baseline survey that included information on demographic characteristics, socioeconomics, health behaviors, and physical and mental health.…”

“…The original IRB protocol (Supplement 1, section 1) and preanalysis plan (Supplement 1, section 2) were supplemented with a detailed published study protocol. 13,14 The timing of trial registration and selection of outcomes are detailed in the eMethods (Supplement 2, section 2). Study participants were randomly assigned either to an intervention group that was offered access to the program or to a control group (Figure 1).…”

“…11 Motivated in part by this evidence and by South Carolina's preterm birth rate, which in 2016 was the sixth highest in the US, 12 the state began to offer program services to Medicaideligible nulliparous women through a Medicaid 1915(b) waiver. 13 Philanthropic funding supported the scale-up of the project through a "Pay for Success" model that embedded a randomized clinical trial of program effectiveness. The objective of this study was to determine the effect of an intensive nurse home visiting program on a composite outcome of any of preterm birth, low birth weight, small for gestational age, or perinatal mortality.…”

Transitioning to telehealth due to COVID‐19: Maintaining model fidelity in a home visiting program for parents of vulnerable infants

“…Until 2020, the home visiting as a field as a whole had not embraced telehealth as a mode of intervention. Some models had used phone calls or telehealth visits as a potential method of connection when necessary or preferred (e.g., Nurse Family Partnership; McConnell et al., 2020 ), but, to our knowledge, evidence‐based home visiting models had not been rigorously tested for efficacy when services were administered via videoconferencing or other remote connections. As in‐person visits were restricted due to safety concerns, home visiting model leadership across the United States quickly developed guidance and best practices for maintaining relationships with families as home visits were disrupted (National Alliance of Home Visiting Models, 2020 ; Rapid Response Virtual Home Visiting, 2020 ).…”