Effect of a Community Agency-Administered Nurse Home Visitation Program on Program Use and Maternal and Infant Health Outcomes: A Randomized Clinical Trial.

Importance: Postnatal home visitation to support parenting and infant healthy development is becoming increasingly common based on university efficacy studies, but effectiveness when disseminated by communities is not clear. Objective: To test implementation and impact of the Family Connects (FC) program when administered by a community agency. Design, Setting, and Participants: In this randomized clinical trial, births were randomly assigned to receive FC or treatment as usual. Independent evaluation was conducted through parent interviews and review of health and child protective services records. Interviewers were blind to the experimental condition of participants, and participants were blind about the purpose of the interview as an intervention evaluation. A total of 936 consecutive residential births at Duke University Hospital from January 1, 2014, through June 30, 2014, were included. Data were analyzed preliminarily for reporting to funders in early 2015 before all birth-record covariates were scored and were analyzed more comprehensively in mid-2019 after administrative birth and child protective service records became available. Interventions: The goals of the FC brief universal program were to assess family-specific needs, complete brief interventions, and connect families with community resources. Community agencies and families were aligned through an electronic data system. Main Outcomes and Measures: Case records documented program penetration and quality. The primary outcome was child protective services investigations for maltreatment. Secondary outcomes were the number of sustained community connections, maternal mental health, parenting behavior, infant well-child care visits and maternal postpartum care compliance, and emergency health care utilization. Results: Of 936 births, 451 infants (48.2%) were female and 433 (46.3%) were from racial/ethnic minority groups. In all, 456 births (46.5%) were randomized to the intervention and 480 (53.5%) were randomized to the control. All analyses were based on intention to treat. The impact analysis included 158 intervention families and 158 control families. Intervention penetration was 76%, adherence to the protocol was 90%, and independent agreement in scoring (κ) was 0.75. Nurses identified and addressed minor problems for 52% of families and connected an additional 42% to community resources. Analysis of the primary outcome of child abuse investigations revealed a mean (SD) of 0.10 (0.30) investigations for the intervention group vs 0.18 (0.56) investigations for the control group (b = -0.09; 90% CI, -0.01 to -0.12; 95% CI, -0.18 to 0.01; P = .07). The intervention group's rate of possible maternal anxiety or depression was 18.2% vs 25.9% for the control group (b = -7.70; 90% CI, -15.2 to -0.1; 95% CI, -16.6 to 1.3; P = .09). Conclusions and Relevance: This study indicates that a nurse home visitation program for families of newborns can be implemented by a community agency with high penetration and quality. Other communities could benefit from wider dissemination of the program provided that quality remains strong and evaluation continues. Trial Registration: ClinicalTrials.gov identifier: NCT01843036.