Manuscript Detail | Home Visiting Evidence of Effectiveness

McConnell, M. A., Rokicki, S., Ayers, S., Allouch, F., Perreault, N., Gourevitch, R. A., Martin, M. W., Zhou, R., A., Zera, C., Hacker, M. R., Chien, A., Bates, M. A., & Baicker, K. (2022). Effect of an intensive nurse home visiting program on adverse birth outcomes in a Medicaid-eligible population: A randomized clinical trial. JAMA, 328(1), 27–37. https://doi.org/10.1001/jama.2022.9703

Manuscript screening details
Screening decision	Screening conclusion	HomVEE procedures and standards version
Passes screens	Eligible for review	Version 2

Study design details
Rating	Design	Attrition	Baseline equivalence	Compromised randomization	Confounding factors	Valid, reliable measure(s)
High	Randomized controlled trial	Low	Not assessed for randomized controlled trials with low attrition	No	No	Yes

Notes:

Information on sample sizes and adjusted means for the study’s findings is based on correspondence with the authors.

Study characteristics
Study participants	Participants could refer themselves to the program or be referred through clinicians, schools, or Medicaid. Eligible participants had to be pregnant (< 28 weeks’ gestation) with no previous live births, income-eligible for Medicaid during pregnancy, and residing in a program-served county in South Carolina. Participants were ineligible if they were age 14 or younger or were incarcerated or in a lockdown facility. They were randomized to either the Nurse-Family Partnership intervention (3,806 participants) or the comparison condition (1,864 participants). Four thousand nine hundred and sixty-six mothers were included in the analyses in this manuscript (3,319 in the intervention group and 1,647 in the comparison group). Participants were in the study from the time of enrollment at pregnancy until the child was 24 months old. Outcomes presented in this manuscript were measured at the child’s birth. In the study, 55 percent of the participants were Black and 35 percent were White, and at enrollment, 82 percent were age 19 or older. Thirty-five percent had a high school diploma or equivalent, whereas 42 percent had some college, a college degree, or postgraduate training.
Setting	The study took place in South Carolina.
Intervention services	As described in this manuscript, the Nurse-Family Partnership intervention consisted of prenatal and infancy home visits until the focal child was 24 months old. All participants in the intervention received four weekly visits at the beginning of the intervention to establish a relationship with the nurse. Nurses tailored the content of the visit to clients’ strengths, risks, and preferences; and used motivational interviews, educational tools, health assessments, and goal-setting related to prenatal health, child health and development, and maternal life course. They encouraged the mothers to use available health care and made referrals to health and social services. The first four home visits after enrollment were conducted every week, and follow-up visits were scheduled every other week until delivery. Visits lasted between 60 to 90 minutes, and nurses were trained to flexibly support their clients if additional or fewer visits were necessary. Intervention services were provided in English and Spanish if bilingual nurses were available, and translation services were available for clients who spoke other languages.
Comparison conditions	Participants assigned to the comparison condition were not eligible to receive home visits through Nurse-Family Partnership. They received usual care, including access to all other community and medical services. They were provided with a list of available community resources.
Subgroups examined	This field lists subgroups examined in the manuscript (even if they were not replicated in other samples and not reported on the summary page for this model’s report). • Mother has vulnerability (yes or no) • Race/ethnicity (Black or non-Black)
Funding sources	This research was supported by the Children’s Trust of South Carolina, Arnold Ventures, The Duke Endowment, BlueCross BlueShield Foundation of South Carolina, and the Abdul Latif Jameel Poverty Action Lab North America Health Care Delivery Initiative.
Author affiliation	The study authors are affiliated with Harvard T.H. Chan School of Public Health, Boston, Abdul Latif Jameel Poverty Action Lab, Massachusetts Institute of Technology, Rutgers School of Public Health, Harvard Graduate School of Education, Tulane School of Public Health and Tropical Medicine, Harvard Medical School, RAND Corporation, Beth Israel Deaconess Medical Center, Boston Children's Hospital, State of California Office of Cradle-to-Career Data, National Bureau of Economic Research, and University of Chicago Harris School of Public Policy. HomVEE is not aware of any relationship between the authors and the home visiting model developer or distributor.
Peer reviewed	Yes

Study Registration:

Clinicaltrials.gov Identifier: NCT03360539. Study registration was assessed by HomVEE for Clinicaltrials.gov beginning with the 2014 review, and for other registries beginning with the 2021 review.

Findings that rate moderate or high

Child health
Rating	Outcome measure	Effect	Sample	Timing of follow-up	Sample size	Intervention group	Comparison group	Group difference	Effect size	Statistical significance	Notes
High	Adverse birth outcome composite	FavorableUnfavorable or ambiguousNo Effect	NFP vs. usual care RCT, South Carolina 2016-2021, full sample	Child's birth	4,966 children	Adjusted proportion = 0.27	Adjusted proportion = 0.26	Mean difference = 0.01	Study reported = 0.02	Not statistically significant, p= ≥0.05	Submitted by user on Fri, 03/15/2019 - 14:29 Negative effect is favorable to the intervention.
High	Extremely preterm birth	FavorableUnfavorable or ambiguousNo Effect	NFP vs. usual care RCT, South Carolina 2016-2021, full sample	Child's birth	4,932 children	Adjusted proportion = 0.01	Adjusted proportion = 0.01	Mean difference = 0.00	Study reported = 0.00	Not statistically significant, p= ≥0.05	Submitted by user on Fri, 03/15/2019 - 14:29 Negative effect is favorable to the intervention.
High	Large for gestational age	FavorableUnfavorable or ambiguousNo Effect	NFP vs. usual care RCT, South Carolina 2016-2021, full sample	Child's birth	4,932 children	Adjusted proportion = 0.05	Adjusted proportion = 0.06	Mean difference = -0.01	Study reported = -0.11	Not statistically significant, p= ≥0.05
High	Mean birth weight (in grams)	FavorableUnfavorable or ambiguousNo Effect	NFP vs. usual care RCT, South Carolina 2016-2021, full sample	Child's birth	4,932 children	Adjusted mean = 3086.10	Adjusted mean = 3093.90	Mean difference = -7.80	HomVEE calculated = -0.01	Not statistically significant, p = 0.67	Submitted by nwu on Fri, 04/12/2019 - 18:31 Statistical significance is based on HomVEE calculations.
High	Mean gestational age (in weeks)	FavorableUnfavorable or ambiguousNo Effect	NFP vs. usual care RCT, South Carolina 2016-2021, full sample	Child's birth	4,932 children	Adjusted mean = 38.20	Adjusted mean = 38.10	Mean difference = 0.10	HomVEE calculated = 0.04	Not statistically significant, p = 0.15	Submitted by nwu on Fri, 04/12/2019 - 18:31 Statistical significance is based on HomVEE calculations.
High	Neonatal morbidity	FavorableUnfavorable or ambiguousNo Effect	NFP vs. usual care RCT, South Carolina 2016-2021, full sample	Child's birth	4,932 children	Unadjusted proportion = 0.10	Unadjusted proportion = 0.09	Mean difference = 0.01	Study reported = 0.09	Not statistically significant, p= ≥0.05	Submitted by user on Fri, 03/15/2019 - 14:29 Negative effect is favorable to the intervention.
High	Overnight NICU stay	FavorableUnfavorable or ambiguousNo Effect	NFP vs. usual care RCT, South Carolina 2016-2021, full sample	Child's birth	4,543 children	Adjusted proportion = 0.08	Adjusted proportion = 0.09	Mean difference = -0.01	Study reported = -0.06	Not statistically significant, p= ≥0.05	Submitted by user on Fri, 03/15/2019 - 14:29 Negative effect is favorable to the intervention.
High	Very low birth weight	FavorableUnfavorable or ambiguousNo Effect	NFP vs. usual care RCT, South Carolina 2016-2021, full sample	Child's birth	4,932 children	Adjusted proportion = 0.02	Adjusted proportion = 0.03	Mean difference = -0.01	Study reported = -0.17	Not statistically significant, p= ≥0.05	Submitted by user on Fri, 03/15/2019 - 14:29 Negative effect is favorable to the intervention.

Maternal health
Rating	Outcome measure	Effect	Sample	Timing of follow-up	Sample size	Intervention group	Comparison group	Group difference	Effect size	Statistical significance	Notes
High	Cesarean delivery	FavorableUnfavorable or ambiguousNo Effect	NFP vs. usual care RCT, South Carolina 2016-2021, full sample	Child's birth	4,932 mothers	Adjusted proportion = 0.31	Adjusted proportion = 0.33	Mean difference = -0.02	Study reported = -0.06	Not statistically significant, p= ≥0.05	Submitted by user on Fri, 03/15/2019 - 14:29 Negative effect is favorable to the intervention.
High	Severe maternal morbidity	FavorableUnfavorable or ambiguousNo Effect	NFP vs. usual care RCT, South Carolina 2016-2021, full sample	Child's birth	5,158 mothers	Adjusted proportion = 0.02	Adjusted proportion = 0.01	Mean difference = 0.00	Study reported = 0.13	Not statistically significant, p= ≥0.05	Submitted by user on Fri, 03/15/2019 - 14:29 Negative effect is favorable to the intervention.