Nurse-Family Partnership Impact Evaluation in South Carolina

NCT03360539 | Active Not Recruiting Results

• 1 other identifier: IRB15-2939
• Study Type: interventional
• Target: 5,670
• Locations: 1 country
• Sites: 9

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.

Conditions

Preterm Birth; Injuries; Maternal Behavior

Outcome Measures

Primary Outcomes (3)

• Number of Participants With a 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 index birth; vital records, mortality records, and fetal death records

• Number of Participants Whose Child Experienced a Major Injury or Concern for Abuse or Neglect

  Composite of at least one health care encounter or mortality associated with International Classification of Diseases (ICD) codes indicating either major injury, or, concern for abuse or neglect for the participant's index child(ren).

  within 24 months after index birth; Medicaid claims or hospital discharge data

• Number of Participants With an Inter-birth Interval of < 21 Months

  Having a subsequent birth within the first 21 months of the index birth

  within 21 months after index birth; vital records

Secondary Outcomes (57)

• Number of Participants With an Infant Born Small for Gestational Age (SGA)

  At index birth; vital records

• Number of Participants With an Infant Born Large for Gestational Age (LGA)

  At index birth birth; vital records

• Number of Participants With an Infant Born With Low Birth Weight (LBW)

  At index birth; vital records

• Number of Participants With an Infant With Very Low Birth Weight

  At index birth; vital records

• Birth Weight (Continuous)

  At index birth; vital records

Study Arms (2)

Treatment-NFP

EXPERIMENTAL

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.

Behavioral: Nurse-Family Partnership

Control

NO INTERVENTION

Control group members have access to the standard of care and whatever other programs and services are available in the community.

Interventions

Nurse-Family Partnership BEHAVIORAL

Treatment-NFP

Eligibility Criteria

• Age: 15 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Harvard School of Public Health (HSPH): lead
• University of Chicago: collaborator
• Abdul Latif Jameel Poverty Action Lab: collaborator

Study Sites (9)

Nurse-Family Partnership of Anderson County

Anderson, South Carolina, 29625, United States

Location

NFP of Berkeley/Charleston/Dorchester Counties

Charleston, South Carolina, 29405, United States

Location

Nurse-Family Partnership of Lexington-Richland Co.

Columbia, South Carolina, 29204, United States

Location

Nurse-Family Partnership of Horry County

Conway, South Carolina, 29526, United States

Location

McLeod Health NFP

Florence, South Carolina, 29506, United States

Location

Nurse-Family Partnership of Greenville County

Greenville, South Carolina, 29605, United States

Location

Carolina Health Centers NFP

Greenwood, South Carolina, 29646, United States

Location

Family Solutions of the Lowcountry NFP

Orangeburg, South Carolina, 29118, United States

Location

Spartanburg Regional Hospital NFP

Spartanburg, South Carolina, 29303, United States

Location

Related Publications (6)

• Swanson K, Ayers S, Oviedo D, Zhou RA, Bates MA, Baicker K, Chien AT, McConnell M. Intensive Nurse Home Visiting and Early Childhood Outcomes: A Randomized Clinical Trial. JAMA Pediatr. 2025 Aug 1;179(8):857-866. doi: 10.1001/jamapediatrics.2025.1600.

  PMID: 40522648 DERIVED

• Rokicki S, Oviedo D, Perreault N, Bates MA, Zhou RA, Baicker K, McConnell MA. Impact of nurse home visiting on take-up of social safety net programs in a Medicaid population. Health Aff Sch. 2025 Apr 2;3(4):qxaf038. doi: 10.1093/haschl/qxaf038. eCollection 2025 Apr.

  PMID: 40177469 DERIVED

• Rokicki S, Oviedo D, Perreault N, Zera C, McGregor AJ, Bates MA, Zhou RA, Baicker K, McConnell MA. Home Visits and the Use of Routine and Emergency Postpartum Care Among Low-Income People: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2024 Dec 2;7(12):e2451605. doi: 10.1001/jamanetworkopen.2024.51605.

  PMID: 39714843 DERIVED

• Steenland MW, Oviedo D, Bates MA, Zhou A, Zera C, Baicker K, McConnell MA. Effect of an Intensive Nurse Home Visiting Program on Postpartum Contraceptive Use and Birth Spacing: A Randomized Controlled Trial. Obstet Gynecol. 2025 Jan 1;145(1):3-12. doi: 10.1097/AOG.0000000000005786. Epub 2024 Nov 14.

  PMID: 39671266 DERIVED

• 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.

  PMID: 35788794 DERIVED

• 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.

  PMID: 33276816 DERIVED

MeSH Terms

Conditions

Premature Birth; Wounds and Injuries

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Limitations and Caveats

The study ended enrollment earlier than planned on March 17, 2020, due to safety concerns arising from the Coronavirus disease 2019 (COVID-19) pandemic. The original plan was to enroll 6,000 mothers (4,000 in the treatment group and 2,000 in the control group) over a four-year period (April 2016-2020), with NFP services provided through the children's second birthday (2016-2022). At the close of enrollment, a total of 5,670 participants had been enrolled.

Results Point of Contact

• Title: Dr. Margaret McConnell
• Organization: Harvard University

mmcconne@hsph.harvard.edu

6174321232

Study Officials

• Margaret McConnell, PhD

  Harvard School of Public Health (HSPH)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Global Health Economics

Model Details: 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.

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: December 4, 2017
• Study Start: April 1, 2016
• Primary Completion: April 1, 2023
• Study Completion (Estimated): April 1, 2046
• Last Updated: December 12, 2025
• Results First Posted: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)