Nurse-Family Partnership Impact Evaluation in South Carolina (NFP)

• ClinicalTrials.gov Identifier: NCT03360539
• Recruitment Status: Active, not recruiting
• First Posted: December 4, 2017
• Last Update Posted: May 3, 2023
• Sponsor: Harvard School of Public Health (HSPH)
• Collaborators: Abdul Latif Jameel Poverty Action Lab; University of Chicago
• Information provided by (Responsible Party): Margaret McConnell, Harvard School of Public Health (HSPH)

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Preterm Birth; Injuries; Maternal Behavior	Behavioral: Nurse-Family Partnership	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 5820 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Nurse-Family Partnership Impact Evaluation in South Carolina
• Actual Study Start Date: April 1, 2016
• Actual Primary Completion Date: April 1, 2023
• Estimated Study Completion Date: April 1, 2046

Arms and Interventions

Arm	Intervention/treatment
Experimental: Treatment-NFP; 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
No Intervention: Control; Control group members have access to the standard of care and whatever other programs and services are available in the community.

Outcome Measures

Primary Outcome Measures :

1. Composite birth outcome [ Time Frame: 0-7 days after birth; vital records, mortality records, and fetal death records ]
   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)
2. Major injury or concern for abuse or neglect [ Time Frame: 24 months postpartum; Medicaid claims or hospital discharge data ]
   Composite of at least one health care encounter or mortality associated with ICD codes indicating either major injury, or, concern for abuse or neglect
3. Inter-birth interval of < 21 months [ Time Frame: 21 months postpartum; vital records ]
   Having a subsequent birth within the first 21 months of the index birth

Secondary Outcome Measures :

1. Small for gestational age (SGA) [ Time Frame: At birth; vital records ]
   Infant birth weight below the 10th percentile for infants of the same gestational age
2. Large for gestational age (LGA) [ Time Frame: At birth; vital records ]
   Infant birth weight above the 90th percentile for infants of the same gestational age
3. Low birth weight (LBW) [ Time Frame: At birth; vital records ]
   Infant born with a birth weight of less than 2500 grams
4. Very low birth weight [ Time Frame: At birth; vital records ]
   Infant born with a birth weight of less than 1500 grams
5. Birth weight (continuous) [ Time Frame: At birth; vital records ]
   A continuous measure of infant birth weight (grams)
6. Preterm birth [ Time Frame: At birth; vital records ]
   Infant born before 37 weeks' gestation (obstetric estimate)
7. Extremely preterm birth [ Time Frame: At birth; vital records ]
   Infant born before 28 weeks' gestation
8. Gestational age at birth [ Time Frame: At birth; vital records ]
   Gestational age at birth in weeks (continuous)
9. Perinatal mortality [ Time Frame: 1 month postpartum; mortality records and fetal death records ]
   Fetal death at or after 20 weeks of gestation or mortality in the first 7 days of life
10. NICU admission of at least overnight [ Time Frame: At birth; hospital discharge ]
    Infant admitted to the neonatal intensive care unit (NICU) for at least one night
11. Neonatal morbidity [ Time Frame: At birth; hospital discharge ]
    Assisted ventilation immediately after delivery, assisted ventilation for more than six hours, seizure, receipt of surfactant replacement therapy, and receipt of antibiotics for suspected sepsis.
12. Cesarean delivery [ Time Frame: At birth; vital records ]
    Cesarean delivery
13. Severe acute maternal morbidity [ Time Frame: At birth; hospital discharge ]
    As defined by the CDC
14. Maternal mortality [ Time Frame: One year postpartum; mortality records ]
    Death of mother within one year postpartum
15. Neonatal abstinence disorder (NAS) or maternal drug/substance abuse [ Time Frame: Two years postpartum; Medicaid claims, hospital discharge ]
    Evidence of NAS or maternal drug or substance abuse in first two years postpartum
16. Maternal experience of violence or homicide [ Time Frame: 24 months postpartum; Medicaid claims, mortality records ]
    Includes any ICD code for healthcare encounter associated with experiencing violence or mortality associated with homicide based on ICD code
17. Postpartum visit [ Time Frame: 12 weeks postpartum; Medicaid claims ]
    Postpartum visit in first 12 weeks after birth
18. Adequate prenatal care [ Time Frame: At birth; vital records ]
    Adequacy of Prenatal Care Utilization Index (APNCU)
19. Number of emergency department visits during pregnancy [ Time Frame: At birth; hospital discharge ]
    Number of emergency department visits during pregnancy
20. Dental visit during pregnancy [ Time Frame: At birth; Medicaid claims and dental records ]
    Dental visit during pregnancy (preventive or treatment)
21. Ultrasound at 18-22 weeks [ Time Frame: At birth; Medicaid claims ]
    Ultrasound at 18-22 weeks (anatomy scan)
22. Prenatal screenings [ Time Frame: At birth; Medicaid claims ]
    Obstetric panel (D (Rh), RBC antibody screen, CBC, urine culture, urinalysis), STI screenings (HIV, Syphilis, Hep B, Chlamydia if <25, gonorrhea if <25), Group B screening, Glucose screening at 24-28 weeks
23. Mental health diagnosis or outpatient treatment [ Time Frame: During pregnancy or 60 days postpartum; Medicaid claims ]
    Diagnosis for depression/anxiety/stress reaction or antidepressant prescription or outpatient mental health visit
24. Diagnosis of depression/anxiety/stress reaction [ Time Frame: During pregnancy or 60 days postpartum; Medicaid claims ]
    Diagnosis of depression/anxiety/stress reaction
25. Antidepressant prescription [ Time Frame: During pregnancy or 60 days postpartum; Medicaid claims ]
    Antidepressant prescription
26. Outpatient mental health visit [ Time Frame: During pregnancy or 60 days postpartum; Medicaid claims ]
    Outpatient mental health visit
27. Mental health treatment follow up [ Time Frame: 120 days of treatment initiation; Medicaid claims ]
    Second antidepressant prescription or outpatient mental health visit within 120 days of treatment initiation ("acute phase")
28. Any mental health related emergency/inpatient visit [ Time Frame: During pregnancy or 12 months postpartum; Hospital discharge ]
    Based on all-listed diagnoses (i.e. primary or secondary) for depression/anxiety/stress reaction
29. Number of mental health related emergency/inpatient visits [ Time Frame: During pregnancy or 12 months postpartum; Hospital discharge ]
    Based on all-listed diagnoses (i.e. primary or secondary) for depression/anxiety/stress reaction
30. Health care encounter or mortality associated with ICD codes indicating major injury [ Time Frame: 24 months of life; Medicaid claims, hospital discharge, mortality records ]
    Child experiences a major injury
31. Health care encounter or mortality associated with ICD codes indicating concern for abuse or neglect [ Time Frame: 24 months of life; Medicaid claims, hospital discharge, mortality records ]
    Concern for abuse or neglect of child
32. Number of injuries [ Time Frame: 24 months of life; hospital discharge ]
    Number of injuries
33. Any emergency department visit for child [ Time Frame: 24 months of life; hospital discharge ]
    Child visit to the emergency department
34. Number of emergency department visits [ Time Frame: 24 months of life; hospital discharge ]
    Total number of child visits to the emergency department
35. Child mortality [ Time Frame: 24 months; Mortality records ]
    All-cause child mortality in first 24 months of life
36. Well-child visits [ Time Frame: 15 months; Medicaid claims ]
    Proportion of recommended well-child visits
37. Lead screening [ Time Frame: 15 months; Medicaid claims ]
    Child receives at least one lead screening
38. Developmental screening [ Time Frame: 12 months; Medicaid claims ]
    Child receives at least one developmental screening
39. Dental visit [ Time Frame: 24 months; Medicaid claims and dental records ]
    Child visits the dentist at least once in first 24 months
40. Flouride treatment [ Time Frame: 24 months; Medicaid claims and dental records ]
    Share of recommended fluoride treatments received by child
41. Inter-birth interval of < 24 months [ Time Frame: 24 months; vital records ]
    Having a subsequent birth within the first 24 months of the index birth
42. Inter-birth interval of < 15 months [ Time Frame: 15 months; vital records ]
    Having a subsequent birth within the first 21 months of the index birth
43. Inter-birth interval [ Time Frame: 60 months; vital records ]
    Continuous measure of inter-birth interval
44. Family planning visit (6 weeks) [ Time Frame: 6 weeks postpartum; Medicaid claims, hospital discharge ]
    Any family planning-related counseling or service
45. Received a highly or moderately effective method of contraception (6 weeks) [ Time Frame: 6 weeks postpartum; Medicaid claims, hospital discharge ]
    Received implant, IPP-LARC, LARC, or sterilization and moderately effective contraception to include path, ring, diaphragm, injectables and contraceptive pills
46. Received immediate postpartum long-acting reversible contraception (6 weeks) [ Time Frame: 6 weeks postpartum; Medicaid claims, hospital discharge ]
    Received Immediate postpartum long-acting reversible contraception in first 6 weeks postpartum
47. Family planning visit (1 year) [ Time Frame: 12 months postpartum; Medicaid claims, hospital discharge ]
    Any family planning-related counseling or service
48. Received a highly or moderately effective method of contraception (1 year) [ Time Frame: 12 months postpartum; Medicaid claims, hospital discharge ]
    Received implant, IPP-LARC, LARC, or sterilization and moderately effective contraception to include path, ring, diaphragm, injectables and contraceptive pills
49. Postpartum intrauterine device insertion (1 year) [ Time Frame: 12 months postpartum; Medicaid claims, hospital discharge ]
    Postpartum intrauterine device insertion in first 12 months postpartum
50. Time to first take-up of family planning counseling or service [ Time Frame: 24 months postpartum; Medicaid claims, hospital discharge ]
    Months from pregnancy to first take up of family planning counseling or service
51. Time to first take-up of highly effective contraceptive method [ Time Frame: 24 months postpartum; Medicaid claims, hospital discharge ]
    Months from discharge to first take up of highly effective contraceptive method (include implant, IPP-LARC, LARC, or sterilization)
52. Receipt of SNAP or WIC [ Time Frame: During pregnancy, assessed up to 42 weeks; South Carolina Department of Social Services data and birth certificate data respectively ]
    Any receipt of Supplemental Nutrition Assistance Program or Special Supplemental Nutrition Program for Women, Infants, and Children during pregnancy
53. Number of months receiving SNAP or TANF [ Time Frame: 24 months postpartum; South Carolina Department of Social Services data ]
    Total months receiving Supplemental Nutrition Assistance Program or Temporary Assistance for Needy Families
54. Measure of SNAP or TANF benefit churn [ Time Frame: 24 months postpartum; South Carolina Department of Social Services data ]
    Receiving Supplemental Nutrition Assistance Program or Temporary Assistance for Needy Families at any time during a given year and having experienced at least one break in participation of four months or less that started and/or ended during the year

Eligibility Criteria

• Ages Eligible for Study: 15 Years to 55 Years (Child, Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, South Carolina

Nurse-Family Partnership of Anderson County

Anderson, South Carolina, United States, 29625

NFP of Berkeley/Charleston/Dorchester Counties

Charleston, South Carolina, United States, 29405

Nurse-Family Partnership of Lexington-Richland Co.

Columbia, South Carolina, United States, 29204

Nurse-Family Partnership of Horry County

Conway, South Carolina, United States, 29526

McLeod Health NFP

Florence, South Carolina, United States, 29506

Nurse-Family Partnership of Greenville County

Greenville, South Carolina, United States, 29605

Carolina Health Centers NFP

Greenwood, South Carolina, United States, 29646

Family Solutions of the Lowcountry NFP

Orangeburg, South Carolina, United States, 29118

Spartanburg Regional Hospital NFP

Spartanburg, South Carolina, United States, 29303

Sponsors and Collaborators

Harvard School of Public Health (HSPH)

Abdul Latif Jameel Poverty Action Lab

University of Chicago

Investigators

• Principal Investigator: Margaret McConnell, PhD; Harvard School of Public Health (HSPH)

  Study Documents (Full-Text)

Documents provided by Margaret McConnell, Harvard School of Public Health (HSPH):

Informed Consent Form  [PDF] June 20, 2017

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Erratum In: JAMA. 2023 Feb 28;329(8):687.

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.

• Responsible Party: Margaret McConnell, Associate Professor of Global Health Economics, Harvard School of Public Health (HSPH)
• ClinicalTrials.gov Identifier: NCT03360539
• Other Study ID Numbers: IRB15-2939
• First Posted: December 4, 2017
• Last Update Posted: May 3, 2023
• Last Verified: May 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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