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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03360539
Recruitment Status : Active, not recruiting
First Posted : December 4, 2017
Last Update Posted : January 22, 2021
Sponsor:
Collaborators:
Abdul Latif Jameel Poverty Action Lab
University of Chicago
Information provided by (Responsible Party):
Margaret McConnell, Harvard School of Public Health

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.

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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
Estimated Primary Completion Date : April 1, 2023
Estimated Study Completion Date : April 1, 2046

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.



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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03360539


Locations
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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
Abdul Latif Jameel Poverty Action Lab
University of Chicago
Investigators
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Principal Investigator: Margaret McConnell, PhD Harvard School of Public Health
  Study Documents (Full-Text)

Documents provided by Margaret McConnell, Harvard School of Public Health:
Informed Consent Form  [PDF] June 20, 2017

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Margaret McConnell, Associate Professor of Global Health Economics, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT03360539    
Other Study ID Numbers: IRB15-2939
First Posted: December 4, 2017    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications