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

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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

Tracking Information
First Submitted Date  ICMJE November 28, 2017
First Posted Date  ICMJE December 4, 2017
Last Update Posted Date January 22, 2021
Actual Study Start Date  ICMJE April 1, 2016
Estimated Primary Completion Date April 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2020)
  • 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)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: November 28, 2017)
  • Birth spacing [ Time Frame: Captured by Vital Records Birth Certificates between first birth and potential second birth at time of birth(s). Participants will be followed for at least two years after the first birth ]
    Number of months from the birth of the first child until the subsequent birth
  • Injury [ Time Frame: Captured in all-payer discharge data within 24 months post-partum ]
    Fraction of infants with emergency department visits and hospitalizations within 24 months post-partum
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2021)
  • 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
  • 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
  • Low birth weight (LBW) [ Time Frame: At birth; vital records ]
    Infant born with a birth weight of less than 2500 grams
  • Very low birth weight [ Time Frame: At birth; vital records ]
    Infant born with a birth weight of less than 1500 grams
  • Birth weight (continuous) [ Time Frame: At birth; vital records ]
    A continuous measure of infant birth weight (grams)
  • Preterm birth [ Time Frame: At birth; vital records ]
    Infant born before 37 weeks' gestation (obstetric estimate)
  • Extremely preterm birth [ Time Frame: At birth; vital records ]
    Infant born before 28 weeks' gestation
  • Gestational age at birth [ Time Frame: At birth; vital records ]
    Gestational age at birth in weeks (continuous)
  • 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
  • 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
  • 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.
  • Cesarean delivery [ Time Frame: At birth; vital records ]
    Cesarean delivery
  • Severe acute maternal morbidity [ Time Frame: At birth; hospital discharge ]
    As defined by the CDC
  • Maternal mortality [ Time Frame: One year postpartum; mortality records ]
    Death of mother within one year postpartum
  • 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
  • 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
  • Postpartum visit [ Time Frame: 12 weeks postpartum; Medicaid claims ]
    Postpartum visit in first 12 weeks after birth
  • Adequate prenatal care [ Time Frame: At birth; vital records ]
    Adequacy of Prenatal Care Utilization Index (APNCU)
  • Number of emergency department visits during pregnancy [ Time Frame: At birth; hospital discharge ]
    Number of emergency department visits during pregnancy
  • Dental visit during pregnancy [ Time Frame: At birth; Medicaid claims and dental records ]
    Dental visit during pregnancy (preventive or treatment)
  • Ultrasound at 18-22 weeks [ Time Frame: At birth; Medicaid claims ]
    Ultrasound at 18-22 weeks (anatomy scan)
  • 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
  • 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
  • Diagnosis of depression/anxiety/stress reaction [ Time Frame: During pregnancy or 60 days postpartum; Medicaid claims ]
    Diagnosis of depression/anxiety/stress reaction
  • Antidepressant prescription [ Time Frame: During pregnancy or 60 days postpartum; Medicaid claims ]
    Antidepressant prescription
  • Outpatient mental health visit [ Time Frame: During pregnancy or 60 days postpartum; Medicaid claims ]
    Outpatient mental health visit
  • 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")
  • 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
  • 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
  • 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
  • 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
  • Number of injuries [ Time Frame: 24 months of life; hospital discharge ]
    Number of injuries
  • Any emergency department visit for child [ Time Frame: 24 months of life; hospital discharge ]
    Child visit to the emergency department
  • Number of emergency department visits [ Time Frame: 24 months of life; hospital discharge ]
    Total number of child visits to the emergency department
  • Child mortality [ Time Frame: 24 months; Mortality records ]
    All-cause child mortality in first 24 months of life
  • Well-child visits [ Time Frame: 15 months; Medicaid claims ]
    Proportion of recommended well-child visits
  • Lead screening [ Time Frame: 15 months; Medicaid claims ]
    Child receives at least one lead screening
  • Developmental screening [ Time Frame: 12 months; Medicaid claims ]
    Child receives at least one developmental screening
  • Dental visit [ Time Frame: 24 months; Medicaid claims and dental records ]
    Child visits the dentist at least once in first 24 months
  • Flouride treatment [ Time Frame: 24 months; Medicaid claims and dental records ]
    Share of recommended fluoride treatments received by child
  • 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
  • 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
  • Inter-birth interval [ Time Frame: 60 months; vital records ]
    Continuous measure of inter-birth interval
  • Family planning visit (6 weeks) [ Time Frame: 6 weeks postpartum; Medicaid claims, hospital discharge ]
    Any family planning-related counseling or service
  • 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
  • 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
  • Family planning visit (1 year) [ Time Frame: 12 months postpartum; Medicaid claims, hospital discharge ]
    Any family planning-related counseling or service
  • 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
  • Postpartum intrauterine device insertion (1 year) [ Time Frame: 12 months postpartum; Medicaid claims, hospital discharge ]
    Postpartum intrauterine device insertion in first 12 months postpartum
  • 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
  • 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)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2017)
  • Preterm birth [ Time Frame: Captured by Vital Records Birth Certificate at birth ]
    Proportion of infants born at less than 37 weeks
  • Very preterm birth [ Time Frame: Captured by Vital Records Birth Certificate at birth ]
    Proportion of infants born at less than 32 weeks
  • Extremely preterm birth [ Time Frame: Captured by Vital Records Birth Certificate at birth ]
    Proportion of infants born at less than 28 weeks
  • Low birth weight [ Time Frame: Captured by Vital Records Birth Certificate at birth ]
    Proportion of infants born with a birth weight of less than 2500 grams
  • Very low birth weight [ Time Frame: Captured by Vital Records Birth Certificate at birth ]
    Proportion of infants born with a birth weight of less than 1500 grams
  • Neonatal intensive care unit (NICU) admission [ Time Frame: Captured in all-payer discharge data over length of NICU stay within three months post-partum ]
    Proportion of infants admitted to the NICU
  • Length of stay in NICU [ Time Frame: Captured in all-payer discharge data over length of NICU stay within three months post-partum ]
    Number of days an infants stay in NICU before discharge
  • Short birth interval [ Time Frame: Captured by Vital Records Birth Certificates within 24 months post-partum ]
    Proportion of subsequent infants born within 24 months after the first birth
  • Very short birth interval [ Time Frame: Captured by Vital Records Birth Certificates within 18 months post-partum ]
    Proportion of subsequent infants birth within 18 months after the first birth
  • Delivery method [ Time Frame: Captured by Vital Records Birth Certificate at birth ]
    Proportion of infants born via different delivery methods (e.g. c-section)
  • Tobacco use [ Time Frame: Captured by Vital Records Birth Certificate at birth ]
    Proportion of mothers with any tobacco use during their pregnancy
  • Long-acting reversible contraception (LARC) use in 3 days after birth [ Time Frame: Captured in all-payer discharge data within a three day post-partum period ]
    Proportion of mothers with any LARC use (implant or intrauterine device insertion) within three days after birth
  • Neonatal mortality [ Time Frame: Captured by Vital Records Birth Certificate and National Death Index provided by the Centers for Disease Control and Prevention within 28 days post-partum ]
    Proportion of infants that die under 28 days of age
  • Infant mortality [ Time Frame: Captured by Vital Records Birth Certificate and National Death Index provided by the Centers for Disease Control and Prevention within one year post-partum ]
    Proportion of infants that die under one year of age
  • Child mortality [ Time Frame: Captured by Vital Records Birth Certificate and National Death Index provided by the Centers for Disease Control and Prevention within five years post-partum ]
    Proportion of infants that die under five years of age
  • Exceeding recommended pregnancy weight gain [ Time Frame: Captured by Vital Records Birth Certificate at birth ]
    Proportion of mothers who exceed recommended pregnancy weight gain
  • Still birth [ Time Frame: Captured in all-payer discharge data at birth ]
    Proportion of infants stillborn
  • Gestational diabetes [ Time Frame: Captured by Vital Records Birth Certificate at birth ]
    Proportion of mothers diagnosed with diabetes during pregnancy
  • Gestational hypertension [ Time Frame: Captured by Vital Records Birth Certificate at birth ]
    Proportion of mothers diagnosed with hypertension during pregnancy
  • Preeclampsia [ Time Frame: Captured by Vital Records Birth Certificate at birth ]
    Proportion of mothers diagnosed with preeclampsia during pregnancy
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nurse-Family Partnership Impact Evaluation in South Carolina
Official Title  ICMJE Nurse-Family Partnership Impact Evaluation in South Carolina
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Preterm Birth
  • Injuries
  • Maternal Behavior
Intervention  ICMJE Behavioral: Nurse-Family Partnership
Study Arms  ICMJE
  • 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.
    Intervention: 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.
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 18, 2020)
5820
Original Estimated Enrollment  ICMJE
 (submitted: November 28, 2017)
6000
Estimated Study Completion Date  ICMJE April 1, 2046
Estimated Primary Completion Date April 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 15 Years to 55 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03360539
Other Study ID Numbers  ICMJE IRB15-2939
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Margaret McConnell, Harvard School of Public Health
Study Sponsor  ICMJE Harvard School of Public Health
Collaborators  ICMJE
  • Abdul Latif Jameel Poverty Action Lab
  • University of Chicago
Investigators  ICMJE
Principal Investigator: Margaret McConnell, PhD Harvard School of Public Health
PRS Account Harvard School of Public Health
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP