Improving Health Outcomes for New Mothers and Babies
Condition: Hyperbilirubinemia; Jaundice; Dehydration; Postpartum Depression
MeSH terms: Depression, Postpartum; Dehydration; Jaundice; Hyperbilirubinemia
Study type: Interventional
Phase: Phase 3

Summary: 
      Because adherence to postnatal care guidelines across the United States (U.S.) is poor,
      newborns and mothers often are placed at undue risk for adverse medical and social outcomes.
      This study aims to evaluate an alternative model of care and improve healthcare delivery to
      and reduce health disparities for "well" newborns and mothers after hospital discharge by
      using single postnatal home nurse visits. The principal investigator has previously shown a
      reduction in poor outcomes for infants who receive a home visit after discharge when studied
      retrospectively. The proposed research will build on the previous study and prospectively
      evaluate the impact of a single home nursing visit on morbidities and health disparities for
      newborns and mothers in a randomized, controlled trial involving 1154 mother/infant
      breastfeeding dyads. Home visits should guarantee detailed assessment during an at-risk
      period of infancy and motherhood, where medical and social problems can be recognized,
      anticipated, and/or treated, and can bridge the gap between hospital care and primary care.
      The investigators' program, The Nurses for Infants Through Teaching and Assessment after the
      NurserY (NITTANY) Initiative, also will consider the cost-effectiveness of home visitation
      compared with guidelines-adherent outpatient clinic care.
    

Detailed description: 
      In the NITTANY Initiative the effectiveness of a single postnatal/postpartum home nurse visit
      will be evaluated prospectively and compared with outpatient clinic-based care using a
      randomized, controlled study design. We will attempt to reduce morbidity in the
      neonatal/postpartum period using a well-timed home visit measured first by a reduction in the
      need for additional hospital services (inpatient hospitalization and ED visitation) in the
      first 14 days after delivery. While healthcare utilization may not be the most important
      health outcome for newborns and mothers from a long-term perspective, the demographic groups
      at-risk for these outcomes tend to parallel those at greater long-term risk. Also, in the
      short-term these outcomes may be the most costly ones for insurance providers and can be used
      in a cost-effectiveness analysis to justify home nurse visits. Readmissions and use of urgent
      care also may be the most noticeable outcome for clinicians, which should help to modify
      practice patterns and improve compliance with guidelines for healthcare delivery.

      Over a 3-year period we will prospectively enroll a cohort of 1154 "well" singleton newborns
      and their mothers admitted to the hospital nursery that are most at-risk for readmission
      based on demographic features. Previous data have indicated those at greatest risk for
      adverse health outcomes are infants born to breastfeeding mothers and those with less
      parenting experience. Minorities and Medicaid recipients are more likely to suffer from
      healthcare disparities. For mothers, morbidities may occur in all socioeconomic groups, but
      those undergoing operative delivery or instrument assisted vaginal deliveries tend to suffer
      greater morbidity. In this study, patients will be randomized to receive usual, guideline
      adherent, post-discharge care with or without a home nurse visit 1-2 days after nursery
      discharge. For each newborn and mother, information from the pregnancy, obstetrical record,
      and the nursery course will be collected. Data also will be recorded regarding continuity of
      care during the perinatal period, hospital readmissions, ED visits, compliance with and
      extent of outpatient care, satisfaction with and convenience of care, and costs of
      healthcare. Method of infant feeding, maternal confidence, maternal depression and anxiety,
      and satisfaction with care will also be assessed.

      To accomplish the objectives of this project, we will focus on the following 3 specific aims:

      SPECIFIC AIM 1. Establish that single home nursing visits improve healthcare delivery to and
      reduce adverse health outcomes for breastfeeding newborns.

      This model of home visitation will be shown to reduce postnatal morbidities, improve
      compliance with post-discharge guidelines, and reduce disparities in health outcomes for
      those enrolled in a prospective trial based on data presented under Preliminary Studies
      conducted by the PI. A randomized, controlled trial will be conducted over a period of 36
      months to demonstrate that infants that receive a single home visit have a reduced need for
      subsequent hospital-based or non-scheduled urgent care services. Secondary outcomes of
      importance will include compliance with follow-up guidelines and breastfeeding rates that
      also are expected to improve in those receiving a home visit.

      SPECIFIC AIM 2. Establish that single home nursing visits improve healthcare delivery to and
      reduce adverse outcomes for mothers who are breastfeeding their newborns. Maternal
      readmission, emergency department utilization, and need for non-scheduled urgent care
      services will be reduced in the group of women receiving a single, postpartum home visit
      compared with standard care. Additionally, parenting sense of competence, satisfaction with
      postpartum healthcare, level of perceived social support, and the incidence of postpartum
      depression and anxiety will be improved among women randomized to receive a home nursing
      visit during the stressful and emotional period following childbirth compared with those
      randomized to not receive a home visit.

      SPECIFIC AIM 3. Prospectively evaluate the cost-effectiveness of a single postnatal home
      nursing visit after maternity/nursery hospital discharge.

      Data from the trial will be used to perform a stochastic cost-effectiveness analysis to
      demonstrate prospectively that a single home nursing visit is cost-effective based upon the
      reduction of the need for subsequent hospital or non-scheduled urgent care based services
      (inpatient, emergency department, and outpatient) for newborns and mothers in the first 14
      postnatal/postpartum days. Again based on the previous retrospective study conducted by the
      PI, home visits are expected to be a cost-effective intervention. Other factors including
      maternal health outcomes, breastfeeding, and long-term health and social outcomes will be
      assessed in terms of their relationship with cost.
    

Intervention name(s): Home Nurse Visit
Intervention type(s): Behavioral
Intervention description(s): Home nurse visit by maternal child health nurse within first 24-48 after post-partum hospital discharge.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Infant health; parenting competence; Home nurse visit; maternal post-partum care; postpartum health utilization; Breastfeeding