Improving Health Outcomes for New Mothers and Babies

July 25, 2017 updated by: Ian M. Paul, MD, Milton S. Hershey Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1154

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Milton S. Hershey Medical Center
      • Hershey, Pennsylvania, United States, 17033-0850
        • Penn State Milton S. Hershey Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 7 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Full term or late pre-term infant (> 34 0/7 weeks gestational age) discharged from the newborn nursery
  • Feeding human milk (breast milk) during the maternity/newborn stay with intent to continue to breastfeed after discharge
  • English speaking mother
  • Singleton or twin infant

Exclusion Criteria:

  • Premature infant < 34 weeks gestational age
  • Exclusively formula fed infant during nursery stay
  • Complicated maternity/nursery stay requiring > 2 night stay after a vaginal delivery or > 4 night stay after a cesarean section
  • A nursery course with atypical complications (e.g. a work-up for ambiguous genitalia)
  • Infant with hyperbilirubinemia requiring phototherapy during the nursery stay
  • Any major maternal morbidities and/or pre-existing condition that would effect postpartum care such as cancer, multiple sclerosis, lupus, etc.
  • Previous maternal participation in the NITTANY trial
  • Residence outside of the coverage area for the Visiting Nurses Association (VNA) of Central Pennsylvania
  • Family with no active telephone number (home or cellular)
  • Infant being put up for adoption
  • Non-English speaking mother
  • Family requiring a home visit due to Social Work or other staff request/order
  • Triplets or higher order gestation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Use of unplanned maternal and child healthcare services (inpatient, Emergency Department (ED), urgent/acute care, primary care, and mental health) in the first 14 days after delivery
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Adherence to continuity of care guidelines
Time Frame: 3 years
3 years
Postpartum anxiety
Time Frame: 3 years
3 years
Breastfeeding duration
Time Frame: 3 years
3 years
Maternal satisfaction with post-discharge healthcare
Time Frame: 3.5 years
3.5 years
Parenting sense of competence
Time Frame: 3.5 years
3.5 years
Cost of care
Time Frame: 4 years
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Collaborators

Department of Health and Human Services
Health Resources and Services Administration (HRSA)
HRSA/Maternal and Child Health Bureau

Investigators

  • Principal Investigator: Ian M Paul, MD, MSc, Penn State Milton S. Hershey Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

August 3, 2006

First Submitted That Met QC Criteria

August 3, 2006

First Posted (Estimate)

August 4, 2006

Study Record Updates

Last Update Posted (Actual)

July 28, 2017

Last Update Submitted That Met QC Criteria

July 25, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22163
  • R40 MC 06630-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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