Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00360204
Status:
COMPLETED
Last Update Posted:
2017-07-28
First Post:
2006-08-03
Brief Title:
Improving Health Outcomes for New Mothers and Babies
Sponsor:
Milton S Hershey Medical Center
Organization:
Milton S Hershey Medical Center
Study Overview
Official Title:
Improving Health Outcomes for New Mothers and Babies
Status:
COMPLETED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Because adherence to postnatal care guidelines across the United States US 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 motherinfant 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 andor 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 postnatalpostpartum 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 neonatalpostpartum 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 maternitynursery 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 postnatalpostpartum 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
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 maternitynursery 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 postnatalpostpartum 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R40 MC 06630-01 | None | None | None |