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Clinical Trials/NCT01088945
NCT01088945
Completed
Phase 3

Safe Passages: Ensuring Quality Transitions From NICU to Ambulatory Care

Virginia Moyer1 site in 1 country229 target enrollmentMarch 2010

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Infant, Premature, Diseases
Sponsor
Virginia Moyer
Enrollment
229
Locations
1
Primary Endpoint
adverse outcomes in first 30 days after discharge from NICU
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

Infants born prematurely or with complex congenital abnormalities are surviving to discharge in growing numbers and often require significant monitoring and coordination of care in the ambulatory setting. The specific aims of this project are to determine the effectiveness of a redesigned discharge process that includes a Health Coach and an expanded discharge binder to improve health outcomes in the post discharge follow-up period as compared with usual care. The outcomes to be evaluated include the occurrence of adverse events in the post-discharge period, quality of follow up care, and caregiver satisfaction with the process.

Detailed Description

Infants born prematurely or with complex congenital abnormalities are surviving to discharge in growing numbers and often require significant monitoring and coordination of care in the ambulatory setting. These complicated infants have spent all of their lives in the hospital setting, and are strangers in their own homes. Although the transition of the fragile child from intensive care specialist to the ambulatory care provider begins at hospital discharge, it is incomplete until the child receives appropriate outpatient follow-up with a primary care pediatrician. Over this prolonged time period, the child is especially vulnerable to errors related to breakdowns in care coordination and communication because the responsibility for the patient's care is often not clearly specified. Our team of investigators has recently completed a Health Care Failure Modes and Effects Analysis (HFMEA) of the transition from neonatal intensive care to the ambulatory environment. We will expand upon the Care Transitions Intervention developed by Coleman et al that addressed the problems of older adults who were discharged from hospital to home. In this model, advanced practice nurses, trained as coaches, taught patients and families to coordinate care for themselves, fostering independence. We will include the use of a personal health record, to include specific instructions to recognize and self-manage the most common problems in this population and we will use information technology (IT) to enhance communication with families and with community providers, in particular the primary care provider. Having identified that lack of knowledge and skills on the part of community providers about how to manage these infants as an important risk point, we will add to the Coleman intervention by providing "just-in-time" information to the primary care providers to enhance their knowledge and skill in managing the common problems of neonatal nursery graduates, provided electronically via the Texas Children's Hospital (TCH) clinical decision support program.

Registry
clinicaltrials.gov
Start Date
March 2010
End Date
September 2011
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Virginia Moyer
Responsible Party
Sponsor Investigator
Principal Investigator

Virginia Moyer

Professor of Pediatrics (Adjunct)

Baylor College of Medicine

Eligibility Criteria

Inclusion Criteria

  • Infant hospitalized since birth
  • Anticipated total length of stay at least 2 weeks
  • Speaks English or Spanish
  • Planned follow up physician within the hospital's system
  • Exclusion Criteria
  • follow up physician outside of hospital system
  • child in protective custody
  • child not anticipated to survive

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

adverse outcomes in first 30 days after discharge from NICU

Time Frame: 30 days

unplanned ER visits, Unplanned readmissions, deaths, missed appointments

Secondary Outcomes

  • adherence to recommended practices for care of the fragile newborn(6 months)
  • Caregiver assessment of the discharge process(2-3 and 30 days after discharge)

Study Sites (1)

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