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Safe Passages: Ensuring Quality Transitions From NICU (Neonatal Intensive Care Unit) to Ambulatory Care

Safe Passages: Ensuring Quality Transitions From NICU to Ambulatory Care

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01088945
Enrollment
229
Registered
2010-03-18
Start date
2010-03-31
Completion date
2011-09-30
Last updated
2015-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant, Premature, Diseases

Keywords

Infant, Premature, Diseases

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.

Interventions

BEHAVIORALEnhanced Discharge process

Health Coaching prior to discharge, with an enhanced discharge binder to reinforce the teaching of the Health Coach

Sponsors

Agency for Healthcare Research and Quality (AHRQ)
CollaboratorFED
Virginia Moyer
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
adverse outcomes in first 30 days after discharge from NICU30 daysunplanned ER visits, Unplanned readmissions, deaths, missed appointments

Secondary

MeasureTime frameDescription
adherence to recommended practices for care of the fragile newborn6 monthsadherence by primary care physicians to recommended practices for management of the fragile NICU graduate
Caregiver assessment of the discharge process2-3 and 30 days after dischargeUsing a validated measure, the CTM-Neo, caregivers will be interviewed both shortly after discharge and at 30 days to determine satisfaction with the transition from hospital to home.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026