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

Infant, Premature, Diseases Clinical Trial

Official title:

Safe Passages: Ensuring Quality Transitions From NICU to Ambulatory Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01088945
• Other study ID #: H-26059
• Status: Completed
• Phase: Phase 3
• First received: March 10, 2010
• Last updated: July 24, 2015
• Start date: March 2010
• Est. completion date: September 2011

Study information

• Verified date: July 2015
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 229
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infant, Premature, Diseases

Intervention

Behavioral:
• Enhanced Discharge process
Health Coaching prior to discharge, with an enhanced discharge binder to reinforce the teaching of the Health Coach

Locations

Country	Name	City	State
United States	Texas Children's Hospital	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Moyer	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adverse outcomes in first 30 days after discharge from NICU	unplanned ER visits, Unplanned readmissions, deaths, missed appointments	30 days	Yes
Secondary	adherence to recommended practices for care of the fragile newborn	adherence by primary care physicians to recommended practices for management of the fragile NICU graduate	6 months	No
Secondary	Caregiver assessment of the discharge process	Using 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.	2-3 and 30 days after discharge	Yes