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

NCT ID: NCT01088945

Last Updated: 2015-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 229 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2011-09-30

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.

Conditions

Infant, Premature, Diseases

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Enhanced Discharge Process

Caregivers of these infants will receive individual coaching in order to enhance their understanding of their infant's problems and enhance their knowledge and skills to care for their fragile infants.

Group Type: EXPERIMENTAL

Enhanced Discharge process

Intervention Type: BEHAVIORAL

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

Standard Discharge Process

These infants will receive the hospital's current standard of care for the discharge of fragile infants from the NICU.

Group Type: ACTIVE_COMPARATOR

Enhanced Discharge process

Intervention Type: BEHAVIORAL

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

Interventions

Enhanced Discharge process

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

Intervention Type: BEHAVIORAL

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

Virginia Moyer

OTHER

Sponsor Role: lead

Responsible Party

Virginia Moyer

Professor of Pediatrics (Adjunct)

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Virginia A Moyer, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Texas Children's Hospital

Houston, Texas, United States

Countries

United States

References

Moyer VA, Papile LA, Eichenwald E, Giardino AP, Khan MM, Singh H. An intervention to improve transitions from NICU to ambulatory care: quasi-experimental study. BMJ Qual Saf. 2014 Dec;23(12):e3. doi: 10.1136/bmjqs-2012-001726.

Reference Type: DERIVED

PMID: 23832926 (View on PubMed)

Other Identifiers

H-26059

Identifier Type: -

Identifier Source: org_study_id