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

Safe Passages: Ensuring Quality Transitions From NICU to Ambulatory Care

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.

Study Overview

• Status: Completed
• Conditions: Infant, Premature, Diseases
• Intervention / Treatment: Behavioral: Enhanced Discharge 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.

• Study Type: Interventional
• Enrollment (Actual): 229
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Enhanced Discharge process; Health Coaching prior to discharge, with an enhanced discharge binder to reinforce the teaching of the Health Coach
Active Comparator: Standard Discharge Process; These infants will receive the hospital's current standard of care for the discharge of fragile infants from the NICU.	Behavioral: Enhanced Discharge process; Health Coaching prior to discharge, with an enhanced discharge binder to reinforce the teaching of the Health Coach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse outcomes in first 30 days after discharge from NICU	unplanned ER visits, Unplanned readmissions, deaths, missed appointments	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Virginia Moyer
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: Virginia A Moyer, MD, MPH, Baylor College of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: March 10, 2010
• First Submitted That Met QC Criteria: March 17, 2010
• First Posted (Estimate): March 18, 2010

Study Record Updates

• Last Update Posted (Estimate): July 27, 2015
• Last Update Submitted That Met QC Criteria: July 24, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Infant, Premature, Diseases
• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Infant, Premature, Diseases
• Other Study ID Numbers: H-26059