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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Baylor College of Medicine.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT01088945
First received: March 10, 2010
Last updated: June 23, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Infant, Premature, Diseases
Behavioral: Enhanced Discharge process
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Safe Passages: Ensuring Quality Transitions From NICU to Ambulatory Care

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • adverse outcomes in first 30 days after discharge from NICU [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    unplanned ER visits, Unplanned readmissions, deaths, missed appointments


Secondary Outcome Measures:
  • adherence to recommended practices for care of the fragile newborn [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    adherence by primary care physicians to recommended practices for management of the fragile NICU graduate

  • Caregiver assessment of the discharge process [ Time Frame: 2-3 and 30 days after discharge ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 250
Study Start Date: March 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01088945

Contacts
Contact: Virginia A Moyer, MD, MPH 832-822-3441 moyer@bcm.edu
Contact: Ekiria Collins, MS ekcollin@texaschildrens.org

Locations
United States, Texas
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Virginia A Moyer, MD, MPH         
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: Virginia A Moyer, MD, MPH Baylor College of Medicine
  More Information

No publications provided

Responsible Party: Virginia A. Moyer, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01088945     History of Changes
Other Study ID Numbers: H-26059
Study First Received: March 10, 2010
Last Updated: June 23, 2011
Health Authority: United States: Federal Government

Keywords provided by Baylor College of Medicine:
Infant, Premature, Diseases

Additional relevant MeSH terms:
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on July 26, 2014