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

Primary Purpose

Infant, Premature, Diseases

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Enhanced Discharge process
Sponsored by
Virginia Moyer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infant, Premature, Diseases focused on measuring Infant, Premature, Diseases

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Texas Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Enhanced Discharge Process

Standard Discharge Process

Arm Description

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.

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

Outcomes

Primary Outcome Measures

adverse outcomes in first 30 days after discharge from NICU
unplanned ER visits, Unplanned readmissions, deaths, missed appointments

Secondary Outcome Measures

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
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.

Full Information

First Posted
March 10, 2010
Last Updated
July 24, 2015
Sponsor
Virginia Moyer
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
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1. Study Identification

Unique Protocol Identification Number
NCT01088945
Brief Title
Safe Passages: Ensuring Quality Transitions From NICU (Neonatal Intensive Care Unit) to Ambulatory Care
Official Title
Safe Passages: Ensuring Quality Transitions From NICU to Ambulatory Care
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Virginia Moyer
Collaborators
Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Premature, Diseases
Keywords
Infant, Premature, Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
229 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enhanced Discharge Process
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Discharge Process
Arm Type
Active Comparator
Arm Description
These infants will receive the hospital's current standard of care for the discharge of fragile infants from the NICU.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Discharge process
Intervention Description
Health Coaching prior to discharge, with an enhanced discharge binder to reinforce the teaching of the Health Coach
Primary Outcome Measure Information:
Title
adverse outcomes in first 30 days after discharge from NICU
Description
unplanned ER visits, Unplanned readmissions, deaths, missed appointments
Time Frame
30 days
Secondary Outcome Measure Information:
Title
adherence to recommended practices for care of the fragile newborn
Description
adherence by primary care physicians to recommended practices for management of the fragile NICU graduate
Time Frame
6 months
Title
Caregiver assessment of the discharge process
Description
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.
Time Frame
2-3 and 30 days after discharge

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Virginia A Moyer, MD, MPH
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23832926
Citation
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.
Results Reference
derived

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

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