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

NCT01088945 | Completed Phase 3

• 1 other identifier: H-26059
• Study Type: interventional
• Target: 229
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant, Premature, Diseases

Keywords

Infant, Premature, Diseases

Outcome Measures

Primary Outcomes (1)

• adverse outcomes in first 30 days after discharge from NICU

  unplanned ER visits, Unplanned readmissions, deaths, missed appointments

  30 days

Secondary Outcomes (2)

• adherence to recommended practices for care of the fragile newborn

  6 months

• Caregiver assessment of the discharge process

  2-3 and 30 days after discharge

Study Arms (2)

Enhanced Discharge Process

EXPERIMENTAL

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

Standard Discharge Process

ACTIVE COMPARATOR

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

Behavioral: Enhanced Discharge process

Interventions

Enhanced Discharge process BEHAVIORAL

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

Enhanced Discharge Process; Standard Discharge Process

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• follow up physician outside of hospital system
• child in protective custody
• child not anticipated to survive

Sponsors & Collaborators

• Virginia Moyer: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 23832926 DERIVED

MeSH Terms

Conditions

Infant, Premature, Diseases

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Virginia A Moyer, MD, MPH

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Pediatrics (Adjunct)

Study Record Dates

• First Submitted: March 10, 2010
• First Posted: March 18, 2010
• Study Start: March 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: July 27, 2015

Record last verified: 2015-07

Locations

US (1)