NCT01091688

Brief Summary

We, the investigators, will provide "Just-in-Time" information, physician educational material, to primary care pediatricians of Neonatal Intensive Care Unit (NICU) graduates at the time of NICU discharge. We will follow the rate of adverse events (deaths, re-hospitalizations, emergency room visits, and missed appointments) for 6 months after NICU discharge. We will assess levels of physician comfort in caring for NICU specific diseases, as well as physician satisfaction with the discharge process. We hypothesize that the provision of "Just-in-Time" information will decrease the rate of adverse events, and make physicians more comfortable in caring for complicated NICU graduates, and more satisfied with the discharge process.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
229

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

July 27, 2015

Status Verified

July 1, 2015

Enrollment Period

1.3 years

First QC Date

March 18, 2010

Last Update Submit

July 24, 2015

Conditions

Keywords

neonataldischarge planninghealth transitioneducational needs assessmentIntensive care, neonatal

Outcome Measures

Primary Outcomes (1)

  • Adverse events

    The rates of death, rehospitalization, emergency room visits, and missed appointments will be calculated for infants in the first 6 months after discharge from the NICU.

    6 months from hospital discharge

Secondary Outcomes (1)

  • Physician comfort levels

    1 year

Study Arms (2)

Just-in-Time intervention

EXPERIMENTAL

The infants and physicians in the experimental group will receive the "Just-in-Time" intervention sheets at the time of discharge.

Behavioral: Just-in-Time information

Routine discharge care

NO INTERVENTION

The infants and physicians in the routine discharge care arm will receive the same information and details as is per normal routine in the nursery.

Interventions

Infants and physicians assigned to the intervention group will receive Just-in-Time information at the time of NICU discharge, by email and facsimile, and the parents will receive a copy to bring to their first clinic appointment.

Just-in-Time intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pediatric care providers will be identified when they accept into their practices babies who are part of a related study of an enhanced discharge process in the Texas Children's Hospital (TCH) NICU (ClinicalTrials.gov Identifier: NCT01088945)
  • Participating providers must be part of Texas Children's Pediatrics Associates (TCPA), or accept Texas Children's Health Plan (TCHP) insurance.

You may not qualify if:

  • Providers who are not part of Texas Children's Pediatrics Associates (TCPA), or do not accept Texas Children's Health Plan (TCHP) insurance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Newborn Center, Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Study Officials

  • Virginia A Moyer, MD, MPH

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Pediatrics (Adjunct)

Study Record Dates

First Submitted

March 18, 2010

First Posted

March 24, 2010

Study Start

March 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

July 27, 2015

Record last verified: 2015-07

Locations