The Impact of Just-in-time Information on Neonatal Intensive Care Unit (NICU) Discharges

July 24, 2015 updated by: Virginia Moyer

The Impact of "Just-in-time" Information on NICU Discharges

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.

Study Overview

Status

Completed

Conditions

Detailed Description

The purpose of this protocol is to evaluate the impact of providing "Just-in-Time" information, or physician educational material at the time of discharge, to primary care pediatricians caring for Neonatal Intensive Care Unit (NICU) graduates. The material provided will be tailored to the needs of each infant. The educational material will be sent to the physicians via email and facsimile on the day of discharge, and a hard copy will be sent with the parents to bring to their first clinic appointment. Outcomes, including emergency room visits, hospital readmissions, deaths, missed appointments, and improvements in care in the areas of intervention will be assessed. Levels of physician comfort in caring for various disorders specific to NICU graduates will be assessed, and satisfaction with the discharge process will also be evaluated pre- and post- intervention.

Study Type

Interventional

Enrollment (Actual)

229

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Just-in-Time intervention
The infants and physicians in the experimental group will receive the "Just-in-Time" intervention sheets at the time of discharge.
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.
No Intervention: Routine discharge care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 6 months from hospital discharge
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physician comfort levels
Time Frame: 1 year
Physicians will complete pre- and post- intervention surveys that consist of 5-point Likert scales that measure comfort levels with various disorders specific to former premature infants.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Virginia A Moyer, MD, MPH, Baylor College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

March 18, 2010

First Submitted That Met QC Criteria

March 23, 2010

First Posted (Estimate)

March 24, 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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