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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Baylor College of Medicine.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT01091688
First received: March 18, 2010
Last updated: April 1, 2010
Last verified: March 2010
  Purpose

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.


Condition Intervention
Patient Discharge
Behavioral: Just-in-Time information

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Impact of "Just-in-time" Information on NICU Discharges

Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Adverse events [ Time Frame: 6 months from hospital discharge ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Physician comfort levels [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 250
Study Start Date: March 2010
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Just-in-Time information
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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01091688

Contacts
Contact: Amanda Vega 832-822-3441 axvega@texaschildrenshospital.org

Locations
United States, Texas
Newborn Center, Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Virginia A Moyer, MD, MPH    832-822-3441    vamoyer@texaschildrens.org   
Principal Investigator: Virginia A Moyer, MD, MPH         
Sub-Investigator: Catherine C Cibulskis, MD         
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 Moyer, MD MPH / Professor of Pediatrics, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01091688     History of Changes
Other Study ID Numbers: H-25701
Study First Received: March 18, 2010
Last Updated: April 1, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
neonatal
discharge planning
health transition
educational needs assessment
Intensive care, neonatal

ClinicalTrials.gov processed this record on September 18, 2014