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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01091688
Other study ID # H-25701
Secondary ID
Status Completed
Phase N/A
First received March 18, 2010
Last updated July 24, 2015
Start date March 2010
Est. completion date June 2011

Study information

Verified date July 2015
Source Baylor College of Medicine
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 229
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Newborn Center, Texas Children's Hospital Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
Virginia Moyer Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary Physician comfort levels 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 No
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