Bilicurves: Using Information Technology to Improve the Management of Neonatal Hyperbilirubinemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Massachusetts General Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00801619
First received: December 2, 2008
Last updated: July 19, 2011
Last verified: July 2011
  Purpose

We will use information technology to integrate the 2004 American Academy of Pediatrics guidelines for management of neonatal hyperbilirubinemia with laboratory reporting of newborn bilirubin test results to improve physician adherence to the guidelines and quality of care.


Condition
Neonatal Hyperbilirubinemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bilicurves: Using Information Technology to Integrate Clinical Practice Guidelines Into the Management of Neonatal Hyperbilirubinemia

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Estimated Enrollment: 337
Study Start Date: November 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Receive decision support
2
No decision support

Detailed Description:

In 2004, the American Academy of Pediatrics disseminated clinical practice guidelines for the management of neonatal hyperbilirubinemia. Using the infant's age in hours, serum bilirubin levels are applied to hour-specific nomograms to assess risk of developing significant hyperbilirubinemia as well as the necessity for treatment. Prior guidelines did not include nomograms for either. A systems approach to managing neonatal hyperbilirubinemia, including use of the nomograms, has been shown to improve outcomes and patient safety.

Despite the existence of these guidelines, decision support does not exist within MGH clinical information systems for managing neonatal hyperbilirubinemia. We propose to create BiliCurves, an application that integrates perinatal information from the obstetrical health record with that of the newborn's, providing seamless reporting of neonatal bilirubin results in the context of the practice guidelines and relevant obstetrical data. BiliCurves will graphically superimpose bilirubin results onto hour-specific guideline nomograms that providers can view when viewing bilirubin results. We propose to randomize BiliCurves access to pediatric providers, and study its effects on management of hyperbilirubinemia both during birth hospitalization as well as in the outpatient setting after discharge. We hypothesize infants treated by physicians with BiliCurves access will receive birth hospitalization phototherapy at a higher rate and readmission for hyperbilirubinemia at a lower rate than that of the control group. We also hypothesize that physicians with BiliCurves access will report greater ease and confidence in nomogram use and providing evidence-based care as BiliCurves obviates the provider having to have access to paper based versions of the nomogram (usual care) as well decreases potential errors in plotting test results on the nomograms.

  Eligibility

Ages Eligible for Study:   up to 1 Month
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Providers who care for infants in the newborn nursery at MGH will be study eligible. All newborns 35 weeks or more weeks of gestation will be study eligible.

Criteria

Inclusion Criteria:

  • Providers who care for infants in the newborn nursery.
  • All newborns in the newborn nursery that are 35 weeks or more weeks of gestation will be study eligible.

Exclusion Criteria:

  • Infants less than 35 weeks gestation.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00801619

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: John Patrick T Co, MD, MPH Massachusetts General Hospital
  More Information

Publications:
Responsible Party: John Patrick T. Co, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00801619     History of Changes
Other Study ID Numbers: 2006P001624
Study First Received: December 2, 2008
Last Updated: July 19, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hyperbilirubinemia
Hyperbilirubinemia, Neonatal
Pathologic Processes
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on July 24, 2014