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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00801619
Recruitment Status : Completed
First Posted : December 3, 2008
Last Update Posted : March 16, 2016
Information provided by (Responsible Party):
John Patrick Co, Massachusetts General Hospital

Brief Summary:
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 or disease
Neonatal Hyperbilirubinemia

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.

Study Type : Observational
Actual Enrollment : 273 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bilicurves: Using Information Technology to Integrate Clinical Practice Guidelines Into the Management of Neonatal Hyperbilirubinemia
Study Start Date : November 2008
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Jaundice

Receive decision support when reviewing bilirubin results in the clinical information systems/electronic health record
No decision support

Primary Outcome Measures :
  1. Adherence to clinical guidelines [ Time Frame: Initial Newborn Inpatient Stay, which on average is 2-3 days in length ]
    Adeherence to AAP clinical guidelines in treating neonatal hyperbilirubinemia

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00801619

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

Responsible Party: John Patrick Co, Principal Investigator, Massachusetts General Hospital Identifier: NCT00801619     History of Changes
Other Study ID Numbers: 2006P001624
First Posted: December 3, 2008    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016

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