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

Bilicurves: Using Information Technology to Integrate Clinical Practice Guidelines Into the Management of Neonatal Hyperbilirubinemia

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.

Study Overview

• Status: Completed
• Conditions: 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
• Enrollment (Actual): 273

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 month (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Intervention; Receive decision support when reviewing bilirubin results in the clinical information systems/electronic health record
Control; No decision support

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to clinical guidelines	Adeherence to AAP clinical guidelines in treating neonatal hyperbilirubinemia	Initial Newborn Inpatient Stay, which on average is 2-3 days in length

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: John Patrick T Co, MD, MPH, Massachusetts General Hospital

Publications and helpful links

General Publications

• American Academy of Pediatrics Subcommittee on Hyperbilirubinemia. Management of hyperbilirubinemia in the newborn infant 35 or more weeks of gestation. Pediatrics. 2004 Jul;114(1):297-316. doi: 10.1542/peds.114.1.297. Erratum In: Pediatrics. 2004 Oct;114(4):1138.

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (ACTUAL): December 1, 2011
• Study Completion (ACTUAL): December 1, 2011

Study Registration Dates

• First Submitted: December 2, 2008
• First Submitted That Met QC Criteria: December 2, 2008
• First Posted (ESTIMATE): December 3, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): March 16, 2016
• Last Update Submitted That Met QC Criteria: March 14, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Hyperbilirubinemia; Hyperbilirubinemia, Neonatal
• Other Study ID Numbers: 2006P001624