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

NCT ID: NCT00801619

Last Updated: 2016-03-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 273 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2011-12-31

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.

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.

Conditions

Neonatal Hyperbilirubinemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Intervention

Receive decision support when reviewing bilirubin results in the clinical information systems/electronic health record

No interventions assigned to this group

Control

No decision support

No interventions assigned to this group

Eligibility 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.

• Maximum Eligible Age: 1 Month
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

John Patrick Co

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John Patrick T Co, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 15231951 (View on PubMed)

Other Identifiers

2006P001624

Identifier Type: -

Identifier Source: org_study_id