Clinical trial NCT00801619: Bilicurves: Using Information Technology to Improve the Management of Neonatal Hyperbilirubinemia
Official title: Bilicurves: Using Information Technology to Integrate Clinical Practice Guidelines Into the Management of Neonatal Hyperbilirubinemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neonatal Hyperbilirubinemia
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2008-12-03
Enrollment: 273
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Adherence to clinical guidelines
timeFrame: Initial Newborn Inpatient Stay, which on average is 2-3 days in length
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: John Patrick T Co, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.