Implementation of a Clinical Decision Rule for Treatment of Neonatal Jaundice in the Emergency Department

NCT02446951 | Completed

• 1 other identifier: 1404-061
• Study Type: observational
• Target: 925
• Locations: 1 country
• Sites: 2

Brief Summary

Jaundice is a condition caused by elevated levels of bilirubin in the body otherwise known as hyperbilirubinemia. It occurs when there is an increase in bilirubin production or normal production with problems eliminating it from the body. Serum levels of bilirubin in excess of 5 mg/dL signifies clinical jaundice, yet more than half of full term infants experience these levels within the first week of life. For those patients who have markedly elevated serum bilirubin levels, which phototherapy cannot sufficiently treat, the use of exchange transfusions is a viable option within the hospital setting. In comparison, bili-blankets have been used as a form of phototherapy for those patients being treated in a home-based setting to reduce the likelihood of hospital readmissions.

Conditions

Hyperbilirubinemia

Outcome Measures

Primary Outcomes (3)

• Laboratory Testing Utilization

  We will use logistic regression to assess, after controlling for relevant clinical factors, the odds of ordering a specific laboratory test (e.g., CBC, BMP, Coombs, etc.) in the group of patients seen during implementation of the CDS compared to the odds of such an order among patients arriving prior to the implementation of the CDS. We will also use linear regression, controlling for relevant clinical variables, to estimate the impact of the CDS on the number of tests ordered in total for patients presenting to the ED with jaundice symptoms.

  18 months after clinical decision rule implemented

• Reduced Admission/increase in home therapy utlization

  Similar to the analysis of laboratory tests, we will use logistic regression to estimate odds ratios for admission and for home-based phototherapy among patients presenting to the ED with jaundice symptoms before and after the implementation of the CDS.

  18 months after clinical decision rule implemented

• Reduced Medical Expenditures

  Costs of all medical services within 2 weeks of the index ED visit will be captured from insurance claims data. Hospital-based costs for will be assessed from the Hospital charge master. While the goals of the CDS are to reduce hospital admission, the CDS may inadvertently lead to overuse of other diagnostic procedures such as lab tests or consultations. In addition, by discouraging admission, the CDS may result in prolonged observation periods in the ED or an inpatient unit. To capture all potential costs related to the treatment episode, we will include all billed medical services occurring at the ED visit and during the subsequent 14 days. This time window should include the most common complications associated with Jaundice.

  18 months after clinical decision rule implemented

Study Arms (1)

ED Jaundice Patients

Patients presenting to the ED in either the implementation period or pre-implementation period.

Eligibility Criteria

• Age: Up to 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

ED patients presenting with jaundice.

You may qualify if:

• Patients are birth to 7 days post-natal age
• Present in Minneapolis or St Paul ED during the pre-implementation or implementation period with a chief complaint of jaundice.

You may not qualify if:

• Children born prematurely
• Concern for sepsis or bacterial infection
• In-born error of metabolism
• Metabolic disease
• Positive newborn screen (e.g. Sickle Cell Disease, Cystic Fibrosis)

Sponsors & Collaborators

• Children's Hospitals and Clinics of Minnesota: lead

Study Sites (2)

Children's Hospital & Clinics of Minnesota

Minneapolis, Minnesota, 55404, United States

Location

Children's Hopsitals and Clinics of Minnesota

Saint Paul, Minnesota, 55102, United States

Location

MeSH Terms

Conditions

Hyperbilirubinemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anupam B Kharbanda, MD

  Children's Hospitals and Clinics of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2015
• First Posted: May 18, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 31, 2016
• Last Updated: April 19, 2018

Record last verified: 2018-04

Locations

US (2)