Skip to main content
Clinical Trials/NCT05373771
NCT05373771
Recruiting
Not Applicable

Sickle Cell Improvement: Enhancing Care in the Emergency Department

Medical College of Wisconsin1 site in 1 country5,328 target enrollmentSeptember 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sickle Cell Crisis
Sponsor
Medical College of Wisconsin
Enrollment
5328
Locations
1
Primary Endpoint
Timeliness of receipt of opioids
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

Sickle cell disease (SCD) is an inherited blood disorder affecting approximately 36,000 children in the United States, approximately 90% of whom are Black. The disease is characterized by recurrent, severe pain crises which result in high rates of emergency department visits and hospitalizations, and decreased quality of life. The National Heart, Lung and Blood Institute, as well as the American Society of Hematology, have endorsed pain management guidelines regarding the timeliness of care for children presenting with these acute pain crises. These evidence-based guidelines are infrequently followed, resulting in increased pain and hospitalizations. In additional to other barriers to following the guideline, structural racism has been proposed as a significant contributor and the New England Journal of Medicine recently called for the institution of SCD-specific pain management protocols to combat structural racism and reduce time to opioid administration. The investigators' long-term goal is to improve the care and health outcomes of children with acute painful vaso-occlusive crisis treated in the emergency department. The overall aim of the investigators is to test a care pathway using multifaceted implementation strategies to increase guideline adherent care for children in the emergency department with acute painful vaso-occlusive crisis.

Registry
clinicaltrials.gov
Start Date
September 1, 2021
End Date
August 31, 2027
Last Updated
2 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

David Brousseau

Professor, Chair

Nemours Children's Health System

Eligibility Criteria

Inclusion Criteria

  • ED visit for uncomplicated pain crisis
  • Sickle cell disease
  • Receipt of at least one opioid

Exclusion Criteria

  • Acute chest syndrome
  • Fever \> 38.5 in the ED
  • sickle cell trait

Outcomes

Primary Outcomes

Timeliness of receipt of opioids

Time Frame: A maximum of about 6 hours as all opioids received during the ED stay will be captured

The percent of patients who receive first dose of opioids within 60 minutes of arrival and subsequent doses within 30 minutes of previous dose

Secondary Outcomes

  • Median time to opioids(A maximum of about 6 hours as all opioids received during the ED stay will be captured)
  • Percent of children hospitalized(A maximum of about 6 hours as that is the typical maximum time to disposition for patients)

Study Sites (1)

Loading locations...

Similar Trials