Sickle Cell Improvement: Enhancing Care in the Emergency Department

Sickle Cell Crisis Clinical Trial

— SCIENCE  

Official title:

Sickle Cell Improvement: Enhancing Care in the Emergency Department

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05373771
• Other study ID #: 00114249
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: August 31, 2027

Study information

• Verified date: August 2023
• Source: Medical College of Wisconsin
• Contact: David Brousseau, MD, MS
• Phone: (302) 651-4000
• Email: david.brousseau[@]nemours.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5328
• Est. completion date: August 31, 2027
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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
• priapism
• sickle cell trait

Related Conditions & MeSH terms

• Emergencies
• Sickle Cell Crisis

Intervention

Other:
• Care pathway
Implementation of care pathway as part of hybrid type 2 implementation effectiveness study

Locations

Country	Name	City	State
United States	Children's Wisconsin	Milwaukee	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Nemours Children's Health System, Pediatric Emergency Care Applied Research Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timeliness of receipt of opioids	The percent of patients who receive first dose of opioids within 60 minutes of arrival and subsequent doses within 30 minutes of previous dose	A maximum of about 6 hours as all opioids received during the ED stay will be captured
Secondary	Median time to opioids	Median time from arrival to first opioid and then subsequent opioids	A maximum of about 6 hours as all opioids received during the ED stay will be captured
Secondary	Percent of children hospitalized	Disposition of hospitalization or discharge home	A maximum of about 6 hours as that is the typical maximum time to disposition for patients