Sickle Cell Improvement: Enhancing Care in the Emergency Department (SCIENCE)

Medical College of Wisconsin

Status: Enrolling

Conditions: Sickle Cell Crisis

Treatments: Other: Care pathway

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT05373771

00114249

Details and patient eligibility

About

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.

Enrollment: 5,328 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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5,328 participants in 2 patient groups

Post-intervention

Active Comparator group

Treatment:

Other: Care pathway

Delayed intervention

No Intervention group