Sickle Cell Improvement: Enhancing Care in the Emergency Department

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 31, 2026

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: Post-intervention
  • No Intervention: Delayed intervention

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Median time to opioids
    • Time Frame: A maximum of about 6 hours as all opioids received during the ED stay will be captured
    • Median time from arrival to first opioid and then subsequent opioids
  • Disposition
    • Time Frame: A maximum of about 6 hours as that is the typical maximum time to disposition for patients
    • Disposition of hospitalization or discharge home

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Medical College of Wisconsin
  • Collaborator
    • Pediatric Emergency Care Applied Research Network
  • Provider of Information About this Clinical Study
    • Principal Investigator: David Brousseau, Professor – Medical College of Wisconsin
  • Overall Official(s)
    • David Brousseau, MD, MS, Principal Investigator, Medical College of Wisconsin
  • Overall Contact(s)
    • David Brousseau, MD, MS, (414) 266-2625, dbrousse@mcw.edu

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