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

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 Overview

• Status: Recruiting
• Conditions: Sickle Cell Crisis
• Intervention / Treatment: Other: Care pathway

• Study Type: Interventional
• Enrollment (Estimated): 5328
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Brousseau, MD, MS; Phone Number: (302) 651-4000; Email: david.brousseau@nemours.org

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Recruiting
      • Children's Wisconsin
      • Contact: David Brousseau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Post-intervention	Other: Care pathway; Implementation of care pathway as part of hybrid type 2 implementation effectiveness study
No Intervention: Delayed intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Collaborators: Pediatric Emergency Care Applied Research Network; Nemours Children's Health System
• Investigators: Principal Investigator: David Brousseau, MD, MS, Nemours Children's Health

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: May 5, 2022
• First Submitted That Met QC Criteria: May 9, 2022
• First Posted (Actual): May 13, 2022

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 8, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: 00114249

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Outcome data gathered through central data Registry. It is a limited dataset. A public use dataset will be made available after the study consistent with NIH guidelines.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No