Sickle Cell Improvement: Enhancing Care in the Emergency Department

NCT05373771 | Recruiting DMC

• 1 other identifier: 00114249
• Study Type: interventional
• Target: 5,328
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Crisis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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 Arms (2)

Post-intervention

ACTIVE COMPARATOR

Other: Care pathway

Delayed intervention

NO INTERVENTION

Interventions

Care pathway OTHER

Implementation of care pathway as part of hybrid type 2 implementation effectiveness study

Post-intervention

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Pediatric Emergency Care Applied Research Network: collaborator
• Nemours Children's Health System: collaborator

Study Sites (1)

Children's Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Conditions

Vaso-Occlusive Crises

Interventions

Critical Pathways

Condition Hierarchy (Ancestors)

Anemia, Sickle Cell; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• David Brousseau, MD, MS

  Nemours Children's Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Brousseau, MD, MS

CONTACT

(302) 651-4000; david.brousseau@nemours.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chair

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: May 13, 2022
• Study Start: September 1, 2021
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)