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Sickle Cell Improvement: Enhancing Care in the Emergency Department

NCT05373771 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5328

Last updated 2023-08-14

No results posted yet for this study

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

Interventions

OTHER

Care pathway

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

Sponsors & Collaborators

  • Pediatric Emergency Care Applied Research Network

    collaborator NETWORK

  • Nemours Children's Health System

    collaborator OTHER

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • David Brousseau, MD, MS · Nemours Children's Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2026-08-31
Completion
2027-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05373771 on ClinicalTrials.gov