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Sickle Cell Improvement: Enhancing Care in the Emergency Department

Sickle Cell Improvement: Enhancing Care in the Emergency Department

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05373771
Acronym
SCIENCE
Enrollment
5328
Registered
2022-05-13
Start date
2021-09-01
Completion date
2027-08-31
Last updated
2023-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sickle Cell Crisis

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.

Interventions

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

Sponsors

Pediatric Emergency Care Applied Research Network
CollaboratorNETWORK
Nemours Children's Health System
CollaboratorOTHER
Medical College of Wisconsin
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Timeliness of receipt of opioidsA maximum of about 6 hours as all opioids received during the ED stay will be capturedThe percent of patients who receive first dose of opioids within 60 minutes of arrival and subsequent doses within 30 minutes of previous dose

Secondary

MeasureTime frameDescription
Median time to opioidsA maximum of about 6 hours as all opioids received during the ED stay will be capturedMedian time from arrival to first opioid and then subsequent opioids
Percent of children hospitalizedA maximum of about 6 hours as that is the typical maximum time to disposition for patientsDisposition of hospitalization or discharge home

Countries

United States

Contacts

Primary ContactDavid Brousseau, MD, MS
david.brousseau@nemours.org(302) 651-4000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026