Sickle Cell Improvement: Enhancing Care in the Emergency Department

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorMedical College of Wisconsin

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ED visit for uncomplicated pain crisis

Sickle cell disease

Receipt of at least one opioid

Disqualifiers

Acute chest syndrome

Fever > 38.5 in the ED

priapism

sickle cell trait

Trial design

Design model

Sequential

Treatments tested in this trial

  • Care pathway

    Other intervention

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

Treatment groups

5,328 Participants
are divided into 2 treatment groups
Group A: Post-interventionActive comparator 1 intervention
Group B: Delayed interventionNo intervention 0 interventions

Trial outcomes

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

Time frame
A maximum of about 6 hours as all opioids received during the ED stay will be captured

Secondary outcomes

1

Median time to opioids

Median time from arrival to first opioid and then subsequent opioids

Time frame
A maximum of about 6 hours as all opioids received during the ED stay will be captured
2

Percent of children hospitalized

Disposition of hospitalization or discharge home

Time frame
A maximum of about 6 hours as that is the typical maximum time to disposition for patients

Other outcomes

Sponsors and contacts

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Medical College of Wisconsin

Lead sponsor

Nemours Children's Health System

Sponsor institution

Pediatric Emergency Care Applied Research Network

Collaborator

Nemours Children's Health System

Collaborator