Sickle Cell Improvement: Enhancing Care in the Emergency Department

Study Overview
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Brief Summary
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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.

Official Title
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Sickle Cell Improvement: Enhancing Care in the Emergency Department

Conditions
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Sickle Cell Crisis

Intervention / Treatment
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* Other: Care pathway


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |