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NCT05373771 | Recruiting | Sickle Cell Crisis


Sickle Cell Improvement: Enhancing Care in the Emergency Department
Sponsor:

Medical College of Wisconsin

Information provided by (Responsible Party):

David Brousseau

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.

Condition or disease

Sickle Cell Crisis

Intervention/treatment

Care pathway

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 5328 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : Sickle Cell Improvement: Enhancing Care in the Emergency Department
Actual Study Start Date : September 1, 2021
Estimated Primary Completion Date : August 31, 2026
Estimated Study Completion Date : August 31, 2027
Arm Intervention/treatment

Active Comparator: Post-intervention

No Intervention: Delayed intervention

Ages Eligible for Study: to 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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

Sickle Cell Improvement: Enhancing Care in the Emergency Department

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Sickle Cell Improvement: Enhancing Care in the Emergency Department

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Locations


Recruiting

United States, Wisconsin

Children's Wisconsin

Milwaukee, Wisconsin, United States, 53226

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