Sickle Cell Improvement: Enhancing Care in the Emergency Department

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT05373771
Status
Recruiting

Conditions

  • Sickle Cell Crisis

Eligibility Criteria

Sex
ALL
Age
N/A - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Care pathway — OTHER
    Implementation of care pathway as part of hybrid type 2 implementation effectiveness study

Study Details

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.

Key Dates

Start date
Sep 1, 2021
Status verified
Aug 2023
Primary completion
Aug 31, 2026
Completion
Aug 31, 2027

Study Design

Enrollment
5,328 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Post-intervention
  • No Intervention: Delayed intervention

Primary Outcome Measure

Timeliness of receipt of opioids [ Time Frame: A maximum of about 6 hours as all opioids received during the ED stay will be captured ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's WisconsinMilwaukeeWisconsin53226
David Brousseau

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