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 — OTHERImplementation 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
- David Brousseau, MD, MS(302) 651-4000
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Children's Wisconsin | Milwaukee | Wisconsin | 53226 | David Brousseau |
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