Sickle Cell Improvement: Enhancing Care in the Emergency Department
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Care pathway.
- Who it may be relevant to
- Registry conditions: Sickle Cell Crisis. Basic parameters: up to 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other Care pathway
Implementation of care pathway as part of hybrid type 2 implementation effectiveness study
Primary outcome measures
- Timeliness of receipt of opioids [Time frame: A maximum of about 6 hours as all opioids received during the ED stay will be captured]
Secondary outcome measures (2)
- Median time to opioids [Time frame: A maximum of about 6 hours as all opioids received during the ED stay will be captured]
- Percent of children hospitalized [Time frame: A maximum of about 6 hours as that is the typical maximum time to disposition for patients]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Children's Wisconsin — Milwaukee
Identifiers
NCT: NCT05373771 · 00114249