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Recruiting

NCT Number: NCT05373771

Sickle Cell Improvement: Enhancing Care in the Emergency Department

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.

Recruiting

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location status: Recruiting

Location contact

David Brousseau

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Care pathway

Other

Implementation of care pathway as part of hybrid type 2 implementation effectiveness study

Primary outcomes

  1. Timeliness of receipt of opioids

    Time frame: A maximum of about 6 hours as all opioids received during the ED stay will be captured

    The percent of patients who receive first dose of opioids within 60 minutes of arrival and subsequent doses within 30 minutes of previous dose

Secondary outcomes

  1. Median time to opioids

    Time frame: A maximum of about 6 hours as all opioids received during the ED stay will be captured

    Median time from arrival to first opioid and then subsequent opioids

  2. Percent of children hospitalized

    Time frame: A maximum of about 6 hours as that is the typical maximum time to disposition for patients

    Disposition of hospitalization or discharge home

Study contacts

Contact information is provided by the study sponsor or research team.

David Brousseau, MD, MS

CONTACT

[email protected]

(302) 651-4000

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • Nemours Children's Health System
  • Pediatric Emergency Care Applied Research Network

Registry information

Acronym: SCIENCE

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
May 13, 2022
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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