Post-intervention for Sickle Cell Crisis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Children's Wisconsin, Milwaukee, WI
Sickle Cell Crisis+1 More
Care pathway - Other
Eligibility
< 65
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Sickle Cell Crisis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Sickle Cell Crisis

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: A maximum of about 6 hours as all opioids received during the ED stay will be captured

Hour 6
Median time to opioids
Timeliness of receipt of opioids
Hour 6
Disposition
Percent of children hospitalized

Trial Safety

Safety Progress

1 of 3

Other trials for Sickle Cell Crisis

Trial Design

2 Treatment Groups

Delayed intervention
1 of 2
Post-intervention
1 of 2
Active Control

5328 Total Participants · 2 Treatment Groups

Primary Treatment: Post-intervention · No Placebo Group · N/A

Delayed interventionNoIntervention Group · 1 Intervention: Delayed intervention · Intervention Types:
Post-intervention
Other
ActiveComparator Group · 1 Intervention: Care pathway · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: a maximum of about 6 hours as all opioids received during the ed stay will be captured

Trial Background

Prof. David Brousseau, Professor
Principal Investigator
Medical College of Wisconsin
Closest Location: Children's Wisconsin · Milwaukee, WI
Photo of Milwaukee  1Photo of Milwaukee  2Photo of Milwaukee  3
2019First Recorded Clinical Trial
1 TrialsResearching Sickle Cell Crisis
2 CompletedClinical Trials

Eligibility Criteria

Age < 65 · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have sickle cell disease.
You have received at least one prescription for an opioid.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.