Recruiting

Observational Study

Sponsor:

Medical College of Wisconsin

Code:

NCT05373771

Conditions

Sickle Cell Crisis

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

Care pathway

Study Details

Brief 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.

Conditions

Sickle Cell Crisis

Study ID

NCT05373771

Start date

Sep 1, 2021

Status verified date

Aug, 2023

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

5328 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Post-intervention

no intervention: Delayed intervention

Interventions

Care pathway

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

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 and Locations

Central contacts

Locations

Children's Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

More Information

Sponsor

Medical College of Wisconsin

Last update posted

Aug 14, 2023

Last verified

Aug, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Medical College of Wisconsin on 2023-08-14.