Sickle Cell Improvement: Enhancing Care in the Emergency Department

NCT ID: NCT05373771

Last Updated: 2023-08-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 5328 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2027-08-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Post-intervention

Group Type: ACTIVE_COMPARATOR

Care pathway

Intervention Type: OTHER

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

Delayed intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Care pathway

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

Intervention Type: OTHER

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

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pediatric Emergency Care Applied Research Network

NETWORK

Sponsor Role: collaborator

Nemours Children's Health System

OTHER

Sponsor Role: collaborator

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

David Brousseau

Professor, Chair

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Brousseau, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Nemours Children's Health

Locations

Children's Wisconsin

Milwaukee, Wisconsin, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

David Brousseau, MD, MS

Role: CONTACT

david.brousseau@nemours.org

(302) 651-4000

Facility Contacts

David Brousseau

Role: primary

Other Identifiers

00114249

Identifier Type: -

Identifier Source: org_study_id