Sickle Cell Improvement: Enhancing Care in the Emergency Department (SCIENCE)
Primary Purpose
Sickle Cell Crisis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Care pathway
Sponsored by
About this trial
This is an interventional treatment trial for Sickle Cell Crisis
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
Sites / Locations
- Children's WisconsinRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Post-intervention
Delayed intervention
Arm Description
Outcomes
Primary Outcome Measures
Timeliness of receipt of opioids
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 Outcome Measures
Median time to opioids
Median time from arrival to first opioid and then subsequent opioids
Percent of children hospitalized
Disposition of hospitalization or discharge home
Full Information
NCT ID
NCT05373771
First Posted
May 5, 2022
Last Updated
August 8, 2023
Sponsor
Medical College of Wisconsin
Collaborators
Pediatric Emergency Care Applied Research Network, Nemours Children's Health System
1. Study Identification
Unique Protocol Identification Number
NCT05373771
Brief Title
Sickle Cell Improvement: Enhancing Care in the Emergency Department
Acronym
SCIENCE
Official Title
Sickle Cell Improvement: Enhancing Care in the Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
August 31, 2026 (Anticipated)
Study Completion Date
August 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
Collaborators
Pediatric Emergency Care Applied Research Network, Nemours Children's Health System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Crisis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5328 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Post-intervention
Arm Type
Active Comparator
Arm Title
Delayed intervention
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Care pathway
Intervention Description
Implementation of care pathway as part of hybrid type 2 implementation effectiveness study
Primary Outcome Measure Information:
Title
Timeliness of receipt of opioids
Description
The percent of patients who receive first dose of opioids within 60 minutes of arrival and subsequent doses within 30 minutes of previous dose
Time Frame
A maximum of about 6 hours as all opioids received during the ED stay will be captured
Secondary Outcome Measure Information:
Title
Median time to opioids
Description
Median time from arrival to first opioid and then subsequent opioids
Time Frame
A maximum of about 6 hours as all opioids received during the ED stay will be captured
Title
Percent of children hospitalized
Description
Disposition of hospitalization or discharge home
Time Frame
A maximum of about 6 hours as that is the typical maximum time to disposition for patients
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Brousseau, MD, MS
Phone
(302) 651-4000
Email
david.brousseau@nemours.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Brousseau, MD, MS
Organizational Affiliation
Nemours Children's Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Brousseau
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Outcome data gathered through central data Registry. It is a limited dataset. A public use dataset will be made available after the study consistent with NIH guidelines.
Learn more about this trial
Sickle Cell Improvement: Enhancing Care in the Emergency Department
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