N/A
Completed N=483
Comparison of Patient Centered Outcomes for People With Sickle Cell Disease in the Acute Care Setting
Source: ClinicalTrials.gov NCT02411396 ↗Enrolled (actual)
483
Serious AEs
—
Results posted
Jun 2019
Primary outcomePrimary: Time (Minutes) From Arrival to Center to Time First Dose of Parenteral Pain Medication Administered — 125.3; 61.8 minutes
Summary
The Emergency Department has been the standard location where patients with Sickle Cell Disease (SCD) go to seek care for the treatment of acute painful events. Vaso- Occlusive Crisis (VOC) is the most common complication of SCD,
The purpose of this study is to compare patient centered outcomes for patients being treated for an uncomplicated VOC in Infusion Centers (IC) and Emergency Departments (ED) in four locations around the United States.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time (Minutes) From Arrival to Center to Time First Dose of Parenteral Pain Medication Administered |
125.3; 61.8 | — |
| SECONDARY Disposition From Acute Care Visit |
517; 128; 1039; 1340 | — |
| SECONDARY Pain Reassessment Within 30 Minutes of First Dose of Parenteral Pain Medication Administered |
287; 544; 1107; 911 | — |
| SECONDARY Patient Reported Satisfaction With Care Received |
4.8; 5.8 | — |
| SECONDARY Patient Reported Perception of Risk From Visit |
43; 98; 44; 20 | — |
Eligibility Criteria
Inclusion Criteria
- Confirmed Sickle Cell Disease patients who live within 60 miles of the study center or who already receive regular care at the participating centers.
Exclusion Criteria
- Stable patients who have been on chronic transfusion therapy and have not had a painful episode within two years of enrollment.
- Patients who are pregnant.
- Patients who are unwilling or unable to sign consent.
Data sourced from ClinicalTrials.gov (NCT02411396). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.