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NCT04584528 · ClinicalTrials.gov registry record · NA
Implementing an Individualized Pain Plan (IPP) for ED Treatment of VOE's in Sickle Cell Disease
A NA study of Sickle Cell Disease and Genetic Disease, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 279
- Enrollment target
- 8
- Study locations
NCT04584528 is a NA study of Sickle Cell Disease and Genetic Disease that has completed, run by Duke University. The registered enrollment target is 279 participants, roughly in line with the 291-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target. The trial reports 8 study locations across 8 states.
The verdict
NCT04584528, a NA study of Sickle Cell Disease and Genetic Disease, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 279 participants
- Enrollment target
- 8
- Study locations
Study Summary
The overall purpose of this proposed study is to improve management of vaso-occlusive episodes (VOEs) in adult EDs. We aim to implement NHLBI recommendations for VOE treatment by embedding Individualized Pain Plans (IPPs) in the electronic health record (EHR). The EHR-embedded IPP will serve as a record of patients' SCD genotype and will include analgesic medication recommendations developed by the SCD provider. In this project, we will provide access to the IPP for both adult patients with SCD and ED providers. The proposed multisite study will use a pre-post study design, with a core set of mandatory intervention components and strategies for each participating site and optional components and strategies to allow for intervention adaptation to local needs and resources. The EHR-embedded IPP will be available for all adult ED providers to use as their routine practice, and patients will be invited to participate and enroll in the study. We will use a simplified Technology Acceptance Model to explain the use of the IPP and the RE-AIM framework to assess the Reach, Effectiveness, Adoption, Implementation, and Maintenance of the intervention.
Conditions Studied
Interventions
- OTHER Electronic Health Record (EHR) Embedded Individualized Pain Plan (IPP)
Study Locations (8)
California
- University of California San Francisco - Oakland
Georgia
- Georgia Regents University - Augusta
Illinois
- University of Illinois - Chicago
Missouri
- Washington University - St Louis
New York
- Icahn School of Medicine at Mount Sinai - New York
North Carolina
- Duke University - Durham
South Carolina
- Medical University of South Carolina - Charleston
Tennessee
- St. Jude's - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 279 participants |
| Start Date | 2020-10-27 |
| Est. Completion | 2022-10-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04584528
The ClinicalTrials.gov registry entry for NCT04584528 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 279 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 291-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Sickle Cell Disease appearing as the primary indexed condition, and to 1 intervention - of which Electronic Health Record (EHR) Embedded Individualized Pain Plan (IPP) is the first listed.
NCT04584528 reports 8 study locations spanning 8 distinct geographic areas - top geographies include California, Georgia, Illinois.
Frequently Asked Questions
What is clinical trial NCT04584528 about?
NCT04584528 is a clinical study titled "Implementing an Individualized Pain Plan (IPP) for ED Treatment of VOE's in Sickle Cell Disease". The overall purpose of this proposed study is to improve management of vaso-occlusive episodes (VOEs) in adult EDs. We aim to implement NHLBI recommendations for VOE treatment by embedding Individualized Pain Plans (IPPs) in the electronic health record (EHR). The EHR-embedded IPP will serve as a re...
What is the current status of trial NCT04584528?
This trial is currently completed. It is a NA study. The enrollment target is 279 participants. The study started on 2020-10-27. Estimated completion is 2022-10-01.
What conditions does trial NCT04584528 study?
This clinical trial studies the following conditions: Sickle Cell Disease, Genetic Disease, Hematologic Diseases, Anemia, Sickle Cell.
What interventions are being tested in trial NCT04584528?
The interventions under investigation include: Electronic Health Record (EHR) Embedded Individualized Pain Plan (IPP) (OTHER).
Who is sponsoring clinical trial NCT04584528?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04584528 being conducted?
This trial has 8 study locations across California, Georgia, Illinois, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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