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Implementing an Individualized Pain Plan (IPP) for ED Treatment of VOE's in Sickle Cell Disease
NCT04584528 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 279 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,129 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04584528 reports 8 study locations spanning 8 distinct geographic areas — top geographies include California, Georgia, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04584528?
The interventions under investigation include: Electronic Health Record (EHR) Embedded Individualized Pain Plan (IPP) (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04584528?
This trial is sponsored by Duke University, which has 1,129 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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