Who is sponsoring NCT04584528?

NCT04584528 is sponsored by Duke University.

What drugs are being tested in NCT04584528?

Interventions in NCT04584528: Electronic Health Record (EHR) Embedded Individualized Pain Plan (IPP).

What condition does NCT04584528 study?

NCT04584528 studies Sickle Cell Disease, Genetic Disease, Hematologic Diseases, Anemia, Sickle Cell.

Is NCT04584528 still recruiting?

NCT04584528 is currently completed. Last updated 28 October 2022.

Last reviewed 2022-10-28 · How we verify

NCT04584528: ALIGN

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Implementing an Individualized Pain Plan (IPP) for ED Treatment of VOE's in Sickle Cell Disease

Completed NA Last updated 28 October 2022

What this trial tests

NA trial testing Electronic Health Record (EHR) Embedded Individualized Pain Plan (IPP) in Sickle Cell Disease in 279 participants. Completed in 1 October 2022.

Timeline

27 October 2020

Primary endpoint
20 September 2022

1 October 2022

Quick facts

Lead sponsor	Duke University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	279
Start date	27 October 2020
Primary completion	20 September 2022
Estimated completion	1 October 2022
Sites	8 locations across United States

Drugs / interventions tested

Electronic Health Record (EHR) Embedded Individualized Pain Plan (IPP)

Conditions studied

Sickle Cell Disease — all drugs for Sickle Cell Disease →
Genetic Disease — all drugs for Genetic Disease →
Hematologic Diseases — all drugs for Hematologic Diseases →
Anemia, Sickle Cell — all drugs for Anemia, Sickle Cell →

Sponsor

Duke University

Who can join

Adults 18 to 45, any sex, with Sickle Cell Disease or Genetic Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Impact of an individualized pain plan to treat sickle cell disease vaso-occlusive episodes in the emergency department.
Siewny L, King A, Melvin CL, Carpenter CR, et al · · 2024 · cited 9× · PMID 38815230 · DOI 10.1182/bloodadvances.2023012439
Electronic Health Record-Embedded Individualized Pain Plans for Emergency Department Treatment of Vaso-occlusive Episodes in Adults With Sickle Cell Disease: Protocol for a Preimplementation and Postimplementation Study.
Luo L, King AA, Carroll Y, Baumann AA, et al · · 2021 · cited 6× · PMID 33861209 · DOI 10.2196/24818

Verify or expand the search:

Other recruiting trials for Sickle Cell Disease

Currently open trials in the same condition.

NCT07369024 — Sub-dissociative Dose Ketamine in Treatment of Vaso-occlusive Pain Event in Children and Young Adults · Phase 2 · recruiting
NCT06016634 — Alendronate for Osteonecrosis in Adults With Sickle Cell Disease · Phase 2 · recruiting
NCT06260891 — Zinc Supplementation in Sickle Cell Disease: A Precursor to the Think Zinc for Bones Trial · Phase 2 · recruiting
NCT07222475 — Writing Relaxing Beats in Adolescents Who Have Sickle Cell Disease · NA · recruiting
NCT07224360 — Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease (SCD) · Phase 2 · recruiting

Other Duke University trials

Trials by the same sponsor.

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NCT07216963 — The Community Paramedic Response and Overdose Outreach With Supportive Medical-Legal Services Study · NA · not yet recruiting
NCT07459218 — IDEAS for Hope to Reduce Suicide Risk and Improve HIV Care Engagement in Tanzania · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04584528 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Duke University
Last refreshed: 28 October 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04584528.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing