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EHR-embedded Individualized Pain Plan (IPP) for Sickle Cell Anemia (ALIGN Trial)

N/A
Waitlist Available
Led By Paula Tanabe, PhD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least one Vaso-Occlusive Episode (VOE) visit to participating site Emergency Department (ED) the past 90 days from enrollment
Access to a cellular/mobile smart phone with access to text messaging (either Android or iPhone acceptable) .
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 30
Awards & highlights

ALIGN Trial Summary

This trial is testing a way to improve management of sickle cell disease in adults by embedding a plan for each individual patient in the electronic health record. The goal is to make it easier for providers to follow NHLBI recommendations and for patients to get the best pain care.

Eligible Conditions
  • Sickle Cell Anemia
  • Blood Diseases
  • Genetic Disorder
  • Sickle Cell Disease

ALIGN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

ALIGN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 96 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 96 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Patient-perceived quality of ED pain treatment.
Secondary outcome measures
ED revisit rate as measured by EHR retrieval
Hospital readmission rate measured by EHR retrieval
Time to first dose of pain medication measured by EHR retrieval

ALIGN Trial Design

1Treatment groups
Experimental Treatment
Group I: EHR-embedded Individualized Pain Plan (IPP)Experimental Treatment1 Intervention
The EHR embedded IPP will be made accessible to patients and ED providers at each study site.

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,358 Previous Clinical Trials
3,419,790 Total Patients Enrolled
5 Trials studying Sickle Cell Anemia
504 Patients Enrolled for Sickle Cell Anemia
RTI InternationalOTHER
188 Previous Clinical Trials
875,685 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,833 Previous Clinical Trials
47,306,217 Total Patients Enrolled
26 Trials studying Sickle Cell Anemia
2,458 Patients Enrolled for Sickle Cell Anemia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
JMIR Research ProtocolsJournal
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, Lingzi, Allison A King, Yvonne Carroll, Ana A Baumann, Donald Brambilla, Christopher R Carpenter, Joseph Colla, et al.. 2021. “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”. JMIR Research Protocols. JMIR Publications Inc.. doi:10.2196/24818.
clinicaltrials.govStudy
Implementing an Individualized Pain Plan (IPP) for ED Treatment of VOE's in Sickle Cell Disease
2020. "Implementing an Individualized Pain Plan (IPP) for ED Treatment of VOE's in Sickle Cell Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04584528.
~63 spots leftby Apr 2025
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