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

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ClinicalTrials.gov Identifier: NCT04584528
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : April 8, 2022
National Heart, Lung, and Blood Institute (NHLBI)
RTI International
Information provided by (Responsible Party):
Duke University

Brief 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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Genetic Disease Hematologic Diseases Anemia, Sickle Cell Other: Electronic Health Record (EHR) Embedded Individualized Pain Plan (IPP) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Intervention Model Description: Multi-site pre-post study design, with a core set of mandatory patient and provider intervention strategies for each participating site, and optional strategies to allow for intervention adaptation to local needs and resources.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving SCD Care Using Web-based Guidelines, Nurse Care Managers and Peer Mentors in Primary Care and Emergency Departments in Central North Carolina
Actual Study Start Date : October 27, 2020
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
EHR-embedded Individualized Pain Plan (IPP)
The EHR embedded IPP will be made accessible to patients and ED providers at each study site.
Other: Electronic Health Record (EHR) Embedded Individualized Pain Plan (IPP)

The IPPs will be developed by the Sickle Cell Disease providers at each study site based on patients' outpatient chronic opioid use and analgesic agent normally required for treatment of VOE in the ED. The Sickle Cell Disease provider will review the IPP with the patient, then upload the IPP to the patient's EHR in a location that will be accessible by the patient and ED provider. Each participating site will train patients and Emergency Department (ED) providers on how to access the IPP in the Electronic Health Record. The following required elements will be included in the EHR-embedded IPP:

  • Genotype
  • Individual pain plan-preferred analgesic agent, route, dose and dosing interval, last update time
  • Name and contact information for the SCD provider

If the enrolled patient has a VOE visit at a nonparticipating ED, the patient will be able to access their IPP via the web or the patient portal app through their EHR. However, data will not be collected from these visits.

Primary Outcome Measures :
  1. Change in Patient-perceived quality of ED pain treatment. [ Time Frame: Baseline, 96 hours, 2 weeks ]
    Three questions from the Adult Sickle Cell Quality of Life Measure (ASCQ-Me) and Quality of Care (QOC) measure will be used to measure the patient perceived quality of ED pain treatment

Secondary Outcome Measures :
  1. ED revisit rate as measured by EHR retrieval [ Time Frame: Day 7 ]
  2. ED revisit rate as measured by EHR retrieval [ Time Frame: Day 30 ]
  3. Hospital readmission rate measured by EHR retrieval [ Time Frame: Day 7 ]
  4. Hospital readmission rate measured by EHR retrieval [ Time Frame: Day 30 ]
  5. Time to first dose of pain medication measured by EHR retrieval [ Time Frame: Baseline ]

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Patient Inclusion Criteria:

  • Age 18 years up to and including 45 years
  • English speaking
  • Confirmed SCD diagnoses . Confirmed is defined as supported by documentation in the medical record of a positive test for one of the following : Hb SS, Hb SC, Hb S -thalassemia, Hb SO, Hb SD, Hb SG, Hb SE, or Hb SF.
  • Access to a cellular/mobile smart phone with access to text messaging (either Android or iPhone acceptable) .
  • At least one Vaso-Occlusive Episode (VOE) visit to participating site Emergency Department (ED) the past 90 days from enrollment
  • At least one visit at the study site sickle cell disease clinic within the past 12 months
  • Willing and cognitively able to give informed consent

Patient Exclusion criteria:

  • Patient's sickle cell provider states patient should not have a protocol or should not be administered opioids

Provider Inclusion Criteria:

  • Provides pain treatment in one of the participating study Emergency Departments for a patient participant with a qualified ED visit .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04584528

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Contact: Paula Tanabe, PhD 919-970-8968 paula.tanabe@duke.edu
Contact: Nirmish Shah, MD 919-970-8968 nirmish.shah@duke.edu

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United States, California
University of California San Francisco Recruiting
Oakland, California, United States, 94609
Contact: Marsha Treadwell, PhD    510-428-3168    marsha.treadwell@ucsf.edu   
United States, Georgia
Georgia Regents University Recruiting
Augusta, Georgia, United States, 30912
Contact: Abdular Kutlar, MD    706-721-2171    akutlar@augusta.edu   
United States, Illinois
University of Illinois Recruiting
Chicago, Illinois, United States, 60612
Contact: Victor Gordeuk, MD    312-996-5680    vgordeuk@uic.edu   
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Allison King, MD, PhD, MPH    314-454-6018    king_a@wustl.edu   
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Lynne Richardson, MD    212-824-8066    Lynne.Richardson@mssm.edu   
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Paula Tanabe, PhD    919-613-6038    paula.tanabe@duke.edu   
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Cathy Melvin, PhD    843-876-2426    melvinc@musc.edu   
United States, Tennessee
St. Jude's Recruiting
Memphis, Tennessee, United States, 38105
Contact: Jane Hankins, MD    866-278-5833    referralinfo@stjude.org   
Principal Investigator: Jane Hankins, MD         
Sponsors and Collaborators
Duke University
National Heart, Lung, and Blood Institute (NHLBI)
RTI International
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Principal Investigator: Paula Tanabe, PhD Duke University School of Nursing
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04584528    
Other Study ID Numbers: Pro00073506_1
5U01HL133964-05 ( U.S. NIH Grant/Contract )
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: April 8, 2022
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified patient-level data will be available to researchers outside the SCDIC through an application and approval process as part of the SCDIC's Ancillary Studies Policy and Data Dissemination Plan. To protect the confidentiality and privacy of the participants, investigators granted access to the limited access data must adhere to strict requirements incorporated into a standard Data Use Agreement. In accordance with NHLBI policy, outside researchers will also be required to submit an approval tot RTI, the Data Coordinating Center, from their IRB.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data will be made available by RTI, the data coordinating center for the study, upon request.
Access Criteria: Researches outside of the SCDIC must submit requests for de-identified study related data to RTI, the data coordinating center.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
sickle cell disease
vaso occlusive-episodes
Individualized Pain Plans
implementation science
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Hematologic Diseases
Genetic Diseases, Inborn
Anemia, Hemolytic, Congenital
Anemia, Hemolytic