Implementing an Individualized Pain Plan (IPP) for ED Treatment of VOE's in Sickle Cell Disease
ALIGN
Improving SCD Care Using Web-based Guidelines, Nurse Care Managers and Peer Mentors in Primary Care and Emergency Departments in Central North Carolina
2 other identifiers
interventional
279
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2020
Typical duration for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 6, 2020
CompletedFirst Posted
Study publicly available on registry
October 14, 2020
CompletedStudy Start
First participant enrolled
October 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedOctober 28, 2022
October 1, 2022
1.9 years
October 6, 2020
October 26, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Patient-perceived quality of ED pain treatment.
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
Baseline, 96 hours
Secondary Outcomes (5)
ED revisit rate as measured by EHR retrieval
Day 7
ED revisit rate as measured by EHR retrieval
Day 30
Hospital readmission rate measured by EHR retrieval
Day 7
Hospital readmission rate measured by EHR retrieval
Day 30
Time to first dose of pain medication measured by EHR retrieval
Baseline
Study Arms (1)
EHR-embedded Individualized Pain Plan (IPP)
OTHERThe EHR embedded IPP will be made accessible to patients and ED providers at each study site.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patient's sickle cell provider states patient should not have a protocol or should not be administered opioids
- Provides pain treatment in one of the participating study Emergency Departments for a patient participant with a qualified ED visit .
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- RTI Internationalcollaborator
Study Sites (8)
University of California San Francisco
Oakland, California, 94609, United States
Georgia Regents University
Augusta, Georgia, 30912, United States
University of Illinois
Chicago, Illinois, 60612, United States
Washington University
St Louis, Missouri, 63110, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Duke University
Durham, North Carolina, 27710, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
St. Jude's
Memphis, Tennessee, 38105, United States
Related Publications (2)
Siewny L, King A, Melvin CL, Carpenter CR, Hankins JS, Colla JS, Preiss L, Luo L, Cox L, Treadwell M, Davila N, Masese RV, McCuskee S, Gollan SS, Tanabe P. Impact of an individualized pain plan to treat sickle cell disease vaso-occlusive episodes in the emergency department. Blood Adv. 2024 Oct 22;8(20):5330-5338. doi: 10.1182/bloodadvances.2023012439.
PMID: 38815230DERIVEDLuo L, King AA, Carroll Y, Baumann AA, Brambilla D, Carpenter CR, Colla J, Gibson RW, Gollan S, Hall G, Klesges L, Kutlar A, Lyon M, Melvin CL, Norell S, Mueller M, Potter MB, Richesson R, Richardson LD, Ryan G, Siewny L, Treadwell M, Zun L, Armstrong-Brown J, Cox L, Tanabe P. 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 Res Protoc. 2021 Apr 16;10(4):e24818. doi: 10.2196/24818.
PMID: 33861209DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paula Tanabe, PhD
Duke University School of Nursing
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2020
First Posted
October 14, 2020
Study Start
October 27, 2020
Primary Completion
September 20, 2022
Study Completion
October 1, 2022
Last Updated
October 28, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, 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.
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.