Study Detail

Study ID 1022
Name Improving ED Care Using Individualized Pain Plans
Contact Email
Period 2020 - 2022
Design Clinical Trial
Study PI Paula Tanabe
Institution Duke University
Funding Agency NHLBI
Overview The overall purpose of this 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 provide access to the IPP for both adult patients with SCD and their ED providers. The multisite study has 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 is available for all adult ED providers to use as their routine practice, and patients at affiliated local clinics are invited to participate and enroll in the study.
Focus Areas 1. Assess the overall effectiveness of EHR-embedded IPPs on improving patient and provider outcomes associated with pain treatment in the adult ED setting.
2. Assess the reach, adoption, implementation, and maintenance of the EHR-embedded IPP components and implementation strategies at each participating site.
3. Assess organizational readiness at the beginning of the implementation and barriers and facilitators to the use of EHR-embedded IPPs.
Outcomes 1. Change in Patient-perceived quality of ED pain treatment. [ Time Frame: Baseline, 96 hours ]
2. ED revisit rate as measured by EHR retrieval [ Time Frame: Day 7, Day 30 ]
3. Hospital readmission rate measured by EHR retrieval [ Time Frame: Day 7, Day 30 ]
4. Time to first dose of pain medication measured by EHR retrieval [ Time Frame: Baseline ]
Data Location RTI International
Biospecimen Available N/A
Data Consent De-identified data will be shared outside SCDIC; investigators must adhere to Data Use Agreement
Biospecimen Consent No sample
Contact Consent NA
Genomic Data No
Age Range 15-45
No. Subjects 24
Inclusion Criteria 1. Age 18 years up to and including 45 years
2. English speaking
3. 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.
4. Access to a cellular/mobile smart phone with access to text messaging (either Android or iPhone acceptable)
5. At least one Vaso-Occlusive Episode (VOE) visit to participating site Emergency Department (ED) the past 90 days from enrollment
6. At least one visit at the study site sickle cell disease clinic within the past 12 months
7. Willing and cognitively able to give informed consent
8. Provides pain treatment in one of the participating study Emergency Departments for a patient participant with a qualified ED visit .
Exclusion Criteria Patient's sickle cell provider states patient should not have a protocol or should not be administered opioids
Back to Study List