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

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.

Conditions

• Sickle Cell Disease
• Genetic Disease
• Hematologic Diseases
• Anemia, Sickle Cell

Interventions

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.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• RTI International

  collaborator OTHER

• Duke University

  lead OTHER

Principal Investigators

• Paula Tanabe, PhD · Duke University School of Nursing

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-10-27

Primary Completion

2022-09-20

Completion

2022-10-01

Countries

• United States

Study Locations