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Trials
Published in: Trials 1/2020

Open Access 01-12-2020 | Care | Study protocol

Pragmatic cluster randomized trial to evaluate effectiveness and implementation of enhanced EHR-facilitated cancer symptom control (E2C2)

Authors: Lila J. Finney Rutten, Kathryn J. Ruddy, Linda L. Chlan, Joan M. Griffin, Jeph Herrin, Aaron L. Leppin, Deirdre R. Pachman, Jennifer L. Ridgeway, Parvez A. Rahman, Curtis B. Storlie, Patrick M. Wilson, Andrea L. Cheville

Published in: Trials | Issue 1/2020

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Abstract

Background

The prevalence of inadequate symptom control among cancer patients is quite high despite the availability of definitive care guidelines and accurate and efficient assessment tools.

Methods

We will conduct a hybrid type 2 stepped wedge pragmatic cluster randomized clinical trial to evaluate a guideline-informed enhanced, electronic health record (EHR)-facilitated cancer symptom control (E2C2) care model. Teams of clinicians at five hospitals that care for patients with various cancers will be randomly assigned in steps to the E2C2 intervention. The E2C2 intervention will have two levels of care: level 1 will offer low-touch, automated self-management support for patients reporting moderate sleep disturbance, pain, anxiety, depression, and energy deficit symptoms or limitations in physical function (or both). Level 2 will offer nurse-managed collaborative care for patients reporting more intense (severe) symptoms or functional limitations (or both). By surveying and interviewing clinical staff, we will also evaluate whether the use of a multifaceted, evidence-based implementation strategy to support adoption and use of the E2C2 technologies improves patient and clinical outcomes. Finally, we will conduct a mixed methods evaluation to identify disparities in the adoption and implementation of the E2C2 intervention among elderly and rural-dwelling patients with cancer.

Discussion

The E2C2 intervention offers a pragmatic, scalable approach to delivering guideline-based symptom and function management for cancer patients. Since discrete EHR-imbedded algorithms drive defining aspects of the intervention, the approach can be efficiently disseminated and updated by specifying and modifying these centralized EHR algorithms.

Trial registration

ClinicalTrials.gov, NCT03892967. Registered on 25 March 2019.
Appendix
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Metadata
Title
Pragmatic cluster randomized trial to evaluate effectiveness and implementation of enhanced EHR-facilitated cancer symptom control (E2C2)
Authors
Lila J. Finney Rutten
Kathryn J. Ruddy
Linda L. Chlan
Joan M. Griffin
Jeph Herrin
Aaron L. Leppin
Deirdre R. Pachman
Jennifer L. Ridgeway
Parvez A. Rahman
Curtis B. Storlie
Patrick M. Wilson
Andrea L. Cheville
Publication date
01-12-2020
Publisher
BioMed Central
Keyword
Care
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-04335-w

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