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

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 t...

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Main 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
Format: Article
Language:English
Published: BMC 2020-06-01
Series:Trials
Subjects:
Online Access:http://link.springer.com/article/10.1186/s13063-020-04335-w
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author 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
author_facet 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
author_sort Lila J. Finney Rutten
collection DOAJ
description 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.
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spelling doaj.art-e810343eb40940ccaa16062365c3ced12022-12-21T22:45:51ZengBMCTrials1745-62152020-06-0121111910.1186/s13063-020-04335-wPragmatic cluster randomized trial to evaluate effectiveness and implementation of enhanced EHR-facilitated cancer symptom control (E2C2)Lila J. Finney Rutten0Kathryn J. Ruddy1Linda L. Chlan2Joan M. Griffin3Jeph Herrin4Aaron L. Leppin5Deirdre R. Pachman6Jennifer L. Ridgeway7Parvez A. Rahman8Curtis B. Storlie9Patrick M. Wilson10Andrea L. Cheville11Department of Health Sciences Research, Mayo ClinicDivision of Medical Oncology, Mayo ClinicDepartment of Nursing, Mayo ClinicDepartment of Health Sciences Research, Mayo ClinicYale University School of MedicineDepartment of Health Sciences Research, Mayo ClinicCenter for Palliative Care, Mayo ClinicRobert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo ClinicRobert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo ClinicDepartment of Health Sciences Research, Mayo ClinicRobert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo ClinicRobert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo ClinicAbstract 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.http://link.springer.com/article/10.1186/s13063-020-04335-wElectronic health recordNeoplasmPainPalliative carePatient care teamPatient-reported outcome measure
spellingShingle 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
Pragmatic cluster randomized trial to evaluate effectiveness and implementation of enhanced EHR-facilitated cancer symptom control (E2C2)
Trials
Electronic health record
Neoplasm
Pain
Palliative care
Patient care team
Patient-reported outcome measure
title Pragmatic cluster randomized trial to evaluate effectiveness and implementation of enhanced EHR-facilitated cancer symptom control (E2C2)
title_full Pragmatic cluster randomized trial to evaluate effectiveness and implementation of enhanced EHR-facilitated cancer symptom control (E2C2)
title_fullStr Pragmatic cluster randomized trial to evaluate effectiveness and implementation of enhanced EHR-facilitated cancer symptom control (E2C2)
title_full_unstemmed Pragmatic cluster randomized trial to evaluate effectiveness and implementation of enhanced EHR-facilitated cancer symptom control (E2C2)
title_short Pragmatic cluster randomized trial to evaluate effectiveness and implementation of enhanced EHR-facilitated cancer symptom control (E2C2)
title_sort pragmatic cluster randomized trial to evaluate effectiveness and implementation of enhanced ehr facilitated cancer symptom control e2c2
topic Electronic health record
Neoplasm
Pain
Palliative care
Patient care team
Patient-reported outcome measure
url http://link.springer.com/article/10.1186/s13063-020-04335-w
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