Implementation of patient-reported outcomes for symptom management in oncology practice through the SIMPRO research consortium: a protocol for a pragmatic type II hybrid effectiveness-implementation multi-center cluster-randomized stepped wedge trial

Michael J Hassett, Sandra Wong, Raymond U Osarogiagbon, Jessica Bian, Don S Dizon, Hannah Hazard Jenkins, Hajime Uno, Christine Cronin, Deborah Schrag, SIMPRO Co-Investigators, Michael J Hassett, Sandra Wong, Raymond U Osarogiagbon, Jessica Bian, Don S Dizon, Hannah Hazard Jenkins, Hajime Uno, Christine Cronin, Deborah Schrag, SIMPRO Co-Investigators

Abstract

Background: Many cancer patients experience high symptom burden. Healthcare in the USA is reactive, not proactive, and doctor-patient communication is often suboptimal. As a result, symptomatic patients may suffer between clinic visits. In research settings, systematic assessment of electronic patient-reported outcomes (ePROs), coupled with clinical responses to severe symptoms, has eased this symptom burden, improved health-related quality of life, reduced acute care needs, and extended survival. Implementing ePRO-based symptom management programs in routine care is challenging. To study methods to overcome the implementation gap and improve symptom control for cancer patients, the National Cancer Institute created the Cancer-Moonshot funded Improving the Management of symPtoms during And following Cancer Treatment (IMPACT) Consortium.

Methods: Symptom Management IMplementation of Patient Reported Outcomes in Oncology (SIMPRO) is one of three research centers that make up the IMPACT Consortium. SIMPRO, a multi-disciplinary team of investigators from six US health systems, seeks to develop, test, and integrate an electronic symptom management program (eSyM) for medical oncology and surgery patients into the Epic electronic health record (EHR) system and associated patient portal. eSyM supports real-time symptom tracking for patients, automated clinician alerts for severe symptoms, and specialized reports to facilitate population management. To rigorously evaluate its impact, eSyM is deployed through a pragmatic stepped wedge cluster-randomized trial. The primary study outcome is the occurrence of an emergency department treat-and-release event within 30 days of starting chemotherapy or being discharged following surgery. Secondary outcomes include hospitalization rates, chemotherapy use (time to initiation and duration of therapy), and patient quality of life and satisfaction. As a type II hybrid effectiveness-implementation study, facilitators and barriers to implementation are assessed throughout the project.

Discussion: Creating and deploying eSyM requires collaboration between dozens of staff across diverse health systems, dedicated engagement of patient advocates, and robust support from Epic. This trial will evaluate eSyM in routine care settings across academic and community-based healthcare systems serving patients in rural and metropolitan locations. This trial's pragmatic design will promote generalizable results about the uptake, acceptability, and impact of an EHR-integrated, ePRO-based symptom management program.

Trial registration: ClinicalTrials.gov NCT03850912 . Registered on February 22, 2019. Last updated on November 9, 2021.

Keywords: Chemotherapy; Electronic health record; Electronic medical record; Gastrointestinal cancers; Gynecologic cancers; Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®); Patient-reported outcomes (PROs); Patient-reported outcomes measures (PROMS); Pragmatic clinical trial design; Surgery; Symptom management; Thoracic cancers.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
SIMPRO research consortium project schema
Fig. 2
Fig. 2
SIMPRO consortium randomization schema. Abbreviations: BAPT Baptist, WVU West Virginia University, MMC Maine Medical Center, DHMC Dartmouth Hitchcock Medical Center, LCI Lifespan Cancer Institute, DFCI Dana-Farber Cancer Institute, SIMPRO Symptom Management IMplementation of Patient Reported Outcomes in Oncology
Fig. 3
Fig. 3
Description of processes and implementation strategies at SIMPRO sites
Fig. 4
Fig. 4
SIMPRO stepped wedge randomization schema. Abbreviations: BAPT Baptist, WVU West Virginia University, MMC Maine Medical Center, DHMC Dartmouth Hitchcock Medical Center, LCI Lifespan Cancer Institute, DFCI Dana-Farber Cancer Institute, SIMPRO Symptom Management IMplementation of Patient Reported Outcomes in Oncology
Fig. 5
Fig. 5
SIMPRO Consortium data collection and transfer plan. Abbreviations: BAPT Baptist, WVU West Virginia University, MMC Maine Medical Center, DHMC Dartmouth Hitchcock Medical Center, LCI Lifespan Cancer Institute, DFCI Dana-Farber Cancer Institute, SIMPRO Symptom Management IMplementation of Patient Reported Outcomes in Oncology, SDOH social determinants of health, PI principal investigator, PM project manager

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