Implementation and evaluation of an expanded electronic health record-integrated bilingual electronic symptom management program across a multi-site Comprehensive Cancer Center: The NU IMPACT protocol

David Cella*, Sofia F. Garcia, September Cahue, Justin D. Smith, Betina Yanez, Denise Scholtens, Nicola Lancki, Michael Bass, Sheetal Kircher, Ann Marie Flores, Roxanne E. Jensen, Ashley Wilder Smith, Frank J. Penedo

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

Background: People with cancer experience symptoms that adversely affect quality of life. Despite existing interventions and clinical guidelines, timely symptom management remains uneven in oncology care. We describe a study to implement and evaluate an electronic health record (EHR)-integrated symptom monitoring and management program in adult outpatient cancer care. Methods: Our cancer patient-reported outcomes (cPRO) symptom monitoring and management program is a customized EHR-integrated installation. We will implement cPRO across all Northwestern Memorial HealthCare (NMHC) hematology/oncology clinics. We will conduct a cluster randomized modified stepped-wedge trial to evaluate patient and clinician engagement with cPRO. Further, we will embed a patient-level randomized clinical trial to evaluate the impact of an additional enhanced care (EC; cPRO plus web-based symptom self-management intervention) relative to usual care (UC; cPRO alone). The project uses a Type 2 hybrid effectiveness-implementation approach. The intervention will be implemented across seven regional clusters within the healthcare system comprising 32 clinic sites. A 6-month prospective pre-implementation enrollment period will be followed by a post-implementation enrollment period, during which newly enrolled, consenting patients will be randomly assigned (1:1) to EC or UC. We will follow patients for 12 months post-enrollment. Patients randomized to EC will receive evidence-based symptom-management content on cancer-related concerns and approaches to enhance quality of life, using a web-based tool (“MyNM Care Corner”). This design allows for within- and between-site evaluation of implementation plus a group-based comparison to demonstrate effectiveness on patient-level outcomes. Discussion: The project has potential to guide implementation of future healthcare system-level cancer symptom management programs. http://ClinicalTrials.gov

Original languageEnglish (US)
Article number107171
JournalContemporary Clinical Trials
Volume128
DOIs
StatePublished - May 2023

Keywords

  • Cancer
  • Electronic health record
  • Implementation science
  • Patient engagement
  • Patient-reported outcomes
  • Symptom management

ASJC Scopus subject areas

  • Pharmacology (medical)

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