PRIMARY OBJECTIVES:
I. Adapt existing ePRO symptom management systems and integrate them into the electronic health record (EHR) and routine clinical workflow at six health systems. Specifically: (AIM 1)
Ia. Obtain patient, clinician, staff, and leadership input on ePRO form and function;
Ib. Refine the content and algorithms for self-management, alerts, and feedback;
Ic. Develop ePRO training materials for patients, clinicians, and staff;
Id. Pilot an ePRO symptom manager at test and study sites and prepare an implementation strategy.
II. Determine the effectiveness of an EHR-integrated ePRO symptom management system on health outcomes. Specifically: (AIM 2)
IIa. Healthcare utilization, measured by the need for emergency and acute care;
IIb. Impact on cancer care delivery, specifically chemotherapy treatment duration and delays;
IIc. Patients’ outcomes, indicated by levels of self-efficacy and symptom burden;
IId. Patients’ satisfaction with their cancer care.
III. Evaluate the facilitators and barriers to implementation of an EHR-integrated ePRO symptom management system from the patient, clinician, and organizational perspectives. Specifically: (AIM 3)
IIIa. Patient adoption (including program feedback and experiences via qualitative interviews), clinician utilization, and their perspectives on appropriateness and acceptability;
IIIb. The sustainability of ePRO symptom management within a health system;
IIIc. Penetration and scalability of ePROs for symptom management;
IIId. Extent of adaptation of ePRO systems over the course of the implementation process.
IV. Develop algorithms to estimate the risk of adverse events, including emergency department (ED) usage and hospitalization, among patients with suspected or confirmed cancer who are treated in community settings. (ACTIVITY 5)
V. Assess whether inclusion of ePROs improves algorithm performance and how predictions from clinical risk scores compare to predictions from computationally intensive machine learning approaches. (ACTIVITY 5)
VI. Assess model performance among historically under-represented populations, including black patients, and assess for evidence of racial bias in model calibration. (ACTIVITY 5)
OUTLINE: This clinical trial contains 5 activities.
ACTIVITY I: Stakeholders complete a questionnaire and participate in a facilitated meeting to be held one-on-one, in group settings, or remotely via writing, discussion or handheld polling devices.
ACTIVITY II: Build and deploy eSyM.
ACTIVITY III: Patients undergo eSyM training through in-person, phone, and/or virtual visits and utilize eSyM to report symptoms for up to 180 days after trigger event. Additionally, patient's medical records reviewed for demographics and outcomes. Patients follow up for 1 year after trigger event.
ACTIVITY IV: Patients or their proxy utilize eSyM to report symptoms for 60-180 days, but can continue indefinitely at the site's discretion. Patients also complete a questionnaire over 20 minutes up to 180 days after surgery or first dose of chemotherapy. Patient's medical records are reviewed for demographics and outcomes for up to 1 year after trigger event. Patients may optionally participate in a follow-up qualitative interview over 30-120 minutes to evaluate feedback about the eSyM program.
ACTIVITY V: Data previously collected for the SIMPRO project used to develop and evaluate the performance of predictive models for adverse events.
