Evaluating the implementation and impact of navigator-supported remote symptom monitoring and management: a protocol for a hybrid type 2 clinical trial

Abstract

Background Symptoms in patients with advanced cancer are often inadequately captured during encounters with the healthcare team. Emerging evidence demonstrates that weekly electronic home-based patient-reported symptom monitoring with automated alerts to clinicians reduces healthcare utilization, improves health-related quality of life, and lengthens survival. However, oncology practices have lagged in adopting remote symptom monitoring into routine practice, where specific patient populations may have unique barriers. One approach to overcoming barriers is utilizing resources from value-based payment models, such as patient navigators who are ideally positioned to assume a leadership role in remote symptom monitoring implementation. This implementation approach has not been tested in standard of care, and thus optimal implementation strategies are needed for large-scale roll-out. Methods This hybrid type 2 study design evaluates the implementation and effectiveness of remote symptom monitoring for all patients and for diverse populations in two Southern academic medical centers from 2021 to 2026. This study will utilize a pragmatic approach, evaluating real-world data collected during routine care for quantitative implementation and patient outcomes. The Consolidated Framework for Implementation Research (CFIR) will be used to conduct a qualitative evaluation at key time points to assess barriers and facilitators, implementation strategies, fidelity to implementation strategies, and perceived utility of these strategies. We will use a mixed-methods approach for data interpretation to finalize a formal implementation blueprint. Discussion This pragmatic evaluation of real-world implementation of remote symptom monitoring will generate a blueprint for future efforts to scale interventions across health systems with diverse patient populations within value-based healthcare models. Trial registration NCT04809740; date of registration 3/22/2021.

Using Implementation Science Frameworks to Guide the Use of Electronic Patient-Reported Outcome Symptom Monitoring in Routine Cancer Care

“…34,56,66 Other groups have since published study protocols including prospective evaluation of implementation as part of hybrid implementation-effectiveness studies. 67,68 The study captured the perspectives of under-studied stakeholders, including caregivers, clinic administrators, pharmacists, and IT specialists, which helped identify novel barriers and facilitators. Early consultation with stakeholders may also enhance their engagement with future implementation efforts.…”

Remote Symptom Monitoring to Enhance the Delivery of Palliative Cancer Care in Low-Resource Settings: Emerging Approaches from Africa

“…Mechanisms through which remote symptom monitoring improves patient and caregiver outcomes are starting to be determined through research. This includes linkages between patient reporting, clinician actions and subsequent improvements in patient outcomes (e.g., earlier detection, improved symptom management, reduced symptom burden and reduced distress) [35]. However, to date, research depicting how remote symptom monitoring leads to changes in outcomes has been based on research evidence from high-resource settings [35].…”

Evaluating Nurses' Time to Response by Severity and Cancer Stage in a Remote Symptom Monitoring Program for Patients With Breast Cancer

“…The University of Alabama at Birmingham (UAB) has made ePROs standard of care for patients with cancer and is one of the first to enroll patients with early and advanced stages. 12 Additionally, patients with breast cancer are ideal for initial evaluation due to the clear differentiation between early stage breast cancer (EBC) and advanced stage breast cancer. 13 Thus, this study aims to evaluate the association between patients' severity of patient-reported symptom alerts and the time to response by the health care team.…”