Evaluating the Implementation and Impact of Navigator-delivered ePRO System

The University of Alabama at Birmingham

Status: Enrolling

Conditions: Cancer

Treatments: Other: Evaluate implementation of navigator-delivered Home ePRO for all cancer patients

Study type: Interventional

Funder types: Other

Identifiers

NCT04809740

IRB-300007406

Details and patient eligibility

About

1. Evaluate implementation of navigator-delivered Home ePRO for all cancer patients across multiple practice sites; 2) examine the barriers, facilitators, and implementation strategies used in implementing navigator-delivered Home ePRO; and 3) assess the impact of Home ePRO on clinical and utilization outcomes.

Full description

Randomized controlled trials by Basch (collaborator) and colleagues demonstrated that weekly electronic home-based PRO symptom monitoring with automated alerts to clinicians (Home ePRO) in cancer patients was associated with reduced healthcare utilization, improved quality of life, and increased overall survival. However, these trials were administered using infrastructure supported by research funding. A knowledge gap remains about optimal implementation strategies for and effectiveness of Home ePROs in real-world settings. To address this gap, investigators from two institutions will conduct a large-scale population-based implementation of an evidence-based Home ePRO intervention for all adult cancer patients receiving chemotherapy, including vulnerable populations such as African Americans, rural residents, and socioeconomically disadvantaged individuals. This implementation will leverage infrastructure from Medicare's payment reform projects (Oncology Care Model, Oncology Care First Model), which require and financially support patient navigators, a natural workforce for Home ePRO implementation. The investigators' hypothesis is that the deployed implementation strategies will result in successful navigator-delivered Home ePRO, which will improve both patient and health system outcomes. Using the Consolidated Framework for Implementation Research (CFIR), this hypothesis will be tested using a hybrid type 2 design with three specific aims: 1) evaluate implementation of navigator-delivered Home ePRO for all cancer patients across multiple practice sites; 2) examine the barriers, facilitators, and implementation strategies used in implementing navigator-delivered Home ePRO; and 3) assess the impact of Home ePRO on clinical and utilization outcomes. In Aim 1, Home ePRO will be evaluated using implementation outcomes (service penetrance, provider adoption/penetration, intervention fidelity). In Aim 2, the investigators will gauge patient and healthcare team perceptions of barriers, facilitators of navigator-led Home ePRO, implementation strategies used to address these barriers, implementation strategy fidelity, and perception of implementation strategy ability to address barriers using an iterative qualitative analysis. In Aim 3, patient-level outcomes (functional status, distress, depression, healthcare utilization, cost, survival) will be evaluated using real-world data sources. The project is innovative because it will be the first study to evaluate real-world implementation of navigator-led Home ePRO for all cancer patients receiving chemotherapy, an approach that is both immediately scalable and sustainable within value-based payment models. The proposed research is significant because it is expected to demonstrate successful implementation of navigator-delivered Home ePRO and effectiveness of the ePRO intervention on diverse patient populations. Furthermore, the project will generate an implementation blueprint of successful implementation strategies that can be easily applied to other patient-reported outcomes, with the potential to positively impact patient care as health care transitions to a value-based system.

Enrollment: 7,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patient Group:

• Age ≥18
• Cancer patients at participating institution
• Receipt of chemotherapy, targeted therapy, and immunotherapy at participating institution from 2019-2026.

Exclusion criteria

• Second opinion only at participating institution.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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7,500 participants in 1 patient group

Patient Group

Other group

Description:

7,500 Patients from UAB/MCI

Treatment:

Other: Evaluate implementation of navigator-delivered Home ePRO for all cancer patients