Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT04809740 |
Other study ID # |
IRB-300007406 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
May 4, 2021 |
Est. completion date |
January 2026 |
Study information
Verified date |
May 2023 |
Source |
University of Alabama at Birmingham |
Contact |
Stacey A Ingram, MEd |
Phone |
205-934-6287 |
Email |
saadewakun[@]uabmc.edu |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
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.
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.