Evaluating the Implementation and Impact of Navigator-delivered ePRO System

Evaluating the Implementation and Impact of Navigator-delivered ePRO Home Symptom Monitoring and Management

Evaluate implementation of navigator-delivered Home ePRO for all cancer patients across multiple practice sites and assess the impact of Home ePRO on clinical and utilization outcomes.

Study Overview

• Status: Active, not recruiting
• Conditions: Cancer
• Intervention / Treatment: Other: Navigator-delivered Home ePRO

Detailed Description

Randomized controlled trials 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, we will conduct a large-scale population-based implementation of an evidence-based Home ePRO intervention for all adult cancer patients receiving chemotherapy. The investigators' hypothesis is that the implementation of navigator-delivered Home ePRO will be successful and will improve both patient and health system outcomes.

• Study Type: Interventional
• Enrollment (Actual): 3090
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patient Group; Patients from UAB/MCI enrolled	Other: Navigator-delivered Home ePRO; The intervention includes standard of care weekly symptom survey delivery to patients, with alerts generated for symptoms that are sent to clinic nurses to address per standard of care protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Service Penetration	% of eligible patients enrolled	up to 3 months of starting a treatment for cancer

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Alerts Closed Within 48 Hours	alerts are measured by abstracting alert data from the ePRO database	up to 48 hours
% of Patients Completing ≥1 ePRO Survey	ePRO surveys are abstracted from the electronic patient-reported outcome system	up to 6 months
% of Expected ePRO Surveys Completed Per Patient	ePRO surveys are abstracter from the database; the surveys completed are compared to those sent	up to 6 months
% of Surveys Completed of Surveys Sent to Patient	ePRO surveys are abstracted from the ePRO database including surveys completed	up to 6 months
Symptom Trajectory	abstract from ePRO database the symptom alerts; we will report the proportion alerting for the population over 6 months	up to 3 months; up to 6 months
Number of ED Visits	Proportion with patients with an ED visit (abstracted from the electronic medical record)	up to 3 months, up to 6 months
Number of Hospitalizations	Proportion of patients hospitalized (abstracted from the EMR)	up to 3 months, up to 6 months
Number of ICU Visits	Proportion admitted to the ICU	up to 3 months, up to 6 months
Total Cost of Care	total costs sent by UAB to payers (abstracted from billing records)	up to 3 months, up to 6 months

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: National Institute of Nursing Research (NINR); University of South Alabama

Publications and helpful links

General Publications

• Rocque GB, Dionne-Odom JN, Stover AM, Daniel CL, Azuero A, Huang CS, Ingram SA, Franks JA, Caston NE, Dent AN, Basch EM, Jackson BE, Howell D, Weiner BJ, Pierce JY. Evaluating the implementation and impact of navigator-supported remote symptom monitoring and management: a protocol for a hybrid type 2 clinical trial. BMC Health Serv Res. 2022 Apr 22;22(1):538. doi: 10.1186/s12913-022-07914-6.

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2021
• Primary Completion (Actual): December 31, 2025
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: December 10, 2020
• First Submitted That Met QC Criteria: March 18, 2021
• First Posted (Actual): March 22, 2021

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 14, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: IRB-300007406; 5R01NR019058 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No