Cancer
Conditions
Brief summary
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.
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.
Interventions
OTHERNavigator-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
Sponsors
University of Alabama at Birmingham
University of South Alabama
National Institute of Nursing Research (NINR)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Service Penetration | up to 3 months of starting a treatment for cancer | % of eligible patients enrolled |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Alerts Closed Within 48 Hours | up to 48 hours | alerts are measured by abstracting alert data from the ePRO database |
| % of Patients Completing ≥1 ePRO Survey | up to 6 months | ePRO surveys are abstracted from the electronic patient-reported outcome system |
| % of Expected ePRO Surveys Completed Per Patient | up to 6 months | ePRO surveys are abstracter from the database; the surveys completed are compared to those sent |
| % of Surveys Completed of Surveys Sent to Patient | up to 6 months | ePRO surveys are abstracted from the ePRO database including surveys completed |
| Symptom Trajectory | up to 3 months; up to 6 months | abstract from ePRO database the symptom alerts; we will report the proportion alerting for the population over 6 months |
| Number of ED Visits | up to 3 months, up to 6 months | Proportion with patients with an ED visit (abstracted from the electronic medical record) |
| Number of Hospitalizations | up to 3 months, up to 6 months | Proportion of patients hospitalized (abstracted from the EMR) |
| Number of ICU Visits | up to 3 months, up to 6 months | Proportion admitted to the ICU |
| Total Cost of Care | up to 3 months, up to 6 months | total costs sent by UAB to payers (abstracted from billing records) |
Countries
United States
Participant flow
Pre-assignment details
The primary outcome is service penetrance which is the proportion of patients who are eligible who are approached and enroll..
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1421 Participants |
| Age, Categorical Between 18 and 65 years | 1669 Participants |
| Age, Continuous | 61 years STANDARD_DEVIATION 13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 56 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2239 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 795 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 45 Participants |
| Race (NIH/OMB) Black or African American | 803 Participants |
| Race (NIH/OMB) More than one race | 30 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 112 Participants |
| Race (NIH/OMB) White | 2097 Participants |
| Region of Enrollment United States | 3090 Participants |
| Sex: Female, Male Female | 1990 Participants |
| Sex: Female, Male Male | 1100 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
None listed