Behavioral Economic Strategies to Improve PRO Adherence
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- Abramson Cancer Center at Penn Medicine
- Enrollment
- 476
- Locations
- 2
- Primary Endpoint
- PRO Adherence
- Status
- Completed
- Last Updated
- 4 months ago
Overview
Brief Summary
The main purpose of this research study is to evaluate the implementation and effectiveness of patient- and nurse-directed strategies across in-clinic and remote patient reported outcome (PRO) monitoring settings, using a three-arm pragmatic cluster randomized controlled trial. Additionally, the goal is to evaluate moderators of implementation effects on PRO monitoring.
Eligible patients will be randomized independently to: (1) usual practice (i.e., encounter-based PRO administration via patient portal or tablet); (2) encounter-based PRO monitoring with patient reminders and nurse alerts; or (3) remote PRO monitoring with patient reminders and nurse alerts. The investigators hypothesize that nudges to patients and alerts to nurses will improve patient-level PRO completion and clinician-level PRO engagement.
Detailed Description
Routine PRO monitoring is an evidence-based practice that improves patient outcomes. Patients with cancer commonly experience symptoms which go unrecognized by clinical teams up to half of the time. PROs are a powerful tool to bridge this gap, amplifying the patient experience and improving communication between patients and clinicians. A seminal clinical trial was conducted in which weekly PRO symptom assessments with care team alerts led to reduced care utilization, improved quality of life, and lengthened overall survival among patients receiving active treatment for advanced solid tumors. Subsequent randomized trials have corroborated the quality of life and survival advantages of PRO monitoring in other cancer populations and practice settings. Real-world adherence to PRO monitoring is lower than in seminal clinical trials, with potential racial/ethnic disparities. Multilevel barriers to PRO implementation exist at the patient, clinician, practice, and system levels. While patient adherence to PRO monitoring in seminal trials ranged from 70 to 90 percent, real-world adherence is much lower and more variable. Our preliminary research demonstrates that in a large, multi-site rollout of PRO monitoring, mean patient-level adherence was less than 50 percent. Moreover, compared to non-Hispanic White patients, Black and Hispanic patients were 9% and 4% less likely to complete PRO questionnaires, respectively, but more likely to report more severe symptoms. These results highlight that historically marginalized subgroups may benefit less from current methods of PRO administration, potentially reinforcing existing disparities in symptom management if not remediated. This will be the first study to apply behavioral economic strategies to align clinicians and patients in achieving sustained patient-level PRO adherence, and addresses limitations of current PRO approaches. Current approaches to PRO collection are limited by: (1) suboptimal clinician engagement, (2) encounter-based assessments which preclude longitudinal monitoring of PROs outside of the clinic, and (3) insufficient automated effectors actively linking reported symptoms with clinical response. This proposal addresses these limitations by employing behavioral strategies directly targeting clinician engagement, utilizing novel electronic remote monitoring methods to maximize real-time PRO capture, and linking these with pathway-driven automated effectors.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients must initiate a new line of systemic cancer therapy (i.e., intravenous chemotherapy or immunotherapy) at a participating Implementation Lab site
Exclusion Criteria
- •\- Patient opts out of pragmatic research
Outcomes
Primary Outcomes
PRO Adherence
Time Frame: 3 months
The primary outcome will be PRO adherence, measured at the patient level as the proportion of expected PRO questionnaires completed per patient.
Secondary Outcomes
- Percent of Patients With at Least One Note Documenting PROs During Study Period(3 months)
- Percent of Patients With at Least One Note Documenting PROs Per Month During Study Period(3 months)
- Time to Alert Response (for Arms 2 and 3 Only)(3 months)
- Percent of Patients Who Trigger an Alert for Triage Nurses (for Arms 2 and 3 Only)(3 months)
- Acute Care Utilization(3 months)
- Treatment Modifications(3 months)
- Duration of Therapy(3 months)