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OpenTrials
Completed

NCT Number: NCT06013176

Behavioral Economic Strategies to Improve PRO Adherence

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn Medicine Princeton Health, Plainsboro, New Jersey, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Encounter-based PRO monitoring

Other

This arm consists of usual practice plus the addition of patient reminders to complete PRO questionnaires and triage nurse alerts for severe symptoms. Patient reminders will be operationalized through the Epic patient portal. Triage nurse alerts will be routed to Epic symptom management pools in response to a patient reporting moderate or severe symptoms. Patients will have the opportunity to decline or opt-out of triage nurse support. Clinical interventions stemming from triage nurse alerts will be up to the discretion of clinical teams - i.e., clinical responses will be neither prescriptive nor mandatory. Notably, the entry point for triage nurse alerts (i.e., Epic symptom management pools), as well as resultant clinical responses, are existing standard operating procedures/practices for patients reporting symptoms by phone.

Remote PRO monitoring

Other

This arm will consist of weekly PRO questionnaires administered via the patient portal, de-linked from clinical encounters. Patient reminders will be operationalized through the Epic patient portal. Triage nurse alerts will be routed to Epic symptom management pools in response to a patient reporting moderate or severe symptoms. Patients will have the opportunity to decline or opt-out of triage nurse support. Clinical interventions stemming from triage nurse alerts will be up to the discretion of clinical teams - i.e., clinical responses will be neither prescriptive nor mandatory. Notably, the entry point for triage nurse alerts (i.e., Epic symptom management pools), as well as resultant clinical responses, are existing standard operating procedures/practices for patients reporting symptoms by phone.

Primary outcomes

  1. 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

  1. Percent of Patients With at Least One Note Documenting PROs During Study Period

    Time frame: 3 months

  2. Percent of Patients With at Least One Note Documenting PROs Per Month During Study Period

    Time frame: 3 months

  3. Time to Alert Response (for Arms 2 and 3 Only)

    Time frame: 3 months

  4. Percent of Patients Who Trigger an Alert for Triage Nurses (for Arms 2 and 3 Only)

    Time frame: 3 months

  5. Acute Care Utilization

    Time frame: 3 months

    Percent of patients with an emergency department visit or hospitalization

  6. Treatment Modifications

    Time frame: 3 months

    Percent of patients with a treatment modification

  7. Duration of Therapy

    Time frame: 3 months

    Average duration of therapy during the study period

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Acronym: BEST-PRO

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 28, 2023
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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