Behavioral Economic Strategies to Improve PRO Adherence

NCT06013176 | Completed Results DMC

• 3 other identifiers: UPCC 34923P50CA244690852748
• Study Type: interventional
• Target: 476
• Locations: 1 country
• Sites: 2

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• PRO Adherence

  The primary outcome will be PRO adherence, measured at the patient level as the proportion of expected PRO questionnaires completed per patient.

  3 months

Secondary Outcomes (7)

• 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

Study Arms (3)

Usual practice

NO INTERVENTION

This arm will consist of encounter-based PRO monitoring, in which patients have an opportunity to complete PRO questionnaires via patient portal in advance of clinical encounters or via tablet during clinical encounters. While clinicians will be encouraged to view and discuss PROs with patients during clinical encounters, they will not be prompted to do so in real-time, nor will there be alerts for escalating symptoms.

Encounter-based PRO monitoring

EXPERIMENTAL

Encounter-based PRO monitoring (usual practice) plus patient reminders and triage nurse alerts

Other: Encounter-based PRO monitoring

Remote PRO monitoring

EXPERIMENTAL

Remote PRO monitoring plus patient reminders and triage nurse alerts

Other: Remote PRO monitoring

Interventions

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.

Encounter-based PRO monitoring

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.

Remote PRO monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must initiate a new line of systemic cancer therapy (i.e., intravenous chemotherapy or immunotherapy) at a participating Implementation Lab site

You may not qualify if:

• \- Patient opts out of pragmatic research

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Penn Medicine Princeton Health

Plainsboro, New Jersey, 08536, United States

Location

Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

• Basch E, Deal AM, Kris MG, Scher HI, Hudis CA, Sabbatini P, Rogak L, Bennett AV, Dueck AC, Atkinson TM, Chou JF, Dulko D, Sit L, Barz A, Novotny P, Fruscione M, Sloan JA, Schrag D. Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial. J Clin Oncol. 2016 Feb 20;34(6):557-65. doi: 10.1200/JCO.2015.63.0830. Epub 2015 Dec 7.

  PMID: 26644527 BACKGROUND

• Basch E, Deal AM, Dueck AC, Scher HI, Kris MG, Hudis C, Schrag D. Overall Survival Results of a Trial Assessing Patient-Reported Outcomes for Symptom Monitoring During Routine Cancer Treatment. JAMA. 2017 Jul 11;318(2):197-198. doi: 10.1001/jama.2017.7156.

  PMID: 28586821 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

• Title: Dr. Samuel Takvorian
• Organization: Abramson Cancer Center

Samuel.takvorian@pennmedicine.upenn.edu

267-438-8269

Study Officials

• Ravi Parikh, MD

  University of Pennsylvania; Emory University

  PRINCIPAL INVESTIGATOR

• Samuel Takvorian, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible patients will be identified pragmatically and will be independently randomized to study arms using a three-arm design.

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: August 28, 2023
• Study Start: December 4, 2023
• Primary Completion: June 4, 2024
• Study Completion: September 4, 2024
• Last Updated: December 29, 2025
• Results First Posted: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)