Behavioral Economic Strategies to Improve PRO Adherence

Cancer Clinical Trial

— BEST-PRO  

Official title:

Behavioral Economic Strategies to Improve PRO Adherence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06013176
• Other study ID #: 852748
• Secondary ID: P50CA244690UPCC
• Status: Recruiting
• Phase: N/A
• Start date: December 4, 2023
• Est. completion date: September 4, 2024

Study information

• Verified date: January 2024
• Source: Abramson Cancer Center at Penn Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 4, 2024
• Est. primary completion date: June 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Encounter-based PRO monitoring
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
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.

Locations

Country	Name	City	State
United States	Abramson Cancer Center	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. Erratum In: J Clin Oncol. 2016 Jun 20;34(18):2198. J Clin Oncol. 2019 Feb 20;37(6):528. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percent of patients with at least one note documenting PROs during study period		3 months
Secondary	Percent of patients with at least one note documenting PROs per month during study period		3 months
Secondary	Time to alert response (for arms 2 and 3 only)		3 months
Secondary	Percent of patients who trigger an alert for triage nurses (for arms 2 and 3 only)		3 months
Secondary	Acute care utilization	Percent of patients with an emergency department visit or hospitalization	6 months
Secondary	Treatment delays/modifications	Percent of patients with a treatment delay/modification	6 months
Secondary	Duration of therapy		6 months