Predictive Analytics and Behavioral Nudges to Improve Palliative Care in Advanced Cancer

NCT05590962 | Completed Results

• 1 other identifier: 851021
• Study Type: interventional
• Target: 562
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with advanced cancer suffer from high symptom burden and aggressive end-of-life care. Early specialty palliative care is an evidence-based practice that improves symptom burden, quality of life, and survival in advanced cancer. However, over half of patients with advanced cancer die before receiving palliative care. Clinician-level biases and suboptimal identification of high-risk patients are major barriers to palliative care uptake. In this 2-arm pragmatic clinical trial, the investigators will randomize practices within a large community oncology network to receive an intervention consisting of algorithm-based default palliative care referrals. The investigators will study the impact of such an intervention on palliative care utilization and end-of-life outcomes.

Conditions

Cancer

Keywords

Cancer; Palliative Care; Behavioral Economics

Outcome Measures

Primary Outcomes (1)

• Number of Study Participants Who Have Completed a Palliative Care Visit Within 3 Months of Enrollment

  Completed palliative care visit within 3 months among high-risk patients with stage III and IV lung and non-colorectal GI malignancies

  3 months

Other Outcomes (4)

• Aggressive End-of-life Care Via Hospice Enrollment

  ≤3 days before death

• Aggressive End-of-life Care Via Systemic Therapy Receipt

  Within 14 days of death

• Feeling Heard & Understood Quality Measure

  Baseline to 24 weeks

Study Arms (2)

Control

NO INTERVENTION

Clinicians of patients in both arms will receive education on the availability of early palliative care and performance reports. Clinicians will receive no further interventions beyond usual practice.

Intervention

EXPERIMENTAL

Clinicians of patients in both arms will receive education on the availability of early palliative care and performance reports. Clinicians in the intervention arm will receive an EHR nudge with option to opt-out for palliative care referral for any eligible high-risk patient.

Other: EHR Nudge

Interventions

EHR Nudge OTHER

Clinicians in Arm 1 (intervention) will receive a EHR notification with option to opt-out for palliative care referral for any eligible high-risk patient, defined by a risk score ≥1 for Stage IV cancer patients and ≥2 for Stage III cancer patients. If the risk score is above 8, they will be scheduled within 2 weeks, and all other patients will be scheduled within 4 weeks. Clinician will have the option to opt-out for any patient by responding to the notification which will be sent to the research coordinator. If the clinician does not respond, the research coordinator will approach patient via telephone, explain the rationale for referral based on a predetermined script, and offer and schedule an outpatient or telemedicine palliative care consultation per patient preference. Follow-up visits will occur at the discretion of the palliative care clinician, usually monthly.

Intervention

Eligibility Criteria

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

You may qualify if:

• Patients:
• \- Stage III and IV lung, and non-Colorectal GI cancers, defined using internal algorithms based on International Classification of Diseases (ICD) diagnosis codes, EHR entries, and manual screening

You may not qualify if:

• Patients:
• Benign hematology, genetics, survivorship encounters; no prior EHR data;
• Deceased or enrolled in hospice care
• Had a palliative care visit or had no medical oncology visit within the prior 90 days or are seen for a non-medical oncology encounter

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• Tennessee Oncology: collaborator
• Emerson Collective: collaborator

Study Sites (1)

Tennessee Oncology, PLLC

Nashville, Tennessee, 37203, United States

Location

Related Publications (1)

• Parikh RB, Ferrell WJ, Li Y, Chen J, Bilbrey L, Johnson N, White J, Sedhom R, Dickson NR, Schleicher S, Bekelman JE, Mudumbi S. Algorithm-Based Palliative Care in Patients With Cancer: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2025 Feb 3;8(2):e2458576. doi: 10.1001/jamanetworkopen.2024.58576.

  PMID: 39982729 DERIVED

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

• Title: Dr. Ravi Parikh
• Organization: University of Pennsylvania

ravi.parikh@pennmedicine.upenn.edu

3524224285

Study Officials

• Ravi Parikh

  Penn/ACC

  PRINCIPAL INVESTIGATOR

• Sandhya Mudumbi

  TennOnc

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The Principal Investigator (RBP) and primary statistical analyst will be blinded to arm assignment.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: October 21, 2022
• Study Start: November 9, 2022
• Primary Completion: June 13, 2023
• Study Completion: October 3, 2023
• Last Updated: February 6, 2025
• Results First Posted: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)