NCT05365997

Brief Summary

Patients with cancer often undergo costly therapy and acute care utilization that is discordant with their wishes, particularly at the end of life. Despite early palliative care consultations being a National Comprehensive Cancer Network (NCCN) guideline-concordant practice in advanced cancer, palliative care referral rates for stage IV patients are low. In this project, the investigators will evaluate a health system initiative that uses behavioral nudges to prompt palliative care referrals among outpatients with advanced cancer in terms of successful palliative care referrals and downstream quality of life outcomes. In partnership with the health system, this will be conducted as a 2-arm pragmatic cluster randomized trial.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
266

participants targeted

Target at P75+ for not_applicable cancer

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 9, 2022

Completed
14 days until next milestone

Study Start

First participant enrolled

May 23, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2023

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

February 5, 2025

Completed
Last Updated

February 5, 2025

Status Verified

January 1, 2025

Enrollment Period

9 months

First QC Date

May 4, 2022

Results QC Date

August 19, 2024

Last Update Submit

January 13, 2025

Conditions

Keywords

CancerPalliative CareBehavioral Economics

Outcome Measures

Primary Outcomes (1)

  • Completion of Palliative Care Visit

    Binary outcome (yes/no) measured at the patient level among eligible patients based on the date of documented palliative care encounter

    Within 12 weeks of the Index Visit

Study Arms (2)

Control

NO INTERVENTION

Clinicians will receive no further interventions beyond usual practice.

Intervention

EXPERIMENTAL

Clinicians receive a nudge consisting of an electronic health record in-basket message indicating a patient has a default pended order for palliative care.

Other: Default Nudge

Interventions

For patients whose clinician pods are randomized to the intervention arm, the care team pod will receive a message indicating that the patient is eligible for palliative care and that a default referral order has been pended for that patient. Clinicians will be given an opportunity to respond if they do not want their patient to be referred to palliative care. For clinicians who do not respond, after the allotted time, the Clinical Research Coordinator will reach out to the patient to introduce palliative care and ask if staff can schedule an appointment. For clinicians who respond no, the pended order will be removed and no patient contact by the research team will occur.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have a functional telephone number
  • Receive ongoing care from hematology/oncology services within the Ann B. Barshinger Cancer Institute (ABBCI) at Lancaster General Health.

You may not qualify if:

  • Patients appearing for a new patient visit
  • Patients who have previously received palliative care
  • Patients who are enrolled in an ongoing clinical trial of a therapeutic agent
  • Patients who receive primary oncologic care within another institution

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ann B. Barshinger Cancer Institute at Lancaster General Health

Lancaster, Pennsylvania, 17601, United States

Location

Related Publications (1)

  • Parikh RB, Sedhom R, Ferrell WJ, Villarin K, Berwanger K, Scarborough B, Oyer R, Kumar P, Ganta N, Sivendran S, Chen J, Volpp KG, Bekelman JE. Behavioural economic interventions to embed palliative care in community oncology (BE-EPIC): study protocol for the BE-EPIC randomised controlled trial. BMJ Open. 2023 Mar 24;13(3):e069468. doi: 10.1136/bmjopen-2022-069468.

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

Title
Dr. Ravi Parikh
Organization
University of Pennsylvania

Study Officials

  • Ravi Parikh, MD, MPP

    Penn/ACC

    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
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Each clinician pod will be randomized in a 1:1 fashion to either intervention or usual care.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2022

First Posted

May 9, 2022

Study Start

May 23, 2022

Primary Completion

February 20, 2023

Study Completion

August 8, 2023

Last Updated

February 5, 2025

Results First Posted

February 5, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations