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CancerBE-EPiCNCT05365997

Behavioral Nudges to Improve Palliative Care Utilization in Advanced Cancer

A study testing Default Nudge in people with Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
Default Nudge
Could I receive a placebo?
No, everyone receives an active treatment
How many people
266 participants
Where
1 siteUnited States
Study dates
23 May 2022to 8 Aug 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Ann B. Barshinger Cancer Institute at Lancaster General Health

    Lancaster, Pennsylvania, 17601

Other trials in United States

About this study

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.

Read the detailed description

Patients with advanced cancer have poor quality of life and life expectancy. Palliative care is a medical specialty focusing on providing relief from the symptoms and stress of serious illnesses such as cancer. While palliative care referrals often occur in the inpatient setting for acutely ill individuals, early outpatient specialty palliative care concurrent with cancer-directed treatment improves quality of life and survival, is an evidence-based practice, and is endorsed by national guidelines. Palliative care can be provided in the ambulatory, telemedicine, or home-based settings. However, nearly half of patients with advanced cancer do not receive palliative care prior to dying. Lack of standardized referral criteria and screening methods for palliative care contributes to underutilization. There is a high need for strategies to increase use of palliative care in oncology.

Clinicians underutilize palliative care, initiating referrals a median of 2 months before death. This status quo bias, which predisposes clinicians to continue current practice even if not the optimal option, may lead to delayed or missed palliative care referrals. Additionally, optimism bias, the cognitive bias that causes clinicians to believe that their own patients are at lesser risk of negative outcomes, may cause clinicians to underestimate a patient's mortality risk or symptom burden, thus delaying palliative care referral. Finally, overconfidence bias, the propensity to overestimate one's desired behaviors when it is not objectively reasonable, may lead clinicians to incorrectly believe they are initiating more palliative care referrals than their peers.

Overcoming suboptimal clinician decision-making biases are key to increasing palliative care referrals. Principles from behavioral economics can inform "nudges" that change how clinicians receive information and make choices such as palliative care referral. Default, opt-out nudges that make the optimal choice the path of least resistance can mitigate clinicians' status quo bias. Reframing clinicians' prognoses by providing data-driven life expectancy assessments may combat optimism bias.

Early palliative care intervention can improve quality of life for patients with advanced cancer. Outpatient palliative care is available at 98% of National Cancer Institute (NCI)-designated cancer centers and 63% of non-NCI centers. Early outpatient palliative care concurrent with cancer-directed treatment improves quality of life, reduces symptom burden, and decreases rates of aggressive end of life care. Nevertheless, only a minority of patients who qualify for palliative care receive it.

The primary objective of the study is to evaluate the impact of sending behavioral nudges to clinicians, as compared to usual practice, on completion of palliative care referrals among patients with advanced cancer. Our secondary objectives are to identify the impact of prompted palliative care referrals on quality of life, acute care utilization, and end-of-life utilization. This is a 2-arm pragmatic randomized trial among approximately 250 outpatients with advanced cancer to assess response to behavioral nudges to refer to palliative care. The setting will be outpatient oncology at the Ann B. Barshinger Cancer Institute at Lancaster General Health. Eligible clinicians will be randomized in clusters by overlapping clinical team (pod) to receive default electronic medical record-based prompts for palliative care referral among advanced cancer patients (Arm 1) vs no intervention/usual practice (Arm 2). These nudges have been shown to positively influence clinician behavior and are often used to drive value-based oncology care; however, they have never been studied in the context of palliative care referral. The primary outcome is completion of a palliative care referral within 12 weeks of enrollment.

Conditions
Cancer
Being tested
Default Nudge
Keywords
Cancer, Palliative Care, Behavioral Economics
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Default NudgeOther

    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.

Study groups in NCT05365997
Study groupRoleWhat they receive
ControlNo interventionClinicians will receive no further interventions beyond usual practice.
InterventionExperimentalClinicians receive a nudge consisting of an electronic health record in-basket message indicating a patient has a default pended order for palliative care.
Receives: Other: Default Nudge

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Within 12 weeks of the Index Visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2022
  2. Study start23 May 2022
  3. Primary completion20 Feb 2023
  4. Study completion8 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Each clinician pod will be randomized in a 1:1 fashion to either intervention or usual care.
Masking
Single blind
Who is masked
Investigator
Enrolment
266 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05365997
Sponsor's protocol ID
UPCC 29921
Other IDs
849498
Acronym
BE-EPiC
Status last verified
Jan 2025
First submitted
4 May 2022
Last updated
5 Feb 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36963789

Questions about this trial

What is this clinical trial studying?

A study testing Default Nudge in people with Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Completion of Palliative Care Visit (time frame: Within 12 weeks of the Index Visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05365997, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.

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