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.
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
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Default Nudge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted9 May 2022
- Study start23 May 2022
- Primary completion20 Feb 2023
- Study completion8 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ravi Parikh, MD, MPP, Principal investigator, Penn/ACC
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Nudges to Improve Palliative Care Utilization in Advanced Cancer
- ClinicalTrials.gov ID
- NCT05365997
- Acronym / sponsor ID
- BE-EPiC / UPCC 29921
- Conditions
- Cancer
- Keywords
- Cancer, Palliative Care, Behavioral Economics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 23 May 2022 (actual)
- Primary completion
- 20 Feb 2023 (actual)
- Study completion
- 8 Aug 2023 (actual)
- First posted
- 9 May 2022 (actual)
- Results
- Posted 5 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Each clinician pod will be randomized in a 1:1 fashion to either intervention or usual care.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Clinicians will receive no further interventions beyond usual practice. |
| Intervention | Experimental | Other: Default NudgeClinicians receive a nudge consisting of an electronic health record in-basket message indicating a patient has a default pended order for palliative care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have a functional telephone number
- Receive ongoing care from hematology/oncology services within the Ann B. Barshinger Cancer Institute (ABBCI) at Lancaster General Health.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Default NudgeFor 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. | Other | Intervention |
Primary outcome
Completion of Palliative Care Visit
Time frame: Within 12 weeks of the Index Visit
Binary outcome (yes/no) measured at the patient level among eligible patients based on the date of documented palliative care encounter
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36963789Parikh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ravi Parikh, MD, MPP principal investigator
Penn/ACC
1 site in 1 country: see every site and its status.
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.