CancerNCT05590962
Predictive Analytics and Behavioral Nudges to Improve Palliative Care in Advanced Cancer
A study testing EHR Nudge in people with Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- EHR Nudge
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 562 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2022to 3 Oct 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203
About this study
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.
Read the detailed description
2.1 ADVANCED CANCER BURDEN Over half of patients with advanced cancer report moderate-to-severe symptom burden and poor quality of life - both of which are associated with up to 70% lower overall survival.1-3 Despite heavy symptom burden, 40% of patients with advanced cancer receive aggressive end-of-life care, including chemotherapy and lack of hospice referral close to death, that is not concordant with patient goals.4 Suboptimal symptom management, poor communication about expected treatment benefit, and lack of attention to patient goals and wishes near the end of life contribute to these gaps.5
2.2 PALLIATIVE CARE IMPROVES QUALITY OF LIFE \& SYMPTOMS Palliative care is a medical specialty focused on providing relief from the symptoms and stress of serious illnesses such as cancer and is available in inpatient, outpatient, and community-based settings.6 Outpatient palliative care is available at 98% of NCI-designated cancer centers and 63% of non-NCI centers.7 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.8,9 Since 2017, the American Society of Clinical Oncology has recommended specialty outpatient palliative care consultation for patients within 8 weeks of advanced cancer diagnosis.10 During the COVID-19 pandemic, other organizations have called for earlier palliative care to ensure that high-risk cancer care meets patients' goals.11,12 Despite such guidelines, nearly two-thirds of patients with advanced cancer do not receive palliative care prior to death.4 Delayed or missed outpatient palliative care referrals are a major contributor to aggressive end-of-life care.8
2.3 PALLIATIVE CARE RARELY USED NCCN-based indications for palliative care referral include limited prognosis and prognostic risk factors, such as uncontrolled symptoms or poor performance status.13 Better awareness of mortality risk may inform clinicians' decisions around palliative care referral and prompt goal-concordant cancer care.14 However, oncologists correctly identify only 20% of patients with advanced cancer who will die in one year and overestimate prognosis for 70% of patients.15,16 Furthermore, existing palliative care triggers ignore patient- and cancer-specific heterogeneity in important variables such as laboratories and comorbidities.17
2.4 IMPROVE SHORT-TERM MORTALITY PREDICTION Advances in electronic health record (EHR) infrastructure and predictive analytics allow accurate and automated identification of patients with cancer at risk of short-term mortality. We have trained and deployed EHR-based predictive algorithms with better performance (c-statistic >0.80; sensitivity >60%) than traditional prognostic aids into routine oncology practice in order to identify patients who may benefit from early palliative care and advance care planning.18,19 At Tennessee Oncology, a rules-based automated EHR algorithm based on 14 components derived from 2021 NCCN guidelines (Exhibit 1) accurately identifies patients at risk of 180-day-month mortality.20 This algorithm has been incorporated in pilot studies, and has generated weekly reports of high-risk patients who may benefit from timely palliative care referral.
There is an urgent need to implement strategies based on algorithm-based triggers to increase early outpatient palliative care among patients with advanced cancer.
2.5 PALLIATIVE CARE UNDERUTILIZED Two-thirds of patients with advanced cancer do not receive palliative care prior to dying. Furthermore, clinicians underutilize palliative care, usually initiating referrals only 2 months before death. Lack of standardized referral and screening criteria for outpatient palliative care contributes to underutilization. This is particularly true for Black and Hispanic populations, for whom palliative care referrals are 50% lower compared to White populations.
2.6 PALLIATIVE CARE BIASES 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, 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 similar or more palliative care referrals than their peers.
2.7 PALLIATIVE CARE CONSTRAINTS Despite increasing availability in tertiary cancer care settings, specialty palliative care is sparsely available in community oncology practices - where 75% of patients receive their primary oncologic care. Furthermore, while the number of patients with cancer eligible for palliative care is expected to grow by 20% in the upcoming decade, there will be a shortage of 18,000 palliative care specialty physicians, particularly in the outpatient setting. Because of these capacity constraints, it is crucial to identify scalable strategies to automatically identify high-risk patients with advanced cancer in order to initiate timely outpatient palliative care referrals.
2.8 PALLIATIVE CARE UTILIZATION IMPROVEMENTS Overcoming suboptimal clinician decision-making biases is 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 via "triggered" identification of high-risk patients may combat optimism bias. These strategies are associated with 10-25 absolute percentage-point increases in guideline-based practices such as statin prescribing and transition from brand to generic drugs. However, to our knowledge no published randomized trials have used behavioral strategies to improve palliative care utilization in advanced cancer.
Given rising demand for palliative care with constrained supply across the United States oncology care system, our contribution will be significant because it will leverage scalable automated predictive algorithms with a behaviorally informed intervention to increase palliative care utilization among high- risk patients with advanced cancer. This intervention is expected to create a feasible, adaptable, and acceptable process in a community oncology setting that increases palliative care utilization earlier in the advanced cancer disease trajectory.
The main objective is to evaluate the impact of an intervention consisting of default algorithm-based referrals, compared to usual practice, on outpatient palliative care visits and quality of end-of-life care among patients with advanced cancer. The investigators hypothesize that this intervention will increase palliative care visits by 10 percentage points and decrease aggressive end-of-life utilization by 15 percentage points, relative to usual practice
- Conditions
- Cancer
- Being tested
- EHR 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.
EHR NudgeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: EHR Nudge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start9 Nov 2022
- Primary completion13 Jun 2023
- Study completion3 Oct 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 562 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Tennessee Oncology, Emerson Collective
- Responsible party
- Sponsor
- Investigators
- Ravi Parikh, Principal investigator, Penn/ACCSandhya Mudumbi, Principal investigator, TennOnc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05590962
- Sponsor's protocol ID
- 851021
- Status last verified
- Feb 2025
- First submitted
- 14 Oct 2022
- Last updated
- 6 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39982729
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Analytics and Behavioral Nudges to Improve Palliative Care in Advanced Cancer
- ClinicalTrials.gov ID
- NCT05590962
- Acronym / sponsor ID
- 851021
- Conditions
- Cancer
- Keywords
- Cancer, Palliative Care, Behavioral Economics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 562 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- Tennessee Oncology, Emerson Collective
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- 13 Jun 2023 (actual)
- Study completion
- 3 Oct 2023 (actual)
- First posted
- 21 Oct 2022 (actual)
- Results
- Posted 6 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 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.
Detailed description
2.1 ADVANCED CANCER BURDEN Over half of patients with advanced cancer report moderate-to-severe symptom burden and poor quality of life - both of which are associated with up to 70% lower overall survival.1-3 Despite heavy symptom burden, 40% of patients with advanced cancer receive aggressive end-of-life care, including chemotherapy and lack of hospice referral close to death, that is not concordant with patient goals.4 Suboptimal symptom management, poor communication about expected treatment benefit, and lack of attention to patient goals and wishes near the end of life contribute to these gaps.5
2.2 PALLIATIVE CARE IMPROVES QUALITY OF LIFE \& SYMPTOMS Palliative care is a medical specialty focused on providing relief from the symptoms and stress of serious illnesses such as cancer and is available in inpatient, outpatient, and community-based settings.6 Outpatient palliative care is available at 98% of NCI-designated cancer centers and 63% of non-NCI centers.7 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.8,9 Since 2017, the American Society of Clinical Oncology has recommended specialty outpatient palliative care consultation for patients within 8 weeks of advanced cancer diagnosis.10 During the COVID-19 pandemic, other organizations have called for earlier palliative care to ensure that high-risk cancer care meets patients' goals.11,12 Despite such guidelines, nearly two-thirds of patients with advanced cancer do not receive palliative care prior to death.4 Delayed or missed outpatient palliative care referrals are a major contributor to aggressive end-of-life care.8
2.3 PALLIATIVE CARE RARELY USED NCCN-based indications for palliative care referral include limited prognosis and prognostic risk factors, such as uncontrolled symptoms or poor performance status.13 Better awareness of mortality risk may inform clinicians' decisions around palliative care referral and prompt goal-concordant cancer care.14 However, oncologists correctly identify only 20% of patients with advanced cancer who will die in one year and overestimate prognosis for 70% of patients.15,16 Furthermore, existing palliative care triggers ignore patient- and cancer-specific heterogeneity in important variables such as laboratories and comorbidities.17
2.4 IMPROVE SHORT-TERM MORTALITY PREDICTION Advances in electronic health record (EHR) infrastructure and predictive analytics allow accurate and automated identification of patients with cancer at risk of short-term mortality. We have trained and deployed EHR-based predictive algorithms with better performance (c-statistic >0.80; sensitivity >60%) than traditional prognostic aids into routine oncology practice in order to identify patients who may benefit from early palliative care and advance care planning.18,19 At Tennessee Oncology, a rules-based automated EHR algorithm based on 14 components derived from 2021 NCCN guidelines (Exhibit 1) accurately identifies patients at risk of 180-day-month mortality.20 This algorithm has been incorporated in pilot studies, and has generated weekly reports of high-risk patients who may benefit from timely palliative care referral.
There is an urgent need to implement strategies based on algorithm-based triggers to increase early outpatient palliative care among patients with advanced cancer.
2.5 PALLIATIVE CARE UNDERUTILIZED Two-thirds of patients with advanced cancer do not receive palliative care prior to dying. Furthermore, clinicians underutilize palliative care, usually initiating referrals only 2 months before death. Lack of standardized referral and screening criteria for outpatient palliative care contributes to underutilization. This is particularly true for Black and Hispanic populations, for whom palliative care referrals are 50% lower compared to White populations.
2.6 PALLIATIVE CARE BIASES 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, 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 similar or more palliative care referrals than their peers.
2.7 PALLIATIVE CARE CONSTRAINTS Despite increasing availability in tertiary cancer care settings, specialty palliative care is sparsely available in community oncology practices - where 75% of patients receive their primary oncologic care. Furthermore, while the number of patients with cancer eligible for palliative care is expected to grow by 20% in the upcoming decade, there will be a shortage of 18,000 palliative care specialty physicians, particularly in the outpatient setting. Because of these capacity constraints, it is crucial to identify scalable strategies to automatically identify high-risk patients with advanced cancer in order to initiate timely outpatient palliative care referrals.
2.8 PALLIATIVE CARE UTILIZATION IMPROVEMENTS Overcoming suboptimal clinician decision-making biases is 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 via "triggered" identification of high-risk patients may combat optimism bias. These strategies are associated with 10-25 absolute percentage-point increases in guideline-based practices such as statin prescribing and transition from brand to generic drugs. However, to our knowledge no published randomized trials have used behavioral strategies to improve palliative care utilization in advanced cancer.
Given rising demand for palliative care with constrained supply across the United States oncology care system, our contribution will be significant because it will leverage scalable automated predictive algorithms with a behaviorally informed intervention to increase palliative care utilization among high- risk patients with advanced cancer. This intervention is expected to create a feasible, adaptable, and acceptable process in a community oncology setting that increases palliative care utilization earlier in the advanced cancer disease trajectory.
The main objective is to evaluate the impact of an intervention consisting of default algorithm-based referrals, compared to usual practice, on outpatient palliative care visits and quality of end-of-life care among patients with advanced cancer. The investigators hypothesize that this intervention will increase palliative care visits by 10 percentage points and decrease aggressive end-of-life utilization by 15 percentage points, relative to usual practice
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: EHR NudgeClinicians 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| EHR NudgeClinicians 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. | Other | Intervention |
Primary outcome
Number of Study Participants Who Have Completed a Palliative Care Visit Within 3 Months of Enrollment
Time frame: 3 months
Completed palliative care visit within 3 months among high-risk patients with stage III and IV lung and non-colorectal GI malignancies
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39982729Parikh 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.
- 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 principal investigator
Penn/ACC
Sandhya Mudumbi principal investigator
TennOnc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EHR 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 6 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 6 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?
Number of Study Participants Who Have Completed a Palliative Care Visit Within 3 Months of Enrollment (time frame: 3 months). 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 NCT05590962, 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 6 Feb 2025.