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CompletedNCT03984773Updated Apr 24, 2020

Machine-Generated Mortality Estimates and Nudges to Promote Advance Care Planning Discussion Among Cancer Patients

An interventional study of Nudge in Oncology, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-24.

Sponsored by University of Pennsylvania · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

This study will use a stepped-wedge cluster randomized trial to evaluate the effect of a health system initiative using machine learning algorithms and behavioral nudges to prompt oncologists to have serious illness conversations with patients at high-risk of short-term mortality.

Read the detailed description

Patients with cancer often undergo costly therapy and acute care utilization that is discordant with their wishes, particularly at the end of life. Early serious illness conversations (SIC) improve goal-concordant care, and accurate prognostication is critical to inform the timing and content of these discussions. This study will use a stepped-wedge, cluster randomized trial to evaluate the effect of a health system initiative using machine learning algorithms and behavioral nudges to prompt oncologists to have serious illness conversations with patients at high-risk of short-term mortality. Oncology practices will be randomly assigned in sequential four-week blocks to receive the intervention.

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Conditions studied

  • Oncology

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Keywords

  • serious illness conversations
  • advance care planning
  • mortality estimates
  • nudge
  • pre-commitment
  • opt-out
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In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 78 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Care for adults with cancer at the following clinics at Perelman Center for Advanced Medicine

    • Breast Oncology
    • Gastrointestinal Oncology
    • Genitourinary Oncology
    • Lymphoma
    • Melanoma and Central Nervous System Oncology
    • Myeloma
    • Thoracic / Head and Neck Oncology
  • Care for adults with cancer at the Pennsylvania Hospital Oncology clinic

Exclusion criteria

Exclusion Criteria:

  • Providers who care for only patients with benign hematologic disorders
  • Providers who see only genetic consults
  • Providers who see less than 12 high-risk patients in either the pre- or post- intervention periods
  • Visits for patients with lung cancer who are enrolled in an ongoing palliative care clinical trial that may lead to more SICs
  • Patient visits that are for oncology genetics consults (such patients may still be included if they see their primary oncologist during the trial)
  • Providers who have not undergone serious illness conversation program training (SIC)
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
78 participants (actual)

Study arms

  • No intervention
    Control

    Clinicians will receive current standard communications regarding serious illness performance.

  • Experimental
    Mortality Estimates and Nudges

    Clinicians will receive a weekly email with upcoming patients that have high mortality estimates to consider for a serious illness conversation. Clinicians will have the opportunity to review the list and pre-commit (using an opt-out design) to patients appropriate for a conversation. They will receive a nudge on the day of the patient visit through a text message reminding them of their pre-commitment to conduct a serious illness conversation

    Behavioral: Nudge

Interventions

  • BehavioralNudge

    Oncology practices will be randomly assigned to receive an intervention, in which individual clinicians will receive a weekly audit email detailing how many serious illness conversations (SIC) they have had compared to the recommended level, and a link to a list of their patients scheduled in clinic next week at high risk of short-term mortality as identified by a mortality prediction algorithm. Clinicians will have the chance to review the opt-out list and pre-commit to a serious illness conversation with appropriate patients. Clinicians will receive nudge on the day of the patient visit via text message reminding them of their pre-commitment to conduct a serious illness conversation.

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What researchers measure

Primary outcomes

  1. Change in the proportion of patients with a documented serious illness conversation (SIC)

    The change in the proportion of patients that have an outpatient oncology visit with documentation of a serious illness conversation (SIC)

    Time frame: 16 weeks

Secondary outcomes

  1. Change in the proportion of patients with a documented SIC among those identified as high-risk by the algorithm

    The change in the proportion of patients who have an outpatient oncology visit and are identified as high-risk by the machine learning algorithm with documentation of a SIC

    Time frame: 16 weeks

  2. Change in the proportion of patients with a documented advanced care planning

    The change in the proportion of patients with documentation of advanced care planning.

    Time frame: 16 weeks

  3. Change in the proportion of patients with a documented serious illness conversation (SIC) including follow-up

    The change in the proportion of patients that have an outpatient oncology visit with documentation of a serious illness conversation (SIC) including follow-up

    Time frame: 40 weeks

  4. Change in the proportion of patients with a documented SIC among those identified as high-risk by the algorithm including follow-up

    The change in the proportion of patients who have an outpatient oncology visit and are identified as high-risk by the machine learning algorithm with documentation of a SIC including follow-up

    Time frame: 40 weeks

  5. Change in the proportion of patients with a documented advanced care planning including follow-up

    The change in the proportion of patients with documentation of advanced care planning including follow-up

    Time frame: 40 weeks

Other outcomes

  1. Oncology Evaluation Center admissions

    The number of Oncology Evaluation Center admissions

    Time frame: 40 weeks

  2. Healthcare utilization and receipt of chemotherapy in the last 30 days of life

    Healthcare utilization in the last 30 days of life in Penn Medicine facilities including acute care utilization as above and receipt of chemotherapy

    Time frame: 40 weeks

  3. Number of Emergency department admissions

    The number of emergency department admissions

    Time frame: 40 weeks

  4. Inpatient admissions

    The number of inpatient hospital admissions

    Time frame: 40 weeks

  5. Intensive care unit admissions

    The number of intensive care unit admissions

    Time frame: 40 weeks

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Study locations

1 site
  • Penn Medicine
    Philadelphia, Pennsylvania 19103, United States
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References and documents

Publications

  • Parikh RB, Manz CR, Nelson MN, Ferrell W, Belardo Z, Temel JS, Patel MS, Shea JA. Oncologist Perceptions of Algorithm-Based Nudges to Prompt Early Serious Illness Communication: A Qualitative Study. J Palliat Med. 2022 Nov;25(11):1702-1707. doi: 10.1089/jpm.2022.0095. Epub 2022 Aug 18. PubMed 35984992 ↗
  • Li EH, Ferrell W, Klaiman T, Kumar P, O'Connor N, Schuchter LM, Chen J, Patel MS, Manz CR, Parikh RB. Impact of Behavioral Nudges on the Quality of Serious Illness Conversations Among Patients With Cancer: Secondary Analysis of a Randomized Controlled Trial. JCO Oncol Pract. 2022 Apr;18(4):e495-e503. doi: 10.1200/OP.21.00024. Epub 2021 Nov 12. PubMed 34767481 ↗
  • Manz CR, Parikh RB, Small DS, Evans CN, Chivers C, Regli SH, Hanson CW, Bekelman JE, Rareshide CAL, O'Connor N, Schuchter LM, Shulman LN, Patel MS. Effect of Integrating Machine Learning Mortality Estimates With Behavioral Nudges to Clinicians on Serious Illness Conversations Among Patients With Cancer: A Stepped-Wedge Cluster Randomized Clinical Trial. JAMA Oncol. 2020 Dec 1;6(12):e204759. doi: 10.1001/jamaoncol.2020.4759. Epub 2020 Dec 10. Erratum In: JAMA Oncol. 2022 Apr 1;8(4):648. doi: 10.1001/jamaoncol.2022.0019. PubMed 33057696 ↗
  • Manz CR, Parikh RB, Evans CN, Chivers C, Regli SH, Bekelman JE, Small D, Rareshide CAL, O'Connor N, Schuchter LM, Shulman LN, Patel MS. Integrating machine-generated mortality estimates and behavioral nudges to promote serious illness conversations for cancer patients: Design and methods for a stepped-wedge cluster randomized controlled trial. Contemp Clin Trials. 2020 Mar;90:105951. doi: 10.1016/j.cct.2020.105951. Epub 2020 Jan 23. PubMed 31982648 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03984773
Lead sponsor
University of Pennsylvania
Responsible party
Sponsor
First posted
Jun 13, 2019
Start date
Jul 15, 2019
Primary completion
Nov 1, 2019
Completion
Apr 19, 2020
Last update
Apr 24, 2020

Study contacts

Mitesh S Patel, MD
principal investigator · University of Pennsylvania

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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