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

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ClinicalTrials.gov Identifier: NCT03984773
Recruitment Status : Enrolling by invitation
First Posted : June 13, 2019
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Brief 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.

Condition or disease Intervention/treatment Phase
Oncology Behavioral: Nudge Not Applicable

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Practices will be cluster-randomized in 4-week blocks to the intervention over a 16-week period, after which all practices will receive the email intervention.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: The principal study investigator and data analyst will not have knowledge of when the practices are randomized to the intervention.
Primary Purpose: Health Services Research
Official Title: A Stepped-Wedge Cluster Randomized Trial Using Machine-Generated Mortality Estimates and Behavioral Nudges to Promote Advance Care Planning Discussion Among Cancer Patients
Actual Study Start Date : July 15, 2019
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : May 2020

Arm Intervention/treatment
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
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.




Primary Outcome Measures :
  1. Change in the proportion of patients with a documented serious illness conversation (SIC) [ Time Frame: 16 weeks ]
    The change in the proportion of patients that have an outpatient oncology visit with documentation of a serious illness conversation (SIC)


Secondary Outcome Measures :
  1. Change in the proportion of patients with a documented SIC among those identified as high-risk by the algorithm [ Time Frame: 16 weeks ]
    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

  2. Change in the proportion of patients with a documented advanced care planning [ Time Frame: 16 weeks ]
    The change in the proportion of patients with documentation of advanced care planning.

  3. Change in the proportion of patients with a documented serious illness conversation (SIC) including follow-up [ Time Frame: 40 weeks ]
    The change in the proportion of patients that have an outpatient oncology visit with documentation of a serious illness conversation (SIC) including follow-up

  4. Change in the proportion of patients with a documented SIC among those identified as high-risk by the algorithm including follow-up [ Time Frame: 40 weeks ]
    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

  5. Change in the proportion of patients with a documented advanced care planning including follow-up [ Time Frame: 40 weeks ]
    The change in the proportion of patients with documentation of advanced care planning including follow-up


Other Outcome Measures:
  1. Oncology Evaluation Center admissions [ Time Frame: 40 weeks ]
    The number of Oncology Evaluation Center admissions

  2. Healthcare utilization and receipt of chemotherapy in the last 30 days of life [ Time Frame: 40 weeks ]
    Healthcare utilization in the last 30 days of life in Penn Medicine facilities including acute care utilization as above and receipt of chemotherapy

  3. Number of Emergency department admissions [ Time Frame: 40 weeks ]
    The number of emergency department admissions

  4. Inpatient admissions [ Time Frame: 40 weeks ]
    The number of inpatient hospital admissions

  5. Intensive care unit admissions [ Time Frame: 40 weeks ]
    The number of intensive care unit admissions



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984773


Locations
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United States, Pennsylvania
Penn Medicine
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Mitesh S Patel, MD University of Pennsylvania

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03984773     History of Changes
Other Study ID Numbers: 833178
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Pennsylvania:
serious illness conversations
advance care planning
mortality estimates
nudge
pre-commitment
opt-out