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

A Stepped-Wedge Cluster Randomized Trial Using Machine-Generated Mortality Estimates and Behavioral Nudges to Promote Advance Care Planning Discussion Among Cancer Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03984773
Enrollment
78
Registered
2019-06-13
Start date
2019-07-15
Completion date
2020-04-19
Last updated
2020-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oncology

Keywords

serious illness conversations, advance care planning, mortality estimates, nudge, pre-commitment, opt-out

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.

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.

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.

Sponsors

University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
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.

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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)

Design outcomes

Primary

MeasureTime frameDescription
Change in the proportion of patients with a documented serious illness conversation (SIC)16 weeksThe change in the proportion of patients that have an outpatient oncology visit with documentation of a serious illness conversation (SIC)

Secondary

MeasureTime frameDescription
Change in the proportion of patients with a documented serious illness conversation (SIC) including follow-up40 weeksThe change in the proportion of patients that have an outpatient oncology visit with documentation of a serious illness conversation (SIC) including follow-up
Change in the proportion of patients with a documented SIC among those identified as high-risk by the algorithm16 weeksThe 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
Change in the proportion of patients with a documented advanced care planning16 weeksThe change in the proportion of patients with documentation of advanced care planning.
Change in the proportion of patients with a documented SIC among those identified as high-risk by the algorithm including follow-up40 weeksThe 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
Change in the proportion of patients with a documented advanced care planning including follow-up40 weeksThe change in the proportion of patients with documentation of advanced care planning including follow-up

Other

MeasureTime frameDescription
Healthcare utilization and receipt of chemotherapy in the last 30 days of life40 weeksHealthcare utilization in the last 30 days of life in Penn Medicine facilities including acute care utilization as above and receipt of chemotherapy
Number of Emergency department admissions40 weeksThe number of emergency department admissions
Inpatient admissions40 weeksThe number of inpatient hospital admissions
Intensive care unit admissions40 weeksThe number of intensive care unit admissions
Oncology Evaluation Center admissions40 weeksThe number of Oncology Evaluation Center admissions

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026