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

Oncology Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03984773
• Other study ID #: 833178
• Status: Completed
• Phase: N/A
• Start date: July 15, 2019
• Est. completion date: April 19, 2020

Study information

• Verified date: April 2020
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: April 19, 2020
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Neoplasms
• Oncology

Intervention

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.

Locations

Country	Name	City	State
United States	Penn Medicine	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Oncology Evaluation Center admissions	The number of Oncology Evaluation Center admissions	40 weeks
Other	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	40 weeks
Other	Number of Emergency department admissions	The number of emergency department admissions	40 weeks
Other	Inpatient admissions	The number of inpatient hospital admissions	40 weeks
Other	Intensive care unit admissions	The number of intensive care unit admissions	40 weeks
Primary	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)	16 weeks
Secondary	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	16 weeks
Secondary	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.	16 weeks
Secondary	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	40 weeks
Secondary	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	40 weeks
Secondary	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	40 weeks