A Stepped-Wedge Cluster Randomized Trial Using Machine-Generated Mortality Estimates and Behavioral Nudges to Promote Advance Care Planning Discussion Among Cancer Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pennsylvania
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Change in the proportion of patients with a documented serious illness conversation (SIC)
Study Overview
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.
Study Design
- Study Type
- Interventional
- 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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
- •Melanoma and Central Nervous System Oncology
- •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)
Arms & Interventions
Control
Clinicians will receive current standard communications regarding serious illness performance.
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
Intervention: Nudge (Behavioral)
Outcomes
Primary Outcomes
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 Outcomes
- Change in the proportion of patients with a documented advanced care planning including follow-up(40 weeks)
- Change in the proportion of patients with a documented SIC among those identified as high-risk by the algorithm including follow-up(40 weeks)
- Change in the proportion of patients with a documented SIC among those identified as high-risk by the algorithm(16 weeks)
- Change in the proportion of patients with a documented advanced care planning(16 weeks)
- Change in the proportion of patients with a documented serious illness conversation (SIC) including follow-up(40 weeks)