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Clinical Trials/NCT03984773
NCT03984773
Completed
Not Applicable

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

University of Pennsylvania1 site in 1 country78 target enrollmentJuly 15, 2019
ConditionsOncology

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Oncology
Sponsor
University of Pennsylvania
Enrollment
78
Locations
1
Primary Endpoint
Change in the proportion of patients with a documented serious illness conversation (SIC)
Status
Completed
Last Updated
6 years ago

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.

Registry
clinicaltrials.gov
Start Date
July 15, 2019
End Date
April 19, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

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)

Study Sites (1)

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