Clinical trial NCT03984773: Machine-Generated Mortality Estimates and Nudges to Promote Advance Care Planning Discussion Among Cancer Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oncology
Keywords: serious illness conversations
advance care planning
mortality estimates
nudge
pre-commitment
opt-out
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2019-06-13
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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
  * 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)

Primary outcomes:
measure: Change in the proportion of patients with a documented serious illness conversation (SIC)
timeFrame: 16 weeks
Secondary outcomes:
measure: Change in the proportion of patients with a documented SIC among those identified as high-risk by the algorithm
timeFrame: 16 weeks
measure: Change in the proportion of patients with a documented advanced care planning
timeFrame: 16 weeks
measure: Change in the proportion of patients with a documented serious illness conversation (SIC) including follow-up
timeFrame: 40 weeks
measure: Change in the proportion of patients with a documented SIC among those identified as high-risk by the algorithm including follow-up
timeFrame: 40 weeks
measure: Change in the proportion of patients with a documented advanced care planning including follow-up
timeFrame: 40 weeks
Other outcomes:
measure: Oncology Evaluation Center admissions
timeFrame: 40 weeks
measure: Healthcare utilization and receipt of chemotherapy in the last 30 days of life
timeFrame: 40 weeks
measure: Number of Emergency department admissions
timeFrame: 40 weeks
measure: Inpatient admissions
timeFrame: 40 weeks
measure: Intensive care unit admissions
timeFrame: 40 weeks
Locations:
city: Philadelphia
country: United States
facility: Penn Medicine
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Mitesh S Patel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parikh RB, Manz CR, Nelson MN, Ferrell W, Belardo Z, Temel JS, Patel MS, Shea JA. Oncologist Perceptions of Algorithm-Based Nudges to Prompt Early Serious Illness Communication: A Qualitative Study. J Palliat Med. 2022 Nov;25(11):1702-1707. doi: 10.1089/jpm.2022.0095. Epub 2022 Aug 18.
citation: Li EH, Ferrell W, Klaiman T, Kumar P, O'Connor N, Schuchter LM, Chen J, Patel MS, Manz CR, Parikh RB. Impact of Behavioral Nudges on the Quality of Serious Illness Conversations Among Patients With Cancer: Secondary Analysis of a Randomized Controlled Trial. JCO Oncol Pract. 2022 Apr;18(4):e495-e503. doi: 10.1200/OP.21.00024. Epub 2021 Nov 12.
citation: Manz CR, Parikh RB, Small DS, Evans CN, Chivers C, Regli SH, Hanson CW, Bekelman JE, Rareshide CAL, O'Connor N, Schuchter LM, Shulman LN, Patel MS. Effect of Integrating Machine Learning Mortality Estimates With Behavioral Nudges to Clinicians on Serious Illness Conversations Among Patients With Cancer: A Stepped-Wedge Cluster Randomized Clinical Trial. JAMA Oncol. 2020 Dec 1;6(12):e204759. doi: 10.1001/jamaoncol.2020.4759. Epub 2020 Dec 10.
citation: Manz CR, Parikh RB, Evans CN, Chivers C, Regli SH, Bekelman JE, Small D, Rareshide CAL, O'Connor N, Schuchter LM, Shulman LN, Patel MS. Integrating machine-generated mortality estimates and behavioral nudges to promote serious illness conversations for cancer patients: Design and methods for a stepped-wedge cluster randomized controlled trial. Contemp Clin Trials. 2020 Mar;90:105951. doi: 10.1016/j.cct.2020.105951. Epub 2020 Jan 23.