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

NCT03984773 | Completed

• 1 other identifier: 833178
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Oncology

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• 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 advanced care planning including follow-up

  40 weeks

Other Outcomes (5)

• Oncology Evaluation Center admissions

  40 weeks

• Healthcare utilization and receipt of chemotherapy in the last 30 days of life

  40 weeks

• Number of Emergency department admissions

  40 weeks

Study Arms (2)

Control

NO INTERVENTION

Clinicians will receive current standard communications regarding serious illness performance.

Mortality Estimates and Nudges

EXPERIMENTAL

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

Behavioral: Nudge

Interventions

Nudge BEHAVIORAL

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.

Mortality Estimates and Nudges

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Penn Medicine

Philadelphia, Pennsylvania, 19103, United States

Location

Related Publications (6)

• Patel TA, Heintz J, Chen J, LaPergola M, Bilker WB, Patel MS, Arya LA, Patel MI, Bekelman JE, Manz CR, Parikh RB. Spending Analysis of Machine Learning-Based Communication Nudges in Oncology. NEJM AI. 2024 Jun;1(6):10.1056/aioa2300228. doi: 10.1056/aioa2300228. Epub 2024 May 15.

  PMID: 39036423 DERIVED

• Manz CR, Zhang Y, Chen K, Long Q, Small DS, Evans CN, Chivers C, Regli SH, Hanson CW, Bekelman JE, Braun J, Rareshide CAL, O'Connor N, Kumar P, Schuchter LM, Shulman LN, Patel MS, Parikh RB. Long-term Effect of Machine Learning-Triggered Behavioral Nudges on Serious Illness Conversations and End-of-Life Outcomes Among Patients With Cancer: A Randomized Clinical Trial. JAMA Oncol. 2023 Mar 1;9(3):414-418. doi: 10.1001/jamaoncol.2022.6303.

  PMID: 36633868 DERIVED

• 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.

  PMID: 35984992 DERIVED

• 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.

  PMID: 34767481 DERIVED

• 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.

  PMID: 33057696 DERIVED

• 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.

  PMID: 31982648 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Mitesh S Patel, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The principal study investigator and data analyst will not have knowledge of when the practices are randomized to the intervention.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 10, 2019
• First Posted: June 13, 2019
• Study Start: July 15, 2019
• Primary Completion: November 1, 2019
• Study Completion: April 19, 2020
• Last Updated: April 24, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)