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

Sponsor

University of Pennsylvania (Other)

Overall Status

Completed

CT.gov ID

NCT03984773

Collaborator

(none)

Enrollment

Location

Arms

9.2

Actual Duration (Months)

8.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Oncology	Behavioral: Nudge	N/A

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

Actual Enrollment :

78 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

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.

Primary Purpose:

Health Services Research

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

Actual Study Start Date :

Jul 15, 2019

Actual Primary Completion Date :

Nov 1, 2019

Actual Study Completion Date :

Apr 19, 2020

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Clinicians will receive current standard communications regarding serious illness performance.
Experimental: 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	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.

Arm

Intervention/Treatment

No Intervention: Control

Clinicians will receive current standard communications regarding serious illness performance.

Experimental: 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

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.

Outcome Measures

Primary Outcome Measures

Change in the proportion of patients with a documented serious illness conversation (SIC) [16 weeks]
The change in the proportion of patients that have an outpatient oncology visit with documentation of a serious illness conversation (SIC)

Secondary Outcome Measures

Change in the proportion of patients with a documented SIC among those identified as high-risk by the algorithm [16 weeks]
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
Change in the proportion of patients with a documented advanced care planning [16 weeks]
The change in the proportion of patients with documentation of advanced care planning.
Change in the proportion of patients with a documented serious illness conversation (SIC) including follow-up [40 weeks]
The change in the proportion of patients that have an outpatient oncology visit with documentation of a serious illness conversation (SIC) including follow-up
Change in the proportion of patients with a documented SIC among those identified as high-risk by the algorithm including follow-up [40 weeks]
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
Change in the proportion of patients with a documented advanced care planning including follow-up [40 weeks]
The change in the proportion of patients with documentation of advanced care planning including follow-up

Other Outcome Measures

Oncology Evaluation Center admissions [40 weeks]
The number of Oncology Evaluation Center admissions
Healthcare utilization and receipt of chemotherapy in the last 30 days of life [40 weeks]
Healthcare utilization in the last 30 days of life in Penn Medicine facilities including acute care utilization as above and receipt of chemotherapy
Number of Emergency department admissions [40 weeks]
The number of emergency department admissions
Inpatient admissions [40 weeks]
The number of inpatient hospital admissions
Intensive care unit admissions [40 weeks]
The number of intensive care unit admissions

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)