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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03984773
Other study ID # 833178
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 15, 2019
Est. completion date April 19, 2020

Study information

Verified date April 2020
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 78
Est. completion date April 19, 2020
Est. primary completion date November 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Penn Medicine Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Oncology Evaluation Center admissions The number of Oncology Evaluation Center admissions 40 weeks
Other Healthcare utilization and receipt of chemotherapy in the last 30 days of life Healthcare utilization in the last 30 days of life in Penn Medicine facilities including acute care utilization as above and receipt of chemotherapy 40 weeks
Other Number of Emergency department admissions The number of emergency department admissions 40 weeks
Other Inpatient admissions The number of inpatient hospital admissions 40 weeks
Other Intensive care unit admissions The number of intensive care unit admissions 40 weeks
Primary 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 Change in the proportion of patients with a documented SIC among those identified as high-risk by the algorithm 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 16 weeks
Secondary Change in the proportion of patients with a documented advanced care planning The change in the proportion of patients with documentation of advanced care planning. 16 weeks
Secondary Change in the proportion of patients with a documented serious illness conversation (SIC) including follow-up The change in the proportion of patients that have an outpatient oncology visit with documentation of a serious illness conversation (SIC) including follow-up 40 weeks
Secondary Change in the proportion of patients with a documented SIC among those identified as high-risk by the algorithm including follow-up 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 40 weeks
Secondary Change in the proportion of patients with a documented advanced care planning including follow-up The change in the proportion of patients with documentation of advanced care planning including follow-up 40 weeks
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