Impact of Predictive Modeling on Time to Palliative Care in an Outpatient Primary Care Population

June 14, 2021 updated by: Rachel D. Havyer, Mayo Clinic
A machine learning algorithm will be used to accurately identify patients in certain primary care units who may benefit from palliative care consults.

Study Overview

Status

Completed

Conditions

Detailed Description

A machine learning algorithm will be used to accurately identify patients in certain primary care units who may benefit from palliative care consults. These patients will be presented weekly to a palliative care specialist in a custom user interface. The palliative care specialist will reach out to primary care teams if she determines that the patient would benefit from palliative care. If the primary care provider agrees, he/she would write a palliative care consult order for the patient. The goal is to reduce the time to palliative care for these patients, who may not have been identified as quickly without the algorithm.

Study Type

Interventional

Enrollment (Actual)

127070

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patient assigned to a primary care unit from July 2020 to June 2021.
  • Weekly the palliative care specialists will select patients by looking at patients in sorted order starting with the highest score and proceeding down the list and evaluating each patient for exclusion criteria.

Exclusion Criteria:

  • Patients that have been seen by Palliative care will be excluded for 75 days
  • Patients under the age of 18 years.
  • Patients currently enrolled with hospice

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard of Care
Palliative care specialists would not reach out to primary care providers. Palliative care needs would be met via existing mechanisms.
Experimental: Predictive Model
Palliative care specialists review recommendations from the predictive model and contact a patient's primary care provider (PCP) when appropriate to recommend a palliative care consult.
Palliative care specialist reaches out to primary care to recommend a palliative care consult. If the primary care provider agrees, he/she will write an order for a palliative care consult.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timely identification for need of palliative care
Time Frame: Through study completion, an average of 1 year
Time to electronic record of consult by the palliative care team in the outpatient setting
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of palliative care consults
Time Frame: Through study completion, an average of 1 year
Number of palliative care consults that occurred on intervention and standard of care arms
Through study completion, an average of 1 year
Number of advanced care planning notes documented in the EHR
Time Frame: Through study completion, an average of 1 year
Number of advanced care planning notes documented in the EHR on both arms
Through study completion, an average of 1 year
Number of billing codes for palliative care
Time Frame: Through study completion, an average of 1 year
Number of ICD-10 billing codes for palliative care on both arms
Through study completion, an average of 1 year
Positive predictive value of screened patients
Time Frame: Through study completion, an average of 1 year
Percentage of screened patients that received palliative care consults
Through study completion, an average of 1 year
Percent of patients who are eligible for ECH based palliative care
Time Frame: Through study completion, an average of 1 year
Percent of patients who are eligible for employee/community health (ECH) based palliative care compared to the Palliative Care Clinic.
Through study completion, an average of 1 year
Percent agreement between Palliative Care and Primary Care and average time between Primary Care Contact and Response
Time Frame: Through study completion, an average of 1 year
Agreement statistics (percent agreement and Kappa statistics) between Palliative Care and Primary Care and descriptive statistics (mean, etc.) on time between primary care contact and response.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Rachel Havyer, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2020

Primary Completion (Actual)

May 31, 2021

Study Completion (Actual)

May 31, 2021

Study Registration Dates

First Submitted

October 14, 2020

First Submitted That Met QC Criteria

October 21, 2020

First Posted (Actual)

October 27, 2020

Study Record Updates

Last Update Posted (Actual)

June 16, 2021

Last Update Submitted That Met QC Criteria

June 14, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 20-005977

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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