- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04604457
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
Intervention / Treatment
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
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-
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.
Helpful Links
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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