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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03976297
Other study ID # 19-002315
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 19, 2019
Est. completion date December 20, 2020

Study information

Verified date December 2020
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Investigators are testing whether machine learning prediction models integrated into a health care model will accurately identify participants who may benefit from a comprehensive review by a palliative care specialist, and decrease time to receiving a palliative care consult in an inpatient setting.


Description:

The need for timely palliative care is crucial. Aging patient populations are becoming more complex, often needing care from multiple specialties. There has been a growing mismatch between clinical care and patient preferences particularly with regards to services near end-of-life. Research has shown that that most people prefer to die at home despite the majority dying outside of the home (nursing home or hospital). Given the current model of care and incentives palliative care is considered the care of last resort after all attempts at cure have been exhausted. This delay can lead to sub-optimal symptom management for pain and lower quality of life. As the demand for palliative care increases, policy initiatives and referral triage tools to that lead to quality palliative care services are needed. In 2018 the Mayo Clinic developed a fully integrated information technology (IT) solution focusing on the identification of patients who may benefit from early palliative care review. The tool, known as Control Tower, pulls disparate data sources centered on a machine learning algorithm which predicts the need for palliative care in hospital. This algorithm was put into production as of December 2018 into a silent mode. The algorithm along with other key patient indicators are integrated into a graphical user interface (GUI) which allows a human operator to review the algorithm predictions and subsequently record the operator's assessment. The tool is expected to enhance risk assessment and create a healthcare model in which palliative care can pro-actively and effectively screen for patient need. Anticipated benefits of the approach include improved symptom control and patient satisfaction as well as a measurable impact on inpatient hospital mortality. The overall objective of this study is to assess the effectiveness and implementation of the Control Tower palliative care algorithm into hospital practice by creating a stepped wedge cluster randomized trial in 16 inpatient units. By creating an algorithm that automatically screens and monitors patient health status during inpatient hospitalization, the investigators hypothesize that participants will receive needed palliative care earlier than under the usual course of care. In addition to testing clinical effectiveness study members will also collect data for process measures to assess the algorithm and healthcare performance after translation of the prediction algorithm from a research domain to a practice setting.


Recruitment information / eligibility

Status Completed
Enrollment 2231
Est. completion date December 20, 2020
Est. primary completion date November 18, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Admitted to Mayo Clinic St. Mary's Hospital and Methodist Hospital during August 19, 2019 - August 19, 2020. - Once a day Monday through Friday, the CT operator selects 12 patients from all of the nursing units that are participating in the trial (whether or not they are currently in the intervention group) with palliative scores of at least 7 (out of 100), i.e., those that are high risk and displayed as red in the CT GUI (unless they are already being seen by palliative care.) - The CT operator chooses the selected patients by looking at the patients in sorted order starting with the highest score and proceeding down the list, evaluating each patient for exclusion criteria. - Once the CT operator identifies 12 appropriate patients or once they reaches the end of the high-risk patients (score of 7 or higher) they stop. Exclusion Criteria: - We will exclude all patients who do not provide research authorization to review their medical records for general research studies in accordance with Minnesota Statute 144.335. - We will exclude patients under the age of 18 years of age. - We will exclude patients previously seen by Palliative care during the index hospital visit (i.e., green icon within CT user interface regardless of score) - We will exclude patient who no longer have an active encounter (patients who have died or patients who have transferred to another facility are excluded) at the time of the review - We will exclude patients currently enrolled with the Hospice service at Mayo - We will exclude patients currently enrolled in the Palliative Homebound program (an alternative healthcare model at Mayo) - We will exclude patients who are about to be discharged in the next 24 hours through indication of note

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Control Tower
A workstation and software tool that extracts medical data from Mayo's data mart and electronic health record, and processes it through a prediction model that determines whether a patient is suited for a palliative care consult.

Locations

Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Timely identification for need of palliative care Measured as time in hours to the electronic record of consult by the palliative care team in the inpatient setting. 12 months
Secondary The number of inpatient palliative care consults Measured by the rate of palliative care consults in the inpatient units of interest 12 months
Secondary Timely identification for need of palliative care per unit Measured as time in hours to the electronic record of consult by the palliative care team in the inpatient setting for each of the 16 nursing units. 12 months
Secondary Transition time to hospice-designated bed For all patients with Medicare insurance the time until transferred to a hospice-designated bed from admission. 12 months
Secondary Time to hospice designation Measured as time in hours to the electronic record of consult by the hospice care team in the inpatient setting. 12 months
Secondary Emergency Department visit within 30 days of discharge Measured by the number of study participants who upon discharge from the inpatient setting are readmitted to the Emergency Department at any Mayo Clinic facility within 30 days. 12 months
Secondary Hospitalization or readmission within 30 days of discharge Measured by the number of study participants who upon discharge from the inpatient setting are readmitted to an inpatient unit at any Mayo Clinic facility within 30 days (excluding transfers and planned readmits). 12 months
Secondary ICU transfers Measured by the number of study participants who transferred to a intensive care unit during their inpatient stay. 12 months
Secondary Ratio of inpatient hospice death to non-hospice hospital deaths Measured by the number of deaths of study participants in hospice designated beds by the number of deaths in non-hospice beds. 12 months
Secondary Rate of discharge to external hospice Measured by the number of participants whose electronic health record indicates discharge to external hospice. 12 months
Secondary Inpatient length of stay Measured by the difference between admission to first unit to discharge from hospital for all study participants. 12 months
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