NCT03976297

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,231

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 6, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

August 19, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2020

Completed
Last Updated

December 30, 2020

Status Verified

December 1, 2020

Enrollment Period

1.3 years

First QC Date

June 3, 2019

Last Update Submit

December 29, 2020

Conditions

Keywords

Machine learningArtificial IntelligencePragmatic Clinical TrialHealthcare Delivery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • The number of inpatient palliative care consults

    12 months

  • Timely identification for need of palliative care per unit

    12 months

  • Transition time to hospice-designated bed

    12 months

  • Time to hospice designation

    12 months

  • Emergency Department visit within 30 days of discharge

    12 months

  • +5 more secondary outcomes

Study Arms (2)

Control Tower Intervention

EXPERIMENTAL

For participants in the intervention arm, the results of the prediction model will be presented through a GUI interface hereby known as the Control Tower. Participants receive scores from Control Tower (0-100; higher score indicating increased need) for palliative care and are subsequently ranked from highest to lowest. Red (7 or greater) is considered high risk. The intervention will include a Control Tower operator who will interact with the inpatient palliative care consult service. The operator will monitor the Control Tower during weekday normal business hours and select daily a cohort of participants in the intervention units with the highest need of palliative care review. The final list of participants will then be sent to palliative care. The palliative care team who is on service will also assess the need for each participants, and those participants which they agree could benefit they will approach the attending clinical team to suggest a palliative care referral.

Other: Control Tower

Standard of Care

NO INTERVENTION

For participants who are not in an intervention period they will receive the standard of care commensurate with their clinical unit. This is feasible given that this is a pragmatic clinical trial where the investigators can easily control the communication between the control tower operator and palliative care team to prevent any contamination between clusters. In addition to the usual source of care control the investigators intentionally have calibrated the prediction model and the Control Tower review to match the average capacity of the palliative care service, knowing that that the team will still receive palliative care consults through the traditional pathway i.e. the attending care team consulting palliative care directly.

Interventions

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.

Control Tower Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.)

You may not qualify if:

  • 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.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55906, United States

Location

Related Publications (1)

  • Wilson PM, Philpot LM, Ramar P, Storlie CB, Strand J, Morgan AA, Asai SW, Ebbert JO, Herasevich VD, Soleimani J, Pickering BW. Improving time to palliative care review with predictive modeling in an inpatient adult population: study protocol for a stepped-wedge, pragmatic randomized controlled trial. Trials. 2021 Sep 16;22(1):635. doi: 10.1186/s13063-021-05546-5.

Related Links

Study Officials

  • Jon O Ebbert, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: Pragmatic Stepped Wedge Cluster Randomized Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 3, 2019

First Posted

June 6, 2019

Study Start

August 19, 2019

Primary Completion

November 18, 2020

Study Completion

December 20, 2020

Last Updated

December 30, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations