NCT04604457

Brief Summary

A machine learning algorithm will be used to accurately identify patients in certain primary care units who may benefit from palliative care consults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
127,070

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

August 31, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 14, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 27, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

June 16, 2021

Status Verified

June 1, 2021

Enrollment Period

9 months

First QC Date

October 14, 2020

Last Update Submit

June 14, 2021

Conditions

Keywords

machine learningpredictive modelpalliative care

Outcome Measures

Primary Outcomes (1)

  • Timely identification for need of palliative care

    Time to electronic record of consult by the palliative care team in the outpatient setting

    Through study completion, an average of 1 year

Secondary Outcomes (6)

  • Number of palliative care consults

    Through study completion, an average of 1 year

  • Number of advanced care planning notes documented in the EHR

    Through study completion, an average of 1 year

  • Number of billing codes for palliative care

    Through study completion, an average of 1 year

  • Positive predictive value of screened patients

    Through study completion, an average of 1 year

  • Percent of patients who are eligible for ECH based palliative care

    Through study completion, an average of 1 year

  • +1 more secondary outcomes

Study Arms (2)

Standard of Care

NO INTERVENTION

Palliative care specialists would not reach out to primary care providers. Palliative care needs would be met via existing mechanisms.

Predictive Model

EXPERIMENTAL

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.

Other: Palliative care contacts primary care

Interventions

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.

Predictive Model

Eligibility Criteria

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

You may qualify if:

  • Adult patient assigned to a primary care unit from July 2020 to June 2021.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Heinzen EP, Wilson PM, Storlie CB, Demuth GO, Asai SW, Schaeferle GM, Bartley MM, Havyer RD. Impact of a machine learning algorithm on time to palliative care in a primary care population: protocol for a stepped-wedge pragmatic randomized trial. BMC Palliat Care. 2023 Feb 3;22(1):9. doi: 10.1186/s12904-022-01113-0.

Related Links

Study Officials

  • Rachel Havyer, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
CROSSOVER
Model Details: Step-wedge design with 7 wedges: the first wedge has all primary care teams in the standard of care arm; every six weeks one or two care teams switch to the intervention arm.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 14, 2020

First Posted

October 27, 2020

Study Start

August 31, 2020

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

June 16, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations