Embedded Palliative Care in the MICU

July 14, 2025 updated by: Stephen Wen-Yan Chi, Washington University School of Medicine

Impact of an Embedded Palliative Care and Hospice Practitioner in the Medical ICU

The goal of this study is to investigate whether embedding a hospice and palliative care practitioner within a medical intensive care unit will improve patient outcomes and healthcare usage. The practitioner will work solely within the medical intensive care units and offer timely as well as proactive consultations based on clinical criteria and estimated mortality risk. The study team will compare patients seen by the practitioner to patients in an adjacent ICU and historical patients to determine whether patient care is improved by this intervention.

Study Overview

Detailed Description

The study goal is to determine whether an embedded palliative care practitioner in the medical ICU improves patient outcomes, palliative care/hospice utilization, and healthcare quality metrics. The medical ICUs included in this study are comprised of two geographically co-located units that provide care for medically complex patients from a large tertiary referral area. Palliative care services are currently available as a consultative service at the ICU clinicians' discretion for patients with palliative needs such as complex goals of care, advanced symptom management, or chronic critical illness. Under the current consultation model, palliative care consultation is requested in a minority of critically ill patients and consults occur on average 5-14 days after a patient's admission. Hospice services are similarly available on a consultative basis for patients that the primary team has determined are suitable for hospice, however, logistical limitations of hospice consultation may lead to delays in inpatient hospice transfers and home hospice discharges.

This study's intervention is to embed a palliative care/hospice practitioner within the medical ICUs as a dedicated palliative care and hospice consultant who will offer proactively triggered palliative care consultations early in a patient's ICU stay as well as immediate availability for standard-of-care palliative care and hospice consultations.

Study Type

Interventional

Enrollment (Estimated)

2600

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 Contact

  • Name: Stephen Chi, MD
  • Phone Number: 314-273-6176
  • Email: chis@wustl.edu

Study Locations

    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Barnes Jewish Hospital
        • Contact:
        • Principal Investigator:
          • Stephen Chi, MD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients admitted to the medical intensive care units at a tertiary referral center
  • Patients must be at least 18 years of age

Exclusion Criteria:

  • None

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prospective Hospice and Palliative Care Intervention
This arm comprises patients admitted to the specific medical intensive care unit in which the hospice and palliative care practitioner is currently active. This will include all patients admitted to a single medical intensive care unit during the anticipated first half of the intervention timeframe, followed by all patients admitted to both medical intensive care units during the second half of the intervention timeframe.
The hospice and palliative care practitioner will be embedded in one medical intensive care unit for the first half of the study timeframe, after which the practitioner will expand to both medical intensive care units. While active in a medical intensive care unit, the practitioner will proactively trigger palliative care consultations based on clinical criteria and estimated mortality risk, in addition to providing immediate availability for standard-of-care hospice or palliative care consultations.
Active Comparator: Prospective Standard of Care
This arm comprises patients admitted to the medical intensive care unit in which the hospice and palliative care practitioner is not currently active, but which may experience a group effect due to the study's ongoing enrollment and the practitioner's presence. This will include all patients admitted to a single medical intensive care unit during the anticipated first half of the intervention timeframe, prior to the practitioner becoming active in both intensive care units.
While the hospice and palliative care practitioner is active in one medical intensive care unit with respect to triggering consultations, the other medical intensive care unit can still utilize the practitioner's services for standard-of-care hospice or palliative care consultations.
Placebo Comparator: Historical Controls
This arm comprises historical patients admitted to the medical intensive care units in the year prior to study enrollment.
This control arm includes historical patients admitted to the medical intensive care units prior to the study's enrollment timeframe.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU Length of Stay
Time Frame: From date of enrollment until hospital discharge, assessed up to 1 year
Length of stay in any intensive care unit during the hospitalization
From date of enrollment until hospital discharge, assessed up to 1 year
Code Status De-escalation
Time Frame: From date of enrollment until hospital discharge, assessed up to 1 year
Frequency of changes in code status to limited code or comfort measures only
From date of enrollment until hospital discharge, assessed up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of Advance Care Planning Documentation during Current Admission
Time Frame: From date of enrollment until hospital discharge, assessed up to 1 year
Documentation of advance directives, limitations in life-sustaining treatments, or code status that is newly created during the active hospital admission
From date of enrollment until hospital discharge, assessed up to 1 year
Hospice Consultation
Time Frame: From date of enrollment until hospital discharge, assessed up to 1 year
Frequency of Hospice consultations
From date of enrollment until hospital discharge, assessed up to 1 year
Hospice Enrollment
Time Frame: From date of enrollment until hospital discharge, assessed up to 1 year
Frequency of discharge or transition to hospice during or immediately following the hospital stay
From date of enrollment until hospital discharge, assessed up to 1 year
Palliative Care Consultation
Time Frame: From date of enrollment until hospital discharge, assessed up to 1 year
Frequency of Palliative Care consultations
From date of enrollment until hospital discharge, assessed up to 1 year
Time to change in code status, advance care planning documentation, palliative care consultation, and hospice consultation
Time Frame: From date of enrollment until hospital discharge, assessed up to 1 year
Time in days to the first occurrence of the above outcomes
From date of enrollment until hospital discharge, assessed up to 1 year
Inpatient Hospice Duration
Time Frame: From date of enrollment until hospital or hospice discharge, assessed up to 1 year
Days while patients are enrolled in inpatient hospice (GIP)
From date of enrollment until hospital or hospice discharge, assessed up to 1 year
Location of discharge disposition
Time Frame: From date of enrollment until hospital discharge, assessed up to 1 year
Discharge disposition to home, skilled nursing facility, long term acute care facility, inpatient rehabilitation, etc.
From date of enrollment until hospital discharge, assessed up to 1 year
Hospital Length of Stay
Time Frame: From date of enrollment until hospital discharge, assessed up to 1 year
Length of hospital stay in days
From date of enrollment until hospital discharge, assessed up to 1 year
Mortality Index (Vizient)
Time Frame: From date of enrollment until hospital discharge, assessed up to 1 year
Mortality index as calculated by Vizient
From date of enrollment until hospital discharge, assessed up to 1 year
Length of Stay Index (Vizient)
Time Frame: From date of enrollment until hospital discharge, assessed up to 1 year
Length of stay index as calculated by Vizient
From date of enrollment until hospital discharge, assessed up to 1 year
Operating cost in dollars, including departmental breakdown
Time Frame: Assessed six months following discharge
Hospital operating cost for each patient, including departmental breakdown such as ICU, pharmacy, procedural, operating room, etc.
Assessed six months following discharge
Mechanical Ventilation Duration
Time Frame: From date of enrollment until hospital discharge, assessed up to 1 year
Days on mechanical ventilation
From date of enrollment until hospital discharge, assessed up to 1 year
Vasopressor Utilization
Time Frame: From date of enrollment until hospital discharge, assessed up to 1 year
Days on vasopressors
From date of enrollment until hospital discharge, assessed up to 1 year
Hospital Mortality
Time Frame: From date of enrollment until hospital discharge, assessed up to 1 year
Inpatient all-cause mortality
From date of enrollment until hospital discharge, assessed up to 1 year
30-Day Mortality
Time Frame: Assessed 30 days after hospital admission
All-cause mortality within 30 days of hospital admission
Assessed 30 days after hospital admission
30-day Emergency Room Visit
Time Frame: Assessed 30 days after hospital discharge
Emergency Room encounter in the same healthcare system within 30 days of discharge
Assessed 30 days after hospital discharge
30-day Readmission
Time Frame: Assessed 30 days after hospital discharge
Hospital readmission in the same healthcare system within 30 days of discharge
Assessed 30 days after hospital discharge

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Stephen Chi, MD, Washington University School of Medicine

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.

General Publications

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)

July 29, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

August 21, 2024

First Submitted That Met QC Criteria

August 23, 2024

First Posted (Actual)

August 28, 2024

Study Record Updates

Last Update Posted (Actual)

July 16, 2025

Last Update Submitted That Met QC Criteria

July 14, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 202406143

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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