Embedded Palliative Care in the MICU

NCT06574672 | Recruiting

• 1 other identifier: 202406143
• Study Type: interventional
• Target: 2,600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Critical Illness; End of Life; Quality of Life

Keywords

Palliative Care; Hospice; Medical ICU

Outcome Measures

Primary Outcomes (2)

• ICU Length of Stay

  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

  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 Outcomes (17)

• Presence of Advance Care Planning Documentation during Current Admission

  From date of enrollment until hospital discharge, assessed up to 1 year

• Hospice Consultation

  From date of enrollment until hospital discharge, assessed up to 1 year

• Hospice Enrollment

  From date of enrollment until hospital discharge, assessed up to 1 year

• Palliative Care Consultation

  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

  From date of enrollment until hospital discharge, assessed up to 1 year

Study Arms (3)

Prospective Hospice and Palliative Care Intervention

EXPERIMENTAL

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.

Other: Embedded Hospice and Palliative Care Practitioner

Prospective Standard of Care

ACTIVE COMPARATOR

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.

Other: Embedded Hospice and Palliative Care Practitioner (Group Effect)

Historical Controls

PLACEBO COMPARATOR

This arm comprises historical patients admitted to the medical intensive care units in the year prior to study enrollment.

Other: None (Historical)

Interventions

Embedded Hospice and Palliative Care Practitioner OTHER

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.

Prospective Hospice and Palliative Care Intervention

Embedded Hospice and Palliative Care Practitioner (Group Effect) OTHER

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.

Prospective Standard of Care

None (Historical) OTHER

This control arm includes historical patients admitted to the medical intensive care units prior to the study's enrollment timeframe.

Historical Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

RECRUITING

Related Publications (7)

• Aslakson R, Cheng J, Vollenweider D, Galusca D, Smith TJ, Pronovost PJ. Evidence-based palliative care in the intensive care unit: a systematic review of interventions. J Palliat Med. 2014 Feb;17(2):219-35. doi: 10.1089/jpm.2013.0409.

  PMID: 24517300 BACKGROUND

• Khandelwal N, Kross EK, Engelberg RA, Coe NB, Long AC, Curtis JR. Estimating the effect of palliative care interventions and advance care planning on ICU utilization: a systematic review. Crit Care Med. 2015 May;43(5):1102-11. doi: 10.1097/CCM.0000000000000852.

  PMID: 25574794 BACKGROUND

• Kyeremanteng K, Gagnon LP, Thavorn K, Heyland D, D'Egidio G. The Impact of Palliative Care Consultation in the ICU on Length of Stay: A Systematic Review and Cost Evaluation. J Intensive Care Med. 2018 Jun;33(6):346-353. doi: 10.1177/0885066616664329. Epub 2016 Aug 31.

  PMID: 27582396 BACKGROUND

• Braus N, Campbell TC, Kwekkeboom KL, Ferguson S, Harvey C, Krupp AE, Lohmeier T, Repplinger MD, Westergaard RP, Jacobs EA, Roberts KF, Ehlenbach WJ. Prospective study of a proactive palliative care rounding intervention in a medical ICU. Intensive Care Med. 2016 Jan;42(1):54-62. doi: 10.1007/s00134-015-4098-1. Epub 2015 Nov 10.

  PMID: 26556622 BACKGROUND

• Helgeson SA, Burnside RC, Robinson MT, Mack RC, Ball CT, Guru PK, Moss JE. Early Versus Usual Palliative Care Consultation in the Intensive Care Unit. Am J Hosp Palliat Care. 2023 May;40(5):544-551. doi: 10.1177/10499091221115732. Epub 2022 Jul 14.

  PMID: 35833450 BACKGROUND

• Ma J, Chi S, Buettner B, Pollard K, Muir M, Kolekar C, Al-Hammadi N, Chen L, Kollef M, Dans M. Early Palliative Care Consultation in the Medical ICU: A Cluster Randomized Crossover Trial. Crit Care Med. 2019 Dec;47(12):1707-1715. doi: 10.1097/CCM.0000000000004016.

  PMID: 31609772 BACKGROUND

• Chi S, Kim S, Reuter M, Ponzillo K, Oliver DP, Foraker R, Heard K, Liu J, Pitzer K, White P, Moore N. Advanced Care Planning for Hospitalized Patients Following Clinician Notification of Patient Mortality by a Machine Learning Algorithm. JAMA Netw Open. 2023 Apr 3;6(4):e238795. doi: 10.1001/jamanetworkopen.2023.8795.

  PMID: 37071421 BACKGROUND

MeSH Terms

Conditions

Critical Illness; Death

Interventions

Health Records, Personal

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Medical Records; Records; Data Collection; Epidemiologic Methods; Investigative Techniques

Study Officials

• Stephen Chi, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen Chi, MD

CONTACT

314-273-6176; chis@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Stepped Wedge Intervention

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 28, 2024
• Study Start: July 29, 2024
• Primary Completion: June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)