Embedded Palliative Care in the MICU

NCT ID: NCT06574672

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-29
• Study Completion Date: 2027-06-30

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.

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.

Conditions

Critical Illness; End of Life; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Embedded Hospice and Palliative Care Practitioner

Intervention Type: 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 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.

Group Type: ACTIVE_COMPARATOR

Embedded Hospice and Palliative Care Practitioner (Group Effect)

Intervention Type: 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.

Historical Controls

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

Group Type: PLACEBO_COMPARATOR

None (Historical)

Intervention Type: OTHER

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

Interventions

Embedded Hospice and Palliative Care Practitioner

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.

Intervention Type: OTHER

Embedded Hospice and Palliative Care Practitioner (Group Effect)

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.

Intervention Type: OTHER

None (Historical)

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Stephen Wen-Yan Chi

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen Chi, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Barnes Jewish Hospital

St Louis, Missouri, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Stephen Chi, MD

Role: CONTACT

chis@wustl.edu

314-273-6176

Facility Contacts

Stephen Chi, MD

Role: primary

chis@wustl.edu

314-273-6176

References

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.

Reference Type: BACKGROUND

PMID: 24517300 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25574794 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27582396 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26556622 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35833450 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31609772 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37071421 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

202406143

Identifier Type: -

Identifier Source: org_study_id