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Recruiting NCT06574672

Embedded Palliative Care in the MICU

No phase Interventional Critical Illness End of Life Quality of Life

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Embedded Hospice and Palliative Care Practitioner, Embedded Hospice and Palliative Care Practitioner (Group Effect), None (Historical).
Who it may be relevant to
Registry conditions: Critical Illness, End of Life, Quality of Life. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Other 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 consultat
  • 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.
  • Other None (Historical)
    This control arm includes historical patients admitted to the medical intensive care units prior to the study's enrollment timeframe.

Primary outcome measures

  • ICU Length of Stay [Time frame: 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]
Secondary outcome measures (12)
  • Presence of Advance Care Planning Documentation during Current Admission [Time frame: 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]
  • Hospice Enrollment [Time frame: 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]
  • 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]
  • Inpatient Hospice Duration [Time frame: 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]
  • Hospital Length of Stay [Time frame: 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]
  • Length of Stay Index (Vizient) [Time frame: 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]
  • Mechanical Ventilation Duration [Time frame: From date of enrollment until hospital discharge, assessed up to 1 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Barnes Jewish Hospital — St Louis

Publications

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT06574672 · 202406143

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗