Clinical trial NCT06574672: Embedded Palliative Care in the MICU
Official title: Impact of an Embedded Palliative Care and Hospice Practitioner in the Medical ICU
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Critical Illness
End of Life
Quality of Life
Keywords: Palliative Care
Hospice
Medical ICU
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 2600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stepped Wedge Intervention
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: ICU Length of Stay
timeFrame: From date of enrollment until hospital discharge, assessed up to 1 year
measure: Code Status De-escalation
timeFrame: From date of enrollment until hospital discharge, assessed up to 1 year
Secondary outcomes:
measure: Presence of Advance Care Planning Documentation during Current Admission
timeFrame: From date of enrollment until hospital discharge, assessed up to 1 year
measure: Hospice Consultation
timeFrame: From date of enrollment until hospital discharge, assessed up to 1 year
measure: Hospice Enrollment
timeFrame: From date of enrollment until hospital discharge, assessed up to 1 year
measure: Palliative Care Consultation
timeFrame: From date of enrollment until hospital discharge, assessed up to 1 year
measure: Time to change in code status, advance care planning documentation, palliative care consultation, and hospice consultation
timeFrame: From date of enrollment until hospital discharge, assessed up to 1 year
measure: Inpatient Hospice Duration
timeFrame: From date of enrollment until hospital or hospice discharge, assessed up to 1 year
measure: Location of discharge disposition
timeFrame: From date of enrollment until hospital discharge, assessed up to 1 year
measure: Hospital Length of Stay
timeFrame: From date of enrollment until hospital discharge, assessed up to 1 year
measure: Mortality Index (Vizient)
timeFrame: From date of enrollment until hospital discharge, assessed up to 1 year
measure: Length of Stay Index (Vizient)
timeFrame: From date of enrollment until hospital discharge, assessed up to 1 year
measure: Operating cost in dollars, including departmental breakdown
timeFrame: Assessed six months following discharge
measure: Mechanical Ventilation Duration
timeFrame: From date of enrollment until hospital discharge, assessed up to 1 year
measure: Vasopressor Utilization
timeFrame: From date of enrollment until hospital discharge, assessed up to 1 year
measure: Hospital Mortality
timeFrame: From date of enrollment until hospital discharge, assessed up to 1 year
measure: 30-Day Mortality
timeFrame: Assessed 30 days after hospital admission
measure: 30-day Emergency Room Visit
timeFrame: Assessed 30 days after hospital discharge
measure: 30-day Readmission
timeFrame: Assessed 30 days after hospital discharge
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Stephen Chi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.