Critical IllnessNCT06574672
Embedded Palliative Care in the MICU
A study testing Embedded Hospice and Palliative Care Practitioner, Embedded Hospice and Palliative Care Practitioner (Group Effect) and None (Historical) in people with Critical Illness and End of Life, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, End of Life, Quality of Life
- What is being tested?
- Embedded Hospice and Palliative Care Practitioner, Embedded Hospice and Palliative Care Practitioner (Group Effect) and None (Historical)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,600 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2024to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted to the medical intensive care units at a tertiary referral center
- Patients must be at least 18 years of age
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Barnes Jewish Hospital
St Louis, Missouri, 63110
Stephen Chi, MD, 314-273-6176, chis@wustl.edu
Stephen Chi, MD
About this study
Official title: 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.
Read the 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
- Being tested
- Embedded Hospice and Palliative Care Practitioner, Embedded Hospice and Palliative Care Practitioner (Group Effect), None (Historical)
- Keywords
- Palliative Care, Hospice, Medical ICU
- Medical subject headings
- Critical Illness, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embedded Hospice and Palliative Care PractitionerOther
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.
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.
None (Historical)Other
This control arm includes historical patients admitted to the medical intensive care units prior to the study's enrollment timeframe.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: None (Historical) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU Length of Stay
Length of stay in any intensive care unit during the hospitalization
Measured: 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
Measured: From date of enrollment until hospital discharge, assessed up to 1 year
Secondary outcomes (17)
Presence of Advance Care Planning Documentation during Current Admission
Documentation of advance directives, limitations in life-sustaining treatments, or code status that is newly created during the active hospital admission
Measured: From date of enrollment until hospital discharge, assessed up to 1 year
Hospice Consultation
Frequency of Hospice consultations
Measured: From date of enrollment until hospital discharge, assessed up to 1 year
Hospice Enrollment
Frequency of discharge or transition to hospice during or immediately following the hospital stay
Measured: From date of enrollment until hospital discharge, assessed up to 1 year
Palliative Care Consultation
Frequency of Palliative Care consultations
Measured: 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 in days to the first occurrence of the above outcomes
Measured: From date of enrollment until hospital discharge, assessed up to 1 year
Inpatient Hospice Duration
Days while patients are enrolled in inpatient hospice (GIP)
Measured: From date of enrollment until hospital or hospice discharge, assessed up to 1 year
Location of discharge disposition
Discharge disposition to home, skilled nursing facility, long term acute care facility, inpatient rehabilitation, etc.
Measured: From date of enrollment until hospital discharge, assessed up to 1 year
Hospital Length of Stay
Length of hospital stay in days
Measured: From date of enrollment until hospital discharge, assessed up to 1 year
Mortality Index (Vizient)
Mortality index as calculated by Vizient
Measured: From date of enrollment until hospital discharge, assessed up to 1 year
Length of Stay Index (Vizient)
Length of stay index as calculated by Vizient
Measured: From date of enrollment until hospital discharge, assessed up to 1 year
Operating cost in dollars, including departmental breakdown
Hospital operating cost for each patient, including departmental breakdown such as ICU, pharmacy, procedural, operating room, etc.
Measured: Assessed six months following discharge
Mechanical Ventilation Duration
Days on mechanical ventilation
Measured: From date of enrollment until hospital discharge, assessed up to 1 year
Vasopressor Utilization
Days on vasopressors
Measured: From date of enrollment until hospital discharge, assessed up to 1 year
Hospital Mortality
Inpatient all-cause mortality
Measured: From date of enrollment until hospital discharge, assessed up to 1 year
30-Day Mortality
All-cause mortality within 30 days of hospital admission
Measured: Assessed 30 days after hospital admission
30-day Emergency Room Visit
Emergency Room encounter in the same healthcare system within 30 days of discharge
Measured: Assessed 30 days after hospital discharge
30-day Readmission
Hospital readmission in the same healthcare system within 30 days of discharge
Measured: Assessed 30 days after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start29 Jul 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Stepped Wedge Intervention
- Masking
- None (open label)
- Enrolment
- 2,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Wen-Yan Chi, Washington University School of Medicine
- Investigators
- Stephen Chi, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06574672
- Sponsor's protocol ID
- 202406143
- Status last verified
- Jul 2025
- First submitted
- 21 Aug 2024
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 24517300Khandelwal 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.
PubMed 25574794Kyeremanteng 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.
PubMed 27582396Braus 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.
PubMed 26556622Helgeson 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.
PubMed 35833450Ma 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.
PubMed 31609772Chi 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.
PubMed 37071421
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Embedded Palliative Care and Hospice Practitioner in the Medical ICU
- ClinicalTrials.gov ID
- NCT06574672
- Acronym / sponsor ID
- 202406143
- Conditions
- Critical Illness, End of Life, Quality of Life
- Keywords
- Palliative Care, Hospice, Medical ICU
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,600 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 29 Jul 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 28 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Stepped Wedge Intervention
| Arm | Type | Receives |
|---|---|---|
| Prospective Hospice and Palliative Care Intervention | Experimental | Other: Embedded Hospice and Palliative Care PractitionerThis 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. |
| Prospective Standard of Care | Active comparator | Other: Embedded Hospice and Palliative Care Practitioner (Group Effect)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. |
| Historical Controls | Placebo comparator | Other: None (Historical)This arm comprises historical patients admitted to the medical intensive care units in the year prior to study enrollment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients admitted to the medical intensive care units at a tertiary referral center
- Patients must be at least 18 years of age
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Embedded Hospice and Palliative Care PractitionerThe 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. | Other | Prospective Hospice and Palliative Care Intervention |
| 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 | Prospective Standard of Care |
| None (Historical)This control arm includes historical patients admitted to the medical intensive care units prior to the study's enrollment timeframe. | Other | Historical Controls |
Primary outcome
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
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
17 secondary outcomes
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
Vasopressor Utilization
Time frame: 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
30-Day Mortality
Time frame: Assessed 30 days after hospital admission
30-day Emergency Room Visit
Time frame: Assessed 30 days after hospital discharge
30-day Readmission
Time frame: Assessed 30 days after hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Background: PubMed 24517300Aslakson 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.
- Background: PubMed 25574794Khandelwal 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.
- Background: PubMed 27582396Kyeremanteng 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.
- Background: PubMed 26556622Braus 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.
- Background: PubMed 35833450Helgeson 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.
- Background: PubMed 31609772Ma 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.
- Background: PubMed 37071421Chi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephen Chi, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embedded Hospice and Palliative Care Practitioner, Embedded Hospice and Palliative Care Practitioner (Group Effect) and None (Historical) in people with Critical Illness and End of Life, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephen Chi, MD (314-273-6176, chis@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU Length of Stay (time frame: From date of enrollment until hospital discharge, assessed up to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06574672, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.