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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Historical Controls | Placebo Comparator | This arm comprises historical patients admitted to the medical intensive care units in the year prior to study enrollment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From date of enrollment until hospital discharge, assessed up to 1 year |
| Hospice Consultation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephen Chi, MD | Contact | 314-273-6176 | chis@wustl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Stephen Chi, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barnes Jewish Hospital | Recruiting | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24517300 | Background | 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. | |
| 25574794 | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 25, 2024 | Aug 21, 2024 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D003643 | Death |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D055991 | Health Records, Personal |
| ID | Term |
|---|---|
| D008499 | Medical Records |
| D011996 | Records |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
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Stepped Wedge Intervention
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|
| 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. |
|
Frequency of Hospice consultations |
| 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 | From date of enrollment until hospital discharge, assessed up to 1 year |
| Palliative Care Consultation | Frequency of Palliative Care consultations | 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 | From date of enrollment until hospital discharge, assessed up to 1 year |
| Inpatient Hospice Duration | Days while patients are enrolled in inpatient hospice (GIP) | 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. | From date of enrollment until hospital discharge, assessed up to 1 year |
| Hospital Length of Stay | Length of hospital stay in days | From date of enrollment until hospital discharge, assessed up to 1 year |
| Mortality Index (Vizient) | Mortality index as calculated by Vizient | 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 | 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. | Assessed six months following discharge |
| Mechanical Ventilation Duration | Days on mechanical ventilation | From date of enrollment until hospital discharge, assessed up to 1 year |
| Vasopressor Utilization | Days on vasopressors | From date of enrollment until hospital discharge, assessed up to 1 year |
| Hospital Mortality | Inpatient all-cause mortality | From date of enrollment until hospital discharge, assessed up to 1 year |
| 30-Day Mortality | All-cause mortality within 30 days of hospital admission | Assessed 30 days after hospital admission |
| 30-day Emergency Room Visit | Emergency Room encounter in the same healthcare system within 30 days of discharge | Assessed 30 days after hospital discharge |
| 30-day Readmission | Hospital readmission in the same healthcare system within 30 days of discharge | Assessed 30 days after hospital discharge |
| 27582396 | 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. |
| 26556622 | 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. |
| 35833450 | 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. |
| 31609772 | 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. |
| 37071421 | 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. |
| D008919 |
| Investigative Techniques |