Palliative Care in the ICU

Not Applicable

Completed

• Conditions: Palliative Care
• Interventions: Other: Palliative Care

• Registration Number: NCT03263143
• Lead Sponsor: Washington University School of Medicine

Brief Summary

The study compares early palliative care consultation to standard of care in the medical intensive care unit (ICU). The study will assess if the intervention leads to an increased proportion of clearly delineated goals of care and examine if this intervention leads to decreased healthcare resource utilization such as length of stay, duration of intensive treatments including mechanical ventilation, and hospital re-admissions.

Detailed Description

* The medical intensive care unit will be split into two groups, assigned as either early palliative care consultation or standard of care. Current standard of care in the ICU is that primary clinician providers determine the need and time for palliative care consultation, which can occur approximately 5 - 14 days after admission.

* A palliative care screening tool will be used to determine if a newly admitted patient is eligible for palliative care consultation.

* Up to two patients per ICU per weekday will be enrolled into the study, due to workload limitations on the palliative care consult team.

* For patients in the intervention group, a palliative care consultation will be performed within 48 hours of ICU admission and patients will be followed throughout their hospitalization.

* Patients in the standard of care group will receive usual care. Palliative care may be consulted at the primary team's clinical discretion.

* The two medical ICU groups will be crossed over after three months with a washout period of six weeks, for a total of approximately eight months of study

* Electronic medical records will be reviewed after patient discharge to collect data on clinical outcomes as described elsewhere

Study Timeline

• Study First Submitted: 2017-07-26
• Study Start: 2017-08-07
• Study First Submitted QC: 2017-08-23
• Study First Posted: 2017-08-28
• Primary Completion: 2018-06-09
• Study Completion: 2018-11-30
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-22
• Last Update Posted: 2019-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 242

Inclusion Criteria

• Admitted to the ICU in the last 24 hours
• Admitted from Skilled nursing facility (SNF), long term acute care (LTAC)facility, long term ventilator care (vent LTC) unit, or home care with private duty nursing with activity of daily living (ADL) dependencies
• End-stage dementia, amyotrophic lateral sclerosis, Parkinson's, multiple sclerosis
• Advanced or Metastatic Cancer
• Cardiac or respiratory arrest with neurological compromise
• Multi- organ system failure (more than 2 organ failures)
• Known diagnosis of end stage organ disease including cirrhosis, end-stage renal disease, congestive heart failure New York Heart Association >III, chronic obstructive pulmonary disease on home O2
• Shock requiring > 6 hours of vasopressors or inotropes
• Acute Respiratory failure requiring intubation or BiPAP
• Admitted to ICU with hospital length of stay of more than 5 days or ICU readmission with the same diagnosis in 30 days.

Read More

Exclusion Criteria

• All stem cell transplant patients, for solid organ transplant, if undergoing evaluation for solid organ transplant or within 1 year post-transplant.
• Patients who do not speak English if interpreter is unavailable
• Patients without capacity to participate in palliative care discussions without a surrogate available
• Patients or patient surrogate refusal of palliative care consultation
• Prior Palliative Care Consultation during the same hospitalization
• For purposes of primary outcome analysis, patients determined to already be DNR/DNI at time of ICU admission

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Early Palliative Care Consultation	Palliative Care	-

Primary Outcome Measures

Name	Time	Method
Change in code status to do-not-resuscitate/do-not-intubate	Through patient admission until discharge, charts reviewed an average of one month after discharge	As determined by code status orders in the electronic medical record

Secondary Outcome Measures

Name	Time	Method
Total hospital operating cost	Through study completion, an average of 6 months
Hospital Length of Stay	After date of discharge, charts reviewed an average of one month after discharge
In-hospital mortality	After date of discharge, charts reviewed an average of one month after discharge	Excluding patients transitioned to hospice prior to death
Number of participants with tracheostomy performed during hospital stay	Through study completion, an average of six months
Number of participants with Cardiopulmonary Resuscitation (CPR) performed	Through study completion, an average of 6 months
Mechanical Ventilation usage and duration	After date of discharge, charts reviewed an average of one month after discharge
30-day mortality	One to two months after patient discharge, verified at study completion	Including all patients, including those on hospice
ICU Length of Stay	After date of discharge, charts reviewed an average of one month after discharge
Post-discharge ER visits and/or readmissions	One to two months after patient discharge, verified at study completion	Determined by review of the BJC healthcare system electronic medical record
Hospice transition or discharge	Through patient admission until discharge, charts reviewed an average of one month after discharge
Vasopressor usage and duration	After date of discharge, charts reviewed an average of one month after discharge
Antibiotic usage and duration	After date of discharge, charts reviewed an average of one month after discharge
Number of participants treated with hemodialysis	Through study completion, an average of six months

Trial Locations

Locations (1)

Barnes Jewish Hospital; 🇺🇸 Saint Louis, Missouri, United States