Palliative Care in the ICU

January 22, 2019 updated by: Marin Kollef, Washington University School of Medicine

Early Palliative Care in the Medical Intensive Care Unit

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

242

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Barnes Jewish Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard of Care
Other: Early Palliative Care Consultation
Other: Palliative Care
Palliative Care Consultation within 24 to 48 hours after admission

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in code status to do-not-resuscitate/do-not-intubate
Time Frame: 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
Through patient admission until discharge, charts reviewed an average of one month after discharge

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 7, 2017

Primary Completion (Actual)

June 9, 2018

Study Completion (Actual)

November 30, 2018

Study Registration Dates

First Submitted

July 26, 2017

First Submitted That Met QC Criteria

August 23, 2017

First Posted (Actual)

August 28, 2017

Study Record Updates

Last Update Posted (Actual)

January 24, 2019

Last Update Submitted That Met QC Criteria

January 22, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 201707067

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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