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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
242

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 7, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 9, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 26, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 24, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Palliative Care

Clinical Trials on Palliative Care

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings