Critical Care and Palliative Care Medicine Together in the ICU

October 16, 2020 updated by: John E. Moss, Mayo Clinic

Does Early vs Usual Palliative Care Consultation Augment the Critical Care Physician to Decrease Healthcare Utilization and Increase Caregiver Satisfaction

Will earlier palliative care medicine consultation in the ICU result in decreased length of stay in the ICU and hospital, as well as, increased patient and family satisfaction. Secondary questions to be answered is if this early consultation changes ICU and hospital death, discharge destinations, hospice admissions, code status changes, and withdrawal of life sustaining interventions.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

95

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

    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic in Florida

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  1. Age >80 years
  2. Apache II score >14
  3. SOFA score > 9
  4. Pre-existing functional dependency (admitted from ALF, SNF, LTAC, etc.)
  5. Late stage dementia (bed-bound, nonverbal, incontinent, or unable to self-nourish/tube feed)
  6. Stage 4 metastatic disease
  7. Consideration to place permanent feeding tube or trach
  8. Recurrent ICU admissions in the past year
  9. Post-cardiac arrest
  10. End-stage disease (lung, ESRD, ESLD)
  11. ICU perceived need

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: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Standard Care
Standard care with consultant discretion regarding consult of palliative care medicine
EXPERIMENTAL: Experimental
Early palliative care consult based upon meeting study inclusion criteria
Consult of hospital palliative care service for those meeting study inclusion criteria

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: 1 year
Measure will assessed by using the family satisfaction with care in the intensive care unit form (FS-ICU 24)
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
ICU length of stay
Time Frame: 1 year
1 year
Ventilator Days
Time Frame: 1 year
1 year
Percentage admission to hospice
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Investigators

  • Principal Investigator: John E Moss, Mayo Clinic

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.

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)

September 4, 2018

Primary Completion (ACTUAL)

March 1, 2020

Study Completion (ACTUAL)

March 1, 2020

Study Registration Dates

First Submitted

April 23, 2018

First Submitted That Met QC Criteria

May 8, 2018

First Posted (ACTUAL)

May 9, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 20, 2020

Last Update Submitted That Met QC Criteria

October 16, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 18-001107

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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