- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03520023
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
Conditions
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
- Age >80 years
- Apache II score >14
- SOFA score > 9
- Pre-existing functional dependency (admitted from ALF, SNF, LTAC, etc.)
- Late stage dementia (bed-bound, nonverbal, incontinent, or unable to self-nourish/tube feed)
- Stage 4 metastatic disease
- Consideration to place permanent feeding tube or trach
- Recurrent ICU admissions in the past year
- Post-cardiac arrest
- End-stage disease (lung, ESRD, ESLD)
- 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.
Helpful Links
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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