Critical Care and Palliative Care Medicine Together in th... | NCT03520023

Studies
Critical Care and Palliative Care Medicine Together in the ICU

NCT03520023

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Oct 20, 2020Actual

Enrollment

95Actual

Phase

Not Applicable

Conditions

Palliative Care
Intensive Care Unit
Hospice

Interventions

Palliative Care Consult

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 4, 2018Actual

Primary Completion Date

Mar 1, 2020Actual

Completion Date

Mar 1, 2020Actual

First Submitted Date

Apr 23, 2018

First Submission Date that Met QC Criteria

May 8, 2018

First Posted Date

May 9, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 16, 2020

Last Update Posted Date

Oct 20, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

95Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard Care	No Intervention	Standard care with consultant discretion regarding consult of palliative care medicine
Experimental	Experimental	Early palliative care consult based upon meeting study inclusion criteria	Other: Palliative Care Consult

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Palliative Care Consult	Other	Consult of hospital palliative care service for those meeting study inclusion criteria	Experimental

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John E Moss	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Florida		Jacksonville	Florida	32224	United States