NCT03520023

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 9, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

September 4, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

October 20, 2020

Status Verified

October 1, 2020

Enrollment Period

1.5 years

First QC Date

April 23, 2018

Last Update Submit

October 16, 2020

Conditions

Palliative CareIntensive Care UnitHospice

Outcome Measures

Primary Outcomes (1)

  • 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 (3)

  • ICU length of stay

    1 year

  • Ventilator Days

    1 year

  • Percentage admission to hospice

    1 year

Study Arms (2)

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

Palliative Care ConsultOTHER

Consult of hospital palliative care service for those meeting study inclusion criteria

Experimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

Study Officials

  • John E Moss

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Physician

Study Record Dates

First Submitted

April 23, 2018

First Posted

May 9, 2018

Study Start

September 4, 2018

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

October 20, 2020

Record last verified: 2020-10

Locations

US(1)