Back to resultsOutcomes of Early Palliative Care Intervention for High-Risk Patients in the Intensive Care Unit-A Pilot Study
Primary Purpose
End-of-life Care, Palliative Care, Intensive Care Unit
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pro-active palliative care
Sponsored by
About this trial
This is an interventional supportive care trial for End-of-life Care focused on measuring Pro-active palliative care, Intensive care unit, Surprise question, End-of-life care, family satisfaction
Eligibility Criteria
Inclusion Criteria:
- Patients greater than 18 years of age admitted to the medical ICU at West Virginia University Hospital.
- Patients with a predicted six-month mortality greater than 40% on the integrated prognostic model.
- Patients who live longer than 48 hours after medical ICU admission.
Exclusion Criteria:
- Patient who did not meet inclusion criteria will be excluded.
- Pregnant female/incarcerated patients will be excluded.
- Since this is a study in an adult patient population, children will be excluded.
Sites / Locations
- West Virginia University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Usual care
Usual care plus palliative care
Arm Description
Subjects in the ICU with a poor prognosis will receive usual care in time period one.
Subjects in the ICU with a poor prognosis will receive usual care plus targeted pro-active palliative care intervention within 48 hours of ICU admission in time period two.
Outcomes
Primary Outcome Measures
Length Of Stay (LOS) in the medical ICU
Length Of Stay in hospital
Medical ICU re-admission during the hospital stay
Treatment limitation orders (do-not-resuscitate, do-not-intubate, no vasopressors, etc) within 48 hours of admission
Family satisfaction with care in ICU (modified from the FS-ICU 24 and Bereaved Family Survey (BFS) global performance measure #18)
Six-weeks post discharge, a telephone survey will be conducted with health care surrogate or medical power attorney to determine their satisfaction with the care received in ICU. The results will be compared between participants that received early palliative care intervention and those that did not.
Advance directive completion [a written statement of a person's wishes regarding medical treatment]
Difference in completion rate of the advance directive between the baseline period and following the intervention
Physician Orders for Scope of Treatment (POST) form completion
Difference in completion rate of the Physician Orders for scope of Treatment (POST) form between the baseline period and following the intervention
Discharge outcomes
Difference in discharge outcome (location) between the baseline period and following the intervention
Site of death (ICU, hospital, home, hospice nursing home)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04487054
Brief Title
Outcomes of Early Palliative Care Intervention for High-Risk Patients in the Intensive Care Unit-A Pilot Study
Official Title
Outcomes of Early Palliative Care Intervention for High-Risk Patients in the Intensive Care Unit- A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 16, 2019 (Actual)
Primary Completion Date
January 31, 2021 (Anticipated)
Study Completion Date
January 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West Virginia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The investigators propose to conduct a feasibility study of identifying high-risk ICU patients using previously validated integrated prediction model and employing early palliative care intervention. The study will consist of two four-month time periods: usual care in time period one and usual care plus targeted pro-active palliative care intervention within 48 hours of ICU admission in time period two.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-of-life Care, Palliative Care, Intensive Care Unit
Keywords
Pro-active palliative care, Intensive care unit, Surprise question, End-of-life care, family satisfaction
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pre and post phase study evaluating the utility of pro-active palliative care in high risk ICU patients identified using integrated prediction model
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Subjects in the ICU with a poor prognosis will receive usual care in time period one.
Arm Title
Usual care plus palliative care
Arm Type
Experimental
Arm Description
Subjects in the ICU with a poor prognosis will receive usual care plus targeted pro-active palliative care intervention within 48 hours of ICU admission in time period two.
Intervention Type
Other
Intervention Name(s)
Pro-active palliative care
Intervention Description
Patient with high risk of mortality in ICU will be identified using our previously validated prognostic model. Intervention phase will employ pro-active palliative care on eligible patients after they survive 48 hours in ICU.
Primary Outcome Measure Information:
Title
Length Of Stay (LOS) in the medical ICU
Time Frame
From enrollment to Discharge from the ICU, an average of 24 weeks
Title
Length Of Stay in hospital
Time Frame
From enrollment to Discharge from the hospital, an average of 24 weeks
Title
Medical ICU re-admission during the hospital stay
Time Frame
From enrollment to discharge from the hospital, up to 16 weeks
Title
Treatment limitation orders (do-not-resuscitate, do-not-intubate, no vasopressors, etc) within 48 hours of admission
Time Frame
From enrollment to discharge from the hospital, an average of 24 weeks
Title
Family satisfaction with care in ICU (modified from the FS-ICU 24 and Bereaved Family Survey (BFS) global performance measure #18)
Description
Six-weeks post discharge, a telephone survey will be conducted with health care surrogate or medical power attorney to determine their satisfaction with the care received in ICU. The results will be compared between participants that received early palliative care intervention and those that did not.
Time Frame
From enrollment to six weeks post ICU discharge
Title
Advance directive completion [a written statement of a person's wishes regarding medical treatment]
Description
Difference in completion rate of the advance directive between the baseline period and following the intervention
Time Frame
From enrollment to hospital discharge, an average of 24 weeks
Title
Physician Orders for Scope of Treatment (POST) form completion
Description
Difference in completion rate of the Physician Orders for scope of Treatment (POST) form between the baseline period and following the intervention
Time Frame
From enrollment to hospital discharge, an average of 24 weeks
Title
Discharge outcomes
Description
Difference in discharge outcome (location) between the baseline period and following the intervention
Time Frame
From enrollment to six weeks post ICU discharge
Title
Site of death (ICU, hospital, home, hospice nursing home)
Time Frame
From enrollment to six weeks post ICU discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients greater than 18 years of age admitted to the medical ICU at West Virginia University Hospital.
Patients with a predicted six-month mortality greater than 40% on the integrated prognostic model.
Patients who live longer than 48 hours after medical ICU admission.
Exclusion Criteria:
Patient who did not meet inclusion criteria will be excluded.
Pregnant female/incarcerated patients will be excluded.
Since this is a study in an adult patient population, children will be excluded.
Facility Information:
Facility Name
West Virginia University Hospital
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Outcomes of Early Palliative Care Intervention for High-Risk Patients in the Intensive Care Unit-A Pilot Study
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