Outcomes of Early Palliative Care Intervention for High-Risk Patients in the Intensive Care Unit-A Pilot Study

Study Overview
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Brief Summary
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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.

Official Title
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Outcomes of Early Palliative Care Intervention for High-Risk Patients in the Intensive Care Unit- A Pilot Study

Conditions
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End-of-life Care, Palliative Care, Intensive Care Unit

Intervention / Treatment
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* Other: Pro-active palliative care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care<br>Subjects in the ICU with a poor prognosis will receive usual care in time period one. | |
| Experimental: Usual care plus palliative care<br>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. | Other: Pro-active palliative care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length Of Stay (LOS) in the medical ICU |  | From enrollment to Discharge from the ICU, an average of 24 weeks | 
| Length Of Stay in hospital |  | From enrollment to Discharge from the hospital, an average of 24 weeks | 
| Medical ICU re-admission during the hospital stay |  | From enrollment to discharge from the hospital, up to 16 weeks | 
| Treatment limitation orders (do-not-resuscitate, do-not-intubate, no vasopressors, etc) within 48 hours of admission |  | From enrollment to discharge from the hospital, an average of 24 weeks | 
| 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. | From enrollment to six weeks post ICU discharge | 
| 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 | From enrollment to hospital discharge, an average of 24 weeks | 
| 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 | From enrollment to hospital discharge, an average of 24 weeks | 
| Discharge outcomes | Difference in discharge outcome (location) between the baseline period and following the intervention | From enrollment to six weeks post ICU discharge | 
| Site of death (ICU, hospital, home, hospice nursing home) |  | From enrollment to six weeks post ICU discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pro-active palliative care, Intensive care unit, Surprise question, End-of-life care, family satisfaction