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

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

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.

Study Overview

• Status: Completed
• Conditions: Palliative Care; Intensive Care Unit; End-of-life Care
• Intervention / Treatment: Other: Pro-active palliative care

Detailed Description

The emerging challenge in critical care medicine focuses on improving patient- and family-centered outcomes. (1) The gold standard for patient-centered care is that which aligns with patients' values, preferences, and goals. (2) Palliative care consultants are known for utilizing shared decision making conversations in the intensive care unit (ICU) in which they elicit patients' values and goals. Accurate prognostic information based on the patient's overall condition sets the context for shared decision-making. With the gravity of the decisions made every day in the ICU, prognostic information is invaluable to patients, families, and clinicians. Historically, prognostic models in the ICU have focused on short-term mortality, such as death prior to hospital discharge, but studies have shown that information about post-ICU quality of life outcomes is important to patients and families as is information about survival for six months or more. Researchers have identified that future work in ICU prognostication must focus on accurately predicting the scope of patient-centered outcomes without losing sight of the higher mortality risk faced by ICU patients and survivors. The investigators propose to perform a proof of concept study based on our previously validated integrated prognostic model to identify medical ICU patients with high risk of mortality in six months and determine the utility of this model in terms of improving quality of life and quality of care. The study will consist of two 4-month time periods: usual care and usual care + targeted pro-active palliative care intervention within 48 hours of ICU admission, respectively. For both phases, the investigators will use the previously validated and published integrated prognostic model consisting of the 'surprise question' of "Would you be surprised if this patient died in the next six months?" with a response of "No", the APACHE IV score, and the Charlson Comorbidity Index (CCI) score to identify ICU patients within 24 hours of their ICU admission with a probability estimate of six-month mortality greater than 40 percent.

Six weeks after ICU discharge, we will contact the legal decision maker for the patient (family member or friend who is the medical power of attorney or healthcare surrogate) regarding their satisfaction with critical care services the patient received during the ICU stay. After obtaining verbal consent, questions will be asked from the modified Family Survey-ICU (FS-ICU) and the global performance measure #18 from the Bereaved Family Survey (BFS). The investigators hypothesize that the systematic identification of ICU patients at highest risk of six-month mortality as a prompt for a targeted pro-active palliative care approach will decrease length of ICU and hospital stay, reduce ICU readmissions, lead to earlier treatment limitation orders according to patients' wishes, and increase family satisfaction with the quality of care.

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care; Subjects in the ICU with a poor prognosis will receive usual care in time period one.
Experimental: Usual care plus palliative care; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length Of Stay (LOS) in the medical ICU	Number of days subject was admitted to the medical ICU	From enrollment to Discharge from the ICU, an average of 24 weeks
Length Of Stay in hospital	Number of total days subject was hospitalized	From enrollment to Discharge from the hospital, an average of 24 weeks
Medical ICU re-admission during the hospital stay	Number of times a patient was re-admitted to the medical ICU	From enrollment to discharge from the hospital, up to 16 weeks
Treatment limitation orders within 48 hours of admission	Count of subjects that had or completed any 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	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. 5 point scale with 1= very dissatisfied and 5= Completely Satisfied	From enrollment to six weeks post ICU discharge
Advance directive completion	Difference in completion rate of advance directives [a written statement of a person's wishes regarding medical treatment] between the baseline period (Standard of Care Patients) and following the intervention (Early Palliative Care Patients)	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 (Standard of Care Patients) and following the intervention (Early Palliative Care Patients)	From enrollment to hospital discharge, an average of 24 weeks
Discharge Outcome Location-Home	Difference in discharge outcome location from the baseline period (Standard of Care Patients) and following the intervention (Early Palliative Care Patients)	From enrollment to six weeks post ICU discharge
Discharge Outcome Location-Skilled Nursing Facility	Difference in discharge outcome location from the baseline period (Standard of Care Patients) and following the intervention (Early Palliative Care Patients)	From enrollment to six weeks post ICU discharge
Discharge Outcome Location-LTACH	Difference in discharge outcome location from the baseline period (Standard of Care Patients) and following the intervention (Early Palliative Care Patients)	From enrollment to six weeks post ICU discharge
Discharge outcomes-Death	Difference in discharge outcome location from the baseline period (Standard of Care Patients) and following the intervention (Early Palliative Care Patients)	From enrollment to six weeks post ICU discharge
Site of death-ICU	Count of subjects that passed in specific locations.	From enrollment to six weeks post ICU discharge
Site of death-Hospital	Count of subjects that passed in specific locations.	From enrollment to six weeks post ICU discharge
Site of death-Home	Count of subjects that passed in specific locations.	From enrollment to six weeks post ICU discharge
Site of death-Hospice	Count of subjects that passed in specific locations.	From enrollment to six weeks post ICU discharge
Site of death-Skilled Nursing Facility	Count of subjects that passed in specific locations.	From enrollment to six weeks post ICU discharge

Collaborators and Investigators

• Sponsor: West Virginia University

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2019
• Primary Completion (Actual): July 16, 2020
• Study Completion (Actual): July 16, 2020

Study Registration Dates

• First Submitted: June 12, 2020
• First Submitted That Met QC Criteria: July 24, 2020
• First Posted (Actual): July 27, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 20, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Intensive care unit; End-of-life care; family satisfaction; Pro-active palliative care; Surprise question
• Additional Relevant MeSH Terms: Pathologic Processes; Death
• Other Study ID Numbers: 1711863473

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No