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

NCT04487054 | Completed

• 1 other identifier: 1711863473
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (16)

• 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

Study Arms (2)

Usual care

NO INTERVENTION

Subjects in the ICU with a poor prognosis will receive usual care in time period one.

Usual care plus palliative care

EXPERIMENTAL

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

Interventions

Pro-active palliative care OTHER

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.

Usual care plus palliative care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant female/incarcerated patients will be excluded.
• Since this is a study in an adult patient population, children will be excluded.

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

West Virginia University Hospital

Morgantown, West Virginia, 26506, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pre and post phase study evaluating the utility of pro-active palliative care in high risk ICU patients identified using integrated prediction model

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: July 27, 2020
• Study Start: May 16, 2019
• Primary Completion: July 16, 2020
• Study Completion: July 16, 2020
• Last Updated: February 24, 2025

Record last verified: 2025-02

Locations

US (1)