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NCT Number: NCT04487054

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.

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Key information

Conditions

End-of-life Care Intensive Care Unit Palliative Care

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West Virginia University Hospital

Morgantown, West Virginia, 26506, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Length Of Stay (LOS) in the medical ICU

    Time frame: From enrollment to Discharge from the ICU, an average of 24 weeks

    Number of days subject was admitted to the medical ICU

  2. Length Of Stay in hospital

    Time frame: From enrollment to Discharge from the hospital, an average of 24 weeks

    Number of total days subject was hospitalized

  3. Medical ICU re-admission during the hospital stay

    Time frame: From enrollment to discharge from the hospital, up to 16 weeks

    Number of times a patient was re-admitted to the medical ICU

  4. Treatment limitation orders within 48 hours of admission

    Time frame: From enrollment to discharge from the hospital, an average of 24 weeks

    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

  5. Family satisfaction with care in ICU

    Time frame: From enrollment to six weeks post ICU discharge

    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

  6. Advance directive completion

    Time frame: From enrollment to hospital discharge, an average of 24 weeks

    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)

  7. Physician Orders for Scope of Treatment (POST) form completion

    Time frame: From enrollment to hospital discharge, an average of 24 weeks

    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)

  8. Discharge Outcome Location-Home

    Time frame: From enrollment to six weeks post ICU discharge

    Difference in discharge outcome location from the baseline period (Standard of Care Patients) and following the intervention (Early Palliative Care Patients)

  9. Discharge Outcome Location-Skilled Nursing Facility

    Time frame: From enrollment to six weeks post ICU discharge

    Difference in discharge outcome location from the baseline period (Standard of Care Patients) and following the intervention (Early Palliative Care Patients)

  10. Discharge Outcome Location-LTACH

    Time frame: From enrollment to six weeks post ICU discharge

    Difference in discharge outcome location from the baseline period (Standard of Care Patients) and following the intervention (Early Palliative Care Patients)

  11. Discharge outcomes-Death

    Time frame: From enrollment to six weeks post ICU discharge

    Difference in discharge outcome location from the baseline period (Standard of Care Patients) and following the intervention (Early Palliative Care Patients)

  12. Site of death-ICU

    Time frame: From enrollment to six weeks post ICU discharge

    Count of subjects that passed in specific locations.

  13. Site of death-Hospital

    Time frame: From enrollment to six weeks post ICU discharge

    Count of subjects that passed in specific locations.

  14. Site of death-Home

    Time frame: From enrollment to six weeks post ICU discharge

    Count of subjects that passed in specific locations.

  15. Site of death-Hospice

    Time frame: From enrollment to six weeks post ICU discharge

    Count of subjects that passed in specific locations.

  16. Site of death-Skilled Nursing Facility

    Time frame: From enrollment to six weeks post ICU discharge

    Count of subjects that passed in specific locations.

Sponsors and collaborators

Lead sponsor

West Virginia University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 27, 2020
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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