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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04487054
Enrollment
104
Registered
2020-07-27
Start date
2019-05-16
Completion date
2020-07-16
Last updated
2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Pro-active palliative care, Intensive care unit, Surprise question, End-of-life care, family satisfaction

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.

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.

Interventions

OTHERPro-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.

Sponsors

West Virginia University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention 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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Length Of Stay (LOS) in the medical ICUFrom enrollment to Discharge from the ICU, an average of 24 weeksNumber of days subject was admitted to the medical ICU
Length Of Stay in hospitalFrom enrollment to Discharge from the hospital, an average of 24 weeksNumber of total days subject was hospitalized
Medical ICU re-admission during the hospital stayFrom enrollment to discharge from the hospital, up to 16 weeksNumber of times a patient was re-admitted to the medical ICU
Treatment limitation orders within 48 hours of admissionFrom enrollment to discharge from the hospital, an average of 24 weeksCount of subjects that had or completed any treatment limitation orders (do-not-resuscitate, do-not-intubate, no vasopressors, etc) within 48 hours of admission
Family satisfaction with care in ICUFrom enrollment to six weeks post ICU dischargeSix-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
Advance directive completionFrom enrollment to hospital discharge, an average of 24 weeksDifference 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)
Physician Orders for Scope of Treatment (POST) form completionFrom enrollment to hospital discharge, an average of 24 weeksDifference 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)
Discharge Outcome Location-HomeFrom enrollment to six weeks post ICU dischargeDifference in discharge outcome location from the baseline period (Standard of Care Patients) and following the intervention (Early Palliative Care Patients)
Discharge Outcome Location-Skilled Nursing FacilityFrom enrollment to six weeks post ICU dischargeDifference in discharge outcome location from the baseline period (Standard of Care Patients) and following the intervention (Early Palliative Care Patients)
Discharge Outcome Location-LTACHFrom enrollment to six weeks post ICU dischargeDifference in discharge outcome location from the baseline period (Standard of Care Patients) and following the intervention (Early Palliative Care Patients)
Discharge outcomes-DeathFrom enrollment to six weeks post ICU dischargeDifference in discharge outcome location from the baseline period (Standard of Care Patients) and following the intervention (Early Palliative Care Patients)
Site of death-ICUFrom enrollment to six weeks post ICU dischargeCount of subjects that passed in specific locations.
Site of death-HospitalFrom enrollment to six weeks post ICU dischargeCount of subjects that passed in specific locations.
Site of death-HomeFrom enrollment to six weeks post ICU dischargeCount of subjects that passed in specific locations.
Site of death-HospiceFrom enrollment to six weeks post ICU dischargeCount of subjects that passed in specific locations.
Site of death-Skilled Nursing FacilityFrom enrollment to six weeks post ICU dischargeCount of subjects that passed in specific locations.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026