Clinical trial NCT04487054: Outcomes of Early Palliative Care Intervention for High-Risk Patients in the Intensive Care Unit-A Pilot Study
Official title: Outcomes of Early Palliative Care Intervention for High-Risk Patients in the Intensive Care Unit- A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2020-07-27
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Length Of Stay (LOS) in the medical ICU
timeFrame: From enrollment to Discharge from the ICU, an average of 24 weeks
measure: Length Of Stay in hospital
timeFrame: From enrollment to Discharge from the hospital, an average of 24 weeks
measure: Medical ICU re-admission during the hospital stay
timeFrame: From enrollment to discharge from the hospital, up to 16 weeks
measure: Treatment limitation orders within 48 hours of admission
timeFrame: From enrollment to discharge from the hospital, an average of 24 weeks
measure: Family satisfaction with care in ICU
timeFrame: From enrollment to six weeks post ICU discharge
measure: Advance directive completion
timeFrame: From enrollment to hospital discharge, an average of 24 weeks
measure: Physician Orders for Scope of Treatment (POST) form completion
timeFrame: From enrollment to hospital discharge, an average of 24 weeks
measure: Discharge Outcome Location-Home
timeFrame: From enrollment to six weeks post ICU discharge
measure: Discharge Outcome Location-Skilled Nursing Facility
timeFrame: From enrollment to six weeks post ICU discharge
measure: Discharge Outcome Location-LTACH
timeFrame: From enrollment to six weeks post ICU discharge
measure: Discharge outcomes-Death
timeFrame: From enrollment to six weeks post ICU discharge
measure: Site of death-ICU
timeFrame: From enrollment to six weeks post ICU discharge
measure: Site of death-Hospital
timeFrame: From enrollment to six weeks post ICU discharge
measure: Site of death-Home
timeFrame: From enrollment to six weeks post ICU discharge
measure: Site of death-Hospice
timeFrame: From enrollment to six weeks post ICU discharge
measure: Site of death-Skilled Nursing Facility
timeFrame: From enrollment to six weeks post ICU discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University Hospital
state: West Virginia
Study officials:
References: