End-of-life CareNCT04487054
Outcomes of Early Palliative Care Intervention for High-Risk Patients in the Intensive Care Unit-A Pilot Study
A study testing Pro-active palliative care in people with End-of-life Care and Palliative Care, run by West Virginia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-of-life Care, Palliative Care, Intensive Care Unit
- What is being tested?
- Pro-active palliative care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2019to 16 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
West Virginia University Hospital
Morgantown, West Virginia, 26506
About this study
Official title: 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.
Read the 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.
- Conditions
- End-of-life Care, Palliative Care, Intensive Care Unit
- Being tested
- Pro-active palliative care
- Keywords
- Pro-active palliative care, Intensive care unit, Surprise question, End-of-life care, family satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pro-active palliative careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Pro-active palliative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length Of Stay (LOS) in the medical ICU
Number of days subject was admitted to the medical ICU
Measured: From enrollment to Discharge from the ICU, an average of 24 weeks
Length Of Stay in hospital
Number of total days subject was hospitalized
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: From enrollment to six weeks post ICU discharge
Site of death-ICU
Count of subjects that passed in specific locations.
Measured: From enrollment to six weeks post ICU discharge
Site of death-Hospital
Count of subjects that passed in specific locations.
Measured: From enrollment to six weeks post ICU discharge
Site of death-Home
Count of subjects that passed in specific locations.
Measured: From enrollment to six weeks post ICU discharge
Site of death-Hospice
Count of subjects that passed in specific locations.
Measured: From enrollment to six weeks post ICU discharge
Site of death-Skilled Nursing Facility
Count of subjects that passed in specific locations.
Measured: From enrollment to six weeks post ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start16 May 2019
- Primary completion16 Jul 2020
- Study completion16 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-of-life CareStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04487054
- Sponsor's protocol ID
- 1711863473
- Status last verified
- Feb 2025
- First submitted
- 12 Jun 2020
- Last updated
- 24 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Early Palliative Care Intervention for High-Risk Patients in the Intensive Care Unit- A Pilot Study
- ClinicalTrials.gov ID
- NCT04487054
- Acronym / sponsor ID
- 1711863473
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- 16 May 2019 (actual)
- Primary completion
- 16 Jul 2020 (actual)
- Study completion
- 16 Jul 2020 (actual)
- First posted
- 27 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Pro-active palliative careSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pro-active palliative carePatient 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. | Other | Usual care plus palliative care |
Primary outcome
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
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
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
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
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
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)
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)
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)
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)
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)
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)
Site of death-ICU
Time frame: From enrollment to six weeks post ICU discharge
Count of subjects that passed in specific locations.
Site of death-Hospital
Time frame: From enrollment to six weeks post ICU discharge
Count of subjects that passed in specific locations.
Site of death-Home
Time frame: From enrollment to six weeks post ICU discharge
Count of subjects that passed in specific locations.
Site of death-Hospice
Time frame: From enrollment to six weeks post ICU discharge
Count of subjects that passed in specific locations.
Site of death-Skilled Nursing Facility
Time frame: From enrollment to six weeks post ICU discharge
Count of subjects that passed in specific locations.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pro-active palliative care in people with End-of-life Care and Palliative Care, run by West Virginia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length Of Stay (LOS) in the medical ICU (time frame: From enrollment to Discharge from the ICU, an average of 24 weeks). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.