CLINICAL TRIAL

Early Integration of Specialty Palliative Care with Critical Care for Critical Illness

High Risk
Locally Advanced
Metastatic
Recruiting · 18+ · All Sexes · Pittsburgh, PA

This study is evaluating whether early integration of palliative care with standard critical care can improve outcomes for critically ill older patients at high risk of death or severe functional impairments and their family members.

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About the trial for Critical Illness

Treatment Groups

This trial involves 2 different treatments. Early Integration Of Specialty Palliative Care With Critical Care is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Early Integration of Specialty Palliative Care with Critical Care
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
of discharge People who have been in the hospital for 10 days or more, and who are then admitted to the ICU, are more likely to die within 30 days than those who were not in the hospital for 10 days or more. show original
One or more forms of organ support is needed for those over the age of 80. show original
CCM physicians judged that there was a greater than or equal to 50% risk that the patient would die or experience a new, severe long-term functional impairment. show original
Patients admitted to a study ICU are automatically included in the study show original
: This text is about people who need to see a doctor for PC consultation show original
Cardiac or respiratory arrest with coma1
A stroke requiring mechanical ventilation is an ischemic or hemorrhagic stroke. show original
Patient Inclusion Criteria
This refers to a situation where more than one organ system in the body fails show original
Age greater than or equal to 60 years
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Measured at 3 months and 6 months
Screening: ~3 weeks
Treatment: Varies
Reporting: Measured at 3 months and 6 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Measured at 3 months and 6 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Early Integration of Specialty Palliative Care with Critical Care will improve 1 primary outcome, 14 secondary outcomes, and 4 other outcomes in patients with Critical Illness. Measurement will happen over the course of Measured at day 5 post-randomization.

Unmet palliative care needs
MEASURED AT DAY 5 POST-RANDOMIZATION
Measured using the adapted Needs of Social Nature, Existential Concerns, Symptoms, and Therapeutic Interaction (NEST) scale administered to surrogates and patients (if able) on day 5 post-randomization. The adapted NEST scale is designed for ICU use; it is a 13-item instrument developed to identify unmet social, emotional, physical, and care-system needs in serious illness.
MEASURED AT DAY 5 POST-RANDOMIZATION
Surrogates' prognostic awareness
MEASURED ON STUDY DAY 5
Assessed on study day 5 using the validated Clinician-Surrogate Concordance Scale (CSCS), which our research team developed. The single item CSCS has excellent test-retest reliability (r =0.91). It has established criterion validity and responsiveness to change.
MEASURED ON STUDY DAY 5
Surrogates' clarity about patient values and preferences
MEASURED ON STUDY DAY 5
Assessed by surrogates/patients after family meetings on study day 5 using the "informed" and "values clarity" subscales, 6 items out of the 16-item Decisional Conflict Scale (DCS). The scale has established responsiveness to change, test-retest reliability (r=0.81), internal consistency (α=0.92), and discriminant validity.
MEASURED ON STUDY DAY 5
Patient and family centeredness of care
MEASURED AT 3 MONTHS AFTER HOSPITAL DISCHARGE
12-item Patient Perceived Patient-Centeredness of Care Scale (PPPC), previously modified for use by surrogates, completed at 3-month telephone follow-up of surrogates.
MEASURED AT 3 MONTHS AFTER HOSPITAL DISCHARGE
Patients' functional status
MEASURED AT 6 MONTHS
Assessed using the Katz Index of Independence in Activities of Daily Living, a validated and widely-used scale to quantify patients' functional status.
MEASURED AT 6 MONTHS
Days alive outside healthcare facilities
MEASURED AT 6 MONTHS
Investigators will calculate the number of days a patient was alive from discharge to 6 months, then subtract that from the number of days the patient was in a hospital, LTAC, SNF, rehab facility, or hospice.
MEASURED AT 6 MONTHS
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Who is running the study

Principal Investigator
D. W.
Prof. Douglas White, Professor
University of Pittsburgh

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is early integration of specialty palliative care with critical care?

Early integration of palliative care into a critical care environment can improve quality of dying and lead to decreased length of hospitalization among patients who die in the ICU.

Anonymous Patient Answer

What are the signs of critical illness?

Signs and symptoms of critical illness can include increased pain, increased frequency of respiratory rate, fever, and leukocytosis that is not accompanied by infection. Fever and leukocytosis can suggest infection but not necessarily a severe illness. If no other causes are obvious, a diagnosis must be considered.

Anonymous Patient Answer

What are common treatments for critical illness?

Many people with critical illnesses receive medications to treat their illness. These include diuretics, analgesics, and many other agents. Some of the agents may worsen a person's critical illness. In the first 24 hours of critical illness in nursing home residents, the medication should be changed to one with greater therapeutic benefit. In the first 24 hours of critical illness in medical patients, especially those in the ICU or experiencing delirium, the medication should be changed. In the first 24 hours or less of critical illness in medical residents, the medication should not be changed.

Anonymous Patient Answer

How many people get critical illness a year in the United States?

Critically ill patients with multiple comorbidities, as well as those with psychiatric problems, are at high risk for acute admission to a hospital intensive care unit (ICU). The majority of patients admitted to an ICU are in critical condition (primary ICU admission or transfer from another ICU); many of these patients are critically ill with underlying diseases that predispose them to rapid deterioration. Approximately one in three critically ill patients required a primary ICU admission, and they represent a substantial burden to the institutional cost of ICU care. In the absence of randomized controlled trials, the quality of care and associated cost benefits can be evaluated using patient database information.

Anonymous Patient Answer

What is critical illness?

Critical illnesses are the most common cause of death in intensive care units. ICU mortality is primarily related to factors such as co-morbid illness, the underlying illness and the presence of the critically ill patient on extracorporeal technologies. Critical illness is a very varied, complex and heterogeneous group of clinical illnesses and therefore requires the development of tools to diagnose, predict outcome and intervene in order to improve the patient's prognosis and functional status.

Anonymous Patient Answer

What causes critical illness?

Critical illness can be accompanied by many medical conditions that can impair the body and lead to organ dysfunction. In addition, critical illness involves a complex interplay between multiple body systems, such as the neurological system, the immune system, and the cardiovascular system, all with a complex array of hormonal changes and altered endocrine functioning. All of these factors can lead to complications, some of which can be addressed. Current pharmacological practice is imperfect, but can be improved in order to improve the length and quality of life of patients.

Anonymous Patient Answer

Can critical illness be cured?

Survival after intensive care treatment is lower than after intensive care treatment for nonsevere sepsis, even when both groups have a significant chance of survival with a single institution's treatment strategies. However, both groups have improved long-term survival when critically ill patients are discharged from a second institution's intensive care unit.

Anonymous Patient Answer

Is early integration of specialty palliative care with critical care safe for people?

Early integration of palliative care with critical care can be safely implemented into the existing critical care environment. Palliative care should be offered to patients in all areas of intensive care, including the ICU. Palliative services can be provided both within an ICU and from specialist palliative care wards. A multidisciplinary approach is important for optimal patient care and avoids the potential challenges of transferring patients to another provider if palliative services are unavailable. The palliative staff in this setting can be trained both in clinical decision-making and to coordinate palliative care services in critically ill patients who have limited or no advance directives.

Anonymous Patient Answer

Is early integration of specialty palliative care with critical care typically used in combination with any other treatments?

Most hospice patients received a multidisciplinary approach. The majority participated in intensive inpatient treatment. Recent findings strongly suggest that a palliative approach at the end of life could be integrated into critical care services.

Anonymous Patient Answer

How does early integration of specialty palliative care with critical care work?

The integration of palliative care and critical care work can be highly successful within the context of an integrated team of clinicians and a palliative care team. The team composition should include a specialist palliative care team-members and multidisciplinary clinical teams with expertise and responsibilities to integrate palliative and critical care. There is scope for standardization and collaborative development of guidelines and core clinical modules that integrate palliative and critical care.

Anonymous Patient Answer

What is the latest research for critical illness?

There is a lot to offer in the way of critical illness research. Most of the research from the last quarter of the 20th century and some from the first quarter of the 21st century that addresses critical illness remains relevant and potentially useful, and is likely to be used in clinical practice. There is also a real and growing interest in critical illness from researchers who feel that the time has come to address the real and common problem that critically ill patients face rather than just targeting a small group of rare diseases. The challenge then is a balance between choosing a research avenue that is both clinically and economically sensible for your hospital and local clinical populations, and then prioritising the research agenda to tackle the problem that it promises to solve.

Anonymous Patient Answer

Have there been other clinical trials involving early integration of specialty palliative care with critical care?

Early integration of palliative care with critical care may improve the quality of care and help patients with complicated medical illness live longer when compared with standard approaches in which palliative care specialists only visit patients in the final month of life.

Anonymous Patient Answer
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