Status:
COMPLETED
Post-ICU Palliative Care Intervention (PIPCI) Trial
Lead Sponsor:
Columbia University
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Critical Illness
Frailty
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
This is a single center, pilot, randomized, single-blind, usual care controlled, pragmatic clinical trial of a post-ICU palliative care consultation intervention in older (age ≥50 years) survivors of ...
Detailed Description
There is an urgent need for research to improve outcomes for the rapidly growing population of older survivors of critical illness. Most adults, including older adults, survive critical illness. While...
Eligibility Criteria
Inclusion
- Age ≥ 50 years.
- Acute respiratory failure requiring invasive mechanical ventilation, non-invasive mechanical ventilation (continuous or bi-level positive pressure), or high flow nasal cannula for greater than 24 hours in a Columbia University Medical Center medical or surgical ICU.
Exclusion
- Hospital discharge directly from ICU.
- Already received palliative care consultation during the hospitalization.
- Planned discharge to hospice or home hospice. These patients do not need further palliative care consultation since they have already decided on prioritizing palliative care over life-sustaining treatment.
- Respiratory failure due to neurologic diagnosis (intracranial hemorrhage, stroke, or coma). These patients are unlikely to be able to participate in any frailty measurements, and may have difficulty with communicating their symptom burden.
- Pre-existing neurologic disease or stroke with motor deficits. Older adults with motor diseases (e.g Parkinson's disease) will be excluded from frailty measurements because they could present with frailty characteristics from a single disease. This criterion was used to exclude subjects in the original Cardiovascular Health Study from which the Fried frailty phenotype was first assessed.
- Psychiatric history of Bipolar Disorder, Schizoaffective Disorder, or Schizophrenia.
- Current Alcoholism or drug abuse.
- Not English or Spanish speaking. Many surveys are not validated in other languages besides English or Spanish. Obtaining interpreters in other languages for palliative care assessments and intervention can be challenging. We expect \< 3% of all potentially eligible patients/surrogates to not have English or Spanish speaking ability.
- No healthcare proxy or surrogate also consenting to participate.
- Expected to be discharged to a location \>20 miles from Columbia University Medical Center. This discharge radius will make in-person 1-month follow-up feasible.
- Status post heart, lung, or liver transplantation. These patients are not representative of the larger population of older adult survivors of acute respiratory failure.
Key Trial Info
Start Date :
March 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 23 2019
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT03456323
Start Date
March 20 2018
End Date
January 23 2019
Last Update
July 16 2024
Active Locations (1)
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1
Columbia University Irving Medical Center
New York, New York, United States, 10032