Post-ICU Palliative Care Intervention (PIPCI) Trial
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 4/17/2018 |
| Start Date: | March 20, 2018 |
| End Date: | March 20, 2019 |
Post-ICU Palliative Care Consultation Intervention Pilot Trial in Older Survivors of Acute Respiratory Failure
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 acute respiratory failure.
Aim 1: To conduct a pilot post-ICU palliative care consultation intervention trial among
frail older ICU survivors and their surrogates. Hypothesis:The Investigators can achieve an
adequate enrollment rate, protocol adherence, and intervention fidelity.
Aim 2: To estimate effect sizes and variability for changes in symptoms at hospital discharge
and 1 month, and to estimate hospice referral rates and acute-care readmission rates at 1 and
3 months. Hypothesis: Effect sizes and feasibility data will inform and support future
post-ICU palliative care studies focused on improving ICU survivorship.
Exploratory Aim. To assess the use of methylphenidate that is recommended and dosed by the
palliative care physician for the treatment of moderate-to-severe fatigue. Hypothesis: (1)
Not all patients with moderate-to-severe fatigue will be recommended for methylphenidate
therapy. (2) Patients prescribed methylphenidate for treatment of moderate-to-severe fatigue
after critical illness will adhere to methylphenidate therapy.
clinical trial of a post-ICU palliative care consultation intervention in older (age ≥50
years) survivors of acute respiratory failure.
Aim 1: To conduct a pilot post-ICU palliative care consultation intervention trial among
frail older ICU survivors and their surrogates. Hypothesis:The Investigators can achieve an
adequate enrollment rate, protocol adherence, and intervention fidelity.
Aim 2: To estimate effect sizes and variability for changes in symptoms at hospital discharge
and 1 month, and to estimate hospice referral rates and acute-care readmission rates at 1 and
3 months. Hypothesis: Effect sizes and feasibility data will inform and support future
post-ICU palliative care studies focused on improving ICU survivorship.
Exploratory Aim. To assess the use of methylphenidate that is recommended and dosed by the
palliative care physician for the treatment of moderate-to-severe fatigue. Hypothesis: (1)
Not all patients with moderate-to-severe fatigue will be recommended for methylphenidate
therapy. (2) Patients prescribed methylphenidate for treatment of moderate-to-severe fatigue
after critical illness will adhere to methylphenidate therapy.
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 recovery with minimal sequelae occurs, a substantial proportion of survivors
are left with physical disability and cognitive impairment, have an increased risk of death,
and incur high health care costs after hospital discharge. In prior work the Investigators
have shown that about 75% of older survivors of respiratory failure are phenotypically frail
and that these frail ICU survivors have a high burden of uncontrolled symptoms at hospital
discharge and 1-month later. Moderate to severe post-ICU fatigue is the most prevalent
symptom and may interfere with functional recovery.
This study is designed to determine whether consultation with a palliative care team may help
alleviate any physical symptoms or psychological distress that the patients and their
caregivers (surrogates) have coming out of the ICU.
of older survivors of critical illness. Most adults, including older adults, survive critical
illness. While recovery with minimal sequelae occurs, a substantial proportion of survivors
are left with physical disability and cognitive impairment, have an increased risk of death,
and incur high health care costs after hospital discharge. In prior work the Investigators
have shown that about 75% of older survivors of respiratory failure are phenotypically frail
and that these frail ICU survivors have a high burden of uncontrolled symptoms at hospital
discharge and 1-month later. Moderate to severe post-ICU fatigue is the most prevalent
symptom and may interfere with functional recovery.
This study is designed to determine whether consultation with a palliative care team may help
alleviate any physical symptoms or psychological distress that the patients and their
caregivers (surrogates) have coming out of the ICU.
Inclusion Criteria:
- 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 Criteria:
- 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.
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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