Back to resultsPost-ICU Palliative Care Intervention (PIPCI) Trial
Primary Purpose
Critical Illness, Frailty, Palliative Care
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Palliative Care Consultation
Usual Care
Sponsored by
About this trial
This is an interventional supportive care trial for Critical Illness focused on measuring Critical Illness, Frailty, Palliative Care
Eligibility Criteria
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.
Sites / Locations
- Columbia University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Palliative Care Consultation
Usual Care
Arm Description
After enrollment the palliative care consultation team will meet with the patient-surrogate pair one or more times to (1) assess symptoms, (2) provide supportive counseling, (3) make symptom treatment recommendations to the primary team of physicians, and (4) will address goals of care.
Patient-surrogate pairs randomized to usual care will continue to receive care by their primary physicians without having a palliative care consultation intervention offered.
Outcomes
Primary Outcome Measures
Annual enrollment rate
The number of patients who enroll compared to the number of patients who enroll and decline enrolling over 1 year
Adherence to the palliative care consultation intervention
Proportion of patient-surrogate pairs randomized to a palliative care consultation who actually agree to have the palliative care consultation prior to hospital discharge.
Crossover from usual care to post-ICU palliative care
Proportion of patient-surrogate pairs randomized to usual care who end up receiving a post-ICU palliative care consultation prior to hospital discharge.
Fidelity of the palliative care intervention
Documentation in electronic medical record consultation notes of (a) burdensome symptoms, (b) supportive counseling, (c) symptom treatment recommendations, and (d) addressing goals-of-care.
Secondary Outcome Measures
Change in Edmonton Symptom Assessment System (ESAS) scores
Changes in patients' ESAS symptoms (best(0) to worse(10)) from randomization to hospital discharge, and from hospital discharge to 1-month follow-up. ESAS symptoms are: pain, fatigue, drowsiness, nausea, lack of appetite, depression, anxiety, shortness of breath, and wellbeing.
Change in Hospital Anxiety and Depression Scores (HADS) for surrogates
Changes in surrogates' HADS scores (best(0) to worst(42)) from randomization to hospital discharge, and from hospital discharge to 1-month follow-up.
Full Information
NCT ID
NCT03456323
First Posted
February 22, 2018
Last Updated
June 13, 2019
Sponsor
Columbia University
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT03456323
Brief Title
Post-ICU Palliative Care Intervention (PIPCI) Trial
Official Title
Post-ICU Palliative Care Consultation Intervention Pilot Trial in Older Survivors of Acute Respiratory Failure
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 20, 2018 (Actual)
Primary Completion Date
May 31, 2019 (Actual)
Study Completion Date
August 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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 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.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Frailty, Palliative Care
Keywords
Critical Illness, Frailty, Palliative Care
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Older survivors of acute respiratory failure and their surrogates (i.e., patient-surrogate pairs, n = 80 participants total) will be randomized to an inpatient palliative care consultation versus usual care in a 1:1 ratio (i.e. 20 patient-surrogate pairs (40 participants total) in each study arm) once enrolled patients are registered to be transferred from the ICU to the general ward.
Masking
Outcomes Assessor
Masking Description
The research coordinator who makes the baseline assessment and outcome assessments will be blinded to treatment allocation.
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Palliative Care Consultation
Arm Type
Experimental
Arm Description
After enrollment the palliative care consultation team will meet with the patient-surrogate pair one or more times to (1) assess symptoms, (2) provide supportive counseling, (3) make symptom treatment recommendations to the primary team of physicians, and (4) will address goals of care.
Arm Title
Usual Care
Arm Type
Placebo Comparator
Arm Description
Patient-surrogate pairs randomized to usual care will continue to receive care by their primary physicians without having a palliative care consultation intervention offered.
Intervention Type
Behavioral
Intervention Name(s)
Palliative Care Consultation
Other Intervention Name(s)
PIPCI
Intervention Description
The palliative care consultation team will be led by one of the board-certified palliative care physicians at Columbia University Medical Center. Over one or more visits, the palliative care consultation team will first review intervention participants' medical records and baseline Edmonton Symptom Assessment System (ESAS) scores. They will also directly assess participants' physical and psychological symptoms. They will provide supportive counseling, make treatment recommendations for burdensome symptoms to the primary team of physicians, and will address goals of care. They will document these activities in structured electronic medical record consultation notes.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Patient-surrogate pairs randomized to usual care will not have a palliative care consultation intervention offered, and will receive care by their primary physicians. However, if a palliative care consultation is requested after randomization to usual care by the primary team of physicians and/or the patient/surrogate, it will be provided.
Primary Outcome Measure Information:
Title
Annual enrollment rate
Description
The number of patients who enroll compared to the number of patients who enroll and decline enrolling over 1 year
Time Frame
1 year
Title
Adherence to the palliative care consultation intervention
Description
Proportion of patient-surrogate pairs randomized to a palliative care consultation who actually agree to have the palliative care consultation prior to hospital discharge.
Time Frame
From date of Randomization until the date of hospital discharge or 28 days later.
Title
Crossover from usual care to post-ICU palliative care
Description
Proportion of patient-surrogate pairs randomized to usual care who end up receiving a post-ICU palliative care consultation prior to hospital discharge.
Time Frame
From date of Randomization until the date of hospital discharge or 28 days later.
Title
Fidelity of the palliative care intervention
Description
Documentation in electronic medical record consultation notes of (a) burdensome symptoms, (b) supportive counseling, (c) symptom treatment recommendations, and (d) addressing goals-of-care.
Time Frame
From date of Randomization until the date of hospital discharge or 28 days later.
Secondary Outcome Measure Information:
Title
Change in Edmonton Symptom Assessment System (ESAS) scores
Description
Changes in patients' ESAS symptoms (best(0) to worse(10)) from randomization to hospital discharge, and from hospital discharge to 1-month follow-up. ESAS symptoms are: pain, fatigue, drowsiness, nausea, lack of appetite, depression, anxiety, shortness of breath, and wellbeing.
Time Frame
Pre-randomization baseline until the date of hospital discharge or 28 days later, and 1-month follow-up after hospital discharge.
Title
Change in Hospital Anxiety and Depression Scores (HADS) for surrogates
Description
Changes in surrogates' HADS scores (best(0) to worst(42)) from randomization to hospital discharge, and from hospital discharge to 1-month follow-up.
Time Frame
Pre-randomization baseline until the date of hospital discharge or 28 days later, and 1-month follow-up after hospital discharge.
Other Pre-specified Outcome Measures:
Title
Number of patients with moderate-to-severe fatigue who are recommended for and receive methylphenidate treatment.
Description
Number of patients with ESAS fatigue scores greater than or equal to 4 at baseline who are recommended for and receive methylphenidate treatment.
Time Frame
Randomization until 1-month follow-up after hospital discharge.
Title
New limitation of life-sustaining therapy
Description
Number of patients who elect DNR after randomization
Time Frame
Day of hospital discharge until 3-month follow-up after hospital discharge.
Title
Enrollment in Hospice
Description
Number of patients who enroll in-patient hospice or home hospice.
Time Frame
Day of hospital discharge until 3-month follow-up after hospital discharge.
Title
Acute-care readmissions
Description
Number of patients who are re-admitted to an acute care hospital within 1-month and 3-months.
Time Frame
Day of hospital discharge until 3-month follow-up after hospital discharge.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew R Baldwin, MD, MS
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Post-ICU Palliative Care Intervention (PIPCI) Trial
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