Post-ICU Palliative Care Intervention (PIPCI) Trial

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness; Frailty; Palliative Care
• Intervention / Treatment: Behavioral: Palliative Care Consultation; Other: Usual Care

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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Palliative Care Consultation; 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.	Behavioral: Palliative Care Consultation; 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.; Other Names: PIPCI
Placebo Comparator: Usual 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.	Other: Usual Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annual enrollment rate	The number of patients who enroll compared to the number of patients who enroll and decline enrolling over 1 year	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.	From date of Randomization until the date of hospital discharge or 28 days later.
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.	From date of Randomization until the date of hospital discharge or 28 days later.
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.	From date of Randomization until the date of hospital discharge or 28 days later.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Pre-randomization baseline until the date of hospital discharge or 28 days later, and 1-month follow-up after hospital discharge.
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.	Pre-randomization baseline until the date of hospital discharge or 28 days later, and 1-month follow-up after hospital discharge.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with moderate-to-severe fatigue who are recommended for and receive methylphenidate treatment.	Number of patients with ESAS fatigue scores greater than or equal to 4 at baseline who are recommended for and receive methylphenidate treatment.	Randomization until 1-month follow-up after hospital discharge.
New limitation of life-sustaining therapy	Number of patients who elect DNR after randomization	Day of hospital discharge until 3-month follow-up after hospital discharge.
Enrollment in Hospice	Number of patients who enroll in-patient hospice or home hospice.	Day of hospital discharge until 3-month follow-up after hospital discharge.
Acute-care readmissions	Number of patients who are re-admitted to an acute care hospital within 1-month and 3-months.	Day of hospital discharge until 3-month follow-up after hospital discharge.

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Matthew R Baldwin, MD, MS, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2018
• Primary Completion (Actual): January 23, 2019
• Study Completion (Actual): January 23, 2019

Study Registration Dates

• First Submitted: February 22, 2018
• First Submitted That Met QC Criteria: February 28, 2018
• First Posted (Actual): March 7, 2018

Study Record Updates

• Last Update Posted (Actual): July 16, 2024
• Last Update Submitted That Met QC Criteria: July 12, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Palliative Care; Critical Illness; Frailty
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Frailty; Critical Illness
• Other Study ID Numbers: AAAR3202; K23AG045560 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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