Post-ICU Palliative Care Intervention (PIPCI) Trial

NCT03456323 | Completed DMC

• 2 other identifiers: AAAR3202K23AG045560
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Frailty; Palliative Care

Keywords

Critical Illness; Frailty; Palliative Care

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Change in Edmonton Symptom Assessment System (ESAS) scores

  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

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

Other Outcomes (4)

• Number of patients with moderate-to-severe fatigue who are recommended for and receive methylphenidate treatment.

  Randomization until 1-month follow-up after hospital discharge.

• New limitation of life-sustaining therapy

  Day of hospital discharge until 3-month follow-up after hospital discharge.

• Enrollment in Hospice

  Day of hospital discharge until 3-month follow-up after hospital discharge.

Study Arms (2)

Palliative Care Consultation

EXPERIMENTAL

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

Usual Care

PLACEBO COMPARATOR

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

Interventions

Palliative Care Consultation BEHAVIORAL

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.

Also known as: PIPCI

Palliative Care Consultation

Usual Care OTHER

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.

Usual Care

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Critical Illness; Frailty

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthew R Baldwin, MD, MS

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The research coordinator who makes the baseline assessment and outcome assessments will be blinded to treatment allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: March 7, 2018
• Study Start: March 20, 2018
• Primary Completion: January 23, 2019
• Study Completion: January 23, 2019
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)