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| ID | Type | Description | Link |
|---|---|---|---|
| K23AG045560 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew R Baldwin, MD, MS | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center | New York | New York | 10032 | United States |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
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The research coordinator who makes the baseline assessment and outcome assessments will be blinded to treatment allocation.
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| 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. |
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| 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. |
| 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. |