An interventional study of Palliative Care Consultation and Usual Care in Critical Illness, Frailty and Palliative Care, sponsored by Columbia University. Completed at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2024-07-16.
Sponsored by Columbia University · Not applicable, Interventional, and Supportive care
Among 185 studies in Frailty with a site in United States — 50 open to participants now, 62 under way, 1 of them phase 3. Frailty · United States.
Among the 185 studies in Frailty with a site in United States, this one is the 51st largest by enrollment of the 142 interventional ones that give a count, is one of 19 that started in 2018, is one of 93 with no phase, and was the 57th registered.
1,284 studies on the registry are indexed under Frailty; 451 are open to participants now.
Browse Frailty studies →50 of the 185 studies in Frailty with a site in United States are open now. Recruiting first, the newest first:
University of Maryland, Baltimore · Sites in United States
Ages 55+
University of California, San Francisco · Sites in United States
Ages 18–75
Longevity Metrics, Inc. · Sites in United States
Ages 18+ · Healthy volunteers
William Brandenburg, MD · Sites in United States
Ages 18+ · Healthy volunteers
Longevity Metrics, Inc. · Sites in United States
Ages 18+ · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 299 Frailty studies recruiting now, 235 (79%) set no upper age limit and 9 (3%) stop at 75 or younger; 7 take children under 18; 66 take healthy volunteers.
This study: 50 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
185 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 16 · Phase 2 32 · Phase 3 5 · Phase 4 5
First in 2001; this study’s year is marked. 19 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 66 is below the median of 81 across 767 interventional studies indexed under Frailty.
Median enrollment 42 across the 142 interventional studies, 128 across the 42 observational. Of the 112 that completed or were terminated, 42 (38%) have results posted.
This tab as a report to print or save as PDF → With an account.
10 of 185 have an industry lead sponsor. The 10 most frequent:
Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.
Columbia University has 1 study filed under Frailty — fewer than ten, so there is no comparison to draw.
24 of the studies in Frailty with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05422534Phase 3Vanderbilt University Medical CenterCoQ10 and Exercise for Mitochondrial Dysfunction in Advance Kidney Disease | 2027-06-20 |
| NCT03675724Mayo ClinicAlleviation by Fisetin of Frailty, Inflammation, and Related Measures in Older Adults | 2026-11 |
| NCT03430037Mayo ClinicAlleviation by Fisetin of Frailty, Inflammation, and Related Measures in Older Women | 2026-11 |
| NCT07220512Wake Forest University Health SciencesThe Better, Harder, Faster, Stronger Study | 2026-11 |
| NCT05725928The Cleveland ClinicAssisted Ambulation to Improve Health Outcomes for Older Medical Inpatients | 2026-11-30 |
Add all 24 to your calendar (.ics) → With an account.
Among the 185 studies in Frailty with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
1,284 studies on the registry are indexed under Frailty; 451 are open to participants now.
This study's enrollment of 66 is below the median of 81 across 767 interventional studies indexed under Frailty.
Browse Frailty studies →Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.
Compared within Frailty, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Critical Illness. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
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
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.
Annual enrollment rate
The number of patients who enroll compared to the number of patients who enroll and decline enrolling over 1 year
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From date of Randomization until the date of hospital discharge or 28 days later.
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.
Time frame: 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.
Time frame: Pre-randomization baseline until the date of hospital discharge or 28 days later, and 1-month follow-up after hospital discharge.
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.
Time frame: Randomization until 1-month follow-up after hospital discharge.
New limitation of life-sustaining therapy
Number of patients who elect DNR after randomization
Time frame: 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.
Time frame: 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.
Time frame: Day of hospital discharge until 3-month follow-up after hospital discharge.
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2018 to primary completion in Jan 2019, 10 months.
Of 513 non-industry interventional studies with no phase under Frailty, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 39. This study's 10 months is below that.
Counting every sponsor, half of 517 studies reached it within 22 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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