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NCT03456323 · ClinicalTrials.gov registry record · NA
Post-ICU Palliative Care Intervention (PIPCI) Trial
A NA study of Critical Illness and Frailty, sponsored by Columbia University.
- Completed
- Registry status
- NA
- Development phase
- 66
- Enrollment target
- 1
- Study location
NCT03456323: Completed NA study of Critical Illness and Frailty, sponsored by Columbia University.
NCT03456323 is a NA study of Critical Illness and Frailty that has completed, run by Columbia University. The registered enrollment target is 66 participants, below the 3,138-participant average among 91 other Critical Illness trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03456323, a NA study of Critical Illness and Frailty, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- NA
- Development phase
- 66 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The number of patients who enroll compared to the number of patients who enroll and decline enrolling over 1 year
Conditions Studied
Interventions
- OTHER Usual Care
- BEHAVIORAL Palliative Care Consultation
Study Locations (1)
New York
- Columbia University Irving Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2018-03-20 |
| Est. Completion | 2019-01-23 |
| Phase | NA |
What the finished NCT03456323 record still lists
NCT03456323 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 3,138-participant average among 91 other Critical Illness trials with a reported enrollment target (98% lower).
The record links to 3 conditions, with Critical Illness appearing as the primary indexed condition, and to 2 interventions - of which Usual Care is the first listed.
NCT03456323 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03456323 about?
NCT03456323 is a clinical study titled "Post-ICU Palliative Care Intervention (PIPCI) Trial". 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 interven...
What is the current status of trial NCT03456323?
This trial is currently completed. It is a NA study. The enrollment target is 66 participants. The study started on 2018-03-20. Estimated completion is 2019-01-23.
What conditions does trial NCT03456323 study?
This clinical trial studies the following conditions: Critical Illness, Frailty, Palliative Care.
What interventions are being tested in trial NCT03456323?
The interventions under investigation include: Usual Care (OTHER), Palliative Care Consultation (BEHAVIORAL).
Who is sponsoring clinical trial NCT03456323?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03456323 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03456323's enrollment target sits among peer trials
66 73rd of 91 higher than 19 of 91 other Critical Illness trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Critical Illness trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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