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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 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.

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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.

Interventions

  • OTHER Usual Care
  • BEHAVIORAL Palliative Care Consultation

Study Locations (1)

New York

  • Columbia University Irving Medical Center - New York

Trial Details

FieldValue
Enrollment Target 66 participants
Start Date 2018-03-20
Est. Completion 2019-01-23
Phase NA

Sponsor

Columbia University

958 total trials

What the Registry Record Tells You About NCT03456323

The ClinicalTrials.gov registry entry for NCT03456323 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,138-participant average among 91 other Critical Illness trials with a reported enrollment target (98% lower). The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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