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NCT02127086 · ClinicalTrials.gov registry record · NA
Managing Acute Pain in Critically Ill Non-communicative Palliative Care Patients
A NA study of Critically Ill, sponsored by University of Maryland, Baltimore.
- Completed
- Registry status
- NA
- Development phase
- 377
- Enrollment target
- 1
- Study location
NCT02127086: Completed NA study of Critically Ill, sponsored by University of Maryland, Baltimore.
NCT02127086 is a NA study of Critically Ill that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 377 participants, below the 836-participant average among 7 other Critically Ill trials with a reported enrollment target (55% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02127086, a NA study of Critically Ill, has completed, sponsored by University of Maryland, Baltimore.
- COMPLETED
- Registry status
- NA
- Development phase
- 377 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this project is to test an innovative method for managing pain in acutely ill hospitalized patients who are not able to report their pain verbally to health care professionals. Nurses will use a Pain Assessment and Intervention for the Non-communicative (PAIN) Algorithm to guide assessment of pain, selection of pain medications, and management of medication side effects. The researchers will evaluate whether patients who are managed with the PAIN Algorithm have less severe pain and increased use of pharmacologic pain management strategies than those who are not managed with the PAIN Algorithm. The study design is a non-randomized quasi-experimental cohort design with two cohorts who will be sequentially studied. In phase 1, patients will comprise the usual care group (UCG), or control cohort, defined as receiving pain assessment and management practices that nurses are currently performing on the study units. In phase 2 the PAIN Algorithm coupled with analgesic order sets will be introduced to nurses and physicians on all participating units as the intervention. Patients enrolled in this phase will be considered the intervention group (IG), also called the experimental cohort. Nurses will be enrolled from the participating inpatient units to provide data on the clinical utility of the PAIN Algorithm
Primary Outcome
Is measured using: (1) Multi-dimensional Objective Pain Assessment Tool (MOPAT) a measure of acute pain severity consisting of two dimensions -Behavioral Dimension of four items scored from 0-3 depending on severity and Physiologic Dimension of four items scored as no change or change from usual. Because the Physiologic Dimension has lower reliability and literature indicating that physiologic indicators are not consistent measures of acute pain, only the Behavioral Dimension scores is to make d
Conditions Studied
Interventions
- OTHER Intervention Group
Study Locations (1)
Maryland
- University of Maryland Medical Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 377 participants |
| Start Date | 2015-03 |
| Est. Completion | 2017-11-30 |
| Phase | NA |
What the finished NCT02127086 record still lists
NCT02127086 is an interventional study that assigns participants to a tested intervention. The registered 377 participants enrollment target is mid-sized for trials with a published cap, below the 836-participant average among 7 other Critically Ill trials with a reported enrollment target (55% lower).
The record links to 1 condition, with Critically Ill appearing as the primary indexed condition, and to 1 intervention - of which Intervention Group is the first listed.
NCT02127086 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT02127086 about?
NCT02127086 is a clinical study titled "Managing Acute Pain in Critically Ill Non-communicative Palliative Care Patients". The purpose of this project is to test an innovative method for managing pain in acutely ill hospitalized patients who are not able to report their pain verbally to health care professionals. Nurses will use a Pain Assessment and Intervention for the Non-communicative (PAIN) Algorithm to guide asses...
What is the current status of trial NCT02127086?
This trial is currently completed. It is a NA study. The enrollment target is 377 participants. The study started on 2015-03. Estimated completion is 2017-11-30.
What conditions does trial NCT02127086 study?
This clinical trial studies the following conditions: Critically Ill.
What interventions are being tested in trial NCT02127086?
The interventions under investigation include: Intervention Group (OTHER).
Who is sponsoring clinical trial NCT02127086?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02127086 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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