Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03630003 |
| Other study ID # |
H00015391 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 28, 2018 |
| Est. completion date |
April 15, 2023 |
Study information
| Verified date |
April 2023 |
| Source |
University of Massachusetts, Worcester |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The objective of this study is to gather initial information about the testing of a novel
manual communication system - which is currently called MOCS, for Manually Operated
Communicated System - for mechanically ventilated Intensive Care Unit (ICU) subjects. This
study is not hypothesis based; the goal is to gather data about which interaction modes and
teaching approaches of MOCS are most intuitive for subjects and caregivers.
Description:
Intensive Care Unit (ICU) admissions constitute a major part of hospital activity and
resource allocation, and the number of patient days in ICUs and on mechanical ventilation is
increasing. More than 5 million patients are admitted to an ICU annually in the United
States, and approximately 55,000 critically ill patients are cared for each day. The most
common cause for admission is respiratory insufficiency or failure; a study of data from
2005-2007 estimated that nearly 40 percent of ICU patients require mechanical ventilation.
Patients experience frequent emotional and psychiatric complications from ICU stays,
including depression, anxiety, and post-traumatic stress disorder. One 2011 study found a
prevalence of "clinically significant" depressive symptoms ranging from 17 percent to 43
percent among post-ICU patients. In 2013, it was reported that up to 50 percent of patients
experience general anxiety symptoms one year after discharge, a rate much higher than in the
broader US population.
Patients who temporarily lose the ability to speak report a high level of frustration. A
study of 127 patients reported that, "two stressors, being intubated and not being able to
talk, were significantly more stressful… than all the other stressors. The mean stressfulness
score for [25] other stressors was between no distress and mild distress." Improving subject
communication with ICU care team will likely require better technological interventions, and
current best practice for assessing the optimal patient communication method is dependent on
the evaluation of an experienced speech-language pathologist (SLP). Current approaches are
insufficient for patient's needs, as one representative study described: "Patients rated 40%
of the communication sessions with nurses as somewhat difficult to extremely difficult.
Assistive communication strategies were uncommon, with little to no use of assistive
communication materials (e.g., writing supplies, alphabet or word boards)." Designing an
effective mode of communication for ICU patients unable to speak due to mechanical
ventilation will likely improve patient's experiences and, potentially, long-term outcomes.
Some limited technologies exist to address these issues; however, they are not in widespread
use due to a variety of reasons, including cost, lack of intuitiveness, and design that is
not appropriate for the ICU setting. The investigators are designing a technological solution
to assist ICU subjects in communicating with their caregivers, particularly nurses. The
investigators are planning to do the initial testing of MOCS in the adult ICUs at the UMass
Medical Center or at MGH.
The purpose of this stage of the project is to determine whether the device that has been
designed in the previous study will be suitable for the needs of patients, families, and
nurses. The investigators will be measuring duration of use, frequency and type of
engagement, and mechanical stability.
