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Manually Operated Communication System

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ClinicalTrials.gov Identifier: NCT03630003
Recruitment Status : Recruiting
First Posted : August 14, 2018
Last Update Posted : October 19, 2020
Sponsor:
Collaborator:
Brown University
Information provided by (Responsible Party):
J. Matthias Walz, University of Massachusetts, Worcester

Brief 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.

Condition or disease Intervention/treatment Phase
Communication Ventilation Therapy; Complications Device: MOCS Other: Post-use interview Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Manually Operated Communication System
Actual Study Start Date : June 28, 2018
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2021

Arm Intervention/treatment
Experimental: Use of MOCS with post-use interview

The patients in this arm will be asked to utilize the Manually Operated Communication System (MOCS) device and will then be asked to provide feedback on their experiences.

Subjects will be asked to complete up to 3 sessions using the device. Each session is expected to last between 10 and 30 minutes. If the subject is interested in continuing, the session may last up to one hour.

The study team will perform post-study interviews with each subject to ask about their experience with MOCS. The data collection forms will be filled out during the session by a member of the research team.

Device: MOCS

The device consists of a tablet computer that can produce visual and auditory components designed to improve subject knowledge about setting and communication, mounted on a table or at the side of the bed in a place that is visible to the subject.

The Arduino will be connected to switches/buttons and implemented in a 3D-printed platform.

Other Name: Manually Operated Communication System

Other: Post-use interview
The Study team conducts an interview with participants to evaluate their experience with use of the MOCS device.
Other Name: Interview




Primary Outcome Measures :
  1. Ability to use make selections in software using handheld component [ Time Frame: 1 hour ]
    Able to make selection by squeezing handheld component, activating tablet software response, 5 times within 5 minutes of use (including training)


Secondary Outcome Measures :
  1. Satisfaction assessed by modified SUS [ Time Frame: 30 days ]
    Patients, nurses, and family members will be asked to indicate their level of satisfaction with the communication software using a homegrown instrument to assess usability (modeled partly on the System Usability Scale, or SUS). Four questions are derived from the SUS; they assess likelihood of recommending, ease of use, ease of learning, and perceived ability to use the system for communication. Each of these questions are assessed on a 1-5 scale, with higher values representing a better outcome. The subscales of these questions are averaged to reach a total score.

  2. Duration of use [ Time Frame: 1 hour ]
    The time spent using the system will be measured.

  3. Level of engagement [ Time Frame: 1 hour ]
    The number of each type of interaction with the system will be tabulated



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects who are awake with a Glasgow Coma Scale score >10 (Motor 6, Verbal 0-1 [T], Eye opening 4) adult subjects at UMass Medical Center (Memorial and University ICUs) or at MGH (Bigelow 13, Lunder 6, Blake 7, Blake 12, or Ellison 4) are eligible for this study.
  2. Both subjects who are able to speak and subjects who are unable to speak (due to intubation or tracheostomy) will be sought to be included in the study, although the focus will be on subjects who are unable to speak. (If additional feedback about the system from subjects who can speak would be helpful, this type of subject may be enrolled.)
  3. Eligible subjects must have a history of being able to understand and communicate in written and spoken English, since the device software is in English.
  4. May enroll both adults capable of consent and cognitively impaired adults, who will provide assent, if possible, and will have consent given by their legally authorized representative.

Exclusion Criteria:

  1. non-adult individuals
  2. prisoners

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03630003


Contacts
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Contact: Miriam Goldberg, MEng 5084364741 miriam.goldberg@umassmed.edu
Contact: Arlene Williams 508-856-5584 arlene.williams@umassmed.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Leigh R. Hochberg, MD, PhD    617-742-9247    lhochberg@mgh.harvard.edu   
Principal Investigator: Leigh R. Hochberg, MD, PhD         
UMass Medical School Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Miriam Goldberg       miriam.goldberg@umassmed.edu   
Principal Investigator: J. Matthias Walz, MD         
Sub-Investigator: Miriam Goldberg, MEng         
Sponsors and Collaborators
J. Matthias Walz
Brown University
Investigators
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Principal Investigator: J. Matthias Walz, MD UMass Medical School
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Responsible Party: J. Matthias Walz, Professor and Interim Chair, Dept of Anesthesiology and Perioperative Medicine, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT03630003    
Other Study ID Numbers: H00015391
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by J. Matthias Walz, University of Massachusetts, Worcester:
ICU
critical care
alternative communication
augmentative communication