Manually Operated Communication System

NCT ID: NCT03630003

Last Updated: 2023-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-28
• Study Completion Date: 2023-04-15

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.

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.

Conditions

Communication; Ventilation Therapy; Complications

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

MOCS

Intervention Type: DEVICE

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.

Post-use interview

Intervention Type: OTHER

The Study team conducts an interview with participants to evaluate their experience with use of the MOCS device.

Interventions

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.

Intervention Type: DEVICE

Post-use interview

The Study team conducts an interview with participants to evaluate their experience with use of the MOCS device.

Intervention Type: OTHER

Other Intervention Names

Manually Operated Communication System; Interview

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brown University

OTHER

Sponsor Role: collaborator

J. Matthias Walz

OTHER

Sponsor Role: lead

Responsible Party

J. Matthias Walz

Professor and Interim Chair, Dept of Anesthesiology and Perioperative Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

J. Matthias Walz, MD

Role: PRINCIPAL_INVESTIGATOR

UMass Medical School

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

UMass Medical School

Worcester, Massachusetts, United States

Countries

United States

Other Identifiers

H00015391

Identifier Type: -

Identifier Source: org_study_id