Clinical trial NCT03163823: CTSI-iPad for Vented Patient Communication
Official title: A Randomized Controlled Trial of an iPad for Patient Communication During Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Marquette University
First posted: 2017-05-23
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will enroll 75 mechanically vented adults in the ICU to compare self-reported ease of communication, patient satisfaction, and patient anxiety and frustration levels between a group using a communication application on an iPad and a group using standard methods of communication while mechanically vented.

Detailed description: The Investigators will randomize patients to either an iPad application available for communication or usual care. An existing iPad communication application (Proloquo2Go) that allows picture or text to voice communication was tailored to needs of adult mechanically ventilated (MV) patient. In the tailored application, common messages for an adult MV population are depicted on picture tiles organized into folders. When patients touch a picture tile either additional message options appear or a phrase or word is spoken by the device. Access to a pop-up keyboard on each screen allows patients to easily type unique text to voice messages.

Intervention: Patients will be randomized to either an iPad with the tailored communication application or usual care. Patients randomized to the iPad group will be given a brief introduction to the communication application and then will be asked to communicate four messages to verify understanding. Patients who are unable to successfully use the iPad with the initial introduction will remain in the study. Research staff will continue to assist the patient daily and a speech language pathologist will be consulted to facilitate the patients ability to use the device. The iPad will remain at the bedside to be used for communication as desired for the remainder of the time the patient is on the ventilator. A manual providing instruction for the iPad and application operation will be at the bedside of all patients randomized to the intervention group. Research staff will visit patients daily to assist with any problems encountered and will also be available by phone to assist as needed. Although patients will be encouraged to use the iPad for communication, use of other strategies or tools will not be restricted.

Eligibility criteria: Inclusion Criteria:

1. Sufficient motor and visual function to allow use of touch screen
2. Mechanically ventilated
3. Awake and able to participate in informed consent discussion

Exclusion Criteria:

1. Non-English Speaking
2. Receiving ventilator support prior to admission.
3. Delirium present in the last 24 hours
4. Tracheostomy
5. Structural Neurological Injury (such as stroke or traumatic brain injury)
6. Coma
7. Deep Sedation (Richmond Agitation Scale \> -2)

Primary outcomes:
measure: Ease of Communication
timeFrame: 30 Days
Secondary outcomes:
measure: Patient Anxiety
timeFrame: 30 Days
measure: Patient Satisfaction
timeFrame: 30 Days
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Froedtert Memorial Lutheran Hospital
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Rahul Nanchal, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: