VoiceLove: An App-Based COMMunication Tool Designed to Address DeliriUm and Improve Family ENgagement and PatIent/Family SatisfaCtion in CriticAlly Ill PaTiEnts (COMMUNICATE)
Recruiting
N/AInterventional Study
Critical IllnessIntensive Care Medicine
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Supportive Care
Participants needed
100 (estimated)
Sponsor
Vanderbilt University Medical Center · Other
Who this trial is looking for
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VoiceLove is a phone application allowing family and patients to share information in a secure platform. This project will compare the VoiceLove app to usual care to learn about whether VoiceLove improves patient-family communication, family engagement, and ICU delirium.
Trial Locations
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Eligibility Criteria
Inclusion Criteria
Only patients who meet inclusion criteria, have no exclusion criteria, and consent for participation will advance to the Interventional Trial phase (i.e., the randomization phase) of the study. Patients will be eligible for inclusion in the Pre-Randomization Phase of the study (i…
Inclusion Criteria
Only patients who meet inclusion criteria, have no exclusion criteria, and consent for participation will advance to the Interventional Trial phase (i.e., the randomization phase) of the study. Patients will be eligible for inclusion in the Pre-Randomization Phase of the study (i.e., presented for study consent) if they are:
1. Adult patient ≥18 years old
2. Admitted to medical or coronary ICU
3. Intubated on mechanical ventilation with expected intubation of \> 24 hours
Exclusion Criteria
Patients will be excluded (i.e., not consented) for any of the following reasons:
1. Inability to obtain informed consent
* Attending physician refusal
* Patient and/or surrogate refusal
* Patient unable to consent and no surrogate available
2. Acute or chronic neurologic deficit precluding CAM-ICU assessments
3. Inability to understand English
4. Current enrollment in a study that does not allow co-enrollment
5. Prisoners
6. Expected death or comfort measures within 24 hours of enrollment or lack of commitment to intervention by family or the medical team (e.g., likely to withdraw life support measures within 24 hours of enrollment).
7. Bilateral Deafness
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