VoiceLove app to improve communication, family engagement, and delirium in critically ill adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

VoiceLove is a HIPAA-compliant mobile app that lets family members record, archive, and send real-time voice messages to patients who are intubated or otherwise unable to communicate. The study is a prospective, mixed-methods randomized controlled trial comparing VoiceLove implementation to usual care in the medical and coronary ICU. Outcomes include measures of patient-family communication, family engagement and satisfaction, feasibility and acceptability of the app, and prevalence of ICU delirium. Participants are adult ICU patients intubated with an expected duration >24 hours, with consent obtained from the patient or a surrogate.

Why it matters

Who can join: the full rules

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

Where it's running

• Vanderbilt University Medical Center
  Nashville, Tennessee, United States Recruiting

Study contacts

• Principal investigator: E Wesley Ely, MD, MPH — Vanderbilt University Medical Center
• Study coordinator: Christina Boncyk, MD, MPH
• Email: christina.s.boncyk@vumc.org
• Phone: 615-936-2857

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.