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

VoiceLove: An App-Based COMMunication Tool Designed to Address DeliriUm and Improve Family ENgagement and PatIent/Family SatisfaCtion in CriticAlly Ill PaTiEnts (COMMUNICATE)

This trial will test whether the VoiceLove phone app helps families communicate with intubated adults in the medical or coronary ICU and whether it improves family engagement and reduces ICU delirium.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Vanderbilt University Medical Center (Academic / other)
• Locations: 1 site (Nashville, Tennessee)
• Trial ID: NCT06923462 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18) admitted to the medical or coronary ICU at Vanderbilt who are intubated with expected mechanical ventilation >24 hours and who can consent or have an available surrogate, and who understand English.

Not a fit: Patients with acute or chronic neurologic deficits preventing delirium assessment, non–English speakers, prisoners, those expected to die or receive comfort-only measures, or those without available consent/surrogates are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the app could increase family engagement and satisfaction, help maintain meaningful contact for nonverbal patients, and potentially reduce the frequency or severity of ICU delirium.

How similar studies have performed: Previous family-engagement and reorientation interventions have shown modest benefits for delirium and satisfaction, but app-based voice-message tools like VoiceLove remain largely untested in randomized trials.

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.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 this trial is running

Nashville, Tennessee

• 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

Conditions Critical Illness; Intensive Care Medicine