Clinical trial NCT06923462: VoiceLove: An App-Based COMMunication Tool Designed to Address DeliriUm and Improve Family ENgagement and PatIent/Family SatisfaCtion in CriticAlly Ill PaTiEnts (COMMUNICATE)
Official title: VoiceLove: An App-Based COMMunication Tool Designed to Address DeliriUm and Improve Family ENgagement and PatIent/Family SatisfaCtion in CriticAlly Ill PaTiEnts (COMMUNICATE)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Critical Illness
Intensive Care Medicine
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2025-04-11
Enrollment: 100
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: 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.

Detailed description: VoiceLove is a novel, HIPAA compliant mobile phone application that enables families and patients to securely exchange and archive voice messages in real-time. For patients who are intubated or otherwise unable to communicate, VoiceLove allows family members to deliver real-time voice messages when they are away from the bedside without relying on the clinical team to coordinate calls. The investigator group has recently completed formative usability testing of the VoiceLove application with a variety of ICU stakeholders including family members, bedside ICU nurses, and ICU physicians to refine and optimize the app for clinical use in the ICU. During usability testing, stakeholders overall viewed the app favorably and expressed interest in tools to enhance communication in the ICU. As compared to traditional methods of communication, stakeholders identified the ability to customize messaging by unique family groups and to archive and replay messages as strengths. While promising as a tool to improve family engagement in the ICU, it has yet to undergo evaluation in the ICU to assess feasibility and acceptability of use.

The goal in this prospective, mixed method randomized control trial (RCT) is to compare VoiceLove implementation to usual care to investigate the effect of VoiceLove on optimizing patient-family communication, family engagement, and ICU delirium prevalence.

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

Primary outcomes:
measure: Assess engagement among patients during acute hospitalization
timeFrame: Up to 14 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt University Medical Center
name: E Wesley Ely, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: