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

NCT ID: NCT06923462

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-06
• Study Completion Date: 2028-03-15

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.

Conditions

Critical Illness; Intensive Care Medicine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Usual Care recipients

Participants in this arm will be randomized to usual care, or no VoiceLove utilization while in the ICU.

Group Type: NO_INTERVENTION

No interventions assigned to this group

VoiceLove recipients

Participants in this arm will be randomized to utilize VoiceLove while in the ICU.

Group Type: EXPERIMENTAL

Communication Application

Intervention Type: OTHER

Participants will receive the VoiceLove intervention versus the standard care which does not utilize VoiceLove.

Interventions

Communication Application

Participants will receive the VoiceLove intervention versus the standard care which does not utilize VoiceLove.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Wes Ely

Co-Director, CIBS Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

E Wesley Ely, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Christina Boncyk, MD, MPH

Role: CONTACT

christina.s.boncyk@vumc.org

615-936-2857

Rebecca Abel, MA

Role: CONTACT

rebecca.abel@vumc.org

615-875-3763

Facility Contacts

Christina Boncyk, MD

Role: primary

christina.s.boncyk@vumc.org

(615)936-2857

Rebecca Abel

Role: backup

rebecca.abel@vumc.org

615-875-3763

Other Identifiers

242209

Identifier Type: -

Identifier Source: org_study_id