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

ICU delirium is a devastating complication of illness, acute trauma, and surgery often resulting in prolonged mechanical ventilation, longer lengths of stay, and long-term disability. Delirium is associated with over 12 times increased odds of developing Alzheimer’s disease (AD) and AD-related dementias (ADRD). In addition, delirium accelerates cognitive decline in AD/ADRD patients. Likewise, patients with underlying dementia are 2.5-4.7 times more likely to develop delirium. AD/ADRD patients who develop delirium have a marked increase in adverse outcomes including rate of cognitive decline, institutionalization, and death following an episode of delirium compared to those without pre-existing AD/ADRD. The ABCDEF (A2F) Bundle has the best success at decreasing ICU delirium among pharmacologic and nonpharmacologic interventions. The A2F Bundle is a group of evidence-based assessments and interventions (i.e., Assess, prevent, and manage pain, Both spontaneous awakening and breathing trials, Choice of analgesia and sedation, Delirium: assess, prevent, and manage, Early mobility and exercise, and Family engagement and empowerment) designed to improve ICU patient care regardless of illness pathology. Family engagement, an A2F bundle component independently associated with reduced ICU delirium prevalence, was implemented in 63% of ICUs pre-pandemic and dropped to under 20% during the pandemic. As the pandemic resolves, there is a gradual return to normal visitation policies, but, overall, families remain under engaged. Interventions that expand family engagement have the potential to significantly improve short- and long-term patient (e.g., AD/ADRD, disability) and family outcomes. VoiceLove LLC is developing a novel HIPAA-compliant mobile application that enables expanded family engagement by mitigating multifactorial barriers known to influence A2F bundle implementation. The VoiceLove app is a safe and time- efficient tool allowing direct communication between patients and their family members, and between care providers and absent family members, allowing more time for direct patient care. A pilot study with ICU patients at New York-Presbyterian Hospital demonstrated thousands of direct family messages exchanged without any additional nursing burden. In this Fast-Track STTR, we will refine the VoiceLove prototype and evaluate the new application among mechanically ventilated adult patients admitted to a medical, surgical, or coronary ICU. Phase I will optimize the VoiceLove app for ICU patients, families, and providers. Phase II will include a randomized control trial (RCT) comparing VoiceLove implementation to usual care control to investigate the effect on optimizing patient-family-provider communication, engagement, and ICU delirium prevalence. Mitigating ICU delirium is of paramount importance to reducing the risk of long-term complications, including an increased risk of developing AD/ADRD as well as accelerating decline in patients with AD/ADRD. This Fast-Track STTR represents a major step forward in bringing a novel technology to the bedside to expand family engagement and empowerment, decrease the prevalence of ICU delirium, and thus reduce long-term AD/ADRD risk.