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

ICU精神错乱是疾病、急性创伤和手术造成的一种毁灭性的并发症，通常会导致时间延长。 机械通风，住院时间更长，以及长期残疾。精神错乱与12次以上的 罹患阿尔茨海默病(AD)和AD相关痴呆(ADRD)的几率增加。此外，精神错乱 加速AD/ADRD患者的认知能力下降。同样，潜在痴呆症患者的发病率是 更有可能发展为精神错乱。发展为精神错乱的AD/ADRD患者的不良反应显著增加 结果包括认知功能减退、精神病院和一次精神错乱后的死亡 与那些没有预先存在的AD/ADRD的人相比。ABCDEF(A2F)捆绑包在以下方面取得了最大成功 在药物干预和非药物干预中减少ICU妄想。A2F捆绑包是一个组 基于证据的评估和干预(即，评估、预防和管理疼痛，两者都是自发的 觉醒和呼吸试验，止痛和镇静的选择，妄想症：早期评估、预防和处理 活动和锻炼，以及家庭参与和授权)，旨在改善ICU患者护理 无论疾病病理如何。家庭参与，独立关联的A2F捆绑包组件 减少ICU精神错乱的患病率，在大流行前63%的ICU实施了，并下降到20%以下 在大流行期间。随着疫情的解决，逐渐恢复正常的探视政策，但总的来说， 家庭仍然订婚不足。扩大家庭参与度的干预措施有可能显著 改善短期和长期患者(如AD/ADRD、残疾)和家庭结果。VoiceLove LLC是 开发符合HIPAA标准的新型移动应用程序，通过以下方式支持扩展家庭参与度 已知的影响A2F捆绑实施的多因素障碍。VoiceLove应用程序是一款安全和及时的- 高效的工具，可在患者及其家人之间以及护理人员之间进行直接沟通 服务提供者和不在场的家庭成员，让更多的时间直接照顾病人。一项针对ICU患者的初步研究 在纽约长老会医院展示了数千条直接的家庭信息交换，而没有任何 额外的护理负担。在本快速跟踪STTR中，我们将改进VoiceLove原型并评估新的 在内科、外科或冠状动脉ICU接受机械通气的成人患者中的应用。阶段 我将为ICU患者、家属和提供者优化VoiceLove应用程序。第二阶段将包括一个随机的 对照试验(RCT)比较VoiceLove实施与常规护理控制的效果 优化患者-家庭-提供者的沟通、参与度和ICU精神错乱的流行率。减轻ICU的压力 精神错乱对于减少长期并发症的风险至关重要，包括增加的风险。 AD/ADRD的发生以及AD/ADRD患者的加速下降。此Fast-Track STTR 代表着在将一项新技术引入床边以扩大家庭参与度和 增强能力，减少ICU精神错乱的患病率，从而降低AD/ADRD的长期风险。

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.