Effectiveness of a multi-component mHealth intervention to improve post-hospital transitions of care for patients with SMI

多组成部分移动医疗干预对改善 SMI 患者出院后护理过渡的有效性

• 批准号: 10502609
• 负责人: BRANDON A GAUDIANO
• 金额: $ 77.12万
• 依托单位: BUTLER HOSPITAL (PROVIDENCE, RI)
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2027-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10502609
• 关键词: Acute; Address; Administrator; Admission activity; Adopted; Adoption; Adult; Aftercare; Ambulatory Care; Appointment; Attitude; Behavior; Blinded; Caring; Case Manager; Chronic; Clinical; Cognitive; Communities; Continuity of Patient Care; Data; Diagnosis; Disease susceptibility; Drops; Effectiveness; Electronic Health Record; Ensure; Feeling suicidal; Future; Goals; Healthcare; Healthcare Systems; Hospital Moving; Hospitalization; Hospitals; Hybrids; Inpatients; Intervention; Interview; Interviewer; Investigational Therapies; Lead; Measures; Mediating; Mediator of activation protein; Mental Depression; Mental disorders; Modeling; Monitor; Mood Disorders; National Institute of Mental Health; Online Systems; Outcome; Outpatients; Overdose; Patient Care; Patient Self-Report; Patients; Procedures; Promoting Action on Research Implementation in Health Services framework; Psychopathology; Public Health; Randomized; Randomized Controlled Trials; Reach Effectiveness Adoption Implementation and Maintenance; Records; Recovery; Research; Resources; Risk; Safety; Sampling; Services; Severities; Speed; Strategic Planning; Stress; Suicide; System; Target Populations; Testing; Time; Translations; Update; Work; acute care; base; clinical practice; coping; cost; dashboard; disability; effectiveness implementation trial; effectiveness testing; effectiveness trial; follow-up; future implementation; high risk; hospital readmission; hybrid type 1 design; implementation barriers; implementation context; implementation strategy; improved; indexing; ineffective therapies; innovation; mHealth; mobile application; novel; organizational readiness; primary outcome; process evaluation; programs; psychiatric symptom; research study; response; secondary outcome; severe mental illness; standard of care; treatment as usual; treatment effect; treatment risk; uptake; wasting

PROJECT SUMMARY/ABSTRACT The period immediately following discharge from acute psychiatric hospitalization is a time fraught with gaps and discontinuities in care for many patients. Despite this time of elevated risk, patients often lack sufficient transitional supports and related resources for returning to the community and resuming long-term outpatient treatment. The long-term goal is to improve the continuity of care for patients with serious mental illness (SMI) by supporting a safer and more efficient bridge from hospital to outpatient care. The objective of this proposal is to test the effectiveness of our empirically-supported, multi-component mHealth intervention called tFOCUS in comparison to enhanced assessment and monitoring to ensure safety and an adequate standard of care (“SAFE”). tFOCUS will be deployed during the high-risk period directly from hospital to outpatient care and provide real-time assessment and intervention to patients via a mobile app, plus user engagement and clinical status updates to clinicians via a web-based “dashboard.” To speed the translation of findings to clinical practice, we will rigorously test the effectiveness of tFOCUS in a fully-powered Hybrid Type 1 Effectiveness-Implementation trial, while collecting information on implementation barriers/facilitators to promote uptake in real world settings. The central hypothesis is that tFOCUS will improve illness self-coping and treatment attitudes, which will lead to reduced: psychiatric symptoms, rehospitalizations, and suicidal ideation/behaviors. tFOCUS will also lead to improved post-discharge treatment engagement and illness recovery. The aims of this proposal are: (1) to conduct a fully-powered, RCT (n=180) to test the effectiveness of treatment-as-usual (TAU) + tFOCUS vs TAU + SAFE; (2) to examine potential mediators and moderators of treatment effects; and, (3) to identify patient, staff, and organizational/system-level factors that may facilitate/hinder tFOCUS implementation. The primary outcome will be overall psychiatric symptoms. The approach is innovative because it is one of the first randomized controlled trials conducted in the U.S. specifically evaluating an mHealth aftercare support program for patients with SMI directly moving from hospital to outpatient care. Also, this study is unique in that it will collect data to generate hypotheses about implementation strategies via a multi-pronged approach involving key stakeholders and additional implementation ata. Upon successful completion of the proposed R01 research, this study will contribute significant actionable data that will lay the groundwork for a large-scale Hybrid Type 3 trial of tFOCUS in diverse hospital settings.

项目概要/摘要 急性精神病住院出院后的一段时间充满了 尽管目前风险较高，但许多患者的护理仍存在差距和不连续性。 足够的过渡支持和相关资源，用于重返社区和恢复长期 门诊治疗的长期目标是改善严重精神疾病患者的护理连续性。 通过支持从医院到门诊护理的更安全、更高效的桥梁来实现疾病 (SMI) 的目标。 该提案旨在测试我们基于经验的多成分移动医疗干预措施的有效性 与加强评估和监测相比，称为 tFOCUS，以确保安全和充分 标准护理（“SAFE”）将在高风险期间直接从医院部署到医院。 门诊护理，并通过移动应用程序和用户提供实时评估和干预 通过基于网络的“仪表板”对flockon进行参与和临床状态更新，以加快翻译速度。 根据临床实践的结果，我们将严格测试 tFOCUS 在全动力混合型中的有效性 1 有效性实施试验，同时收集有关实施障碍/促进因素的信息 促进现实世界环境中的吸收 核心假设是 tFOCUS 将改善疾病的自我应对。 和治疗态度，这将导致减少：精神症状、再住院和自杀倾向 思想/行为也将改善出院后的治疗参与度和疾病。 恢复。 该提案的目的是：（1）进行全功率随机对照试验（n=180）来测试有效性 照常治疗 (TAU) + tFOCUS 与 TAU + SAFE；(2) 检查潜在的调节因素和调节因素 治疗效果；(3) 识别可能影响患者、工作人员和组织/系统层面的因素 促进/阻碍 tFOCUS 的实施。主要结果将是总体精神症状。 该方法具有创新性，因为它是在美国进行的首批随机对照试验之一。 专门评估针对直接从 SMI 搬来的患者的 mHealth 善后支持计划 此外，这项研究的独特之处在于它将收集数据以生成有关的假设。 通过多管齐下的方法实施战略，涉及主要利益相关者和其他 成功完成拟议的 R01 研究后，本研究将做出贡献 重要的可操作数据将为 tFOCUS 的大规模混合型 3 试验奠定基础 多样化的医院环境。