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.

项目总结/摘要 从急性精神病医院出院后的一段时间充满了 许多患者的护理存在差距和不连续性。尽管这段时间的风险升高，患者往往缺乏 * 为返回社区和恢复长期 门诊治疗。长期目标是改善严重精神疾病患者护理的连续性， 通过支持从医院到门诊治疗的更安全、更有效的桥梁，改善SMI疾病。的目标 该提案旨在测试我们的医疗支持、多组件移动健康干预措施的有效性 与加强评估和监测相比，称为tFOCUS，以确保安全和充分的 护理标准（“安全”）。tFOCUS将在高危时期直接从医院部署， 门诊护理，并通过移动的应用程序为患者提供实时评估和干预， 通过基于网络的“仪表板”向临床医生提供参与和临床状态更新。加快翻译速度 将研究结果应用于临床实践，我们将严格测试tFOCUS在全动力混合型中的有效性。 1个强制性实施试验，同时收集关于实施障碍/促进因素的信息， 促进在真实的世界环境中的吸收。中心假设是tFOCUS将改善疾病自我应对 和治疗态度，这将导致减少：精神症状，再住院，自杀 想法/行为。tFOCUS还将改善出院后的治疗参与和疾病 复苏 本建议的目的是：（1）进行一项全面的随机对照试验（n=180），以测试 常规治疗（TAU）+ tFOCUS vs TAU + SAFE;（2）检查潜在的介质和调节剂， 治疗效果;（3）确定可能影响治疗效果的患者、工作人员和组织/系统水平因素， 促进/阻碍tFOCUS的实施。主要结局是总体精神症状。的 这种方法是创新的，因为它是在美国进行的首批随机对照试验之一。 专门评估了一个mHealth善后支持计划，为患者的SMI直接从 从医院到门诊此外，这项研究的独特之处在于，它将收集数据，以产生假设， 通过涉及主要利益攸关方和其他利益攸关方的多管齐下的办法， 执行ata。在成功完成拟议的R 01研究后，本研究将有助于 重要的可操作数据，将为tFOCUS的大规模混合3型试验奠定基础， 不同的医院设置。