Clinical and Economic Impact of Teleneurology vs Standard in Clinic Care for Multiple Sclerosis: A Randomized Trial

远程神经学与多发性硬化症临床护理标准的临床和经济影响：随机试验

• 批准号: 10583096
• 负责人: Marisa McGinley
• 金额: $ 56.91万
• 依托单位: CLEVELAND CLINIC LERNER COM-CWRU
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-26 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10583096
• 关键词: Academy; Ache; Address; Adherence; Adult; Affect; American; Automobile Driving; COVID-19 pandemic; California; Caregiver Burden; Caring; Chronic; Clinic; Clinic Visits; Clinical; Communities; Comprehensive Health Care; Cost Effectiveness Analysis; Data; Diagnosis; Direct Costs; Disease; Dropout; Emergency department visit; Enrollment; Ensure; Evaluation; Face; Facilities and Administrative Costs; General Population; Goals; Health; Health Care Costs; Health Services Accessibility; Healthcare; Home; Hospitalization; Immune; Improve Access; Intervention; Interview; Knowledge; Mediating; Medical; Methodology; Methods; Modality; Modeling; Multiple Sclerosis; Neurologist; Neurology; Newly Diagnosed; Outcome; Outpatients; Participant; Patient Care Team; Patient Outcomes Assessments; Patients; Patterns of Care; Perception; Persons; Pharmaceutical Preparations; Policies; Population; Positioning Attribute; Procedures; Productivity; Provider; Quality-Adjusted Life Years; Randomized; Randomized Clinical Trials; Recommendation; Regulation; Research; Resources; Sampling; San Francisco; Savings; Schedule; Secure; Services; Site; Specialized Center; Standardization; Surveys; Testing; Time; Travel; Universities; Visit; Work; arm; base; care costs; care delivery; central nervous system demyelinating disorder; clinical care; clinical trial participant; cost; design; digital; disability; economic impact; experience; follow-up; health care delivery; health care service utilization; health related quality of life; hospitalization rates; improved; insight; multidisciplinary; multiple sclerosis patient; novel; pilot trial; preference; randomized trial; satisfaction; telehealth; telehealthcare; teleneurology; theories; two-arm study; usability

PROJECT SUMMARY/ ABSTRACT Multiple sclerosis (MS) patients have higher healthcare utilization, reduced work productivity, reduced quality- adjusted life years, and lower health-related quality of life (QOL) relative to the general population. The current standard of outpatient MS care depends on in-clinic visits, but MS patients face many barriers to accessing this care. These barriers include those resulting from the disease itself, such as physical limitations, driving restrictions and financial limitations, and they are further compounded by an overall shortage of neurologists. Furthermore, MS care has a significant economic impact, with the estimated indirect and direct costs for treating MS in the US estimated to be > $48 billion. Therefore, there is a need to improve access to and reduce cost of MS care, and telehealth is a potential solution. Both our two multidisciplinary MS Centers (UCSF and Cleveland Clinic) have demonstrated that telehealth for MS care is feasible and that it results in travel savings for patients, reduction in missed work, and reduction in caregiver burden. Additionally, patient and provider satisfaction is high for this modality of care at the time of care delivery. These initial results are promising, but to date there are no studies assessing the longer-term impact of care delivery via telehealth on the Quadruple Aims of Healthcare: clinical care, cost, patient experience and clinician experience. The proposed study will directly bridge these research gaps in the longer-term impact of care delivery via telehealth. We will complete a two-Center trial, randomizing newly diagnosed MS patients to receive their routine MS care via telehealth or standard in-office care over 2 years. We will enroll 120 patients (assuming ~ 20% dropout rate for 100 completers), and will assess and compare standard clinical outcomes, patient-reported outcomes, costs, patient experience, and clinician care team experience associated with telehealth vs standard in clinic care. We will also conduct exit interviews with purposefully sampled trial participants to better identify facilitators and barriers to telehealth implementation. This study will generate needed evidence regarding the impact of telehealth on clinical outcomes, its cost, and stakeholder experience, and will inform clinical care implementation in other populations of MS patients and other chronic conditions.

项目摘要/摘要 多发性硬化症(MS)患者的医疗利用率更高，工作效率降低，质量下降- 调整后的寿命年数，与一般人口相比，与健康相关的生活质量(QOL)较低。海流 门诊多发性硬化症的标准取决于门诊就诊，但多发性硬化症患者在获得这一标准方面面临许多障碍 关心。这些障碍包括疾病本身造成的障碍，如身体限制、驾驶 这些限制和资金限制，再加上神经科医生的总体短缺，更是雪上加霜。 此外，多发性硬化症护理具有重大的经济影响，估计治疗的间接和直接成本 据估计，美国女性的身家为480亿美元。因此，有必要改善获取和降低成本。 MS CARE，远程医疗是一种潜在的解决方案。我们的两个多学科MS中心(加州大学旧金山分校和克利夫兰分校 临床)已经证明用于MS护理的远程医疗是可行的，并且它为患者节省了差旅， 减少缺勤，减轻照顾者负担。此外，患者和提供者的满意度是 在提供护理时，这种护理方式很高。这些初步结果是有希望的，但到目前为止，有 没有研究评估通过远程医疗提供的医疗服务对医疗保健四重目标的长期影响： 临床护理、成本、患者体验和临床医生体验。 拟议的研究将直接弥合这些研究在护理提供的长期影响方面的差距，通过 远程医疗。我们将完成一项双中心试验，随机选择新诊断的多发性硬化症患者接受常规治疗 2年以上通过远程医疗或标准办公室护理获得的MS护理。我们将招收120名患者(假设~20% 100名完成者的辍学率)，并将评估和比较患者报告的标准临床结果 与远程医疗和标准医疗相关的结果、成本、患者体验和临床医生护理团队体验 在临床护理中。我们还将对有意抽样的试验参与者进行离职访谈，以更好地确定 远程保健实施的促进者和障碍。这项研究将产生关于 远程医疗对临床结果、成本和利益相关者体验的影响，并将为临床护理提供信息 在其他多发性硬化症患者和其他慢性疾病人群中实施。