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: 10710059
• 负责人: Marisa McGinley
• 金额: $ 51.23万
• 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/10710059
• 关键词: Absenteeism at work; Academy; 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; Digital biomarker; Direct Costs; Disease; Dropout; Emergency department visit; Enrollment; Ensure; Equity; 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 Outcomes Assessments; Patients; Patterns of Care; Perception; Persons; Pharmaceutical Preparations; Policies; Population; Positioning Attribute; Procedures; Productivity; Provider; Quality of life; Quality-Adjusted Life Years; Randomized; Recommendation; Regulation; Research; Resources; Sampling; San Francisco; Savings; Schedule; Secure; Services; Site; Specialized Center; Standardization; Surveys; System; Testing; Time; Travel; Universities; Visit; Work; arm; care costs; care delivery; central nervous system demyelinating disorder; clinical care; clinical trial participant; cost; cost comparison; design; 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; randomized, clinical trials; 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）患者的医疗保健利用率更高，工作效率降低，质量降低， 调整后的生命年，和较低的健康相关的生活质量（QOL）相对于一般人群。当前 门诊MS护理的标准取决于门诊访视，但MS患者在获得这一点方面面临许多障碍。 在乎这些障碍包括疾病本身造成的障碍，如身体限制、驾驶障碍、 限制和财政限制，并进一步加剧了神经科医生的全面短缺。 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 美国的MS估计为> 480亿美元。因此，有必要改善获得保健服务的机会，并降低保健服务的费用。 MS保健和远程保健是一个潜在的解决方案。我们的两个多学科MS中心（UCSF和克利夫兰 诊所）已经证明，远程医疗对MS护理是可行的，它可以节省患者的旅行费用， 减少误工，减轻照顾者的负担。此外，患者和供应商的满意度是 在提供护理时，这种护理方式的风险很高。这些初步结果是有希望的，但迄今为止， 没有研究评估通过远程医疗提供护理对医疗保健四重目标的长期影响： 临床护理、成本、患者经验和临床医生经验。 拟议的研究将通过以下方式直接弥合这些研究差距，即护理服务的长期影响 远程保健我们将完成一项双中心试验，将新诊断的MS患者随机接受常规治疗， MS护理通过远程医疗或标准的办公室护理超过2年。我们将入组120例患者（假设约20%） 100例完成者的脱落率），并将评估和比较标准临床结局、患者报告 结果、成本、患者体验和与远程医疗与标准医疗相关的临床医生护理团队经验 临床护理。我们还将对有目的地抽样的试验参与者进行离职面谈，以更好地确定 远程保健实施的促进因素和障碍。这项研究将产生所需的证据， 远程医疗对临床结果、成本和利益相关者经验的影响，并将为临床护理提供信息 在其他MS患者和其他慢性病患者群体中实施。