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临床试验/NCT04704544
NCT04704544已完成不适用

Effectiveness of Tele-rheumatology for Delivering High Quality Rheumatology Care During the COVID-19 Crisis

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 652 人开始时间: 2021年9月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
652
试验地点
1
主要终点
Patient satisfaction

研究概览

简要总结

While tele-rheumatology (TR) visits are a COVID-19 related necessity, there is a lack of rigorous data on the comparative effectiveness of TR versus (vs) in-person usual care (UC) especially in medically at-risk populations such as people with rheumatic and musculoskeletal disease (RMD) using immunosuppressive drugs (IS). This clear research gap was highlighted by the American College of Rheumatology in its recent Task Force Report on Telehealth in the COVID era. In this study, the investigators will rigorously evaluate the comparative effectiveness of TR visits for high risk people living with RMD and among those from socially vulnerable populations, in the COVID-19 era. This study is of key public health importance and relevance to rheumatology since it addresses the urgent clinical and policy needs to provide safe, efficacious, and equitable care to diverse patients with RMD during and beyond the COVID-19 crisis. Our proposal is very responsive to the RRF's Notice of Special interest on COVID-19 in improving the care of people with RMD during the COVID-19 pandemic. The investigators will perform the first randomized experiment of tele-rheumatology, generating high quality evidence to guide the use of this technology across diverse populations of people with RMDs. Beyond the high public health impact of this study for people with RMDs, the investigators expect that our findings will have high generalizability to other at-risk patient populations with multimorbidity and inform rheumatology practice into the foreseeable future.

详细描述

People with RMDs, especially those with multi-comorbidities and on IS are among the most at-risk for COVID-19-related fragmented care and poor outcomes. RMD burden is high in terms of disability-adjusted-life years (DALYs) and has been escalating. Beyond the prevailing challenges to in-person visits such as scheduling conflicts, transportation, or disability, the COVID-19 pandemic has further exacerbated RMD patient burden through disruptions in healthcare delivery (e.g. limited availability of in-person visits). Thus, high quality adaptations of healthcare services for people living with RMD including through TR in the context of the COVID-19 crisis are badly needed. The investigators found from a recent survey of 24,500 people living with RMD that 60% of respondents avoided in-person clinic visits. However, with the increasing availability of technology (90% Americans have internet access, 81% are online daily most patients and clinicians can engage in some form of TR. Due to widespread social distancing and major health policy changes necessitated by COVID-19, TR has been swiftly adopted (but minimally tested) as a means to deliver ongoing care for people with RMD. Because patients can be evaluated in their own homes, thus avoiding travel that increases COVID-19 risk, this approach provides means of healthcare for socially and medically vulnerable groups, such as those residing in rural areas and those with comorbidities, a group particularly at high risk of COVID-19 complications.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Care Provider)

盲法说明

Providers will be masked to the random assignment of participant visits.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of rheumatic disease (e.g. rheumatoid arthritis, SLE)

排除标准

  • unstable rheumatic disease that needs in-person visits (e.g. recent diagnosis of severe lupus nephritis)
  • expected in-office procedures (e.g., joint injection)
  • lack of access to phone

研究组 & 干预措施

Tele-rheumatology first visit and Usual Care second visit

Experimental

Participants randomized to this visit will receive a tele-rheumatology visit first.

干预措施: Tele-rheumatology (Other)

Usual Care first visit and Tele-rheumatology second visit

Experimental

Participants randomized to this visit will receive a usual care visit first.

干预措施: Tele-rheumatology (Other)

结局指标

主要结局

Patient satisfaction

时间窗: 36-72 hours post visit after the first visit

Patient satisfaction with type visit. Assessed with AHRQ's Consumer Assessment of Healthcare Providers and Systems (CAHPS)® survey

次要结局

  • Patient preference(36-72 hours post visit, after the second visit)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Danila, MD, MSc, MSPH

Professor of Medicine

University of Alabama at Birmingham

研究点 (1)

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