Clinical trial NCT04704544: Effectiveness of Tele-rheumatology for Delivering High Quality Rheumatology Care During the COVID-19 Crisis (EVOLVE)
Official title: Effectiveness of Tele-rheumatology for Delivering High Quality Rheumatology Care During the COVID-19 Crisis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Rheumatic Diseases
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: Tulane University
name: Rheumatology Research Foundation
First posted: 2021-01-11
Enrollment: 652
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will conduct an open label, two-period, multi-center, non-inferiority, patient-level randomized controlled trial comparing tele-rheumatology (audio +/- video) with usual care (in-person) visits. Patients will be randomized to the sequence of care for their next two visits (V1 and V2): i) tele-rheumatology (V1) + usual care (V2), OR ii) usual care (V1) + tele-rheumatology (V2). Primary outcome will be ascertained after the first visit (V1).
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Patient satisfaction
timeFrame: 36-72 hours post visit after the first visit
Secondary outcomes:
measure: Patient preference
timeFrame: 36-72 hours post visit, after the second visit
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
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