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

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ClinicalTrials.gov Identifier: NCT04704544
Recruitment Status : Not yet recruiting
First Posted : January 11, 2021
Last Update Posted : February 17, 2021
Sponsor:
Collaborators:
University of California, San Francisco
Tulane University
Information provided by (Responsible Party):
Maria Danila, MD, MSc, MSPH, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
Rheumatic Diseases Other: Tele-rheumatology Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: We will conduct an open label, two-period, cross-over, 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)
Masking: Single (Care Provider)
Masking Description: Providers will be masked to the random assignment of participant visits.
Primary Purpose: Treatment
Official Title: Effectiveness of Tele-rheumatology for Delivering High Quality Rheumatology Care During the COVID-19 Crisis
Estimated Study Start Date : March 1, 2021
Estimated Primary Completion Date : November 30, 2022
Estimated Study Completion Date : November 30, 2022

Arm Intervention/treatment
Experimental: Tele-rheumatology first visit and Usual Care second visit
Participants randomized to this visit will receive a tele-rheumatology visit first.
Other: Tele-rheumatology
Participants will receive virtual visits via video conferencing and/or phone.

Experimental: Usual Care first visit and Tele-rheumatology second visit
Participants randomized to this visit will receive a usual care visit first.
Other: Tele-rheumatology
Participants will receive virtual visits via video conferencing and/or phone.




Primary Outcome Measures :
  1. Patient satisfaction [ Time Frame: 36-72 hours post visit ]
    Patient satisfaction with type visit. Assessed with AHRQ's Consumer Assessment of Healthcare Providers and Systems (CAHPS)® survey

  2. Patient preference [ Time Frame: 36-72 hours post visit ]
    Patient preference with type visit. Assessed using "If you had a choice, what type of visit would you prefer?" with options a. telemedicine, b. in-office



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of rheumatic disease requiring ≥3 rheumatology outpatient visits spaced ≥2 months apart in the past 1 year (e.g. rheumatoid arthritis, SLE

Exclusion Criteria:

  • very rare or severe rheumatic disease (e.g., vasculitis, scleroderma, inflammatory myopathy)
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04704544


Contacts
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Contact: JEFF FOSTER, MPH 2059966086 pjfoster@uabmc.edu
Contact: Josh Melnick, MPH 205-975-0583 jmelnick@uabmc.edu

Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
University of California, San Francisco
Tulane University
Publications:

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Responsible Party: Maria Danila, MD, MSc, MSPH, Associate Professor of Medicine, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT04704544    
Other Study ID Numbers: IRB-300006553
First Posted: January 11, 2021    Key Record Dates
Last Update Posted: February 17, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rheumatic Diseases
Collagen Diseases
Musculoskeletal Diseases
Connective Tissue Diseases