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

Primary Purpose

Rheumatic Diseases

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tele-rheumatology
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatic Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at BirminghamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Tele-rheumatology first visit and Usual Care second visit

Usual Care first visit and Tele-rheumatology second visit

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Patient preference
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

Full Information

First Posted
January 6, 2021
Last Updated
October 29, 2022
Sponsor
University of Alabama at Birmingham
Collaborators
University of California, San Francisco, Tulane University
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1. Study Identification

Unique Protocol Identification Number
NCT04704544
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
University of California, San Francisco, Tulane University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatic Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
Care Provider
Masking Description
Providers will be masked to the random assignment of participant visits.
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tele-rheumatology first visit and Usual Care second visit
Arm Type
Experimental
Arm Description
Participants randomized to this visit will receive a tele-rheumatology visit first.
Arm Title
Usual Care first visit and Tele-rheumatology second visit
Arm Type
Experimental
Arm Description
Participants randomized to this visit will receive a usual care visit first.
Intervention Type
Other
Intervention Name(s)
Tele-rheumatology
Intervention Description
Participants will receive virtual visits via video conferencing and/or phone.
Primary Outcome Measure Information:
Title
Patient satisfaction
Description
Patient satisfaction with type visit. Assessed with AHRQ's Consumer Assessment of Healthcare Providers and Systems (CAHPS)® survey
Time Frame
36-72 hours post visit after the first visit
Secondary Outcome Measure Information:
Title
Patient preference
Description
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
Time Frame
36-72 hours post visit, after the second visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JEFF FOSTER, MPH
Phone
2059966086
Email
pjfoster@uabmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Holder, MPH
Phone
205-975-0583
Email
eholder@uabmc.edu
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeff Foster, MPH
Phone
205-996-6086
Email
pjfoster@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Maria I Danila, MD, MsC

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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32379381
Citation
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Effectiveness of Tele-rheumatology for Delivering High Quality Rheumatology Care During the COVID-19 Crisis (EVOLVE)

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