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

NCT04704544 | Completed

• 2 other identifiers: IRB-3000065530000000
• Study Type: interventional
• Target: 652
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatic Diseases

Outcome Measures

Primary Outcomes (1)

• Patient satisfaction

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

  36-72 hours post visit after the first visit

Secondary Outcomes (1)

• Patient preference

  36-72 hours post visit, after the second visit

Study Arms (2)

Tele-rheumatology first visit and Usual Care second visit

EXPERIMENTAL

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

Other: Tele-rheumatology

Usual Care first visit and Tele-rheumatology second visit

EXPERIMENTAL

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

Other: Tele-rheumatology

Interventions

Tele-rheumatology OTHER

Participants will receive virtual visits via video conferencing and/or phone.

Tele-rheumatology first visit and Usual Care second visit; Usual Care first visit and Tele-rheumatology second visit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• University of California, San Francisco: collaborator
• Tulane University: collaborator
• Rheumatology Research Foundation: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (12)

• Feldman CH, Ramsey-Goldman R. Widening Disparities Among Patients With Rheumatic Diseases in the COVID-19 Era: An Urgent Call to Action. Arthritis Rheumatol. 2020 Sep;72(9):1409-1411. doi: 10.1002/art.41306. Epub 2020 Aug 9. No abstract available.

  PMID: 32379381 BACKGROUND

• Brooks PM. The burden of musculoskeletal disease--a global perspective. Clin Rheumatol. 2006 Nov;25(6):778-81. doi: 10.1007/s10067-006-0240-3. Epub 2006 Apr 12.

  PMID: 16609823 BACKGROUND

• Donelan K, Barreto EA, Sossong S, Michael C, Estrada JJ, Cohen AB, Wozniak J, Schwamm LH. Patient and clinician experiences with telehealth for patient follow-up care. Am J Manag Care. 2019 Jan;25(1):40-44.

  PMID: 30667610 BACKGROUND

• Michaud K, Wipfler K, Shaw Y, Simon TA, Cornish A, England BR, Ogdie A, Katz P. Experiences of Patients With Rheumatic Diseases in the United States During Early Days of the COVID-19 Pandemic. ACR Open Rheumatol. 2020 Jun;2(6):335-343. doi: 10.1002/acr2.11148. Epub 2020 May 9.

  PMID: 32311836 BACKGROUND

• Webster P. Virtual health care in the era of COVID-19. Lancet. 2020 Apr 11;395(10231):1180-1181. doi: 10.1016/S0140-6736(20)30818-7. No abstract available.

  PMID: 32278374 BACKGROUND

• Bachireddy C, Chen C, Dar M. Securing the Safety Net and Protecting Public Health During a Pandemic: Medicaid's Response to COVID-19. JAMA. 2020 May 26;323(20):2009-2010. doi: 10.1001/jama.2020.4272. No abstract available.

  PMID: 32191260 BACKGROUND

• Uscher-Pines L, Fischer S, Tong I, Mehrotra A, Malsberger R, Ray K. Virtual First Responders: the Role of Direct-to-Consumer Telemedicine in Caring for People Impacted by Natural Disasters. J Gen Intern Med. 2018 Aug;33(8):1242-1244. doi: 10.1007/s11606-018-4440-8. No abstract available.

  PMID: 29691713 BACKGROUND

• Hayes BL, Curtis JR, Laster A, Saag K, Tanner SB, Liu C, Womack C, Johnson KC, Khaliq F, Carbone LD. Osteoporosis care in the United States after declines in reimbursements for DXA. J Clin Densitom. 2010 Oct-Dec;13(4):352-60. doi: 10.1016/j.jocd.2010.08.001.

  PMID: 21029972 BACKGROUND

• Richardson S, Hirsch JS, Narasimhan M, Crawford JM, McGinn T, Davidson KW; the Northwell COVID-19 Research Consortium; Barnaby DP, Becker LB, Chelico JD, Cohen SL, Cookingham J, Coppa K, Diefenbach MA, Dominello AJ, Duer-Hefele J, Falzon L, Gitlin J, Hajizadeh N, Harvin TG, Hirschwerk DA, Kim EJ, Kozel ZM, Marrast LM, Mogavero JN, Osorio GA, Qiu M, Zanos TP. Presenting Characteristics, Comorbidities, and Outcomes Among 5700 Patients Hospitalized With COVID-19 in the New York City Area. JAMA. 2020 May 26;323(20):2052-2059. doi: 10.1001/jama.2020.6775.

  PMID: 32320003 BACKGROUND

• Nesbitt TS, Marcin JP, Daschbach MM, Cole SL. Perceptions of local health care quality in 7 rural communities with telemedicine. J Rural Health. 2005 Winter;21(1):79-85. doi: 10.1111/j.1748-0361.2005.tb00066.x.

  PMID: 15667014 BACKGROUND

• Yang J, Zheng Y, Gou X, Pu K, Chen Z, Guo Q, Ji R, Wang H, Wang Y, Zhou Y. Prevalence of comorbidities and its effects in patients infected with SARS-CoV-2: a systematic review and meta-analysis. Int J Infect Dis. 2020 May;94:91-95. doi: 10.1016/j.ijid.2020.03.017. Epub 2020 Mar 12.

  PMID: 32173574 BACKGROUND

• Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.

  PMID: 32171076 BACKGROUND

MeSH Terms

Conditions

Rheumatic Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Providers will be masked to the random assignment of participant visits.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: 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).

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 11, 2021
• Study Start: September 15, 2021
• Primary Completion: November 30, 2023
• Study Completion: February 18, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)