A technology-enabled multi-disciplinary team-based care model for the management of Long COVID and other fatiguing illnesses within a federally qualified health center: protocol for a two-arm, single-blind, pragmatic, quality improvement professional cluster randomized controlled trial

Trials

Study Protocol

Alexandra Zuber¹  Aaron E. Bunnell²  John D. Scott²  Janna L. Friedly²  Douglas Taren³  Eva Matthews⁴  Jane C. Samaniego⁴  Job G. Godino⁵  Sydney P. Sharp⁶  Christian Ramers⁷  Maureen J. Miller⁸  Jin-Mann S. Lin⁸  Alison Hinckley⁸  Jeanne Bertolli⁸  Elizabeth R. Unger⁸  Azure J. Leyba⁹  Amy J. Armistad⁹  Bruce B. Struminger⁹  Amanda M. Dezan⁹ 

[1] Ata Health Strategies, LLC, 1537 D Street NE, 20002, Washington, DC, USA;Department of Medicine, University of Washington, 1959 NE Pacific St, 98195, Seattle, WA, USA;Rehabilitation Clinic, Harborview Medical Center, 410 9Th Ave, 98104, Seattle, WA, USA;Department of Pediatrics and Nutrition, University of Colorado, 13001 East 17Th Place, 80045, Aurora, CO, USA;Laura Rodriguez Research Institute, Family Health Centers of San Diego, 1750 5Th Ave, 92101, San Diego, CA, USA;Laura Rodriguez Research Institute, Family Health Centers of San Diego, 1750 5Th Ave, 92101, San Diego, CA, USA;Center for Wireless and Population Health Systems, UC San Diego, 9500 Gilman Drive, Dept. 0811, 92093, La Jolla, CA, USA;Herbert Wertheim School of Public Health and Longevity Science, UC San Diego, 9500 Gilman Dr., 92093, La Jolla, CA, USA;Exercise and Physical Activity Resource Center, UC San Diego, 9500 Gilman Drive, Dept. 0811, 92093, La Jolla, CA, USA;Laura Rodriguez Research Institute, Family Health Centers of San Diego, 1750 5Th Ave, 92101, San Diego, CA, USA;Exercise and Physical Activity Resource Center, UC San Diego, 9500 Gilman Drive, Dept. 0811, 92093, La Jolla, CA, USA;Laura Rodriguez Research Institute, Family Health Centers of San Diego, 1750 5Th Ave, 92101, San Diego, CA, USA;School of Medicine, UC San Diego, 9500 Gilman Drive, Dept. 0606, 92093, La Jolla, CA, USA;School of Public Health, San Diego State University, 5500 Campanile Dr, 92182, San Diego, CA, USA;Global Hepatitis Program, Clinton Health Access Initiative, 383 Dorchester Ave, 02127, Boston, MA, USA;National Center for Emerging and Zoonotic Infectious Diseases, U.S. Centers for Disease Control and Prevention, 1600 Clifton Rd, 30333, Atlanta, GA, USA;Project ECHO, University of New Mexico Health Sciences Center, 1650 University Blvd NE, 87102, Albuquerque, NM, USA;

关键词: Post COVID-19 conditions (PCC);    Long COVID;    Myalgic encephalomyelitis (ME);    Chronic fatigue syndrome (CFS);    Post-infectious fatiguing illnesses (PIFI);   

DOI  :  10.1186/s13063-023-07550-3

 received in 2023-05-31, accepted in 2023-07-27,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundThe clinical burden of Long COVID, myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), and other post-infectious fatiguing illnesses (PIFI) is increasing. There is a critical need to advance understanding of the effectiveness and sustainability of innovative approaches to clinical care of patients having these conditions.MethodsWe aim to assess the effectiveness of a Long COVID and Fatiguing Illness Recovery Program (LC&FIRP) in a two-arm, single-blind, pragmatic, quality improvement, professional cluster, randomized controlled trial in which 20 consenting clinicians across primary care clinics in a Federally Qualified Health Center system in San Diego, CA, will be randomized at a ratio of 1:1 to either participate in (1) weekly multi-disciplinary team-based case consultation and peer-to-peer sharing of emerging best practices (i.e., teleECHO (Extension for Community Healthcare Outcomes)) with monthly interactive webinars and quarterly short courses or (2) monthly interactive webinars and quarterly short courses alone (a control group); 856 patients will be assigned to participating clinicians (42 patients per clinician). Patient outcomes will be evaluated according to the study arm of their respective clinicians. Quantitative and qualitative outcomes will be measured at 3- and 6-months post-baseline for clinicians and every 3-months post assignment to a participating clinician for patients. The primary patient outcome is change in physical function measured using the Patient-Reported Outcomes Measurement Information System (PROMIS)-29. Analyses of differences in outcomes at both the patient and clinician levels will include a linear mixed model to compare change in outcomes from baseline to each post-baseline assessment between the randomized study arms. A concurrent prospective cohort study will compare the LC&FIRP patient population to the population enrolled in a university health system. Longitudinal data analysis approaches will allow us to examine differences in outcomes between cohorts.DiscussionWe hypothesize that weekly teleECHO sessions with monthly interactive webinars and quarterly short courses will significantly improve clinician- and patient-level outcomes compared to the control group. This study will provide much needed evidence on the effectiveness of a technology-enabled multi-disciplinary team-based care model for the management of Long COVID, ME/CFS, and other PIFI within a federally qualified health center.Trial registrationClinicalTrials.gov, NCT05167227. Registered on December 22, 2021.

【 授权许可】

CC BY   
© BioMed Central Ltd., part of Springer Nature 2023

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