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
Abstract Background The 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 t...
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| Format: | Article |
| Language: | English |
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BMC
2023-08-01
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| Series: | Trials |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13063-023-07550-3 |
| _version_ | 1797556632469635072 |
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| author | Job G. Godino Jane C. Samaniego Sydney P. Sharp Douglas Taren Alexandra Zuber Amy J. Armistad Amanda M. Dezan Azure J. Leyba Janna L. Friedly Aaron E. Bunnell Eva Matthews Maureen J. Miller Elizabeth R. Unger Jeanne Bertolli Alison Hinckley Jin-Mann S. Lin John D. Scott Bruce B. Struminger Christian Ramers |
| author_facet | Job G. Godino Jane C. Samaniego Sydney P. Sharp Douglas Taren Alexandra Zuber Amy J. Armistad Amanda M. Dezan Azure J. Leyba Janna L. Friedly Aaron E. Bunnell Eva Matthews Maureen J. Miller Elizabeth R. Unger Jeanne Bertolli Alison Hinckley Jin-Mann S. Lin John D. Scott Bruce B. Struminger Christian Ramers |
| author_sort | Job G. Godino |
| collection | DOAJ |
| description | Abstract Background The 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. Methods We 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. Discussion We 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 registration ClinicalTrials.gov, NCT05167227 . Registered on December 22, 2021. |
| first_indexed | 2024-03-10T17:05:39Z |
| format | Article |
| id | doaj.art-25694e8cfec642e4b38fff1e31c52b81 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-03-10T17:05:39Z |
| publishDate | 2023-08-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-25694e8cfec642e4b38fff1e31c52b812023-11-20T10:49:41ZengBMCTrials1745-62152023-08-0124111510.1186/s13063-023-07550-3A 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 trialJob G. Godino0Jane C. Samaniego1Sydney P. Sharp2Douglas Taren3Alexandra Zuber4Amy J. Armistad5Amanda M. Dezan6Azure J. Leyba7Janna L. Friedly8Aaron E. Bunnell9Eva Matthews10Maureen J. Miller11Elizabeth R. Unger12Jeanne Bertolli13Alison Hinckley14Jin-Mann S. Lin15John D. Scott16Bruce B. Struminger17Christian Ramers18Laura Rodriguez Research Institute, Family Health Centers of San DiegoLaura Rodriguez Research Institute, Family Health Centers of San DiegoLaura Rodriguez Research Institute, Family Health Centers of San DiegoDepartment of Pediatrics and Nutrition, University of ColoradoAta Health Strategies, LLCProject ECHO, University of New Mexico Health Sciences CenterProject ECHO, University of New Mexico Health Sciences CenterProject ECHO, University of New Mexico Health Sciences CenterDepartment of Medicine, University of WashingtonDepartment of Medicine, University of WashingtonLaura Rodriguez Research Institute, Family Health Centers of San DiegoNational Center for Emerging and Zoonotic Infectious Diseases, U.S. Centers for Disease Control and PreventionNational Center for Emerging and Zoonotic Infectious Diseases, U.S. Centers for Disease Control and PreventionNational Center for Emerging and Zoonotic Infectious Diseases, U.S. Centers for Disease Control and PreventionNational Center for Emerging and Zoonotic Infectious Diseases, U.S. Centers for Disease Control and PreventionNational Center for Emerging and Zoonotic Infectious Diseases, U.S. Centers for Disease Control and PreventionDepartment of Medicine, University of WashingtonProject ECHO, University of New Mexico Health Sciences CenterLaura Rodriguez Research Institute, Family Health Centers of San DiegoAbstract Background The 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. Methods We 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. Discussion We 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 registration ClinicalTrials.gov, NCT05167227 . Registered on December 22, 2021.https://doi.org/10.1186/s13063-023-07550-3Post COVID-19 conditions (PCC)Long COVIDMyalgic encephalomyelitis (ME)Chronic fatigue syndrome (CFS)Post-infectious fatiguing illnesses (PIFI) |
| spellingShingle | Job G. Godino Jane C. Samaniego Sydney P. Sharp Douglas Taren Alexandra Zuber Amy J. Armistad Amanda M. Dezan Azure J. Leyba Janna L. Friedly Aaron E. Bunnell Eva Matthews Maureen J. Miller Elizabeth R. Unger Jeanne Bertolli Alison Hinckley Jin-Mann S. Lin John D. Scott Bruce B. Struminger Christian Ramers 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 Post COVID-19 conditions (PCC) Long COVID Myalgic encephalomyelitis (ME) Chronic fatigue syndrome (CFS) Post-infectious fatiguing illnesses (PIFI) |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Post COVID-19 conditions (PCC) Long COVID Myalgic encephalomyelitis (ME) Chronic fatigue syndrome (CFS) Post-infectious fatiguing illnesses (PIFI) |
| url | https://doi.org/10.1186/s13063-023-07550-3 |
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