Protocol A technology-enabled multi-disciplinary team-based care model for the management of Long COVID and other fatiguing illnesses ..., 2023, Godino et al

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 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.

https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-023-07550-3

 

Any treatment regimen like this tho' all depends on the content.

PIFI.........thats a new one, sounds a bit too much like piffle for my liking tho'.

 

ECHO is a fairly wide-spread US education approach using remote technology and case-based learning to improve clinician practice and patient outcomes. It's often used to reach doctors in rural areas or to disseminate specialist knowledge, such as with Hep C. If I remember correctly, ECHO programs are intended to create a learning community and always require assessment of outcomes to show program effectiveness

More information on the LC&FIRP ECHO is on their site. Their monthly webinars, which started in January 2022, are open to anyone; materials for previous webinars are here. I've attended many of the monthly LC&FIRP webinars and think they've been generally, although not always, good. The organizing team includes clinicians and people with experience in ME and/or LC. Each webinar includes a person with ME or LC lived experience as part of the presenting or Q&A panels.
Given the lack of knowledge in the medical community about LC and ME, I'd be surprised if the providers who participated don't have better outcomes than those who do not.

 

Technology is not the issue here. They're trying to mix a research study with a pragmatic rehabilitation program when there is zero need to. We know for a fact that this kind of rehabilitation is useless, no amount of technology will change that. We need to understand the physiology here, not try to ram through yet another foolish attempt at creating fake evidence for something that doesn't work.

Pragmatic studies, even research studies that contain pragmatic components like this, need to be stopped entirely. They tell us absolutely nothing, they serve no purpose at all. They're supposed to simply test something, but it's been done thousands of times before, which entirely defeats the purpose they serve. Either study this scientifically or go away forever.

This study could inform about some things, but ramming through yet again some pragmatic stuff says to me that anything useful learned will not inform anything at all.

In the first few months it could have made some sense. But this very kind of rehabilitation has been recommended, sometimes forced, onto hundreds of thousands of people already for 3 years. The lack of evidence for efficacy not only tells us everything about its usefulness, but especially so about the fanaticism behind it, how evidence is irrelevant in so-called evidence-based medicine. This is simply not the right way to solve this problem, damnit.

 

Perhaps I am missing something - does this say it's a pragmatic rehabilitation program?

Edited to add:
Are you referring to the sentence in the paper about comparing findings to Post-COVID Rehabilitation and Recovery Clinic at the University of Washington.

My understanding is that the overall LC&FIRP program is intended to create a learning environment where clinicians attend weekly sessions where they learn about practices like pacing and symptom management that have been used in diseases like ME/CFS and also share with each other the Long COVID, ME and other PIFI cases they are seeing so that they can better target care and treatment approaches. The overall goal of the program is to improve patient outcomes. The study described above is to evaluate those outcomes. This study has a control group of clinicians who only attend the monthly webinars.

But the Post-COVID Rehabilitation and Recovery Clinic at the University of Washington is a separate clinic. I don't know what it recommends. Some rehab clinics here do still recommend exercise without caveats for those who experience PEM. And some clinics with rehab and recovery in their name have changed their early approaches to take PEM into account.

 

Has it be noted that this is a CDC-funded study and Elizabeth Unger, head of the CDC's ME/CFS program is one of the co-authors?