Does a Technology Enabled Multi-disciplinary Team-based Care Model for the Management of Long COVID and Other Fatiguing Illnesses Improve Clinical Care of Patients and Represent a Sustainable Approach Within a Federally Qualified Health Center?

Study Overview
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Brief Summary
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The primary objective of the present research is to determine the effectiveness of Family Health Center of San Diego's Long COVID and Fatiguing Illness Recovery Program (LC&FIRP) on clinician- and patient-level outcomes. LC&FIRP is comprised of a teleECHO program focused on multi-specialty case-consultation and peer-to-peer sharing of emerging best practices to support management of complex cases associated with Long COVID, Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), and other post-infectious fatiguing illnesses (PIFI). Our secondary objective is to determine the feasibility, acceptability, and sustainability of LC&FIRP. Our findings should provide a fuller understanding of the potential impact of innovative technology enabled multi-disciplinary team-based care models in low-resource, community-based primary care settings.

Detailed Description
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The primary objective of the present research is to determine the effectiveness of FHCSD's Long COVID and Fatiguing Illness Recovery Program (LC&FIRP) on clinician- and patient-level outcomes. LC&FIRP is comprised of a teleECHO program focused on multi-specialty case-consultation and peer-to-peer sharing of emerging best practices to support management of complex cases associated with Long COVID, ME/CFS, and other PIFI. Our secondary objective is to determine the feasibility, acceptability, and sustainability of LC&FIRP. Our findings should provide a fuller understanding of the potential impact of innovative technology enabled multi-disciplinary team-based care models in low-resource, community-based primary care settings. This study will provide much needed high-quality 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 community clinic setting, while simultaneously providing evidence regarding the feasibility, acceptability, and sustainability of the approach. Given that LC&FIRP includes a teleECHO program that is case-based, interactive, and occurs in real-time, it has a set of distinct advantages to the traditional practice of sequential in-person specialty referrals to address complex patient cases. The investigators hypothesize that clinician exposure to weekly teleECHO sessions with monthly interactive webinars and quarterly short courses will significantly improve clinician- and patient-level outcomes compared to clinician exposure to monthly interactive webinars and quarterly short courses alone. The investigators will evaluate LC&FIRP using an effectiveness-implementation hybrid type 2 design. Specifically, the investigators will conduct a two-arm, single-blind, pragmatic, quality improvement, professional cluster, randomized controlled trial. The target for weekly teleECHO sessions, monthly interactive webinars, and quarterly short courses are licensed health care professionals. Therefore, the present research will include professional clusters that will consist of primary care physicians, physician assistants, and nurse practitioners at FHCSD caring for patients who have had persistent symptoms and a decline in health-related quality of life associated with Long COVID, ME/CFS, and/or other PIFI. 20 consenting clinicians across primary care clinics at FHCSD will be randomized at a ratio of 1:1 to either participate in 1) weekly teleECHO sessions with monthly interactive webinars and quarterly short courses or 2) monthly interactive webinars and quarterly short courses alone (a control group). All clinicians will have the option to receive continuing medical education credit for the educational sessions they engage in. Throughout participation, the investigators expect that the clinicians will provide care for approximately 856 FHCSD patients diagnosed with Long COVID, ME/CFS, or other PIFI (approximately 42 patients per clinician). The clinicians will be consented and will receive exposure to intervention components (i.e., a professional cluster). Therefore, patient outcomes derived from routine clinical care will be evaluated according to the study arm of their respective clinicians. Outcomes will be measured at 3-, 6-, 9-,12-, 18-, 24-, and 30-months post-baseline for clinicians and for patients at 3-, 6-, 9-, and 12-months post assignment to a participating clinician. Inclusion criteria for clinicians includes 1) being employed by FHCSD for clinical care delivery, 2) being a licensed primary care physician, physician assistant, or nurse practitioner, 3) caring for patients who have had persistent symptoms and a decline in health-related quality of life associated with Long COVID, ME/CFS, and/or other PIFI, and 4) being willing and able to actively participate in LC&FIRP. There are no exclusion criteria. FHCSD medical leadership has verbally extended an invitation to the approximately 200 eligible clinicians at FHCSD to participate in LC&FIRP (a follow-up email will also be sent). Those who are interested will provide written informed consent, complete a baseline survey, and will be randomized to one of the two study arms. An electronic randomization list will be generated using the latest version of the statistical software platform R (version 3.3.2, http://www.r-project.org). The list will be securely integrated into the cloud-based Research Electronic Data Capture (REDCap) tool. Allocation will be concealed from all investigators and staff until the study group is assigned. Only the study manager and research assistants involved in the delivery of the intervention components will subsequently be made aware of allocation. It is not possible to mask participating clinicians, however, patients of participating clinicians will not have knowledge of their clinicians potential participation in weekly teleECHO sessions, monthly interactive webinars, and quarterly short courses. All staff that are involved in the collection of data and investigators that conduct analyses will remain blinded to allocation throughout the study. Clinician participation in this study is voluntary. Participating clinicians may decide not to participate or may leave the study at any time. This decision will not result in any penalty or loss of benefits to which they are entitled. Information that has already been collected may still be used, but no new information will be collected. The withdrawal reason and the withdrawal date will be documented.

Official Title
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The Long COVID and Fatiguing Illness Recovery Program - A Pragmatic, Quality Improvement, Professional Cluster, Randomized Controlled Trial.

Conditions
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SARS-CoV-2 Acute Respiratory Disease, Myalgic Encephalomyelitis, Chronic Fatigue Syndrome, Post-acute Sequelae of SARS-COV-2 Infection, Post COVID-19 Condition

Intervention / Treatment
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* Other: Extension for Community Healthcare Outcomes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion criteria for clinicians includes 1) being employed by FHCSD for clinical care delivery, 2) being a licensed primary care physician, physician assistant, or nurse practitioner, 3) caring for patients who have had persistent symptoms and a decline in health-related quality of life associated with PASC, ME/CFS, and/or OPIFI, and 4) being willing and able to actively participate in LC&FIRP. Exclusion Criteria: There are no exclusion criteria.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 20 consenting clinicians across primary care clinics at FHCSD will be randomized at a ratio of 1:1 to either participate in 1) weekly teleECHO sessions with monthly interactive webinars and quarterly short courses or 2) monthly interactive webinars and quarterly short courses alone (a control group). Throughout participation, the investigators expect that the clinicians will provide care for approximately 856 FHCSD patients diagnosed with PASC, ME/CFS, or OPIFI (approximately 42 patients per clinician). The clinicians will be consented and will receive exposure to intervention components (i.e., a professional cluster). Therefore, patient outcomes derived from routine clinical care will be evaluated according to the study arm of their respective clinicians.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>The Control arm participates in monthly interactive webinars and quarterly short courses. Monthly interactive webinars will offer brief didactic presentations by SMEs, examples of models of care, and a facilitated Q&A. These webinars will be convened to rapidly disseminate findings and emerging best practices to a large-scale, national audience. Quarterly short courses will be developed to summarize key findings from past weekly teleECHO sessions. These quarterly short courses will be formatted as a learning module with the use of presentation slides and videos online that are accessible asynchronously. | |
| Experimental: Intervention<br>The Intervention arm participates in weekly teleECHO sessions with monthly interactive webinars and quarterly short courses. | Other: Extension for Community Healthcare Outcomes<br>* ECHO is a technology enabled multi-disciplinary team-based care model centered on case-consultation and peer-to-peer sharing of emerging best practices (i.e., teleECHO) to support management of complex cases associated with Long COVID, ME/CFS, and other PIFI.<br>* Other names: ECHO;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Patient baseline and quarterly surveys | During 12 months of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient symptom checklist with associated severity for those present | Patient baseline and quarterly surveys, None, Mild, Moderate, Severe | During 12 months of follow-up | 
| If symptom is present, has patient experienced this in the past month | Patient baseline and quarterly surveys, Yes/No | During 12 months of follow-up | 
| If symptom is present, how long has patient experienced this symptom | Patient baseline and quarterly surveys, Under 3 Months, 3 Months or longer | During 12 months of follow-up | 
| If symptom is present, did patient have this symptom before the patient tested positive for COVID-19? | Patient baseline and quarterly surveys, Yes/No | During 12 months of follow-up | 
| If symptom is present, during the past month how often have the patient had this symptom? | Patient baseline and quarterly surveys with use of Likert scale | During 12 months of follow-up | 
| If symptom is present during the past month, how bad was this symptom? | Patient baseline and quarterly surveys with use of Likert scale | During 12 months of follow-up | 
| For symptoms present, do any of them get worse for at least 24 hours after engaging in activities (physical or mental) that patient was used to doing with no problems? | Patient baseline and quarterly surveys with Yes/No/Not Applicable/Don't Know | During 12 months of follow-up | 
| If fatigue, tiredness, or exhaustion is present, doesn't patient describe it as feeling it come on all of a sudden, or slowly over time | Patient baseline and quarterly surveys with All of sudden, Slowly over time, Not applicable, Don't know | During 12 months of follow-up | 
| If fatigue present, what month and year did the fatiguing illness begin? | Patient baseline and quarterly surveys, estimated month and year | During 12 months of follow-up | 
| When fatigued, does rest make patient's fatigue better? | Patient baseline and quarterly surveys, Yes a lot, Yes a little, No not very much, Not applicable, Don't know | During 12 months of follow-up | 
| When fatigued, has this fatigue substantially limited the patient's ability to occupational, educational, social, or personal activities? | Patient baseline and quarterly surveys, Yes, No, Not applicable, Don't know | During 12 months of follow-up | 
| Patient's medical history check-list | Patient baseline survey, Yes, No, Unsure | Through study referral period, an average of 12 weeks | 
| Patient's dietary restrictions | Patient baseline survey, No, Vegan, Vegetarian, Ketogenic, Gluten-free, Dairy-free, Intermittent fasting, Other | Through study referral period, an average of 12 weeks | 
| Patient's food allergies or other food intolerances | Patient baseline survey, Yes/No | Through study referral period, an average of 12 weeks | 
| Has patient's employment been impacted due to contracting COVID-19? | Patient baseline survey, Yes, No | Through study referral period, an average of 12 weeks | 
| Patient's frequency to complete 150-minutes per week of moderate-intensity physical activity (like a brisk walk, slow biking, gardening, or ballroom dancing) prior to contracting COVID-19 | Patient baseline survey, Every week, Most weeks, Some weeks, Very few weeks, Never, I do not know | Through study referral period, an average of 12 weeks | 
| Patient's frequency to complete 150-minutes per week of vigorous-intensity physical activity (like running, swimming laps, competitive sports, or fast bicycling) prior to contracting COVID-19 | Patient baseline survey, Every week, Most weeks, Some weeks, Very few weeks, Never, I do not know | Through study referral period, an average of 12 weeks | 
| Did patient receive a COVID-19 PCR (nasal swab) test | Patient baseline survey, Yes/No | Through study referral period, an average of 12 weeks | 
| Did patient receive a COVID-19 antibody test | Patient baseline survey, Yes/No | Through study referral period, an average of 12 weeks | 
| Patient symptom onset | Patient baseline survey, Date | Through study referral period, an average of 12 weeks | 
| Patient reported medications used for COVID-19 symptoms | Patient baseline survey, free text | Through study referral period, an average of 12 weeks | 
| Patient reported prescribed supplementary oxygen support | Patient baseline survey, Yes/No | Through study referral period, an average of 12 weeks | 
| Patient reported admittance to hospital due to COVID-19 | Patient baseline and quarterly surveys, Yes/No | During 12 months of follow-up | 
| Do any of the following activities exacerbate patients symptoms: Physical exertion, Diet Changes, Big Meal, Dehydration, Weather changes (hot and humid), Tight clothing, Stress or anxiety, Pre Menstrual period, Menstrual period, Alcohol consumption | Patient baseline and quarterly surveys, Yes/No | During 12 months of follow-up | 
| Does patient feel fully recovered from COVID-19 | Patient quarterly surveys, Yes/No | During 9 months of follow-up | 
| Currently minutes per week of moderate-intensity physical activity patient does (like a brisk walk, slow biking, gardening, or ballroom dancing) | Patient quarterly surveys, free text | During 9 months of follow-up | 
| Currently minutes per week of vigorous-intensity physical activity patient does (like running, swimming laps, competitive sports, or fast bicycling) | Patient quarterly surveys, free text | During 9 months of follow-up | 
| Patient Health Questionnaire (PHQ)-2 | Patient baseline and quarterly surveys | During 12 months of follow-up | 
| Patient Health Questionnaire (PHQ)-9 (if applicable) | Patient baseline and quarterly surveys | During 12 months of follow-up | 
| PROMIS Dyspnea Functional Limitations and Severity Short Forms | Patient baseline and quarterly surveys | During 12 months of follow-up | 
| PROMIS Applied Cognition Abilities and General Concerns Short Forms | Patient baseline and quarterly surveys | During 12 months of follow-up | 
| Generalized Anxiety Disorder (GAD)-7 | Patient baseline and quarterly surveys | During 12 months of follow-up | 
| 2-minute step test | Physical Therapy assessment with patient | During 12 months of follow-up | 
| 30 sec sit to stand test | Physical Therapy assessment with patient | During 12 months of follow-up | 
| Grip strength | Physical Therapy assessment with patient | During 12 months of follow-up | 
| Functional Gait Assessment | Physical Therapy assessment with patient | During 12 months of follow-up | 
| Balance tasks | Physical Therapy assessment with patient | During 12 months of follow-up | 
| Post-exertional malaise follow-up | Follow-up Physical Therapy appointment with patient, Not at all, A little bit, Somewhat, Quite a bit, Very much | Per Physical Therapy encounter after PT assessment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ME, Long COVID, CFS, PASC, PCC