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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
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.
Family Health Centers of San Diego
San Diego, California, United States
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Patient baseline and quarterly surveys
Time frame: During 12 months of follow-up
Patient symptom checklist with associated severity for those present
Patient baseline and quarterly surveys, None, Mild, Moderate, Severe
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: During 12 months of follow-up
Patient's medical history check-list
Patient baseline survey, Yes, No, Unsure
Time frame: 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
Time frame: Through study referral period, an average of 12 weeks
Patient's food allergies or other food intolerances
Patient baseline survey, Yes/No
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Through study referral period, an average of 12 weeks
Did patient receive a COVID-19 PCR (nasal swab) test
Patient baseline survey, Yes/No
Time frame: Through study referral period, an average of 12 weeks
Did patient receive a COVID-19 antibody test
Patient baseline survey, Yes/No
Time frame: Through study referral period, an average of 12 weeks
Patient symptom onset
Patient baseline survey, Date
Time frame: Through study referral period, an average of 12 weeks
Patient reported medications used for COVID-19 symptoms
Patient baseline survey, free text
Time frame: Through study referral period, an average of 12 weeks
Patient reported prescribed supplementary oxygen support
Patient baseline survey, Yes/No
Time frame: 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
Time frame: 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
Time frame: During 12 months of follow-up
Does patient feel fully recovered from COVID-19
Patient quarterly surveys, Yes/No
Time frame: 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
Time frame: 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
Time frame: During 9 months of follow-up
Patient Health Questionnaire (PHQ)-2
Patient baseline and quarterly surveys
Time frame: During 12 months of follow-up
Patient Health Questionnaire (PHQ)-9 (if applicable)
Patient baseline and quarterly surveys
Time frame: During 12 months of follow-up
PROMIS Dyspnea Functional Limitations and Severity Short Forms
Patient baseline and quarterly surveys
Time frame: During 12 months of follow-up
PROMIS Applied Cognition Abilities and General Concerns Short Forms
Patient baseline and quarterly surveys
Time frame: During 12 months of follow-up
Generalized Anxiety Disorder (GAD)-7
Patient baseline and quarterly surveys
Time frame: During 12 months of follow-up
2-minute step test
Physical Therapy assessment with patient
Time frame: During 12 months of follow-up
30 sec sit to stand test
Physical Therapy assessment with patient
Time frame: During 12 months of follow-up
Grip strength
Physical Therapy assessment with patient
Time frame: During 12 months of follow-up
Functional Gait Assessment
Physical Therapy assessment with patient
Time frame: During 12 months of follow-up
Balance tasks
Physical Therapy assessment with patient
Time frame: 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
Time frame: Per Physical Therapy encounter after PT assessment
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