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?
- Conditions
- SARS-CoV-2 Acute Respiratory DiseaseChronic Fatigue SyndromePost-acute Sequelae of SARS-COV-2 InfectionMyalgic EncephalomyelitisPost COVID-19 Condition
- Interventions
- Other: Extension for Community Healthcare Outcomes
- Registration Number
- NCT05167227
- Lead Sponsor
- Family Health Centers of San Diego
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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.
- There are no exclusion criteria.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Extension for Community Healthcare Outcomes The Intervention arm participates in weekly teleECHO sessions with monthly interactive webinars and quarterly short courses.
- Primary Outcome Measures
Name Time Method Patient-Reported Outcomes Measurement Information System (PROMIS)-29 During 12 months of follow-up Patient baseline and quarterly surveys
- Secondary Outcome Measures
Name Time Method Patient symptom checklist with associated severity for those present During 12 months of follow-up Patient baseline and quarterly surveys, None, Mild, Moderate, Severe
If symptom is present, how long has patient experienced this symptom During 12 months of follow-up Patient baseline and quarterly surveys, Under 3 Months, 3 Months or longer
If symptom is present, during the past month how often have the patient had this symptom? During 12 months of follow-up Patient baseline and quarterly surveys with use of Likert scale
If symptom is present, did patient have this symptom before the patient tested positive for COVID-19? During 12 months of follow-up Patient baseline and quarterly surveys, Yes/No
If symptom is present during the past month, how bad was this symptom? During 12 months of follow-up Patient baseline and quarterly surveys with use of Likert scale
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 During 12 months of follow-up Patient baseline and quarterly surveys, Yes/No
Patient's dietary restrictions Through study referral period, an average of 12 weeks Patient baseline survey, No, Vegan, Vegetarian, Ketogenic, Gluten-free, Dairy-free, Intermittent fasting, Other
Patient's food allergies or other food intolerances Through study referral period, an average of 12 weeks Patient baseline survey, Yes/No
If symptom is present, has patient experienced this in the past month During 12 months of follow-up Patient baseline and quarterly surveys, Yes/No
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? During 12 months of follow-up Patient baseline and quarterly surveys with Yes/No/Not Applicable/Don't Know
When fatigued, has this fatigue substantially limited the patient's ability to occupational, educational, social, or personal activities? During 12 months of follow-up Patient baseline and quarterly surveys, Yes, No, Not applicable, Don't know
Patient's medical history check-list Through study referral period, an average of 12 weeks Patient baseline survey, Yes, No, Unsure
Patient symptom onset Through study referral period, an average of 12 weeks Patient baseline survey, Date
Patient reported admittance to hospital due to COVID-19 During 12 months of follow-up Patient baseline and quarterly surveys, Yes/No
2-minute step test During 12 months of follow-up Physical Therapy assessment with patient
30 sec sit to stand test During 12 months of follow-up Physical Therapy assessment with patient
Functional Gait Assessment During 12 months of follow-up Physical Therapy assessment with patient
If fatigue present, what month and year did the fatiguing illness begin? During 12 months of follow-up Patient baseline and quarterly surveys, estimated month and year
When fatigued, does rest make patient's fatigue better? During 12 months of follow-up Patient baseline and quarterly surveys, Yes a lot, Yes a little, No not very much, Not applicable, Don't know
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 During 12 months of follow-up Patient baseline and quarterly surveys with All of sudden, Slowly over time, Not applicable, Don't know
Has patient's employment been impacted due to contracting COVID-19? Through study referral period, an average of 12 weeks Patient baseline survey, Yes, No
Does patient feel fully recovered from COVID-19 During 9 months of follow-up Patient quarterly surveys, Yes/No
Currently minutes per week of moderate-intensity physical activity patient does (like a brisk walk, slow biking, gardening, or ballroom dancing) During 9 months of follow-up Patient quarterly surveys, free text
Balance tasks During 12 months of follow-up Physical Therapy assessment with patient
PROMIS Dyspnea Functional Limitations and Severity Short Forms During 12 months of follow-up Patient baseline and quarterly surveys
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 Through study referral period, an average of 12 weeks Patient baseline survey, Every week, Most weeks, Some weeks, Very few weeks, Never, I do not know
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 Through study referral period, an average of 12 weeks Patient baseline survey, Every week, Most weeks, Some weeks, Very few weeks, Never, I do not know
Did patient receive a COVID-19 PCR (nasal swab) test Through study referral period, an average of 12 weeks Patient baseline survey, Yes/No
Did patient receive a COVID-19 antibody test Through study referral period, an average of 12 weeks Patient baseline survey, Yes/No
Patient reported prescribed supplementary oxygen support Through study referral period, an average of 12 weeks Patient baseline survey, Yes/No
Currently minutes per week of vigorous-intensity physical activity patient does (like running, swimming laps, competitive sports, or fast bicycling) During 9 months of follow-up Patient quarterly surveys, free text
Patient Health Questionnaire (PHQ)-2 During 12 months of follow-up Patient baseline and quarterly surveys
Patient reported medications used for COVID-19 symptoms Through study referral period, an average of 12 weeks Patient baseline survey, free text
Patient Health Questionnaire (PHQ)-9 (if applicable) During 12 months of follow-up Patient baseline and quarterly surveys
Generalized Anxiety Disorder (GAD)-7 During 12 months of follow-up Patient baseline and quarterly surveys
Grip strength During 12 months of follow-up Physical Therapy assessment with patient
Post-exertional malaise follow-up Per Physical Therapy encounter after PT assessment Follow-up Physical Therapy appointment with patient, Not at all, A little bit, Somewhat, Quite a bit, Very much
PROMIS Applied Cognition Abilities and General Concerns Short Forms During 12 months of follow-up Patient baseline and quarterly surveys
Trial Locations
- Locations (1)
Family Health Centers of San Diego
🇺🇸San Diego, California, United States