Clinical trial NCT05167227: 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?
Official title: The Long COVID and Fatiguing Illness Recovery Program - A Pragmatic, Quality Improvement, Professional Cluster, Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: SARS-CoV-2 Acute Respiratory Disease
Myalgic Encephalomyelitis
Chronic Fatigue Syndrome
Post-acute Sequelae of SARS-COV-2 Infection
Post COVID-19 Condition
Keywords: Long COVID
ME
CFS
PASC
PCC
Lead sponsor: Family Health Centers of San Diego
Sponsor class: OTHER
First posted: 2021-12-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient-Reported Outcomes Measurement Information System (PROMIS)-29
timeFrame: During 12 months of follow-up
Secondary outcomes:
measure: Patient symptom checklist with associated severity for those present
timeFrame: During 12 months of follow-up
measure: If symptom is present, has patient experienced this in the past month
timeFrame: During 12 months of follow-up
measure: If symptom is present, how long has patient experienced this symptom
timeFrame: During 12 months of follow-up
measure: If symptom is present, did patient have this symptom before the patient tested positive for COVID-19?
timeFrame: During 12 months of follow-up
measure: If symptom is present, during the past month how often have the patient had this symptom?
timeFrame: During 12 months of follow-up
measure: If symptom is present during the past month, how bad was this symptom?
timeFrame: During 12 months of follow-up
measure: 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?
timeFrame: During 12 months of follow-up
measure: 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
timeFrame: During 12 months of follow-up
measure: If fatigue present, what month and year did the fatiguing illness begin?
timeFrame: During 12 months of follow-up
measure: When fatigued, does rest make patient's fatigue better?
timeFrame: During 12 months of follow-up
measure: When fatigued, has this fatigue substantially limited the patient's ability to occupational, educational, social, or personal activities?
timeFrame: During 12 months of follow-up
measure: Patient's medical history check-list
timeFrame: Through study referral period, an average of 12 weeks
measure: Patient's dietary restrictions
timeFrame: Through study referral period, an average of 12 weeks
measure: Patient's food allergies or other food intolerances
timeFrame: Through study referral period, an average of 12 weeks
measure: Has patient's employment been impacted due to contracting COVID-19?
timeFrame: Through study referral period, an average of 12 weeks
measure: 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
timeFrame: Through study referral period, an average of 12 weeks
measure: 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
timeFrame: Through study referral period, an average of 12 weeks
measure: Did patient receive a COVID-19 PCR (nasal swab) test
timeFrame: Through study referral period, an average of 12 weeks
measure: Did patient receive a COVID-19 antibody test
timeFrame: Through study referral period, an average of 12 weeks
measure: Patient symptom onset
timeFrame: Through study referral period, an average of 12 weeks
measure: Patient reported medications used for COVID-19 symptoms
timeFrame: Through study referral period, an average of 12 weeks
measure: Patient reported prescribed supplementary oxygen support
timeFrame: Through study referral period, an average of 12 weeks
measure: Patient reported admittance to hospital due to COVID-19
timeFrame: During 12 months of follow-up
measure: 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
timeFrame: During 12 months of follow-up
measure: Does patient feel fully recovered from COVID-19
timeFrame: During 9 months of follow-up
measure: Currently minutes per week of moderate-intensity physical activity patient does (like a brisk walk, slow biking, gardening, or ballroom dancing)
timeFrame: During 9 months of follow-up
measure: Currently minutes per week of vigorous-intensity physical activity patient does (like running, swimming laps, competitive sports, or fast bicycling)
timeFrame: During 9 months of follow-up
measure: Patient Health Questionnaire (PHQ)-2
timeFrame: During 12 months of follow-up
measure: Patient Health Questionnaire (PHQ)-9 (if applicable)
timeFrame: During 12 months of follow-up
measure: PROMIS Dyspnea Functional Limitations and Severity Short Forms
timeFrame: During 12 months of follow-up
measure: PROMIS Applied Cognition Abilities and General Concerns Short Forms
timeFrame: During 12 months of follow-up
measure: Generalized Anxiety Disorder (GAD)-7
timeFrame: During 12 months of follow-up
measure: 2-minute step test
timeFrame: During 12 months of follow-up
measure: 30 sec sit to stand test
timeFrame: During 12 months of follow-up
measure: Grip strength
timeFrame: During 12 months of follow-up
measure: Functional Gait Assessment
timeFrame: During 12 months of follow-up
measure: Balance tasks
timeFrame: During 12 months of follow-up
measure: Post-exertional malaise follow-up
timeFrame: Per Physical Therapy encounter after PT assessment
Other outcomes:
measure: Knowledge improvement of appropriate PASC diagnosis as a result of participation in randomized arm (teleECHO or monthly webinar)
timeFrame: During 37 months of follow-up
measure: Knowledge improvement of effective PASC care and treatment as a result of participation in randomized arm (teleECHO or monthly webinar)
timeFrame: During 37 months of follow-up
measure: Knowledge improvement of approaches for complex cases of PASC as a result of participation in randomized arm (teleECHO or monthly webinar)
timeFrame: During 37 months of follow-up
measure: Self-efficacy in abilities related to identify tools and methods for PASC care
timeFrame: During 37 months of follow-up
measure: Self-efficacy in abilities to diagnose patients with PASC
timeFrame: During 37 months of follow-up
measure: Self-efficacy in abilities to screen for co-morbidities of PASC
timeFrame: During 37 months of follow-up
measure: Self-efficacy in abilities to generate a patient-specific treatment plan for patients with PASC
timeFrame: During 37 months of follow-up
measure: Self-efficacy in abilities related to to implement a patient-specific treatment plan for patients with PASC
timeFrame: During 37 months of follow-up
measure: Self-efficacy in abilities to select appropriate special or diagnostic tests for PASC patients
timeFrame: During 37 months of follow-up
measure: Self-efficacy in abilities to interpret special or diagnostic test results for my PASC patients
timeFrame: During 37 months of follow-up
measure: Self-efficacy in abilities to provide appropriate patient education about their PASC condition
timeFrame: During 37 months of follow-up
measure: Self-efficacy in abilities to educate clinic staff about PASC care
timeFrame: During 37 months of follow-up
measure: Self-efficacy in abilities to address PASC patients using a multidisciplinary approach
timeFrame: During 37 months of follow-up
measure: Self-efficacy in abilities to assess and manage concerns that PASC patients face
timeFrame: During 37 months of follow-up
measure: Self-efficacy in abilities to assess severity of disease in patients with PASC
timeFrame: During 37 months of follow-up
measure: Self-efficacy in abilities to deal with complex cases of PASC
timeFrame: During 37 months of follow-up
measure: Utility of an encountered case presented during randomized arm (teleECHO or monthly webinar)
timeFrame: During 34 months of follow-up
measure: Overall satisfaction with randomized arm (teleECHO or monthly webinar)
timeFrame: During 34 months of follow-up
measure: Satisfaction to recommend to colleague randomized arm (teleECHO or monthly webinar)
timeFrame: During 34 months of follow-up
measure: Satisfaction to participate in future randomized arm (teleECHO or monthly webinar) again
timeFrame: During 34 months of follow-up
measure: Changes to practice in helping colleague with information learned from randomized arm (teleECHO or monthly webinar)
timeFrame: During 34 months of follow-up
measure: Changes to practice by participating in randomized arm (teleECHO or monthly webinar) to understand further monitoring and follow-up plan
timeFrame: During 34 months of follow-up
measure: Changes to practice by participating in randomized arm (teleECHO or monthly webinar) to develop more appropriate treatment plans
timeFrame: During 34 months of follow-up
measure: Changes to practice by participating in randomized arm (teleECHO or monthly webinar) to have a better understanding of underlying disease process and the role of specialist referral
timeFrame: During 34 months of follow-up
measure: Changes to practice by participating in randomized arm (teleECHO or monthly webinar) to more independently manage my PASC patients without referral to a specialist
timeFrame: During 34 months of follow-up
measure: Changes to practice by participating in randomized arm (teleECHO or monthly webinar) to apply specialist recommendations to patient care.
timeFrame: During 34 months of follow-up
measure: Unable to apply learnings from randomized arm (teleECHO or monthly webinar)
timeFrame: During 34 months of follow-up
measure: Other changes to practice by participating in randomized arm (teleECHO or monthly webinar)
timeFrame: During 34 months of follow-up
measure: Knowledge gained about topic presented during teleECHO before and after
timeFrame: During 37 months after each weekly ECHO session
measure: Knowledge gained about topic presented during teleECHO before and after
timeFrame: Through study completion, an average of 37 months
measure: Satisfaction with stated objectives being met
timeFrame: Through study completion, an average of 37 months
measure: Satisfaction with session delivering balanced and objective, evidence-based content
timeFrame: Through study completion, an average of 37 months
measure: Satisfaction with pace of session
timeFrame: Through study completion, an average of 37 months
measure: Satisfaction with opportunities to ask questions
timeFrame: Through study completion, an average of 37 months
measure: Satisfaction with organization of the presenters' presentations
timeFrame: Through study completion, an average of 37 months
measure: Satisfaction with presenters' ability to clearly communicate
timeFrame: Through study completion, an average of 37 months
measure: Desired content for future sessions
timeFrame: Through study completion, an average of 37 months
measure: Satisfaction with source evidence presented
timeFrame: Through study completion, an average of 37 months
measure: Satisfaction with commercial bias present
timeFrame: Through study completion, an average of 37 months
measure: Recommendations for program improvement
timeFrame: Through study completion, an average of 37 months
measure: Relevance of session to clinicians current work
timeFrame: Through study completion, an average of 37 months
measure: Intent to change practice based on learnings from session
timeFrame: Through study completion, an average of 37 months
measure: Best part of session
timeFrame: Through study completion, an average of 37 months
measure: Worst part of session
timeFrame: Through study completion, an average of 37 months
measure: Recommend this session to a colleague
timeFrame: Through study completion, an average of 37 months
measure: Changes to practice planned
timeFrame: Through study completion, an average of 37 months
measure: If no changes to practice are planned, barriers
timeFrame: Through study completion, an average of 37 months
measure: Participating clinician retention
timeFrame: Semi-annually during 37 months of follow-up
measure: Participating clinic settings
timeFrame: Semi-annually during 37 months of follow-up
measure: Participation in intervention
timeFrame: Weekly during 37 months of follow-up
measure: Exposure of weekly teleECHO topics
timeFrame: Weekly during 37 months of follow-up
measure: Monthly webinar attendance
timeFrame: Monthly during 37 months of follow-up
measure: Quarterly short course attendance
timeFrame: Quarterly during 37 months of follow-up
measure: Exposure of monthly webinar topics
timeFrame: Monthly during 37 months of follow-up
measure: Exposure of quarterly short course topics
timeFrame: Quarterly during 37 months of follow-up
measure: Participation in case consultation
timeFrame: Quarterly during 37 months of follow-up
measure: Participation in post-session survey
timeFrame: Weekly during 37 months of follow-up
measure: Volume of total patient case load
timeFrame: Monthly during 37 months of follow-up
measure: Volume of PASC patient case load
timeFrame: Monthly during 37 months of follow-up
measure: Volume of patient referrals to specialists
timeFrame: Monthly during 37 months of follow-up
measure: Application of specialist recommendations
timeFrame: Quarterly during 37 months of follow-up
measure: Average consultation duration
timeFrame: Monthly during 37 months of follow-up
measure: Volume of specialists seen by patients
timeFrame: Monthly during 37 months of follow-up
measure: Specialty types patient was exposed to
timeFrame: Monthly during 37 months of follow-up
measure: Clinician session drop-off
timeFrame: Weekly during 37 months of follow-up
measure: Quarterly attendance
timeFrame: Quarterly during 37 months of follow-up
measure: Clinician satisfaction with series
timeFrame: Up to 8 weeks after end of study
measure: Clinician overall best part of series
timeFrame: Up to 8 weeks after end of study
measure: Clinician overall worst part of series
timeFrame: Up to 8 weeks after end of study
measure: Clinician challenges in participating
timeFrame: Up to 8 weeks after end of study
measure: Perceived change in the relationship between clinicians and specialists in panel as a result of this series?
timeFrame: Up to 8 weeks after end of study
measure: Clinician barriers to sustained participation in series
timeFrame: Up to 8 weeks after end of study
measure: Did clinician experience an improvement in the number of PASC patients they could manage at any given time as a result of the series?
timeFrame: Up to 8 weeks after end of study
measure: Did clinicians experience an increase in PASC patients in their panel composition over time as a result of participation in the series?
timeFrame: Up to 8 weeks after end of study
measure: Did clinic directors observe an increase in PASC patients in the clinicians panel composition over time as a result of their participation in the series?
timeFrame: Up to 8 weeks after end of study
measure: Did clinicians experience an improvement in the quality of care for patients as a result of participating in the series?
timeFrame: Up to 8 weeks after end of study
measure: Did clinic directors observe an improvement in the quality of care for patients as a result of a clinician participating in the series?
timeFrame: Up to 8 weeks after end of study
measure: Did clinicians participating influence other providers in their clinic?
timeFrame: Up to 8 weeks after end of study
measure: Did clinic directors observe clinicians who participated in the series influence other providers within the clinic?
timeFrame: Up to 8 weeks after end of study
measure: Clinician benefits gained from participating in the series
timeFrame: Up to 8 weeks after end of study
measure: Clinician recommendations for improving the scalability or sustainability of this model
timeFrame: Up to 8 weeks after end of study
measure: Clinic directors recommendations for improving the scalability or sustainability of this model
timeFrame: Up to 8 weeks after end of study
Locations:
city: San Diego
country: United States
facility: Family Health Centers of San Diego
state: California
Study officials:
affiliation: Family Health Centers of San Diego
name: Christian Ramers, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Family Health Centers of San Diego
name: Job Godino, PhD
role: PRINCIPAL_INVESTIGATOR
References: