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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05167227
Other study ID # HS-2021-0241
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 30, 2021
Est. completion date October 31, 2024

Study information

Verified date November 2023
Source Family Health Centers of San Diego
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Active, not recruiting
Enrollment 20
Est. completion date October 31, 2024
Est. primary completion date October 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Other:
Extension for Community Healthcare Outcomes
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.

Locations

Country Name City State
United States Family Health Centers of San Diego San Diego California

Sponsors (1)

Lead Sponsor Collaborator
Family Health Centers of San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Knowledge improvement of appropriate PASC diagnosis as a result of participation in randomized arm (teleECHO or monthly webinar) Clinician quarterly follow-up survey with use of Likert scale agreement During 37 months of follow-up
Other Knowledge improvement of effective PASC care and treatment as a result of participation in randomized arm (teleECHO or monthly webinar) Clinician quarterly follow-up survey with use of Likert scale agreement During 37 months of follow-up
Other Knowledge improvement of approaches for complex cases of PASC as a result of participation in randomized arm (teleECHO or monthly webinar) Clinician quarterly follow-up survey with use of Likert scale agreement During 37 months of follow-up
Other Self-efficacy in abilities related to identify tools and methods for PASC care Clinician baseline and quarterly follow-up survey with use of Likert scale agreement During 37 months of follow-up
Other Self-efficacy in abilities to diagnose patients with PASC Clinician baseline and quarterly follow-up survey with use of Likert scale agreement During 37 months of follow-up
Other Self-efficacy in abilities to screen for co-morbidities of PASC Clinician baseline and quarterly follow-up survey with use of Likert scale agreement During 37 months of follow-up
Other Self-efficacy in abilities to generate a patient-specific treatment plan for patients with PASC Clinician baseline and quarterly follow-up survey with use of Likert scale agreement During 37 months of follow-up
Other Self-efficacy in abilities related to to implement a patient-specific treatment plan for patients with PASC Clinician baseline and quarterly follow-up survey with use of Likert scale agreement During 37 months of follow-up
Other Self-efficacy in abilities to select appropriate special or diagnostic tests for PASC patients Clinician baseline and quarterly follow-up survey with use of Likert scale agreement During 37 months of follow-up
Other Self-efficacy in abilities to interpret special or diagnostic test results for my PASC patients Clinician baseline and quarterly follow-up survey with use of Likert scale agreement During 37 months of follow-up
Other Self-efficacy in abilities to provide appropriate patient education about their PASC condition Clinician baseline and quarterly follow-up survey with use of Likert scale agreement During 37 months of follow-up
Other Self-efficacy in abilities to educate clinic staff about PASC care Clinician baseline and quarterly follow-up survey with use of Likert scale agreement During 37 months of follow-up
Other Self-efficacy in abilities to address PASC patients using a multidisciplinary approach Clinician baseline and quarterly follow-up survey with use of Likert scale agreement During 37 months of follow-up
Other Self-efficacy in abilities to assess and manage concerns that PASC patients face Clinician baseline and quarterly follow-up survey with use of Likert scale agreement During 37 months of follow-up
Other Self-efficacy in abilities to assess severity of disease in patients with PASC Clinician baseline and quarterly follow-up survey with use of Likert scale agreement During 37 months of follow-up
Other Self-efficacy in abilities to deal with complex cases of PASC Clinician baseline and quarterly follow-up survey with use of Likert scale agreement During 37 months of follow-up
Other Utility of an encountered case presented during randomized arm (teleECHO or monthly webinar) Clinician quarterly follow-up survey Yes/No During 34 months of follow-up
Other Overall satisfaction with randomized arm (teleECHO or monthly webinar) Clinician quarterly follow-up survey with use of Likert scale agreement During 34 months of follow-up
Other Satisfaction to recommend to colleague randomized arm (teleECHO or monthly webinar) Clinician quarterly follow-up survey with use of Likert scale likelihood During 34 months of follow-up
Other Satisfaction to participate in future randomized arm (teleECHO or monthly webinar) again Clinician quarterly follow-up survey with use of Likert scale likelihood During 34 months of follow-up
Other Changes to practice in helping colleague with information learned from randomized arm (teleECHO or monthly webinar) Clinician quarterly follow-up survey Yes/No During 34 months of follow-up
Other Changes to practice by participating in randomized arm (teleECHO or monthly webinar) to understand further monitoring and follow-up plan Clinician quarterly follow-up survey with use of Likert scale agreement During 34 months of follow-up
Other Changes to practice by participating in randomized arm (teleECHO or monthly webinar) to develop more appropriate treatment plans Clinician quarterly follow-up survey with use of Likert scale agreement During 34 months of follow-up
Other 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 Clinician quarterly follow-up survey with use of Likert scale agreement During 34 months of follow-up
Other Changes to practice by participating in randomized arm (teleECHO or monthly webinar) to more independently manage my PASC patients without referral to a specialist Clinician quarterly follow-up survey with use of Likert scale agreement During 34 months of follow-up
Other Changes to practice by participating in randomized arm (teleECHO or monthly webinar) to apply specialist recommendations to patient care. Clinician quarterly follow-up survey with use of Likert scale agreement and free text During 34 months of follow-up
Other Unable to apply learnings from randomized arm (teleECHO or monthly webinar) Clinician quarterly follow-up survey with use of Likert scale agreement and free text During 34 months of follow-up
Other Other changes to practice by participating in randomized arm (teleECHO or monthly webinar) Clinician quarterly follow-up survey with free text During 34 months of follow-up
Other Knowledge gained about topic presented during teleECHO before and after Clinician intervention teleECHO survey During 37 months after each weekly ECHO session
Other Knowledge gained about topic presented during teleECHO before and after Clinician intervention teleECHO survey with use of Likert scale knowledge Through study completion, an average of 37 months
Other Satisfaction with stated objectives being met Clinician intervention teleECHO survey with use of Likert scale quality Through study completion, an average of 37 months
Other Satisfaction with session delivering balanced and objective, evidence-based content Clinician intervention teleECHO survey with use of Likert scale quality Through study completion, an average of 37 months
Other Satisfaction with pace of session Clinician intervention teleECHO survey with use of Likert scale quality Through study completion, an average of 37 months
Other Satisfaction with opportunities to ask questions Clinician intervention teleECHO survey with use of Likert scale quality Through study completion, an average of 37 months
Other Satisfaction with organization of the presenters' presentations Clinician intervention teleECHO survey with use of Likert scale quality Through study completion, an average of 37 months
Other Satisfaction with presenters' ability to clearly communicate Clinician intervention teleECHO survey with use of Likert scale quality Through study completion, an average of 37 months
Other Desired content for future sessions Clinician intervention teleECHO survey, free text Through study completion, an average of 37 months
Other Satisfaction with source evidence presented Clinician intervention teleECHO survey Yes/No Through study completion, an average of 37 months
Other Satisfaction with commercial bias present Clinician intervention teleECHO survey Yes/No and free text Through study completion, an average of 37 months
Other Recommendations for program improvement Clinician intervention teleECHO survey free text Through study completion, an average of 37 months
Other Relevance of session to clinicians current work Clinician intervention teleECHO survey with use of Likert scale relevance Through study completion, an average of 37 months
Other Intent to change practice based on learnings from session Clinician intervention teleECHO survey Yes/No and free text Through study completion, an average of 37 months
Other Best part of session Clinician intervention teleECHO survey free text Through study completion, an average of 37 months
Other Worst part of session Clinician intervention teleECHO survey free text Through study completion, an average of 37 months
Other Recommend this session to a colleague Clinician intervention teleECHO survey with use of Likert scale likelihood Through study completion, an average of 37 months
Other Changes to practice planned Clinician intervention teleECHO survey free text Through study completion, an average of 37 months
Other If no changes to practice are planned, barriers Clinician intervention teleECHO survey free text Through study completion, an average of 37 months
Other Participating clinician retention Mean number of months clinicians participate in the trial (intervention and control groups) Semi-annually during 37 months of follow-up
Other Participating clinic settings Number of clinic settings in which providers see patients (intervention and control groups) Semi-annually during 37 months of follow-up
Other Participation in intervention Number of weekly sessions each RCT (intervention) provider attends, and mean number Weekly during 37 months of follow-up
Other Exposure of weekly teleECHO topics Number of topics covered in Weekly ECHO sessions RCT (intervention) provider attends Weekly during 37 months of follow-up
Other Monthly webinar attendance Number of monthly webinars RCT providers attends Monthly during 37 months of follow-up
Other Quarterly short course attendance Number of quarterly short courses RCT providers attends Quarterly during 37 months of follow-up
Other Exposure of monthly webinar topics Number of topics covered in monthly webinars provider attends Monthly during 37 months of follow-up
Other Exposure of quarterly short course topics Number of topics covered in quarterly short courses provider attends Quarterly during 37 months of follow-up
Other Participation in case consultation Number of patient cases presented by RCT (intervention) provider Quarterly during 37 months of follow-up
Other Participation in post-session survey Proportion of participants that complete each session poll (disaggregated by monthly webinar, weekly session, RCT vs. non-RCT provider) Weekly during 37 months of follow-up
Other Volume of total patient case load Number of patients seen by RCT provider, and mean number (intervention and control) Monthly during 37 months of follow-up
Other Volume of PASC patient case load Number of PASC patients seen by RCT provider, and mean number (intervention and control) Monthly during 37 months of follow-up
Other Volume of patient referrals to specialists Number of referrals to specialists by RCT provider, and mean number (intervention and control) Monthly during 37 months of follow-up
Other Application of specialist recommendations Number of specialist recommendations applied by RCT (intervention) providers from weekly ECHO sessions Quarterly during 37 months of follow-up
Other Average consultation duration Mean duration of consultation for PASC patients by RCT providers, intervention and control Monthly during 37 months of follow-up
Other Volume of specialists seen by patients Number of specialists seen by patient Monthly during 37 months of follow-up
Other Specialty types patient was exposed to Number of specialty types the patient was exposed to Monthly during 37 months of follow-up
Other Clinician session drop-off How long an (intervention) provider attended an ECHO session Weekly during 37 months of follow-up
Other Quarterly attendance Number of individuals who attended and watched short course Quarterly during 37 months of follow-up
Other Clinician satisfaction with series Interview with Likert satisfaction Up to 8 weeks after end of study
Other Clinician overall best part of series Interview Up to 8 weeks after end of study
Other Clinician overall worst part of series Interview Up to 8 weeks after end of study
Other Clinician challenges in participating Interview Up to 8 weeks after end of study
Other Perceived change in the relationship between clinicians and specialists in panel as a result of this series? Interview, Yes/No with free response Up to 8 weeks after end of study
Other Clinician barriers to sustained participation in series Interview Up to 8 weeks after end of study
Other Did clinician experience an improvement in the number of PASC patients they could manage at any given time as a result of the series? Interview, Yes/No with free response Up to 8 weeks after end of study
Other Did clinicians experience an increase in PASC patients in their panel composition over time as a result of participation in the series? Interview, Yes/No with free response Up to 8 weeks after end of study
Other 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? Interview, Yes/No with free response Up to 8 weeks after end of study
Other Did clinicians experience an improvement in the quality of care for patients as a result of participating in the series? Interview, Yes/No with free response Up to 8 weeks after end of study
Other Did clinic directors observe an improvement in the quality of care for patients as a result of a clinician participating in the series? Interview, Yes/No with free response Up to 8 weeks after end of study
Other Did clinicians participating influence other providers in their clinic? Interview, Yes/No with free response Up to 8 weeks after end of study
Other Did clinic directors observe clinicians who participated in the series influence other providers within the clinic? Interview, Yes/No with free response Up to 8 weeks after end of study
Other Clinician benefits gained from participating in the series Interview, free response Up to 8 weeks after end of study
Other Clinician recommendations for improving the scalability or sustainability of this model Interview, free response Up to 8 weeks after end of study
Other Clinic directors recommendations for improving the scalability or sustainability of this model Interview, free response Up to 8 weeks after end of study
Primary Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Patient baseline and quarterly surveys During 12 months of follow-up
Secondary Patient symptom checklist with associated severity for those present Patient baseline and quarterly surveys, None, Mild, Moderate, Severe During 12 months of follow-up
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Patient's medical history check-list Patient baseline survey, Yes, No, Unsure Through study referral period, an average of 12 weeks
Secondary 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
Secondary Patient's food allergies or other food intolerances Patient baseline survey, Yes/No Through study referral period, an average of 12 weeks
Secondary 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
Secondary 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
Secondary 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
Secondary Did patient receive a COVID-19 PCR (nasal swab) test Patient baseline survey, Yes/No Through study referral period, an average of 12 weeks
Secondary Did patient receive a COVID-19 antibody test Patient baseline survey, Yes/No Through study referral period, an average of 12 weeks
Secondary Patient symptom onset Patient baseline survey, Date Through study referral period, an average of 12 weeks
Secondary Patient reported medications used for COVID-19 symptoms Patient baseline survey, free text Through study referral period, an average of 12 weeks
Secondary Patient reported prescribed supplementary oxygen support Patient baseline survey, Yes/No Through study referral period, an average of 12 weeks
Secondary Patient reported admittance to hospital due to COVID-19 Patient baseline and quarterly surveys, Yes/No During 12 months of follow-up
Secondary 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
Secondary Does patient feel fully recovered from COVID-19 Patient quarterly surveys, Yes/No During 9 months of follow-up
Secondary 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
Secondary 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
Secondary Patient Health Questionnaire (PHQ)-2 Patient baseline and quarterly surveys During 12 months of follow-up
Secondary Patient Health Questionnaire (PHQ)-9 (if applicable) Patient baseline and quarterly surveys During 12 months of follow-up
Secondary PROMIS Dyspnea Functional Limitations and Severity Short Forms Patient baseline and quarterly surveys During 12 months of follow-up
Secondary PROMIS Applied Cognition Abilities and General Concerns Short Forms Patient baseline and quarterly surveys During 12 months of follow-up
Secondary Generalized Anxiety Disorder (GAD)-7 Patient baseline and quarterly surveys During 12 months of follow-up
Secondary 2-minute step test Physical Therapy assessment with patient During 12 months of follow-up
Secondary 30 sec sit to stand test Physical Therapy assessment with patient During 12 months of follow-up
Secondary Grip strength Physical Therapy assessment with patient During 12 months of follow-up
Secondary Functional Gait Assessment Physical Therapy assessment with patient During 12 months of follow-up
Secondary Balance tasks Physical Therapy assessment with patient During 12 months of follow-up
Secondary 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
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