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? (LC&FIRP)

• ClinicalTrials.gov Identifier: NCT05167227
• Recruitment Status: Recruiting
• First Posted: December 22, 2021
• Last Update Posted: February 15, 2023
• Sponsor: Family Health Centers of San Diego
• Information provided by (Responsible Party): Family Health Centers of San Diego

Study Description

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 PASC, ME/CFS, and OPIFI. 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.

Condition or disease	Intervention/treatment	Phase
SARS-CoV-2 Acute Respiratory Disease; Myalgic Encephalomyelitis; Chronic Fatigue Syndrome; Post-acute Sequelae of SARS-COV-2 Infection	Other: Extension for Community Healthcare Outcomes	Not Applicable

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 PASC, ME/CFS, and OPIFI. 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 PASC, ME/CFS, and OPIFI 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 PASC, ME/CFS, and/or OPIFI.

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 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. Outcomes will be measured at 3-, 6-, 9-,12-, 18-, 24-, 30-, and 33-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 PASC, ME/CFS, and/or OPIFI, 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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.
• Masking: Double (Investigator, Outcomes Assessor)
• Masking Description: 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.
• Primary Purpose: Treatment
• Official Title: The Long COVID and Fatiguing Illness Recovery Program - A Pragmatic, Quality Improvement, Professional Cluster, Randomized Controlled Trial.
• Actual Study Start Date: November 30, 2021
• Estimated Primary Completion Date: July 31, 2024
• Estimated Study Completion Date: July 31, 2024

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Control; 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; The Intervention arm participates in weekly teleECHO sessions with monthly interactive webinars and quarterly short courses.	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 PASC, ME/CFS, and OPIFI.; Other Name: ECHO

Outcome Measures

Primary Outcome Measures :

1. Patient-Reported Outcomes Measurement Information System (PROMIS)-29 [ Time Frame: During 12 months of follow-up ]
   Patient baseline and quarterly surveys

Secondary Outcome Measures :

1. Patient symptom checklist with associated severity for those present [ Time Frame: During 12 months of follow-up ]
   Patient baseline and quarterly surveys, None, Mild, Moderate, Severe
2. If symptom is present, has patient experienced this in the past month [ Time Frame: During 12 months of follow-up ]
   Patient baseline and quarterly surveys, Yes/No
3. If symptom is present, how long has patient experienced this symptom [ Time Frame: During 12 months of follow-up ]
   Patient baseline and quarterly surveys, Under 3 Months, 3 Months or longer
4. If symptom is present, did patient have this symptom before the patient tested positive for COVID-19? [ Time Frame: During 12 months of follow-up ]
   Patient baseline and quarterly surveys, Yes/No
5. If symptom is present, during the past month how often have the patient had this symptom? [ Time Frame: During 12 months of follow-up ]
   Patient baseline and quarterly surveys with use of Likert scale
6. If symptom is present during the past month, how bad was this symptom? [ Time Frame: During 12 months of follow-up ]
   Patient baseline and quarterly surveys with use of Likert scale
7. 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? [ Time Frame: During 12 months of follow-up ]
   Patient baseline and quarterly surveys with Yes/No/Not Applicable/Don't Know
8. 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 [ Time Frame: During 12 months of follow-up ]
   Patient baseline and quarterly surveys with All of sudden, Slowly over time, Not applicable, Don't know
9. If fatigue present, what month and year did the fatiguing illness begin? [ Time Frame: During 12 months of follow-up ]
   Patient baseline and quarterly surveys, estimated month and year
10. When fatigued, does rest make patient's fatigue better? [ Time Frame: 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
11. When fatigued, has this fatigue substantially limited the patient's ability to occupational, educational, social, or personal activities? [ Time Frame: During 12 months of follow-up ]
    Patient baseline and quarterly surveys, Yes, No, Not applicable, Don't know
12. Patient's medical history check-list [ Time Frame: Through study referral period, an average of 12 weeks ]
    Patient baseline survey, Yes, No, Unsure
13. Patient's dietary restrictions [ Time Frame: Through study referral period, an average of 12 weeks ]
    Patient baseline survey, No, Vegan, Vegetarian, Ketogenic, Gluten-free, Dairy-free, Intermittent fasting, Other
14. Patient's food allergies or other food intolerances [ Time Frame: Through study referral period, an average of 12 weeks ]
    Patient baseline survey, Yes/No
15. Has patient's employment been impacted due to contracting COVID-19? [ Time Frame: Through study referral period, an average of 12 weeks ]
    Patient baseline survey, Yes, No
16. 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 [ Time Frame: 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
17. 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 [ Time Frame: 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
18. Did patient receive a COVID-19 PCR (nasal swab) test [ Time Frame: Through study referral period, an average of 12 weeks ]
    Patient baseline survey, Yes/No
19. Did patient receive a COVID-19 antibody test [ Time Frame: Through study referral period, an average of 12 weeks ]
    Patient baseline survey, Yes/No
20. Patient symptom onset [ Time Frame: Through study referral period, an average of 12 weeks ]
    Patient baseline survey, Date
21. Patient reported medications used for COVID-19 symptoms [ Time Frame: Through study referral period, an average of 12 weeks ]
    Patient baseline survey, free text
22. Patient reported prescribed supplementary oxygen support [ Time Frame: Through study referral period, an average of 12 weeks ]
    Patient baseline survey, Yes/No
23. Patient reported admittance to hospital due to COVID-19 [ Time Frame: During 12 months of follow-up ]
    Patient baseline and quarterly surveys, Yes/No
24. 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 [ Time Frame: During 12 months of follow-up ]
    Patient baseline and quarterly surveys, Yes/No
25. Does patient feel fully recovered from COVID-19 [ Time Frame: During 9 months of follow-up ]
    Patient quarterly surveys, Yes/No
26. Currently minutes per week of moderate-intensity physical activity patient does (like a brisk walk, slow biking, gardening, or ballroom dancing) [ Time Frame: During 9 months of follow-up ]
    Patient quarterly surveys, free text
27. Currently minutes per week of vigorous-intensity physical activity patient does (like running, swimming laps, competitive sports, or fast bicycling) [ Time Frame: During 9 months of follow-up ]
    Patient quarterly surveys, free text
28. Patient Health Questionnaire (PHQ)-2 [ Time Frame: During 12 months of follow-up ]
    Patient baseline and quarterly surveys
29. Patient Health Questionnaire (PHQ)-9 (if applicable) [ Time Frame: During 12 months of follow-up ]
    Patient baseline and quarterly surveys
30. PROMIS Dyspnea Functional Limitations and Severity Short Forms [ Time Frame: During 12 months of follow-up ]
    Patient baseline and quarterly surveys
31. PROMIS Applied Cognition Abilities and General Concerns Short Forms [ Time Frame: During 12 months of follow-up ]
    Patient baseline and quarterly surveys
32. Generalized Anxiety Disorder (GAD)-7 [ Time Frame: During 12 months of follow-up ]
    Patient baseline and quarterly surveys
33. 2-minute step test [ Time Frame: During 12 months of follow-up ]
    Physical Therapy assessment with patient
34. 30 sec sit to stand test [ Time Frame: During 12 months of follow-up ]
    Physical Therapy assessment with patient
35. Grip strength [ Time Frame: During 12 months of follow-up ]
    Physical Therapy assessment with patient
36. Functional Gait Assessment [ Time Frame: During 12 months of follow-up ]
    Physical Therapy assessment with patient
37. Balance tasks [ Time Frame: During 12 months of follow-up ]
    Physical Therapy assessment with patient
38. Post-exertional malaise follow-up [ Time Frame: 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

Other Outcome Measures:

1. Knowledge improvement of appropriate PASC diagnosis as a result of participation in randomized arm (teleECHO or monthly webinar) [ Time Frame: During 30 months of follow-up ]
   Clinician quarterly follow-up survey with use of Likert scale agreement
2. Knowledge improvement of effective PASC care and treatment as a result of participation in randomized arm (teleECHO or monthly webinar) [ Time Frame: During 30 months of follow-up ]
   Clinician quarterly follow-up survey with use of Likert scale agreement
3. Knowledge improvement of approaches for complex cases of PASC as a result of participation in randomized arm (teleECHO or monthly webinar) [ Time Frame: During 30 months of follow-up ]
   Clinician quarterly follow-up survey with use of Likert scale agreement
4. Self-efficacy in abilities related to identify tools and methods for PASC care [ Time Frame: During 33 months of follow-up ]
   Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
5. Self-efficacy in abilities to diagnose patients with PASC [ Time Frame: During 33 months of follow-up ]
   Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
6. Self-efficacy in abilities to screen for co-morbidities of PASC [ Time Frame: During 33 months of follow-up ]
   Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
7. Self-efficacy in abilities to generate a patient-specific treatment plan for patients with PASC [ Time Frame: During 33 months of follow-up ]
   Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
8. Self-efficacy in abilities related to to implement a patient-specific treatment plan for patients with PASC [ Time Frame: During 33 months of follow-up ]
   Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
9. Self-efficacy in abilities to select appropriate special or diagnostic tests for PASC patients [ Time Frame: During 33 months of follow-up ]
   Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
10. Self-efficacy in abilities to interpret special or diagnostic test results for my PASC patients [ Time Frame: During 33 months of follow-up ]
    Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
11. Self-efficacy in abilities to provide appropriate patient education about their PASC condition [ Time Frame: During 33 months of follow-up ]
    Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
12. Self-efficacy in abilities to educate clinic staff about PASC care [ Time Frame: During 33 months of follow-up ]
    Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
13. Self-efficacy in abilities to address PASC patients using a multidisciplinary approach [ Time Frame: During 33 months of follow-up ]
    Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
14. Self-efficacy in abilities to assess and manage concerns that PASC patients face [ Time Frame: During 33 months of follow-up ]
    Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
15. Self-efficacy in abilities to assess severity of disease in patients with PASC [ Time Frame: During 33 months of follow-up ]
    Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
16. Self-efficacy in abilities to deal with complex cases of PASC [ Time Frame: During 33 months of follow-up ]
    Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
17. Utility of an encountered case presented during randomized arm (teleECHO or monthly webinar) [ Time Frame: During 30 months of follow-up ]
    Clinician quarterly follow-up survey Yes/No
18. Overall satisfaction with randomized arm (teleECHO or monthly webinar) [ Time Frame: During 30 months of follow-up ]
    Clinician quarterly follow-up survey with use of Likert scale agreement
19. Satisfaction to recommend to colleague randomized arm (teleECHO or monthly webinar) [ Time Frame: During 30 months of follow-up ]
    Clinician quarterly follow-up survey with use of Likert scale likelihood
20. Satisfaction to participate in future randomized arm (teleECHO or monthly webinar) again [ Time Frame: During 30 months of follow-up ]
    Clinician quarterly follow-up survey with use of Likert scale likelihood
21. Changes to practice in helping colleague with information learned from randomized arm (teleECHO or monthly webinar) [ Time Frame: During 30 months of follow-up ]
    Clinician quarterly follow-up survey Yes/No
22. Changes to practice by participating in randomized arm (teleECHO or monthly webinar) to understand further monitoring and follow-up plan [ Time Frame: During 30 months of follow-up ]
    Clinician quarterly follow-up survey with use of Likert scale agreement
23. Changes to practice by participating in randomized arm (teleECHO or monthly webinar) to develop more appropriate treatment plans [ Time Frame: During 30 months of follow-up ]
    Clinician quarterly follow-up survey with use of Likert scale agreement
24. 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 [ Time Frame: During 30 months of follow-up ]
    Clinician quarterly follow-up survey with use of Likert scale agreement
25. Changes to practice by participating in randomized arm (teleECHO or monthly webinar) to more independently manage my PASC patients without referral to a specialist [ Time Frame: During 30 months of follow-up ]
    Clinician quarterly follow-up survey with use of Likert scale agreement
26. Changes to practice by participating in randomized arm (teleECHO or monthly webinar) to apply specialist recommendations to patient care. [ Time Frame: During 30 months of follow-up ]
    Clinician quarterly follow-up survey with use of Likert scale agreement and free text
27. Unable to apply learnings from randomized arm (teleECHO or monthly webinar) [ Time Frame: During 30 months of follow-up ]
    Clinician quarterly follow-up survey with use of Likert scale agreement and free text
28. Other changes to practice by participating in randomized arm (teleECHO or monthly webinar) [ Time Frame: During 30 months of follow-up ]
    Clinician quarterly follow-up survey with free text
29. Knowledge gained about topic presented during teleECHO before and after [ Time Frame: During 33 months after each weekly ECHO session ]
    Clinician intervention teleECHO survey
30. Knowledge gained about topic presented during teleECHO before and after [ Time Frame: Through study completion, an average of 33 months ]
    Clinician intervention teleECHO survey with use of Likert scale knowledge
31. Satisfaction with stated objectives being met [ Time Frame: Through study completion, an average of 33 months ]
    Clinician intervention teleECHO survey with use of Likert scale quality
32. Satisfaction with session delivering balanced and objective, evidence-based content [ Time Frame: Through study completion, an average of 33 months ]
    Clinician intervention teleECHO survey with use of Likert scale quality
33. Satisfaction with pace of session [ Time Frame: Through study completion, an average of 33 months ]
    Clinician intervention teleECHO survey with use of Likert scale quality
34. Satisfaction with opportunities to ask questions [ Time Frame: Through study completion, an average of 33 months ]
    Clinician intervention teleECHO survey with use of Likert scale quality
35. Satisfaction with organization of the presenters' presentations [ Time Frame: Through study completion, an average of 33 months ]
    Clinician intervention teleECHO survey with use of Likert scale quality
36. Satisfaction with presenters' ability to clearly communicate [ Time Frame: Through study completion, an average of 33 months ]
    Clinician intervention teleECHO survey with use of Likert scale quality
37. Desired content for future sessions [ Time Frame: Through study completion, an average of 33 months ]
    Clinician intervention teleECHO survey, free text
38. Satisfaction with source evidence presented [ Time Frame: Through study completion, an average of 33 months ]
    Clinician intervention teleECHO survey Yes/No
39. Satisfaction with commercial bias present [ Time Frame: Through study completion, an average of 33 months ]
    Clinician intervention teleECHO survey Yes/No and free text
40. Recommendations for program improvement [ Time Frame: Through study completion, an average of 33 months ]
    Clinician intervention teleECHO survey free text
41. Relevance of session to clinicians current work [ Time Frame: Through study completion, an average of 33 months ]
    Clinician intervention teleECHO survey with use of Likert scale relevance
42. Intent to change practice based on learnings from session [ Time Frame: Through study completion, an average of 33 months ]
    Clinician intervention teleECHO survey Yes/No and free text
43. Best part of session [ Time Frame: Through study completion, an average of 33 months ]
    Clinician intervention teleECHO survey free text
44. Worst part of session [ Time Frame: Through study completion, an average of 33 months ]
    Clinician intervention teleECHO survey free text
45. Recommend this session to a colleague [ Time Frame: Through study completion, an average of 33 months ]
    Clinician intervention teleECHO survey with use of Likert scale likelihood
46. Changes to practice planned [ Time Frame: Through study completion, an average of 33 months ]
    Clinician intervention teleECHO survey free text
47. If no changes to practice are planned, barriers [ Time Frame: Through study completion, an average of 33 months ]
    Clinician intervention teleECHO survey free text
48. Participating clinician retention [ Time Frame: Semi-annually during 33 months of follow-up ]
    Mean number of months clinicians participate in the trial (intervention and control groups)
49. Participating clinic settings [ Time Frame: Semi-annually during 33 months of follow-up ]
    Number of clinic settings in which providers see patients (intervention and control groups)
50. Participation in intervention [ Time Frame: Weekly during 33 months of follow-up ]
    Number of weekly sessions each RCT (intervention) provider attends, and mean number
51. Exposure of weekly teleECHO topics [ Time Frame: Weekly during 33 months of follow-up ]
    Number of topics covered in Weekly ECHO sessions RCT (intervention) provider attends
52. Monthly webinar attendance [ Time Frame: Monthly during 33 months of follow-up ]
    Number of monthly webinars RCT providers attends
53. Quarterly short course attendance [ Time Frame: Quarterly during 33 months of follow-up ]
    Number of quarterly short courses RCT providers attends
54. Exposure of monthly webinar topics [ Time Frame: Monthly during 33 months of follow-up ]
    Number of topics covered in monthly webinars provider attends
55. Exposure of quarterly short course topics [ Time Frame: Quarterly during 33 months of follow-up ]
    Number of topics covered in quarterly short courses provider attends
56. Participation in case consultation [ Time Frame: Quarterly during 33 months of follow-up ]
    Number of patient cases presented by RCT (intervention) provider
57. Participation in post-session survey [ Time Frame: Weekly during 33 months of follow-up ]
    Proportion of participants that complete each session poll (disaggregated by monthly webinar, weekly session, RCT vs. non-RCT provider)
58. Volume of total patient case load [ Time Frame: Monthly during 33 months of follow-up ]
    Number of patients seen by RCT provider, and mean number (intervention and control)
59. Volume of PASC patient case load [ Time Frame: Monthly during 33 months of follow-up ]
    Number of PASC patients seen by RCT provider, and mean number (intervention and control)
60. Volume of patient referrals to specialists [ Time Frame: Monthly during 33 months of follow-up ]
    Number of referrals to specialists by RCT provider, and mean number (intervention and control)
61. Application of specialist recommendations [ Time Frame: Quarterly during 33 months of follow-up ]
    Number of specialist recommendations applied by RCT (intervention) providers from weekly ECHO sessions
62. Average consultation duration [ Time Frame: Monthly during 33 months of follow-up ]
    Mean duration of consultation for PASC patients by RCT providers, intervention and control
63. Volume of specialists seen by patients [ Time Frame: Monthly during 33 months of follow-up ]
    Number of specialists seen by patient
64. Specialty types patient was exposed to [ Time Frame: Monthly during 33 months of follow-up ]
    Number of specialty types the patient was exposed to
65. Clinician session drop-off [ Time Frame: Weekly during 33 months of follow-up ]
    How long an (intervention) provider attended an ECHO session
66. Quarterly attendance [ Time Frame: Quarterly during 33 months of follow-up ]
    Number of individuals who attended and watched short course
67. Clinician satisfaction with series [ Time Frame: Up to 8 weeks after end of study ]
    Interview with Likert satisfaction
68. Clinician overall best part of series [ Time Frame: Up to 8 weeks after end of study ]
    Interview
69. Clinician overall worst part of series [ Time Frame: Up to 8 weeks after end of study ]
    Interview
70. Clinician challenges in participating [ Time Frame: Up to 8 weeks after end of study ]
    Interview
71. Perceived change in the relationship between clinicians and specialists in panel as a result of this series? [ Time Frame: Up to 8 weeks after end of study ]
    Interview, Yes/No with free response
72. Clinician barriers to sustained participation in series [ Time Frame: Up to 8 weeks after end of study ]
    Interview
73. Did clinician experience an improvement in the number of PASC patients they could manage at any given time as a result of the series? [ Time Frame: Up to 8 weeks after end of study ]
    Interview, Yes/No with free response
74. Did clinicians experience an increase in PASC patients in their panel composition over time as a result of participation in the series? [ Time Frame: Up to 8 weeks after end of study ]
    Interview, Yes/No with free response
75. 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? [ Time Frame: Up to 8 weeks after end of study ]
    Interview, Yes/No with free response
76. Did clinicians experience an improvement in the quality of care for patients as a result of participating in the series? [ Time Frame: Up to 8 weeks after end of study ]
    Interview, Yes/No with free response
77. Did clinic directors observe an improvement in the quality of care for patients as a result of a clinician participating in the series? [ Time Frame: Up to 8 weeks after end of study ]
    Interview, Yes/No with free response
78. Did clinicians participating influence other providers in their clinic? [ Time Frame: Up to 8 weeks after end of study ]
    Interview, Yes/No with free response
79. Did clinic directors observe clinicians who participated in the series influence other providers within the clinic? [ Time Frame: Up to 8 weeks after end of study ]
    Interview, Yes/No with free response
80. Clinician benefits gained from participating in the series [ Time Frame: Up to 8 weeks after end of study ]
    Interview, free response
81. Clinician recommendations for improving the scalability or sustainability of this model [ Time Frame: Up to 8 weeks after end of study ]
    Interview, free response
82. Clinic directors recommendations for improving the scalability or sustainability of this model [ Time Frame: Up to 8 weeks after end of study ]
    Interview, free response

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Jane Samaniego, MS; 619-515-2300; janes@fhcsd.org

Contact: Job Godino, PhD; 619-515-2344 ext 2344; jobg@fhcsd.org

Locations

United States, California

Family Health Centers of San Diego; Recruiting

San Diego, California, United States, 92102

Contact: Jane Samaniego, MS

Sponsors and Collaborators

Family Health Centers of San Diego

Investigators

• Principal Investigator: Christian Ramers, MD; Family Health Centers of San Diego
• Principal Investigator: Job Godino, PhD; Family Health Centers of San Diego

More Information

• Responsible Party: Family Health Centers of San Diego
• ClinicalTrials.gov Identifier: NCT05167227
• Other Study ID Numbers: HS-2021-0241
• First Posted: December 22, 2021
• Last Update Posted: February 15, 2023
• Last Verified: February 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Family Health Centers of San Diego:

Long COVID; ME; CFS; PASC

Additional relevant MeSH terms:

COVID-19; Fatigue Syndrome, Chronic; Encephalomyelitis; Respiration Disorders; Respiratory Tract Diseases; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Muscular Diseases; Musculoskeletal Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Central Nervous System Infections