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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)

Primary Purpose

SARS-CoV-2 Acute Respiratory Disease, Myalgic Encephalomyelitis, Chronic Fatigue Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Extension for Community Healthcare Outcomes
Sponsored by
Family Health Centers of San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for SARS-CoV-2 Acute Respiratory Disease focused on measuring Long COVID, ME, CFS, PASC, PCC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Family Health Centers of San DiegoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

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.

The Intervention arm participates in weekly teleECHO sessions with monthly interactive webinars and quarterly short courses.

Outcomes

Primary Outcome Measures

Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Patient baseline and quarterly surveys

Secondary Outcome Measures

Patient symptom checklist with associated severity for those present
Patient baseline and quarterly surveys, None, Mild, Moderate, Severe
If symptom is present, has patient experienced this in the past month
Patient baseline and quarterly surveys, Yes/No
If symptom is present, how long has patient experienced this symptom
Patient baseline and quarterly surveys, Under 3 Months, 3 Months or longer
If symptom is present, did patient have this symptom before the patient tested positive for COVID-19?
Patient baseline and quarterly surveys, Yes/No
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
If symptom is present during the past month, how bad was this symptom?
Patient baseline and quarterly surveys with use of Likert scale
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
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
If fatigue present, what month and year did the fatiguing illness begin?
Patient baseline and quarterly surveys, estimated month and year
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
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
Patient's medical history check-list
Patient baseline survey, Yes, No, Unsure
Patient's dietary restrictions
Patient baseline survey, No, Vegan, Vegetarian, Ketogenic, Gluten-free, Dairy-free, Intermittent fasting, Other
Patient's food allergies or other food intolerances
Patient baseline survey, Yes/No
Has patient's employment been impacted due to contracting COVID-19?
Patient baseline survey, Yes, No
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
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
Did patient receive a COVID-19 PCR (nasal swab) test
Patient baseline survey, Yes/No
Did patient receive a COVID-19 antibody test
Patient baseline survey, Yes/No
Patient symptom onset
Patient baseline survey, Date
Patient reported medications used for COVID-19 symptoms
Patient baseline survey, free text
Patient reported prescribed supplementary oxygen support
Patient baseline survey, Yes/No
Patient reported admittance to hospital due to COVID-19
Patient baseline and quarterly surveys, Yes/No
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
Does patient feel fully recovered from COVID-19
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)
Patient quarterly surveys, free text
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
Patient Health Questionnaire (PHQ)-2
Patient baseline and quarterly surveys
Patient Health Questionnaire (PHQ)-9 (if applicable)
Patient baseline and quarterly surveys
PROMIS Dyspnea Functional Limitations and Severity Short Forms
Patient baseline and quarterly surveys
PROMIS Applied Cognition Abilities and General Concerns Short Forms
Patient baseline and quarterly surveys
Generalized Anxiety Disorder (GAD)-7
Patient baseline and quarterly surveys
2-minute step test
Physical Therapy assessment with patient
30 sec sit to stand test
Physical Therapy assessment with patient
Grip strength
Physical Therapy assessment with patient
Functional Gait Assessment
Physical Therapy assessment with patient
Balance tasks
Physical Therapy assessment with patient
Post-exertional malaise follow-up
Follow-up Physical Therapy appointment with patient, Not at all, A little bit, Somewhat, Quite a bit, Very much

Full Information

First Posted
December 17, 2021
Last Updated
April 28, 2023
Sponsor
Family Health Centers of San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT05167227
Brief Title
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?
Acronym
LC&FIRP
Official Title
The Long COVID and Fatiguing Illness Recovery Program - A Pragmatic, Quality Improvement, Professional Cluster, Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 30, 2021 (Actual)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Family Health Centers of San Diego

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
The Intervention arm participates in weekly teleECHO sessions with monthly interactive webinars and quarterly short courses.
Intervention Type
Other
Intervention Name(s)
Extension for Community Healthcare Outcomes
Other Intervention Name(s)
ECHO
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Description
Patient baseline and quarterly surveys
Time Frame
During 12 months of follow-up
Secondary Outcome Measure Information:
Title
Patient symptom checklist with associated severity for those present
Description
Patient baseline and quarterly surveys, None, Mild, Moderate, Severe
Time Frame
During 12 months of follow-up
Title
If symptom is present, has patient experienced this in the past month
Description
Patient baseline and quarterly surveys, Yes/No
Time Frame
During 12 months of follow-up
Title
If symptom is present, how long has patient experienced this symptom
Description
Patient baseline and quarterly surveys, Under 3 Months, 3 Months or longer
Time Frame
During 12 months of follow-up
Title
If symptom is present, did patient have this symptom before the patient tested positive for COVID-19?
Description
Patient baseline and quarterly surveys, Yes/No
Time Frame
During 12 months of follow-up
Title
If symptom is present, during the past month how often have the patient had this symptom?
Description
Patient baseline and quarterly surveys with use of Likert scale
Time Frame
During 12 months of follow-up
Title
If symptom is present during the past month, how bad was this symptom?
Description
Patient baseline and quarterly surveys with use of Likert scale
Time Frame
During 12 months of follow-up
Title
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?
Description
Patient baseline and quarterly surveys with Yes/No/Not Applicable/Don't Know
Time Frame
During 12 months of follow-up
Title
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
Description
Patient baseline and quarterly surveys with All of sudden, Slowly over time, Not applicable, Don't know
Time Frame
During 12 months of follow-up
Title
If fatigue present, what month and year did the fatiguing illness begin?
Description
Patient baseline and quarterly surveys, estimated month and year
Time Frame
During 12 months of follow-up
Title
When fatigued, does rest make patient's fatigue better?
Description
Patient baseline and quarterly surveys, Yes a lot, Yes a little, No not very much, Not applicable, Don't know
Time Frame
During 12 months of follow-up
Title
When fatigued, has this fatigue substantially limited the patient's ability to occupational, educational, social, or personal activities?
Description
Patient baseline and quarterly surveys, Yes, No, Not applicable, Don't know
Time Frame
During 12 months of follow-up
Title
Patient's medical history check-list
Description
Patient baseline survey, Yes, No, Unsure
Time Frame
Through study referral period, an average of 12 weeks
Title
Patient's dietary restrictions
Description
Patient baseline survey, No, Vegan, Vegetarian, Ketogenic, Gluten-free, Dairy-free, Intermittent fasting, Other
Time Frame
Through study referral period, an average of 12 weeks
Title
Patient's food allergies or other food intolerances
Description
Patient baseline survey, Yes/No
Time Frame
Through study referral period, an average of 12 weeks
Title
Has patient's employment been impacted due to contracting COVID-19?
Description
Patient baseline survey, Yes, No
Time Frame
Through study referral period, an average of 12 weeks
Title
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
Description
Patient baseline survey, Every week, Most weeks, Some weeks, Very few weeks, Never, I do not know
Time Frame
Through study referral period, an average of 12 weeks
Title
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
Description
Patient baseline survey, Every week, Most weeks, Some weeks, Very few weeks, Never, I do not know
Time Frame
Through study referral period, an average of 12 weeks
Title
Did patient receive a COVID-19 PCR (nasal swab) test
Description
Patient baseline survey, Yes/No
Time Frame
Through study referral period, an average of 12 weeks
Title
Did patient receive a COVID-19 antibody test
Description
Patient baseline survey, Yes/No
Time Frame
Through study referral period, an average of 12 weeks
Title
Patient symptom onset
Description
Patient baseline survey, Date
Time Frame
Through study referral period, an average of 12 weeks
Title
Patient reported medications used for COVID-19 symptoms
Description
Patient baseline survey, free text
Time Frame
Through study referral period, an average of 12 weeks
Title
Patient reported prescribed supplementary oxygen support
Description
Patient baseline survey, Yes/No
Time Frame
Through study referral period, an average of 12 weeks
Title
Patient reported admittance to hospital due to COVID-19
Description
Patient baseline and quarterly surveys, Yes/No
Time Frame
During 12 months of follow-up
Title
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
Description
Patient baseline and quarterly surveys, Yes/No
Time Frame
During 12 months of follow-up
Title
Does patient feel fully recovered from COVID-19
Description
Patient quarterly surveys, Yes/No
Time Frame
During 9 months of follow-up
Title
Currently minutes per week of moderate-intensity physical activity patient does (like a brisk walk, slow biking, gardening, or ballroom dancing)
Description
Patient quarterly surveys, free text
Time Frame
During 9 months of follow-up
Title
Currently minutes per week of vigorous-intensity physical activity patient does (like running, swimming laps, competitive sports, or fast bicycling)
Description
Patient quarterly surveys, free text
Time Frame
During 9 months of follow-up
Title
Patient Health Questionnaire (PHQ)-2
Description
Patient baseline and quarterly surveys
Time Frame
During 12 months of follow-up
Title
Patient Health Questionnaire (PHQ)-9 (if applicable)
Description
Patient baseline and quarterly surveys
Time Frame
During 12 months of follow-up
Title
PROMIS Dyspnea Functional Limitations and Severity Short Forms
Description
Patient baseline and quarterly surveys
Time Frame
During 12 months of follow-up
Title
PROMIS Applied Cognition Abilities and General Concerns Short Forms
Description
Patient baseline and quarterly surveys
Time Frame
During 12 months of follow-up
Title
Generalized Anxiety Disorder (GAD)-7
Description
Patient baseline and quarterly surveys
Time Frame
During 12 months of follow-up
Title
2-minute step test
Description
Physical Therapy assessment with patient
Time Frame
During 12 months of follow-up
Title
30 sec sit to stand test
Description
Physical Therapy assessment with patient
Time Frame
During 12 months of follow-up
Title
Grip strength
Description
Physical Therapy assessment with patient
Time Frame
During 12 months of follow-up
Title
Functional Gait Assessment
Description
Physical Therapy assessment with patient
Time Frame
During 12 months of follow-up
Title
Balance tasks
Description
Physical Therapy assessment with patient
Time Frame
During 12 months of follow-up
Title
Post-exertional malaise follow-up
Description
Follow-up Physical Therapy appointment with patient, Not at all, A little bit, Somewhat, Quite a bit, Very much
Time Frame
Per Physical Therapy encounter after PT assessment
Other Pre-specified Outcome Measures:
Title
Knowledge improvement of appropriate PASC diagnosis as a result of participation in randomized arm (teleECHO or monthly webinar)
Description
Clinician quarterly follow-up survey with use of Likert scale agreement
Time Frame
During 37 months of follow-up
Title
Knowledge improvement of effective PASC care and treatment as a result of participation in randomized arm (teleECHO or monthly webinar)
Description
Clinician quarterly follow-up survey with use of Likert scale agreement
Time Frame
During 37 months of follow-up
Title
Knowledge improvement of approaches for complex cases of PASC as a result of participation in randomized arm (teleECHO or monthly webinar)
Description
Clinician quarterly follow-up survey with use of Likert scale agreement
Time Frame
During 37 months of follow-up
Title
Self-efficacy in abilities related to identify tools and methods for PASC care
Description
Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
Time Frame
During 37 months of follow-up
Title
Self-efficacy in abilities to diagnose patients with PASC
Description
Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
Time Frame
During 37 months of follow-up
Title
Self-efficacy in abilities to screen for co-morbidities of PASC
Description
Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
Time Frame
During 37 months of follow-up
Title
Self-efficacy in abilities to generate a patient-specific treatment plan for patients with PASC
Description
Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
Time Frame
During 37 months of follow-up
Title
Self-efficacy in abilities related to to implement a patient-specific treatment plan for patients with PASC
Description
Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
Time Frame
During 37 months of follow-up
Title
Self-efficacy in abilities to select appropriate special or diagnostic tests for PASC patients
Description
Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
Time Frame
During 37 months of follow-up
Title
Self-efficacy in abilities to interpret special or diagnostic test results for my PASC patients
Description
Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
Time Frame
During 37 months of follow-up
Title
Self-efficacy in abilities to provide appropriate patient education about their PASC condition
Description
Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
Time Frame
During 37 months of follow-up
Title
Self-efficacy in abilities to educate clinic staff about PASC care
Description
Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
Time Frame
During 37 months of follow-up
Title
Self-efficacy in abilities to address PASC patients using a multidisciplinary approach
Description
Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
Time Frame
During 37 months of follow-up
Title
Self-efficacy in abilities to assess and manage concerns that PASC patients face
Description
Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
Time Frame
During 37 months of follow-up
Title
Self-efficacy in abilities to assess severity of disease in patients with PASC
Description
Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
Time Frame
During 37 months of follow-up
Title
Self-efficacy in abilities to deal with complex cases of PASC
Description
Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
Time Frame
During 37 months of follow-up
Title
Utility of an encountered case presented during randomized arm (teleECHO or monthly webinar)
Description
Clinician quarterly follow-up survey Yes/No
Time Frame
During 34 months of follow-up
Title
Overall satisfaction with randomized arm (teleECHO or monthly webinar)
Description
Clinician quarterly follow-up survey with use of Likert scale agreement
Time Frame
During 34 months of follow-up
Title
Satisfaction to recommend to colleague randomized arm (teleECHO or monthly webinar)
Description
Clinician quarterly follow-up survey with use of Likert scale likelihood
Time Frame
During 34 months of follow-up
Title
Satisfaction to participate in future randomized arm (teleECHO or monthly webinar) again
Description
Clinician quarterly follow-up survey with use of Likert scale likelihood
Time Frame
During 34 months of follow-up
Title
Changes to practice in helping colleague with information learned from randomized arm (teleECHO or monthly webinar)
Description
Clinician quarterly follow-up survey Yes/No
Time Frame
During 34 months of follow-up
Title
Changes to practice by participating in randomized arm (teleECHO or monthly webinar) to understand further monitoring and follow-up plan
Description
Clinician quarterly follow-up survey with use of Likert scale agreement
Time Frame
During 34 months of follow-up
Title
Changes to practice by participating in randomized arm (teleECHO or monthly webinar) to develop more appropriate treatment plans
Description
Clinician quarterly follow-up survey with use of Likert scale agreement
Time Frame
During 34 months of follow-up
Title
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
Description
Clinician quarterly follow-up survey with use of Likert scale agreement
Time Frame
During 34 months of follow-up
Title
Changes to practice by participating in randomized arm (teleECHO or monthly webinar) to more independently manage my PASC patients without referral to a specialist
Description
Clinician quarterly follow-up survey with use of Likert scale agreement
Time Frame
During 34 months of follow-up
Title
Changes to practice by participating in randomized arm (teleECHO or monthly webinar) to apply specialist recommendations to patient care.
Description
Clinician quarterly follow-up survey with use of Likert scale agreement and free text
Time Frame
During 34 months of follow-up
Title
Unable to apply learnings from randomized arm (teleECHO or monthly webinar)
Description
Clinician quarterly follow-up survey with use of Likert scale agreement and free text
Time Frame
During 34 months of follow-up
Title
Other changes to practice by participating in randomized arm (teleECHO or monthly webinar)
Description
Clinician quarterly follow-up survey with free text
Time Frame
During 34 months of follow-up
Title
Knowledge gained about topic presented during teleECHO before and after
Description
Clinician intervention teleECHO survey
Time Frame
During 37 months after each weekly ECHO session
Title
Knowledge gained about topic presented during teleECHO before and after
Description
Clinician intervention teleECHO survey with use of Likert scale knowledge
Time Frame
Through study completion, an average of 37 months
Title
Satisfaction with stated objectives being met
Description
Clinician intervention teleECHO survey with use of Likert scale quality
Time Frame
Through study completion, an average of 37 months
Title
Satisfaction with session delivering balanced and objective, evidence-based content
Description
Clinician intervention teleECHO survey with use of Likert scale quality
Time Frame
Through study completion, an average of 37 months
Title
Satisfaction with pace of session
Description
Clinician intervention teleECHO survey with use of Likert scale quality
Time Frame
Through study completion, an average of 37 months
Title
Satisfaction with opportunities to ask questions
Description
Clinician intervention teleECHO survey with use of Likert scale quality
Time Frame
Through study completion, an average of 37 months
Title
Satisfaction with organization of the presenters' presentations
Description
Clinician intervention teleECHO survey with use of Likert scale quality
Time Frame
Through study completion, an average of 37 months
Title
Satisfaction with presenters' ability to clearly communicate
Description
Clinician intervention teleECHO survey with use of Likert scale quality
Time Frame
Through study completion, an average of 37 months
Title
Desired content for future sessions
Description
Clinician intervention teleECHO survey, free text
Time Frame
Through study completion, an average of 37 months
Title
Satisfaction with source evidence presented
Description
Clinician intervention teleECHO survey Yes/No
Time Frame
Through study completion, an average of 37 months
Title
Satisfaction with commercial bias present
Description
Clinician intervention teleECHO survey Yes/No and free text
Time Frame
Through study completion, an average of 37 months
Title
Recommendations for program improvement
Description
Clinician intervention teleECHO survey free text
Time Frame
Through study completion, an average of 37 months
Title
Relevance of session to clinicians current work
Description
Clinician intervention teleECHO survey with use of Likert scale relevance
Time Frame
Through study completion, an average of 37 months
Title
Intent to change practice based on learnings from session
Description
Clinician intervention teleECHO survey Yes/No and free text
Time Frame
Through study completion, an average of 37 months
Title
Best part of session
Description
Clinician intervention teleECHO survey free text
Time Frame
Through study completion, an average of 37 months
Title
Worst part of session
Description
Clinician intervention teleECHO survey free text
Time Frame
Through study completion, an average of 37 months
Title
Recommend this session to a colleague
Description
Clinician intervention teleECHO survey with use of Likert scale likelihood
Time Frame
Through study completion, an average of 37 months
Title
Changes to practice planned
Description
Clinician intervention teleECHO survey free text
Time Frame
Through study completion, an average of 37 months
Title
If no changes to practice are planned, barriers
Description
Clinician intervention teleECHO survey free text
Time Frame
Through study completion, an average of 37 months
Title
Participating clinician retention
Description
Mean number of months clinicians participate in the trial (intervention and control groups)
Time Frame
Semi-annually during 37 months of follow-up
Title
Participating clinic settings
Description
Number of clinic settings in which providers see patients (intervention and control groups)
Time Frame
Semi-annually during 37 months of follow-up
Title
Participation in intervention
Description
Number of weekly sessions each RCT (intervention) provider attends, and mean number
Time Frame
Weekly during 37 months of follow-up
Title
Exposure of weekly teleECHO topics
Description
Number of topics covered in Weekly ECHO sessions RCT (intervention) provider attends
Time Frame
Weekly during 37 months of follow-up
Title
Monthly webinar attendance
Description
Number of monthly webinars RCT providers attends
Time Frame
Monthly during 37 months of follow-up
Title
Quarterly short course attendance
Description
Number of quarterly short courses RCT providers attends
Time Frame
Quarterly during 37 months of follow-up
Title
Exposure of monthly webinar topics
Description
Number of topics covered in monthly webinars provider attends
Time Frame
Monthly during 37 months of follow-up
Title
Exposure of quarterly short course topics
Description
Number of topics covered in quarterly short courses provider attends
Time Frame
Quarterly during 37 months of follow-up
Title
Participation in case consultation
Description
Number of patient cases presented by RCT (intervention) provider
Time Frame
Quarterly during 37 months of follow-up
Title
Participation in post-session survey
Description
Proportion of participants that complete each session poll (disaggregated by monthly webinar, weekly session, RCT vs. non-RCT provider)
Time Frame
Weekly during 37 months of follow-up
Title
Volume of total patient case load
Description
Number of patients seen by RCT provider, and mean number (intervention and control)
Time Frame
Monthly during 37 months of follow-up
Title
Volume of PASC patient case load
Description
Number of PASC patients seen by RCT provider, and mean number (intervention and control)
Time Frame
Monthly during 37 months of follow-up
Title
Volume of patient referrals to specialists
Description
Number of referrals to specialists by RCT provider, and mean number (intervention and control)
Time Frame
Monthly during 37 months of follow-up
Title
Application of specialist recommendations
Description
Number of specialist recommendations applied by RCT (intervention) providers from weekly ECHO sessions
Time Frame
Quarterly during 37 months of follow-up
Title
Average consultation duration
Description
Mean duration of consultation for PASC patients by RCT providers, intervention and control
Time Frame
Monthly during 37 months of follow-up
Title
Volume of specialists seen by patients
Description
Number of specialists seen by patient
Time Frame
Monthly during 37 months of follow-up
Title
Specialty types patient was exposed to
Description
Number of specialty types the patient was exposed to
Time Frame
Monthly during 37 months of follow-up
Title
Clinician session drop-off
Description
How long an (intervention) provider attended an ECHO session
Time Frame
Weekly during 37 months of follow-up
Title
Quarterly attendance
Description
Number of individuals who attended and watched short course
Time Frame
Quarterly during 37 months of follow-up
Title
Clinician satisfaction with series
Description
Interview with Likert satisfaction
Time Frame
Up to 8 weeks after end of study
Title
Clinician overall best part of series
Description
Interview
Time Frame
Up to 8 weeks after end of study
Title
Clinician overall worst part of series
Description
Interview
Time Frame
Up to 8 weeks after end of study
Title
Clinician challenges in participating
Description
Interview
Time Frame
Up to 8 weeks after end of study
Title
Perceived change in the relationship between clinicians and specialists in panel as a result of this series?
Description
Interview, Yes/No with free response
Time Frame
Up to 8 weeks after end of study
Title
Clinician barriers to sustained participation in series
Description
Interview
Time Frame
Up to 8 weeks after end of study
Title
Did clinician experience an improvement in the number of PASC patients they could manage at any given time as a result of the series?
Description
Interview, Yes/No with free response
Time Frame
Up to 8 weeks after end of study
Title
Did clinicians experience an increase in PASC patients in their panel composition over time as a result of participation in the series?
Description
Interview, Yes/No with free response
Time Frame
Up to 8 weeks after end of study
Title
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?
Description
Interview, Yes/No with free response
Time Frame
Up to 8 weeks after end of study
Title
Did clinicians experience an improvement in the quality of care for patients as a result of participating in the series?
Description
Interview, Yes/No with free response
Time Frame
Up to 8 weeks after end of study
Title
Did clinic directors observe an improvement in the quality of care for patients as a result of a clinician participating in the series?
Description
Interview, Yes/No with free response
Time Frame
Up to 8 weeks after end of study
Title
Did clinicians participating influence other providers in their clinic?
Description
Interview, Yes/No with free response
Time Frame
Up to 8 weeks after end of study
Title
Did clinic directors observe clinicians who participated in the series influence other providers within the clinic?
Description
Interview, Yes/No with free response
Time Frame
Up to 8 weeks after end of study
Title
Clinician benefits gained from participating in the series
Description
Interview, free response
Time Frame
Up to 8 weeks after end of study
Title
Clinician recommendations for improving the scalability or sustainability of this model
Description
Interview, free response
Time Frame
Up to 8 weeks after end of study
Title
Clinic directors recommendations for improving the scalability or sustainability of this model
Description
Interview, free response
Time Frame
Up to 8 weeks after end of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jane Samaniego, MS
Phone
619-515-2300
Email
janes@fhcsd.org
First Name & Middle Initial & Last Name or Official Title & Degree
Job Godino, PhD
Phone
619-515-2344
Ext
2344
Email
jobg@fhcsd.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Ramers, MD
Organizational Affiliation
Family Health Centers of San Diego
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Job Godino, PhD
Organizational Affiliation
Family Health Centers of San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
Family Health Centers of San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jane Samaniego, MS

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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?

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