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)

November 3, 2023 updated by: Family Health Centers of San Diego

The Long COVID and Fatiguing Illness Recovery Program - A Pragmatic, Quality Improvement, Professional Cluster, Randomized Controlled Trial.

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • San Diego, California, United States, 92102
        • Family Health Centers of San Diego

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.
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.
Other Names:
  • ECHO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Time Frame: During 12 months of follow-up
Patient baseline and quarterly surveys
During 12 months of follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During 12 months of follow-up
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
During 12 months of follow-up
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
During 12 months of follow-up
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
During 12 months of follow-up
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
During 12 months of follow-up
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
During 12 months of follow-up
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
During 12 months of follow-up
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
During 12 months of follow-up
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
During 12 months of follow-up
Patient's medical history check-list
Time Frame: Through study referral period, an average of 12 weeks
Patient baseline survey, Yes, No, Unsure
Through study referral period, an average of 12 weeks
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
Through study referral period, an average of 12 weeks
Patient's food allergies or other food intolerances
Time Frame: Through study referral period, an average of 12 weeks
Patient baseline survey, Yes/No
Through study referral period, an average of 12 weeks
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
Through study referral period, an average of 12 weeks
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
Through study referral period, an average of 12 weeks
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
Through study referral period, an average of 12 weeks
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
Through study referral period, an average of 12 weeks
Did patient receive a COVID-19 antibody test
Time Frame: Through study referral period, an average of 12 weeks
Patient baseline survey, Yes/No
Through study referral period, an average of 12 weeks
Patient symptom onset
Time Frame: Through study referral period, an average of 12 weeks
Patient baseline survey, Date
Through study referral period, an average of 12 weeks
Patient reported medications used for COVID-19 symptoms
Time Frame: Through study referral period, an average of 12 weeks
Patient baseline survey, free text
Through study referral period, an average of 12 weeks
Patient reported prescribed supplementary oxygen support
Time Frame: Through study referral period, an average of 12 weeks
Patient baseline survey, Yes/No
Through study referral period, an average of 12 weeks
Patient reported admittance to hospital due to COVID-19
Time Frame: During 12 months of follow-up
Patient baseline and quarterly surveys, Yes/No
During 12 months of follow-up
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
During 12 months of follow-up
Does patient feel fully recovered from COVID-19
Time Frame: During 9 months of follow-up
Patient quarterly surveys, Yes/No
During 9 months of follow-up
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
During 9 months of follow-up
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
During 9 months of follow-up
Patient Health Questionnaire (PHQ)-2
Time Frame: During 12 months of follow-up
Patient baseline and quarterly surveys
During 12 months of follow-up
Patient Health Questionnaire (PHQ)-9 (if applicable)
Time Frame: During 12 months of follow-up
Patient baseline and quarterly surveys
During 12 months of follow-up
PROMIS Dyspnea Functional Limitations and Severity Short Forms
Time Frame: During 12 months of follow-up
Patient baseline and quarterly surveys
During 12 months of follow-up
PROMIS Applied Cognition Abilities and General Concerns Short Forms
Time Frame: During 12 months of follow-up
Patient baseline and quarterly surveys
During 12 months of follow-up
Generalized Anxiety Disorder (GAD)-7
Time Frame: During 12 months of follow-up
Patient baseline and quarterly surveys
During 12 months of follow-up
2-minute step test
Time Frame: During 12 months of follow-up
Physical Therapy assessment with patient
During 12 months of follow-up
30 sec sit to stand test
Time Frame: During 12 months of follow-up
Physical Therapy assessment with patient
During 12 months of follow-up
Grip strength
Time Frame: During 12 months of follow-up
Physical Therapy assessment with patient
During 12 months of follow-up
Functional Gait Assessment
Time Frame: During 12 months of follow-up
Physical Therapy assessment with patient
During 12 months of follow-up
Balance tasks
Time Frame: During 12 months of follow-up
Physical Therapy assessment with patient
During 12 months of follow-up
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
Per Physical Therapy encounter after PT assessment
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
During 12 months of follow-up
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
During 12 months of follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinician overall best part of series
Time Frame: Up to 8 weeks after end of study
Interview
Up to 8 weeks after end of study
Clinician overall worst part of series
Time Frame: Up to 8 weeks after end of study
Interview
Up to 8 weeks after end of study
Clinician challenges in participating
Time Frame: Up to 8 weeks after end of study
Interview
Up to 8 weeks after end of study
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
Up to 8 weeks after end of study
Clinician barriers to sustained participation in series
Time Frame: Up to 8 weeks after end of study
Interview
Up to 8 weeks after end of study
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
Up to 8 weeks after end of study
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
Up to 8 weeks after end of study
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
Up to 8 weeks after end of study
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
Up to 8 weeks after end of study
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
Up to 8 weeks after end of study
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
Up to 8 weeks after end of study
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
Up to 8 weeks after end of study
Clinician benefits gained from participating in the series
Time Frame: Up to 8 weeks after end of study
Interview, free response
Up to 8 weeks after end of study
Clinician recommendations for improving the scalability or sustainability of this model
Time Frame: Up to 8 weeks after end of study
Interview, free response
Up to 8 weeks after end of study
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
Up to 8 weeks after end of study
Clinician satisfaction with series
Time Frame: Up to 8 weeks after end of study
Interview with Likert satisfaction
Up to 8 weeks after end of study
Knowledge improvement of appropriate PASC diagnosis as a result of participation in randomized arm (teleECHO or monthly webinar)
Time Frame: During 37 months of follow-up
Clinician quarterly follow-up survey with use of Likert scale agreement
During 37 months of follow-up
Knowledge improvement of effective PASC care and treatment as a result of participation in randomized arm (teleECHO or monthly webinar)
Time Frame: During 37 months of follow-up
Clinician quarterly follow-up survey with use of Likert scale agreement
During 37 months of follow-up
Knowledge improvement of approaches for complex cases of PASC as a result of participation in randomized arm (teleECHO or monthly webinar)
Time Frame: During 37 months of follow-up
Clinician quarterly follow-up survey with use of Likert scale agreement
During 37 months of follow-up
Self-efficacy in abilities related to identify tools and methods for PASC care
Time Frame: During 37 months of follow-up
Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
During 37 months of follow-up
Self-efficacy in abilities to diagnose patients with PASC
Time Frame: During 37 months of follow-up
Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
During 37 months of follow-up
Self-efficacy in abilities to screen for co-morbidities of PASC
Time Frame: During 37 months of follow-up
Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
During 37 months of follow-up
Self-efficacy in abilities to generate a patient-specific treatment plan for patients with PASC
Time Frame: During 37 months of follow-up
Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
During 37 months of follow-up
Self-efficacy in abilities related to to implement a patient-specific treatment plan for patients with PASC
Time Frame: During 37 months of follow-up
Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
During 37 months of follow-up
Self-efficacy in abilities to select appropriate special or diagnostic tests for PASC patients
Time Frame: During 37 months of follow-up
Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
During 37 months of follow-up
Self-efficacy in abilities to interpret special or diagnostic test results for my PASC patients
Time Frame: During 37 months of follow-up
Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
During 37 months of follow-up
Self-efficacy in abilities to provide appropriate patient education about their PASC condition
Time Frame: During 37 months of follow-up
Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
During 37 months of follow-up
Self-efficacy in abilities to educate clinic staff about PASC care
Time Frame: During 37 months of follow-up
Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
During 37 months of follow-up
Self-efficacy in abilities to address PASC patients using a multidisciplinary approach
Time Frame: During 37 months of follow-up
Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
During 37 months of follow-up
Self-efficacy in abilities to assess and manage concerns that PASC patients face
Time Frame: During 37 months of follow-up
Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
During 37 months of follow-up
Self-efficacy in abilities to assess severity of disease in patients with PASC
Time Frame: During 37 months of follow-up
Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
During 37 months of follow-up
Self-efficacy in abilities to deal with complex cases of PASC
Time Frame: During 37 months of follow-up
Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
During 37 months of follow-up
Utility of an encountered case presented during randomized arm (teleECHO or monthly webinar)
Time Frame: During 34 months of follow-up
Clinician quarterly follow-up survey Yes/No
During 34 months of follow-up
Overall satisfaction with randomized arm (teleECHO or monthly webinar)
Time Frame: During 34 months of follow-up
Clinician quarterly follow-up survey with use of Likert scale agreement
During 34 months of follow-up
Satisfaction to recommend to colleague randomized arm (teleECHO or monthly webinar)
Time Frame: During 34 months of follow-up
Clinician quarterly follow-up survey with use of Likert scale likelihood
During 34 months of follow-up
Satisfaction to participate in future randomized arm (teleECHO or monthly webinar) again
Time Frame: During 34 months of follow-up
Clinician quarterly follow-up survey with use of Likert scale likelihood
During 34 months of follow-up
Changes to practice in helping colleague with information learned from randomized arm (teleECHO or monthly webinar)
Time Frame: During 34 months of follow-up
Clinician quarterly follow-up survey Yes/No
During 34 months of follow-up
Changes to practice by participating in randomized arm (teleECHO or monthly webinar) to understand further monitoring and follow-up plan
Time Frame: During 34 months of follow-up
Clinician quarterly follow-up survey with use of Likert scale agreement
During 34 months of follow-up
Changes to practice by participating in randomized arm (teleECHO or monthly webinar) to develop more appropriate treatment plans
Time Frame: During 34 months of follow-up
Clinician quarterly follow-up survey with use of Likert scale agreement
During 34 months of follow-up
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 34 months of follow-up
Clinician quarterly follow-up survey with use of Likert scale agreement
During 34 months of follow-up
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 34 months of follow-up
Clinician quarterly follow-up survey with use of Likert scale agreement
During 34 months of follow-up
Changes to practice by participating in randomized arm (teleECHO or monthly webinar) to apply specialist recommendations to patient care.
Time Frame: During 34 months of follow-up
Clinician quarterly follow-up survey with use of Likert scale agreement and free text
During 34 months of follow-up
Unable to apply learnings from randomized arm (teleECHO or monthly webinar)
Time Frame: During 34 months of follow-up
Clinician quarterly follow-up survey with use of Likert scale agreement and free text
During 34 months of follow-up
Other changes to practice by participating in randomized arm (teleECHO or monthly webinar)
Time Frame: During 34 months of follow-up
Clinician quarterly follow-up survey with free text
During 34 months of follow-up
Knowledge gained about topic presented during teleECHO before and after
Time Frame: During 37 months after each weekly ECHO session
Clinician intervention teleECHO survey
During 37 months after each weekly ECHO session
Knowledge gained about topic presented during teleECHO before and after
Time Frame: Through study completion, an average of 37 months
Clinician intervention teleECHO survey with use of Likert scale knowledge
Through study completion, an average of 37 months
Satisfaction with stated objectives being met
Time Frame: Through study completion, an average of 37 months
Clinician intervention teleECHO survey with use of Likert scale quality
Through study completion, an average of 37 months
Satisfaction with session delivering balanced and objective, evidence-based content
Time Frame: Through study completion, an average of 37 months
Clinician intervention teleECHO survey with use of Likert scale quality
Through study completion, an average of 37 months
Satisfaction with pace of session
Time Frame: Through study completion, an average of 37 months
Clinician intervention teleECHO survey with use of Likert scale quality
Through study completion, an average of 37 months
Satisfaction with opportunities to ask questions
Time Frame: Through study completion, an average of 37 months
Clinician intervention teleECHO survey with use of Likert scale quality
Through study completion, an average of 37 months
Satisfaction with organization of the presenters' presentations
Time Frame: Through study completion, an average of 37 months
Clinician intervention teleECHO survey with use of Likert scale quality
Through study completion, an average of 37 months
Satisfaction with presenters' ability to clearly communicate
Time Frame: Through study completion, an average of 37 months
Clinician intervention teleECHO survey with use of Likert scale quality
Through study completion, an average of 37 months
Desired content for future sessions
Time Frame: Through study completion, an average of 37 months
Clinician intervention teleECHO survey, free text
Through study completion, an average of 37 months
Satisfaction with source evidence presented
Time Frame: Through study completion, an average of 37 months
Clinician intervention teleECHO survey Yes/No
Through study completion, an average of 37 months
Satisfaction with commercial bias present
Time Frame: Through study completion, an average of 37 months
Clinician intervention teleECHO survey Yes/No and free text
Through study completion, an average of 37 months
Recommendations for program improvement
Time Frame: Through study completion, an average of 37 months
Clinician intervention teleECHO survey free text
Through study completion, an average of 37 months
Relevance of session to clinicians current work
Time Frame: Through study completion, an average of 37 months
Clinician intervention teleECHO survey with use of Likert scale relevance
Through study completion, an average of 37 months
Intent to change practice based on learnings from session
Time Frame: Through study completion, an average of 37 months
Clinician intervention teleECHO survey Yes/No and free text
Through study completion, an average of 37 months
Best part of session
Time Frame: Through study completion, an average of 37 months
Clinician intervention teleECHO survey free text
Through study completion, an average of 37 months
Worst part of session
Time Frame: Through study completion, an average of 37 months
Clinician intervention teleECHO survey free text
Through study completion, an average of 37 months
Recommend this session to a colleague
Time Frame: Through study completion, an average of 37 months
Clinician intervention teleECHO survey with use of Likert scale likelihood
Through study completion, an average of 37 months
Changes to practice planned
Time Frame: Through study completion, an average of 37 months
Clinician intervention teleECHO survey free text
Through study completion, an average of 37 months
If no changes to practice are planned, barriers
Time Frame: Through study completion, an average of 37 months
Clinician intervention teleECHO survey free text
Through study completion, an average of 37 months
Participating clinician retention
Time Frame: Semi-annually during 37 months of follow-up
Mean number of months clinicians participate in the trial (intervention and control groups)
Semi-annually during 37 months of follow-up
Participating clinic settings
Time Frame: Semi-annually during 37 months of follow-up
Number of clinic settings in which providers see patients (intervention and control groups)
Semi-annually during 37 months of follow-up
Participation in intervention
Time Frame: Weekly during 37 months of follow-up
Number of weekly sessions each RCT (intervention) provider attends, and mean number
Weekly during 37 months of follow-up
Exposure of weekly teleECHO topics
Time Frame: Weekly during 37 months of follow-up
Number of topics covered in Weekly ECHO sessions RCT (intervention) provider attends
Weekly during 37 months of follow-up
Monthly webinar attendance
Time Frame: Monthly during 37 months of follow-up
Number of monthly webinars RCT providers attends
Monthly during 37 months of follow-up
Quarterly short course attendance
Time Frame: Quarterly during 37 months of follow-up
Number of quarterly short courses RCT providers attends
Quarterly during 37 months of follow-up
Exposure of monthly webinar topics
Time Frame: Monthly during 37 months of follow-up
Number of topics covered in monthly webinars provider attends
Monthly during 37 months of follow-up
Exposure of quarterly short course topics
Time Frame: Quarterly during 37 months of follow-up
Number of topics covered in quarterly short courses provider attends
Quarterly during 37 months of follow-up
Participation in case consultation
Time Frame: Quarterly during 37 months of follow-up
Number of patient cases presented by RCT (intervention) provider
Quarterly during 37 months of follow-up
Participation in post-session survey
Time Frame: Weekly during 37 months of follow-up
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
Volume of total patient case load
Time Frame: Monthly during 37 months of follow-up
Number of patients seen by RCT provider, and mean number (intervention and control)
Monthly during 37 months of follow-up
Volume of PASC patient case load
Time Frame: Monthly during 37 months of follow-up
Number of PASC patients seen by RCT provider, and mean number (intervention and control)
Monthly during 37 months of follow-up
Volume of patient referrals to specialists
Time Frame: Monthly during 37 months of follow-up
Number of referrals to specialists by RCT provider, and mean number (intervention and control)
Monthly during 37 months of follow-up
Application of specialist recommendations
Time Frame: Quarterly during 37 months of follow-up
Number of specialist recommendations applied by RCT (intervention) providers from weekly ECHO sessions
Quarterly during 37 months of follow-up
Average consultation duration
Time Frame: Monthly during 37 months of follow-up
Mean duration of consultation for PASC patients by RCT providers, intervention and control
Monthly during 37 months of follow-up
Volume of specialists seen by patients
Time Frame: Monthly during 37 months of follow-up
Number of specialists seen by patient
Monthly during 37 months of follow-up
Specialty types patient was exposed to
Time Frame: Monthly during 37 months of follow-up
Number of specialty types the patient was exposed to
Monthly during 37 months of follow-up
Clinician session drop-off
Time Frame: Weekly during 37 months of follow-up
How long an (intervention) provider attended an ECHO session
Weekly during 37 months of follow-up
Quarterly attendance
Time Frame: Quarterly during 37 months of follow-up
Number of individuals who attended and watched short course
Quarterly during 37 months of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2021

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

October 31, 2024

Study Registration Dates

First Submitted

December 17, 2021

First Submitted That Met QC Criteria

December 20, 2021

First Posted (Actual)

December 22, 2021

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 3, 2023

Last Verified

November 1, 2023

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Fatigue Syndrome

Clinical Trials on Extension for Community Healthcare Outcomes

3
Subscribe