Family Health Centers of San Diego
San Diego, California, 92102, United States
NCT Number: NCT05167227
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
San Diego, California, 92102, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: During 12 months of follow-up
Patient baseline and quarterly surveys
Time frame: During 12 months of follow-up
Patient baseline and quarterly surveys, None, Mild, Moderate, Severe
Time frame: During 12 months of follow-up
Patient baseline and quarterly surveys, Yes/No
Time frame: During 12 months of follow-up
Patient baseline and quarterly surveys, Under 3 Months, 3 Months or longer
Time frame: During 12 months of follow-up
Patient baseline and quarterly surveys, Yes/No
Time frame: During 12 months of follow-up
Patient baseline and quarterly surveys with use of Likert scale
Time frame: During 12 months of follow-up
Patient baseline and quarterly surveys with use of Likert scale
Time frame: During 12 months of follow-up
Patient baseline and quarterly surveys with Yes/No/Not Applicable/Don't Know
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
Time frame: During 12 months of follow-up
Patient baseline and quarterly surveys, estimated month and year
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
Time frame: During 12 months of follow-up
Patient baseline and quarterly surveys, Yes, No, Not applicable, Don't know
Time frame: Through study referral period, an average of 12 weeks
Patient baseline survey, Yes, No, Unsure
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
Time frame: Through study referral period, an average of 12 weeks
Patient baseline survey, Yes/No
Time frame: Through study referral period, an average of 12 weeks
Patient baseline survey, Yes, No
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
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
Time frame: Through study referral period, an average of 12 weeks
Patient baseline survey, Yes/No
Time frame: Through study referral period, an average of 12 weeks
Patient baseline survey, Yes/No
Time frame: Through study referral period, an average of 12 weeks
Patient baseline survey, Date
Time frame: Through study referral period, an average of 12 weeks
Patient baseline survey, free text
Time frame: Through study referral period, an average of 12 weeks
Patient baseline survey, Yes/No
Time frame: During 12 months of follow-up
Patient baseline and quarterly surveys, Yes/No
Time frame: During 12 months of follow-up
Patient baseline and quarterly surveys, Yes/No
Time frame: During 9 months of follow-up
Patient quarterly surveys, Yes/No
Time frame: During 9 months of follow-up
Patient quarterly surveys, free text
Time frame: During 9 months of follow-up
Patient quarterly surveys, free text
Time frame: During 12 months of follow-up
Patient baseline and quarterly surveys
Time frame: During 12 months of follow-up
Patient baseline and quarterly surveys
Time frame: During 12 months of follow-up
Patient baseline and quarterly surveys
Time frame: During 12 months of follow-up
Patient baseline and quarterly surveys
Time frame: During 12 months of follow-up
Patient baseline and quarterly surveys
Time frame: During 12 months of follow-up
Physical Therapy assessment with patient
Time frame: During 12 months of follow-up
Physical Therapy assessment with patient
Time frame: During 12 months of follow-up
Physical Therapy assessment with patient
Time frame: During 12 months of follow-up
Physical Therapy assessment with patient
Time frame: During 12 months of follow-up
Physical Therapy assessment with patient
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
Time frame: During 37 months of follow-up
Clinician quarterly follow-up survey with use of Likert scale agreement
Time frame: During 37 months of follow-up
Clinician quarterly follow-up survey with use of Likert scale agreement
Time frame: During 37 months of follow-up
Clinician quarterly follow-up survey with use of Likert scale agreement
Time frame: During 37 months of follow-up
Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
Time frame: During 37 months of follow-up
Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
Time frame: During 37 months of follow-up
Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
Time frame: During 37 months of follow-up
Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
Time frame: During 37 months of follow-up
Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
Time frame: During 37 months of follow-up
Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
Time frame: During 37 months of follow-up
Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
Time frame: During 37 months of follow-up
Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
Time frame: During 37 months of follow-up
Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
Time frame: During 37 months of follow-up
Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
Time frame: During 37 months of follow-up
Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
Time frame: During 37 months of follow-up
Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
Time frame: During 37 months of follow-up
Clinician baseline and quarterly follow-up survey with use of Likert scale agreement
Time frame: During 34 months of follow-up
Clinician quarterly follow-up survey Yes/No
Time frame: During 34 months of follow-up
Clinician quarterly follow-up survey with use of Likert scale agreement
Time frame: During 34 months of follow-up
Clinician quarterly follow-up survey with use of Likert scale likelihood
Time frame: During 34 months of follow-up
Clinician quarterly follow-up survey with use of Likert scale likelihood
Time frame: During 34 months of follow-up
Clinician quarterly follow-up survey Yes/No
Time frame: During 34 months of follow-up
Clinician quarterly follow-up survey with use of Likert scale agreement
Time frame: During 34 months of follow-up
Clinician quarterly follow-up survey with use of Likert scale agreement
Time frame: During 34 months of follow-up
Clinician quarterly follow-up survey with use of Likert scale agreement
Time frame: During 34 months of follow-up
Clinician quarterly follow-up survey with use of Likert scale agreement
Time frame: During 34 months of follow-up
Clinician quarterly follow-up survey with use of Likert scale agreement and free text
Time frame: During 34 months of follow-up
Clinician quarterly follow-up survey with use of Likert scale agreement and free text
Time frame: During 34 months of follow-up
Clinician quarterly follow-up survey with free text
Time frame: During 37 months after each weekly ECHO session
Clinician intervention teleECHO survey
Time frame: Through study completion, an average of 37 months
Clinician intervention teleECHO survey with use of Likert scale knowledge
Time frame: Through study completion, an average of 37 months
Clinician intervention teleECHO survey with use of Likert scale quality
Time frame: Through study completion, an average of 37 months
Clinician intervention teleECHO survey with use of Likert scale quality
Time frame: Through study completion, an average of 37 months
Clinician intervention teleECHO survey with use of Likert scale quality
Time frame: Through study completion, an average of 37 months
Clinician intervention teleECHO survey with use of Likert scale quality
Time frame: Through study completion, an average of 37 months
Clinician intervention teleECHO survey with use of Likert scale quality
Time frame: Through study completion, an average of 37 months
Clinician intervention teleECHO survey with use of Likert scale quality
Time frame: Through study completion, an average of 37 months
Clinician intervention teleECHO survey, free text
Time frame: Through study completion, an average of 37 months
Clinician intervention teleECHO survey Yes/No
Time frame: Through study completion, an average of 37 months
Clinician intervention teleECHO survey Yes/No and free text
Time frame: Through study completion, an average of 37 months
Clinician intervention teleECHO survey free text
Time frame: Through study completion, an average of 37 months
Clinician intervention teleECHO survey with use of Likert scale relevance
Time frame: Through study completion, an average of 37 months
Clinician intervention teleECHO survey Yes/No and free text
Time frame: Through study completion, an average of 37 months
Clinician intervention teleECHO survey free text
Time frame: Through study completion, an average of 37 months
Clinician intervention teleECHO survey free text
Time frame: Through study completion, an average of 37 months
Clinician intervention teleECHO survey with use of Likert scale likelihood
Time frame: Through study completion, an average of 37 months
Clinician intervention teleECHO survey free text
Time frame: Through study completion, an average of 37 months
Clinician intervention teleECHO survey free text
Time frame: Semi-annually during 37 months of follow-up
Mean number of months clinicians participate in the trial (intervention and control groups)
Time frame: Semi-annually during 37 months of follow-up
Number of clinic settings in which providers see patients (intervention and control groups)
Time frame: Weekly during 37 months of follow-up
Number of weekly sessions each RCT (intervention) provider attends, and mean number
Time frame: Weekly during 37 months of follow-up
Number of topics covered in Weekly ECHO sessions RCT (intervention) provider attends
Time frame: Monthly during 37 months of follow-up
Number of monthly webinars RCT providers attends
Time frame: Quarterly during 37 months of follow-up
Number of quarterly short courses RCT providers attends
Time frame: Monthly during 37 months of follow-up
Number of topics covered in monthly webinars provider attends
Time frame: Quarterly during 37 months of follow-up
Number of topics covered in quarterly short courses provider attends
Time frame: Quarterly during 37 months of follow-up
Number of patient cases presented by RCT (intervention) provider
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)
Time frame: Monthly during 37 months of follow-up
Number of patients seen by RCT provider, and mean number (intervention and control)
Time frame: Monthly during 37 months of follow-up
Number of PASC patients seen by RCT provider, and mean number (intervention and control)
Time frame: Monthly during 37 months of follow-up
Number of referrals to specialists by RCT provider, and mean number (intervention and control)
Time frame: Quarterly during 37 months of follow-up
Number of specialist recommendations applied by RCT (intervention) providers from weekly ECHO sessions
Time frame: Monthly during 37 months of follow-up
Mean duration of consultation for PASC patients by RCT providers, intervention and control
Time frame: Monthly during 37 months of follow-up
Number of specialists seen by patient
Time frame: Monthly during 37 months of follow-up
Number of specialty types the patient was exposed to
Time frame: Weekly during 37 months of follow-up
How long an (intervention) provider attended an ECHO session
Time frame: Quarterly during 37 months of follow-up
Number of individuals who attended and watched short course
Time frame: Up to 8 weeks after end of study
Interview with Likert satisfaction
Time frame: Up to 8 weeks after end of study
Interview
Time frame: Up to 8 weeks after end of study
Interview
Time frame: Up to 8 weeks after end of study
Interview
Time frame: Up to 8 weeks after end of study
Interview, Yes/No with free response
Time frame: Up to 8 weeks after end of study
Interview
Time frame: Up to 8 weeks after end of study
Interview, Yes/No with free response
Time frame: Up to 8 weeks after end of study
Interview, Yes/No with free response
Time frame: Up to 8 weeks after end of study
Interview, Yes/No with free response
Time frame: Up to 8 weeks after end of study
Interview, Yes/No with free response
Time frame: Up to 8 weeks after end of study
Interview, Yes/No with free response
Time frame: Up to 8 weeks after end of study
Interview, Yes/No with free response
Time frame: Up to 8 weeks after end of study
Interview, Yes/No with free response
Time frame: Up to 8 weeks after end of study
Interview, free response
Time frame: Up to 8 weeks after end of study
Interview, free response
Time frame: Up to 8 weeks after end of study
Interview, free response
Family Health Centers of San Diego
Other
The Long COVID and Fatiguing Illness Recovery Program - A Pragmatic, Quality Improvement, Professional Cluster, Randomized Controlled Trial.
Acronym: LC&FIRP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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