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?

NCT05167227 | Active Not Recruiting

• 1 other identifier: HS-2021-0241
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Patient-Reported Outcomes Measurement Information System (PROMIS)-29

  Patient baseline and quarterly surveys

  During 12 months of follow-up

Secondary Outcomes (38)

• Patient symptom checklist with associated severity for those present

  During 12 months of follow-up

• If symptom is present, has patient experienced this in the past month

  During 12 months of follow-up

• If symptom is present, how long has patient experienced this symptom

  During 12 months of follow-up

• If symptom is present, did patient have this symptom before the patient tested positive for COVID-19?

  During 12 months of follow-up

• If symptom is present, during the past month how often have the patient had this symptom?

  During 12 months of follow-up

Other Outcomes (82)

• Knowledge improvement of appropriate PASC diagnosis as a result of participation in randomized arm (teleECHO or monthly webinar)

  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)

  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)

  During 37 months of follow-up

Study Arms (2)

Control

NO INTERVENTION

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.

Intervention

EXPERIMENTAL

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

Other: Extension for Community Healthcare Outcomes

Interventions

Extension for Community Healthcare Outcomes OTHER

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.

Also known as: ECHO

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Family Health Centers of San Diego: lead

Study Sites (1)

Family Health Centers of San Diego

San Diego, California, 92102, United States

Location

Related Publications (1)

• Godino JG, Samaniego JC, Sharp SP, Taren D, Zuber A, Armistad AJ, Dezan AM, Leyba AJ, Friedly JL, Bunnell AE, Matthews E, Miller MJ, Unger ER, Bertolli J, Hinckley A, Lin JS, Scott JD, Struminger BB, Ramers C. A technology-enabled multi-disciplinary team-based care model for the management of Long COVID and other fatiguing illnesses within a federally qualified health center: protocol for a two-arm, single-blind, pragmatic, quality improvement professional cluster randomized controlled trial. Trials. 2023 Aug 12;24(1):524. doi: 10.1186/s13063-023-07550-3.

  PMID: 37573421 DERIVED

MeSH Terms

Conditions

Fatigue Syndrome, Chronic; Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders

Study Officials

• Christian Ramers, MD

  Family Health Centers of San Diego

  PRINCIPAL INVESTIGATOR

• Job Godino, PhD

  Family Health Centers of San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: December 22, 2021
• Study Start: November 30, 2021
• Primary Completion: November 20, 2024
• Study Completion: November 28, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)