Clinician Training Program for Long COVID

Overseen By Shannon Nugent, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Non-VA care, ICU for COVID-19

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

348 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special training program for doctors can improve care for Veterans dealing with Long-COVID. The program focuses on teaching doctors to engage in meaningful conversations with patients, validate their experiences, and collaborate on a care plan. Veterans experiencing persistent COVID-19 symptoms and who have appointments with participating doctors might be suitable candidates. The trial consists of two parts, testing two different training methods: Concordant Care Training and Education Packet Training, to identify which method enhances doctors' ability to provide better care. As an unphased trial, this study offers Veterans an opportunity to contribute to improving healthcare practices for Long-COVID.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on training clinicians rather than changing participants' medication routines.

What prior data suggests that this training program is safe for clinicians and patients?

A previous study showed that Concordant Care creates positive experiences for patients with complex conditions. This approach emphasizes recognizing and understanding patients' experiences and collaborating to develop personalized care plans. These elements make it well-received because the care centers on patients' needs.

No known negative effects are directly linked to Concordant Care Training. It is important to note that this is not a drug or medical procedure. Instead, it is a training program for healthcare providers to enhance their interactions with patients. Therefore, there are no physical side effects like those associated with medications. Since it is not a traditional clinical trial, there is no specific phase for safety evidence. However, the program's design suggests it is a safe way to improve patient-provider relationships. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to improve how healthcare providers manage Long COVID through specialized training. Unlike traditional approaches that focus solely on patient treatment, this trial emphasizes equipping clinicians with enhanced skills and knowledge. The Concordant Care Training offers a hands-on approach to align care with patient needs, while the Education Packet Training provides structured learning materials. By focusing on clinician training, the trial hopes to improve patient outcomes through more personalized and informed care.

What evidence suggests that this trial's treatments could be effective for Long-COVID?

Research shows that the Concordant Care approach improves patient experiences by acknowledging their feelings, creating mutual understanding, and developing personalized care plans. Strong evidence indicates that both patients and doctors report positive experiences, especially for conditions not well understood, like Long COVID. Studies have found that when doctors use this approach, patients feel more understood and supported, leading to greater satisfaction and better adherence to care plans. In this trial, providers will be randomized to receive either Concordant Care Training or Education Packet Training. Although promising, no specialized training programs currently exist for doctors to use Concordant Care specifically for Long COVID. The goal is to adapt this approach to improve care and outcomes for Veterans dealing with this challenging condition. ^{2 4 6 7 8}

Who Is on the Research Team?

Lisa Marie McAndrew, PhD

Principal Investigator

East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ

Are You a Good Fit for This Trial?

This trial is for English-speaking VA primary care providers and Veterans with Long-COVID who are receiving care in the VA. Providers must not have prior Concordant Care training, and Veterans need to have an upcoming appointment within 1-6 months after clinician consent.

Inclusion Criteria

Part 2, Veterans must also have a scheduled appointment with one of the participating clinicians within one to six months of the clinician being consented.

Veterans who have Long-COVID symptoms as determined by a specific questionnaire will be included.

I am an English-speaking VA primary care provider.

Exclusion Criteria

Part 1 and Part 2, clinicians who have already taken Concordant Care training will be excluded.

Part 1, Veterans will be excluded if they are not receiving care in the VA.

Part 2, Veterans will be excluded if they were in the Intensive Care Unit (ICU) for COVID-19.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training and Optimization

Part 1 of the study will optimize and test if a Concordant Care training improves VA clinicians' engagement in recommended practices to provide Concordant Care for Veterans with Long-COVID.

Varies

Interviews and focus groups

Randomized Parallel Cluster Trial

Part 2 of the study will determine if Concordant Care training increases clinicians' engagement in recommended practices and explore the effectiveness of Concordant Care on care outcomes.

3 months

Baseline and follow-up assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Concordant Care Training
• Education Packet Training

Trial Overview The study tests a Concordant Care training program for clinicians treating Long-COVID. It aims to see if this training helps them engage better with patients by validating experiences, understanding conditions together, and planning patient-centered actions.

How Is the Trial Designed?

Group I: Providers receiving Long-COVID Concordant Care Training Experimental Treatment 1 Intervention

Providers randomized to this arm will receive concordant care training.

Group II: Providers receiving Education Packet Training Active Control 1 Intervention

Providers randomized to this arm will receive education packet training

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

The Duke-Watts Family Medicine Program successfully integrated geriatric medicine training into its residency program by involving residents in the planning process and focusing on practical, relevant goals.

Key strategies included developing a conference series, identifying training sites, and incorporating various healthcare professionals, which enhanced the training experience across different care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Geriatric training in family medicine: the natural history of a developing program. Moore, JT., Kane, WJ.[2004]

The COVID-19 Clinical Rounds Initiative, developed by the US Department of Health and Human Services and the University of New Mexico, created a large-scale peer-to-peer learning network to enhance clinical education during the pandemic, engaging participants from all 50 states and over 100 countries.

Between March 2020 and February 2021, the initiative conducted 125 learning sessions, providing more than 58,000 hours of educational contact, focusing on critical areas of COVID-19 care such as emergency medical services, emergency departments, and inpatient critical care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Peer-to-Peer Learning to Enhance and Accelerate the Health System Response to COVID-19: The HHS ASPR Project ECHO COVID-19 Clinical Rounds Initiative. Hunt, RC., Struminger, BB., Redd, JT., et al.[2022]

A rapid training program for contact tracing and case investigation was developed and successfully scaled, training 7,499 individuals in California from April to August 2020, demonstrating the feasibility of quickly mobilizing a workforce to combat COVID-19.

The training emphasized interactive, skills-based learning, particularly in rapport building and health coaching, which are crucial for effective case investigation and contact tracing, highlighting the importance of practical training and feedback in public health education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

California's COVID-19 Virtual Training Academy: Rapid Scale-Up of a Statewide Contact Tracing and Case Investigation Workforce Training Program. Brickley, DB., Forster, M., Alonis, A., et al.[2021]

An interdisciplinary educational initiative significantly improved palliative care knowledge and skills among over 1000 clinicians through 27 educational sessions.

The initiative led to measurable increases in palliative care referrals and advanced directive documentation, demonstrating a positive cultural shift in the hospital workforce and earning two national awards for its impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transforming the Workforce for Primary Palliative Care Through a System-Wide Educational Initiative. Duty, SM., Loftus, J.[2019]

The Clinical Quality Fellowship Program (CQFP) significantly improved quality improvement skills among 87 healthcare professionals in New York, with participants reporting enhanced abilities across all assessed areas after completing the program.

Over half (56%) of the participants received promotions after finishing the CQFP, indicating that the program not only fostered skill development but also positively impacted career advancement in the healthcare field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Clinical Quality Fellowship Program: Developing Clinical Quality Leadership in the Greater New York Region. Bhalla, R., Jalon, HS., Ryan, L.[2019]

In response to the COVID-19 pandemic, a Palliative Care Toolkit was developed to support nonpalliative care clinicians in managing symptoms like dyspnea and delirium, providing evidence-based guidance and resources for effective patient care.

The Toolkit has successfully increased the acceptance of palliative care practices among hospital staff, allowing specialized teams to focus on the most critical cases while ensuring broader access to essential palliative care resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Palliative Care Toolkit for the COVID-19 Pandemic. deLima Thomas, J., Leiter, RE., Abrahm, JL., et al.[2021]

The small-group airway skills workshops for experienced clinicians were successfully implemented during the clinical workday, with 47 anesthesiologists and 17 CRNAs participating, demonstrating feasibility and high acceptability among attendees.

While the workshops did not significantly increase participants' confidence in airway management skills, they received positive feedback, indicating that this flexible training approach can effectively complement traditional large-format educational methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practice what you teach: An approach to integrate airway education for experienced anesthesia clinicians. Daly Guris, RJ., Toy, S., Bruins, BB., et al.[2022]

An outpatient telehealth program was successfully implemented to monitor 296 patients diagnosed with COVID-19, with over 800 phone calls made during the 8-month study, demonstrating the feasibility of remote patient care during the pandemic.

The program involved 30 medical student volunteers and ensured continued access to care, with only four patient deaths reported, indicating a potentially effective approach to managing COVID-19 patients at home.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

COVID-19 Home Monitoring: An Institutional Approach to Bridging Care During a Pandemic. Wong, GJ., Douglas, K., Fuest, S., et al.[2022]

The Center to Advance Palliative Care (CAPC) clinical curriculum, launched in 2015, has trained over 26,000 clinicians in essential skills for managing serious illness, with a significant portion being registered nurses and advanced practice providers.

Post-course evaluations showed that 84% of participants intended to change their practice based on the training, indicating the curriculum's effectiveness in enhancing care quality for patients with serious illness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of an Online Palliative Care Clinical Curriculum to Train U.S. Hospital Staff: 2015-2019. Rogers, MM., Chambers, B., Esch, A., et al.[2021]

A study of COVID-19 patients at an academic medical center found that 97% had goals-of-care (GOC) documentation within 48 hours of admission, indicating effective communication and prioritization of patient values during a health crisis.

The use of a structured note template for GOC discussions was beneficial, especially for patients with dementia in nursing facilities, who had timely documentation, while healthier patients experienced delays, highlighting the need for tailored approaches in different patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing Goals-of-Care Documentation during the COVID-19 Patient Surge in an Academic Safety-Net Medical Center. Reidy, J., Savageau, JA., Sullivan, K., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05787379?cond=Chronic%20post-COVID-19%20syndrome&locStr=United%20States&country=United%20States&aggFilters=status:rec%20enr%20not&rank=1

NCT05787379 | Care for Veterans Post-COVID-19 Part 1 of the study will optimize and test if a Concordant Care training improves VA clinicians' engagement in recommended practices to provide Concordant Care ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11418572/

Long COVID or Post-Acute Sequelae of SARS-CoV-2 Infection ... Long COVID/PASC is the continuation or development of new symptoms after three months from the initial SARS-CoV-2 infection, which lasts for at least two ...

3. research.va.gov research.va.gov/corc/VA-Long-COVID-Projects.pdf

VA Funded Studies on Long COVID The CORC conducts and supports rigorous research to understand the long-term effects of SARS-CoV-2 infection. To achieve this goal,. CORC will ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11493926/

Post-acute sequelae of SARS-CoV-2 infection (Long COVID ... Determinants of post-COVID-19 symptoms among adults aged 55 or above with chronic conditions in primary care: data from a prospective cohort in Hong Kong.

5. pnas.org pnas.org/doi/10.1073/pnas.2426874122

Patient-reported treatment outcomes in ME/CFS and long ... With no known effective FDA-approved treatments for either condition, patient-reported outcomes of treatments may prove helpful in identifying management ...

6. trialstoday.org trialstoday.org/search/results?status=recruiting&gender=&age=&zip=&radius=25&condition=covid-19&healthy=&type=&interventionalpurpose=&observationalmodel=&page=eJyLVspLrShR0lHycw4xMDU1MTYzNFPS0bWEARxME1M9U0szM2MTHUNzU0sjczMLAxDQUcpLLjEwNTA3MTEyUIoFAO1dFNU-

Save Selected The evidence-based Concordant Care approach involves engaging in processes that: 1) validate the patient's experience, 2) develop a shared understanding of ...

7. fnih.org fnih.org/sites/default/files/2022-12/PASC%20Seminar%20Series%20Whitepaper_vFINAL2.pdf

Acute Sequelae of SARS-CoV-2 (PASC)/Long COVID ... Persistent inflammation could help explain the variability of PASC/long COVID manifestations - through different types of inflammatory activation, responses to ...

8. recovercovid.org recovercovid.org/publications/post-acute-sequelae-severe-acute-respiratory-syndrome-coronavirus-2-sars-cov-2-after

Post-acute sequelae of severe acute respiratory syndrome ... Objective: To estimate the prevalence of post-acute sequelae of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (PASC) after infection ...