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?

Chronic Fatigue Syndrome Clinical Trial

— LC&FIRP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05167227
• Other study ID #: HS-2021-0241
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 30, 2021
• Est. completion date: October 31, 2024

Study information

• Verified date: November 2023
• Source: Family Health Centers of San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Fatigue Syndrome
• COVID-19
• Encephalomyelitis
• Fatigue Syndrome, Chronic
• Myalgic Encephalomyelitis
• Respiration Disorders
• Respiratory Tract Diseases
• SARS-CoV-2 Acute Respiratory Disease

Intervention

Other:
• Extension for Community Healthcare Outcomes
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.

Locations

Country	Name	City	State
United States	Family Health Centers of San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Family Health Centers of San Diego

Country where clinical trial is conducted

United States, 

Outcome

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