The Long COVID and Fatiguing Illness Recovery Program - A Pragmatic, Quality Improvement, Professional Cluster, Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Patient-Reported Outcomes Measurement Information System (PROMIS)-29
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •There are no exclusion criteria.
研究组 & 干预措施
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.
Intervention
The Intervention arm participates in weekly teleECHO sessions with monthly interactive webinars and quarterly short courses.
干预措施: Extension for Community Healthcare Outcomes (Other)
结局指标
主要结局
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
时间窗: During 12 months of follow-up
Patient baseline and quarterly surveys
次要结局
- Currently minutes per week of moderate-intensity physical activity patient does (like a brisk walk, slow biking, gardening, or ballroom dancing)(During 9 months of follow-up)
- Patient symptom checklist with associated severity for those present(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, during the past month how often have the patient had 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 bad was this symptom?(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(During 12 months of follow-up)
- Patient's dietary restrictions(Through study referral period, an average of 12 weeks)
- If symptom is present, has patient experienced this in the past month(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?(During 12 months of follow-up)
- When fatigued, has this fatigue substantially limited the patient's ability to occupational, educational, social, or personal activities?(During 12 months of follow-up)
- Patient's medical history check-list(Through study referral period, an average of 12 weeks)
- Patient symptom onset(Through study referral period, an average of 12 weeks)
- Patient reported admittance to hospital due to COVID-19(During 12 months of follow-up)
- 2-minute step test(During 12 months of follow-up)
- 30 sec sit to stand test(During 12 months of follow-up)
- Functional Gait Assessment(During 12 months of follow-up)
- If fatigue present, what month and year did the fatiguing illness begin?(During 12 months of follow-up)
- When fatigued, does rest make patient's fatigue better?(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(During 12 months of follow-up)
- Patient's food allergies or other food intolerances(Through study referral period, an average of 12 weeks)
- Has patient's employment been impacted due to contracting COVID-19?(Through study referral period, an average of 12 weeks)
- Does patient feel fully recovered from COVID-19(During 9 months of follow-up)
- Balance tasks(During 12 months of follow-up)
- PROMIS Dyspnea Functional Limitations and Severity Short Forms(During 12 months of follow-up)
- 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(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(Through study referral period, an average of 12 weeks)
- Did patient receive a COVID-19 PCR (nasal swab) test(Through study referral period, an average of 12 weeks)
- Did patient receive a COVID-19 antibody test(Through study referral period, an average of 12 weeks)
- Patient reported prescribed supplementary oxygen support(Through study referral period, an average of 12 weeks)
- Currently minutes per week of vigorous-intensity physical activity patient does (like running, swimming laps, competitive sports, or fast bicycling)(During 9 months of follow-up)
- Patient Health Questionnaire (PHQ)-2(During 12 months of follow-up)
- Patient reported medications used for COVID-19 symptoms(Through study referral period, an average of 12 weeks)
- Patient Health Questionnaire (PHQ)-9 (if applicable)(During 12 months of follow-up)
- Generalized Anxiety Disorder (GAD)-7(During 12 months of follow-up)
- Grip strength(During 12 months of follow-up)
- Post-exertional malaise follow-up(Per Physical Therapy encounter after PT assessment)
- PROMIS Applied Cognition Abilities and General Concerns Short Forms(During 12 months of follow-up)