Evaluation of the "safe multidisciplinary app-assisted remote patient-self-testing (SMART) model" for warfarin home management during the COVID-19 pandemic: study protocol of a multi-center randomized controlled trial.

BACKGROUND: Warfarin treatment requires frequent monitoring of INR (international normalized ratio) to adjust dosage in a therapeutic range. In China, patients living in small towns usually go to tertiary hospitals to get warfarin monitoring and dosing, resulting in low frequencies of follow-ups and high incidence of complications. Influenced by the COVID-19 pandemic, patients on warfarin have further reduced their visits to healthcare institutions. While patient self-testing (PST) via using a point-of-care testing device for INR measuring at home has been widely used in developed countries and demonstrated improved clinical outcomes compared to usual care in clinics, it is rarely applied in developing countries, including China. This proposed study will develop and assess the "Safe Multidisciplinary App-assisted Remote patient-self-Testing (SMART) model" for warfarin home management in China during the COVID-19 pandemic. METHODS: This is a multi-center randomized controlled trial. We will carry out the study in three county hospitals, three small tertiary hospitals and three large tertiary hospitals with anticoagulation clinics in Hunan province of China. Eligible patients will be randomly assigned to the SMART model group (n = 360) or the control group (usual care clinic group, n = 360; anticoagulation clinic group, n = 120). Patients in the SMART model group do PST at home once every two to 4 weeks. Controls receive usual care in the clinics. All the patients will be followed up through outpatient clinics, phone call or online interviews at the 3rd, 6th, 9th and 12th month. The percentage of time in therapeutic range (TTR), incidence of warfarin associated major bleeding and thromboembolic events and costs will be compared between the SMART model group and control groups. DISCUSSION: Patients in the SMART model group would show improved TTR, lower incidence of complications and better quality of life compared to the control groups. Our design, implementation and usage of the SMART model will provide experience and evidence in developing a novel model for chronic disease management to solve the problem of healthcare service maldistribution, an issue particularly obvious in developing countries during the COVID-19 pandemic. TRIAL REGISTRATION: ChiCTR, ChiCTR 2000038984 . Registered 11 October, 2020.

Management Strategies for Patients After CABG Surgery in the Outbreak of the COVID-19 Pandemic.

BACKGROUND: The novel coronavirus 2019 pandemic (COVID-19) has quickly spread over the world and affected over 100 countries so far. Patients with pre-existing cardiovascular disease may have a higher risk of infection of COVID-19 and worse outcomes than others. To improve the outcome during the pandemic, management strategies for the patients recovering from coronary artery bypass graft (CABG) surgery need to be reconsidered. METHODS: Some precaution advices including self-protection, blood glucose and blood pressure controlling are recommended for the patients recovering from CABG during the pandemic. They are encouraged to communicate with doctors by telephone or Internet when COVID-19 related symptoms such as cough, fever and dyspnea occur. As a follow-up strategy for patients after CABG surgery, cardiac biomarkers and CTA could also be helpful to the diagnosis of COVID-19. Some medications being investigated for COVID-19 therapy may have side effects relevant to cardiovascular disease. Appropriate personal protection equipment (PPE) is necessary for cardiovascular health-care workers operating in clinical settings. RESULTS: There was zero out of over 300 follow-up patients after CABG surgery confirmed to be infected with COVID-19 from January to June 2020. No cardiovascular health-care workers were reported to be infected neither in the Second Xiangya Hospital during the pandemic. CONCLUSION: The management strategy here we proposed could improve the outcome of patients after CABG during the pandemic and benefit both cardiovascular patients and health-care workers.