A telehealth-based randomized controlled trial: A model for outpatient trials of off-label medications during the COVID-19 pandemic.
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ABSTRACT:
SUBMITTER: Keyhani S
PROVIDER: S-EPMC8292190 | biostudies-literature | 2021 Aug
REPOSITORIES: biostudies-literature
Publications
A telehealth-based randomized controlled trial: A model for outpatient trials of off-label medications during the COVID-19 pandemic.
Keyhani Salomeh S Kelly J Daniel JD Bent Stephen S Boscardin W John WJ Shlipak Michael G MG Leonard Sam S Abraham Ann A Lum Emily E Lau Nicholas N Austin Charles C Oldenburg Catherine E CE Zillich Allan A Lopez Lenny L Zhang Ying Y Lietman Tom T Bravata Dawn M DM
Clinical trials (London, England) 20210520 4
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Project description:ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications
| PRJNA1227596 | ENA
Project description:ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications
| PRJNA1227597 | ENA
Project description:Executive summaryThe COVID-19 pandemic, with its resultant social distancing, has disrupted the delivery of healthcare for both patients and providers. Fortunately, changes to legislation and regulation in response to the pandemic allowed Emory Healthcare to rapidly implement telehealth care. Beginning in early March 2020 and continuing through the initial 2-month implementation period (when data collection stopped), clinicians received telehealth training and certification. Standard workflows created by means of a hub-and-spoke operational model enabled rapid sharing and deployment of best practices throughout the system's physician group practice. Lean process huddles facilitated successful implementation. In total, 2,374 healthcare professionals, including 986 attending physicians, 416 residents and fellows, and 555 advanced practice providers, were trained and certified for telehealth; 53,751 new- and established-patient audio-video telehealth visits and 10,539 established-patient telephone visits were performed in 8 weeks for a total of 64,290 virtual visits. This initiative included a new COVID-19 virtual patient clinic that saw 705 patients in a 6-week period. A total of $14,662,967 was charged during this time; collection rates were similar to in-person visits. Initial patient satisfaction scores were equivalent to in-person visits. We conclude that rapid deployment of virtual visits can be accomplished through a structured, organized approach including training, certification, and Lean principles. A hub-and-spoke model enables bidirectional feedback and timely improvements, thus facilitating swifter implementation and a quick rise in patient volume. Financial sustainability is achievable, but to sustain that, telehealth requires the support of continued deregulation by legislative and regulatory bodies.
| S-EPMC7671820 | biostudies-literature
Project description:The novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) altered the logistics of ongoing randomized controlled trials (RCTs). The need to reduce in-person research and clinical activities, however, presented an additional level of complexity in order to continue conducting RCTs that focused on the development of medications for Alcohol Use Disorder (AUD). The visits required a systematic objective evaluation from the physician and mental health professional and clinical staff, as many of the safety and efficacy assessments are self-reported. The following commentary addresses the successes and limitations our RCTs encountered during the coronavirus (COVID-19) pandemic.
| S-EPMC7832637 | biostudies-literature
Project description:PurposeIn response to the COVID-19 pandemic, new policy waivers permitted reimbursement of telehealth services in urban settings. The aim of this study was to assess patient satisfaction with telehealth services during the COVID-19 pandemic in an outpatient urban nephrology practice.MethodsPatients who had virtual encounters were asked to complete an online survey regarding their experiences with telehealth services.ResultsTwenty-one percent of eligible patients completed the survey. Patients (83.6%) reported overall positive experiences with telehealth and want to see a hybrid healthcare model in the future (80.1%). Additionally, most patients found telehealth appointments convenient to make and telehealth encounters convenient to conduct. Ethnicity, age, gender, and insurance type did not have a statistically significant impact on satisfaction ratings. Technical issues were not encountered by 79.5% of patients and patients were willing to use the video feature. However, if they had technical issues, patient satisfaction ratings were negatively impacted.ConclusionTelehealth services are beneficial to patients with regards to convenience, decreased transportation costs and time, increased accessibility to healthcare, and decreased overall opportunity costs. However, challenges still remain with the deployment of telehealth and will be dependent on patients' digital health literacy, access to broadband internet and devices, and legislation and/or regulations. Limitations of the study, including small sample size and surveying patients from a nephrology practice, may prevent it from being generalizable. Additional studies with a larger sample size and multiple specialties may be needed to generalize patients' satisfaction with telehealth services.
| S-EPMC10173904 | biostudies-literature
Project description: Not available
| S-EPMC7393781 | biostudies-literature
Project description:ObjectivesThis study sought to determine whether the increased use of telehealth was associated with a difference in outcomes for outpatients with heart failure.BackgroundThe COVID-19 pandemic led to dramatic changes in the delivery of outpatient care. It is unclear whether increased use of telehealth affected outcomes for outpatients with heart failure.MethodsIn March 2020, a large Midwestern health care system, encompassing 16 cardiology clinics, 16 emergency departments, and 12 hospitals, initiated a telehealth-based model for outpatient care in the setting of the COVID-19 pandemic. A propensity-matched analysis was performed to compare outcomes between outpatients seen in-person in 2018 and 2019 and via telemedicine in 2020.ResultsAmong 8,263 unique patients with heart failure with 15,421 clinic visits seen from March 15 to June 15, telehealth was employed in 88.5% of 2020 visits but in none in 2018 or 2019. Despite the pandemic, more outpatients were seen in 2020 (n = 5,224) versus 2018 and 2019 (n = 5,099 per year). Using propensity matching, 4,541 telehealth visits in 2020 were compared with 4,541 in-person visits in 2018 and 2019, and groups were well matched. Mortality was similar for telehealth and in-person visits at both 30 days (0.8% vs 0.7%) and 90 days (2.9% vs 2.4%). Likewise, there was no excess in hospital encounters or need for intensive care with telehealth visits.ConclusionsA telehealth model for outpatients with heart failure allowed for distanced encounters without increases in subsequent acute care or mortality. As the pressures of the COVID-19 pandemic abate, these data suggest that telehealth outpatient visits in patients with heart failure can be safely incorporated into clinical practice.
| S-EPMC8494054 | biostudies-literature
Project description: Not available
| S-EPMC9164452 | biostudies-literature
Project description:The COVID-19 pandemic remains the pre-eminent global health problem, and yet after more than three years there is still no prophylactic agent against the disease aside from vaccines. The objective of this study was to evaluate whether pre-existing, outpatient medications approved by the US Food and Drug Administration (FDA) reduce the risk of hospitalization due to COVID-19. This was a retrospective cohort study of patients from across the United States infected with COVID-19 in the year 2020. The main outcome was adjusted odds of hospitalization for COVID-19 amongst those positive for the infection. Outcomes were adjusted for known risk factors for severe disease. 3,974,272 patients aged 18 or older with a diagnosis of COVID-19 in 2020 met our inclusion criteria and were included in the analysis. Mean age was 50.7 (SD 18). Of this group, 290,348 patients (7.3%) were hospitalized due to COVID-19, similar to the CDC's reported estimate (7.5%). Four drugs showed protective effects against COVID-19 hospitalization: rosuvastatin (aOR 0.91, p = 0.00000024), empagliflozin-metformin (aOR 0.69, p = 0.003), metformin (aOR 0.97, p = 0.017), and enoxaparin (aOR 0.88, p = 0.0048). Several pre-existing medications for outpatient use may reduce severity of disease and protect against COVID-19 hospitalization. Well-designed clinical trials are needed to assess the efficacy of these agents in a therapeutic or prophylactic setting.
| S-EPMC10065249 | biostudies-literature
Project description:BackgroundOutpatient clinics were shifted rapidly to telehealth in Australia during the Coronavirus disease 19 (COVID-19) pandemic, drastically altering patient care and experience.AimsTo investigate patient satisfaction and acceptability of telehealth consultations during the COVID-19 pandemic.MethodsProspective observation study conducted in two hospital rheumatology outpatient departments (OPD) undertaking telehealth consultations during COVID-19. A modified version of a validated telehealth evaluation survey was posted to all patients attending the telehealth OPD rheumatology clinics, including balanced 5-point Likert scales and free-text responses. Cluster analysis was applied to the Likert-scale questions, alongside thematic analysis of free-text responses.ResultsThere were 128 respondents (29% response rate), of which 69.5% were women and the majority (87.5%) was aged 50 years or older. All telehealth consultations were conducted by telephone. Nearly one-fifth of patients indicated consistent dissatisfaction with telehealth across the range of questions. These patients were older, reported lower educational qualifications and lower health literacy scores and lacked access to the Internet. While many patients found this mode of consultation to be convenient, patients expressed concerns regarding absence of physical examination. A recurrent theme was a desire for a mixed-model clinic in the future, with flexibility of having both telehealth and face-to-face consultations.ConclusionsThis study offers unique insights into patients' experiences with telehealth, which until the current global pandemic, has been an uncommon mode of consultation delivery in urban areas. This study suggests when defining the place of telehealth in future healthcare delivery, patient perspective and careful patient selection will be key. Disease progression, language and cognitive ability, health literacy, technology access and patient and clinician preference are important considerations when deciding how effectively to embed and integrate telehealth into consultations.
| S-EPMC8444675 | biostudies-literature