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 |
REPOSITORIES: biostudies-literature
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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: Not available
| S-EPMC7393781 | biostudies-literature
Project description:Objectives This study sought to determine whether the increased use of telehealth was associated with a difference in outcomes for outpatients with heart failure. Background The 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. Methods In 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. Results Among 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. Conclusions A 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. Central Illustration
| S-EPMC8494054 | 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
Project description:BackgroundThe COVID-19 pandemic resulted in a rapid and expansive roll out of telehealth applications as a mode of intervention delivery. The effectiveness of this model of care is currently unclear.ObjectiveA cross-sectional observational study evaluating the Irish physiotherapist's experience of telehealth.MethodIrish Physiotherapists completed an online survey, distributed by the Irish Society of Chartered Physiotherapists (ISCP), exploring considerations and barriers to commencing telehealth, advantages and disadvantages to telehealth, overall experience of telehealth, and their opinion on the future of telehealth. A descriptive approach and conceptual content analysis were used to analysis the data to derive determinants for the continuation of telehealth.ResultsIn total, 205 physiotherapists completed the survey. Seventy-eight per cent were female. Participant's mean age range was 36 to 45 years with 17 years of physiotherapy experience. Eighty-three per cent had no experience with telehealth pre COVID-19. Considerations to commencing telehealth included service user's suitability, adequate technical and organisational resources, physiotherapist's professional conduct, physiotherapist's skills and COVID-19 restrictions. No outstanding barrier to telehealth was identified. Respondents identify that telehealth offered a reduction in travel time for the service user (82%), offer flexibility in the delivery of physiotherapy (81%) and avoid contact with a potential COVID-19 spreader (92%). The limited scope of the physical examination (86%) via telehealth is the significant disadvantage. Telehealth is considered a temporary stop-gap during the COVID-19 pandemic by forty per cent of physiotherapists while sixty per cent consider telehealth as a sustainable alternative mode of health care delivery.ConclusionAt present, health care providers have not universally accepted telehealth as a mode of health care delivery. Our study's findings identify key areas to address to encourage acceptance.
| S-EPMC8503965 | biostudies-literature
Project description:AimsTo assess the impact of teleintervention on mental health parameters in type 2 diabetes patients during the coronavirus disease 2019 (COVID-19) pandemic.MethodsThis is a controlled randomized trial for a multidisciplinary telehealth intervention in Southern Brazil, with social distancing measures. Adults aged 18 years or older with previous diagnosis of type 2 diabetes were included in the study. The intervention performed was a set of strategies to help patients stay healthy during the COVID-19 pandemic and included the maintaining of telephone contacts and providing educational materials on issues related to mental health, healthy habits, and diabetes care. The primary outcome was a positive screening for mental health disorders (Self-Reporting Questionnaire) after 16 weeks of intervention. A positive screening for mental health disorders was considered when the survey scored greater than or equal to 7. Secondary outcomes included a positive screening for diabetes-related emotional distress (Problem Areas in Diabetes), eating (Eating Attitudes Test), and sleep disorders (Mini Sleep Questionnaire). Comparisons with χ2 tests for dichotomous outcomes, along with the Mann-Whitney U test, was used for between group analyses.ResultsA total of 91 individuals agreed to participate (46 intervention group and 45 control group). There were no differences in demographic and clinical data at baseline. After 16 weeks of follow-up, a positive screening for mental health disorders was found in 37.0% of participants in the intervention group vs. 57.8% in the control group (P = 0.04). Diabetes-related emotional distress was found in 21.7% of participants in the intervention group vs. 42.2% in the control group (P = 0.03). No differences were found between groups with regard to eating and sleep disorders.ConclusionThis study demonstrated that maintaining remote connections with health professionals during social distancing and quarantine have the potential to reduce the prevalence of positive screening for mental health disorders and diabetes-related emotional distress in adults with type 2 diabetes.
| S-EPMC7959296 | biostudies-literature
Project description: Not available
| S-EPMC7508503 | biostudies-literature
Project description:BackgroundWith over 37.8 million cases and over 1 million deaths worldwide, the COVID-19 pandemic has created a societal and economic upheaval of unparalleled magnitude. A positive transformation has been brought about by innovative solutions in the health care sector that aim to mitigate the impact of COVID-19 on human health. For instance, the use of telehealth has been on the rise amidst this public health emergency.ObjectiveGiven the unprecedented scale of the pandemic with no definitive endpoint, we aimed to scope the existing telehealth-related literature during a defined period of the ongoing pandemic (ie, January to June 2020).MethodsOur scoping review was guided by the Joanna Briggs Institute Reviewer Manual. We systematically searched PubMed and Embase databases with specific eligibility criteria. Data extracted from the shortlisted articles included first author and affiliation, journal title, publication type, terminologies used to describe telehealth and their accompanying definitions, health discipline or medical specialties and subspecialties wherein telehealth had been applied, the purpose of telehealth use, and the authors' overall sentiment on telehealth use. We collated the available information and used descriptive statistics to analyze the synthesized data.ResultsIn all, 543 articles published across 331 different journals were included in this scoping review. The Journal of Medical Internet Research and its sister journals featured the highest number of articles (25/543, 4.6%). Nearly all (533/543, 98.2%) articles were in English. The majority of the articles were opinions, commentaries, and perspectives (333/543, 61.3%). Most authors of the articles reviewed were from high-income countries (470/543, 86.6%), especially from the United States of America (237/543, 43.6%). In all, 39 different definitions were used to describe terms equivalent to telehealth. A small percentage (42/543, 7.7%) of the articles focused on the provision of COVID-19-related care. Moreover, 49.7% (270/543) of the articles primarily focused on the provision of multiple components of clinical care, and 23% (125/543) of the articles focused on various specialties and subspecialties of internal medicine. For a vast majority (461/543, 84.9%) of the articles, the authors expressed a celebratory sentiment about the use of telehealth.ConclusionsThis review identified considerable emerging literature on telehealth during the first six months of the COVID-19 pandemic, albeit mostly from high-income countries. There is compelling evidence to suggest that telehealth may have a significant effect on advancing health care in the future. However, the feasibility and application of telehealth in resource-limited settings and low- and middle-income countries must be established to avail its potential and transform health care for the world's population. Given the rapidity with which telehealth is advancing, a global consensus on definitions, boundaries, protocols, monitoring, evaluation, and data privacy is urgently needed.
| S-EPMC7710390 | biostudies-literature
Project description:BackgroundDramatic decreases in outpatient visits and sudden increases in telehealth visits were observed during the COVID-19 pandemic, but it was unclear whether these changes differed by patient demographics and socioeconomic status.ObjectiveThis study aimed to assess the impact of the pandemic on in-person outpatient and telehealth visits (telephone and video) by demographic characteristics and household income in a diverse population.MethodsWe calculated weekly rates of outpatient and telehealth visits by age, sex, race/ethnicity, and neighborhood-level median household income among members of Kaiser Permanente Southern California (KPSC) from January 5, 2020, to October 31, 2020, and the corresponding period in 2019. We estimated the percentage change in visit rates during the early pandemic period (March 22 to April 25, 2020) and the late pandemic period (October 4 to October 31, 2020) from the prepandemic period (January 5 to March 7, 2020) in Poisson regression models for each subgroup while adjusting for seasonality using 2019 data. We examined if the changes in visit rates differed by subgroups statistically by comparing their 95% CIs.ResultsAmong 4.56 million KPSC members enrolled in January 2020, 15.0% (n=682,947) were ≥65 years old, 51.5% (n=2,345,020) were female, 39.4% (n=1,795,994) were Hispanic, and 7.7% (n=350,721) lived in an area of median household income <US $40,000. Increases in telehealth visits during the pandemic varied across subgroups, while decreases in outpatient visits were similar, except by age. Among age groups, the ≥65 years population had the least increase in telehealth visits (236.6%, 95% CI 228.8%-244.5%), with 4.9 per one person-year during the early pandemic period versus 1.5 per one person-year during the prepandemic period. During the same periods, across racial/ethnic groups, Hispanic individuals had the largest increase in telehealth visits (295.5%, 95% CI 275.5%-316.5%). Across income levels, telehealth visits in the low-income group increased the most (313.5%, 95% CI 294.8%-333.1%). The rate of combined outpatient and telehealth visits in the Hispanic, non-Hispanic Black, and low-income groups returned to prepandemic levels by October 2020.ConclusionsThe Hispanic group and low-income group had the largest percentage increase in telehealth utilization in response to the COVID-19 pandemic. The use of virtual care potentially mitigated the impact of the pandemic on health care utilization in these vulnerable populations.
| S-EPMC8412134 | biostudies-literature