Colchicine and high-intensity rosuvastatin in the treatment of non-critically ill patients hospitalised with COVID-19: a randomised clinical trial.

OBJECTIVE: To evaluate the effect of colchicine and high-intensity rosuvastatin in addition to standard of care on the progression of COVID-19 disease in hospitalised patients. DESIGN: A pragmatic, open-label, multicentre, randomised controlled trial conducted from October 2020 to September 2021. Follow-up was conducted at 30 and 60 days. The electronic medical record was used at all stages of the trial including screening, enrolment, randomisation, event ascertainment and follow-up. SETTING: Four centres in the Yale New Haven Health System. PARTICIPANTS: Non-critically ill hospitalised patients with COVID-19. INTERVENTIONS: Patients were randomised 1:1 to either colchicine plus high-intensity rosuvastatin in addition to standard of care versus standard of care alone. Assigned treatment was continued for the duration of index hospitalisation or 30 days, whichever was shorter. PRIMARY AND SECONDARY OUTCOME MEASURES: The prespecified primary endpoint was progression to severe COVID-19 disease (new high-flow or non-invasive ventilation, mechanical ventilation, need for vasopressors, renal replacement therapy or extracorporeal membrane oxygenation, or death) or arterial/venous thromboembolic events (ischaemic stroke, myocardial infarction, deep venous thrombosis or pulmonary embolism) evaluated at 30 days. RESULTS: Among the 250 patients randomised in this trial (125 to each arm), the median age was 61 years, 44% were women, 15% were Black and 26% were Hispanic/Latino. As part of the standard of care, patients received remdesivir (87%), dexamethasone (92%), tocilizumab (18%), baricitinib (2%), prophylactic/therapeutic anticoagulation (98%) and aspirin (91%). The trial was terminated early by the data and safety monitoring board for futility. No patients were lost to follow-up due to electronic medical record follow-up. There was no significant difference in the primary endpoint at 30 days between the active arm and standard of care arm (15.2% vs 8.8%, respectively, p=0.17). CONCLUSIONS: In this small, open-label, randomised trial of non-critically ill hospitalised patients with COVID-19, the combination of colchicine and rosuvastatin in addition to standard of care did not appear to reduce the risk of progression of COVID-19 disease or thromboembolic events, although the trial was underpowered due to a lower-than-expected event rate. The trial leveraged the power of electronic medical records for efficiency and improved follow-up and demonstrates the utility of incorporating electronic medical records into future trials. TRIAL REGISTRATION: NCT04472611.

Impact of a Social Justice Course in Graduate Nursing Education.

BACKGROUND: Social justice and health equity are foundational concepts to the graduate-prepared nurse's role. However, the integration of these concepts into graduate nursing education has been unclear. PURPOSE: This study examined the impact of a newly created social justice course in a graduate nursing program. METHODS: The impact of the Health Equity and Social Justice course on students' values and attitudes toward social justice was investigated through analysis of quantitative and qualitative data generated in the course. RESULTS: Data were collected from 41 graduate nursing students. Findings demonstrated that students who completed the course had an increased endorsement of social justice values, goals, and behaviors. Students universally found the course to be transformational. CONCLUSIONS: A social justice course in graduate education can be transformational in shaping students' values and attitudes toward health equity and social justice.

Design and rationale of the colchicine/statin for the prevention of COVID-19 complications (COLSTAT) trial.

BACKGROUND: Despite improvement in the standard of care (SOC) for hospitalized COVID-19 patients, rates of morbidity and mortality remain high. There continues to be a need for easily available and cost-effective treatments. Colchicine and rosuvastatin are both safe and well-studied medications with anti-inflammatory and other pleiotropic effects that may provide additional benefits to hospitalized COVID-19 patients. METHODS AND RESULTS: The Colchicine/Statin for the Prevention of COVID-19 Complications (COLSTAT) trial is a pragmatic, open-label, multicenter, randomized trial comparing the combination of colchicine and rosuvastatin in addition to SOC to SOC alone in hospitalized COVID-19 patients. Four centers in the Yale New Haven Health network will enroll a total of 466 patients with 1:1 randomization. The trial will utilize the electronic health record (Epic® Systems, Verona, Wisconsin, USA) at all stages including screening, randomization, intervention, event ascertainment, and follow-up. The primary endpoint is the 30-day composite of progression to severe COVID-19 disease as defined by the World Health Organization ordinal scale of clinical improvement and arterial/venous thromboembolic events. The secondary powered endpoint is the 30-day composite of death, respiratory failure requiring intubation, and myocardial injury. CONCLUSIONS: The COLSTAT trial will provide evidence on the efficacy of repurposing colchicine and rosuvastatin for the treatment of hospitalized COVID-19 patients. Moreover, it is designed to be a pragmatic trial that will demonstrate the power of using electronic health records to improve efficiency and enrollment in clinical trials in an adapting landscape. CLINICAL TRIAL REGISTRATION: NCT04472611 (https://clinicaltrials.gov/ct2/show/NCT04472611).

Association of Posture and Ambulation With Function 30 Days After Hospital Discharge in Older Adults with Heart Failure.

PURPOSE: The aim of this work was to investigate the predictive value of in-hospital posture and ambulatory activity for 30 days following discharge on functional status in older patients with heart failure. METHODS AND RESULTS: We undertook a prospective observational pilot study of 27 patients (78 ± 9.8 y, 51.8% female) admitted with heart failure. Participants wore 2 inclinometric accelerometers to record posture in-hospital and an ankle accelerometer to record ambulatory activity in-hospital and 30 days after discharge. Function was assessed on the day after discharge (Timed Up and Go [TUG], Short Physical Performance Battery [SPPB], hand grip strength) and 30 days after discharge. Length of stay was 5.1 ± 3.9 days. Participants spent 63.0 ± 19.2% of their hospital time lying down, 30.2 ± 18.7% sitting, 5.3 ± 4.2% standing, and 1.9 ± 8.6% ambulating. Thirty-day mean post-discharge stepping was 4890 ± 2285 steps/day. Each 10% increase in hospital lying time was associated with 0.7 s longer TUG time (95% confidence interval [CI] 0.2-1.9) at 30 days. Each 1000 additional daily steps in the post-discharge period was associated with a 0.8-point higher SPPB score (95% CI 0.1-1.0) at 30 days. Handgrip strength was unchanged. CONCLUSIONS: Older patients with heart failure were sedentary during hospitalization, which may contribute to decreased functional performance. Physical activity after discharge may minimize this negative effect.

Solving the puzzle of Alzheimer disease.

Managing patients with dementia and Alzheimer disease can be a challenge. Often, families and caregivers ask clinicians about the latest treatments. This article summarizes the latest evidence-based practice related to pharmacologic and nonpharmacologic management of patients with Alzheimer disease.

The meaning of health: perspectives of Anglo and Latino older women.

This qualitative study, utilizing the dimensional analysis approach, was conducted to generate a substantive theory about the description and meaning of functional health from the perspectives of older Anglo and Latino women. Through focus group interviews with older Anglo and Latino women and data analysis, the investigators learned that the women's perceptions of functional health were vastly different. As planners and providers, we usually are trained in a health culture that is predominantly based on White, middle-class values. This ethnocentrism can act as a barrier leading us to disregard the notion that concepts such as health are not universally perceived. Findings from this study may enable us to achieve a closer approximation of the real experiences of our clients and to sensitize us to different world views.

Detecting acute confusion in older adults: Comparing clinical reasoning of nurses working in acute, long-term, and community health care environments.

In an article on a previous study involving hospitalized older adults (McCarthy, 2003), it was argued that the theory of situated clinical reasoning explains why nurses often fail to recognize acute confusion. Further, the theory illuminates how nurses' perspectives toward health in aging affect the ways they regard and ultimately deal with older people in this particular clinical situation. The purpose of the current study was to challenge and refine the theory by exploring the influence of different care environments on clinical reasoning related to acute confusion. Following a period of participant observation, a purposive sample of 30 nurses, 10 each from a teaching hospital, a long-term facility, and a home care agency, participated in semistructured interviews. Dimensional analysis provided the methodological framework for data collection and interpretation. The results reinforce prior findings that the ability of nurses to recognize acute confusion and to distinguish it from dementia can be attributed to their personal philosophies about aging. Care environment was identified as a factor that influenced clinical reasoning in limited ways under certain conditions and within certain contexts.

Situated clinical reasoning: distinguishing acute confusion from dementia in hospitalized older adults.

In this study a dimensional analysis approach was used to explore the clinical reasoning of nurses who care for hospitalized older adults to identify factors that might explain their failure to detect acute confusion and to distinguish it from dementia in this patient population. Data analysis yielded a grounded theory of situated clinical reasoning, which proposes that the ability of nurses to identify acute confusion varies widely. This variation can be attributed to the differences in nurses' philosophical perspectives on aging. According to this theory, three distinct perspectives are unwittingly embraced by nurses who care for older patients. These perspectives influence how nurses characterize aging and the aged and condition the ways in which they judge and ultimately deal with older adults in clinical situations.