Contemporary clinical trials
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Contemp Clin Trials · Jan 2018
Randomized Controlled Trial Multicenter StudyThe Study of Neurocognitive Outcomes, Radiological and Retinal Effects of Aspirin in Sleep Apnoea- rationale and methodology of the SNORE-ASA study.
Sleep disordered breathing (SDB) is highly prevalent in older adults. Increasing evidence links SDB to the risk of dementia, mediated via a number of pathways, some of which may be attenuated by low-dose aspirin. This study will evaluate, in a healthy older cohort, the prospective relationship between SDB and cognitive function, changes in retinal and cerebral microvasculature, and determine whether low-dose aspirin ameliorates the effects of SDB on these outcomes over 3years. ⋯ ACTRN12612000891820: The Principal ASPREE study is registered with the International Standardized Randomized Controlled Trials Register, ASPirin in Reducing Events in the Elderly, Number: ISRCTN83772183 and clinicaltrials.gov Number NCT01038583.
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Contemp Clin Trials · Jan 2018
Randomized Controlled Trial Multicenter StudyTopical vancomycin to reduce surgical-site infections in neurosurgery: Study protocol for a multi-center, randomized controlled trial.
Surgical-site infections (SSIs) account for 20% of all healthcare-associated infections, are the most common nosocomial infection among surgical patients, and are a focus of quality improvement initiatives. Despite implementation of many quality care measures (e.g. prophylactic antibiotics), SSIs remain a significant cause of morbidity, mortality, and economic burden, particularly in the field of neurosurgery. Topical vancomycin is increasingly utilized in instrumented spinal and cardiothoracic procedures, where it has been shown to reduce the risk of SSIs. ⋯ Univariate analysis and logistic regression will determine the effect of topical vancomycin on SSIs at 30days. A randomized controlled trial is needed to determine the efficacy of this treatment. Results of this trial are expected to directly influence the standard of care and prevention of SSIs in neurosurgical patients.
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Contemp Clin Trials · Jan 2018
Randomized Controlled Trial Multicenter StudySPIRIT trial: A phase III pragmatic trial of an advance care planning intervention in ESRD.
Advance care planning (ACP) is a central tenet of dialysis care, but the vast majority of dialysis patients report never engaging in ACP discussions with their care providers. Over the last decade, we have developed and iteratively tested SPIRIT (Sharing Patient's Illness Representation to Increase Trust), a theory-based, patient- and family-centered advance care planning intervention. SPIRIT is a six-step, two-session, face-to-face intervention to promote cognitive and emotional preparation for end-of-life decision making for patients with ESRD and their surrogates. ⋯ Simultaneously, we will evaluate the implementation of SPIRIT, including sustainability. We will recruit 400 dyads of patients at high risk of death in the next year and their surrogates from 30 dialysis clinics in four states. This trial of SPIRIT will generate novel, meaningful insights about improving ACP in dialysis care.
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Contemp Clin Trials · Jan 2018
Randomized Controlled TrialA hypertension emergency department intervention aimed at decreasing disparities: Design of a randomized clinical trial.
Effective interventions to identify and treat uncontrolled hypertension (HTN), particularly in underrepresented populations that use the emergency department (ED) for primary care, are critically needed. Uncontrolled HTN contributes significantly to cardiovascular morbidity and mortality and is more frequently encountered among patients presenting to the ED as compared to the primary care setting. EDs serve as the point of entry into the health care system for high-risk patient populations, including minority and low-income patients. ⋯ The primary outcome is mean BP differences between study arms. Secondary outcomes are proportion of participants with BP control (BP<140/90mmHg), and improvements in HTN knowledge and medication adherence scores between study arms. The objective of this report is to describe the development of the AHEAD2 trial, including the methods, research infrastructure, and other features of the randomized clinical trial design.