Protocol implementation during the COVID-19 pandemic: experiences from a randomized trial of stress ulcer prophylaxis.

BACKGROUND: During the COVID-19 pandemic, many intensive care units (ICUs) halted research to focus on COVID-19-specific studies. OBJECTIVE: To describe the conduct of an international randomized trial of stress ulcer prophylaxis (Re-Evaluating the Inhibition of Stress Erosions in the ICU [REVISE]) during the pandemic, addressing enrolment patterns, center engagement, informed consent processes, data collection, a COVID-specific substudy, patient transfers, and data monitoring. METHODS: REVISE is a randomized trial among mechanically ventilated patients, comparing pantoprazole 40 mg IV to placebo on the primary efficacy outcome of clinically important upper gastrointestinal bleeding and the primary safety outcome of 90-day mortality. We documented protocol implementation status from March 11th 2020-August 30th 2022. RESULTS: The Steering Committee did not change the scientific protocol. From the first enrolment on July 9th 2019 to March 10th 2020 (8 months preceding the pandemic), 267 patients were enrolled in 18 centers. From March 11th 2020-August 30th 2022 (30 months thereafter), 41 new centers joined; 59 were participating by August 30th 2022 which enrolled 2961 patients. During a total of 1235 enrolment-months in the pandemic phase, enrolment paused for 106 (8.6%) months in aggregate (median 3 months, interquartile range 2;6). Protocol implementation involved a shift from the a priori consent model pre-pandemic (188, 58.8%) to the consent to continue model (1615, 54.1%, p < 0.01). In one new center, an opt-out model was approved. The informed consent rate increased slightly (80.7% to 85.0%, p = 0.05). Telephone consent encounters increased (16.6% to 68.2%, p < 0.001). Surge capacity necessitated intra-institutional transfers; receiving centers continued protocol implementation whenever possible. We developed a nested COVID-19 substudy. The Methods Centers continued central statistical monitoring of trial metrics. Site monitoring was initially remote, then in-person when restrictions lifted. CONCLUSION: Protocol implementation adaptations during the pandemic included a shift in the consent model, a sustained high consent rate, and launch of a COVID-19 substudy. Recruitment increased as new centers joined, patient transfers were optimized, and monitoring methods were adapted.

Vitamin D and the critically ill patient.

PURPOSE OF REVIEW: To summarize the current knowledge on vitamin D with a special focus on critically ill patients. RECENT FINDINGS: Vitamin D deficiency is associated with adverse health outcomes including increased risk of cardiovascular disease, morbidity and mortality in the general population. In critically ill patients, the pleiotropic effects of vitamin D including its role in immune function are of great interest. SUMMARY: To date, it is not clear whether vitamin D deficiency is a surrogate marker for increased morbidity or whether treatment with sufficiently large doses of vitamin D may improve patient outcome in an intensive care setting.

Vitamin D in the ICU: anything new under the sun?

The recent recognition of the myriad roles of vitamin D beyond those of bone health and calcium homoeostasis has resulted in a large body of clinical studies demonstrating an association between vitamin D deficiency and a number of adverse health outcomes. While these studies in chronic disease states have shown a strong association between vitamin D deficiency and poor outcomes, they have been unable to demonstrate cause and effect. Several studies to date have demonstrated a high prevalence of vitamin D deficiency in critically ill patients, and some of these have shown an association with poor outcomes. It is possible that low vitamin D levels may contribute to the acute multiorgan dysfunction seen in critical illness by similar mechanisms to those seen in chronic conditions. In this commentary, we briefly review the physiology of vitamin D, examine the evidence for association of hypovitaminosis with poor outcome in both ambulatory and intensive care unit patients, and debate the role of routine vitamin D supplementation in the ICU.

Uni- and interdisciplinary effects on round and handover content in intensive care units.

OBJECTIVE: The aim of this study was to explore differences in the verbal content of handovers and rounds conducted in uni- and interdisciplinary social contexts. We expected higher proportions of goals to be articulated during interdisciplinary rounds. BACKGROUND: Lack of explanatory connections between round improvement initiatives and outcomes suggest insufficient understanding about health care communications, especially the role of social interaction. METHODS: The recognition-primed abstract decomposition space (RP-ADS) was used to analyze the information content of nurse handovers and morning rounds in a unidisciplinary- (physicians only) and an interdisciplinary-round intensive care unit (ICU). Data were collected using audio recordings of rounds and handovers for five patients for 5 days each in both ICUs. RESULTS: Hierarchical log-linear analyses show strong associations between events (medical rounds vs. nurses' shift handovers), type (uni- vs. interdisciplinary), and focus (levels of the RP-ADS) with highly significant combined two-way and higher-order interactions, LRchi2(df=4) = 30.91, p < .0001. All tests of partial association were also highly significant. Differences among levels of the variables were evaluated using standardized residuals. CONCLUSION: Nurses focused on RP-ADS data and intervention levels, whereas physicians focused on diagnoses and expectations. Clinical goals that integrate these orientations emerged to a greater extent in interdisciplinary rounds. In addition, social context of rounds appears to influence nurse handovers. Unidisciplinary ICU nurse handovers consisted of a series of data- and intervention-related observations, whereas ICU nurse handovers in interdisciplinary ICUs tended to integrate data, interventions and clinical goals. APPLICATION: These results are relevant to the design and implementation of clinical communication improvement initiatives and support tools.