Early High-Dose Vitamin D3 for Critically Ill, Vitamin D-Deficient Patients.

BACKGROUND: Vitamin D deficiency is a common, potentially reversible contributor to morbidity and mortality among critically ill patients. The potential benefits of vitamin D supplementation in acute critical illness require further study. METHODS: We conducted a randomized, double-blind, placebo-controlled, phase 3 trial of early vitamin D3 supplementation in critically ill, vitamin D-deficient patients who were at high risk for death. Randomization occurred within 12 hours after the decision to admit the patient to an intensive care unit. Eligible patients received a single enteral dose of 540,000 IU of vitamin D3 or matched placebo. The primary end point was 90-day all-cause, all-location mortality. RESULTS: A total of 1360 patients were found to be vitamin D-deficient during point-of-care screening and underwent randomization. Of these patients, 1078 had baseline vitamin D deficiency (25-hydroxyvitamin D level, <20 ng per milliliter [50 nmol per liter]) confirmed by subsequent testing and were included in the primary analysis population. The mean day 3 level of 25-hydroxyvitamin D was 46.9±23.2 ng per milliliter (117±58 nmol per liter) in the vitamin D group and 11.4±5.6 ng per milliliter (28±14 nmol per liter) in the placebo group (difference, 35.5 ng per milliliter; 95% confidence interval [CI], 31.5 to 39.6). The 90-day mortality was 23.5% in the vitamin D group (125 of 531 patients) and 20.6% in the placebo group (109 of 528 patients) (difference, 2.9 percentage points; 95% CI, -2.1 to 7.9; P = 0.26). There were no clinically important differences between the groups with respect to secondary clinical, physiological, or safety end points. The severity of vitamin D deficiency at baseline did not affect the association between the treatment assignment and mortality. CONCLUSIONS: Early administration of high-dose enteral vitamin D3 did not provide an advantage over placebo with respect to 90-day mortality or other, nonfatal outcomes among critically ill, vitamin D-deficient patients. (Funded by the National Heart, Lung, and Blood Institute; VIOLET ClinicalTrials.gov number, NCT03096314.).

Community Implementation of a Prehospital Spinal Immobilization Guideline.

OBJECTIVE: The purpose of this study was to qualitatively describe the underpinnings of the successful implementation of a collaborative prehospital spinal immobilization guideline throughout the emergency medical services (EMS) community in two counties in Colorado. We also describe lessons learned that may be beneficial to other communities considering similar initiatives. METHODS: Qualitative data were collected from key informants who were directly involved in the implementation of a new prehospital spinal immobilization guideline among four community hospitals in two different hospital systems and the associated EMS providers within the two counties. We interviewed a purposively selected sample of emergency department (ED) physicians and other ED staff, hospital decision makers, EMS educators as well as fire department and EMS medical directors. Data were collected and reviewed until saturation was achieved. We conducted qualitative analysis to summarize and synthesize themes. RESULTS: Ten key informants were interviewed, at which point saturation was achieved and several clear themes emerged. Participants described successful community-wide guideline implementation despite a history of competition, isolation, and conflict between the various EMS organizations and hospitals on past EMS and trauma initiatives. Factors related to success included the nearly universal perception that the initiative was "cutting edge" and thus an important paradigm shift in care for the community, as a whole. Participants reported the ability of community stakeholders to jointly assure a collaborative approach, characterized by intensive education for EMS personnel and others involved, and the ability of the community to together secure the new equipment required for success. CONCLUSIONS: Key informants described a convergence of factors as leading to the successful implementation of a prehospital spinal immobilization guideline. Lessons learned regarding how to overcome a tradition of competition and isolation to allow for success may be useful to other communities considering similar initiatives.

A single-site pilot implementation of a novel trauma training program for prehospital providers in a resource-limited setting.

BACKGROUND: Prehospital (ambulance) care can reduce morbidity and mortality from trauma. Yet, there is a dearth of effective evidence-based interventions and implementation strategies. Emergency Medical Services Traumatic Shock Care (EMS-TruShoC) is a novel bundle of five core evidence-based trauma care interventions. High-Efficiency EMS Training (HEET) is an innovative training and sensitization program conducted during clinical shifts in ambulances. We assess the feasibility of implementing EMS-TruShoC using the HEET strategy, and feasibility of assessing implementation and clinical outcomes. Findings will inform a main trial. METHODS: We conducted a single-site, prospective cohort, multi-methods pilot implementation study in Western Cape EMS system of South Africa. Of the 120 providers at the study site, 12 were trainers and the remaining were eligible learners. Feasibility of implementation was guided by the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework. Feasibility of assessing clinical outcomes was assessed using shock indices and clinical quality of care scores, collected via abstraction of patients' prehospital trauma charts. Thresholds for progression to a main trial were developed a priori. RESULTS: The average of all implementation indices was 83% (standard deviation = 10.3). Reach of the HEET program was high, with 84% learners completing at least 75% of training modules. Comparing the proportion of learners attaining perfect scores in post- versus pre-implementation assessments, there was an 8-fold (52% vs. 6%) improvement in knowledge, 3-fold (39% vs. 12%) improvement in skills, and 2-fold (42% vs. 21%) increase in self-efficacy. Clinical outcomes data were successfully calculated-there were clinically significant improvements in shock indices and quality of prehospital trauma care in the post- versus pre-implementation phases. Adoption of HEET was good, evidenced by 83% of facilitator participation in trainings, and 100% of surveyed stakeholders indicating good programmatic fit for their organization. Stakeholders responded that HEET was a sustainable educational solution that aligned well with their organization. Implementation fidelity was very high; 90% of the HEET intervention and 77% of the implementation strategy were delivered as originally planned. Participants provided very positive feedback, and explained that on-the-job timing enhanced their participation. Maintenance was not relevant to assess in this pilot study. CONCLUSIONS: We successfully implemented the EMS-TruShoC educational intervention using the HEET training strategy in a single-site pilot study conducted in a low-resource international setting. All clinical outcomes were successfully calculated. Overall, this pilot study suggests high feasibility of our future, planned experimental trial.

Treating Decompression Sickness: Military Flight Simulation Site-Community Hospital Partnership.

BACKGROUND: High-altitude flight simulation familiarizes military trainees with the symptoms of hypoxia to prepare them for emergency situations. Decompression sickness (DCS) can occur as a result of these simulations. In cases when ground-level supplemental oxygen does not resolve symptoms, hyperbaric oxygen (HBO) therapy is indicated. Many military hyperbaric chambers have been closed because of cost reductions, necessitating partnerships with community hospitals to ensure access to treatment. MATERIALS AND METHODS: This article describes the unique arrangement between a community hospital in Colorado and a military training site to treat DCS cases emergently. We gathered cost data from the community hospital to estimate and compare the cost of providing HBO therapy in the hospital versus a standalone chamber similar to the former military hyperbaric chamber. RESULTS: Since the closure of the military hyperbaric chamber, the community hospital treated an estimated 50 patients with DCS requiring HBO therapy attributed to high-altitude flight simulation between October 2003 and April 2015. Cost to the institution providing HBO treatment varies widely on the basis of patient volume. Assuming a volume of five treatments, per-treatment cost at a standalone center is $95,380. In contrast, per-treatment cost at the hospital assuming a volume of 1,000 treatments commensurate with the hospital's ability to bill for other services is $698 per treatment. CONCLUSION: The cost analysis demonstrates that the per-treatment cost of operating a standalone HBO therapy center may be greater than 100 times that of operating a center at a community hospital, suggesting the arrangement is beneficial to the military.