Chest Pain Choice Pathway

Current clinical, electrocardiographic, and laboratory tests miss approximately 1.5 percent of patients with symptoms of a heart attack. Given the potential for a missed diagnosis, clinicians have a low risk threshold to admit patients for observation and advanced cardiac testing, leading to false positive test results, unnecessary follow-up procedures, and increased burden to patients and the healthcare system. Evidence for the effectiveness, safety, and acceptability of a shared decision-making approach to communicate risk to patients and engage them in decisions about testing and follow-up is limited.

In a recent multicenter randomized trial published in the British Medical Journal, the project team compared the effectiveness of a decision aid, Chest Pain Choice, to usual care in 898 patients enrolled from six US emergency departments. Adults (>17 years of age) with a primary complaint of chest pain who were being considered for admission for cardiac testing were enrolled. Compared to patients in the usual care arm, patients in the decision aid arm had greater knowledge of their risk and options for care (questions correct: decision aid, 4.2 vs. usual care, 3.6; mean difference 0.66, 95 percent confidence interval 0.46 to 0.86), were more involved in the decision (observing patient involvement scores: decision aid, 18.3 vs. usual care, 7.9; 10.3, 9.1 to 11.5), and less frequently decided with their clinician to be admitted for cardiac testing (decision aid, 37 percent vs. usual care, 52 percent; absolute difference 15 percent; P<0.001). The decision aid was found to be acceptable to both patients and clinicians and took on average only 1.3 additional minutes of clinician time.

To date, few shared decision-making interventions have been integrated into the flow of usual clinical care, and none have been implemented in the emergency care setting. This focused implementation project funded by the Patient Centered Outcomes Research Institute will improve the experience of emergency care for over 30,000 patients, measure the degree to which the stakeholder-guided implementation strategy is successful, address barriers to using patient decision aids in practice, and produce a training package to help other hospitals apply the study findings to their patients, ultimately impacting the care of over 6 million US citizens annually.

Pragmatic Airway Resuscitation Trial (PART)

PART_Graphic.pngThis study is a randomized controlled trial that will compare the effectiveness of endotracheal intubation (ETI) to laryngeal tube(LT) airway management in victims of out-of-hospital cardiac arrest. Both the ET and LT are used by EMS personnel, but previous studies have not shown whether one device is superior to the other. The primary outcome of this trial is 72 hour survival. Secondary outcomes include return of spontaneous circulation, survival to hospital discharge, neurologically intact survival at hospital discharge, airway management performance, and clinical adverse events. Use these links to See a Q&A about this study, which uses EFIC (exception from informed consent), read a UAB news article about PART, or find out how to opt out of the PART study.

Prehospital Tranexamic Acid Use (TXA) for Traumatic Brain InjuryTXA Molecule

TXA_Molecule.pngThis is a multicenter, Phase II randomized trial of Tranexamic Acid (TXA) versus placebo. The purpose of this study is to determine if patients suspected of having a traumatic brain injury given TXA as soon as possible after injury have better outcomes than patients with traumatic brain injury who are not given TXA. This study is using an exception from informed consent (EFIC) process. See a Q&A about this study, which uses EFIC (exception from informed consent). Find out how to opt out of this study.

Rapid Administration of Carnitine in Sepsis (RACE) (L-Carnitine Treatment for Vasopressor Dependent Septic Shock)

The purpose of this protocol is to study the effect of L-carnitine in patients with sepsis. This is an adaptive, phase II trial designed to efficiently identify the dose of L-carnitine that provides the greatest improvement in SOFA (Sequential Organ Failure Assessment) score. The specific aims are: 1) to test if intravenous L-carnitine reduces cumulative organ failure in septic shock, and 2) to test if L-carnitine improves blood flow in the sublingual microvasculature during septic shock.

Multi-Center Randomized Trial to Study Tamsulosin for Urolithiasis in the Emergency Department (STONE)

The study is a multi-center randomized, placebo-controlled, double-blind clinical trial. Participants are randomized to one of two treatment groups, placebo or active tamsulosin (Flomax). The primary objectives of this study are to test the hypothesis that tamsulosin is clinically useful in the treatment of acute urolithiasis (stones/calcifications located within the kidneys, ureters, or bladder), focusing specifically on stones within the ureters. If tamsulosin achieves similar results in a properly conducted placebo controlled trial to those noted in previous smaller pilot studies, we expect to see a significant reduction in days lost from work and decreased morbidity, as well as cost savings resulting from a decreased number of patients referred for the surgical management of retained stones.

ProAct GraphicProcalcitonin Antibiotic Consensus Trial (ProACT)

ProAct_Graphic.jpgProcalcitonin is a new FDA-approved blood test which can help to determine whether a lung infection is caused by a bacteria or a virus. The purpose of this study is to test the effect of implementation of a novel procalcitonin guideline on antibiotic and adverse outcomes in emergency department patients with lower respiratory tract infection. Procalcitonin levels are typically high with bacterial infection, and low with viral infection. This study will randomize emergency department patients to a procalcitonin testing group, or a usual care group. In the procalcitonin group, participants will be tested for procalcitonin, and the treating physician will be informed of the test results. The physician is not obligated to follow antibiotic guidelines based on this testing, but is given the guidelines. The usual care group will be treated per usual standard protocols. Both groups will be followed for 30 days, and we will track antibiotic use and hospitalizations.

Prehospital Resuscitation on Helicopter Study (PROHS)helicopter

This is a pragmatic, multicenter, prospective observational study of air ambulance-based prehospital resuscitation regimens. The objective of the study is to compare the effectiveness of two different existing pre-hospital resuscitation approaches in severely injured trauma patients transported by helicopter. Level 1 adult trauma centers will participate in this study, selected based on their current prehospital study procedures. Currently, some Level 1 trauma centers have blood products available on their air ambulances, while others do not. It is not the intent of this study to change current prehospital practice at the participating centers, and sites must agree to not change their prehospital resuscitation regimens during the enrollment phase of the study. No other trauma care variable will be controlled. The study will compare mortality in patients who are transported by helicopters that administer blood products to patients who are transported by helicopters that do not administer blood products.