Randomized Controlled Trial (RCT) Leaders – Yale Emergency Medicine

The Nation’s healthcare system is undergoing major change.

On March 23, 2010, the Affordable Care Act became law, which raised the stakes for providing high quality, affordable patient care in the United States. Every decision maker—from providers to administrators to funders to policy makers—faces tough choices about how to best deliver such care. For example, the practicing emergency medicine physician routinely makes rapid decisions on complicated patients, often without the benefit of an optimal evidence base to draw upon. Fortunately, we can increase the frequency and quality of evidence-based decision making in healthcare by improving the evidence base. The gold standard for research conduct is the randomized controlled trial. To be clear: increased funding for randomized trials in emergency medicine will improve the care provided in this setting. The Department of Emergency Medicine is a national leader in the conduct of such trials, which is translating into higher quality, more affordable healthcare for patients nationwide.

In total, the Department of Emergency Medicine has more than $19 million in active research grant funding. In particular, the department employs many of the foremost researchers in the conduct of National Institute of Health (NIH) Research Project Grants (R01)—the original and historically oldest grant mechanism used by NIH.


Dr. Gail D’Onofrio, Chair of the Department of Emergency Medicine, is the Principal Investigator of an R01 entitled, “Models of Screening, Brief Intervention with a Facilitated Referral to Treatment (SBIRT) for Opioid Patients in the Emergency Department.” Patients with heroin and prescription opioid dependence are at increased risk for adverse health consequences and often utilize the ED as their source of medical care. Screening, brief intervention and referral to treatment (SBIRT) has been effective in decreasing high risk behaviors such as alcohol and tobacco use, and unsafe sexual practices. This prospective, randomized controlled trial of 360 opioid dependent subjects will compare two models of brief intervention with a control condition. The primary outcome will be self-reported engagement in formal substance abuse treatment at 30 days, as well as changes in opioid use, HIV risk behaviors, and health care service utilization.


Dr. D’Onofrio is also the Principal Investigator of an R01 entitled, “Enhancing Emergency Practitioner (EP)-Performed Alcohol Interventions in the Emergency Department (ED).” The purpose of this study is to evaluate the effectiveness of an enhanced emergency practitioner performed brief negotiated interview to intervene with hazardous and harmful drinkers. This includes a basic, brief negotiated interview performed in the ED with referral to a primary care provider, followed by a telephone booster intervention performed by trained nurses 1-month post ED visit. The study will enroll an estimated 900 ED patients upon completion.


Dr. Steven Bernstein, Associate Professor of Emergency Medicine, is the Principal Investigator of an R01 entitled, “Treating Low-Income Smokers in the Hospital Emergency Department.” Of the nation's 45 million adult smokers, nearly 20 million visit hospital EDs each year. ED patients, particularly smokers, are disproportionately low-income, with limited access to traditional primary care settings. This study aims to test the efficacy of an ED-initiated tobacco intervention which includes counseling and medication. The intervention combines a brief negotiated interview with initiation of nicotine replacement therapy and a referral to the state Smokers' Quitline during the ED visit. The project will enroll 778 smokers over the course of the study.


Dr. Lori Post , Associate Professor of Emergency Medicine, is the Principal Investigator of an R01 entitled, “ED Disability Diagnostic Tool: An HIT Feasibility Study.” Many ED patients, especially older adults, require an assessment of their cognitive and functional status to be properly treated and referred elsewhere for follow-up care. The aim of this study is to improve health outcomes for elderly patients presenting to EDs by developing, validating, and testing a health information technology (HIT) disability diagnostic tool. Four-hundred twenty-five (425) patients will be enrolled over the course of the study.


In summary, the increasing demand for high quality, affordable patient care requires that emergency medicine researchers continually strengthen the evidence base to inform decision making. Increased funding for randomized controlled trials in emergency medicine will improve said evidence and translate into better patient care. Yale’s Department of Emergency Medicine is paving the way in this endeavor as a national leader among academic emergency medicine research departments.