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When attempting to activate a clinical trial, one of the biggest concerns an institution faces is turnaround time. At Cedars-Sinai Medical Center in Los Angeles, activation of a new clinical trial could sometimes take 118 days, including IRB review, study team response time, and non-IRB required reviews such as contract negotiations. But for some protocols, including early-stage oncology or therapeutic studies, the institution looked for other ways to bring those new therapies to patients as efficiently and safely as possible.
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Creating clear, truly understandable informed consent documentation can sometimes be a challenge for IRB members and researchers, particularly in the area of international research. Making sure that details are not lost in translation and that the documentation meets U.S. federal and international regulations can also present some difficulty.
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Assessing risks and benefits is an evolving process in the human research protection world especially for IRBs that handle social-behavioral, as well as biomedical, studies. One size in risk-benefit assessment definitely does not fit all. For instance, IRBs sometimes over-emphasize risks in studies involving social-behavioral topics without considering protections that researchers have put in place, IRB experts say.
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To address identified patient safety risks in the handoff process, a group of emergency providers developed Safer Sign Out, a paper-based template that prompts clinicians to jointly review issues of concern on patients who are being passed from one clinician to another at the end of a shift. Already in practice at 12 hospitals in the Mid-Atlantic region, the approach is now being disseminated nationwide with the help of the non-profit Emergency Medicine Patient Safety Foundation.
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To reduce mortality and improve the care of patients with sepsis, Wake Forest Baptist Medical Center in Winston-Salem, NC, created a new rapid-response protocol aimed at facilitating earlier diagnosis and treatment. In this approach, clinicians who suspect a patient may have sepsis can call a Code Sepsis, which will fast-track the series of tests and evaluations that are needed to confirm the diagnosis and get appropriate patients on IV antibiotics quickly. Administrators say the approach fits in with the culture of the ED, and it has quickly slashed time-to-treatment in this environment.
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Getting the entire clinical staff on board with a new process for assessing and treating sepsis was a daunting task when administrators at Wake Forest Baptist Medical Center in Winston-Salem, NC, began the effort in April of 2012. However, by eliciting the assistance of department champions, and by mandating that everyone complete an online module that explains the new process, the transition to the new process was smooth. We had a very strong expectation and we followed through, explains Catherine Messick Jones, MD, MS, associate chief medical officer, medical services.
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Administrators interested in implementing the Safer Sign Out process should first reach out to physicians and nurses to discuss problems related to handoffs and get their feedback, advises Fuller. If you show them what the issue is up front, then they will be more prepared for it, he says.
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In a study dubbed Emergency Department Telemedicine Initiative to Rapidly Accommodate in Times of Emergency (EDTITRATE), investigators at the University of California San Diego Health System are gauging whether remote physicians can be quickly and cost-effectively mobilized to evaluate patients when the ED is busy. While there have been administrative hurdles involved with implementing the approach, investigators say the strategy could offer big savings in terms of time and efficiency.
