The research process for a cluster randomized trial essentially begins once a clinical question has been identified that begs to be answered in order to advance medicine.
The interested parties — usually government agencies or academic institutions — will reach out to HCA Healthcare in order to make use of our industry-leading capabilities. To appreciate the scope and scale of one of HCA Healthcare’s cluster randomized trials, consider the swap-out trial that was recently detailed in the Journal of the American Medical Association. Commissioned by the CDC and conducted in collaboration with the Department of Population Medicine (an affiliate of Harvard Medical School), the study started in 2015 and took eight years from initiation to publication.
The trial was designed to build on previous work by Harvard and HCA Healthcare that was published in The New England Journal of Medicine in 2012 and studied the best way to prevent intensive care unit (ICU) patients from contracting methicillin-resistant Staphylococcus aureus (MRSA) in hospitals.
The question? Was the practice of using the nasal antibiotic mupirocin to prevent MRSA, a potentially lethal bacterial infection, at risk of becoming less effective. “There’s been a stewardship concern of ‘if we keep using this single antibiotic for trying to prevent MRSA, pretty soon [MRSA is] going to be resistant, and then we’re going to be left with nothing that is as effective,’” says Dr. Sands.
There was previously inadequate data to determine whether hospitals should consider swapping out mupirocin for the nasal antiseptic iodophor.
The actual trial lasted 18 months and was conducted in 137 HCA Healthcare hospitals across 18 states. Overall, the mupirocin-iodophor swap-out trial involved more than 800,000 ICU patients.
“During the study period, we found that mupirocin was in fact better and that resistance didn’t seem to matter,” reports Dr. Sands. “We were able to indicate that resistance didn’t seem to make a difference in terms of its effectiveness. Sometimes resistance can be a lab phenomenon but doesn’t actually change the ability of the antibiotic to work in the clinical sense.”
In short, the exhaustive study determined that the nasal antibiotic mupirocin reduced MRSA cultures by 18% compared to the antiseptic iodophor.
“We use the term ‘clinical differentiation.’ This allows HCA Healthcare the first opportunity to understand and implement what’s best practice for our patients,” he says. “If along the way we can provide information that allows the rest of the world to know what’s the best thing to do, we would argue that’s part of our mission.”
Just as important, says Richard Platt, MD, chair of the Department of Population Medicine at the Harvard Pilgrim Health Care Institute, a Harvard Medical School affiliate, is that the study reveals the strength of HCA Healthcare’s partnerships.
“The Institute has a major interest in helping clinicians use antibiotics in the most appropriate way,” says Dr. Platt. “HCA Healthcare’s leadership, physician providers and pharmacists in many locations have worked with our team to develop support programs that are highly effective and well received throughout the organization. We expect these will become widely adopted by other organizations.”