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Analysis

Hospital-Acquired Infection Pragmatic Clinical Trial Shows Best Practice

By Christopher Cheney  
   March 05, 2019

Research demonstrates a method to prevent MRSA and vancomycin-resistant Enterococci infections in patients with medical devices.

A new study based on a recently developed form of clinical trial has advanced efforts to prevent hospital-acquired infections.

Unlike traditional explanatory clinical trials, which focus on specific interventions in controlled settings, pragmatic clinic trials are done in real-world clinical practice settings and produce more generalizable results.

"What constitutes a pragmatic trial is that it is conducted in a typical care environment—oftentimes with unselected patients—by usual caregivers in the course of routine operations. In contrast, more traditional trials are limited to small numbers of patients with high exclusion criteria conducted in dedicated research units with dedicated research personnel," says Jonathan Perlin, MD, PhD, president of clinical services and CMO at HCA Healthcare in Nashville, Tennessee.

The pragmatic clinical trial research published today in The Lancet sought to determine whether interventions to prevent multidrug-resistant organisms and bloodstream infections that had been found effective in the ICU setting could be effective for all inpatients. Methicillin-resistant Staphylococcus aureus (MRSA) was one of the primary targeted organisms.

The study featured 53 hospitals in HCA Healthcare's health system. Patients in some non-critical care units received routine care, while other patients in non-critical care units received daily chlorhexidine bathing for all patients plus nasal mupirocin for known MRSA carriers.

There were 156,889 patients in the routine care group and 183,013 patients in the intervention group.

The study has three key findings.

  • When compared to a control group, intervention patients with medical devices such as central lines experienced a 32% greater reduction in all-cause bacteremia and a 37% greater reduction in MRSA or vancomycin-resistant Enterococci (VRE) clinical cultures
     
  • Patients with medical devices accounted for 10% of the routine care population, but they accounted for 37% of MRSA or VRE cultures and 56% of bloodstream infections
     
  • Universal chlorhexidine bathing and the antiseptic bathing plus nasal mupirocin for MRSA carriers did not reduce multidrug-resistant organisms or bloodstream infections for all non-critical care patients

"There was a specific group of patients in the general medical and surgical units who received the biggest benefit," Perlin says.

Adopting pragmatic clinical trials
 

The Lancet research, which was completed in 21 months, demonstrates the speed potential of pragmatic clinical trials, he says.

"We discovered a new best practice that can help reduce life-threatening infections for a set of patients who are at high risk. For this study, it would otherwise take a single hospital 93 years to aggregate the data to answer the question solved by our 53 hospitals in 21 months."

HCA Healthcare plans to adopt the new best practice to prevent infections in non-critical care patients with medical devices immediately. "We will eat our own cooking. The first thing we will do is put this new best practice into place across all of HCA," Perlin says.

Speed is not the only advantage of pragmatic clinical trials, he says.

"You also have the advantage of generalizability. These studies are incredibly powerful because they have a breadth of patients, so the signal is very strong in terms of applicability. They are conducted in routine care settings, so it's a real-world environment with real-world hospitals, and the findings are generalizable to the real-world."

HCA Healthcare is well-suited to conduct pragmatic clinical trials for four reasons, Perlin says.

  • An organizational mission committed to the care and improvement of human life
     
  • A learning-health-system culture
     
  • Scale that allows for the aggregation of voluminous data
     
  • A clinical data warehouse and information systems that create a platform for learning and improving care

Christopher Cheney is the senior clinical care​ editor at HealthLeaders.


KEY TAKEAWAYS

Pragmatic clinical trials feature research conducted in real-world settings.

Findings from a recent pragmatic clinical trial include methods to reduce hospital-acquired infections in non-critical care patients with medical devices.

HCA Healthcare, which participated in the pragmatic clinical trial, plans immediate adoption of the new best practice at the health system's 185 hospitals.


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