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Study: Wearable Sensors Protect Against Pressure Injuries

The results of a new randomized controlled trial from Stanford Health Care show that a wearable patient sensor goes a long way toward preventing pressure injuries.

The study, “Effect of a wearable patient sensor on care delivery for preventing pressure injuries in acutely ill adults: A pragmatic randomized clinical trial (LS-HAPI study),” was published in the January 1, 2018 edition of the International Journal of Nursing Studies. The study found that patients treated by wearable sensors were 73% less likely to develop a pressure injury. The manufacturer is Pleasanton, California based Leaf Healthcare.

According to the company, “The investigator-initiated, prospective, blinded, randomized, controlled trial involved over 1,200 patients and over 100,000 hours of data was analyzed…. In the Treatment group, the Leaf sensor was used to help ensure that patients were repositioned with sufficient frequency and quality. The Leaf sensor continuously monitors all patient movements and is designed to notify providers if repositioning is required to prevent a pressure injury. The sensor seamlessly monitors patient position and activity, regardless of whether they are in bed, a chair, or ambulating.”

“This large, randomized, controlled trial confirms what has been demonstrated in smaller studies and is consistent with real-world customer experience,” said Leaf Healthcare CEO and Co-Founder Barrett Larson, M.D. “This study is an important step towards redefining the standard of care for pressure injury prevention.”

Dr. Larson told OTW, “This landmark research study has the potential to fundamentally change the way care is delivered for patients at risk for pressure injuries. The clinical and financial benefits associated with improved patient mobility are well established. As we think about the hospital of the future, it’s hard to imagine turning protocols being coordinated using manual methods, clinical observation, and intuition. It’s time for this fundamental nursing practice to evolve through the use of technology. The LS-HAPI study proves that a wearable sensor can be used to intelligently optimize patient mobility protocols and significantly improve patient outcomes.”

“The LS-HAPI study was one of the largest and most scientifically rigorous studies ever to be conducted in the field of pressure injury prevention. This was a ‘gold standard’ study that had the following design elements:

  • Investigator-initiated: Study was initiated by Stanford (not Leaf). Leaf had no role in the design of the study, recruitment of subjects, data collection or management, analysis or interpretation of results, drafting of manuscript, or decision to publish.
  • Pragmatic: Study was done in a real-world clinical environment, not a hyper-controlled research setting that doesn’t reflect clinical reality.
  • Prospective and Parallel: After randomization, patients were assigned to treatment or control groups which ran in parallel (same ICUs, no difference in clinical environment between groups).
  • Blinded: Wound care nurses responsible for staging HAPIs were blinded to subject group allocation. Data analysts were also blinded to subject group allocation.
  • Randomized: Patients were randomly allocated to either a Treatment or Control Group. The randomization schema minimizes bias. This is considered the ‘gold-standard’ approach for clinical trials.”

“The Leaf system helped ensure that patients were turned with with sufficient frequency and quality. In patients treated with Leaf, there was a significant improvement in position optimization and a significant decrease in rates of hospital-acquired pressure injuries (73% reduction).”

“Patient turning is considered one of the most effective strategies for pressure injury prevention (Class A Evidence). However, in the busy hospital setting, it can be difficult to ensure that every patient reaches their individual mobility goals. The Leaf System intelligently optimizes turning and mobility protocols for large groups of patients and it is much more effective than standard reminder systems (i.e., kitchen timers, musical chimes, manual documentation, etc.). The Leaf System can be used to significantly improve patient mobility and clinical outcomes. Leaf has been clinically proven to prevent pressure injuries.”

“Improved post-operative mobility is associated with lower complication rates (i.e., pressure injuries, DVT, etc.) and reduced length of stay. The Leaf System is designed to monitor, coordinate, and optimize care throughout the mobility continuum—from bedridden to fully ambulating patients. When patients are in bed, the Leaf system will help ensure that they are repositioned with sufficient frequency and quality in order to prevent pressure injuries. As a patient’s mobility level improves, the Leaf System will track other important mobility metrics (i.e., time spent upright, steps taken, etc.) as part of a comprehensive mobility management program.”

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