Innovation and Technology in Pressure Injury Prevention

Hospital-acquired pressure injuries (HAPIs) represent a significant source of morbidity, mortality, and cost burden. These wounds often become chronic, resulting in continued impairments in quality of life, and mortality as high as 60,000 deaths per year¹. The estimated cost burden of HAPIs in the United States is over 26.8 billion USD, 59% of which is due to full-thickness ulcers or those that are Stage 3, Stage 4, or unstageable.² Cost estimation for a single HAPI of any stage is around $10000 to $30000,² and a single-stage 4 HAPI can cost organizations $130000.³ These costs represent additional direct costs that hospitals pay for the treatment of pressure injuries and do not represent indirect costs. Sources of indirect costs associated with HAPIs include the Center for Medicare Services non-payment model, the Affordable Care Act 1% penalty for hospital stays with acquired conditions, the over 17000 pressure injury lawsuits filed yearly in the US, or long-term chronic care.^1,4 Interventions to prevent HAPIs include turning, repositioning, microclimate control, support surfaces, and nutritional optimization. Turning and repositioning patients has been a consistent intervention in the prevention of HAPIs. In their recommendations to reduce HAPIs, the National Pressure Injury Advisory Panel (NPIAP) specifically recommends minimizing pressure via positioning and "provide a mechanism to cue/remind staff”.⁵ However, research on turn adherence and reminder aids indicates low turn protocol adherence, high variability in the care provided based on patient characteristics and even the time of the day, and increasing HAPI rates despite use.^6-8

Leaf (Smith & Nephew) is an innovative piece of technology created to decrease hospital-acquired pressure injury incidence by addressing issues with turning adherence, effectiveness, and documentation. Leaf is a small, lightweight, wearable patient monitoring system. The concept is to identify at-risk patients, invest a small amount for the device during their hospital stay, and ultimately avoid a costly HAPI. How does Leaf accomplish this? It has the ability to increase turning adherence and quality of patient repositioning significantly.^7-9 Leaf is a wireless, single-use/disposable device that is adhered to the patient’s sternum. It monitors the patient's position, orientation, movement, and activity. These are data points that the device can capture and transmit through a MeSH network to a workstation or other console, where it can then be analyzed by Leaf software. When used by organizations, the Leaf software can analyze thousands of hours of data per day and deliver unit-based as well as individual reports on turning adherence and effectiveness. The device populates positioning and turn information to a computer screen, which provides visual notification for when care is needed, including when the patient was last adequately repositioned, how much time is due until the next turn, and what turning surfaces the patient cannot be positioned onto. The device also credits adequate self-turns by patients, preventing unnecessary patient disruption, sleep fragmentation, and reduced staff efficiency. This information is also available at the bedside as the device itself displays whether the patient needs repositioning or will need repositioning in the next 15 minutes.

The Leaf device assists facilities in meeting a number of the NPIAP’s pressure injury prevention recommendations,⁵ including:

• - Implement repositioning reminder strategies to promote adherence to repositioning regimens.
• - Use the 30° lateral side-lying position in preference to the 90° side-lying position when positioning.      
• - Reposition all individuals with or at risk of pressure injuries on an individualized schedule, unless contraindicated.

It also functions to remind staff of a patient’s overall pressure injury risk and get them thinking about other prevention interventions. Protocols for usage vary and can be quite broad, excluding patients who have an allergy or decline to wear the device, and including everyone with a Braden scale score of <16, requires assisted turning, or has any pre-existing pressure injury. Protocols can be individualized to units and patient populations depending on HAPI risk.

There is already mounting evidence that Leaf can assist facilities in reducing HAPI incidence while also providing a positive return on investment. One study of a device pilot in the community hospital medical-surgical unit setting of 138 patients analyzed over 7000 hours of data.⁸ This study found a turn adherence of 64% before the Leaf pilot and a turn adherence of 98% during the pilot, indicating an overall improvement in the optimum patient repositioning of 53%.⁸ Another study of a device pilot analyzed over 11000 hours of data from 105 patients and found a 67% HAPI reduction.⁹ When used to calculate a return on investment for the device, the authors found a 3.5-month return of $561340, equating to an enterprise-wide yearly return on investment of $3.4 million.⁹ The largest randomized controlled trial for the product involved two critical care units in California.⁶ The intervention arm using the Leaf device contained 659 participants, and the control arm was 653 patients. This study analyzed over 100000 hours of data and found a 74% reduction in HAPIs. Turn adherence in this study also increased. These studies demonstrate not only the clinical effectiveness of the device but also the potential cost savings for organizations.

Process improvement in turning and repositioning adherence and effectiveness is challenging for pressure injury prevention teams. Leaf is a wearable piece of innovative technology that health systems can use to decrease HAPIs by significantly improving the frequency and quality of patient turning while also providing reliable documentation of repositioning care. 

References

1. Bauer K, Rock K, Nazzal M, Jones O, Qu W. Pressure ulcers in the United States' inpatient population from 2008 to 2012: results of a retrospective nationwide study. Ostomy Wound Manage. 2016;62(11):30–38. Accessed June 9, 2021. https://www.hmpgloballearningnetwork.com/site/wmp/article/pressure-ulcers-united-states-inpatient-population-2008-2012-results-retrospective
2. Padula WV, Delarmente BA. The national cost of hospital-acquired pressure injuries in the United States. Int Wound J. 2019;16(3):634–640. doi:10.1111/iwj.13071
3. Brem H, Maggi J, Nierman D, et al. High cost of stage IV pressure ulcers. Am J Surg. 2010;200(4):473–477. doi:10.1016/j.amjsurg.2009.12.021
4. Beckers Hospital Review Staff. 4 direct and indirect costs of pressure ulcers. Beckers Hospital Review. Sept 5, 2015. Accessed June 9, 2021. https://www.beckershospitalreview.com/quality/4-direct-and-indirect-costs-of-pressure-ulcers.html
5. European Pressure Ulcer Advisory Panel, National Pressure Injury Advisory Panel and Pan Pacific Pressure Injury Alliance. Prevention and Treatment of Pressure Ulcers/Injuries: Quick Reference https://www.epuap.org/download/11182/ Accessed June 9, 2021. https://www.npuap.org/wp-content/uploads/2014/08/Updated-10-16-14-Quick-Reference-Guide-DIGITAL-NPUAP-EPUAP-PPPIA-16Oct2014.pdf
6. Pickham D, Pihulic M, Valdez A, Mayer B, Duhon P, Larson B. Pressure injury prevention practices in the ICU: real world data captured by wearable patient sensors. Wounds. 2018;30(8):229–234. Accessed June 9, 2021. https://www.hmpgloballearningnetwork.com/site/wounds/article/pressure-injury-prevention-practices-intensive-care-unit-real-world-data-captured-wearable
7. Pickham D, Berte N, Pihulic M, Valdez A, Mayer B, Desai M. 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). Int J Nurs Stud. 2018;80:12–19. doi:10.1016/j.ijnurstu.2017.12.012
8. Schutt SC, Tarver C, Pezzani M. Pilot study: assessing the effect of continual position monitoring technology on compliance with patient turning protocols. Nurs Open. 2017;5(1):21–28.  doi:10.1002/nop2.105
9. Gasparini R. “Turning” to technology: reducing hospital acquired pressure injuries in critical care with visual turn cueing. Poster presented at: NPIAP Annual Conference; March 10–March 12, 2021; Virtual Conference.