Head Protection Device for Individuals at Risk for Head Injury due to Ground-Level Falls: Single Trauma Center User Experience Investigation (Preprint)

Abstract

BACKGROUND Falls represent a large percentage of hospitalized patients with trauma as they may result in head injuries. Brain injury from ground-level falls (GLFs) in patients is common and has substantial mortality. As fall prevention initiatives have been inconclusive, we changed our strategy to injury prevention. We identified a head protection device (HPD) with impact-resistant technology, which meets head impact criteria sustained in a GLF. HPDs such as helmets are ubiquitous in preventing head injuries in sports and industrial activities; yet, they have not been studied for daily activities. OBJECTIVE We investigated the usability of a novel HPD on patients with head injury in acute care and home contexts to predict future compliance. METHODS A total of 26 individuals who sustained head injuries, wore an HPD in the hospital, while ambulatory and were evaluated at baseline and 2 months post discharge. Clinical and demographic data were collected; a usability survey captured HPD domains. This user experience design revealed patient perceptions, satisfaction, and compliance. Nonparametric tests were used for intragroup comparisons (Wilcoxon signed rank test). Differences between categorical variables including sex, race, and age (age group 1: 55-77 years; age group 2: 78+ years) and compliance were tested using the chi-square test. RESULTS Of the 26 patients enrolled, 12 (46%) were female, 18 (69%) were on anticoagulants, and 25 (96%) were admitted with a head injury due to a GLF. The median age was 77 (IQR 55-92) years. After 2 months, 22 (85%) wore the device with 0 falls and no GLF hospital readmissions. Usability assessment with 26 patients revealed positive scores for the HPD post discharge regarding satisfaction (mean 4.8, SD 0.89), usability (mean 4.23, SD 0.86), effectiveness (mean 4.69, SD 0.54), and relevance (mean 4.12, SD 1.10). Nonparametric tests showed positive results with no significant differences between 2 observations. One issue emerged in the domain of aesthetics; post discharge, 8 (30%) patients had a concern about device weight. Analysis showed differences in patient compliance regarding age (χ<sub>1</sub><sup>2</sup>=4.27; <i>P</i>=.04) but not sex (χ<sub>1</sub><sup>2</sup>=1.58; <i>P</i>=.23) or race (χ<sub>1</sub><sup>2</sup>=0.75; <i>P</i>=.60). Age group 1 was more likely to wear the device for normal daily activities. Patients most often wore the device ambulating, and protection was identified as the primary benefit. CONCLUSIONS The HPD intervention is likely to have reasonably high compliance in a population at risk for GLFs as it was considered usable, protective, and relevant. The feasibility and wearability of the device in patients who are at risk for GLFs will inform future directions, which includes a multicenter study to evaluate device compliance and effectiveness. Our work will guide other institutions in pursuing technologies and interventions that are effective in mitigating injury in the event of a fall in this high-risk population. CLINICALTRIAL