Abstract

Background: Pressure sensor alarm systems have shown to be ineffective in preventing falls in hospitals. The AmbIGeM system involves a novel wearable sensor (accelerometer and gyroscope) worn by patients where the data captured by the sensor is interpreted by algorithms to trigger alerts on clinician handheld mobile devices when risk movements are detected. Multiple patients in multiple locations undertaking multiple activities are monitored, augmenting best practice and affording the clinicians the opportunity to intervene before a fall. Methods: A 3-cluster stepped wedge pragmatic trial investigating the effect on the primary outcome of falls rate and secondary outcome of injurious fall and proportion of fallers. Two wards in Western Australia (WA) and one ward in South Australia (SA) were included. Patients aged > 65 years were eligible. Patients requiring palliative care were excluded. A waiver (WA) and opt-out (SA) of consent were obtained for this study. Findings: 4924 older patients were admitted to the study wards with 1076 excluded and 3240 (1995 control, 1245 intervention) enrolled. The median proportion of study duration with valid readings per patient was 49% (IQR 25-67%). There was no significant difference between intervention and control relating to the falls rate (ARR=1.41, 95% CI (0.85, 2.34; p=0.192)), proportion of fallers (OR=1.54, 95% CI (0.91, 2.61); P=0.105) and injurious falls rate (ARR=0.90, 95% CI (0.38, 2.14); p=0.807). In a post hoc analysis, falls and injurious falls rate were reduced in the Geriatric Evaluation and Management Unit (GEMU) wards when the intervention period was compared to the control period. Interpretation: The AmbIGeM system did not reduce the rate of falls, rate of injurious falls or proportion of fallers. There remains a case for further exploration and refinement of this technology given the post hoc analysis findings with the GEMU wards. Trial Registration: The trial was registered with the Australia and New Zealand Clinical Trials registry, number (ANZCTR)12617000981325. Funding Statement: Funded by the National Health and Medical Research Council of Australia (APP1082197) Declaration of Interests: Previously, there was a patent filed (mid 2013) by A/Prof Ranasinghe and Professor Visvanathan titled system, method, software application and data signal for determining movement but this has since lapsed. Professor Visvanathan is the Head of Unit of the Aged & Extended Care Services at the Queen Elizabeth Hospital in South Australia within which the GEM Unit is a service for which, Mr Stephen Hoskins is the Nurse Manager. Dr Kate Ingram is the Falls Lead at Sir Charles Gairdner Hospital in Western Australia. All others have nothing to declare. Ethics Approval Statement: Ethics and governance approval were achieved from TQEH/Lyell McEwin Hospital (LMH)/Modbury Hospital (MH) (HREC/15/TQEH/17) and Curtin University (HRE2017- 0449)/SCGH (PRN 2015-110).

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