Abstract：
BACKGROUND: The AmbIGeM system augments best practice and 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.
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. Three wards across two states were included. Patients aged >65 years were eligible. Patients requiring palliative care were excluded. The trial was registered with the Australia and New Zealand Clinical Trials registry, number 12617000981325.
RESULTS: 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.
CONCLUSIONS: 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.
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. Three wards across two states were included. Patients aged >65 years were eligible. Patients requiring palliative care were excluded. The trial was registered with the Australia and New Zealand Clinical Trials registry, number 12617000981325.
RESULTS: 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.
CONCLUSIONS: 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.
摘要：
背景：AmbIGeM系统增强了最佳实践，并涉及患者佩戴的新型可穿戴传感器（加速度计和陀螺仪），其中传感器捕获的数据由算法解释，以在检测到风险移动时在临床医生手持移动设备上触发警报。
方法：一项3簇阶梯式楔形实用试验，调查对跌倒率的主要结局和跌倒的次要结局以及跌倒的比例的影响。包括两个州的三个病房。年龄>65岁的患者符合条件。需要姑息治疗的患者被排除在外。该试验已在澳大利亚和新西兰临床试验注册中心注册，编号12617000981325。
结果：4924名老年患者被纳入研究病房，其中1076名被排除，3240名被排除（1995年对照，1245干预）登记。每个患者的有效读数的研究持续时间的中位数比例为49％（IQR25-67％）。干预和对照组之间在跌倒率方面没有显着差异（ARR=1.41，95％CI（0.85，2.34；p=0.192）），跌倒比例(OR=1.54，95%CI(0.91，2.61)；p=0.105)和伤害跌倒率(ARR=0.90，95%CI(0.38，2.14)；p=0.807)。在事后分析中，在老年评估和管理部门(GEMU)病房中,当干预期与对照期相比较时,跌倒和跌倒伤害率降低.
结论：AmbIGeM系统没有降低跌倒率，伤害性跌倒率或跌倒比例。鉴于GEMU病房的事后分析结果，仍有进一步探索和完善该技术的理由。
方法：一项3簇阶梯式楔形实用试验，调查对跌倒率的主要结局和跌倒的次要结局以及跌倒的比例的影响。包括两个州的三个病房。年龄>65岁的患者符合条件。需要姑息治疗的患者被排除在外。该试验已在澳大利亚和新西兰临床试验注册中心注册，编号12617000981325。
结果：4924名老年患者被纳入研究病房，其中1076名被排除，3240名被排除（1995年对照，1245干预）登记。每个患者的有效读数的研究持续时间的中位数比例为49％（IQR25-67％）。干预和对照组之间在跌倒率方面没有显着差异（ARR=1.41，95％CI（0.85，2.34；p=0.192）），跌倒比例(OR=1.54，95%CI(0.91，2.61)；p=0.105)和伤害跌倒率(ARR=0.90，95%CI(0.38，2.14)；p=0.807)。在事后分析中，在老年评估和管理部门(GEMU)病房中,当干预期与对照期相比较时,跌倒和跌倒伤害率降低.
结论：AmbIGeM系统没有降低跌倒率，伤害性跌倒率或跌倒比例。鉴于GEMU病房的事后分析结果，仍有进一步探索和完善该技术的理由。
