Dai Pu, Kelly Stephen, Cassie E. McDonald, Jessica Baker, Georgina Sinforosa, Anastasia Hutchinson, Kerry Bradley, Kirsten Woods-Lyon, Michelle Tuck, Natasha K. Brusco, Lisa O’Brien, Debra Mitchell, Kate Steen, Melinda Webb‐St Mart, Peter Hunter, Philip L. Russo, Bernice Redley, Kelly‐Ann Bowles, Mari Botti, Alison M. Hutchinson, Ronald I. Shorr, Terry Haines
BACKGROUND: Mobilisation alarms are commonly used in hospitals to prevent falls in patients who are at high risk for falls, yet the evidence for their effectiveness is uncertain. OBJECTIVE: To investigate the effectiveness of mobilisation alarms to prevent falls in hospitals. DESIGN: This was a 3-group, concurrent, non-inferiority, stepped wedge, clinical trial with an embedded parallel, cluster randomised design that adopted a disinvestment approach. Disinvestment from the intervention was carried out from 1st April 2023 to 31st January 2024. SETTING(S): This study was conducted in one private health service and four public health services in Metropolitan Melbourne, Australia. PARTICIPANTS: Acute and sub-acute hospital wards with at least a 3 % rate of use of mobilisation alarms. Twenty-two wards were screened and found eligible for the trial, 18 wards were recruited and randomised. A random subsample of patients in the recruited wards completed questionnaires. METHODS: Two conditions were evaluated against the "current" condition of high alarm use (>3 %), a "reduced" rate of use of mobilisation alarms (<3 % but >0 %) and "eliminated" use of alarms (0 %). Rate of falls was the primary clinical outcome; data for a range of other measures were collected for secondary clinical and intervention outcomes. RESULTS: There were 11 acute wards and 7 sub-acute wards with 157,037 occupied bed days observed; 1319 individual patients completed questionnaires. Non-inferiority of the "reduced" condition compared to the "current" condition was demonstrated [95 %, one-tailed, non-inferiority confidence limit of 2.00 falls/1000 occupied bed days (OBDs) increase] but not for the "eliminated" condition (3.68 falls/1000 OBDs increase). Superiority of any intervention condition was not demonstrated over another ["current" vs "reduced": 0.22 falls/1000 OBDs (two-tailed, 95 % CI: -1.89 to 2.34), "current" vs "eliminated": 0.90 (-2.41 to 4.21), "reduced" vs "eliminated": 0.67 (-2.12 to 3.47)]. Patients' frequency of sleep disturbance due to alarms was reduced in the "eliminated" condition [ordered logistic coefficient 0.47 (0.08 to 0.87)]. CONCLUSIONS: Reduction in use of mobilisation alarms was not inferior to usual care, but complete elimination was uncertain. REGISTRATION: The trial was registered with the Australian New Zealand Clinical Trials Registry, trial ID: ACTRN12621000823875p (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12621000823875p). Registered on 28/06/2021, first enrolment on 26/10/2022.