Investigating the acceptability of remotely monitoring the vital signs of hospital-in-the-home patients using wearable devices, from the perspective of the patients, clinicians and administrators.

The Biobeat Wrist Monitor or Biobeat Chest Monitor will be issued to participants (n=10 for each group) and will constantly monitor respiratory rate, oxygen saturation, heart rate and blood pressure during the trial. Standard care will not be altered. If a device indicates medical attention is required, additional care will be given. Both devices have been approved by the Australian Government Department of Health Therapeutic Goods Administration (TGA) as a Class IIa medical device (certificate number: DV-2020-MC-18871-1; ARTG identifier: 338811; date of approval: 02/07/2020). Both Device A and Device B are classified as non-invasive for the use of vital sign monitoring in adults, in clinical and non-clinical settings. Both devices are capable of monitoring and measuring an array of patient vital signs, though for the purposes of this project only respiratory rate, oxygen saturation (SPO2), heart rate, and blood pressure will be assessed. The effective range and accuracy of both devices are the same. Watches and adhesive patches are required to be worn 24 hours a day for 6 days. The watch is to be worn on the preferred wrist and will be calibrated by the clinician issuing the device and remote monitoring team. The watch will be collected from the client post the study. The adhesive patch will be applied to the chest and be calibrated by the issuing clinician and remote monitoring team. Patches are single use and will be discarded by the client after use. A potentially unstable client is a client that has appeared on the exceeding vitals tile within the monitoring dashboard, having passed the threshold for one of the following vitals: heart rate, SPO2, systolic blood pressure or temperature. An alert within the web dashboard will be triggered every time a vital is measured above or below the set threshold. The thresholds are customised for each client that is admitted to the study. The clinical monitoring process will monitor alerts 24/7. If an abnormal vital sign is detected a nurse will triage the observations based on the Silverchain escalation protocol (e.g. level 1 increase monitoring, level 2 medical governance review, level 3 emergency response). Medical governance will make a treatment / intervention plan as clinically required. The nurse visiting the clients home as part of standard care (post consent) will set up the device with the client with the support of the remote monitoring team. The web dashboard communicates for each client if there are any instances where the device has been turned off, taken off or if the signal is poor. To mitigate this we verify the placement of the device is according to the instructions. We also make sure the devices are properly used (e.g., excluding sports activity, extreme physical effort). The system has a threshold for the signal’s quality, and data below that threshold level will not be recorded (will be defined as invalid data) in the system’s database. Participants will be allocated to one of three conditions (wrist monitor, chest monitor, or standard care) using computer-generated random numbers. However, in the event that a participant presents with a physiological risk factor precluding use one of the monitors (e.g., a skin condition that precludes the use of adhesives), that participant will be allocated to another condition, using computer-generated random numbers where multiple other conditions are suitable.