Trial Design
neurology/stroke
RECRUITMENT
Our hypothesis was that the use of CBPM technology by health care clinicians of patients at high risk of high interface pressures and PI development would decrease these risks. A parallel, 2-group randomized clinical trial (RCT) was conducted at a tertiary acute care center of approximately 1100 beds. Patients at high risk of PI development were recruited from acute general medical, neurology/stroke, neurosurgery, nephrology, and intensive care units (ICU). The primary outcome measures were interface pressures. Secondary measures reported here were pressure-related skin and soft tissue changes (eg, pressure injuries). Participants were randomly assigned to either the intervention or control groups in a ratio of 1:1 stratified by unit. The Research Electronic Data Capture (REDCap) secure database web application hosted at the University of Calgary was used for data storage.Both groups had the CPBM systems placed on their hospital bed to capture interface pressure data. Standard care for PI prevention was provided to both groups. In the intervention group, the monitor was turned on so health care clinicians caring for the participant could visualize the pressure data and target areas of the body requiring pressure relief. The CPBM systems were monitored daily to ensure that they were working. A brief 5-minute educational session was provided to nursing staff 1 to 2 months prior to the initiation of recruitment on the features of the CPBM system and how the data presented on the monitor could be used to reposition patients. Complete information on study design and methods is provided in Wong et al,This study was approved by the Conjoint Health Research Ethics Board at the University of Calgary prior to data collection. Written informed consent was obtained from all study participants (or legal proxies). This study followed the Consolidated Standards of Reporting Trials (