Identifying contextual and patient-level factors associated with the utilization of the Understand me!' heart rate-informed communication tool in care for non-communicative patients: A study protocol

BackgroundSome patients with profound intellectual and multiple disabilities (PIMD) have major communication difficulties, making them unable to notify their caregivers when they experience pain or stress. These people have been referred to as minimally communicative patients (MCP). Preliminary studies have found that heart rate (HR) monitoring can be used for understanding potential painful or stressful procedures in MCPs. For such a communication tool to function effectively, it must be actively utilized. However, obstacles to the adoption of this communication tool have been insufficiently explored, particularly regarding the feasibility of HR-informed communication tool in the care of MCPs. ObjectivesThe study explores contextual and patient-level factors associated with the utilization of the "Understand me!" HR-informed communication tool. Utilization is quantified primarily as hours of device use and secondarily as the caregivers response rate to system alarms and the number of registered situations. HypothesesHypothesis 1: Patients in larger staffed residential units ([&ge;] 8 staff) will have a lower proportion of alarms answered by caregivers than smaller units (< 8 staff), adjusted for patient function level. Hypothesis 2: There will be a positive correlation between the number of distinct caregivers and the proportion of alarms answered by caregivers, adjusting for hours of device exposure and number of alarms. Hypothesis 3: Patients classified as immobile will have a higher proportion of alarms answered by caregivers than mobile patients, after accounting for hours of monitoring and number of alarms. Hypothesis 4: Greater patient medication burden will be associated with a higher proportion of alarms answered by caregivers, compared with lower medication burden, after adjustment for patient function level and size of residential unit. MethodsAnalysis of factors involved in utilization for caregivers of 40 non-communicative patients. Data will be collected during a clinical testing phase of 2-3 months where caregivers will be asked to report contexts for when the app alerted them of a stark increase in HR. DiscussionThis study will advance the field of wearable physiological sensor use in patient care by providing insight into various contextual and patient-level factors that may influence the use of assistive devices. Trial registrationThe larger clinical trial that this study is part of was registered prospectively at ClinicalTrials.gov (NCT05738278).