Introduction: OPTIMISTmain was an international, multicenter, stepped wedge, cluster randomized controlled, blinded outcome assessed, non-inferiority trial that aimed to determine the safety and effectiveness of low-intensity versus standard monitoring in thrombolysis-treated patients with mild-to-moderate neurological deficit from acute ischemic stroke (AIS). An embedded process evaluation explored clinician perspectives on the integration and impact of the intervention.
Methods: A mixed-methods evaluation of qualitative (semi-structured interviews a purposive sample of clinicians) and quantitative (an implementer survey) data were collected at participating sites in Australia, China, Chile, Mexico, Malaysia, UK and Vietnam between Sept 2021 and Sept 2024.
Results: There were 55 interviews (27 physicians, 28 nurses) conducted at 28 hospitals; and 141 surveys from 62 hospitals. Low-intensity monitoring was acceptable and feasible, causing less disturbance to patients and reducing the workload of nurses. Early challenges with implementation were overcome once the habit of a new routine of care was established, but reminders and additional training were required to facilitate adoption. Nurses reported time being freed up to provide patient education (70%), daily living care (62%), early mobilization (54%) and mood/cognition assessment (52%). Most (84%) of respondents considered the new monitoring schedule should be widely used, albeit supported by recommendations in relevant local policies and guidelines.
Conclusions: An trial-embedded process evaluation offers insights into implementation of low-intensity monitoring care after thrombolysis treatment for AIS across diverse setting on a global scale.