Early stopping rules and contingency plan
We will conduct two interim efficacy analyses approximately 12 and 24 months after trial launch to evaluate performance of TEACH intervention versus control. If introduction of the TEACH enhancement plus usual audit and feedback approach leads to substantially greater uptake and adherence during the first part of the study period versus control, such that the benefits of using TEACH far exceed the harms, the DSMB may recommend to stop the clinical trial early, and significant findings will be reported. These interim looks will use prespecified conservative O’Brien-Fleming [If the TEACH mechanism demonstrates significantly better adherence to C-SAT/SBT and increased ventilator-free days over the usual audit and feedback approach at an early interim analysis, leading to early stopping of the clinical trial, further actions would be deliberated by the principal investigators and sponsor, with the DSMB having an advisory role. As part of this deliberation, the study principal investigators may propose adjusting or redesigning the existing study, for example, eliminating the sustain measurement in later years and conducting a cost-effectiveness analysis to compare relative implementation performance costs of the TEACH method versus usual audit and feedback approach.