Statistical methods for primary and secondary outcomes {20a}
SECONDARY
The primary analysis will be at the cluster level while some secondary endpoints are at the resident or caregiver level. The significance level for one-sided testing and confidence intervals is set to 2.5% while two-sided testing and confidence intervals are set to 5%.Demonstration of the treatment effects on both primary endpoints is considered necessary for the demonstration of clinical benefit (co-primary endpoints).The care efficiency and skin health co-primary endpoints are evaluated using linear mixed models (LMMs) to account for intra-cluster correlation using a random intercept effect. For each primary endpoint, the treatment effect is quantified using the difference in the least squares means of the treatment groups. For the care efficiency score, superiority is assessed by a one-sided test of the group mean difference where no superiority margin is added. For the skin health score, non-inferiority is assessed by a one-sided test of the group mean difference where a non-inferiority margin of + 0.5 will be used. Analysis will be per protocol. There are no plans for an intention-to-treat analysis.