Primary outcome
deaths, death
REGRESSION, EVENT, SECONDARY
We will use a time-to-event approach to compare time to first incident medically treated fall between the intervention and usual care groups. This approach accounts for censoring due to disenrollment from the health plan. Since death precludes the observation of a fall, we will use methods that account for competing risks. In this analysis, we consider non-fall deaths to be a competing risk; deaths that are contemporaneous with a fall event are considered to be medically treated fall outcomes. The statistical literature suggests that using multiple, complementary analysis approaches in competing-risk settings can provide richer information about any effects of an intervention on the outcome of interest and the competing risk [Follow-up time for all primary outcome analyses is defined relative to the first brochure mailing date for study participants in the intervention group and proxy first brochure mailing date for those in the usual care group (see “Our primary analysis is to fit a cause-specific proportional hazards regression model for time to first incident medically treated fall accounting for the competing risk of non-fall death by censoring at the time of non-fall death. We will estimate an adjusted cause-specific hazard ratio for intervention effect and a 95% confidence interval and To support this primary analysis, we will fit two further models. The first is a cause-specific proportional hazards regression model for time to non-fall death accounting for the competing risk of incident falls by censoring. Under this model, we can interpret the hazard ratio as comparing the instantaneous risk of death among those who have not fallen nor died at any given time point between participants in the intervention and usual care groups. We will next use a subdistribution hazards model to estimate adjusted cause-specific cumulative incidences of both first medically treated fall and death over time [Finally, we will run a secondary analysis using a composite outcome of time to first incident medically treated fall or death and fit a Cox proportional hazards model [