Discussion
SECONDARY
In this secondary analysis of a randomized clinical trial, when analysis of program outcomes was concentrated on the population most likely to engage with the intervention, the estimated effectiveness of the Camden Core Model intervention increased, and the confidence intervals became statistically significant. Like other randomized evaluations with variability in patient uptake,The central motivation for the distillation method is that ITT methods for analyzing RCTs may lead to missed insights. Even when randomization occurs after patient outreach, the average treatment effect in ITT analysis is for the offer of the treatment rather than the delivery of the service itself. If a clinical trial has complete uptake and full treatment dose for all treatment arm participants, there is no difference between these concepts. However, as the rate of successful intervention delivery moves further from ideal, the ITT estimate may diverge from the intervention delivery effect. Beyond the power implications of this dilution, the ITT estimate may no longer estimate the effect that is of most policy or practical interest.Randomized clinical trials of care management interventions can be prone to incomplete enrollment or engagement because these interventions are typically prolonged and multifaceted, unlike treatments that are assigned at a point in time (ie, insurance coverage) or given immediately after randomization (ie, a vaccine). Ultimately, ITT analyses of diluted trials may overlook the effect of a treatment on the treated, potentially mistaking trial implementation challenges for an intervention failure.In our analysis, a history of criminal justice involvement and housing instability were associated with lower probabilities of engaged participation. These findings may reflect the difficulty of maintaining contact with participants whose lives are in flux, highlighting the importance of engagement strategies tailored to patient circumstances and needs.One of the Camden Coalition’s key takeaways from the Health Care Hotspotting trial’s null results was that broader investments in social services and other resources are needed to improve outcomes for individuals living with complex health and social needs. During and after the initial study, the Camden Coalition expanded its services in response to patient needs, including developing Housing First and Medical Legal Partnership programs, and deepening partnerships with addiction medicine and behavioral health providers across the region. This new analysis emphasizes the value of those activities, given that patients who were experiencing homelessness and other social needs were among the least likely to fully engage in the intervention.