Introduction
RECRUITMENT
Randomized evaluations of complex care management programs have yielded mixed evidence of effectiveness in improving health outcomes. An approach to care for individuals with concurrent medical and social needs, complex care is distinct from other care management approaches for its interdisciplinary team-based models, prioritization of patients’ self-defined goals, and emphasis on cross-sector partnerships to improve care transitions across multiple settings.The Camden Coalition received support in 2012 from the US Centers for Medicare and Medicaid Services to refine, test, and scale their signature care management model: the Camden Core Model. In 2020, randomized clinical trial results challenged a key value proposition for complex care, finding no significant effect of the Core Model on readmissions 180 days after hospital discharge.The Health Care Hotspotting trial randomized patients after recruitment and consent, leading to complete trial enrollment within the intervention group. However, patients enrolled in the trial varied on characteristics that could have influenced participation in and responsiveness to the intervention, and while enrollment was complete within the intervention group by virtue of the trial design, the intensity and nature of care services received by enrollees varied.The original analysis of the Health Care Hotspotting trial adhered to the standard intent-to-treat (ITT) framework, in which patients are analyzed as randomized. However, variable intervention delivery meant that the average treatment effect in the main analysis was a blended estimate of effectiveness across varying doses of intervention services.In this new analysis of Health Care Hotspotting trial data, we applied the distillation method, a framework for analyzing data from randomized clinical trials that are underpowered due to low participant enrollment or variable participation levels while maintaining the trial’s original randomization.