Design and rationale for a randomized controlled trial to reduce readmissions among patients with depressive symptoms.

BACKGROUND: The Re-Engineered Discharge (Project RED) reduces 30-day readmission rates by 30%. However, our data indicates that for patients displaying depressive symptoms during hospitalization, Project RED is less effective in preventing unplanned readmission. We aim to examine the effectiveness of RED-D, a modified brief Cognitive behavioral therapy (CBT) protocol delivered as a post-discharge extension of the Re-Engineered Discharge, in reducing 30-day readmissions rates and emergency department (ED) use as well as depressive symptoms for medical patients with comorbid depressive symptoms. METHODS: This paper details the study design and implementation of an ongoing, federally funded randomized controlled trial of our post-discharge mental health intervention, RED-D, compared to the RED plus usual care. This research has two primary objectives: (1) to determine whether RED-D delivered telephonically by a mental health professional immediately following discharge is effective in reducing hospital readmission and emergency department use for patients displaying depressive symptoms during their inpatient stay, and (2) to examine whether this approach yields a clinically significant reduction in depressive symptoms. We intend to recruit 1200 participants randomized to our intervention, RED-D (n=600), and to RED plus usual care (n=600). CONCLUSIONS: Hospitalized patients with depressive symptoms are at increased risk for 30-day readmission. We aim to conduct a randomized clinical trial to evaluate the comparative effectiveness of RED-D, our post-discharge modified brief CBT intervention compared to RED alone in reducing readmissions and depressive symptoms for this at-risk population.