Efficacy of a Blended Collaborative Care Intervention to Promote Recovery following Acute Cardiovascular Events: The Total Health Randomized Clinical Trial

Abstract: Background/Significance: Depression and anxiety disorders affect 12-15% of individuals with cardiovascular disease (Celano 2011, Easton 2016). Following acute cardiac events, these disorders are associated with impaired recovery. Blended collaborative care interventions, which utilize a care manager to facilitate the treatment of both psychiatric and medical disorders within the framework of existing care, appear to be effective at improving mental health, and in some cases, physical health, outcomes. However, existing collaborative care programs have focused on individuals with stable cardiovascular disease, despite the potential benefits of initiating these interventions during hospitalization to promote recovery following acute cardiac events. Accordingly, we developed Total Health, a six-month blended collaborative care program to promote mental and physical recovery following acute cardiac events. In this randomized clinical trial, we examined the efficacy of the Total Health program, compared to enhanced usual care, in 260 adults hospitalized for an acute coronary syndrome or heart failure exacerbation and found to have clinical depression, generalized anxiety disorder, and/or panic disorder.

Methods: Participants were recruited from two academic medical centers between November 2017 and February 2023. Following completion of baseline assessments, they were randomized to receive the Total Health program or enhanced usual care. In the Total Health program, participants received phone calls from nurse care managers, who assessed psychiatric symptoms, cardiovascular symptoms and signs (i.e., weight for individuals with heart failure, blood pressure for those with hypertension), and health behavior adherence. With input from a psychiatrist, psychologist, and cardiologist, the nurse care manager communicated treatment recommendations to the participant’s outpatient providers. Follow-up assessments occurred at 26- and 52-weeks post-randomization. Outcomes included physical function (Duke Activity Status Index; primary study outcome), health-related quality of life, depression (Hopkins Symptom Checklist-20), anxiety (Hospital Anxiety and Depression Scale – Anxiety subscale), and other psychological, functional, and adherence-related outcomes. To assess the efficacy of the program, we performed an analysis of response profiles regression model, with a categorical effect of time and unstructured covariance matrix.

Results: Ultimately, 290 participants were enrolled, and 260 were randomized. Data collection is complete, and statistical analysis is ongoing. We will present the main findings of the trial, including the impact of Total Health on function, psychological, physical, and health behavior outcomes. We hypothesize that the Total health program will lead to significant increases in function, reductions in depressive and anxiety symptoms, and improvements in other outcomes.

Discussion: The results of this trial will add significantly to the collaborative care literature, which has found collaborative care to be a promising treatment option for individuals with comorbid psychiatric and medical conditions but has received little attention in acute medical settings.

Conclusion/Implications: If effective, the Total Health program has the potential to be implemented in clinical care to improve the recovery of patients hospitalized for acute cardiac events.