I-CARE randomized clinical trial integrating depression and acute coronary syndrome care in low-resource hospitals in China: Design and rationale

Depression and acute coronary syndromes (ACS) are both common public health challenges. Patients with ACS often develop depression, which in turn adversely affects prognosis. Low-cost, sustainable, and effective service models that integrate depression care into the management of ACS patients to reduce depression and improve ACS outcomes are critically needed. Integrating Depression Care in ACS patients in Low Resource Hospitals in China (I-CARE) is a multicenter, randomized controlled trial to evaluate the efficacy of an 11-month integrated care (IC) intervention compared to usual care (UC) in management of ACS patients. Four thousand inpatients will be recruited and then randomized in a 1:1 ratio to an IC intervention consisting of nurse-led risk factor management, group-based counseling supplemented by individual problem-solving therapy, and antidepressant medications as needed, or to UC. The primary outcomes are depression symptoms measured by the Patient Health Questionnaire-9 at 6 and 12 months. Secondary endpoints include anxiety measured by the Generalized Anxiety Disorder-7; quality of life measured by the EQ-5D at 6 and 12 months; and major adverse events including the combined end point of all-cause death, suicide attempts, nonfatal myocardial infarction, nonfatal stroke, and all-cause rehospitalization at yearly intervals for a median follow-up of 2 years. Analyses of the cost-effectiveness and cost-utility of IC also will be performed. I-CARE trial will be the largest study to test the effectiveness of an integrated care model on depression and cardiovascular outcomes among ACS patients in resource-limited clinical settings.