P3623Integrating depression and acute coronary syndrome care in low-resource hospitals in china: primary results from the I-Care randomised clinical trial

Abstract

Abstract Background Depression and acute coronary syndromes (ACS) are significant public health challenges. Patients with ACS often experience depression, which 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. Purpose I-CARE study is a multi-center, randomised clinical trial (RCT) to evaluate the efficacy of an 11-month integrated care (IC) intervention compared to usual care (UC) in the management of ACS patients. Methods The I-CARE RCT was conducted between October 2014 and March 2018 in 16 rural Chinese hospitals. A total of 4041 patients with ACS were consecutively enrolled and randomly assigned 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 UC. The primary outcome was change in Patient Health Questionnaire-9 (PHQ-9) scores from baseline to 6 and 12 months. Secondary outcomes included incidence of major adverse events (MAEs) after discharge, quality of life (EQ5D), and adherence to ACS secondary prevention medications. Data analysis used a multilevel mixed-effects model with hospital-level and subject-level random-effect intercepts and hospital-level random slope incorporated to adjust for clustering effect. Primary analyses followed the intent-to-treat principle. Results The mean age of the patients was 61±10 years and 63% were men; however, only 3.3% were classified as depressed based upon a cutoff of ≥10 on the PHQ-9, and 26.9% had PHQ-9 scores between 5 to 9 at the baseline. There were no significant differences in patients' clinical characteristics between IC and UC groups. Changes in PHQ-9 scores from baseline to 6- and 12-months did not differ between treatment groups (−1.47 in IC group vs −1.40 in UC group; adjusted mean difference, −0.04; 95% CI, −0.17 to 0.08 at 6-months; −1.62 in IC group vs −1.54 in UC group; adjusted mean difference, −0.06; 95% CI: −0.19 to 0.06 at 12-months).The risk of MAEs after discharge between IC and UC groups also did not differ significantly (42.1% vs 43.1%; p=0.307). Conclusions Results from the I-CARE trial showed that a nurse-coordinated ACS and depression IC intervention did not reduce depression or improve clinical outcomes among patients with ACS compared to usual care controls. The low prevalence of depression was unexpected and may have minimized the potential added benefits of the IC intervention on depression and clinical outcomes compared to UC. Acknowledgement/Funding This study is supported by a grant from the National Institute of Mental Health (R01MH100332).