Integrating Depression Care in Acute Coronary Syndromes Patients in Low Resource Hospitals in China (I-Care Study)
Aim: to develop, pilot test, implement, and evaluate a nurse-coordinated depression care model integrated into the care of ACS patients with rigorous assessment of feasibility, effectiveness, acceptability and cost in rural China.
Method: This study is a large multi-center, randomized clinical trial among 4,000 ACS patients from 20 rural county hospitals selected from a well-established research network across China. The standard CPACS-3 interventions that are limited to in-patient ACS care (refer to “Usual Care” [UC]), will be implemented in the participating hospitals, and hence will be received by all patients in both intervention (IC) and control (UC) groups; standardized CVD education also will be provided to all participants. After ACS patients are stabilized but before they are discharged, patients will be recruited for the current study. Once patient consent is obtained, baseline assessment and chart review will be performed. Patients subsequently will be randomized into IC or UC group. Patients allocated to the IC group will receive the integrated care (described below) prior to discharge and for 6 months after discharge. Patients randomized to the UC group will receive usual care only. All patients will be followed up at 6 and 12 months after discharge for outcomes evaluation In addition, MACE will be followed up, once a year after 12 months, to the end of the study, i.e the last enrolled patients have completed 12 months follow up.The primary outcome is Changes in mean PHQ-9 score from baseline to 6 and 12 months.
Current status: The patient enrollment ended at the beginning of Jan 2017 with more than 4000 ACS patients having participated in our study. Follow-up is predicted to end by Jan 2018. The protocol paper of I-Care study has been drafted and prepared to be published. Baseline data will be published in the following months.