Integrating Depression Care in Acute Coronary Syndromes Care in China

Study Overview
=================
Brief Summary
-----------------
The overall goal of this study is to develop, pilot test, implement, and evaluate a nurse-coordinated depression care model integrated into the care of Acute Coronary Syndromes (ACS) patients with rigorous assessment of feasibility, effectiveness, acceptability and cost in rural China. 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.

Official Title
-----------------
Integrating Depression Care in Acute Coronary Syndromes Patients in Low Resource Hospitals in China

Conditions
-----------------
Acute Coronary Syndromes, Depression

Intervention / Treatment
-----------------
* Other: Integrated care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 20 to 79 years old Hospitalized due to a diagnosis of Acute Coronary Syndromes (ACS) ACS is stable (as judged by the treating cardiologist/internist) Signed patient informed consent Exclusion Criteria: Affected by severe cardiovascular disease or medical comorbidity that indicate the patient's life expectancy is less than 12 months (e.g. class IV heart failure, terminal cancer) Seriously disabled (unable to travel to the hospital, class IV heart failure at baseline) Suffering from problems that affect normal communication (e.g., intellectual impairment, observed mental confusion suggesting dementia, deafness, blindness, etc.) Non-permanent local residents or permanent residents planning to move out within 12 months Pregnant or breast-feeding or planning pregnancy within 12 months Affected by bipolar disorder, schizophrenia or severe depression that meet criteria for referral including patients with acutely suicidal risk (Beck Depression Inventory Item9=3) Having alcohol dependence (defined by MINI Alcohol Dependence/Abuse Part)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 79 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care (UC)<br>The standard interventions from Clinical Pathway for Acute Coronary Syndromes in China-Phase 3 (CPACS-3) study 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 cardiovascular disease education also will be provided to all participants.CPACS-3 registration number is NCT01398228 | |
| Experimental: Intervention Care (IC)<br>Besides of the UC, an nurse-coordinated integrated care model for Acute Coronary Syndromes(ACS) and depression will be delivered to intervention group, including ACS secondary prevention therapies at and after discharge, screening and treatment of depression during hospitalization and after discharge. | Other: Integrated care<br>* an integrated care model for ACS and depression delivered by a collaborative team composed of cardiologists/internists and nurses in the same rural county hospital. The collaborative team will be able to provide medical services for the diagnosis and treatment at acute phase of ACS during hospitalization, ACS secondary prevention therapies at and after discharge, and screening and treatment of depression depressive symptom during hospitalization and after discharge. The core of the interventions includes: depressidepressive symptomon screening and classification, individual counseling and medical treatment of depression, group counseling and health education, and follow-up for ACS and depression treatments compliance, IT- system- assisting theassisted management and necessary referral.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in mean Patient Health Questionnaire-9 (PHQ-9) score from baseline to 6 months | Changes in mean Patient Health Questionnaire-9 (PHQ-9) score from baseline to 6 months | Before patient discharge and after 6 months from discharge | 
| Changes in mean PHQ-9 score from baseline to 12 months | Changes in mean Patient Health Questionnaire-9 (PHQ-9) score from baseline to 12 months | Before patient discharge and after 12 months from discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Major Adverse Cardiovascular Events (MACE) | MACE includes all cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and re-hospitalization due to cardiovascular disease. | At least 12 months after discharge | 
| Proportion of patients with self-reported adherence to evidence-based Acute Coronary Syndromes (ACS) secondary prevention treatment at 6 and 12 months | ACS secondary prevention treatment means combination use of aspirin, clopidogrel, statin, Angiotensin-Converting Enzyme Inhibitors/ Angiotensin Receptor Blocker and/or beta-blocker. | At 6 and 12 months after discharge | 
| Quality of life (EQ5D) at 6 and 12 months after discharge |  | At 6 and 12 months after discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Health Services Research, Acute Coronary Syndromes, Depression, Integrated care