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The goal of this cluster randomized trial is to evaluate the effectiveness of the RISIMA model based on an integrated county healthcare consortium implemented by multi-level family health teams (FHTs)on patients with diabetes and/or hypertension, including CVD risk assessment, treatment, and management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | During the study, control participant will be provided with existing essential public health service including quarterly follow-ups and annual physical examination, and be advised to see their usual provider for care, as appropriate. | |
| Intervention | Experimental | Intervention group will receive the risk-stratified integrated CVD management (RISIMA) model consisting of 5 core elements provided as a package: (1) Team-based care; (2) Risk-stratified care pathway; (3) Strengthened health education; (4) Financial incentives for integration of care; (5) Supporting health information system. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Team-based care | Other | The RISIMA model is provided by a family healthcare team composed of one village doctor, one general physician at township health centers and one specialist including cardiologists, neurologists or endocrinologists from county hospital. For villages without village doctor, public health professionals from township health centers would join the service team as the supplement. Within the team, three team members carry the different function. Village doctor is responsible for regular home visits, CVD risk measurement and organizing health education course. GP as the core service provider in the team is responsible for CVD risk monitoring, providing health education course for middle-high risk participants, and generating integrated care plans for each participant. Specialist is responsible for providing guidance particularly for high-risk population management to township and village doctors within the team. |
| Measure | Description | Time Frame |
|---|---|---|
| 10-year CVD risk score | This study intervention is designed to address CVD risk by introducing an integrated care package. Therefore, a validated risk score is required to properly evaluate the effect of interventions. The WHO/ISH score is a tool to estimate the risk of CVD development based on age, sex, BP, total cholesterol, smoking and diabetes. The primary objective of this study is to evaluate whether or not the intervention can substantially lower the risk at 1 year. The primary outcome is the mean difference in WHO/ISH risk score change from baseline to 12 months between the intervention and control townships. The WHO/ISH risk score will be calculated using the lab-based measurements, but if there are missing, a nonlaboratory measurements will be used. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 10-year CVD risk score changes | change in 10-year CVD risk score changes between the intervention and control FDTs at 6 months | 6 months |
| blood pressure control rate | change in blood pressure control rate between the intervention and control FDTs at 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jin Prof. Xu, PhD | Contact | 0086-82805701 | xujin@hsc.pku.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shaxian County General Hospital | Recruiting | Sanming | Fujian | China |
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The follow-up data collection, data entry, and data quality checks will be conducted by researchers unaware of the group assignments. The analysis of results will also be performed by statisticians unaware of the allocation.
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| Risk-stratified care pathway | Procedure | Based on WHO/ISH score, baseline population will be divided into three groups-low risk (10-year CVD risk: <10%), middle risk (10-year CVD risk: 10%~20%) and high risk (10-year risk: >20%). With the support from experts and health care professionals, study had developed a risk-stratified care pathway on the basis of clinical guidance. According to the pathway, participants at different risk tertile are provided with differentiated management plan especially in terms of health education, follow-up frequency and treatment plan. |
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| Strengthened health education | Behavioral | The education comprised 8 monthly sessions developed by GP and village doctors. At the 4th month, individual health counseling by village doctors will be done to encourage the imitation and maintenance of self-management behaviors, and to identify any potential problems in the program. It took half an hour per each participant. At the 8th month, self-management evaluation will be done to assess personal self-management ability. High risk participants are required to take the education course, and middle risk participants are only encouraging to take. All participants would receive the education messages twice a month, which introduce tips about the management of hypertension, diabetes and CVD risk factors. |
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| Financial incentives for integration of care | Other | Specialists receive reimbursement for case discussion and high risk population management; GP receive reimbursement for providing education program and risk monitoring; Village doctor receive reimbursement for assisting education program, risk measurement and home visits. And overall services quality will be measured, and taken into account for annual performance evaluation. |
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| Supporting health information system | Other | A dynamic patient risk monitoring information system is established for simplifying the risk data collection and entry for village doctors, meanwhile, GP and specialist can receive the updates of risk scores simultaneously. Apart from the function of risk monitoring, this system also incorporates the e-records of home visits, health education attendance as well as medical records including outpatient visits and hospitalizations. The upgraded information systems not only can support the healthcare professionals with comprehensive and real-time data, but also provide the performance evaluation data for policymakers. |
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| 12 months |
| systolic blood pressure | change in SBP between the intervention and control FHTs at 12 months | 12 months |
| systolic blood pressure | change in SBP between the intervention and control FHTs at 6 months | 6 months |
| total cholesterol | change in total cholesterol between the intervention and control FHTs at 12 months. | 12 months |
| fasting blood glucose | change in fasting blood glucose between the intervention and control FDTs at 12 months | 12 months |
| CVD incidence rate | difference of incidence rate of major adverse cardiovascular events (including acute myocardial infarction, stroke, angina, and sudden cardiac death) between the intervention and control FDTs at 12 months | 12 months |
| cost-effectiveness outcome | a health economic evaluation to assess the cost-effectiveness of the intervention compared with usual care at 12 months | 12 months |
| Luzhai County People's hospital | Recruiting | Liuzhou | Guangxi | China |
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| Luzhai County Traditional Medicine hospital | Recruiting | Liuzhou | China |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D003924 | Diabetes Mellitus, Type 2 |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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