County Medical Community-based, Cardiovascular Risk Stratified Integrated Care Model: a Pragmatic Cluster Randomised Control Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 2,560
- Locations
- 3
- Primary Endpoint
- 10-year CVD risk score
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 40 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged between 40 and 70 years old;
- •Patients with hypertension or diabetes;
- •Permanent residents of the county where the research is conducted;
- •Already signed up with the family doctor team in the township where the research is located.
Exclusion Criteria
- •Unable to independently carry out the interventions required for the study;
- •Residing far from the village or township health center where the research is located, making it difficult to cooperate with visits;
- •Patients who refuse to participate;
- •Patients with comorbidities such as cancer that may interfere with the study visits or intervention effects;
- •Pregnant or lactating women
Arms & Interventions
Control
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
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.
Intervention: Financial incentives for integration of care (Other)
Intervention
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.
Intervention: Strengthened health education (Behavioral)
Intervention
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.
Intervention: Team-based care (Other)
Intervention
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.
Intervention: Risk-stratified care pathway (Procedure)
Intervention
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.
Intervention: Supporting health information system (Other)
Outcomes
Primary Outcomes
10-year CVD risk score
Time Frame: 12 months
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.
Secondary Outcomes
- CVD incidence rate(12 months)
- systolic blood pressure(12 months)
- total cholesterol(12 months)
- 10-year CVD risk score changes(6 months)
- blood pressure control rate(12 months)
- systolic blood pressure(6 months)
- total cholesterol(12 months)
- fasting blood glucose(12 months)
- CVD incidence rate(12 months)
- cost-effectiveness outcome(12 months)