County Medical Community-based, Cardiovascular Risk Stratified Integrated Care Model: a Pragmatic Cluster Randomised Control Trial
NCT ID: NCT06302127
Last Updated: 2025-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
2560 participants
INTERVENTIONAL
2024-05-20
2025-12-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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.
No interventions assigned to this group
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.
Strengthened health education
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.
Financial incentives for integration of care
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.
Supporting health information system
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.
Team-based care
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.
Risk-stratified care pathway
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.
Interventions
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Strengthened health education
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.
Financial incentives for integration of care
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.
Supporting health information system
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.
Team-based care
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.
Risk-stratified care pathway
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.
Eligibility Criteria
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Inclusion Criteria
2. Patients with hypertension or diabetes;
3. Permanent residents of the county where the research is conducted;
4. Already signed up with the family doctor team in the township where the research is located.
Exclusion Criteria
2. Residing far from the village or township health center where the research is located, making it difficult to cooperate with visits;
3. Patients who refuse to participate;
4. Patients with comorbidities such as cancer that may interfere with the study visits or intervention effects;
5. Pregnant or lactating women
40 Years
70 Years
ALL
No
Sponsors
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Peking University
OTHER
Responsible Party
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Locations
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Shaxian County General Hospital
Sanming, Fujian, China
Luzhai County People's hospital
Liuzhou, Guangxi, China
Luzhai County Traditional Medicine hospital
Liuzhou, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CCHDS
Identifier Type: -
Identifier Source: org_study_id
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