Recruiting NCT06302127
County Medical Community-based, Cardiovascular Risk Stratified Integrated Care Model: a Pragmatic Cluster Randomised Control Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Team-based care, Risk-stratified care pathway, Strengthened health education, Financial incentives for integration of care.
- Who it may be relevant to
- Registry conditions: Hypertension, Diabetes Mellitus Type 2, Cardiovascular Diseases. Basic parameters: 40 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other 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, C - Procedure 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, - Behavioral 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, an - Other 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. - Other 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 healthcar
Primary outcome measures
- 10-year CVD risk score [Time frame: 12 months]
Secondary outcome measures (8)
- 10-year CVD risk score changes [Time frame: 6 months]
- blood pressure control rate [Time frame: 12 months]
- systolic blood pressure [Time frame: 12 months]
- systolic blood pressure [Time frame: 6 months]
- total cholesterol [Time frame: 12 months]
- fasting blood glucose [Time frame: 12 months]
- CVD incidence rate [Time frame: 12 months]
- cost-effectiveness outcome [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
China · 3 centers
- Shaxian County General Hospital — Sanming
- Luzhai County People's hospital — Liuzhou
- Luzhai County Traditional Medicine hospital — Liuzhou
Identifiers
NCT: NCT06302127 · CCHDS